Welcome to the 22 Annual Statewide Geriatric Medicine ... Syllabus.pdf · Physicians should claim...

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Welcome to the 22 dt Annual Statewide Geriatric Medicine Conference: Improving the Health of Our Elders: Topics in Geriatric Medicine This is your course syllabus, which you are required to bring to all sessions. Please remember to sign in at the registration desk each day, as well as at the Saturday Workshops. Registration envelope includes: Participant and any additional paid guest badges MUST BE WORN TO ALL FUNCTIONS/MEALS Additional Dinner tickets for Saturday night (if paid separately)

Transcript of Welcome to the 22 Annual Statewide Geriatric Medicine ... Syllabus.pdf · Physicians should claim...

Page 1: Welcome to the 22 Annual Statewide Geriatric Medicine ... Syllabus.pdf · Physicians should claim only credit commensurate with the extent of their participation in the activity.

Welcome to the

22dt Annual Statewide Geriatric Medicine

Conference: Improving the Health of Our Elders:

Topics in Geriatric Medicine

This is your course syllabus, which you are required to bring to all sessions.

Please remember to sign in at the registration desk each day, as well as at the

Saturday Workshops.

Registration envelope includes:

� Participant and any additional paid guest badges

� MUST BE WORN TO ALL FUNCTIONS/MEALS

� Additional Dinner tickets for Saturday night (if paid separately)

Page 2: Welcome to the 22 Annual Statewide Geriatric Medicine ... Syllabus.pdf · Physicians should claim only credit commensurate with the extent of their participation in the activity.

This program is

Sponsored by:

The Consortium of Ohio Geriatric Academic Programs:

The Offices of Geriatric Medicine/Gerontology at:

Case Western Reserve University, School of Medicine

Northeast Ohio Medical University

The Ohio State University, College of Medicine

Ohio University Heritage College of Osteopathic Medicine

University of Cincinnati, College of Medicine

The University of Toledo, College of Medicine and Life Sciences

Wright State University, Boonshoft School of Medicine

Supported by: Ohio Geriatrics Society

Office of Continuing Medical Education at the Ohio University College of

Osteopathic Medicine (OU-COM)

and the Western Reserve Geriatric Education Center (WRGEC)

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ACKNOWLEDGEMENT

Please be sure to visit our exhibitor booths:

Central Ohio Geriatrics, LLC.

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ACCREDITATIONSThe University of Toledo is accredited by the Accreditation Council for Continuing Medical

Education (ACCME) to provide continuing medical education for physicians. The University of Toledo designates this live activity for a maximum of 12 AMA PRA Category 1

Credits™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

This Live activity, 22nd Annual Statewide Geriatric Medicine: Improving the Health of Our Elders, with a beginning date of October 14, 2011, has been reviewed and is acceptable for up to 12.00

Prescribed credits by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Ohio University College of Medicine is approved by the American Osteopathic Association as an accredited continuing medical education provider. This program anticipates being approved for

12 AOA Category 2-A credits.

CREDITPlease remember to sign in at the registration desk each day, as well as at the Saturday workshops, as

this will confirm actual credits to be awarded.

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EVALUATIONEvaluation is an important component of continuing education programs. In addition to providing

feedback to the program planners and faculty, it provides information to improve future programs.

Please consider evaluation of this symposium an integral part of your participation in this meeting.

There will be only one overall evaluation for the program, which should be completed and returned

as you depart on Saturday. It may be found in the front of this syllabus on the blue paper. An

evaluation must be completed in order to obtain CME credit.

TO OBTAIN YOUR CME CREDITPlease complete the Overall Evaluation form and turn in to the front registration desk at the end of

Saturday’s program. Please be aware if you do not complete an evaluation form, you will not be

able to print your certificate as directed below.

CME Certificates will be available for, paid participants, to print on

Monday, October 24, 2011 � Go to website cme.utoledo.edu.

� Go to Upcoming Events

� Choose Credit Transcripts (which will take you to the login stage)

� Login: last name and first name (no commas, no spaces)

� Password: zip code (unless you have changed in our system previously)

� Then, look for the Statewide Geriatric Medicine` program and you should see a “certificate icon”

� Click on the icon and print the certificate

Page 6: Welcome to the 22 Annual Statewide Geriatric Medicine ... Syllabus.pdf · Physicians should claim only credit commensurate with the extent of their participation in the activity.

FACULTY

Orson J. Austin, MD, Associate Professor, Family Medicine University of Cincinnati, College of Medicine

Robert L. Brandt, Jr., MD, FAAFP, AAHIVS, Clinical Professor, Department of Family Practice, Wright State University, Boonshoft School of Medicine

Peter A. DeGolia, MD, CMD, Director, Center for Geriatric Medicine, University Hospitals, Case Western Reserve University, School of Medicine

Ronan Factora, MD, FACP, Assistant Professor, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, School of Medicine; Staff, Center for Geriatric Medicine of the Medicine Institute, Cleveland Clinic

Jen-Tzer Gau, MD, PhD Associate Professor, Geriatric Medicine/Gerontology, Ohio University Heritage College of Osteopathic Medicine

Golara Honari, MD, Dermatologist, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, School of Medicine

Sarah Jonaus, MD, Assistant Professor, General Internal Medicine, The Ohio State University

Robin L. P. Jump, MD, PhD, Senior Clinical Instructor, Division of Infectious Diseases and HIV Medicine, Louis Stokes Cleveland VA Medical Center, Case Western Reserve University, School of Medicine

Brendan Kelley, MD, Assistant Professor, Director of Memory Disorders Clinic, University of Cincinnati, College of Medicine

John R. Kues, PhD, Assistant Senior VP for Continuous Professional Development, University of Cincinnati, College of Medicine

Larry Lawhorne, MD, Professor and Chair, Department of Geriatrics, Wright State University, Boonshoft School of Medicine

Donald O Mack, MD, FAAFP, CMD, ClinicalAssistant Professor, Department of Family Medicine, The Ohio State University, College of Medicine

John F. McGreevey, Jr., MD, Medical Director, Hospice of Northwest Ohio

A John McSweeny, JD, PhD, Professor Emeritus of Psychiatry and Neurology, The University of Toledo, College of Medicine and Life Sciences

Barbara J. Messinger-Rapport, MD, PhD, FACP, CMD, Associate Professor, Director Center for Geriatric Medicine, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, School of Medicine

Arvind Modawal, MD, MPH, AGSF, FAAFP, Professor, Family and Community Medicine, Section of Geriatrics and Palliative Medicine, University of Cincinnati, College of Medicine

Alina Rais, MD, Associate Professor, Department of Psychiatry, The University of Toledo, College of Medicine and Life Sciences

David W. Regule, MD, PT, MS, Clinical Assistant Professor of Internal Medicine, Northeast Ohio Medical University, Rheumatologist and Faculty, Internal Medicine, St Elizabeth Health Center

Jeffrey D. Schlaudecker, MD, Assistant Professor, Family and Community Medicine, University of Cincinnati, College of Medicine

Ramon V. Tiu, MD, Assistant Professor of Molecular Medicine, Department of Translational Hematology and Oncology Research, Taussig Cancer Institute, Cleveland Clinic, Lerner College of Medicine, Case Western Reserve University, School of Medicine

Brian J. Weiss, DPM, Clinical Faculty, Ohio College of Podiatric Medicine

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MODERATORS

Allison J. Batchelor, MD, CMD Associate Professor, Geriatric Medicine and Gerontology

Ohio University Heritage College of Osteopathic Medicine

Cynthia Olsen, MD, FAAFP, CMD Acting Chair, Department of Family Medicine

Wright State University, Boonshoft School of Medicine

Donald O. Mack, MD, FAAFP, CMD Clinical Assistant Professor, Department of Family Medicine

The Ohio State University, College of Medicine

Victoria Steiner, PhD Assistant Professor, Department of Public Health and Preventive Medicine

Assistant Director, Center for Successful Aging The University of Toledo College of Medicine and Life Sciences

PLANNING COMMITTEE MEMBERSVictoria Steiner, Ph.D., The University of Toledo, College of Medicine and Life Sciences

Sandra Buty, Ohio State University, College of Medicine Jen-Tzer Gau, M.D. Ohio University Heritage College of Osteopathic Medicine

Cletus Iwuagwu, M.D., The University of Toledo, College of Medicine and Life Sciences Larry W. Lawhorne, M.D., Wright State University, Boonshoft School of Medicine

Linda Mauger, The Ohio State University, College of Medicine Barbara Messinger-Rapport, M.D., Ph.D., Cleveland Clinic

Deborah Meyer, Ph.D., RN, Ohio University Heritage College of Osteopathic Medicine Cynthia Olsen, M.D., FAAFP, CMD, Wright State University, Boonshoft School of Medicine

Elizabeth O’Toole, M.D., Case Western Reserve University, School of Medicine Barbara Palmisano, M.A., R.N., Northeast Ohio Medical University

Kelly Randall, Wright State University, Boonshoft School of Medicine Becky Roberts, The University of Toledo, College of Medicine and Life Sciences

Margaret B. Sanders, M.A., LSW, Northeast Ohio Medical University Gregg Warshaw, M.D., University of Cincinnati, College of Medicine

Madelon Watts, B.A., Case Western Reserve University School of Medicine

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DISCLOSURES

Faculty Disclosures

Dr. Brandt discloses he is a consultant for Gilead Sciences and Merck. Is on the Speaker’s Bureau for Gilead Sciences. Is a stock shareholder Gilead Sciences, Merck and Johnson & Johnson.

Dr. Factora discloses he is on the Speaker’s Bureau and a stock shareholder for Pfizer.

Dr Jump discloses she is a consultant for GOJO and Pfizer.

Dr. Modawal discloses he is on the Speaker’s Bureau for Merck.

Dr. Tiu discloses he is on the Speaker’s Bureau for Alesion pharmaceuticals and Novartis. Is a consultant for Allos Therapeutics, Incyte, and Alexion. He receives grant/research support for Aplastic Anemia MDs and International Foundation.

Drs. Austin, DeGolia, Gau, Honari, Jonaus, Kelley, Kues, Lawhorne, Mack, McGreevey, McSweeny6, Rais, Regule, Schlaudecker, and Weiss have no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

Moderator DisclosuresDrs. Batchelor, Olsen, Mack and Steiner have no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

Planning Committee Disclosures

No other Planning Committee member has any financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Agenda Friday Evening, October 14, 2011 Improving the Health of out Elders: Topics in Geriatric Medicine

6:00-6:45pm Conference Registration and Wine Hors d’oeuvres Reception (for paid families and participants only (2nd level)

6:45-7:00 pm Welcome and Introduction, Victoria Steiner, PhD

7:00-8:30 pm Symposium I: Understanding Restoration & Maintenance in Elders (2nd level ballroom) Moderator: Victoria Steiner, PhD

7:00-7:30 pm FrailtyDonald O. Mack, MD, FAAFP, CMD

7:30-8:00 pm An Exercise Prescription for Elders: Does It Matter?Ronan Factora, MD, FACP

8:00-8:30 pm Updates in Geriatric Diabetes Sarah Jonaus, MD

8:30-9:00 pm Discussion and Questions

9:00 pm Adjournment Saturday Morning, October 15, 2011

7:15 am Breakfast for paid families and participants only (4th level)

7:30 am Registration (2nd level)

8:00-10:00 am Symposium II: Updates on Medical Issues (2nd level Ballroom) Moderator: Cynthia Olsen, MD. FAAFP, CMD

8:00-8:30 am Prostate Disease in Elderly Men Orson J. Austin, MD

8:30-9:00 am Urinary Infections in the Elderly: What Has Changed?Jen-Tzer Gau, MD, PhD

9:00-9:30 am Clinical Considerations in Aging Adults with HIV Robert L. Brandt, Jr, MD

9:30-10:00 am Discussion and Questions

10:00-10:30 am Break

10:30-12:30 pm Symposium III: Management Issues for Better Patient Care (2nd level Ballroom) Moderator: Donald Mack, MD

10:30-11:00 am Post-Operative Management in the Elderly Arvind Modawal, MD, MPH, GSF, FAAFP

11:00-11:30 am Clinical Pearls in Management of Fracture Risk in Your Patients David W. Regule, MD, PT, MS

11:30-12:00 pm Myeloproliferative Neoplasms: Approach to Diagnosis and Treatment Ramon V. Tiu, MD

12:00-12:30 pm Discussion & Questions

12:30 pm General Luncheon Buffet for paid families and participants only (4th level) Or Annual Meeting of the Ohio Geriatrics Society and Buffet (3rd level Morgan Room)

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Saturday Late Afternoon, October 15, 2011 3:30-6:25 pm Workshops (2nd level sign in) see goldenrod paper in front pocket for each workshop location

Saturday Workshop Discussion Seminars

Workshops

A. Learning to Communicate: Bad News and Beyond John F. McGreevey, Jr, MD

3:30-4:25 pm A

B. Driving and the Older Adult: Talking About the Keys to the Car Barbara Messinger-Rapport, MD, PhD, FACP, CMD

3:30-4:25 pm B, D, F, G

C. Going Beyond Welcome to Medicare! Peter A. DeGolia, MD, CMD

4:30-5:25 pm B, C, D, E

D. Foot Exam and Common Problems & Remedies for the Elderly Brian J. Weiss, DPM

5:30-6:25 pm C, F, E, G

E. Name That Lesion Golara Honari, MD

F. How To Set Up A QI Project In Your Practice That Is Meaningful John R. Kues, PhD, CCMEP

G. No-monia and No-uria: Practical Recommendations for Using Fewer Antibiotics Robin L. P. Jump, MD, PhD

Saturday Evening, October 15, 2011

7:00 pm Dinner Banquet for paid families and participants only (4th level)

8:30pm BonFire Sunday Morning, October 16, 2011

7:15 am Breakfast for paid families and participants only (4th level)

7:45 am Registration/sign-in (2nd level)

8:00-9:15 am Symposium IV: Special Issues for Geriatricians (2nd level Ballroom) Moderator: Allison J. Batchelor, MD, CMD

8:00-8:30am Travel Medicine for Seniors Jeffrey D. Schlaudecker, MD

8:30-9:00am No Risks! Know Risks! Larry Lawhorne, MD

9:00-9:15am Discussion & Questions

9:15-9:30am Break

9:30-11:30 am Symposium V: Mental Health Concerns in Older Patients (2nd level Ballroom) Moderator: Allison J. Batchelor, MD, CMD

9:30-10:00 am Anxiety Spectrum Disorders in the Elderly Alina Rais, MD

10:00-10:30 am Dementia Overview Brendan Kelley, MD

10:30-11:00 am Determining Decision Making Capacity: Who Wants Ice Cream? A John McSweeny, JD PhD

11:00-11:30 am Discussion & Questions

11:30 a.m. Adjournment

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Friday October 14, 2011

6:00-6:45pm Conference Registration and Reception (2nd level)

6:45-7:00 pm Welcome and Introduction, Victoria Steiner, PhD

7:00-9:00 pm Symposium I: Understanding Restoration & Maintenance In Elders Moderator: Victoria Steiner, PhD

7:00-7:30 pm Frailty Donald O. Mack, MD, FAAFP, CMD

7:30-8:00 pm An Exercise Prescription for Elders: Does It Matter? Ronan Factora, MD, FACP

8:00-8:30 pm Update on Geriatric Diabetes Sarah Jonaus, MD

8:30-9:00 pm Discussion and Questions

9:00 pm Adjournment

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Symposium I

Updates

Moderator:

Victoria Steiner, Ph.D. Assistant Professor, Department of Public Health and

Preventive Medicine Assistant Director, Center for Successful Aging

The University of Toledo College of Medicine and Life Sciences

Moderator Disclosure:

Dr. Steiner has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Frailty

Donald O. Mack, MD, FAAFP, CMD

Learning Objective:

Define Frailty and review the components and interventions.

Speaker Disclosure:

Dr. Mack has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Donald Mack, MD, FAAFP, CMDAssistant Professor-ClinicalOhio State University, Family Medicine

1. Definitions of Frailty

2 Components of Frailty2. Components of Frailty

3. Interventions for Frailty

As a geriatric provider, you are asked by your friend, an orthopedic surgeon, which patient is likely to do better with a Total Knee Replacement surgery?

Ms. Scarlet, 72 y/o with controlled DM 2, HTN, and Hyperlipidemia, or

Ms. Gray, 72 y/o with CAD, HTN, and Osteoporosis.

You note that they are of the same age and similar co-morbidities.

You ask for more history to assess Frailty.

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DefinitionA geriatric syndrome characterized by increased vulnerability due to loss of reserves and resilience.

More detailed definitionA i t i d h t i d b i d l bilitA geriatric syndrome characterized by increased vulnerabilitydue to an accumulation of unrelated morbidities, that together increase the risk of mortality.

A geriatric syndrome characterized by increased vulnerabilitydue to homeostenosis or dysregulation of multiple physiological processes, which together increase the risk of mortality.

Pacala JT, Sullivan GM, eds. Geriatrics Review Syllabus: A Core Curriculum in Geriatric Medicine. 7th ed. New York: American Geriatrics Society; 2010.

Sarcopenia—the age associated loss of skeletal mass and function. Skeletal Muscle increases with growth & sex hormones, and physical

activity. It decreases with decreased physical activity, increased catabolic cytokines, and poor nutrition

Other hormonesIncreased Cortisol and decreased Vitamin D

Chronic InflammationElevated Interleukin 6, CRP, Neutrophils/Macrophages

Multisystem Effects that are synergistic

Sarcopenia: An Undiagnosed Condition in Older Adults. J Am Med Dir Assoc 2011; 12:249-256. International Sarcopenia Consensus Conference Working Group Meeting, Rome, Italy, November 18, 2009.

In 2001, Linda Fried, MD, MPH, from Columbia University, defined the “Frailty Phenotype”, and demonstrated that it predicted adverse outcomes of falls, disability, hospitalization, and mortality over 3 and 7 year follow up periods.

Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146–M156.

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• Weight Loss • >10 pounds unintentionally in the last year

• Exhaustion • Self reported 3 or more days in the last week• “I felt like everything I did was an effort”• “I felt like I couldn’t get going”

• Slowness• Speed to walk 15 feet

• Low Activity Level• Unable to do moderate exercise, or household chores

• Weakness• Measured by grip strength with a hand dynamometer

Rockwood Model• Nutrition• Mobility and Balance• ADL’s (bathing, dressing, feeding, transfers, toileting, and ambulation)• IADL’s (driving, shopping, finances, cooking, etc.)• Cognition and Mood• Other co-morbidities

Steverink-Sheets Model• Mobility• Physical fitnessPhysical fitness• Nourishment• Morbidity• Cognition

Puts Model• Lowest Quintile Peak Expiratory Flow• Mini-Mental State Exam• Incontinence• Depression• Anemia• Renal Function

The “Crystal” StudyA Prospective Cohort Study of community dwelling

individuals aged 65 and older in Kolpino district of St. Petersburg, Russia, found a 21.1% incidence of Frailty using the Fried criteria.

The Survey of Health, Aging and Retirement in EuropeThe Survey of Health, Aging and Retirement in EuropeRevealed regional differences in the prevalence of frailty in

community dwelling people aged 65 and older using the Fried criteria.

Spain 27.3% Italy 23.0%Sweden 8.6% Switzerland 5.8%

Gurina NA, Frolova EV, and Degryse JM. A Roadmap of Aging in Russia: The Prevalence of Frailty in Community-Dwelling Older Adults in the St. Petersburg District—The “Crystal” Study. J Am Geriatr Soc 59:980-988, 2011.

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Your orthopedic friend relates that both patients move slowly during his exam, and also the following details:

Ms. Scarlet lives independently, still enjoys gardening, and reports her weight has been stable over the last yearyear.

Ms. Gray lives independently, has lost weight in the last year, and at times doesn’t use her walker as “it is just too heavy to move.”

Your friend asks you to guess which patient is now living at home with home health, and which one is living in a nursing home?

You correctly identify Ms Scarlet as havingYou correctly identify Ms. Scarlet as havingonly one component of frailty (slowness), and Ms. Gray as having three components (slowness, weight loss, and weakness), which is consistent with being Frail.

Exercise InterventionImproves muscle strength, aerobic capacity,

balance, mobility, ADL performance, and independent livingp g

Decreases falls and disabilityImproved perceived quality of life without

increased painImproved emotional health

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Tai ChiA dynamic balance exercise, first published in the literature in 1996,

showed improvement in decreasing frailty.

Resistance trainingStudies show it increases muscle mass into the 90’s

Aerobic ExerciseStudies show increased muscle mass compared to sedentary

counterparts, in contrast to studies in athletes that promote primarily anaerobic exercises.

Liu CK, Fielding RA. Exercise as an Intervention for Frailty. Clin Geriatr Med 27 (2011) 101–110Serra-Rexach JA, et al. Short-Term, Light- to Moderate-Intensity Exercise Training Improves Leg Muscle Strength in the Oldest Old: A Randomized Controlled Trial. J Am Geriatr Soc 59:594-602, 2011.

Hormonal InterventionTestosterone—Studies show increased muscle mass, strength, and

sexual function, but with an increased risk of CHF and rates of Prostate Cancer. Currently only recommended if documented deficiency.

Dehydroepiandrosterone (DHEA)—Studies have not shown clear benefit in men or women.

Vitamin D—has shown decreased falls/fractures, but has not shown an impact on frailty.

Growth Hormone—Studies are inconclusive at this time.

Anti-inflammatory InterventionSome preliminary studies using anti-rheumatoid medications have

been published, but still not proven to be beneficial in Frailty.

Comprehensive Geriatric Assessment

Interdisciplinary and Consultative—Geriatrician, Nurse, PT, and Social Worker

E l ti f di l h i l d f ti lEvaluation of medical, psychosocial, and functionalcapabilities and limitations

Most effective if coupled with a Primary Care Provider who has knowledge of social supports, history of chronic health problems, viewpoint of level of care, and ability to motivate change.

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Think like a geriatrician. . .Clarify Patient Goals and MotivationEvaluate Medications—Avoid Polypharmacy and

Medications that are not recommended in geriatric patients (next slide)

Maximize Chronic Disease ManagementMaximize Chronic Disease ManagementAssess for Weight Loss/Possible Interventions

Delivered meals, Assisted Living, SupplementsCognitive evaluation—Consider meds/social supportTreat Inactivity—

Evaluate etiology—Depression, End stage OA, etc.Consider PT referral or an Exercise Program

Benzodiazepines—associated with increased risk of fallsAnticholinergics—Benadryl, Tricyclic Antidepressants, Urinary or

GI Antispasmodics (Ditropan, Detrol, Bentyl, Levsin), and Muscle Relaxants

Barbiturates—Fiorinal (butalbital)Stimulants—Amphetamine and Methylphenidate

Use with caution and reassessAntipsychoticsAnti-inflammatories

Frailty as a terminal signHospice Criteria are similar and include the following:

Weight Loss, Low Albumin, Low CholesterolLoss of ADL’s (bathing, dressing, feeding, transfers, toileting,

and ambulation)Increased sleepDementia

Case Example 78 y/o metastatic breast cancer presents with 22Case Example—78 y/o metastatic breast cancer presents with 22pound weight loss, increased weakness, loss of appetite, and refuses cancer treatment.

Discuss End of Life Care

Consider Hospice Consult

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An Exercise Prescription for Elders: Does It Matter?

Ronan Factora, MD, FACP

Learning Objectives:

Counsel patients on the benefits of specific exercises to mind and body.

Speaker Disclosure:

Dr. Factora discloses he is on the Speaker’s Bureau and is a stock shareholder for Pfizer.

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FactoraSalt Fork 2011

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An Exercise Prescription for Elders: Does It Matter? 22nd Annual Geriatric Medicine Conference, 2011 Salt Fork Resort and Conference Center Cambridge Ohio

Ronan Factora, MD, FACP Center for Geriatric Medicine Medicine Institute Cleveland Clinic Cleveland, OH

Exercise Types and evidence for their benefits:

Balance training - Tai chi – 15 week program: reduces risk of falls by improving balance

Resistance training - What constitutes resistance training:

o American Heart Association: � 8 to 10 different exercises, with a minimum of one exercise per major

muscle group: chest press, shoulder press, triceps extension, biceps curl, pull-down (upper back), lower-back extension, abdominal crunch/curl-up, quadriceps extension or leg press, leg curls (hamstrings), calf raise

� 8 to 12 reps per exercise for age <50 years, and 10 to 15 repetitions for age 50 to 60 years

o American Geriatrics Society � maximum repetition: maximum weight at which a particular exercise

can be done only once (1 RM) � low intensity: 40% of 1 RM, performed 10-15 times � medium intensity 40% to 60% of 1 RM, 8-10 repetitions � high intensity: >60% of 1 RM, 6-8 repetitions

- Resistance training increases muscle mass and quality - Resistance training , combined with aerobic exercise, may lead to loss of body fat

while body weight is preserved.- Resistance training improves walking endurance, walking speed, and dynamic

balance, and reduces falls in men and women.

Endurance training - The purpose of endurance training is to improve aerobic capacity, reduce associated

risk factors for cardiovascular disease, and promote cognitive health.- Function improves if endurance exercises are coupled with resistance training - Function improves most in the frailest people, while smaller improvements were

noted in the more functionally intact, healthy older people

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FactoraSalt Fork 2011

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Benefits of Exercise: Many of these benefits are well studied and recognised, but is worthwhile to emphasize them.: - Exercise protects your brain:

o Increased physical activity associated with reduced risk of dementia. o Exercising 3 or more times a week at an intensity greater than walking was

associated with a lower risk of developing Alzheimer disease in 5 years when compared with no exercise

- Exercise can maintain your function: o Improvements in balance and performance of ADLs have been seen in

women participating in exercise programs o People who are physically active are more likely to die without a disability

than are sedentary people. - Exercise reduces your risk of dying:

o There is direct dose related correlation with intensity of participation in physical activity and mortality reduction

- It is never too late to start exercise o Even when started later in life, physical activity can improve mortality o Regardless of current level of function, participation in exercise to help

preserve their current functional status - Benefits of exercise are durable:

o Participation in structured physical activities may continue to provide benefits for up to 2 years after such activities have ceased..

Guidelines for Exercise in Elders

Centers for Disease Control and Prevention: Adults need at least:

2 hours and 30 minutes (150 minutes) of moderate-intensity aerobic activity (i.e., brisk walking) every week and muscle-strengthening activities on 2 or more days a week that work all major muscle groups (legs, hips, back, abdomen, chest, shoulders, and arms).

- OR - 1 hour and 15 minutes (75 minutes) of vigorous-intensity aerobic activity (i.e., jogging or running) every week and muscle-strengthening activities on 2 or more days a week that work all major muscle groups (legs, hips, back, abdomen, chest, shoulders, and arms).

- OR - An equivalent mix of moderate- and vigorous-intensity aerobic activity and muscle-strengthening activities on 2 or more days a week that work all major muscle groups

(legs, hips, back, abdomen, chest, shoulders, and arms). http://www.cdc.gov/physicalactivity/everyone/guidelines/adults.html

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FactoraSalt Fork 2011

- 3 -

World Health Organization: In order to improve cardiorespiratory and muscular fitness, bone and functional health, reduce the risk of NCDs, depression and cognitive decline: - Older adults should do at least 150 minutes of moderate-intensity aerobic physical

activity throughout the week or do at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.

- Aerobic activity should be performed in bouts of at least 10 minutes duration. - For additional health benefits, older adults should increase their moderate-intensity

aerobic physical activity to 300 minutes per week, or engage in 150 minutes of vigorous-intensity aerobic physical activity per week, or an equivalent combination of moderate-and vigorous-intensity activity.

- Older adults, with poor mobility, should perform physical activity to enhance balance and prevent falls on 3 or more days per week.

- Muscle-strengthening activities, involving major muscle groups, should be done on 2 or more days a week.

- When older adults cannot do the recommended amounts of physical activity due to health conditions, they should be as physically active as their abilities and conditions allow.

http://www.who.int/dietphysicalactivity/factsheet_olderadults/en/index.html

Barriers to Exercise (from Nied 2002):Self-efficacy: Begin slowly with exercises that are easily accomplished; advance gradually; provide frequent encouragement. Attitude: Promote positive personal benefits of exercise; identify enjoyable activities. Discomfort: Vary intensity and range of exercise; employ crosstraining; start slowly; avoid overdoing. Disability: Specialized exercises; consider personal trainer or physical therapist. Poor balance/ataxia: Assistive devices can increase safety as well as increase exercise intensity. Fear of injury: Balance and strength training initially; use of appropriate clothing,, equipment, and supervision; start slowly. Habit: Incorporate into daily routine; repeat encouragement; promote active lifestyle (Examples of an active lifestyle include using a golf pull cart while golfing, using a push mower, participating in activities such as stand and cast fishing or gardening, and taking the stairs)Subjective norms: Identify and recruit influential others; education of patient and influential family/friends. Fixed income: Walking and other simple exercises; use of household items; promote active lifestyle. Environmental factors (e.g., inclement weather): Walk in the mall; use senior centers; promote active lifestyle. Cognitive decline: Incorporate into daily routine; keep exercises simple. Illness/fatigue: Use a range of exercises/intensities that patients can match to their varying energy level.

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FactoraSalt Fork 2011

- 4 -

Tips on Promoting Exercise - Teach patients that all movement counts. - Use terms such as “becoming physically active” instead of “exercise” and “staying

fit” - Ask the patient how they can start being active - Personalize exercise benefits: tell each individual specifically how they would benefit

from exercise - Encourage fun – link exercise to leisure activities

Recommended Reading: - Nied RJ, Franklin B. Promoting and Prescribing Exercise for the Elderly. Am Fam

Physician. 2002 Feb 1;65(3):419-427 - Nelson ME, Rejeski WJ, Blair SN, et al. Physical activity and public health in older

adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116:1094-1105.

- American Geriatrics Society Panel on Exercise and Osteoarthritis. Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations: a supplement to the AGS clinical practice guidelines on the management of chronic pain in older adults. J Am Geriatr Soc. 2001;49:808-823.

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Update on Geriatric Diabetes

Sarah Jonaus, MD

Learning Objectives:

Recognize the importance of individualized management of diabetes in the elderly.

Speaker Disclosure:

Dr. Jonaus has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Updates�in�Geriatric�Diabetes

Sarah�Jonaus�MD

The�Ohio�State�University

Defining�the�“Geriatric”�patient

• Traditionally,�we�have�considered�patients�65�and�older�to�be�geriatric.– At�least�20%�over�65�have�diabetes

• Due to the acceleration of the aging process• Due�to�the�acceleration�of�the�aging�process,�middle�aged�patients�may�need�to�be�included�in�this�category.

How�is�the�geriatric�patient�different?

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How�is�the�geriatric�patient�different?

• There�is�a�tremendous�amount�of�clinical�and�functional�heterogeneity�within�the�population.

• Life expectancy is often longer than providers• Life�expectancy�is�often�longer�than�providers�realize.

• There�are�few�geriatric�studies.

How�is�the�geriatric�patient�different?

• Assessment:– Functional

• Quality�of�life�issues�with�testing�and�treating• Barriers�to�appropriate�care

– Example:�nail�care�in�a�patient�with�immobility• Home hazard assessmentHome�hazard�assessment• Depression

– Therapy,�medications• Dementia

– Supervision�of�medication�use�and�exercise• Urinary�incontinence

– Kegel exercises– Weight�loss– Improve�mobility– Biofeedback�

How�is�the�geriatric�patient�different?

Exercise

• Benefits– ��insulin�sensitivity

– ��glucose�uptake

– ��cardiac�risk�factors

• Risks– ��blood�glucose

• Cardiac�risks

– neuropathic�changes�in�th f t– ��mobility

– ��weight

– ��sense�of�well�being

the�feet

– falls

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How�is�the�geriatric�patient�different?Exercise

• Start�slowly

• Consider�supervision

• Make�goals:– Improved�mobility

– Weight�loss

– Improved�diabetic�control

How�is�the�geriatric�patient�different?

• Assessment:– Medications

• Constant�medication�reconciliation• Barriers�to�compliance• Combination�medications�improve�compliance• Interactions�between�medications• Dose�adjustments

– Nutritional�status– Renal/hepatic�impairment– With�addition�of�new�agents

*Although�polypharmacy has�many�risks,�it�also�results�in�improved�glycemic�control�and�decreased�long�term�disease�related�risks.

Drug�Drug�Interactions�to�consider

• Thiazide�diuretics�(�BG)• Niacin�(�insulin�resistance;��BG)• Beta�adrenergic�blockers�(insulin�secretion�,�resistance�;�

weight�gain;�dyslipidemia)• Glucocorticoids• Trimethoprim�sulfamethoxazole (�BG)• Floxacin antibiotics�(��BG)• Gemfibrozil (elevates�levels�of�repaglinide and�TZDs)• Digoxin�(decreased�absorption�with�AGIs;�slowed�

absorption�with�exenatide)• Warfarin�(increased�absorption�with�AGIs)• Acetaminophen�(slowed�absorption�with�AGIs)

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How�is�the�geriatric�patient�different?

• Assessment:– Testing

• Home�monitoring– HypoglycemiaH l i– Hypoglycemic�awareness

– Ensure�appropriate�meter» Finger�sticks�require�coordination/dexterity» Forearm�sticks�require�proper�technique» Speaking�meter�for�the�visually�impaired

• Lab– Nutritional�assessment– Typical�testing

How�is�the�geriatric�patient�different?

• Physical�exam�will�be�similar– Check�BP�supine�and�standing

– BMI

Vision testing– Vision�testing

– Mental�status�evaluation

How�is�the�geriatric�patient�different?

• Management– Education

• Hypoglycemia should�be�discussed�at�every�appt,�particularly�with�medication�changes

– Symptoms

» Increased�risk�of�unawareness�in�the�elderly�would�suggest�that�target�goals�be�defined�individually�and�based�both�on�age�and�duration�of�disease

– Management�

– Avoidance�of�hypoglycemia�is�paramount�(ACCORD�study)

» Excess�mortality

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How�is�the�geriatric�patient�different?

• Management– Education

• Hypoglycemia�

• Effects of stress (infection, fever, trauma, surgery,Effects�of�stress�(infection,�fever,�trauma,�surgery,�social,�etc)�on�glycemic�control�should�be�reviewed

• Avoid�alcohol�while�taking�meds

How�is�the�geriatric�patient�different?

• Management– Screening�studies�should�focus�on

• Preventing�short�term�complications

• Maintaining functional statusMaintaining�functional�status– Vision

– Lower�extremity�complications

Medication�management�in�the�elderly�diabetic�patienty p

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Sage�advice�for�all�geriatric�patients

• Start�low,�go�slow!– Hepatic/renal�insufficiency�common– Malnourishment�common– Dosage�will�need�to�be�adjusted

• Drug�drug�interactions�are�VERY�commong g– Assess�risk�with�every�new�medication�and�dose�adjustment

• Medications�only�work�if�they�are�taken– Barriers�to�compliance

• Cost• Access�to�care/pharmacy• Medication�administration�(vial�vs pen�for�insulin)

Biguanides

• Metformin– General�comments:

• Recommended�as�1st line�therapy�in�most�patients• Suppresses�hepatic�glucose�production�(fasting�&�postprandial)postprandial)

• Positive�effects�on�metabolic�syndrome�(weight�loss,�improved�lipids�&�fibrinolysis)

• GI�side�effects�minimized�by�gradually�increasing�dose• Lactic�acidosis�is�rare• Avoid�if�creatinine clearance�less�than�60�ml/min�(creatinine��1.5�mg/dL men;�1.4�mg/dL women)�or�significant�heart�failure

Biguanides

• Metformin�(Glucophage�500,�850,�1000�mg/Glucophage�XR�500,�1000�mg)– Decreases�hepatic�glucose�production– Decreases�intestinal�absorption�of�glucose– Improves�insulin�sensitivity

• Increases�peripheral�glucose�uptake�and�utilization– Does�not�cause�hypoglycemia�or�hyperinsulinemia– Class�1,�Category�A�level�of�recommendation– Avoid�use�in�tx’d CHF,�elderly�with�CC<60,�active�liver�disease,�chronic�alcohol�abuse,�during�use�of�IV�radiographic�contrast�material,�other�risks�for�lactic�acidosis

– Annual�B12�screening�may�be�appropriate

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Sulfonylureas

• General�thoughts:– Stimulate�second�phase�insulin�secretion�(delayed)

– Can�result�in�fasting�hypoglycemia

Often associated with mild moderate weight gain– Often�associated�with�mild�moderate�weight�gain,�especially�when�combined�with�insulin�or�TZDs�(also�fluid�retention,�CHF)

– Avoid�in�the�elderly

Sulfonylureas

• Glimepiride�(Amaryl�1,�2,�and�4�mg)– Stimulates�insulin�release�from�pancreatic�beta�cells

– Increases�sensitivity�of�peripheral�tissues�to�insulin– Hepatic�metabolism– Both�fecal�and�renal�excretion– Results�in�an�increased�risk�for�hypoglycemia,�particularly�in�elderly�patients�with�hepatic�or�renal�dysfunction

– Take�with�first�meal�of�the�day

Sulfonylureas

• Glipizide (Glucotrol�5,�10�mg/Glucotrol�XL�2.5,�5,�10�mg)– Stimulates�insulin�release�from�pancreatic�beta�cells,�particularly�

in�response�to�a�meal– May�increase�insulin�sensitivity– May�lower�hepatic�glucose�production– Hepatic metabolism– Hepatic�metabolism– Fecal�(10%)�and�renal�(80%)�excretion;�less�than�10%�unchanged– Increased�risk�of�hypoglycemia�in�the�elderly�patient– Food�decreases�the�peak�serum�concentration�of�the�medication�

and�delays�absorption– Take�30�minutes�prior�to�first�meal�(do�not�crush/chew�XL)

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Sulfonylureas

• Glyburide�(Diabeta 1.25,�2.5,�5�mg;�Micronase/Glynase1.25,�2.5,�5�mg)– Stimulates�pancreatic�beta�cells�to�release�insulin– Mild�diuretic�due�to�increasing�renal�free�water�clearance– Hepatic and renal metabolism– Hepatic�and�renal�metabolism– Biliary�(50%)�and�renal�(50%)�excretion– Taken�with�first�meal�of�the�day– Variation�in�bioequivalence�amongst�the�preparations,�so�must�retitrate if�switching�to�Glynase)

– Increased�risk�of�hypoglycemia�in�the�elderly�patient,�particularly�with�adrenal�or�pituitary�insufficiency

Meglitinides

• General�thoughts:– Increases�1st and�2nd phase�insulin�secretion

– Relatively�glucose�dependent�response

Rapid onset of action– Rapid�onset�of�action

– Less�late�postprandial�hypoglycemia

– No�need�to�max�out�dose�as�most�benefit�seen�at�lower�doses

Meglitinides

• Nateglinide (Starlix 60,�120�mg)– Stimulates�pancreatic�beta�cells�to�release�insulin

• Not�used�with�or�in�place�of�an�insulin�secretagogue

– Hepatic�metabolism�(active�metabolites�M1&M7)• M1�has�a�modest�hypoglycemic�effect�and�accumulates�with�time;�dialyzable,�so�can�be�used�in�ESRD�on�HD�but�should�likely�be�avoided�in�severe�renal�impairment

• No�dose�adjustment�officially�advised�in�CRI�or�elderly

– Fecal�(10%)�and�renal�(83%)�excretion– Taken�3�x�daily�1�30�minutes�before�meals

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Meglitinides

• Repaglinide (Prandin 0.5,�1,�2�mg)– Stimulates�insulin�release�from�the�pancreatic�beta�cells

– Hepatic�metabolism�(P450�3A4�and�2C8)– Fecal�(90%�(60%�as�M2))�and�renal�(8%)��excretion

• Reduce�dose�in�severe�renal�impairment• No�adjustment�in�elderly

– Contraindicated�if�pt on�gemfibrozil due�to�sig�increased�levels�of�repaglinide

– Taken�15�30�minutes�prior�to�meals

Thiazolidinediones (TZDs)

• General�comments:– Insulin�sensitizers

• Increase�insulin�dependent�glucose�uptake

• Decrease hepatic glucose productionDecrease�hepatic�glucose�production

– Effective�as�monotherapy or�in�combination

– Main�SE�is�weight�gain,�edema�which�can�result�in�CHF

– 1.5�2.5�fold�increased�risk�of�bone�fractures�in�men�and�woman

Thiazolidinediones (TZDs)• Pioglitazone�(Actos 15,�30,�45�mg)�{significant�restrictions�on�use�of�rosiglitazone�(Avandia)}

– Decreases�peripheral/hepatic�insulin�resistance• Increases�insulin�dependent�glucose�uptake• Decreases�hepatic�glucose�production

– Can�be�used�with�other�oral�agents�and�insulin– Hepatic�metabolism�(CYP�450)

• Check�liver�enzymes�prior�to�starting�AND– Periodically�in�patients�with�liver�disease– Promptly�with�any�symptoms�of�hepatic�change

– Fecal�and�renal�excretion– Can�be�taken�with/without�food– Can�cause�or�exacerbate�CHF�and�fluid�retention,�so�patients�must�be�monitored�closely�with�initiation�and�

dose�adjustments.�• Consider�discontinuation�of�Actos with�CHF• Contraindicated�with�NYHA�Class�III/IV�CHF• Start�with�15�mg�with�Class�I/II�CHF

– Incidence�of�distal�UE�and�LE�fractures�higher�in�women�than�men�• 5.1%�(44/870)�Actos 45�mg�vs 2.5%�placebo;�mean�f/u�34.5�mo (PROactive trial)• No�special�monitoring�suggested

– Incidence�of�bladder�cancer�is�increased• In�patients�taking�Actos for�more�than�12�months

– 40%�increased�relative�risk– 7/10,000�to�10/10,000�absolute�risk�increase

• Avoid�use�in�patients�with�active�bladder�cancer• Consider�potential�increased�risk�in�patients�with�a�history�of�bladder�cancer

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Alpha�glucosidase inhibitors

• General�comments:– Inhibit�conversion�of�oligosaccharides�into�monosaccarides at�the�intestinal�brush�border

• Decreased postprandial hyperglycemiaDecreased�postprandial�hyperglycemia

• Particularly�useful�in�patients�who�consume�a�high�carbohydrate�diet�(>50%)

• As�monotherapy,�the�AGIs�rarely�cause�hypoglycemia

• When�used�in�combination�therapy,�must�treat�hypoglycemia�with�glucose

Alpha�glucosidase inhibitors

• Acarbose (Precose 25,�50,�100�mg)– Competitively,�reversibly�inhibits�pancreatic�alpha�amylase�and�

intestinal�membrane�bound�alpha�glucoside hydrolases• Inhibits�hydrolysis�of�complex�starches�to�oligosaccharides�in�the�small�

intestinal�lumen• Inhibits�hydrolysis�of�oligo/tri/di�saccharides�to�glucose�and�other�

monosaccharides in�the�small�intestinal�brush�border• As�monotherapy,�should�not�cause�hypoglycemia• With�sulfonylureas,�Acarbose:

– decreases�the�release�of�insulin– minimizes�the�weight�gain

• Due�to�mechanism�of�action,�must�use�glucose�for�hypoglycemia– Gastrointestinal�metabolism

• Contraindicated�in�intestinal�disease– Fecal�(51%�passed�unabsorbed)�and�renal�(34%)�excretion

• Avoid�with�renal�dysfunction– Taken�on�initiation�of�meals

Alpha�glucosidase inhibitors

• Miglitol (Glyset 25,�50,�100�mg)– Reversibly�inhibits�intestinal�membrane�bound�alpha�glucoside

hydrolases• Inhibits�hydrolysis�of�complex�starches�to�oligosaccharides�in�the�small�

intestinal�lumen• Inhibits�hydrolysis�of�oligo/tri/di�saccharides�to�glucose�and�other�

monosaccharides in�the�small�intestinal�brush�border• As�monotherapy,�should�not�cause�hypoglycemia• With�sulfonylureas,�Miglitol:

– decreases�the�release�of�insulin– minimizes�the�weight�gain

• Due�to�mechanism�of�action,�must�use�glucose�for�hypoglycemia– Gastrointestinal�metabolism

• Contraindicated�in�intestinal�disease– Renal�excretion�(creatinine below�2�advised)– Taken�on�initiation�of�meals

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Amylin�analogue

• Pramlintide (SymlinPen 1000�mcg/ml;�Symlin 0.6�mg/ml)– Analog�of�amylin�(small�peptide�hormone�released�with�insulin�

by�beta�cells�after�a�meal)– Promotes�glucose�absorption

• Slows�gastric�emptying• Promotes�satiety�(hypothalamic�receptors�other�than�GLP�1);�may�y ( yp p ); yresult�in�decreased�intake�and�weight�loss

• Inhibits�postprandial�glucagon secretion�– Can�result�in�significant�hypoglycemia�with�insulin�use– Renal�metabolism– No�dose�adjustment�in�renal�insufficiency�or�elderly– Contraindicated�if�patient�lacks�hypoglycemic�awareness– Subcutaneous�injection�immediately�prior�to�each�major�meal�

(never�mixed�with�insulin)

Bile�acid�sequestrant

• Colesevelam (Welchol 625�mg;�3.75�gm/packet�powder)– Binds�to�bile�acids;�prevents�intestinal�reabsorption

– Not�absorbed,�so�no�metabolism/excretion�issuesNot absorbed, so no metabolism/excretion issues

– Contraindicated�with�bowel�obstruction�history�or�triglycerides�above�500;�worsens�constipation

– Lowers�A1C�0.4�0.8%

– Taken�with�meals• At�least�4�hours�after�thyroid�hormones,�phenytoin,�fat�soluble�vitamins,�any�med�with�narrow�therapeutic�index

Insulin

• Use�requires:– Adequate�vision

– Motor�skills

Cognitive ability– Cognitive�ability

• Risk�for�hypoglycemia�is�significant– Unawareness�is�very�common

– Slowed�response�time�following�hypoglycemic�episodes�is�extended

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Long�acting�insulin

• Detemir (Levemir 100�U/ml;�vial�and�FlexPen)• Glargine (Lantus�100�U/ml�vial�(10�ml)�and�SoloStar pen�(3�ml))

• Stimulates:– Uptake�of�glucose�by�cardiac,�skeletal,�and�adipose�tissues– GlycogenesisGlycogenesis– Lipogenesis– Protein�synthesis

• Inhibits�lypolysis• Metabolized�in�blood�and�subcutaneous�tissues• Use�cautiously�in�elderly�patients�and�those�with�renal�or�hepatic�

impairment• SC�injection�1�2�times�daily

– Can�not�be�mixed�with�other�insulins

Short�acting�insulin

• Aspart (NovoLog;�Novolog FlexPen 100�U/ml)• Glulisine (Apidra;�Apidra SoloStar 100�U/ml)

– SC injection 5�10 minutes prior to meals (Aspart)SC�injection�5 10�minutes�prior�to�meals�(Aspart)�and�within�15�minutes�prior�to�and�20�minutes�after�meals�(Glulisine)

– Do�not�mix�with�other�insulins (May�be�mixed�with�NPH�only)

– Use�cautiously�with�elderly�patients,�particularly�those�with�renal�or�hepatic�impairment

Not�recommended:

• Regular�insulin�(Humulin R;�Novolin R)– Slow�onset�of�action

– Long�duration�of�action

Results in inadequate prandial control and– Results�in�inadequate�prandial�control�and�increased�risk�of�postprandial�hypoglycemia

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Not�recommended:

• NPH�insulin�(Humulin N;�Novolin N)– Variable�absorption�between�and�within�individuals

– Variable effect (does not provide stable basalVariable�effect�(does�not�provide�stable�basal�insulin)

– Increased�risk�of�hypoglycemia

The�Incretin Modulators

GLP�1�(Glucagon�Like�Peptide)GIP�(Glucose�dependent�insulinotropic polypeptide

GLP-1; GIP

Active FormDPP-IV Inactivates

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GLP�1�as�a�treatment�for�Type�2�DM

• Increases�glucose�dependent�insulin�release

• Regulates�postprandial�glucagon

• Slows�gastric�emptying

• Reduces�food�intake�(SE=N,V)

• Stimulates beta�cell proliferation and• Stimulates�beta�cell�proliferation�and�differentiation�in�animal�models

*In�the�absence�of�other�agents,�no�hypoglycemia

The�Incretin ModulatorsGLP�1�(Glucagon�Like�Peptide)

GIP (Glucose dependent insulinotropic polypeptideGIP�(Glucose�dependent�insulinotropic polypeptide

DPP�4�Inhibitors

GLP�1�receptor�agonists

DPP�4�inhibitors

• General�comments:– Inhibit�the�inactivation�of�GLP�1�and�GIP�which:

• Increases�1st phase�insulin�secretion

• Reduces postprandial glucagon secretionReduces�postprandial�glucagon�secretion

• Results�in�lower�fasting�AND�postprandial�glucose�levels

– Because�they�are�glucose�dependent,�hypoglycemia�is�rare�in�monotherapy or�in�combination�with�metformin�or�TZDs

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DPP�4�inhibitors

• Saxagliptin (Onglyza 2.5,�5�mg)– Inhibits�the�degradation�of�incretin hormones�(Glucose�

dependent�insulinotropic polypeptide�(GIP)�and�glucagon�like�peptide�1�(GLP�1))�which�are�released�in�response�to�meals

• Competitively�inhibits�dipeptidyl peptidase�4�(DPP�4)• More�active�at�high�glucose�levels• Less�active�at�low�glucose�levels• Low�risk�for�hypoglycemia

– Hepatic�metabolism�(CYP450�3A4/5)– Renal�(60%)�and�fecal�(22%)�excretion– No�dose�adjustment�in�elderly�patients– Dose�adjustment�in�mod�severe�renal�insufficiency�and�ESRD– Taken�once�daily�regardless�of�meals

DPP�4�inhibitors

• Sitagliptin (Januvia�25,�50,�100�mg)– Inhibits�the�degradation�of�incretin hormones�(Glucose�

dependent�insulinotropic polypeptide�(GIP)�and�glucagon�like�peptide�1�(GLP�1))�which�are�released�in�response�to�meals

• Competitively�inhibits�dipeptidyl peptidase�4�(DPP�4)• More�active�at�high�glucose�levels• Less�active�at�low�glucose�levels• Low�risk�for�hypoglycemia

– Renal�metabolism– Renal�(87%�with�79%�unchanged)�excretion– No�dose�adjustment�in�elderly�patients– Dose�adjustment�in�mod�severe�renal�insufficiency�and�ESRD– Taken�once�daily�regardless�of�meals

• If�taken�with�a�sulfonylurea,�may�need�to�lower�dose�of�sulfonylurea

DPP�4�inhibitors

• Linagliptin (Tradjenta 5�mg�tablet)– Inhibits�the�degradation�of�incretin hormones�(Glucose�

dependent�insulinotropic polypeptide�(GIP)�and�glucagon�like�peptide�1�(GLP�1))�which�are�released�in�response�to�meals

• Competitively�inhibits�dipeptidyl peptidase�4�(DPP�4)• More�active�at�high�glucose�levels• Less�active�at�low�glucose�levels• Low�risk�for�hypoglycemia

– Limited�metabolism– Bile�(80%)�and�renal�(5�7%)�excretion– No�dose�adjustment�in�elderly�patients– Dose�adjustment�in�mod�severe�renal�insufficiency�and�ESRD– Taken�once�daily�regardless�of�meals

• If�taken�with�a�sulfonylurea,�may�need�to�lower�dose�of�sulfonylurea

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GLP�1�receptor�agonists• Exenatide (Byetta pen�250�mcg/ml)

– Mimics�GLP�1• Increases�glucose�dependent�insulin�release�from�the�pancreas• Suppresses�glucose�dependent�pancreatic�release�of�glucagon• Slows�gastric�emptying• Promotes�satiety�(hypothalamic�response)• May�reverse�hepatic�steatosis

– May�be�taken�with:• Metformin, sulfonylurea, thiazolidinedioneMetformin,�sulfonylurea,�thiazolidinedione• Combination�of�metformin�&�sulfonylurea�OR�thiazolidinedione

– Renal�metabolism– Renal�excretion

• Use�caution�with�moderate�renal�insufficiency�(monitor�creatinine if�CC�30�55�ml/min)• Do�not�use�with�severe�renal�insufficiency�(CC�<30�ml/min)�and�ESRD

– No�dose�adjustment�for�elderly�patients– 5�mcg�SC�BID�for�1�month,�then�10�mcg�SC�BID�to�be�taken�within�60�mins prior�to�two�main�

meals�of�the�day,�6�hours�apart*Use�resulted�in�lowered�A1C�and�average�12�lb weight�loss�at�2�years�which�was�a/w improved�BP�and�lipids�in�extended�open�label�studies

GLP�1�receptor�agonists

• Liraglutide (Victoza 6�mg/ml)�– *Causes�dose�dependent�and�treatment�duration�dependent�thyroid�

C�cell�tumors�in�animals*• Contraindicated�in�patient�with/with�a�history�of�medullary�thyroid�carcinoma�

and�multiple�endocrine�neoplasia syndrome�type�2– Mimics�GLP�1

• Increases glucose dependent insulin release from the pancreasIncreases�glucose�dependent�insulin�release�from�the�pancreas• Suppresses�glucose�dependent�pancreatic�release�of�glucagon• Slows�gastric�emptying• Promotes�satiety�(hypothalamic�response)• May�reverse�hepatic�steatosis

– Endogenously�metabolized– No�specific�excretion– No�dose�adjustment�in�elderly�or�renal�dysfunction– 0.6�mg�SC�injection�daily�for�one�week,�then�1.2�mg�SC�daily�regardless�

of�meals

What�does�the�future�hold?• Once�weekly�exenatide• Glucokinase activators

– Increase�insulin�production– Increase�hepatic�glucose�uptake

• Glucagon�receptor�antagonists• SGLT�inhibitors

l k l k i h l i l b l– Block�glucose�reuptake�in�the�renal�proximal�tubule• Advances�in�insulin�delivery

– Needle�free�jet�injection�(recent�study�suggesting�improved�glycemic�control�compared�with�conventional�injection)

– Inhaled– Intranasal– Buccal– Patch– Oral�

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Non�diabetic�medications

• ASA�81�mg�daily*• Lipid�management*• Hypertension�management

*assuming�the�patient’s�life�expectancy�meets�or�exceeds�the�time�frame�of�the�trials

Resources

• Micromedex�for�specific�medication�information�and�consideration�of�interactions

• AACE�(American�Association�of�Clinical�Endocrinologists) website for consensusEndocrinologists)�website�for�consensus�statements�on�DM�management

• ADA�(American�Diabetes�Association)�website�“for�professionals”�portal

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Saturday October 15, 2011

7:15 am Breakfast (4th level)

7:30 am Registration (2nd level)

8:00-10:00 am Symposium II: Updates on Medical Issues Moderator: Cynthia Olsen, MD, FAAFP, CMD

8:00-8:30 am Prostate Disease in Elderly Men Orson J. Austin, MD

8:30-9:00 am Urinary Infections in the Elderly: What Has Changed ? Jen-Tzer Gau, MD, PhD

9:00-9:30 am Clinical Considerations in Aging Adults with HIV Robert L. Brandt, Jr, MD

9:30-10:00 am Discussion and Questions

10:00-10:30 am Break

10:30-12:30 pm Symposium III: Management Issues for Better Patient Care Moderator: Cynthia Olsen, MD, FAAFP, CMD

10:30-11:00 am Post-Operative Management of the Elderly Arvind Modawal, MD, MPH, GSF, FAAFP

11:00-11:30 am Clinical Pearls in Management of Fracture Risk in Your Patients

David W. Regule, MD, PT, MS

11:30-12:00 pm Myeloproliferative Neoplasm: Approach to Diagnosis and Treatment Ramon V. Tiu, MD

12:00-12:30 pm Discussion & Questions

12:30 pm General Luncheon Buffet (4th level) or Annual OGS Meeting and Buffet (3rd level)

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Symposium II

Neuropsychiatric Geriatric Disorders

Moderator:

Donald O. Mack, MD, FAAFP, CMD Clinical Assistant Professor

Department of Family Medicine The Ohio State University, College of Medicine

Moderator Disclosure:

Dr. Mack has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Prostate Disease in Elderly Men

Orson J. Austin, MD

Learning Objectives:

Demonstrate the use of “decision aids” to patients, and thus assist them in making decisions regarding prostate cancer screening.

Apply current randomized controlled trial evidence to patient discussions regarding prostate cancer screening.

Counsel their patients on the evidence regarding the use of Finasteride and Dutasteride for prostate cancer prevention.

Speaker Disclosure:

Dr. Austin discloses has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Orson J. Austin, M.D.

PROSTATE DISEASE IN ELDERLY MEN

J ,Associate Professor of Family Medicine

University of Cincinnati 22ND Annual Statewide Geriatric Medicine Conference

October 15th 2011

Objectives1. Participants will demonstrate the use of “Decision Aids” to

patients, and thus assist them in making decisions regarding prostate cancer screening.

2. Clinicians will be able to apply current randomized controlled trial evidence to patient discussions regardingcontrolled trial evidence to patient discussions regarding prostate cancer screening.

3. Clinicians will be able to counsel their patients on the evidence regarding the use of Finasteride and Dutasteride for prostate cancer prevention.

Introduction- Prostate Cancer

� US 2009 data: 192,000 with 27,000 expected deaths

� 2nd leading cause of mortality from cancer in US men

� Decline in mortality from prostate cancer in US over past 20 yrs

� Reasons for mortality decline controversial

� High rate of overdiagnosis & overtreatment

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

Barry, MJ. Screening for Prostate Cancer –The Controversy That Refuses to Die. NEJM 2009

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Informed Decision Making(IDM)/Shared Decision Making(SDM)

� Obstacles –Time constraints and complexity of issue � Studies: “decisional conflict” decreased in pts who use decisional aid � ACS “discourages participation” in PSA cancer screening programs

(community-based)� IDM process and f/u process both should be considered before

participation in such programs

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

Decision Aids for Prostate Cancer Screening

� ACS – “Should I be tested for Prostate Cancer” www.cancer.org/prostatemd

� Foundation for informed Medical Decision Making – “Is a PSA Test Right for You?” http://www.healthdialog.com

� CDC Prostate Cancer Screening: “A Decision Guide”� CDC- Prostate Cancer Screening: A Decision Guide –http://www.cdc.gov/cancer/prostate/pdf/prosguide.pdf

Informed Decision Making(IDM)/Shared Decision Making (SHD)

� ACS: Discourage men older than 65 ( most have Medicare) from being participants in community based screening programs

� R f h t PCP’ f i di i� Refer such men to PCP’s for screening discussions

� Promote use of decision aids as these are now supported by medical evidence

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

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PROSTATE CANCER SCREENING A Review of the Current Randomized

Evidence Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer

Screening TrialMETHODS

� US randomized trial 1993 to 2001� US randomized trial-1993 to 2001� Over 76,000 men at 10 US centers – annual screening or usual

care � Screening group –offered yearly PSA screening for 6 yrs and DRE

for 4 yrs � Usual care sometimes included screening

Andriole, et al. NEJM 2009;360:1310-9

PROSTATE CANCER SCREENING A Review of the Current Randomized Evidence

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

� Primary end point – cause specific mortality for each of the PLCO cancers

� Secondary end points - PLCO cancer incidence, staging and survival

PROSTATE CANCER SCREENING A Review of the Current Randomized Evidence

Prostate, Lung, Colorectal, and

Ovarian (PLCO) Cancer

CONCLUSIONS

� After 7 -10 yrs of f/u, mortality rates were very

low and no significant Ovarian (PLCO) Cancer Screening Trial

gdifferences were seen

between the two groups

Andriole, et al. NEJM 2009;360:1310-9

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PROSTATE CANCER SCREENING A Review of the Current Randomized Evidence-PLCO Trial

Study OPROSTATE CANCER SCREENING A Review of the Current Randomized Evidence v

� European Randomized Study of Screening for Prostate Cancer (ERSPC)

� In this trial, investigators tested the effect of prostate-specific-antigen testing on the death rate from prostate cancer in more than 162,000 men between the ages of 55 and 69 years in seven European countriesmen between the ages of 55 and 69 years in seven European countries

• A significant reduction in prostate-cancer mortality was found after a median follow-up of 9 years

• Overdiagnosis and overtreatment were important limitations of the screening program

Schroder, et al NEJM 2009;360:1320-8

European Randomized Study of Screening for Prostate Cancer (ERSPC)

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European Randomized Study of Screening for

Prostate Cancer

� Conclusion - PSA screening reduced death rate from prostate cancer by 20%

� High rate of over-diagnosis

Schroder, et al NEJM 2009;360:1320-8

Randomized Controlled Trial Evidence Prostate Cancer Screening

PLCO ERSPC � 77,000 aged 55 -74� PSA and DRE annually� Biopsy recomm for PSA > 4

� Trials in different countries with different criteria, etc

� 162,000 aged 55 -69� Every 4 yrs –mostly PSA only� Biopsy for PSA >3

� Contamination rate 20% (increased to 38% during study)

� No decreased mortality after 7 yrs

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin

2010

Biopsy for PSA 3� Contamination rate 20% � Men diagnosed with Prostate Ca more likely

to be treated at university hospital� 20 % reduction in mortality after 9 yrs

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

Barry, MJ. Screening for Prostate Cancer –The Controversy That Refuses to Die. NEJM 2009

Randomized Controlled Trial Evidence -Prostate Cancer Screening

Possible reasons for differences in PLCO and ERSPC trial results

� Prescreening differences

� Contamination

� Compliance with biopsy

� PSA cutoff points

� Differential Rx in 2 arms of ERSPC

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Prostate Cancer – Overdiagnosis and Overtreatment � Most pts with prostate ca die of other causes

� Prior to PSA screening, only 25% of prostate ca’s were clinically evident

� Sensitive screening cancer tests – increases potential for overdiagnosis and overtreatment g

� Studies: estimated prostate ca overdiagnosis rates from 23% to 42% (screen-detected cancers)

� ERSPC study - about 48 men with prostate cancer (screen-detected) would need to be treated to prevent one death

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

Radical Prostatectomy – Adverse Effects � Multiple Approaches

1. Laparoscopic2. Retropubic

3. Robotic 4 Perineal

� Perioperative adverse effects

1. Bleeding primary risk (transfusions not

uncommon)4. Perineal

� 2 types of adverse effects: perioperative & longer term

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

2. Rectal injury and death within 30 days (rare)

� Longer term (primary)1. Urinary2. Sexual

Radical Prostatectomy – Adverse Effects

Urinary Adverse Effects Sexual Adverse Events

� Total or Stress Urinary Incontinence (precise rates unclear – long term UI

� Sexual dysfunction –common but exact rate unclearg

probably 12-16%)

Stricture (bladder to urethra)- 5 to 14%

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

� Even with nerve-sparing prostatectomy, sexual dysfunction can occur (return to max function may be delayed 1-2 yrs)

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Prostate Cancer – Adverse Effects of Radiation Therapy � 2 forms of Radiation Rx – external-beam radiation & interstitial

brachytherapy (“seed therapy”)

� New radiation delivery techniques – more precise Rx and lower toxicity

� Acute problems in up to 50% of men reported – mostly lower p p p yurinary tract symptoms (e.g. urgency and dysuria)

� GI side effects may occur: (e.g. loose stools or diarrhea)

� Late toxicities (> 6 mo): ED most common – up to 50% of pts

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

PSA screening – High Risk Populations

Risk Factors Does screening of High-risk

reduce mortality?

� Age “We still do not know whether PSA screening

� Race(AA and African-Caribbean)

� Family Hx

gperforms better in higher

risk men in terms of reduced prostate cancer-

specific mortality”Wolf, et al ACS Guideline for the early detection of Prostate Cancer

CA J Clin 2010

Prostate Cancer – Screening Not Recommended � Consensus opinion: Men with less than a 10 year life

expectancy (based on advanced age or co-morbidities) should not be screened

� Use life tables as estimates of life expectancy if needed

� At age 75 about 50% have life expectancy of > 10 yrs� At age 75, about 50% have life expectancy of > 10 yrs

� Severity of co-morbidities and functional impairment may have greater impact of life expectancy (vs. age)

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

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American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010

CA: A Cancer Journal for CliniciansVolume 60, Issue 2, pages 70-98, 3 MAR 2010 DOI: 10.3322/caac.20066http://onlinelibrary.wiley.com/doi/10.3322/caac.20066/full#fig3

Prostate Cancer – Screening Not Recommended

Common life-limiting co-morbidities (Examples)

� NYHA Class 4 CHF

� COPD (Moderate to Severe)

� Cancer (Life-limiting) g

� Despite consensus, evidence reveal significant physician prostate cancer screening for men unlikely to benefit

� VA study: 45% screening in men >80; 36% among men aged >85

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

5�-Reductase Inhibitors and Prostate Cancer Prevention

2 Large Randomized Trials

� Prostate Cancer Prevention Trial (PCPT) with Finasteride

� Reduction by Dutasteride of Prostate Cancer Events (REDUCE ) trial

B h i l “O ll l i d i f 23 25% i� Both trials: “Overall relative reduction of 23-25% in prostate cancer diagnoses”

� Reduction: decreased low-grade prostate cancer only (Gleason score < 6)

Theoret, et al. NEJM July 2011

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Relative and Absolute Risk of Prostate Cancer According to Modified Gleason Score (mGS), PCPT and REDUCE Trial.

Theoret MR et al. N Engl J Med 2011;365:97-99.

Robot –Assisted Prostatectomy

“MEN ARE OFTEN REASSURED THAT ROBOT-ASSISTED PROSTATECTOMY OPERATIONS WILL

LEAVE THEM WHOLE”. PARKER-POPE, NY TIMES, 9/24/11.

Prostate Cancer Screening –Recommendations

U.S. Preventive Services Task Force American Cancer Society

� “Prostate-specific antigen screening is associated with psychological harms, and

� “Asymptomatic men who have at least a 10-year life expectancy should have an

opportunity to make an p y gits potential benefits remain uncertain”

Ann Intern Med. 2008;149:192-199

pp yinformed decision with their health care provider about whether to be screened for

prostate cancer ….”

Wolf, et al ACS Guideline for the early detection of Prostate Cancer

CA J Clin 2010

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Prostate Cancer PSA Screening Recommendations – ACS

American Cancer Society American Cancer Society� Yes but informed decision

(for asymptomatic men for > 10 yr life expectancy)

� Informed decision for high

� Do not screen asymptomatic men with less than 10 yr life

b dInformed decision for high risked men at age 45 (e.g. AA men

� Age 40 for very high risk (e.g. multiple family members before age 65)

� Consider use of “Patient decision Aids” – evidence based support

expectancy (based on age and co-morbid health status)

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

ACS position(for men who choose to be screened)� Screen with PSA (with or w/o DRE)

� Screen annually for men with PSA>2.5 ng/ml

� PSA < 2.5 ng/ml: can extend screening to every 2 yrs

� PSA > 4.0 ng/ml: referral

� PSA 2.5-4.0 ng/ml: individualized risk assessment (look at other risk factors for prostate cancer)

Wolf, et al ACS Guideline for the early detection of Prostate Cancer CA J Clin 2010

5�-Reductase Inhibitors and Prostate Cancer Prevention

PCPT & REDUCE Trials� Both trials: increase in incidence

of high-grade prostate ca’s

FDA analysis of the trials:

PCPT & REDUCE Trials � FDA analysis used “modified

Gleason scores” (not reported originally in REDUCE)

� No reduction seen by FDA inFDA analysis of the trials:1. 25% reduction in overall

incidence of prostate ca 2. Significant increased

incidence of high grade prostate ca’s

Theoret, et al. NEJM July 2011

No reduction seen by FDA in tumors with modified Gleason scores between 7 and 10

� 0.5% increase in incidence of tumors (modified Gleason of 8-10)

Theoret, et al. NEJM July 2011

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5�-Reductase Inhibitors and Prostate Cancer Prevention

PCPT & REDUCE Trials

� FDA analysis: 1 additional man with diagnosis of high-grade prostate ca (MGS 8-10) for 150-200 men treated with 5�-reductase inhibitor

� 80% of tumors in REDUCE trial “very low risk” disease� 80% of tumors in REDUCE trial – very-low risk disease –MGS of < 6 – reduction likely NOT clinically significant

• FDA Conclusion – Finasteride & Dutasteride – No favorable risk-benefit profile for prevention of prostate cancer

Theoret, et al. NEJM July 2011

Summary � Prostate cancer is a significant cause of morbidity and mortality in

U.S. men

� Prostate cancer screening continues to be controversial with two randomized controlled studies yielding conflicting results

� Patients should be active participants in decision making regarding p p g g gprostate cancer screening (shared decision making)

� Physicians should seriously consider using “Decision aids” to help facilitate patient discussion regarding prostate cancer screening

� Physicians should NOT perform prostate cancer screening on men with less than a 10 year life expectancy (based on age and/or co-

morbidities)

Summary � Prostate cancer treatment - via Radical prostatectomy and

Radiation therapy - both have the potential to cause significant short-term and long-term adverse events

� The FDA analysis of 5� –Reductase inhibitors revealed that while these agents reduced the overall incidence of prostatewhile these agents reduced the overall incidence of prostate

cancer, they significantly increased the incidence of high-grade prostate cancer

� Finasteride and Dutasteride should not be used for the prevention of prostate cancer

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References 1. Wolf, et al. American Cancer Society Guideline for the

Early Detection of Prostate Cancer - Update 2010. Ca Cancer J Clin 2010;60:70-98

2. Andriole, et al. Mortality Results from a Randomized Prostate-Cancer Screening Trial. NEJM 2009;360:1310-9g

3. Schroder, et al. Screening and Prostate-Cancer Mortality in a Randomized European Study. NEJM 2009;360:1320-8

4. Lin, et al. Benefits and Harms of Prostate-Specific Antigen Screening for Prostate Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149:192-199.

References 5. Bill-Axelson, et al. Radical Prostatectomy versus Watchful

Waiting in Early Prostate Cancer. NEJM 2011;364:1708-17

6. Barry, MJ. Screening for Prostate Cancer –The Controversy That Refuses to Die. NEJM 360;13.

7. Andriole, et al. Effect of Dutasteride on the Risk of Prostate Cancer. NEJM 2010;362:1192-202

8. Theoret, et al. The Risks and Benefits of 5 Reductase Inhibitors for Prostate-Cancer Prevention. NEJM365;2.

9. Epstein, JI. An Update of the Gleason Grading System. The Journal of Urology 2010;183:433-440.

References 10. Parker-Pope, T. The Side Effects? Well, There Is

One…New York Times. Sept 24, 2011.

11. Friedrich, M.J. Debate Continues on Use of PSA Testing for Early Detection of Prostate Cancer. JAMA, June 8, 2011-Vol 305, No. 22.305, No. 22.

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Urinary Infections in the Elderly: What Has Changed?

Jen-Tzer Gau, MD, PhD

Learning Objectives:

Recognize the recent changes in the guidelines and practices of urinary infections in older adults.

Define the Areas of uncertainty.

Speaker Disclosure:

Dr. Gau has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Urinary Infections in the Urinary Infections in the Elderly: What Has Changed?Elderly: What Has Changed?

JenJen--Tzer Gau, MD, PhD.Tzer Gau, MD, PhD.Department of Geriatric Department of Geriatric

Medicine/Ge ontologMedicine/Ge ontologMedicine/GerontologyMedicine/GerontologyOhio University Heritage College of Ohio University Heritage College of

Osteopathic MedicineOsteopathic MedicineAthens, OHAthens, OH

Statewide Geriatric Education ConferenceStatewide Geriatric Education ConferenceSalt Fork State Park, October 15, 2011Salt Fork State Park, October 15, 2011

ObjectivesObjectives

�� Recognize the recent changes in the Recognize the recent changes in the guidelines and practices of urinary infections guidelines and practices of urinary infections in older adults in older adults

�� Define the areas of uncertaintyDefine the areas of uncertainty

Management of UTI in Management of UTI in CommunityCommunity--residing Older Adultsresiding Older Adults

No published guidelines for this age groupNo published guidelines for this age group

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Emergence of Resistant Uropathogens

� Resistance rates (E. Coli): Resistance rates (E. Coli): For TMPFor TMP--SMZ: from 10% to 24%, SMZ: from 10% to 24%, For ciprofloxacin: from 1% to 8%.For ciprofloxacin: from 1% to 8%.

�� More common in LTCF than the community. More common in LTCF than the community. �� Risk factors: Prior antimicrobial exposure; Risk factors: Prior antimicrobial exposure;

Higher functional impairment. Higher functional impairment.

Nicolle LE. J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S230-5.Al-Hasan et al., J Infect. 2010;60(4):278-85.

Choice for Antibiotic UseChoice for Antibiotic UseFor acute uncomplicated cystitis in For acute uncomplicated cystitis in

premenopausal, nonpremenopausal, non--pregnant women:pregnant women:

1.Nitrofurantoin (100 mg BID for 5 days)1.Nitrofurantoin (100 mg BID for 5 days)( g y )( g y )Efficacy comparable to 3 days of TMP/SMZEfficacy comparable to 3 days of TMP/SMZ(A(A--I)I)

2. TMP/SMZ (160/800 mg) BID for 3 days 2. TMP/SMZ (160/800 mg) BID for 3 days Choice for therapy if local resistance rates do Choice for therapy if local resistance rates do not exceed 20% or if the infection strain is not exceed 20% or if the infection strain is known to be susceptible. known to be susceptible.

New IDSA Guidelines 2010 (1)New IDSA Guidelines 2010 (1)

Choice for Antibiotic Use Choice for Antibiotic Use 3. 3. FluoroquinolonesFluoroquinolones: :

Highly efficacious in 3Highly efficacious in 3--day regimens (Aday regimens (A--I) I) Should be reserved for important uses (AShould be reserved for important uses (A--III) III) d t th f ll t l dd t th f ll t l ddue to the concern of collateral damages due to the concern of collateral damages

4. 4. ��--LactamLactam agent (3agent (3--7 days) regimens: 7 days) regimens: is appropriate when other agents could not be is appropriate when other agents could not be used (Bused (B--I).I).

New IDSA Guidelines 2010 (2)New IDSA Guidelines 2010 (2)

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3

Choice for Antibiotic Use Choice for Antibiotic Use 5. Amoxicillin/5. Amoxicillin/ampicillinampicillin should not be used should not be used for

empirical treatment given the poor efficacy given the poor efficacy and high prevalence of resistance to these and high prevalence of resistance to these agents worldwide (Aagents worldwide (A--III)III)agents worldwide (Aagents worldwide (A III).III).

New IDSA Guidelines 2010 (3)

Treatment for Treatment for AcuteAcute PyelonephritisPyelonephritis (1)(1)

1. Urine C/S test should be performed; 1. Urine C/S test should be performed; Initial therapy should be tailored on the basis Initial therapy should be tailored on the basis of the infecting agent (Aof the infecting agent (A--III).III).

2. Oral ciprofloxacin (500 mg BID) for 7 days, 2. Oral ciprofloxacin (500 mg BID) for 7 days, +/+/-- an initial 400 mg dose of IV is an an initial 400 mg dose of IV is an appropriate choice for patients not requiring appropriate choice for patients not requiring hospitalization when the resistance rate is not hospitalization when the resistance rate is not known to exceed 10% (Aknown to exceed 10% (A--I). I).

New IDSA Guidelines 2010 (4)

Treatment for Treatment for AcuteAcute PyelonephritisPyelonephritis (1)(1)

3. Alternatives: 3. Alternatives: �� Ciprofloxacin 1000 mg ER daily x 7 days; Ciprofloxacin 1000 mg ER daily x 7 days;

LevofloxacinLevofloxacin 750 mg for 5 days; or 750 mg for 5 days; or �� TMPTMP--SMZ bid for 14 days; SMZ bid for 14 days; �� ��--lactamlactam is less effective. is less effective.

New IDSA Guidelines 2010 (5)

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Treatment for Treatment for AcuteAcute PyelonephritisPyelonephritis (2)(2)

4. Women with 4. Women with pyelonephritispyelonephritis requiring requiring hospitalization should initially receive an IV hospitalization should initially receive an IV regimen, such as a FQL; orregimen, such as a FQL; org , Q ;g , Q ;

�� an an aminoglycosideaminoglycoside +/+/-- ampicillinampicillin; or; or�� ES cephalosporin or ES PCN, ES cephalosporin or ES PCN,

+/+/-- aminoglycosideaminoglycoside; or; or�� a a carbepenemcarbepenem. .

New IDSA Guidelines 2010 (6)

Special Considerations in Special Considerations in Older Adults with UTIOlder Adults with UTI

1.1. Renal function impairment is common in older Renal function impairment is common in older adultsadults---- limiting the use of limiting the use of NitrofurantoinNitrofurantoin

2.2. Urological abnormalities may become Urological abnormalities may become common as people age (impaired emptying, common as people age (impaired emptying, urinary retention, stone, and cancer, etc).urinary retention, stone, and cancer, etc).

3.3. Resistance to antibiotics is increasingResistance to antibiotics is increasing4.4. *Obtaining urine sample for UA and C/S *Obtaining urine sample for UA and C/S

before treatment is recommended for older before treatment is recommended for older adultsadults

Duration of Treatment Duration of Treatment For Older WomenFor Older Women

�� Optimal duration of antibiotic therapy: Optimal duration of antibiotic therapy: 3 to 7 days3 to 7 days

�� 33--day treatment course appears as good as day treatment course appears as good as 77--day treatment for uncomplicated day treatment for uncomplicated symptomatic UTI in older women.symptomatic UTI in older women.

Vogel T et al. CMAJ. 2004 Feb 17;170(4):469-73.Lutters M, Vogt-Ferrier NB. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD001535.

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Optimal Duration of Antibiotic Therapy for Uncomplicated UTI in Older Women: a double-blind randomized controlled trial

��183 women (>65 years ) uncomplicated UTI183 women (>65 years ) uncomplicated UTI

Setting: clinics and hospital acute care units. Setting: clinics and hospital acute care units. •• Exclusion:Exclusion: pyelonephritispyelonephritis urinary tracturinary tract•• Exclusion: Exclusion: pyelonephritispyelonephritis, urinary tract , urinary tract abnormalities and DMabnormalities and DM•• Ciprofloxacin 250 mg BID for 3 days followed by Ciprofloxacin 250 mg BID for 3 days followed by placebo for 4 days (3placebo for 4 days (3--day group, N=93) or 250 mg day group, N=93) or 250 mg BID for 7 days (N=90). BID for 7 days (N=90).

CMAJ 2004;170:469-73

Optimal Duration of Antibiotic Therapy for Uncomplicated UTI in Older Women: a double-blind randomized controlled trial

RESULTS:

� Bacterial eradication at 2 days after treatment was Bacterial eradication at 2 days after treatment was 98% (91/93) in the 398% (91/93) in the 3--day group vs 93% (83/89) inday group vs 93% (83/89) in98% (91/93) in the 398% (91/93) in the 3 day group vs. 93% (83/89) in day group vs. 93% (83/89) in the 7the 7--day group (p = 0.16). day group (p = 0.16).

�� Adverse events significantly lower in the 3Adverse events significantly lower in the 3--day group.day group.

Diagnosis of UTI in Older Diagnosis of UTI in Older Adults: Two ComponentsAdults: Two Components

Clinical SymptomsClinical Symptoms�� Lower UTILower UTI�� Upper UTIUpper UTI

Laboratory diagnosticLaboratory diagnostic�� Urine dipstick test: useful for exclusion Urine dipstick test: useful for exclusion �� Urinalysis: Urinalysis: pyuriapyuria�� culture/sensitivity: Routine vs. as needed (unless culture/sensitivity: Routine vs. as needed (unless treatment is ineffective)treatment is ineffective)

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Symptoms Suggestive of “Symptomatic” UTI in the Elderly� Lower UTI:Lower UTI:

Classical: local symptoms, Classical: local symptoms, suprapubicsuprapubic area painarea pain

�� Upper UTI:Upper UTI:Fever, chill, frank area pain, and/or lower urinary Fever, chill, frank area pain, and/or lower urinary

tract symptomstract symptoms

Treatments

� Empirical use of antibiotic Empirical use of antibiotic

v.sv.s..

�� Wait until C/S result availableWait until C/S result available

Risk Factors for Quinolone-resistant E. coli in UTI

1.1.Previous use of ciprofloxacin or Previous use of ciprofloxacin or ofloxacinofloxacin22 Previous invasive procedurePrevious invasive procedure2.2.Previous invasive procedurePrevious invasive procedure3.3.Recurrent UTIRecurrent UTI4.4.Previous hospitalizationPrevious hospitalization

Colodner et al. Infection 2008 Feb;36(1):41-5

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Antibiotics for Empirical Treatment

Guidelines:Guidelines:�� In communities that E In communities that E Coli’sColi’s resistance rate to resistance rate to TMP/SMZ more than 20%, TMP/SMZ more than 20%, nitrofuratoninnitrofuratonin is is considered the first line of choice.considered the first line of choice.

�� For those with risk factors for For those with risk factors for quinolonequinolone--resistant resistant E. Coli, may consider other choices (such as E. Coli, may consider other choices (such as nitrofuratoninnitrofuratonin, or first, or first--generation of generation of cephalosporinscephalosporins).).

Asymptomatic Bacteriuria� Laboratory: Laboratory: pyuriapyuria and and bacteriuriabacteriuria�� If truly asymptomatic, no treatmentIf truly asymptomatic, no treatment�� Common in communities, LTCF, and hospital Common in communities, LTCF, and hospital

settings: 10settings: 10--40% prevalence rate40% prevalence rate� The challenges are those with “Atypical”The challenges are those with “Atypical”The challenges are those with AtypicalThe challenges are those with Atypical

symptomssymptoms•• Cognitively impairedCognitively impaired•• Delirium Delirium •• Unreliable historiansUnreliable historians•• Worsening neurological conditionWorsening neurological condition

Asymptomatic Bacteriuria(ASB)

� Who should be treated?Who should be treated?Pregnant women Pregnant women

�� Patients with DM with ASB in postmenopausal Patients with DM with ASB in postmenopausal women: no evidence of benefits for treatmentwomen: no evidence of benefits for treatment

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ASB vs. UTI in older adults

The challenge involved in distinguishing ASB The challenge involved in distinguishing ASB from UTI results from other cofrom UTI results from other co--morbid morbid illnesses that may present with symptoms illnesses that may present with symptoms similar to UTI, and from elderly adults whosimilar to UTI, and from elderly adults whosimilar to UTI, and from elderly adults who similar to UTI, and from elderly adults who have cognitive impairment not being able to have cognitive impairment not being able to report their symptoms.report their symptoms.

Juthani-Mehta M. Clin Geriatr Med. 2007 Aug;23(3):585-94, vii.Gau et al. J Am Osteopath Assoc 2009; 109(4):220-226.

Why Older Women Develop UTI? p

Risk Factors

Risk Factors for UTI in Older Adults

METHODS:METHODS: A populationA population--based, casebased, case--control control study of women aged between 55 and 75 y/o study of women aged between 55 and 75 y/o enrolled in a large, staffenrolled in a large, staff--model health model health maintenance organizationmaintenance organizationmaintenance organization.maintenance organization.

RISK FACTORSRISK FACTORS::�� A history of UTI (OR=4.20 [3.25A history of UTI (OR=4.20 [3.25--5.42]) 5.42]) �� Diabetes mellitus (OR=2.78 [1.78Diabetes mellitus (OR=2.78 [1.78--4.35]) 4.35]) �� Incontinent (OR=1.36 [1.03Incontinent (OR=1.36 [1.03--1.78])1.78])�� Sexually active (OR=1.42 [1.07Sexually active (OR=1.42 [1.07--1.87]) 1.87])

Hu et al., Arch Intern Med. 2004;164(9):989-93.

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UTI in Older MenUTI in Older Men

�� Older men with UTI often have underlying Older men with UTI often have underlying conditions (e.g., BPH, functional disability, conditions (e.g., BPH, functional disability, autonomic neuropathy from DM). autonomic neuropathy from DM). A tibi ti th h ld l t t l t 14A tibi ti th h ld l t t l t 14�� Antibiotic therapy should last at least 14 Antibiotic therapy should last at least 14 days.days.

�� If prostatic involvement is suspected, If prostatic involvement is suspected, therapy should last at least 6 weeks. therapy should last at least 6 weeks.

High KP. Geriatrics Review Syllabus, 7th edition, 2010; p542

New changes from New changes from French Health French Health Products Safety Agency 2008Products Safety Agency 2008

�� In men, cystitis must be treated as In men, cystitis must be treated as prostatitisprostatitis. . �� A 14A 14--day antibiotic regimen is enough for the day antibiotic regimen is enough for the

easiesteasiest--toto--treat infectionstreat infectionseasiesteasiest toto treat infections. treat infections.

Presse Med. 2010 Jan;39(1):42-8

Urinary Tract Infections in Urinary Tract Infections in yyLongLong--Term Care Facility Term Care Facility

(LTCF)(LTCF)

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Guidelines for LTCF (1)Guidelines for LTCF (1)

�� UA & C/S should not be performed for UA & C/S should not be performed for asymptomatic patients asymptomatic patients

�� Without catheter: Only indicated for those withWithout catheter: Only indicated for those with�� Without catheter: Only indicated for those with Without catheter: Only indicated for those with s/s (fever, s/s (fever, dysuriadysuria, gross , gross hematuriahematuria, new or , new or worsening UI, and/or suspected worsening UI, and/or suspected bacteremiabacteremia))

�� With catheter: obtain UA if suspected With catheter: obtain UA if suspected urosepsisurosepsis with symptoms (fever, rigor, with symptoms (fever, rigor, hypotension, or delirium) in the context of hypotension, or delirium) in the context of recent catheter obstruction or change. recent catheter obstruction or change.

High et al., JAGS 2009;57:375-394

Guidelines for LTCF (2)Guidelines for LTCF (2)

�� For those with catheter: the catheter For those with catheter: the catheter should be changed and urine is obtained should be changed and urine is obtained from that changed catheterfrom that changed catheter--urine urine ggsamples. samples.

High et al., JAGS 2009;57:375-394

Implications and Challenges Implications and Challenges in Treating UTI in LTCFin Treating UTI in LTCF

�� Despite ASB or atypical symptoms, nursing Despite ASB or atypical symptoms, nursing staff may pressure health care providers to staff may pressure health care providers to prescribe antibioticsprescribe antibioticsS bS b li i l t b btlli i l t b btl�� SubSub--clinical symptoms may be subtle or unclinical symptoms may be subtle or un--recognized, particularly in those with recognized, particularly in those with dementia, aphasia, and cognitively impaired dementia, aphasia, and cognitively impaired patientspatients

�� May consider other causes for those with May consider other causes for those with acute clinical changes and lack of typical acute clinical changes and lack of typical symptoms for UTIsymptoms for UTI

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Others to be consideredOthers to be considered

�� Older Adults with lower abdominal discomfort Older Adults with lower abdominal discomfort with increasing frequency or urinary with increasing frequency or urinary incontinenceincontinence

�� UA: UA: pyuriapyuria�� C/S: no bacterial growthC/S: no bacterial growth�� Differential Differential DxDx: :

–– in older menin older men--------consider consider prostatitisprostatitis–– in older women and men: acute diverticulitis and in older women and men: acute diverticulitis and

othersothers

Acute Urine Retention in Older Acute Urine Retention in Older AdultsAdults–– reversible causesreversible causes�� Side effects of medications Side effects of medications

antianti--histamines, decongestants, histamines, decongestants, iprotropiumiprotropium((AtroventAtrovent) inhalers, ) inhalers, muscarinicmuscarinic receptor receptor bl k f UI ti dbl k f UI ti dblockers for UI; narcotic drugs.blockers for UI; narcotic drugs.

�� Fecal impaction/stool retention or BPHFecal impaction/stool retention or BPH�� Electrolyte imbalance: Low K, calcium, Electrolyte imbalance: Low K, calcium,

MagnesiumMagnesium�� A shortA short--term trial of term trial of urecholineurecholine therapy?therapy?�� ShortShort--term catheter use for decompressionterm catheter use for decompression

Areas of Uncertainty (1)Areas of Uncertainty (1)

�� Atypical symptoms: Atypical symptoms:

�� confusion, incontinence, anorexia, or confusion, incontinence, anorexia, or functional declinefunctional decline----------limited studies suggest limited studies suggest ggggthat these symptoms may not be associated that these symptoms may not be associated with UTIs with UTIs

Berman et al., Age Ageing 1987;16:201–207

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Areas of Uncertainty (2)Areas of Uncertainty (2)�� �� consciousness or consciousness or �� sleepiness sleepiness �� “lateral slump sign” “lateral slump sign” � falls� decreased oral intake �� �� cooperation cooperation �� �� resisting careresisting care�� disorganized speech disorganized speech �� behavioral changes not well studied for behavioral changes not well studied for

predicting UTI symptoms.predicting UTI symptoms.Rousseau P. J Am Geriatr Soc 1992;40:1024–1025

Do Cranberries Prevent Do Cranberries Prevent Recurrent UTI?Recurrent UTI?

Cranberries for preventing urinary tract Cranberries for preventing urinary tract infectionsinfectionsinfections infections

Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001321.

Cranberries and UTI

Cranberries: effective in vitro and in vivo in Cranberries: effective in vitro and in vivo in animals for the prevention of UTI; animals for the prevention of UTI;

MechanismMechanism: by inhibiting the adhesion of type I : by inhibiting the adhesion of type I and Pand P--fimbriatedfimbriated uropathogensuropathogens to the to the uroepitheliumuroepithelium, thus impairing colonization and , thus impairing colonization and subsequent infection.subsequent infection.

Guay DR. Drugs. 2009;69(7):775-807.

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TakeTake--Home Message (1)Home Message (1)

�� NitrofurantoinNitrofurantoin is as effective as TMP/SMZ for is as effective as TMP/SMZ for E. Coli UTI (probably also applied to older E. Coli UTI (probably also applied to older adults) adults) UTI i ld h ld b t t d f tUTI i ld h ld b t t d f t�� UTI in older men should be treated for at UTI in older men should be treated for at least 2 weeks.least 2 weeks.

�� UA and C/S should be obtained after bladder UA and C/S should be obtained after bladder catheter has been changed for those with catheter has been changed for those with chronic catheter indwelling.chronic catheter indwelling.

TakeTake--Home Messages (2) Home Messages (2)

�� Consider other diagnosis if clinical picture Consider other diagnosis if clinical picture and lab results do not matchand lab results do not match

�� Do no harmDo no harmT t t f ASB d t h l ti tT t t f ASB d t h l ti t–– Treatment for ASB does not help patients Treatment for ASB does not help patients but impose adverse effects of antibiotic usebut impose adverse effects of antibiotic use

–– CatheterCatheter--related bacteriuria without related bacteriuria without symptoms: Resist the temptation for symptoms: Resist the temptation for treatmenttreatment------do not treatdo not treat

In the following statements regarding the In the following statements regarding the management of UTI in older adults, which one management of UTI in older adults, which one is is not not correct?correct?

1) 1) nitrofurantoinnitrofurantoin (100 mg bid for 5 days) (100 mg bid for 5 days) therapy is comparable to therapy is comparable to trimethoprimtrimethoprim--

lf th llf th l (TMP/SMZ) 3(TMP/SMZ) 3 d th ifd th if

QuestionQuestion

sulfamethoxazolesulfamethoxazole (TMP/SMZ) 3(TMP/SMZ) 3--day therapy if day therapy if renal function is not significantly impaired renal function is not significantly impaired ((eGFReGFR>60 ml/min/1.73 m>60 ml/min/1.73 m22).).

2). Amoxicillin or 2). Amoxicillin or ampicillinampicillin should not be used should not be used for empirical treatment for UTI given the for empirical treatment for UTI given the relatively poor efficacy and the very high relatively poor efficacy and the very high prevalence of resistance to these agents prevalence of resistance to these agents worldwide.worldwide.

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In the following statements regarding the In the following statements regarding the management of UTI in older adults, which one management of UTI in older adults, which one is is not not correct?correct?

QuestionQuestion

3). UTI in older men can be effectively treated 3). UTI in older men can be effectively treated with 3 days of TMP/SMZ. with 3 days of TMP/SMZ.

4). When suspecting an acute 4). When suspecting an acute pyelonephritispyelonephritis, a , a urine culture and susceptibility test should urine culture and susceptibility test should always be performed. always be performed.

ReferencesReferences

�� Caron F. Diagnosis and treatment of communityCaron F. Diagnosis and treatment of community--acquired urinary tract infections in adults: what has acquired urinary tract infections in adults: what has changed. 2008 guidelines of the French Health changed. 2008 guidelines of the French Health Products Safety Agency (AFSSAPS)Products Safety Agency (AFSSAPS) PressePresse MedMedProducts Safety Agency (AFSSAPS). Products Safety Agency (AFSSAPS). PressePresse Med.Med.2010;39(1):422010;39(1):42--8. 8.

�� Hooton et al. Diagnosis, prevention, and treatment of Hooton et al. Diagnosis, prevention, and treatment of cathetercatheter--associated UTI in adults: 2009 International associated UTI in adults: 2009 International Clinical Practice Guidelines from the IDSA. Clinical Practice Guidelines from the IDSA. ClinClin Infect Infect Dis.Dis. 2010;50(5):6252010;50(5):625--63.63.

ReferencesReferences�� High KP. Geriatrics Review Syllabus, 7High KP. Geriatrics Review Syllabus, 7thth edition, 2010; edition, 2010;

pp 541pp 541--22

�� High et al., Clinical Practice Guideline for the High et al., Clinical Practice Guideline for the Evaluation of Fever and Infection in Older Adult Evaluation of Fever and Infection in Older Adult Residents of LongResidents of Long--Term Care Facilities: 2008 Update Term Care Facilities: 2008 Update by the IDSA. by the IDSA.

�� J Am J Am GeriatrGeriatr Soc 57:375Soc 57:375––394, 2009.394, 2009.

�� International clinical practice guidelines for the International clinical practice guidelines for the treatment of acute uncomplicated cystitis and treatment of acute uncomplicated cystitis and pyelonephritispyelonephritis in women: A 2010 update by the IDSA in women: A 2010 update by the IDSA and the European Society for Microbiology and ID. and the European Society for Microbiology and ID. ClinClinInfect Infect DisDis 2011;52(5):5612011;52(5):561--64.64.

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Clinical Considerations in Aging Adults with HIV

Robert L. Brandt, Jr, MD

Learning Objectives:

Design and implement strategies for managing aging and HIV-related comorbidities in older adults

Speaker Disclosure:

Dr Brandt has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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NOTES

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Symposium III

Management Issues for Better Patient Care

Moderator:

Cynthia Olsen, MD, FAAFP, CMD Acting Chairman, Department of Family Medicine

Wright State University Boonshoft School of Medicine

Moderator Disclosure:

Dr. Olsen has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Post-Operative Management of the Elderly

Arvind Modawal, MD, MPH, GSF, FAAFP

Learning Objective:

Present an overview of post operative management of selected medical conditions in the elderly.

Speaker Disclosure:

Dr. Modawal discloses he is on the Speaker’s Bureau for Merck.

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Postoperative management of Postoperative management of the elderlythe elderly

Arvind Modawal, MD MPH AGSF FAAFPProfessor of Family and Community Medicine Section of Geriatrics and Palliative careUniversity of Cincinnati College of [email protected] Fork, Cambridge Ohio October 15, 2011

Objectives Objectives

Present an overview of post operative management of selected medical conditions in the elderly

Look at aging related issues during oo at ag g e ate ssues u g hospitalization

Touch on aspects of Rehabilitation after surgical procedures

Post-hospital care transition to SNF, ALF and Home

Surgery in the elderlySurgery in the elderly Common - >55% operative procedures in

patients >65yrs Many chronic conditions are treatable by

surgery – OA, cataract, vascular lesions, cancer Major improvements in surgical techniques,

anesthetic, and medical care – more outpatient surgery is done

Elderly still suffer three-quarters of post-op mortality

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Aging physiology Aging physiology –– changes changes

Wide heterogeneity Altered body composition Decreased kidney function Hepatic blood flow and enzyme activity Hepatic blood flow and enzyme activity Cardiac and vascular stiffness Decrease in pulmonary reserve Brain changes – atrophy and cognitive Skin changes

PeriPeri--operative medical therapy operative medical therapy

Pre-op evaluations for ‘clearance’ for surgery as 25-30% deaths from cardiac causes◦ Low risk vs. High risk surgery◦ Elective vs. emergency◦ Assessment of function◦ Quality of life◦ Patient and family preferences and goals◦ Cardiac risk index, EKG, Echo, exercise capacity,

uncontrolled hypertension◦ Peri-operative Beta-blockade

PostPost--anesthesia recoveryanesthesia recovery

Respiratory distress and hypoxemia- all should get Oxygen (keep in PACU/ICU)

Cardiovascular instability – low BP and high heart rate – need volume g ea t ate ee vo u e resuscitation first

Blood sugar control <150mg% Mental status changes Pain control – often manifests as high BP

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Cardiovascular problemsCardiovascular problems

Most common cause of mortality is myocardial infarction occurring in first 5 days post-operatively

May not have ‘typical’ chest painay ot ave typ ca c est pa Administer B blockers pre-op and 7 days

post-op to keep HR <70 and BP >100, IV labetalol or metoprolol

Control pain with IV opioids or PCAs Statins for vascular surgery and high risk

Kidney and electrolyte disordersKidney and electrolyte disorders Renal failure usually due to inadequate

fluid replacement and or fluid/blood loss May not manifest for 24-48 hours Opioid induced sphincter spasm may

require indwelling urinary catheter despite desire to remove asap

ARF - Acute hypotension, ATN, contrast, post transfusion myoglobulins, and rhabdomyolysis

50% mortality after acute renal failure

Gastrointestinal problemsGastrointestinal problems Nausea and vomiting ◦ Women◦ Poorly controlled pain◦ Hypotension◦ Hx of motion sicknessT d i h 5HT3 iTreated with 5HT3 receptor antagonists

Postoperative ileus – much reduced by laparoscopic procedures

Stress ulcers – PPI not for routine prophylaxis but for the critically ill

Elevation of liver enzymes common after major surgery

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Endocrine abnormalitiesEndocrine abnormalities Diabetes – measure glucose q 4hrs and

maintain blood glucose <130mg% Infection rate doubles if HbAic >7% Intraoperative and postoperative insulin for

those needing insuling If on steroids continue usual dose and give

additional Hydrocortisone 50-100mg IV q 8hrs

Thyroid disorders – cause of hypotension, CHF and cardiac death, ‘sick euthyroid’ disorder

Delirium and postDelirium and post--operative operative cognitive declinecognitive decline Delirium 5-50% in over >50yrs most

prominent after hip and aortic surgery◦ Increase in complications (pulm./cardiac)◦ Poor functional recoveryy◦ Increase length of stay◦ Increase risk of dementia◦ Functional decline◦ Increase in mortality ◦ Can be prevented!

Delirium screeningDelirium screening Confusion Assessment Method (CAM)1. Acute onset and fluctuating course- AND2. Inattention- AND EITHER3. Disorganized thinking- OR4. Altered level of consciousness(Sensitivity and specificity 95%)

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Delirium and cognitive dysfunctionDelirium and cognitive dysfunction

Prevention – attention to underlying risk factors hypoxemia, Co2, electrolytes, sepsis, by keeping hct >30%, minimize benzos and anticholinergics, regular bowel function maintenance, early discontinuation of u. catheter, early mobilization,

i f i l d h i i i correction of visual and hearing impairment, use of low dose risperidone and haloperidol

Postoperative cognitive dysfunction◦ Transient lasts 3 months◦ 25% cardio-pulmonary surgery◦ 15% after non-cardiac surgery◦ For both general and regional anesthesia

Pain managementPain management

Pain must be controlled Risk of MI/ respiratory failure and atelectasis Regular scheduled IV opioids and later oral PCA safe (‘lock out’ mode and Co2 sensors)PCA safe ( lock out mode and Co2 sensors) Epidural analgesia – outcomes better Avoid NSAIDS – increase risk of bleeding

and renal failure Avoid morphine if renal failure, IV Fentanyl

or hydromorphone may be better

DVT and PE prophylaxisDVT and PE prophylaxis If already on warfarin – stop 5 days prior to

bring INR <1.6, ‘bridge’ for 3 days until a day pre-op and recommence oral night of surgery for high risk with IV heparin or LMWH post-opH d d Th b (HIT) Heparin induced Thrombocytopenia (HIT)

- common cause of thrombosis 50% - develops 5-10 days after IV heparin - Platelet count drops by 50% - diagnosis by heparin antibody ELISA or functional assay

Sequential compression device (SCD) if risk of bleeding

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DVT prophylaxisDVT prophylaxis

Total hip or knee arthroplasty◦ Dalteparin 5000u SC daily for 7-14days◦ Enoxaparin 40mg SC q24h for 7-14days◦ Fondaparinux 2.5mg/d SC q daily 7-14 daysp g q y y

◦ Beginning 6-12 hrs post-op◦ Abdominal surgery – start 2h pre-op◦ Monitor CBC before starting and every 2-3

days when on Heparin or LMWH

Pulmonary complicationsPulmonary complications Complication rate 9-19% for thoracic,

cardiac and abdominal surgery, increases with increased anesthesia time, general anesthesia and emergency operations

Age strongest predictor, complications Age strongest predictor, complications four times in >50 years besides COPD, CHF, dependent function, impaired sensorium, prior stroke, long-term steroid use, heavy alcohol consumption, current cigarette smoking

Prevention: Incentive Spirometry for15 minutes q2hrs, and deep breathing exercises every hour, Acapella to clear secretion for COPD/pneumonia

Antibiotic prophylaxisAntibiotic prophylaxis

Prophylactic antibiotics are considered standard of care

No single regimen shown to be superior- usually 1st generation cephalosporin (Cefazolin)- usually 1 generation cephalosporin (Cefazolin)

- give 60 minutes prior to incision

- repeat dose if surgery > 4 hours

Nasal carriage of staph increases infection 2-9 fold, screening interventions has failed to reduce infection rates

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Hematologic issues, blood loss and Hematologic issues, blood loss and replacementreplacement Preoperative anemia is common (43% in

large cohort of elderly veterans) but there are no recommendations on need for preoperative transfusion

Postoperative transfusion – traditionally Hb>10 /dl d d b t l t di h t >10 g/dl recommended but several studies have not shown benefit of transfusion above a threshold of 7 g/dl

Care of bowel, bladder and skinCare of bowel, bladder and skin

Typical Ileus after abdominal surgery last 72 - 91 hours

Remove Foley ASAP unless there is opioidinduced spasm of sphincteruce spas o sp cte

Opioid induced constipation – digital examination

Skin and wound care Early post-op mobilization

Hip fracture rehabilitationHip fracture rehabilitation Functional outcomes are better with hip

replacement than nail-and-plate or pin-and-plate fixation

Femoral Neck fracture◦ Multiple pins/plate – OOB in wheelchair, begin

standing days 5-7, weight bearing as tolerated, ambulation with walker, full weight bearing in 6-12 weeks with walker

Intertrochanteric and subtrochanteric◦ Nail plate or medullary nail – progressing

weight bearing in first week, initially partial weight bearing then weight bearing as tolerated

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Discharge planningDischarge planning

Communication - begin early by informing discharge planner/social worker

Sites - acute rehab, LTAC, SNF, ALF or home with ‘Home health care’ agency

Complete continuity of care (interfacility) forms/ discharge summaries – listing all diagnoses, specific orders IV, O2, dressing changes, therapies and services needed, weight bearing status, cognitive impairment, dysphagia and diet, tube feeding instruction, medications, falls risk, wound, follow up appointments with PCP/specialists

SNF careSNF care

SNF – requires 3 day hospital stay for eligibility, Medicare part A pays 100% days 1-20, then patient pays $140/day for days 21-100 with Medicare covering the rest, gpatient pays 100% after day 100

Benefits of multidisciplinary care in nursing homes

Assisted Living facilityAssisted Living facility

Usually for those patient who already live there

Post-op therapies is out of pocket expense unless covered by some long e pe se u ess cove e by so e o g term insurance

Contractual arrangements made by facility with therapy agencies

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Home Home with Home Health carewith Home Health care

Best if patient is independent in ADLs with other caregiver support available

Medicare part A benefit of Home Health care available for a limited period for ca e ava ab e o a te pe o o therapies, nursing care etc.

Needs physician certification – of home bound status, eligibility and face-to-face encounter documentation

Take home pointsTake home points

Due to aging related changes post-operative care in the elderly requires careful attention to pre-op heath status, function, social support and underlying pp y gmedical conditions

Early mobilization, removal of indwelling catheters, therapies, discharge planning prevents complications and improves outcomes

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Clinical Pearls in Management of Fracture Risk in Your Patients

David W. Regule, MD, PT, MS

Learning Objective:

Identify high risk patients who would most benefit from pharmacologic therapy to mitigate bone fracture risk.

Speaker Disclosure:

Dr. Regule has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Clinical Pearls in Management of Fracture Clinical Pearls in Management of Fracture Risk in Your PatientsRisk in Your Patients

DavidDavid ReguleRegule, MD, MDRheumatologist Rheumatologist

Internal Medicine Residency Faculty, Internal Medicine Residency Faculty, SEHCSEHC

Note that I have NO financial disclosuresNote that I have NO financial disclosures

�� 68 yo 68 yo caucasioncaucasion female new to your practice had female new to your practice had DEXA 6 years ago with DEXA 6 years ago with TscoreTscore --1.8 at hip and 1.8 at hip and was started on was started on AlendronateAlendronate at that time. She at that time. She concerned because her sister fractured her ankle concerned because her sister fractured her ankle and her mom has “osteoporosis and is on that new and her mom has “osteoporosis and is on that new medicine medicine BonivaBoniva”, she’s a former heavy smoker ”, she’s a former heavy smoker and drinks a lot of coffee. and drinks a lot of coffee.

�� You repeat a DEXA which shows a worsening hip You repeat a DEXA which shows a worsening hip score Ward’s L hip T score score Ward’s L hip T score --1.91.9

�� She also complains of occasional GERD and has She also complains of occasional GERD and has been taking OTC been taking OTC PepcidPepcid for a few years.for a few years.

�� What do you advise?What do you advise?

I will explain laterI will explain later

�� 1. Continue 1. Continue AledronateAledronate and start PPIand start PPI�� 2. Switch to 2. Switch to RaloxifeneRaloxifene�� 3. Stop 3. Stop AledronateAledronate and stop H2RA if not and stop H2RA if not

neededneeded�� 4. Start PTH / 4. Start PTH / TeraparitideTeraparitide treatmenttreatment�� 5. Start IV bisphosphonate therapy5. Start IV bisphosphonate therapy

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Let’s talk who’s at RISKLet’s talk who’s at RISK�� Predict who is at high risk for future fragility fractures Predict who is at high risk for future fragility fractures

AND would benefit from pharmacologic therapyAND would benefit from pharmacologic therapy

�� What are the significant risk factors?What are the significant risk factors?–– Age?Age?Age?Age?–– CaucasionCaucasion Female?Female?–– DEXA DEXA --1.9?1.9?–– Family history of Osteoporosis?Family history of Osteoporosis?–– Family history of ankle fracture?Family history of ankle fracture?–– Former heavy Former heavy mokermoker??–– OTC OTC pepcidpepcid use?use?

Strongest Osteoporotic Risk Strongest Osteoporotic Risk FactorsFactors

–– 1. Personal Prior History of FRAGILITY 1. Personal Prior History of FRAGILITY fracture after age 40fracture after age 40»» Increase risk of future fracture by 2Increase risk of future fracture by 2--4 fold4 fold

–– 2. Elderly / Advanced AGE particularly 2. Elderly / Advanced AGE particularly 70s70s--80s80s

�� THESE TWO are MORE predictive than THESE TWO are MORE predictive than low risk DEXAlow risk DEXA–– measurements T score measurements T score --1.0 to 1.0 to --2.02.0

AGE risk vs. DEXA riskAGE risk vs. DEXA risk�� Hypothetical patients with Hypothetical patients with No OtherNo Other risk factors risk factors

for osteoporosisfor osteoporosis�� All of the following have All of the following have EQUAL risk of 3EQUAL risk of 3%%

in next 10 years of sustaining a hip fracture:in next 10 years of sustaining a hip fracture:

–– 55 yo F with DEXA T 55 yo F with DEXA T --2.62.6–– 62 yo F with DEXA T 62 yo F with DEXA T --2.12.1–– 67 yo F with DEXA T 67 yo F with DEXA T --1.91.9–– 72 yo F with DEXA T 72 yo F with DEXA T --1.41.4–– 77 yo F with DEXA T 77 yo F with DEXA T --0.90.9

�� Numbers plugged into WHO FRAX calculatorNumbers plugged into WHO FRAX calculator

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Age is more predictive than DEXAAge is more predictive than DEXA

�� Same BMD: 60 yo with 2.3% Same BMD: 60 yo with 2.3% vsvs 80 yo with 9.7% risk of 80 yo with 9.7% risk of hip hip fxfx in next ten yearsin next ten years

�� Telling the 60 yo “she has the bones of an elderly 80 year Telling the 60 yo “she has the bones of an elderly 80 year old” is NOT an accurate reflection of fracture riskold” is NOT an accurate reflection of fracture risk

–– she’s at she’s at 1/51/5thth the riskthe risk

“80 yo with the bones of a 60 yo (average 60 yo T score “80 yo with the bones of a 60 yo (average 60 yo T score --1.0)1.0)hashas moremore of a fracture risk than a 60 yo with bones of an of a fracture risk than a 60 yo with bones of an 80 yo (average 80 yo T score 80 yo (average 80 yo T score --2.0)”2.0)”

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Prior History of Non Traumatic or Prior History of Non Traumatic or Fragility FractureFragility Fracture

�� Once one fx then risk for repeat fx 2Once one fx then risk for repeat fx 2--44times greatertimes greater–– The Study of Osteoporotic Fractures in the USA relative risks The Study of Osteoporotic Fractures in the USA relative risks

above 2 for the osteoporotic fractures, no increase in risk for above 2 for the osteoporotic fractures, no increase in risk for ankle fracturesankle fractures

�� ONLY vertebral, hip, forearm and ONLY vertebral, hip, forearm and humerus are predictive of 2 fold riskhumerus are predictive of 2 fold risk

»» Non traumatic fractures only Non traumatic fractures only

–– Prior vertebra, humerus, forearm, and hip fx also Prior vertebra, humerus, forearm, and hip fx also predicted T score less than predicted T score less than --2.5 study by Leslie 2.5 study by Leslie

»» Foot fractures and ankle fractures were not Foot fractures and ankle fractures were not related to bone densityrelated to bone density

–– http://courses.washington.edu/bonephys/ophome.htmlhttp://courses.washington.edu/bonephys/ophome.html

The Major Risk FactorsThe Major Risk Factors

�� 1. History of prior fragility fracture in 1. History of prior fragility fracture in hip,hip,vertebra, forearm, humerus, pelvisvertebra, forearm, humerus, pelvis–– not ankle/feetnot ankle/feet–– Fall from standing height,Fall from standing height, nontraumaticnontraumaticg g ,g g ,

�� 2.2. Advanced ageAdvanced age and Femaleand Female

�� 3. In the elderly 3. In the elderly Frequent FallsFrequent Falls–– even with low risk DEXAeven with low risk DEXA

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Some other “truly significant” risk Some other “truly significant” risk factorsfactors

�� WeightWeight <127<127 lbslbs

�� 11stst degree Family History (degree Family History (mommom ororsistersister) who had ) who had HIPHIP fracturefracture

�� Current smokerCurrent smoker

�� >2 alcoholic beverages daily>2 alcoholic beverages daily

Medication Risk Factors, increased Medication Risk Factors, increased risk for accelerated bone lossrisk for accelerated bone loss

�� High riskHigh risk medication: medication: –– PrednisonePrednisone >7.5mg/day for >3months>7.5mg/day for >3months

»» Especially if hypercalciuria >300mg/day developsEspecially if hypercalciuria >300mg/day develops

L lidL lid–– LeuprolideLeuprolide–– Letrozole/Letrozole/Aromatase inhibitor Aromatase inhibitor

»» Even in men aromatase inhibition is high riskEven in men aromatase inhibition is high risk

�� Low risk meds like phenytoin or therapeutic synthroid, Low risk meds like phenytoin or therapeutic synthroid, heparin don’t require special monitoring.heparin don’t require special monitoring.–– Phenytoin interferes with vitamin D metabolism may Phenytoin interferes with vitamin D metabolism may

cause cause osteomalaciaosteomalacia----add vit Dadd vit D

�� Is chronic daily PPI or H2RA high risk?Is chronic daily PPI or H2RA high risk?

Does PPI or H2RA cause bone Does PPI or H2RA cause bone loss?loss?

�� per online Digestive Disease Weekper online Digestive Disease Week

10 years of10 years of chronic PPI usechronic PPI use»» 12%12% increased hip fracture risk increased hip fracture risk <1 pill<1 pill dailydaily

»» 30%30% for those taking usual dose of for those taking usual dose of one pillone pill dailydaily

»» 41%41% for those taking for those taking moremore than one pill dailythan one pill daily

–– Risk with PPI Risk with PPI greatest among 50greatest among 50--59 age59 age groupgroup–– Most fractures occur age 80Most fractures occur age 80--89 because of age risk89 because of age risk

�� Retrospective Kaiser Permanente analysisRetrospective Kaiser Permanente analysis Hip Fracture Hip Fracture increased by 30% more likely with PPIincreased by 30% more likely with PPIandand 18% risk with H2RA18% risk with H2RA when used for at when used for at least 2 yearsleast 2 years

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Medical Conditions high risk for Medical Conditions high risk for accelerated bone lossaccelerated bone loss

�� Long term Long term UncontrolledUncontrolled HyperthyroidismHyperthyroidism

�� HyperHyperParaParathyroidismthyroidism untreateduntreatedL diL di ACTIVEACTIVE i fl t dii fl t di�� Long standingLong standing ACTIVEACTIVE inflammatory diseaseinflammatory disease–– RA or Ankylosing SpondylitisRA or Ankylosing Spondylitis

�� GI DiseasesGI Diseases–– Inflammatory Bowel Disease or other malabsorptive Inflammatory Bowel Disease or other malabsorptive

conditions like Celiac Sprue, primary biliary cirrhosis conditions like Celiac Sprue, primary biliary cirrhosis or post bariatric surgeryor post bariatric surgery

Early Menopause?Early Menopause?

�� If premature Menopausal (natural or If premature Menopausal (natural or surgical)surgical)

risk factor for SOONER screeningrisk factor for SOONER screening–– risk factor for SOONER screeningrisk factor for SOONER screeningDEXA only DEXA only »»i.e. menopause at age 45 than screen at i.e. menopause at age 45 than screen at

age 55age 55–– NOT a factor when considering treatment NOT a factor when considering treatment

decisionsdecisions

Review True Risk FactorsReview True Risk Factors�� Female Advanced AgeFemale Advanced Age�� Fragility Fx after age 40Fragility Fx after age 40�� Frequent fallsFrequent falls�� Current smokerCurrent smokerCurrent smokerCurrent smoker�� >2 alcoholic beverages per day>2 alcoholic beverages per day�� Weight <127Weight <127�� Mom or sister sustained hip FxMom or sister sustained hip Fx�� High Risk medicationHigh Risk medication�� High Risk medical conditionHigh Risk medical condition

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Next ConsiderationNext Consideration�� DEXA interpretationsDEXA interpretations�� VFA, 2 inch loss of heightVFA, 2 inch loss of height�� Work up for Work up for SecondarySecondary osteoporosisosteoporosis

–– Situations with high PTHSituations with high PTH�� Treatment optionsTreatment options�� Bone turnover markersBone turnover markers�� When to start therapy after fractureWhen to start therapy after fracture�� Therapeutic failure recommendationsTherapeutic failure recommendations

Label OsteoporosisLabel Osteoporosis�� MorphometricMorphometric DEXA definitionDEXA definition

–– T score more negative than T score more negative than --2.5 in one of the 3 2.5 in one of the 3 »» 1. Either Hip Total1. Either Hip Total»» 2. Either Hip neck (ignore wards, 2. Either Hip neck (ignore wards, trochantertrochanter sites)sites)»» 3. Average Lumbar Spine 3. Average Lumbar Spine –– exclude outliers, scoliosis, compressed, or post surgical exclude outliers, scoliosis, compressed, or post surgical

levelslevels

»» May substitute Distal 1/3 radius for spineMay substitute Distal 1/3 radius for spiney py p

�� CLINICALCLINICAL OP definition also called “ OP definition also called “ ESTABLISHEDESTABLISHED or or SEVERESEVEREOsteoporosis”Osteoporosis”–– ““Fragility Fracture of a long bone or vertebralFragility Fracture of a long bone or vertebral””——not ankle/footnot ankle/foot

»» Clinical judgment “Clinical judgment “NONNON--TRAUMATICTRAUMATIC””–– VFA shows compression VFA shows compression fxfx (occurred without (occurred without

trauma)trauma)

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Low Bone Mass = Low Bone Mass = OsteopeniaOsteopenia“a useless designation”“a useless designation”

�� OsteopeniaOsteopenia is a is a morphometricmorphometric term term –– T score T score --1.0 to 1.0 to --2.52.5

HH t it i ll d ’t ill d ’t i–– HoweverHowever osteopeniaosteopenia generally doesn’t requiregenerally doesn’t requiretherapy in patients not on steroids or recent therapy in patients not on steroids or recent fracturefracture

–– DEXAs should be interpreted with “numbers!” DEXAs should be interpreted with “numbers!” »» T<T<--2.0 cut off might yield more significance and 2.0 cut off might yield more significance and

“less confusion”“less confusion”»» recommend not “labeling patients” T recommend not “labeling patients” T --1.0 to 1.0 to --2.02.0

“Osteopenia” a useless term“Osteopenia” a useless termcompared to T score <compared to T score <--2.02.0

NNT to prevent one fractureNNT to prevent one fracture�� T <T <--2.5 152.5 15�� T <T <--2.0 202.0 20�� T<T<--1.6 to 1.6 to --2.0 >5002.0 >500�� One prior Vertebral Fx 40One prior Vertebral Fx 40�� Two or more Vertebral Fx 10Two or more Vertebral Fx 10

–– Doug Paauw, MedStudy presentationDoug Paauw, MedStudy presentationUniversity of Washington School of MedicineUniversity of Washington School of Medicine

“Normal” bone loss“Normal” bone loss–– A normal female with peak mass in 30A normal female with peak mass in 30--40s and a T 40s and a T

score of 0 = Z score of 0score of 0 = Z score of 0–– Will normally regress to a T score of Will normally regress to a T score of ––1.0 by age 60 1.0 by age 60

and T score and T score --2.0 by age 80 will still be Z score = 02.0 by age 80 will still be Z score = 0�� Post menopausal period NORMAL to loss 1% per Post menopausal period NORMAL to loss 1% per

year BMD (accelerated immediate stage more)year BMD (accelerated immediate stage more)year BMD (accelerated immediate stage more)year BMD (accelerated immediate stage more)�� Average Female age 60 to Age 80Average Female age 60 to Age 80

–– Loss of one standard deviation will Loss of one standard deviation will doubledouble her fracture her fracture risk based on Change of T score risk based on Change of T score --1.0 to 1.0 to --12.0 = typical 12.0 = typical age related bone lossage related bone loss

–– This does NOT include the additional fracture risk base This does NOT include the additional fracture risk base based solely on advancing age = 5x the riskbased solely on advancing age = 5x the risk

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DEXA ExceptionsDEXA Exceptions

�� Age <50 do NOT use T score, but use Age <50 do NOT use T score, but use ZZscore <score <--2.02.0 = “high risk for accelerated = “high risk for accelerated b l ”b l ”bone loss”bone loss”

��Distal 1/3 radiusDistal 1/3 radius preferred in younger preferred in younger patient with patient with accelerated bone lossaccelerated bone loss likelikeuncontrolleduncontrolled hyperparathyroidismhyperparathyroidism

Ask if 2 inch height lossAsk if 2 inch height loss�� Height loss >2 inches and Height loss >2 inches and asymptomaticasymptomaticTHEN Order separately a THEN Order separately a VFA with the DEXAVFA with the DEXA

“vertebral fracture assessment”“vertebral fracture assessment”((sagittalsagittal thoracolumbarthoracolumbar composite film)composite film)

�� Screens for Screens for old compression fracturesold compression fractures–– if they did NOT have major symptomatic fall to cause if they did NOT have major symptomatic fall to cause

the vertebral compression the vertebral compression fxfx

Work Up for Secondary causes OPWork Up for Secondary causes OP�� 2525 HydroxyHydroxy Vitamin DVitamin D�� EarlyEarly amam fastingfasting spot Urinespot Urine

–– CalciumCalcium // CreatinineCreatinine ratioratio

�� Intact PTHIntact PTH with Calciumwith CalciumCC�� CMPCMP withwith phoshorousphoshorous (calcium, (calcium, creatininecreatinine,,liver, AP)liver, AP)–– Elevated Elevated Alkaline Alkaline PhosphatasePhosphatase suggests bone suggests bone

disorderdisorder

�� ConsiderConsider SPEP and UPEPSPEP and UPEP»» UPEP also screens for early UPEP also screens for early nephroticnephrotic syndromesyndrome

�� Males check TestosteroneMales check Testosterone levelslevels

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Vitamin D screeningVitamin D screening

�� 1,25 Vitamin D1,25 Vitamin D testingtesting NOTNOT necessarynecessary–– unless RENAL patient with increased PTHunless RENAL patient with increased PTH–– unexplained unexplained HypercalcemiaHypercalcemia

�� 2525 HydroxyVitaminHydroxyVitamin D levelsD levels 2 subtypes2 subtypes�� 2525 HydroxyVitaminHydroxyVitamin D levelsD levels –– 2 subtypes2 subtypes–– D2 shows supplemental D2 shows supplemental DrisdolDrisdol ingestioningestion

»» can be used to confirm compliancecan be used to confirm compliance–– D3 endogenous production D3 endogenous production –– most labs give total result onlymost labs give total result only

�� Goal Goal VitVit D (25 D (25 hydroxyhydroxy) >35 if on ) >35 if on pharmacologic therapy for bone losspharmacologic therapy for bone loss

Increased PTH, now what?Increased PTH, now what?�� IsIs serum Calciumserum Calcium low, normal, or high?low, normal, or high?

�� IonizedIonized calcium levels? Chronic acidosis?calcium levels? Chronic acidosis?

�� 25 Vitamin D level25 Vitamin D level deficient? Shoulddeficient? Should 11--2525�� 25 Vitamin D level25 Vitamin D level deficient? Shoulddeficient? Should 11 2525Dihydroxy Vit DDihydroxy Vit D be checked?be checked?

�� Any renal insufficiency or increased Any renal insufficiency or increased serumserumphosphorousphosphorous??

�� What does What does UrineUrine Calcium, Phosphorus, or Calcium, Phosphorus, or calcium/creatininecalcium/creatinine ratio show?ratio show?

Most common reason for Most common reason for increased PTHincreased PTH

�� 25 Hydroxy Vitamin D deficiency25 Hydroxy Vitamin D deficiency

–– Inhouse St. Es study in NE Ohio:Inhouse St. Es study in NE Ohio:

Drawn in during winter months Dec 08Drawn in during winter months Dec 08--Jan 09Jan 09

MeanMean Vitamin D level of Vitamin D level of 21.521.5Distribution shown on next graftDistribution shown on next graft

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Vitamin D Vitamin D DistributionDistributionNE Ohio in NE Ohio in

Winter monthsWinter months

Gary Turner, Gary Turner, Dinah Fedyna, Brian Dinah Fedyna, Brian

Selius,Selius,Department of Family Medicine, Department of Family Medicine,

St. Elizabeth Health Center, St. Elizabeth Health Center, Youngstown, OhioYoungstown, Ohio

Primary HyperparathyroidismPrimary Hyperparathyroidism�� Generally HIGH CalciumGenerally HIGH Calcium

�� Normal or High PTH Normal or High PTH –– “NORMAL” level PTH“NORMAL” level PTH when Calcium high is when Calcium high is

INAPPROPRIATELY elevated to normal rangeINAPPROPRIATELY elevated to normal rangeggand not suppressedand not suppressed

�� +/+/-- Increased 1,25 diHydroxy Vit DIncreased 1,25 diHydroxy Vit D

�� INCREASEDINCREASED URINEURINE CALCIUMCALCIUM–– >400/day or >400/day or Calcium/ CrCalcium/ Cr ratio >0.02ratio >0.02–– LOW PHOSPHOROUS in UrineLOW PHOSPHOROUS in Urine

Calcium SupplementationCalcium Supplementation�� Up to BIDUp to BID Calcium tabs 500Calcium tabs 500--600mg (preferably 600mg (preferably

one tab on 2 separate meals)one tab on 2 separate meals)–– Antacid/PPIs may decrease absorption when taken on Antacid/PPIs may decrease absorption when taken on

empty stomachempty stomach

�� QDQD Calcium tab adequate if:Calcium tab adequate if:–– >2 servings of dairy products daily>2 servings of dairy products daily>2 servings of dairy products daily>2 servings of dairy products daily–– if on HCTZ if on HCTZ –– if elderly or/with mild CKDif elderly or/with mild CKD

»» Newly identified increased CV risk mortality with higher doses Newly identified increased CV risk mortality with higher doses of calcium:of calcium:

»» if elderly or GFR<45 if elderly or GFR<45 advise advise againstagainst >700mg day>700mg day

�� hx of CALCIUM kidney stone (use hctz?)hx of CALCIUM kidney stone (use hctz?)»» Calcium tablets taken on Calcium tablets taken on empty stomachempty stomach may increase risk may increase risk

for Calcium kidney stones, however high salt diet is higher riskfor Calcium kidney stones, however high salt diet is higher risk»» Probably NO significant risk if calcium taken with foodProbably NO significant risk if calcium taken with food

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Classic Pharmacologic TherapyClassic Pharmacologic Therapy�� 1.1. Calcitonin nasal sprayCalcitonin nasal spray

–– not recommended chronically b/c Tachyphylaxis /Loss of not recommended chronically b/c Tachyphylaxis /Loss of efficacy after few monthsefficacy after few months

–– helpful after ACUTE compression fracture for pain reliefhelpful after ACUTE compression fracture for pain relief

�� 2.2. Raloxifene, Tamoxifen, or EstrogenRaloxifene, Tamoxifen, or EstrogenEstrogen for 2 years if Estrogen for 2 years if severe hot flashes awakeningssevere hot flashes awakeningsContraindicated with hx: Contraindicated with hx: DVT, MI, CVA, active smokerDVT, MI, CVA, active smoker

�� 3.3. BisphosphonatesBisphosphonates 3 oral agents3 oral agents»» 2 IV agents if severe GERD or malabsorption noted2 IV agents if severe GERD or malabsorption noted»» Denosumab new osteoclast inhibitor Denosumab new osteoclast inhibitor

�� 4. 4. TeraparitideTeraparitide subQ QD inj for 2 yearssubQ QD inj for 2 years»» Stop bisphosphonate while on ForteoStop bisphosphonate while on Forteo»» Strongest anabolic agent availableStrongest anabolic agent available

What about Breast Cancer ReductionWhat about Breast Cancer ReductionSERMSERM vsvs BisphosphonateBisphosphonate

�� Bisphosphonates recently have also demonstrated primary Bisphosphonates recently have also demonstrated primary and secondary breast CA reduction data and secondary breast CA reduction data

–– Note Bisphosphonate therapy significantly decreases Note Bisphosphonate therapy significantly decreases CANCER CANCER RECURRENCE and future fracture riskRECURRENCE and future fracture risk in Breast CA patients in Breast CA patients –– 2009 highlights Hem2009 highlights Hem--OncOnc ACP confACP conf

–– large NIHlarge NIH study …study …a third fewer casesa third fewer cases of breast cancer.of breast cancer.–– bisphosphonatesbisphosphonates for five or more years experiencedfor five or more years experienced 30 percent 30 percent

fewer cases of breast cancer than nonfewer cases of breast cancer than non--users.users.

:: http://www.fiercepharma.com/story/studyhttp://www.fiercepharma.com/story/study--bisphosphonatesbisphosphonates--maymay-- cutcut--breastbreast--cancer/2009cancer/2009--1212--11#ixzz0l2fwxyBl11#ixzz0l2fwxyBl

Mortality dataMortality data� Treatment 11% reduction in mortality

– relative risk, 0.89; 95% confidence interval, 0.80–0.99

� Mortality reduction was not related to age or incidence of hip or nonvertebral fracture but was greatest in trialship or nonvertebral fracture, but was greatest in trialsconducted in populations with higher mortality rate

� 8 studies with all types bisphosphonates showing mortality benefit

Effect of Osteoporosis Treatment on Mortality: A Meta-Analysis Bolland, Grey, Gamble, Reid Journal of Clinical Endocrinology Metabolism, 10.1210/jc.2009-0852 .

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How effective are How effective are bisphosphonatesbisphosphonates??�� US Preventative Task force web siteUS Preventative Task force web site

–– studied a metastudied a meta--analysis of 11 randomized trials involving 13,000 analysis of 11 randomized trials involving 13,000 women women

–– Reduced Reduced vertebralvertebral fractures fractures in halfin half ((RR 0.52RR 0.52))–– ReducedReduced hiphip fractures byfractures by 37% (37% (RR 0.63)RR 0.63)ReducedReduced hiphip fractures byfractures by 37% (37% (RR 0.63)RR 0.63)

�� FIT trials showed hip fracture reduction FIT trials showed hip fracture reduction only in high risk patients only in high risk patients (T score worse than (T score worse than --2.5)2.5)

�� Most bisphosphonate trials had Most bisphosphonate trials had no effect no effect on hip fractures on hip fractures (the most difficult to effect with therapy) among lower risk (the most difficult to effect with therapy) among lower risk women who had Twomen who had T--scores between scores between --1.6 and 1.6 and --2.5.2.5.

Simplified Way to Consider this Simplified Way to Consider this DataData

NNT to prevent one fractureNNT to prevent one fracture�� T <T <--2.5 152.5 15�� T <T <--2.0 202.0 20�� T<T<--1.6 to 1.6 to --2.0 >5002.0 >500�� One prior Vertebral Fx 40One prior Vertebral Fx 40�� Two or more Vertebral Fx 10Two or more Vertebral Fx 10

–– Doug Paauw, MedStudy presentationDoug Paauw, MedStudy presentationUniversity of Washington School of MedicineUniversity of Washington School of Medicine

Newest agentNewest agent——DenosumabDenosumab AB ABto RANKL affects to RANKL affects osteoclastsosteoclasts

�� SubQSubQ injection Q 6 monthsinjection Q 6 months�� reducedreduced vertebralvertebral fracture, 2.3% fracture, 2.3% TxTx group group vsvs 7.2%7.2%

–– decrease of decrease of 68%68%�� reducedreduced hiphip fracture, 0.7%fracture, 0.7% TxTx group group vsvs 1.2% placebo1.2% placebo

40%40%–– decrease ofdecrease of 40%40%

�� Slightly better than Slightly better than AldrondrenateAldrondrenate�� StopsStops osteoclastsosteoclasts therefore should therefore should

suppress bone turnover markerssuppress bone turnover markers�� can be used in CKD GFR<30can be used in CKD GFR<30

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OsteoclastOsteoclast inhibitorsinhibitors

�� Both bisphosphonates and RANK ligand Both bisphosphonates and RANK ligand inhibitors inhibit osteoclastsinhibitors inhibit osteoclasts

�� Both suppress bone turnover markers and Both suppress bone turnover markers and i i k f ONJi i k f ONJmay increase risk for ONJmay increase risk for ONJ

�� Bisphosphonates can’t be used with Bisphosphonates can’t be used with GFR<30, denusomab can be usedGFR<30, denusomab can be used–– Denusomab has a very slight increase infection Denusomab has a very slight increase infection

risk associated with its userisk associated with its use–– Off label use denosumab may help prevent Off label use denosumab may help prevent

radiographic RA erosionsradiographic RA erosions

Bone Turnover MarkersBone Turnover Markers�� OsteoclastOsteoclast activity measured by:activity measured by:

–– serum or urine NTX / serum or urine NTX / TelopeptideTelopeptide

�� ElevatedElevated == high riskhigh risk for further accelerated for further accelerated bone lossbone loss

Ab f f l f l iAb f f l f l i–– Above reference range for premenopausal female, urineAbove reference range for premenopausal female, urineNN--telopeptidetelopeptide//creatininecreatinine ratio usually > 50ratio usually > 50

�� ““OsteoclastOsteoclast Suppression Therapy” is working Suppression Therapy” is working ififsuppressed:suppressed:–– to premenopausal female range <40to premenopausal female range <40–– If pre If pre txtx and post and post txtx measurements decrease by 40% measurements decrease by 40%

then low risk for accelerated bone lossthen low risk for accelerated bone loss

Are there other therapies?Are there other therapies?

�� Testosterone for men? concern risk for Testosterone for men? concern risk for development prostate CA?development prostate CA?

�� HCTZ? Not just for HTN or calcium HCTZ? Not just for HTN or calcium kid tkid tkidney stoneskidney stones

�� Nitroglycerin ointment? Not just for anginaNitroglycerin ointment? Not just for angina

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Fracture in man check for low Fracture in man check for low testosteronetestosterone

�� ConsiderConsider testosteronetestosterone replacementreplacement–– Discuss unknown prostate CA risk, check PSADiscuss unknown prostate CA risk, check PSA–– Probably related to Probably related to estradiolestradiol depletiondepletion–– In obese diabetic male check a In obese diabetic male check a FreeFree

testosterone leveltestosterone level»» less false positives than total testosterone levelless false positives than total testosterone level

–– Can also check for appropriately increased LH / Can also check for appropriately increased LH / FSH with primary FSH with primary gonadalgonadal failure failure vsvs low lowLH/FSH in brain injury/pituitary function lossLH/FSH in brain injury/pituitary function loss

Thiazides?Thiazides?�� 20 epidemiological studies show risk reduction 20 epidemiological studies show risk reduction

of fractures in patients taking of fractures in patients taking thiazidesthiazides

–– In largest studies 10In largest studies 10--20% reduction 20% reduction http://courses.washington.edu/bonephys/ophome.htlhttp://courses.washington.edu/bonephys/ophome.htl

�� Small but significant improvements in Small but significant improvements in BMD in clinical trialsBMD in clinical trialsBMD in clinical trialsBMD in clinical trials

�� Recommended hypercalciRecommended hypercalciuricuric statesstates>300/24 hr from medications like chronic >300/24 hr from medications like chronic prednisone prednisone oror recurring calcium kidney recurring calcium kidney stones or menierres stones or menierres (50mg/day dose?)(50mg/day dose?)

NITRO creamNITRO cream15mg/day overnight nitroglycerin cream daily with 15mg/day overnight nitroglycerin cream daily with

postmenopausal females postmenopausal females Tscore 0 to Tscore 0 to --2.02.0 “lower risk patients”“lower risk patients” over 2 yearsover 2 years

NOTED large statistical improvement in BMDNOTED large statistical improvement in BMDLumbar spine BMD increased by 7%Lumbar spine BMD increased by 7%Lumbar spine BMD increased by 7%Lumbar spine BMD increased by 7%Total hip BMD 5% Total hip BMD 5% improvement (noted 1% loss in placebo)improvement (noted 1% loss in placebo)

Femoral Femoral neck BMD 5%neck BMD 5% improvement (placebo lost 1%)improvement (placebo lost 1%)Increased boneIncreased bone--specific alkaline phosphatase by 35% “ANABOLIC”specific alkaline phosphatase by 35% “ANABOLIC”Decreased urine N Decreased urine N --telopeptide by 55% “STOPS CATABOLIC” and “uncouples”telopeptide by 55% “STOPS CATABOLIC” and “uncouples”

serious adverse events 4% serious adverse events 4% did not differ with placebodid not differ with placebo

If continued treatment for 24 months, If continued treatment for 24 months, headaches were reported by 35% headaches were reported by 35% nitroglycerin nitroglycerin and 5% in placebo during first month, and 5% in placebo during first month, decreasing substantially decreasing substantially after 12 monthsafter 12 months..

�� JAMA.JAMA. 2011 Feb 23;305(8):8002011 Feb 23;305(8):800--7.7.

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Bone Turnover Markers ReviewBone Turnover Markers Review

�� ElevatedElevated ratio >50 without treatment = high risk ratio >50 without treatment = high risk for accelerated bone lossfor accelerated bone loss

�� SuppressedSuppressed ratio after treatment withratio after treatment with�� SuppressedSuppressed ratio after treatment withratio after treatment withbisphosphonate or bisphosphonate or DenosumabDenosumab means therapy is means therapy is workingworking–– Urine NTX suppresses with nitro creamUrine NTX suppresses with nitro cream

�� ElevatedElevated ratio is expected after treatment with ratio is expected after treatment with Anabolic agent like Anabolic agent like TeraparitideTeraparitide

What are the indications to start What are the indications to start pharmacologic therapy to prevent fractures pharmacologic therapy to prevent fractures in high risk patients?in high risk patients?

Remember these meds haven’t been shown to Remember these meds haven’t been shown to lower fracture risk in low risk patients tolower fracture risk in low risk patients tolower fracture risk in low risk patients tolower fracture risk in low risk patients toprevent fractures prevent fractures (although can increase BMD)(although can increase BMD)

No evidence to suggest taking these medications in a No evidence to suggest taking these medications in a younger patient who is not on high risk meds will younger patient who is not on high risk meds will build up bone strength and prevent fractures years build up bone strength and prevent fractures years later.later.

Pharmacologic Treatment thresholds Pharmacologic Treatment thresholds based on 10 year hip fracture riskbased on 10 year hip fracture risk�� WHO fracture risk calculator helps to identify high risk fracture WHO fracture risk calculator helps to identify high risk fracture

patients:patients:–– /http://www.shef.ac.uk/FRAX/http://www.shef.ac.uk/FRAX

�� >=>=3%3% 1010--year hip fracture year hip fracture b bilitb bilit id did d hi h i khi h i kprobabilityprobability consideredconsidered high riskhigh risk

––US NOF and US Task force US NOF and US Task force »»>3% treatment cut off>3% treatment cut off

––UKUK Task Force CONCLUSIONS:Task Force CONCLUSIONS:

»» Treat withTreat with >1.1% risk if age 50 >1.1% risk if age 50 »» Treat withTreat with >9.0% risk if age 85>9.0% risk if age 85

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Based on a 3% Cut off for hip Based on a 3% Cut off for hip fracturefracture

�� Most very old elderly patients with slightly low TMost very old elderly patients with slightly low T--scores (normal z scores for their age) based on age scores (normal z scores for their age) based on age will be high risk of fracturewill be high risk of fracture

�� Fewer “younger” 50Fewer “younger” 50--60 yo patients with lower T60 yo patients with lower T--�� Fewer younger 50Fewer younger 50 60 yo patients with lower T60 yo patients with lower Tscores and lower risk of fracture in next 10 years scores and lower risk of fracture in next 10 years will be selected for treatment will be selected for treatment

–– Bisphosphonate data from studies only suggests most Bisphosphonate data from studies only suggests most fracture risk reduction in first few years of use:fracture risk reduction in first few years of use:

–– Does use early on mitigate fracture risk years later? Does use early on mitigate fracture risk years later? Answer unknownAnswer unknown

If prolonged steroids expectedIf prolonged steroids expected

�� Rapid loss 10% within first year (equivalent to post Rapid loss 10% within first year (equivalent to post bariatric surgery) and slow 3% BMD yearly loss thereafterbariatric surgery) and slow 3% BMD yearly loss thereafter

�� Risk of fracture increases by 75% within the first Risk of fracture increases by 75% within the first 3 months of steroid use3 months of steroid use

»» Osteoclasts is usually maintainedOsteoclasts is usually maintained»» osteoblasts numbers plummet and bone formation is osteoblasts numbers plummet and bone formation is

substantially reducedsubstantially reduced

�� American College of Rheumatology American College of Rheumatology Recommendation:Recommendation:–– >7.5 mg per day of prednisone for at least 3 >7.5 mg per day of prednisone for at least 3

months.months.»» Bisphosphonates first lineBisphosphonates first line

Who is at high risk for future Who is at high risk for future fracture?fracture?

–– Which 68 in tall female has higher risk?Which 68 in tall female has higher risk?»» 1. 1. 5555 yo WF, 130 lbs, aunt had fracture, surgical menopause at yo WF, 130 lbs, aunt had fracture, surgical menopause at

age 40, age 40, hxhx of “arthritis” with of “arthritis” with TT scorescore ––1.91.9

»» 2. 2. 7070 yo AAF, yo AAF, hxhx of prior broken ankle, current smoker, weight of prior broken ankle, current smoker, weight 114 with 114 with TT ––1.41.4

»» 3. 3. 6565 yo AAF, 140 lbs, yo AAF, 140 lbs, hxhx of of vertvert fxfx fracture fall from standing fracture fall from standing height, former smoker, on chronic height, former smoker, on chronic predpred >5mg/day >5mg/day TT ––0.90.9

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More than a T scoreMore than a T score

�� FRAX calculator 10 year risk of future hip FRAX calculator 10 year risk of future hip FractureFracture

�� 1. 55W no risk fx T 1. 55W no risk fx T --1.9= hip Fx risk 0.4% 1.9= hip Fx risk 0.4% �� 2. 70AA 2 risk fx T 2. 70AA 2 risk fx T --1.4=hip Fx risk 3.5%1.4=hip Fx risk 3.5%�� 3. 65AA prior fx, steroid use T3. 65AA prior fx, steroid use T--0.9 = 3.0%0.9 = 3.0%

Treatment SummaryTreatment Summary�� FRAX >3% is considered “high risk” FRAX >3% is considered “high risk” �� but I agree with UK recommend treatment when:but I agree with UK recommend treatment when:

–– 1. young 501. young 50--60 yo 60 yo andand T score T score --2.0 or lower 2.0 or lower andandmultiplemultiple other risk factors >FRAX 2other risk factors >FRAX 2--3%3%

–– 2. elderly 702. elderly 70--80 yo DEXA T close to 80 yo DEXA T close to --2 approx 2 approx >FRAX 6>FRAX 6--8%8%

–– 3. younger patient T score 3. younger patient T score --1.5 to 2.0 1.5 to 2.0 andand high risk high risk medication like ongoing medication like ongoing prednisoneprednisone >7.5mg/day or >7.5mg/day or history of history of prior nontraumatic fragility fractureprior nontraumatic fragility fracture

–– 4. R/o and treat other secondary causes of osteoporosis4. R/o and treat other secondary causes of osteoporosis

Duration of bisphosphonate therapyDuration of bisphosphonate therapy�� Development spiral subtrochanteric femur Development spiral subtrochanteric femur

fractures? fractures? increasing risk with prolonged many year useincreasing risk with prolonged many year use

Fosamax use risk / benefit 1:20 one causally associated Fosamax use risk / benefit 1:20 one causally associated for every 20 hip fractures avoided in high risk patients for every 20 hip fractures avoided in high risk patients with short duration txwith short duration tx

Consider “Consider “Drug HolidayDrug Holiday” after 5 years? 10 years?” after 5 years? 10 years?–– Stop therapy and one year later check Bone turnover Stop therapy and one year later check Bone turnover

markers if risesmarkers if rises may restart or consider may restart or consider denusomab/proliadenusomab/prolia

–– If bone turnover markers at that time If bone turnover markers at that time suppressed and suppressed and BMD still poor or still fracturingBMD still poor or still fracturing then consider an then consider an anabolic agent like Teraperatide/Forteo or Nitro creamanabolic agent like Teraperatide/Forteo or Nitro cream

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Should medication be started Should medication be started immediately after fracture?immediately after fracture?

�� Fracture healing best with Fracture healing best with FORTEO/TeriparatideFORTEO/Teriparatide

Compared to no treatment, oral Compared to no treatment, oral bisphosphonatebisphosphonate exposureexposurewas independently associated with reduced was independently associated with reduced mortalitymortality16% vs. 7%16% vs. 7%

�� Zolindronic Acid intravenous bisphosphonates after Zolindronic Acid intravenous bisphosphonates after hip fracture has hip fracture has also been shown to reduce all cause mortalityalso been shown to reduce all cause mortality,, Osteoporos Int.Osteoporos Int. 20112011

Mar;22(3):983Mar;22(3):983--91. Epub 2010 Nov 491. Epub 2010 Nov 4..

Non traumatic Fx Take HomeNon traumatic Fx Take Home�� S/p Fx on Bisphosphonate and use has been less than S/p Fx on Bisphosphonate and use has been less than

5 years 5 years ---- continue tx if DEXA shows improvementscontinue tx if DEXA shows improvements–– All meds at best will only decrease fracture risk by 50%All meds at best will only decrease fracture risk by 50%–– Longer than 10 year use may cause abnormalities to bone Longer than 10 year use may cause abnormalities to bone

strengthstrength

S bi h h ( l i hi 2S bi h h ( l i hi 2�� Start bisphosphonate soon (at least within 2Start bisphosphonate soon (at least within 2weeks) may delay for few weeksweeks) may delay for few weeks in a non operative in a non operative severe long bone fracture at high risk of NONsevere long bone fracture at high risk of NON--unionunion–– focus on smoking cessation focus on smoking cessation (most important for short (most important for short

term union prospects) term union prospects)

After acute vertebral compression After acute vertebral compression fractures?fractures?

�� DEXA soon for baseline read to compare later? DEXA soon for baseline read to compare later? »» S/p compression lumbar spine reads which will show falsely S/p compression lumbar spine reads which will show falsely

higher T scores or more “normal scores”higher T scores or more “normal scores”——order forearm?order forearm?

�� Stop high risk meds if possible (like PPI) Stop high risk meds if possible (like PPI)

�� Vit D bolus and Calcitonin in the short termVit D bolus and Calcitonin in the short term

�� Forteo if very high risk for further fractureForteo if very high risk for further fracture

�� SPEP, r/o CA,Work up secondary causes of OPSPEP, r/o CA,Work up secondary causes of OP

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Surgical Treatment for Acute Surgical Treatment for Acute Vertebral Compression FractureVertebral Compression Fracture

�� No statistical differenceNo statistical difference in sham procedures arm vs actual in sham procedures arm vs actual VertebroplastyVertebroplasty in pain relief, function, etcin pain relief, function, etc....–– NEJM Aug 2009 Buchbinder et al. and Kallmes et al. studies demonstrate NEJM Aug 2009 Buchbinder et al. and Kallmes et al. studies demonstrate

strength of treatment response in sham procedures. strength of treatment response in sham procedures.

–– Raised expectations of an invasive intervention may Raised expectations of an invasive intervention may explain the positive effects of a sham procedureexplain the positive effects of a sham procedure..

�� To date NO To date NO KYPHOPLASTYKYPHOPLASTY study has had a double study has had a double blind controlled trial to SHAM procedure blind controlled trial to SHAM procedure –– one study compared to standard NOT SHAM showed statistically one study compared to standard NOT SHAM showed statistically

significance of pain at ONE MONTH interval onlysignificance of pain at ONE MONTH interval only

Repeat DEXA comparisonRepeat DEXA comparison

“Least significant change” LSC >2%“Least significant change” LSC >2%True change exceeds 0.02 change in Bone Mineral True change exceeds 0.02 change in Bone Mineral

Density (BMD g/m2) from prior DEXA Density (BMD g/m2) from prior DEXA –– Compare BMD at same site Compare BMD at same site ---- not T score comparisonsnot T score comparisons

�� If score worse Verify compliance of prior therapyIf score worse Verify compliance of prior therapy–– Vit D level <35 and one calcium tab dailyVit D level <35 and one calcium tab daily–– medicine on an empty stomach with full glass water?medicine on an empty stomach with full glass water?

»» Taking with Calcium, iron?Taking with Calcium, iron?–– Urine NTX elevated=Urine NTX elevated=Nonabsorption/noncomplianceNonabsorption/noncompliance

�� “Stabilization of BMD” should be considered a “Stabilization of BMD” should be considered a “Success” or “acceptable”“Success” or “acceptable”

N h i BMD h f i k dN h i BMD h f i k d

Therapeutic Failure on Oral Therapeutic Failure on Oral bisphosphonatebisphosphonate

�� May consider use of IV BisphosphonateMay consider use of IV Bisphosphonate–– IV Ibandronate Q3 monthsIV Ibandronate Q3 months–– IV Zolindronic Acid yearlyIV Zolindronic Acid yearly

�� May consider subQ Terperatide / Forteo daily for May consider subQ Terperatide / Forteo daily for 2 years2 years

�� May consider Denosumab / Prolia May consider Denosumab / Prolia subQ Q 6 monthssubQ Q 6 months�� Add estrogen or SERMS or estrogen like Add estrogen or SERMS or estrogen like

products? products? �� Add HCTZ?Add HCTZ?�� Add Nitro paste qhsAdd Nitro paste qhs�� r/o secondary causes like hyperparathyroidismr/o secondary causes like hyperparathyroidism�� Stop high risk meds like PPIs, if possibleStop high risk meds like PPIs, if possible

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�� 68 yo caucasion female new to your practice had 68 yo caucasion female new to your practice had DEXA 6 years ago with Tscore DEXA 6 years ago with Tscore --1.7 at hip and 1.7 at hip and was started on Alendronate at that time. She was started on Alendronate at that time. She concerned because her sister fractured her ankle concerned because her sister fractured her ankle and her mom “has osteoporosis and is on that new and her mom “has osteoporosis and is on that new medicine Boniva”, she’s a former heavy smoker medicine Boniva”, she’s a former heavy smoker and drinks a lot of coffeeand drinks a lot of coffeeand drinks a lot of coffee.and drinks a lot of coffee.

�� You repeat a DEXA which shows a worsening hip You repeat a DEXA which shows a worsening hip score Ward’s L hip T score score Ward’s L hip T score --1.81.8

�� She also complains of occasional GERD and has She also complains of occasional GERD and has been taking OTC Pepcid for a few years.been taking OTC Pepcid for a few years.

�� What do you advise?What do you advise?

Choose nowChoose now

�� 1. Continue 1. Continue AledronateAledronate and start PPIand start PPI�� 2. Switch to 2. Switch to RaloxifeneRaloxifene�� 3. Stop 3. Stop AledronateAledronate and stop H2RA if not and stop H2RA if not

neededneeded�� 4. Start PTH / 4. Start PTH / TeriparatideTeriparatide treatmenttreatment�� 5. Start IV bisphosphonate therapy5. Start IV bisphosphonate therapy

AnswerAnswer�� 3. I wouldn’t have recommended therapy to begin 3. I wouldn’t have recommended therapy to begin

with she has a low risk DEXA has no risk factors with she has a low risk DEXA has no risk factors other than advancing age other than advancing age –– Wards score in hip shouldn’t be usedWards score in hip shouldn’t be used–– Do Not compare T scoresDo Not compare T scores

�� LSC 2>% difficult to compare different LSC 2>% difficult to compare different machinesmachines——most likely she has “stabilized”most likely she has “stabilized”

�� B/c of the GERD (maybe B/c of the GERD (maybe aggrevatedaggrevated by bybisphosphonate) iatrogenic increase in bisphosphonate) iatrogenic increase in FxFx risk risk18% with daily H2RA (30% with daily PPI)18% with daily H2RA (30% with daily PPI)

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Thank You Thank You Questions?Questions?

Supplemental info on:Supplemental info on:1.1. Frequent concerns regarding Frequent concerns regarding

Bisphosphonate useBisphosphonate use2.2. Renal Bone Disease Renal Bone Disease 3.3. PagetsPagets

Supplemental material sectionSupplemental material section

Femur Fracture caused by Femur Fracture caused by bisphosphonatebisphosphonate

�� 716716 subtrochantericsubtrochanteric or femoral shaft or femoral shaft fracturefracture following following initiationinitiation ofofbisphosphonatebisphosphonate therapy and 9723 women who sustained a typical therapy and 9723 women who sustained a typical osteoporoticosteoporotic fracturefracture of the of the intertrochantericintertrochanteric region or femoral neck. region or femoral neck.

�� Compared with transient Compared with transient bisphosphonatebisphosphonate use, treatment for 5 years or longer use, treatment for 5 years or longer was associated with an increased risk of was associated with an increased risk of subtrochantericsubtrochanteric or femoral shaft or femoral shaft fracturefracture (adjusted odds ratio, 2.74; 95% confidence interval, 1.25(adjusted odds ratio, 2.74; 95% confidence interval, 1.25--6.02).6.02).

�� A reduced risk of typical osteoporotic A reduced risk of typical osteoporotic fracturesfractures occurred among women with occurred among women with more than 5 years of more than 5 years of bisphosphonatebisphosphonate therapy (adjusted odds ratio, 0.76; 95% therapy (adjusted odds ratio, 0.76; 95% confidence interval, 0.63confidence interval, 0.63--0.93). 0.93).

�� Among 52,595 women with at least 5 years of Among 52,595 women with at least 5 years of bisphosphonatebisphosphonate therapy, a therapy, a subtrochantericsubtrochanteric or femoral shaft or femoral shaft fracturefracture occurred in 71 (0.13%) during the occurred in 71 (0.13%) during the subsequent year and 117 (0.22%) within 2 yearssubsequent year and 117 (0.22%) within 2 years

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Osteonecrosis of Jaw RiskOsteonecrosis of Jaw Risk�� Review article:Review article:

»» Carey, Carey, PalomoPalomo Bisphosphonates and ONJ, Cleveland Clinic Journal of Bisphosphonates and ONJ, Cleveland Clinic Journal of Medicine Medicine VolVol 75, number 12, Dec 2008. 87175, number 12, Dec 2008. 871

�� VERY RAREVERY RARE when used for OP preventionwhen used for OP prevention>90% of patients with suspected Bisphosphonate>90% of patients with suspected Bisphosphonate associatedassociated–– >90% of patients with suspected Bisphosphonate>90% of patients with suspected Bisphosphonate--associatedassociatedONJ were ONJ were CANCER patients most of whom were CANCER patients most of whom were receiving HIGH dose IV therapyreceiving HIGH dose IV therapy

�� >50,000 patients in trials for osteoporosis or >50,000 patients in trials for osteoporosis or PagetsPagetsNONE got ONJ NONE got ONJ ——Cleveland Clinic JournalCleveland Clinic Journal

Other Bisphosphonate Other Bisphosphonate considerationsconsiderations

�� Bone pain, Bone pain, myalgiasmyalgias have been notedhave been noted–– Related to uncovering underlying Related to uncovering underlying VitVit D def?D def?

�� Flu like illness x2 days not uncommon after IV Flu like illness x2 days not uncommon after IV bi h hbi h hbisphosphonatebisphosphonate

�� Pregnancy issues? How long is it in the system?Pregnancy issues? How long is it in the system?–– A few days in blood, urine, breast milk after ingestion A few days in blood, urine, breast milk after ingestion

but for monthsbut for months--years bound to boneyears bound to bone–– “years of poisoned “years of poisoned osteoclastosteoclast” but medication is not ” but medication is not

circulating more than few days after circulating more than few days after eacheachadministrationadministration

Treatment of Vit D deficiencyTreatment of Vit D deficiency�� D2 Drisdol/Ergocalciferol 50,000 unitsD2 Drisdol/Ergocalciferol 50,000 units

once weekly (generally inexpensive)once weekly (generally inexpensive)–– During “Loading” May consider more often During “Loading” May consider more often

--less frequently once monthly for maintenanceless frequently once monthly for maintenance–– If level <7 does NOT correct consider compliance, fat If level <7 does NOT correct consider compliance, fat pp

malabsorption, celiac spruemalabsorption, celiac sprue

�� D3 VITD3 VIT OTC 1,000OTC 1,000--2,000 units for OTC daily 2,000 units for OTC daily –– D3 CholecalciferolD3 Cholecalciferol because better absorption because better absorption

–– more AUC in studiesmore AUC in studies

�� 1,25 Vitamin D Calcitriol (Hectoral, Zemplar)? 1,25 Vitamin D Calcitriol (Hectoral, Zemplar)? –– Generally only indicated in renal patientsGenerally only indicated in renal patients

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Renal Patients with Inc PTHRenal Patients with Inc PTH

�� If acidotic then give bicarb supplementationIf acidotic then give bicarb supplementation�� Increased PTH and hyperphosphotemia Increased PTH and hyperphosphotemia

–– 1. (low Calcium, slightly high phos) Calcium/phos 1. (low Calcium, slightly high phos) Calcium/phos index <55index <55

»» Tx Calcium CarbonateTx Calcium Carbonate–– 2. (very high Phos) Calcium/phos index >552. (very high Phos) Calcium/phos index >55

»» Tx phosphate bindersTx phosphate binders–– 3. Significantly increased PTH and low 13. Significantly increased PTH and low 1--25 Vit D25 Vit D

»» Next add 1,25 ergocalciferol Vit D Calcitriol (Renagel, Next add 1,25 ergocalciferol Vit D Calcitriol (Renagel, Hectoral)Hectoral)

–– 4. If very high PTH4. If very high PTH»» Consider adding Calcimimetics Cinacalet (Sensipar) to lower Consider adding Calcimimetics Cinacalet (Sensipar) to lower

PTH to goal of <250 vs evaluation for surgical PTH to goal of <250 vs evaluation for surgical parathyroidectomyparathyroidectomy

Renal Bone DiseasesRenal Bone Diseases

�� May NOT be accurately assessed by DEXA May NOT be accurately assessed by DEXA ““AdynamicAdynamic bone disease” difficult to detect and bone disease” difficult to detect and treattreat

�� Bisphosphonate are contraindicated if GFR <30Bisphosphonate are contraindicated if GFR <30�� ForteoForteo contraindicated with high PTHcontraindicated with high PTH�� Treat with various medications for phosphate Treat with various medications for phosphate

binding, repletion of low 1,25 binding, repletion of low 1,25 VitVit D levels, or D levels, or suppression of elevated PTH levels (goal<200)suppression of elevated PTH levels (goal<200)

Paget’s DiseasePaget’s Disease�� Suspect when:Suspect when:

–– Isolated increase in Isolated increase in AlkAlk PhosPhos in elderly patientin elderly patient–– May be incidental finding noted on pelvic, spine, skull May be incidental finding noted on pelvic, spine, skull

filmfilm–– Diagnosed by Bone Scan which gives both diagnosis Diagnosed by Bone Scan which gives both diagnosis

and whether disease is “active”and whether disease is “active”�� If “SYMPTOMATIC” then Treat with If “SYMPTOMATIC” then Treat with

bisphosphonate (1/2 dose) but DAILY for few bisphosphonate (1/2 dose) but DAILY for few monthsmonths–– Treat if concerned for vertebral canal compromise or Treat if concerned for vertebral canal compromise or

long bone hip long bone hip fxfx or skull Cranial N compromiseor skull Cranial N compromise–– May treat if planned immobilization (upcoming May treat if planned immobilization (upcoming

orthopedic surgery)orthopedic surgery)�� Treat 3Treat 3--6 months 6 months dailydaily tilltill AlkAlk PhosPhos normalizesnormalizes

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Myeloproliferative Neoplasms: Approach to Diagnosis and Treatment

Ramon V. Tiu, MD

Learning Objective:

Discuss the history of myeloproliferative neoplasms (MPNs)

Discuss the signs and symptoms and additional laboratory findings that may make us suspect an underlying MPN.

Discuss the different methods we use to diagnose MPNs.

Discuss common problems that people may experience when they have the disease.

Discuss treatment strategies used in MPNs.

Speaker Disclosure:

Dr. Tiu discloses he is on the Speaker’s Bureau for Alesion Pharmaceuticals and Novartis. Is a Consultant for Allos Therapeutics, Incyte, and Alexion. He receives grant/research support from

Aplastic Anemia MDs and International Foundation.

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Myeloproliferative NeoplasmsApproach to Diagnosis and Treatment

Statewide Geriatric SymposiumSaltFork Resort Cambridge, Ohio

Ramon V. Tiu, MDAssistant Professor of Molecular Medicine

Cleveland ClinicTaussig Cancer Institute

October 15, 2011

Taussig Cancer Center

• To briefly discuss the history of Myeloproliferative Neoplasms (MPNs)

• To discuss the signs and symptoms and additional laboratory findings that may make us suspect an underlying MPN

• To discuss the different methods we use to diagnose MPNs

Objectives

• To discuss the different methods we use to diagnose MPNs

• To discuss common problems that people may experience when they have the disease

• To discuss treatment strategies used in MPNs

Taussig Cancer Center

Leukemia1845

Polycythemia Vera1892

Erythroleukemia1923

Agnogenic Myeloid

Metaplasia of Spleen

1879

Chronic Granulocytic

Leukemia1845

Megakaryocytic Leukemia

1931

History behind the Mystery

MyeloproliferativeDisorders

Dr. William Dameshek 1951

Acute Myeloid

Leukemia

Erythroleukemia1923

Megakaryocytic Leukemia

1931

Taussig Cancer Center

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Let us dissect the meaning of MPN

Myelo

Neoplasm

bone marrow

cancer

GranulocytesErythrocytesPlatelets

Stem Cell

Proliferative increased production of cellsTaussig Cancer Center

• Elevated White blood cell, Hgb/Hct, platelet count

• This had been a chronic process (several months)

• I repeated the CBC and (WBC, Hgb/Hct/ platelet) still remains l t d

When do we suspect an underlying MPN ?

elevated

• I don’t have any obvious suspected cause for the elevated blood values

• Patient has a history of unexplained splenomegaly

• Patient has a history of unexplained Thrombosis

Taussig Cancer Center

Polycythemia Vera

Primary Myelofibrosis

Chronic Myelogenous

Leukemia

WHO Classification of Chronic Myeloproliferative Neoplasms

BCR-ABL

Essential Thrombocythemia

MastocytosisChronic

Eosinophilic Leukemia

Chronic Neutrophilic

Leukemia

MPN-unclassifiable

Ph chromosome negative MPNTaussig Cancer Center

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3

What can happen when I have MPN?

Clinical Findings

Blood Clots (Thrombosis)

Laboratory Findings

Bleeding (Hemorrhage)

Constitutional SymptomsFever, fatigue, weight loss

Symptoms related extramedullary hematopoiesise.g. enlarged spleen

Very High Blood counts

Low or very low blood counts

Major Complications

Taussig Cancer Center

Myelofibrosis

Acute myeloid leukemia

Vasomotor symptomsHeadaches, erythromelalgia, atypical chest pain, tinnituslightheadedness, transient ocular or neurologic disturbances

Itchiness

Life of a patient with MPN

Polycythemia VeraPolycythemia Vera

Polycythemia Vera

Generalities

Key Concept: Increased RBC production w/ other proliferative features not explained by other causes

• 2.3 new cases per 100,000

• Over-all mortality was 2.9/100 patients per year

• More common in males than females 2.8 : 1.3

• The life expectancy of P. vera patients is shorter compared to thosewithout the disease (35 years vs 65 years)

• Mortality compared to the normal population is 1.6 fold higher in P. vera patients

Ania BJ et al. Am J Hematol. 1994 & Passamonti F et al. Am J Med. 2004

Taussig Cancer Center

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Polycythemia Vera

What tests can be used to help diagnosis Pvera

• JAK2 mutational testing (JAK2 mutation is found in 95-98% of P vera patients)

• Erythropoietin level

• Blood counts

• Sometimes a bone marrow biopsy

Tefferi A. Am J Hematol. 2011Taussig Cancer Center

Diagnostic Criteria for Polycythemia Vera

2008 WHO criteria for P Vera

Major Criteria1. Hgb >18.5 g/dL in men, 16.5 g/dL in women or other evidence of increased red cell volume *2. Presence of JAK2 V617F or other functionally similar mutation such as JAK2 exon 12 mutation

Minor Criteria

Swedlow S et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 2008

1. BM biopsy showing hypercellularity fro age with trilineage growth panmyelosis with prominent erythroid, granulocytic and megakaryo- tic proliferation2. Serum EPO level below the reference range for normal 3. Endogenous erythroid colony formation in vitro

2 Major criteria + 1 minor criteriaFirst major criteria + 2 minor criteria

* Hgb or Hct > 99 th percentile of method specific refernece range for age, sex, altitudeof resident or Hgb > 17 g/dL in men, 15 g/dL in women if associated with a documented and sustained increae oif at least 2 g/dL from an individual's baseline value that cannot be attributed top correction of iron deficiency, or elevated red cell mass >25% above mean normal predicted value

Taussig Cancer Center

Age at diagnosis (y)

0 10 20 30 40 50 60 70 90 10080

Median Age: 60 (range 20-85)

Over-all Survival (y) from the time of diagnosis

Natural History of Polycythemia Vera

Berlin N. Semin Hematol. 1975

Gangat N et al. Br J Haematol. 2007

300 1 2 3 4

Both factors present : ~9 months

1) Thrombosis (29%)2) Hematologic Malignancies (<10% - 10 year risk)3) Non-hematologic malignancy (16%)4) Hemorrhage (7%)5) Post-polycythemic Myelofibrosis (<5% - 10 year risk)

Causes of Death in P vera

5 6 7 8 9 10

No factors present: ~23 years

Influenced by Poor Prognostic Factors:1. Leukocytosis 2. Advanced age

Crisa E et al. Ann Hematol. 2010

Taussig Cancer Center

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Thrombosis may present 2 years before dx of P vera

0 2 64 8 10

Facts and Controversies about the Natural History of Polycythemia Vera

12 14 16 18 20

Thrombosis may occur atAny time thereafter

Leukemic Transformation Median time: 14 years

Understand that the increased risk ofAML transformation may be related moreTo the Tx given for the disease rather thanBeing part of the natural history of the disease

Onset of Myelofibrotic phaseMedian time: 12.5 years

Passamonti F et al. Am J Med. 2004 & Kiladjian J. et al. Semin Thromb & Hemostasis. 2006

Taussig Cancer Center

vs

Management of Polycythemia Vera

Management strategy with the intent to prolong life and treat symptomsCure

Quality of Life Symptoms

NeurologicHeadache Thrombosis

Life Threatening Complications

Dizziness

DermatologicItchinessErythromelalgiaExcessive Sweating

RheumatologicWeaknessGout

GIPUDSplenomegaly Sxs

Bone Marrow Transplant

Hemorrhage

Leukemia

Myelofibrosis

Taussig Cancer Center

Management of Polycythemia Vera

• Thrombotic Complications

– Arterial > venous thrombosis

– Main cause of death in P. vera 20 to 40%

Erythromelalgia is a thrombotic complication– Erythromelalgia is a thrombotic complication

– The CNS is the most frequent site of thrombosis

– The presenting symptom in 12 to 49% of patients w/ P. vera

– May present during the course of the illness in 40%

– P vera is the most frequent cause of hepatic vein thrombosis in the western hemisphere

Spivak J. Blood. 2002

Taussig Cancer Center

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Vascular Thrombosis Risk Stratification

• Low Risk– Age <60– No prior vascular event– No CV Risk Factors

P vera ET

ASA + phlebotomy ASA

Platelet count (x 109/L)

0 1 10 100 350 1,000 2,000 6,000

Thrombosis Hemorrhage/ThrombosisNormal

• Intermediate Risk– Age <60– No prior vascular event– With CV Risk Factors

• High Risk– Age >60 or– Prior vascular event

ASAASA + phlebotomy

ASA + Phlebotomy + HU

ASA + HU

Taussig Cancer Center

Quality of Life Symptoms

NeurologicHeadache

Management strategy with the intent to treat symptoms

Management of Polycythemia Vera

Dizziness

DermatologicPruritus

ErythromelalgiaExcessive Sweating

RheumatologicWeaknessGout

GIPUD

Allopurinol

Anti-histamines

ASA

H2 blockers

Taussig Cancer Center

• Venesection or Phlebotomy– goal is to keep Hct <0.45– Rationale: Increasing packed cell volume or Hct correlates with

increase incidence of vaso-occlusive episodes – Evidence: Pearson TC et al. Lancet. 1978 – We do not know the ideal Hct target for women

Summary of Treatment Recommendations for P. Vera

We do not know the ideal Hct target for women

• Anti-platelet agent– Aspirin 100 mg/day unless contraindicated.– Rationale: Thrombotic episodes continue to occur despite low

hematocrits because of the inherent qualitative abnormality of P. vera platelets

Taussig Cancer Center

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• Cytoreductive agents– Hydroxyurea, interferon, busulfan

– Rationale: Thrombosis/hemorrhage in P vera is related to increasing Hct and increased platelet counts. To help relieve symptoms of

Summary of Treatment Recommendations for P. Vera

splenomegaly if a surgical approach is not possible

McMullin MF. Hematol Onc. 2007

Taussig Cancer Center

Essential Thrombocythemia

• Generalities

• Key concept: Too many platelets w/ some proliferative features not explained by other MPDs or other diseases

– Incidence 2.5 new cases/ 100,000

Essential Thrombocythemia

– Life expectancy is normal

– More common in females than males 2:1

– Median age at diagnosis is 60 y/o with 20% presenting at the age of 40

– ET can occur in children although rarely with an incidence of 0.09/ million for children up till the age of 14

– ET is a diagnosis of exclusion

Taussig Cancer Center

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Proposed Revised WHO criteria for ET1. Sustained plt count �450 x 10 9/L2. Bone Marrow biopsy specimen showing proliferation mainly of the megakaryocytic lineage with increased numbers of enlarged, mature megakaryocyes; no significant increase or left-shift of neutrophil granulopoiesis or erythropoiesis3. Not meeting WHO criteria for PV, PMF, CML, MDS or other

Diagnostic Criteria for Essential Thrombocythemia

2008 WHO Criteria for ET

myeloid neoplasm4. Demonstration of JAK2 V617F or other clonal marker, or in the absence of a clonal marker, no evidence fo reactive thrombocytosis

* Requires all 4 criteria†The presence of a condition associated w/ reactive thrombocytosis does not exclude the possibility of ET if the first three criterai are met

Swedlow S et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 2008Taussig Cancer Center

Suspected Thrombocytosis

Secondary Causes + Secondary Cause -

Diagnostic Approach for Essential Thrombocythemia

r/o other MPDsInfection

Post-surgical status

Malignancy

Acute bleeding/IronDeficiency

Post-splenectomy

EssentialThrombocythemia

Polycythemia vera

ChronicMyelogenous Leukemia

Idiopathic Myelofibrosis

Taussig Cancer Center

Onset of Thrombosis Mean time: 3 years prior to dx

0 2 64 8 10

Natural History of ET(Onset of Complications)

12 14 16 18 20

Leukemic Transformation Median time: 14.5 years

Onset of Myelofibrotic phaseMedian time: 10.9 years

Passamonti F et al. Am J Med. 2004 & Kiladjian J. et al. Semin Thromb & Hemostasis. 2006

Pathogenesis of Thrombosis similarTo P vera

Taussig Cancer Center

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• Although most patients with ET will enjoy a normal life expectancy, treatment should still be considered to alleviate vasomotor symptoms and to help minimize thrombosis and hemorrhagic symptoms

• Anti-platelet agent (For control of vasomotor sxs and prevent thrombosis)

Summary of Treatment Recommendations for ET

thrombosis)– Aspirin 40-81 mg/day unless contraindicated.

– Rationale: Thrombotic episodes are due to the inherent qualitative abnormality of ET platelets

– Evidence:• Michels JJ et al. Neurology. 1993• Michels JJ et al. Ann of Int Med. 1985

Taussig Cancer Center

• Cytoreductive agents like HU and Anagrelide– Rationale: To decrease plt counts to <350 x 109/L as values higher than

this but <1,000 x 109/L can increase the risk of developing thrombosis and to lower it from �1000x109/L as values in this level predispose patients to higher bleeding risk

Summary of Treatment Recommendations for ET

– Which is better for high risk ET, HU or Anagrelide? HU

• Evidence: Harrison C et al. NEJM. 2005. (N=809) Median ff up time: 39 months

Taussig Cancer Center

Management of Thrombosis in Polycythemia Vera and ET

Vascular Thrombosis Risk Stratification

• Low Risk– Age <60– No prior vascular event– No CV Risk Factors

P vera ET

ASA + phlebotomy ASA

• Intermediate Risk– Age <60– No prior vascular event– With CV Risk Factors

• High Risk– Age >60 or– Prior vascular event

ASAASA + phlebotomy

ASA + Phlebotomy + HU

ASA + HU

Taussig Cancer Center

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P i M l fib iPrimary Myelofibrosis

• Generalities

• Main Concept: Too much Fibrosis in the BM not accounted for by other diseases w/ some proliferative features

– Incidence 1.5 new cases/ 100,000

Primary Myelofibrosis

– More common in females than males 2:1

– Median age at diagnosis is 67 y/o with 5-17% presenting before the age of 40

– May occur in children rarely

– Most common presenting symptom is fatigue (50-70%) and symptoms related to splenomegaly. Most common physical exam finding is a palpable splenomegaly (>90%)

Taussig Cancer Center

Age at diagnosis (y)

0 10 20 30 40 50 60 70 90 10080

Median Age: 67

Over-all Survival (y) – depends on prognostic risk groupinga Gangat N et al. JCO. 2011

Natural History of Myelofibrosis

Mesa R et al. Am J hematol. 1999

low: 15 y

Leukemic Transformation (y) depends on prognostic risk groupingb

300 1 2 3 4 5 6 7 8 9 10

Int-1: 7 yInt-2: 3 yHigh: 1.3 y

300 1 3 4 5 6 7 8 9 102

10 year risk if 2 factors are present is 31% and 12% if no factors are present

Gangat N et al. JCO. 2011

b. Factors: presence of unfavorable cytogenetics or <100,000 platelets

a. Factors: Age >65, Hgb <10, presence of circulating blasts, constitutional Sxs, unfavorable Cyto, low platelets, transfusion needs, WBC>25,000

Taussig Cancer Center

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Diagnostic Criteria forPrimary Myelofibrosis

2008 WHO PMF CriteriaMajor Criteria 1. Presence of megakaryocyte proliferation and atypia, usually accompanied by either reticulin and/or collagen fibrosis, or, in the absence of significant reticulin fibrosis, the mega- karyocyte changes must be accompanied by an increased BM cellularity characterized by granulocytic proliferation and often decreased erythropoiesis (ie, prefibrotic cellular- phase disease)

2 Not meeting WHO criteria for PV CML MDS or other 2. Not meeting WHO criteria for PV, CML, MDS, or other myelid neoplasm 3. Demonstration of JAK2V617F or other clonal markers (eg MPL515W>L/K, or in the absence of a clonal marker, no evidence of BM fibrosis due to underlying inflammatory or other neoplastic diseases

Minor Criteria 1. Leukoerythroblastosis 2. Increase in serum LDH 3. Anemia 4. Plapable Splenomegaly

Dx requires all 3 major + 2 minor criteria

Taussig Cancer Center

Androgen + Prednisone Erythropoietin

Darbepoetin alfa

Decreased EPO

Autoimmuneattack

Lenalidomide

Thalidomide

Interferon-�

Hydroxyurea

DanazolDanazolBMT

Overview of Pathophysiology of Idiopathic Myelofibrosis

Anemia

Splenic sequestration

Bone MarrowFibrosis

SplenomegalyThrombosis

Leukemia

Anagrelide

ExtramedullaryHematopoiesis

LeukoerythroBlastic smear

MF stem cellclone

Thrombocytosis

RadiotherapySplenectomy

Taussig Cancer Center

Management of Primary Myelofibrosis

• Type of Treatment is driven by Prognosis

Taussig Cancer CenterTefferi A. Blood. 2011

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• Also known as Janus Kinase 2

• Janus is a Roman god with two faces that guards the entrance to heaven and is named as such because of the near identical phosphate binding domains

The JAK2 story

• Implicated in the pathogenesis of MPNs

Taussig Cancer Center

• A new class of drugs

• Developed because JAK2 mutations are found in high frequencies in MPNs

The JAK2 inhibitors

• Incidence of JAK2V617F Exon 14 mutation – P vera 65-97%

– ET 23-57%

– PMF 35-57%

Kralovics R et al. NEJM. 2005 Baxter EM et al. Lancet. 2005James C et al. Nature. 2005Levine RL et al. Cancer Cell. 2005

Taussig Cancer Center

The JAK2 inhibitors

Mesa RA. Hematology. 2011;2010:115-121Taussig Cancer Center

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The JAK2 inhibitors

Better for Ruxolitnib Tx pts

Taussig Cancer Center

Better for Ruxolitnib Tx pts

No difference

Verstovstek S and Vannucchi A. ASCO 2011 Investor Presentation

• Thrombo-hemorrhagic complications account for most of the problems in P vera and ET

• ASA is the best anti-platelet treatment option to prevent thrombotic events

• As platelets and Hct rise so does the risk of thrombosis and should

Summary for P vera and ET

• As platelets and Hct rise so does the risk of thrombosis and should make one consider the use of cytoreductive treatment

• Realize that cytoreductive treatments have potential risk of causing MF and Leukemogenicity

• It is still controversial whether ET and P vera perse leads to increased risk of MF and LT

Taussig Cancer Center

• Treatment is mainly supportive and new therapies are needed

• New drugs like JAK2 inhibitors are showing currently being investigated and showing promise

Summary for Myelofibrosis

• Cure is achieved only through BMT

Taussig Cancer Center

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14

On-going / Upcoming Clinical trials for MPNin Cleveland Clinic Taussig Cancer Institute

• Pomalidomide study for PMF, Post-ET MF, Post-PV MF– Status: Open– Quick Summary: MF patients with transfusion dependent Anemia

• Ruxolitinib (INCYTE) trial for PMF, Post-ET MF, Post-PV MFStat s Will open soon

Taussig Cancer Center

– Status: Will open soon– Quick Summary: MF Patients with splenomegaly and symptomatic

disease (1st study 50,000-100,000 platelets) (2nd Study >100,000 platelets)

• A third JAK2 inhibitor trial will open for ET and PV patients

MPNs

Taussig Cancer Center

THANK YOU VERY MUCH

Acknowledgements

Tiu Laboratory1) Fabiola Traina, MD, PhD2) Valeria Visconte, PhD3) Manoj Bupathi, MD4) Sara Slatkin

Jaroslaw P. Maciejewski, MD, PhD

Research Nurses1) Ricki Englehaupt, RN2) Joyce Juersivich, RN3) Kathleen Cooper, RN

Research Coordinators/ Managers1) Josephine Chan, PhD

Taussig Cancer Center

Maciejewski Laboratory1) Anna Jankowska, MS2) Hideki Makishima, MD, PhD3) Manny Afable, MD

Mikkael A. Sekeres, MD, MSMatt Kalaycio, MDEdward Copelan, MDAnjali S. Advani, MDYogen Saunthararajah, MDHien Duong, MD

2) Lindsey Mooney3) Lori Strozniak4) Casandra Kendeigh

Other Support Staff1) John Desamito

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15

CCF MPN Program

• Development of a Myeloproliferative Neoplasm/ Disorder Program in Cleveland Clinic

CCF MPN Program

MPN Registry

1) Primary Myelofibrosis2) Mastocytosis

3) Hypereosinophilic Disorders/ Eosinophilic Leukemia4) Polycythemia Vera

Head: Ramon V. TiuContact info: 216-444-6833

Taussig Cancer Center

Clinical Trials

Translational Research

Cytopenias AML Progression Thrombosis Fibrosis Quality of Life

Advancing the care and treatment of MPNs

5) Essential Thrombocytosis6) Chronic Neutrophilic Leukemia

Blood/ BM Sample Repository

Clinical Research+

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Saturday Afternoon

Workshop/Discussion Seminars SaturdayWorkshop

Workshops

Discussion Seminars A. Learning to Communicate: Bad News and BeyondJohn F. McGreevey,Jr, MD

B. Driving and the Older Adult: Talking About the Keys to the CarBarbara Messinger-Rapport, MD, PhD, FACP, CMD

C. Going Beyond Welcome to Medicare!Peter A. DeGolia, MD, CMD

D. Foot Exam and Common Problems & Remedies for the ElderlyBrian J. Weiss, DPM

E. Name that LesionGolara Honari, MD

F. How To Set Up A QI Project In Your Practice That Is MeaningfulJohn R. Kues, PhD, CCMEP

G. No-monia and No-Uria: Practical Recommendations for Using Fewer Antibiotics Robin L.P. Jump, MD, PhD

LocationsWORKSHOP 3:30 p.m.

A, B, D, F 4:30 p.m. B, C, D, E

5:30 p.m. A, C, E, F

A Learning to Communicate: Bad News and Beyond

Stone House Room (2rd floor)

B Driving and the Older Adult: Talking About the Keys to the Car

Wheelwright Room (2nd floor)

Wheelwright (2nd floor)

C Going Beyond Welcome to Medicare! Carriage Room (2nd floor)

Carriage Room (2nd floor)

D Foot Exam and Common Problems & Remedies for the Elderly

Anvil Room (2nd floor)

Anvil Room (2nd floor)

E Name That Lesion Summit Room (4th floor)

Summit Room (4th floor)

F How To Set Up A QI Project In Your Practice that Is Meaningful

Carriage Room (2nd floor)

Anvil Room (2nd floor)

F No-monia and No-uria: Practical Recommendations for using Fewer

Antibiotics

Summit Room (4th floor)

Wheelwright Room (2nd floor)

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Learning to Communicate:Bad News and Beyond

John F. McGreevey, Jr., M.D.

Learning Objectives:

Identify key tools to assist students/residents in learning to communicate with patients in difficult situations.

Speaker Disclosure:

Dr. McGreevey has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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1

Learning to Communicate Learning to Communicate Bad News and BeyondBad News and Beyond

John McGreevey, MDJohn McGreevey, MDMedical DirectorMedical Director

Hospice of Northwest OhioHospice of Northwest Ohio

IntroductionIntroduction

�� The medical interview is the commonest The medical interview is the commonest procedure in medicine.procedure in medicine.

�� Successful and unsuccessful conversations Successful and unsuccessful conversations have lasting effects that can be therapeutichave lasting effects that can be therapeutichave lasting effects that can be therapeutichave lasting effects that can be therapeuticor adverse.or adverse.

�� There is some evidence that we have a There is some evidence that we have a performance problem in this regard.performance problem in this regard.

Teaching CommunicationTeaching Communication�� What to teachWhat to teach

�� Establishing the relationshipEstablishing the relationship�� Conversational skillsConversational skills�� Approach to key decisions & topicsApproach to key decisions & topics

�� How to teachHow to teach�� How to teachHow to teach�� LectureLecture�� Simulation and exercisesSimulation and exercises�� Real life experienceReal life experience

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The Value of the ConversationThe Value of the Conversation

�� Education and comprehension.Education and comprehension.�� Dealing with fears and misperceptions.Dealing with fears and misperceptions.�� The discussion itself may be The discussion itself may be

therapeutictherapeutictherapeutic.therapeutic.�� It helps with medical decision making.It helps with medical decision making.

�� Even in terminally ill.Even in terminally ill.�� It allows people to make plans and It allows people to make plans and

avoid “crisis management.”avoid “crisis management.”

The Challenges in the The Challenges in the ConversationConversation

�� The subject matter and it’s The subject matter and it’s implications.implications.

�� How people will reactHow people will react�� How people will react.How people will react.�� Our own emotions.Our own emotions.

Concerns about Bad News Concerns about Bad News DiscussionsDiscussions

�� Abandonment and “giving up.”Abandonment and “giving up.”�� Concerns about shortening lifespan.Concerns about shortening lifespan.�� “I don’t want to take away his hope ”“I don’t want to take away his hope ”�� I don t want to take away his hope.I don t want to take away his hope.�� The perceived dichotomy between The perceived dichotomy between

“curative” and “palliative” care.“curative” and “palliative” care.

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Establishing the relationshipEstablishing the relationship

�� Listening and reflectingListening and reflecting�� Sometimes silence is the right Sometimes silence is the right

response.response.�� Losing presumptionsLosing presumptions�� S lfS lf hh�� Self awareness Self awareness -- how are you how are you

reacting to the situation?reacting to the situation?�� Listen to yourselfListen to yourself..

�� Stay engaged Stay engaged -- Avoid the Avoid the “distancing moves.”“distancing moves.”

�� One size does not fit all.One size does not fit all.�� Building trust.Building trust.

Conversational SkillsConversational Skills

�� Setting the stageSetting the stage�� Acknowledging emotionsAcknowledging emotions�� Understanding people’s rolesUnderstanding people’s roles

�� Informed consentInformed consent�� Substituted decisions makersSubstituted decisions makers�� Who needs to be involvedWho needs to be involved

�� Goal of the conversationGoal of the conversation�� Don’t be blunt but get to the point.Don’t be blunt but get to the point.

�� Framing the conversation.Framing the conversation.�� Goals, benefits and burdensGoals, benefits and burdens

Communications TipsCommunications Tips

�� Be comfortableBe comfortable�� Maintain focusMaintain focus�� Maintain awarenessMaintain awareness�� Maintain awarenessMaintain awareness�� Watch the roomWatch the room�� Express appropriate empathy but Express appropriate empathy but

observe appropriate boundaries.observe appropriate boundaries.

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SPIKESSPIKES -- a protocol for bad news a protocol for bad news deliverydelivery

�� SSet up et up -- right people, comfortable setting.right people, comfortable setting.�� PPatientatient -- Find out what they knowFind out what they know�� IInvitation nvitation -- What does the patient want to What does the patient want to

kkknow.know.�� KKnowledgenowledge -- Provide the informationProvide the information�� EEmotionmotion -- Acknowledge with empathyAcknowledge with empathy�� SStrategytrategy -- What next What next -- follow upfollow up

Encountering AngerEncountering Anger

�� Don’t take it personally.Don’t take it personally.�� Where is it coming from?Where is it coming from?�� Don’t get sucked in but don’t patronize.Don’t get sucked in but don’t patronize.�� Acknowledge the anger and listen.Acknowledge the anger and listen.�� Explore where the trouble is.Explore where the trouble is.�� Explore possible resolutions.Explore possible resolutions.�� Set appropriate boundaries.Set appropriate boundaries.

Words that Don’t HelpWords that Don’t Help

�� “There’s nothing we can do.”“There’s nothing we can do.”�� “Do you want us to do everything?”“Do you want us to do everything?”�� “Do you want them to try to save “Do you want them to try to save

you?”you?”�� “Do you want to give up?”“Do you want to give up?”�� “I know how you feel.”“I know how you feel.”

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Sample Conversational FlowSample Conversational Flow

�� Here is what I understand your concerns to Here is what I understand your concerns to be. (Am I right?)be. (Am I right?)

�� Here is what I think is going on and why. Here is what I think is going on and why. (Do you understand?)(Do you understand?)(Do you understand?)(Do you understand?)

�� Here are the choices or options…and the Here are the choices or options…and the pros and cons of each. (Thoughts on this?)pros and cons of each. (Thoughts on this?)

�� Here is my recommendation. (and Here is my recommendation. (and alternatives)alternatives)

Other Discussion PointsOther Discussion Points

�� “I don’t want him/them to “I don’t want him/them to know……”know……”

�� “Can you give me something “Can you give me something to end it?”to end it?”to end it?to end it?

�� “How long have I got?”“How long have I got?”

The Decision PointsThe Decision Points

�� Decision about therapyDecision about therapy�� Hospitalization for symptoms and flare ups.Hospitalization for symptoms and flare ups.

�� When does a Palliative approach make sense?.When does a Palliative approach make sense?.�� CPRCPR�� NutritionNutrition

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Considering End of Life CareConsidering End of Life Care

�� Over the course of an illness the benefits, risks Over the course of an illness the benefits, risks and goals of care change.and goals of care change.

�� It’s only logical that there would be changes in It’s only logical that there would be changes in care decisions in the early, middle and advanced care decisions in the early, middle and advanced yystages of an illness.stages of an illness.

�� In advanced stages of disease goals of care and In advanced stages of disease goals of care and benefits and burdens of treatments change.benefits and burdens of treatments change.

�� This is not about giving up. It’s about making This is not about giving up. It’s about making choices.choices.

Decisions about CPR, Life Decisions about CPR, Life SupportSupport

�� Description of CPRDescription of CPR�� Outcomes of CPR (vs. Outcomes of CPR (vs.

expectations)expectations)�� In the context of the illnessIn the context of the illness

�� What other concerns are What other concerns are present?present?

Decisions about FeedingDecisions about Feeding

�� Cessation of eating is part of the progression of Cessation of eating is part of the progression of most illnesses.most illnesses.

�� “Is the patient dying because they’re not eating or “Is the patient dying because they’re not eating or not eating because they’re dying?”not eating because they’re dying?”g y y gg y y g

�� Remember the role of food in comfort and Remember the role of food in comfort and community.community.

�� Review the patient’s prognosis Review the patient’s prognosis -- short and long short and long term.term.

�� Review the pros and cons of intervention. Review the pros and cons of intervention.

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Teaching MethodsTeaching Methods

�� Formal presentationsFormal presentations�� Limited value but can share tips and pointers.Limited value but can share tips and pointers.�� Draw on experiences, story.Draw on experiences, story.

�� Si l ti l l d fl tiSi l ti l l d fl ti�� Simulations, role play and reflective Simulations, role play and reflective exercises.exercises.�� Call help put the students in the patient’s role.Call help put the students in the patient’s role.�� Can provide real time 360Can provide real time 360oo feedbackfeedback

Teaching MethodsTeaching Methods

�� Real life experienceReal life experience�� The hidden curriculumThe hidden curriculum�� ObservationObservation�� The teachable momentThe teachable moment�� Self assessment and reflection.Self assessment and reflection.�� Appreciative InquiryAppreciative Inquiry

Final PointsFinal Points

�� Be aware of yourself.Be aware of yourself.�� Be aware of the people around you.Be aware of the people around you.�� Try to ensure understanding.Try to ensure understanding.�� Lay out options and likely outcomes withLay out options and likely outcomes with�� Lay out options and likely outcomes withLay out options and likely outcomes with

recommendations.recommendations.�� Revisit things and reevaluate goals as Revisit things and reevaluate goals as

needed.needed.

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Driving and the Older Adult:Talking About the Keys to the Car

Barbara Messinger-Rapport, MD, PhD, FACP, CMD

Learning Objectives:

Identify vision, motor, and cognitive impairments related to driving safety

List differences in regulations between local states

Develop an action plan for demented patients based on stage of dementia.

Discuss/Offer tips to patients/families regarding driving cessation.

Speaker Disclosure:

Dr Messinger-Rapport has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Driving and the Older Adult; Talking About the

Keys to the Car

Driving and the Older Adult; Talking About the

Keys to the CarKeys to the CarKeys to the CarBJ MessingerBJ Messinger--Rapport, MDRapport, MD

Director, Center for Geriatric Director, Center for Geriatric Medicine of the Medicine InstituteMedicine of the Medicine Institute

Cleveland ClinicCleveland Clinic

DISCLOSURESDISCLOSURESDISCLOSURESDISCLOSURES

•• AMA/ NHTSA Older Drivers’ ProjectAMA/ NHTSA Older Drivers’ Project

ObjectivesObjectivesObjectivesObjectivesAfter this session, learners will be able toAfter this session, learners will be able to•• Identify vision, motor, and cognitive Identify vision, motor, and cognitive

impairments related to driving safetyimpairments related to driving safety•• List differences in regulations between List differences in regulations between gg

local stateslocal states•• Develop an action plan for demented Develop an action plan for demented

patients based on stage of dementiapatients based on stage of dementia•• Offer tips to patients/families regarding Offer tips to patients/families regarding

driving cessationdriving cessation

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Why should you be interested?Why should you be interested?Why should you be interested?Why should you be interested?

•• Driving is an instrumental activity of Driving is an instrumental activity of daily livingdaily living

•• Essential to completion of other ADL in Essential to completion of other ADL in ppmost of U.S.most of U.S.

•• Inability to drive safely necessitates Inability to drive safely necessitates multiple lifestyle changesmultiple lifestyle changes

Don’t we already Don’t we already have enough to do?have enough to do?

Don’t we already Don’t we already have enough to do?have enough to do?

•• SeatbeltsSeatbelts•• Colonoscopy and mammogram?Colonoscopy and mammogram?•• ImmunizationsImmunizationsImmunizationsImmunizations•• Acute careAcute care•• Disease ManagementDisease Management•• Now I have to talk about driving?Now I have to talk about driving?

Adapted from Boustani. SGIM. 2007

BUT: driving is anBUT: driving is anInstrumental ADLInstrumental ADL

BUT: driving is anBUT: driving is anInstrumental ADLInstrumental ADL

•• Complex activity of daily livingComplex activity of daily living-- Cooking, shopping, housekeepingCooking, shopping, housekeeping-- Managing finances, meds, mailManaging finances, meds, mail

•• Essential to Americans forEssential to Americans for-- TransportationTransportation-- SocializationSocialization-- Medical appointmentsMedical appointments-- SelfSelf--esteem/ identityesteem/ identity

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Driving Concerns may beDriving Concerns may bean opportunity to:an opportunity to:

Driving Concerns may beDriving Concerns may bean opportunity to:an opportunity to:

•• Reassess medical conditionsReassess medical conditions•• Reassess polypharmacyReassess polypharmacy•• Direct elder to resourcesDirect elder to resources

-- Social servicesSocial services-- Therapy/ driving trainingTherapy/ driving training-- BMVBMV

Father JackFather JackFather JackFather Jack

•• Living in rectoryLiving in rectory•• Retired but assists in serviceRetired but assists in service•• At least 2 ETOH dailyAt least 2 ETOH daily•• Blood pressure not controlledBlood pressure not controlled•• Recent highRecent high--speed driving accidentspeed driving accident•• “Generous” with his money“Generous” with his money•• My assessment:My assessment:•• Your assessment?Your assessment?

Driver AssessmentDriver AssessmentFather JackFather Jack

Driver AssessmentDriver AssessmentFather JackFather Jack

•• MMSE 30/30MMSE 30/30•• MOCA: 19/30MOCA: 19/30•• Simulator: borderline passSimulator: borderline pass•• OnOn--thethe--road: dramatically failedroad: dramatically failed

-- Signaling errorsSignaling errors-- Speeding (60 mph on offSpeeding (60 mph on off--ramp)ramp)-- Drifting into incoming trafficDrifting into incoming traffic-- Etc.Etc.

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Rural RuthRural RuthRural RuthRural Ruth

•• Over past two years, dtr increased Over past two years, dtr increased “need to help her”“need to help her”AppointmentsAppointments

M di ti tM di ti t-- Medication mgtMedication mgt-- FinancesFinances

•• Claims mom could really do it herselfClaims mom could really do it herself•• Claims her driving is just fineClaims her driving is just fine•• Just a little memory issuesJust a little memory issues

Assessing RuthAssessing RuthAssessing RuthAssessing Ruth

•• MMSE: 18/30 (HS ed)MMSE: 18/30 (HS ed)•• Pentagons (unable)Pentagons (unable)•• CDT:CDT:CDT:CDT:

•• Dementia stage: mild Dementia stage: mild •• Driver evaluation: failedDriver evaluation: failed

Busy BerthaBusy BerthaBusy BerthaBusy Bertha

•• 80 year old woman80 year old woman•• Referred for memory assessmentReferred for memory assessment•• Started on donepezil by PCPStarted on donepezil by PCP•• Appt 7:30 amAppt 7:30 am-- still dark outsidestill dark outside•• Saw her crash car into post in garageSaw her crash car into post in garage•• MMSE 30/30MMSE 30/30•• My assessment: Mild cog impairmentMy assessment: Mild cog impairment•• Referral for Driver AssessmentReferral for Driver Assessment

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Driver AssessmentDriver AssessmentDriver AssessmentDriver Assessment

•• Macular degenerationMacular degeneration•• Vision acceptable in bright lightVision acceptable in bright light•• Poor contrast sensitivityPoor contrast sensitivityPoor contrast sensitivityPoor contrast sensitivity•• High sensitivity to glareHigh sensitivity to glare•• Driving test: Low risk during dayDriving test: Low risk during day•• Agrees not to drive unless bright Agrees not to drive unless bright

outsideoutside

40

60

ntag

e (%

)

More Sensory Impairment with Age

0

20

Perc

en

65-74 75-84 85+

Visual Hearing

Older Americans 2004

2025303540

ent (

%)

Serious Chronic Illness among Adults 65+

05

1015

Perc

e

Heart CVA Cancer DMOlder Americans 2004

MW

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1520253035

ent (

%)

Elders with moderate-severe memory impairment

05

1015

Perc

e

All 65+ 65-69 70-74 75-79 80-84 85+

Age range (years)

Health and Retirement Study. Older Americans 2004

WHAT’S THE FUSS?WHAT’S THE FUSS?WHAT’S THE FUSS?WHAT’S THE FUSS?•• MVA #1 cause of injury death Age < 75 yrMVA #1 cause of injury death Age < 75 yr•• MVA #2 cause of injury death Age 75MVA #2 cause of injury death Age 75--84 yr84 yr•• Adults 65+ constitute 12.7% US populationAdults 65+ constitute 12.7% US population

-- 11% motor vehicle injuries11% motor vehicle injuries-- 19% all motor vehicle deaths19% all motor vehicle deaths

•• Mortality from a MVA Mortality from a MVA -- Age 70Age 70--74: twice drivers 3074: twice drivers 30--59 yrs59 yrs-- Age 80+: five times drivers 30Age 80+: five times drivers 30--59 yrs59 yrs

Impairments affecting driving Impairments affecting driving skillsskills

Impairments affecting driving Impairments affecting driving skillsskills

•• VisualVisual•• MusculoskeletalMusculoskeletal•• CognitiveCognitiveCognitiveCognitive

•• Alcohol, polypharmacy may influence Alcohol, polypharmacy may influence the above!!the above!!

AMA Guidelines Counseling Older Drivers

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Aging and VisionAging and VisionAging and VisionAging and Vision

•• Contrast sensitivityContrast sensitivity•• Contrast acuity in glareContrast acuity in glare•• Visual field limitationsVisual field limitationsVisual field limitationsVisual field limitations

-- CentralCentral-- PeripheralPeripheral

•• Actual acuity less importantActual acuity less importantBabryn. Optometry and Vision Science. 2005Freeman. Optometry and Vision Science. 2005

Low contrast:Low contrast:curbs, urban driveways, dusk, gray curbs, urban driveways, dusk, gray

cars on cement roadscars on cement roads

Low contrast:Low contrast:curbs, urban driveways, dusk, gray curbs, urban driveways, dusk, gray

cars on cement roadscars on cement roads

Henry Ford Visual Rehabilitationand Research Center

Low contrast:Low contrast:cluttered environmentscluttered environments

Low contrast:Low contrast:cluttered environmentscluttered environments

Henry Ford Visual Rehabilitationand Research Center

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Low contrast:Low contrast:cluttered environmentscluttered environments

Low contrast:Low contrast:cluttered environmentscluttered environments

Henry Ford Visual Rehabilitationand Research Center

Driving safety & visionDriving safety & visionDriving safety & visionDriving safety & vision

•• Binocular Acuity differs per stateBinocular Acuity differs per state-- Better 20/200 each eye w/wo lensesBetter 20/200 each eye w/wo lenses-- Together 20/40 unrestrictedTogether 20/40 unrestricted

T th 20/50T th 20/50 20/60 d ti l20/60 d ti l-- Together 20/50Together 20/50 –– 20/60 daytime only20/60 daytime only-- Horizon field > 70Horizon field > 70°° temporal ea. eye. temporal ea. eye.

•• Provisions for special circumstancesProvisions for special circumstances-- Monocular visionMonocular vision

Ohio Administrative Code Section 4501:1Ohio Administrative Code Section 4501:1--11--2020

VisionVisionVisionVisionVisual fields Visual fields

confrontation testing: confrontation testing: any deficit, refer to any deficit, refer to ophthalmologyophthalmology

Visual acuity with the Visual acuity with the Snellen E Chart: acuity Snellen E Chart: acuity in any eye less than in any eye less than 20/40, refer to 20/40, refer to ophthalmologyophthalmology

Static acuity not as important as: contrast, visual fields,Sensitivity to glare, etc.

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Macular Perimetry Macular Perimetry -- 20/40+20/40+Macular Perimetry Macular Perimetry -- 20/40+20/40+

Henry Ford Visual Rehabilitationand Research Center

Your ViewYour ViewYour ViewYour View

Henry Ford Visual Rehabilitationand Research Center

Patient’s View Patient’s View –– 20/40+20/40+Patient’s View Patient’s View –– 20/40+20/40+

Henry Ford Visual Rehabilitationand Research Center

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Physical Physical changeschanges

alter driving alter driving abilityability

Aging and Musculoskeletal Aging and Musculoskeletal SystemSystem

Aging and Musculoskeletal Aging and Musculoskeletal SystemSystem

•• Higher prevalence ofHigher prevalence of-- OsteoporosisOsteoporosis-- Joint mobility impairment, painJoint mobility impairment, pain-- Neuropathy (diabetic, PAD, idiopathic)Neuropathy (diabetic, PAD, idiopathic)

•• Chronic DiseaseChronic DiseaseChronic DiseaseChronic Disease-- Cardiovascular, pulmonary, DMCardiovascular, pulmonary, DM-- ImmunologicImmunologic-- Seizure disorderSeizure disorder-- Cognitive impairmentsCognitive impairments

•• Diminished physiologic reserveDiminished physiologic reserve

MotorMotorFunctionFunctionTestingTesting

MotorMotorFunctionFunctionTestingTesting

•• Up & Go (timed or not)Up & Go (timed or not)•• Sensation/ proprioceptionSensation/ proprioception•• General strengthGeneral strength

-- ArmsArms-- Legs, especially RLELegs, especially RLE

•• FlexibilityFlexibility-- especially neckespecially neck•• Presence of kyphosisPresence of kyphosis

-- History of height lossHistory of height loss

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Cognition in Normal AgingCognition in Normal AgingCognition in Normal AgingCognition in Normal Aging

DiminishedDiminished::•• processing speedprocessing speed•• ability to process multipleability to process multipleability to process multipleability to process multiple

simultaneous stimulisimultaneous stimuliIn general, no change in:In general, no change in:•• Intelligence, organization, judgment Intelligence, organization, judgment These abilities compensate to maintain These abilities compensate to maintain

performanceperformance

Clock Drawing Test (CDT)Clock Drawing Test (CDT)Clock Drawing Test (CDT)Clock Drawing Test (CDT)•• CDT can assess: CDT can assess:

-- memorymemory-- visual perception visual perception

& visual spatial & visual spatial skillsskills

-- selective attentionselective attention-- executive skillsexecutive skills

•• Draw clock face, Draw clock face, numbers, and set time at numbers, and set time at 11:1011:10

•• Errors on any of the Errors on any of the components signals a components signals a potential problempotential problem

Pictures courtesy of Barbara Freund, PhD Eastern Virginia Medical School

TrailTrail--Making Test, Part BMaking Test, Part BTrailTrail--Making Test, Part BMaking Test, Part B•• Tests attention, Tests attention,

working memory, working memory, visual processing, visual processing, visuospatial skills, visuospatial skills, and psychomotorand psychomotorand psychomotorand psychomotorcoordinationcoordination

•• Time to completionTime to completion-- Abn: > 180 secAbn: > 180 sec

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Possible office testsPossible office tests30 point tests30 point tests

Possible office testsPossible office tests30 point tests30 point tests

•• Folstein “MMSE”Folstein “MMSE”-- ProprietaryProprietary-- Score itself limited predictive (ceiling Score itself limited predictive (ceiling

effect)effect)effect)effect)-- Pentagon accuracyPentagon accuracy-- some predictivitysome predictivity

•• Better differentiation Better differentiation Normal & Mild dementiaNormal & Mild dementia-- MOCAMOCA-- Montreal Cognitive AssessmentMontreal Cognitive Assessment-- SLUMSSLUMS-- St Louis University Mental StateSt Louis University Mental State

Prevalence Alzheimer DiseasePrevalence Alzheimer DiseasePrevalence Alzheimer DiseasePrevalence Alzheimer Disease2050: 13.2 million

2000: 4.5 million

2030: 7.7 million

Cognitive red flagsCognitive red flagsCognitive red flagsCognitive red flags•• Clinician observeClinician observe

-- Med nonMed non--compliancecompliance-- Missed AppointmentsMissed Appointments

•• Family/ friend reportFamily/ friend report::-- Erratic driving habitsErratic driving habits-- Lost in familiar areaLost in familiar area-- Unexplained dentsUnexplained dents-- Long time to get to drugstoreLong time to get to drugstore-- Needing a navigatorNeeding a navigator

•• Clinician should considerClinician should consider: cognitive testing: cognitive testing

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Alzheimer Disease StagesAlzheimer Disease StagesAlzheimer Disease StagesAlzheimer Disease Stages•• Clinical Dementia RatingClinical Dementia Rating

-- 0 = no dementia0 = no dementia-- 0.5 = mild memory deficit but intact 0.5 = mild memory deficit but intact

function. “MCI”function. “MCI”-- 1.0 = moderate memory loss; 1.0 = moderate memory loss; mildmild functionfunctionyy

impairmentimpairment-- 2.0 = severe memory loss; 2.0 = severe memory loss; moderatemoderate

function impairmentfunction impairment-- 3.0 = severe memory loss; no significant 3.0 = severe memory loss; no significant

function outside of homefunction outside of home

Morris. Neurology. 1993MCI = mild cognitive impairment. Peterson 2001

Stages of DementiaStages of DementiaStages of DementiaStages of DementiaCDRCDR 0.5: MCI0.5: MCI 1: Mild1: Mild 2: mod2: modMemory impairedMemory impaired ++ ++++ ++++++B ADL impairedB ADL impaired -- -- ++I ADL impairedI ADL impaired ++ ++++I ADL impairedI ADL impaired -- ++ ++++DrivingDriving < 50% unsafe< 50% unsafe > 50% unsafe> 50% unsafe Not safeNot safe

Chol InhChol Inh -- FDAFDA FDAFDA

NMDANMDA -- FDAFDA

MCI = Mild Cognitive Impairment. Peterson. 2001Iverson. Neurology. 2010 and www.alz.org

Identifying Identifying �� driving riskdriving riskin dementiain dementia

Identifying Identifying �� driving riskdriving riskin dementiain dementia

•• Higher CDR (A) Higher CDR (A) •• Adverse caregiver rating (B)Adverse caregiver rating (B)•• Reduced mileage (selfReduced mileage (self--restriction) (C )restriction) (C )Reduced mileage (selfReduced mileage (self restriction) (C )restriction) (C )•• Agitation/ aggression (C )Agitation/ aggression (C )•• Crash in past 1Crash in past 1--5 years (C )5 years (C )•• Citation past 2Citation past 2--3 years3 years•• MMSEMMSE �� 2424 (C )(C )

Iverson. 2010

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What is not useful:What is not useful:What is not useful:What is not useful:

•• Patient’s selfPatient’s self--rating of safe driving rating of safe driving ability (A)ability (A)

•• Lack of situational avoidance ( C )Lack of situational avoidance ( C )( )( )

Algorithm for driving concernsAlgorithm for driving concernsAMA counseling/assessing older drivers 2003 AMA counseling/assessing older drivers 2003 Adapted from Iverson. 2010Adapted from Iverson. 2010

Algorithm for driving concernsAlgorithm for driving concernsAMA counseling/assessing older drivers 2003 AMA counseling/assessing older drivers 2003 Adapted from Iverson. 2010Adapted from Iverson. 2010

Vision?

Refer to ophthal

Motor?Cognitive?

CDT, TMT B,30-pt test?

No No No

Y YY: Deficit w/ possible dementia

ETOH, PIM, sleep disorder?

Interval reassessment?

Refer for carfit, PM&R, PT, neuro, rheum, etc

CDR 0.5

CDR 0.5 + RF

CDR 1.0

CDR � 2 High risk; Driving Cessation

Low risk at this time.

Consider driver assessment.

CDT: clock draw testTMT: trail-making testCDR: Clinical dementia rating30-test: MMSE, MOCA, SLUMSPIM: Potentially inappropriate medicationRF: Risk factorPT: Physical Therapy

Consider referring for driver Consider referring for driver assessmentassessment

Consider referring for driver Consider referring for driver assessmentassessment

•• Any CDR 1.0 (“mild” dementia)Any CDR 1.0 (“mild” dementia)•• Any CDR 0.5 with Any CDR 0.5 with �� 1 “1 “risk factorrisk factor””

-- Adverse caregiver rating Adverse caregiver rating Reduced mileage (selfReduced mileage (self restriction)restriction)-- Reduced mileage (selfReduced mileage (self--restriction)restriction)

-- Agitation/ aggression Agitation/ aggression -- Crash in past 1Crash in past 1--5 years 5 years -- Citation past 2Citation past 2--3 years3 years-- MMSEMMSE �� 2424-- Iverson. Neurology. 2010Iverson. Neurology. 2010

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No Gold Standard for No Gold Standard for determining safetydetermining safety

No Gold Standard for No Gold Standard for determining safetydetermining safety

•• Bureau of Motor VehiclesBureau of Motor Vehicles•• SimulatorSimulator•• Psychometric testing (screening)Psychometric testing (screening)•• OnOn--road testingroad testing

On the RoadOn the RoadOn the RoadOn the Road

The Driving EvaluationThe Driving EvaluationThe Driving EvaluationThe Driving Evaluation

The Eye Check MirrorThe Eye Check Mirror

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On the Road Functional On the Road Functional AssessmentAssessment

On the Road Functional On the Road Functional AssessmentAssessment

•• Vehicle ingress/egressVehicle ingress/egress•• Mobility aid mgmtMobility aid mgmt (e.g., scooter, wheelchair)(e.g., scooter, wheelchair)•• Vehicle prep (e.g., tires, mirrors, Vehicle prep (e.g., tires, mirrors, CAR FITCAR FIT))•• Vehicle controlVehicle control•• Traffic rules/regulation adherenceTraffic rules/regulation adherence•• Awareness of changing environmentAwareness of changing environment•• Managing distractionsManaging distractions•• Compensation strategies (vision, sensation, Compensation strategies (vision, sensation,

ROM, Strength, cognition)ROM, Strength, cognition)

Possible OutcomesPossible OutcomesPossible OutcomesPossible Outcomes

1.1. Return to driving, Return to driving, with or without adaptive with or without adaptive driving equipment; w/ or wo recommendation to driving equipment; w/ or wo recommendation to retestretest

2.2. Limit driving with restrictionsLimit driving with restrictionsG hiG hi•• Geographic areasGeographic areas

•• Other: Day time only; remedial Other: Day time only; remedial driving course driving course

•• Adaptive driving instruction Adaptive driving instruction using a vehicle matched to the client’s using a vehicle matched to the client’s individual needsindividual needs

3.3. Cease drivingCease driving

OTR/L Referral requiresOTR/L Referral requiresOTR/L Referral requiresOTR/L Referral requires

•• Current driver licenseCurrent driver license•• Licensed driver for the ride homeLicensed driver for the ride home•• Prescription for OTR/LPrescription for OTR/LPrescription for OTR/LPrescription for OTR/L•• Example of “Acceptable” diagnosisExample of “Acceptable” diagnosis

-- Lack of coordination 781.3Lack of coordination 781.3-- Stroke 434.91Stroke 434.91-- Dementia is not acceptableDementia is not acceptable

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Counseling after Counseling after Cessation RecommendationCessation Recommendation

Counseling after Counseling after Cessation RecommendationCessation Recommendation

•• ComplicatedComplicated•• Driving is more than transportationDriving is more than transportation•• NonNon--driving spouse may be affecteddriving spouse may be affectedNonNon driving spouse may be affecteddriving spouse may be affected

-- collusioncollusion•• Tied in with living arrangementsTied in with living arrangements•• May be a process rather than a stepMay be a process rather than a step

Strategies for counselingStrategies for counselingStrategies for counselingStrategies for counseling

•• Enlist family memberEnlist family member•• Try to preserve dignity of driverTry to preserve dignity of driver

-- “Not a bad driver“Not a bad driver-- but bad traffic”but bad traffic”Not a bad driverNot a bad driver but bad trafficbut bad traffic•• Advance planningAdvance planning

-- Retirement communityRetirement community-- Independent living/ assisted livingIndependent living/ assisted living-- Use of funds from car sale for taxiUse of funds from car sale for taxi

Enforcing cessationEnforcing cessationEnforcing cessationEnforcing cessation

•• TwoTwo--car to onecar to one--carcar•• Ignition killIgnition kill

-- From $19.95 to several hundredFrom $19.95 to several hundredFrom $19.95 to several hundredFrom $19.95 to several hundred-- Alzheimer Store or Auto shopAlzheimer Store or Auto shop

•• BrokeBroke-- “we can’t afford to fix”“we can’t afford to fix”•• Notify BMV (revocation process)Notify BMV (revocation process)•• Removal of car (guardianship?)Removal of car (guardianship?)

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Legal considerationsLegal considerations

•• Protecting the patientProtecting the patient-- Case lawCase law: failure to advise patients : failure to advise patients

on medical conditions/ medications on medical conditions/ medications is negligent behavioris negligent behavioris negligent behavioris negligent behavior

-- Case lawCase law: health care system can be : health care system can be liable for breaching confidentialityliable for breaching confidentiality

•• Protecting the publicProtecting the public-- Legal precedentsLegal precedents: physicians may be : physicians may be

held liable for thirdheld liable for third--party injuriesparty injuries

OHIO LAWOHIO LAWOHIO LAWOHIO LAW•• PatientsPatients report med conditions to BMV.report med conditions to BMV.•• BMVBMV contacts clinician to corroborate. contacts clinician to corroborate.

-- Physician, CNS, NP, nursePhysician, CNS, NP, nurse--midwife, PA…midwife, PA…•• Conduct physical examConduct physical exam

Complete formComplete form•• Complete formComplete form•• BMVBMV decides: decides:

-- Driver test? limited license? Suspend Driver test? limited license? Suspend license?license?

-- Will suspend license if pt ignores themWill suspend license if pt ignores them•• No mandatory reporting lawNo mandatory reporting law

Ohio revised code: 4507.20 Examination of licensee's competency

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New Ohio RegulationsNew Ohio RegulationsNew Ohio RegulationsNew Ohio Regulations

•• Physician Physician maymay report confidentiallyreport confidentially-- Not OT, not NP or PANot OT, not NP or PA-- Not subject to disclosureNot subject to disclosureNot subject to disclosureNot subject to disclosure-- Not part of public recordNot part of public record

•• State medical reasons unable operate State medical reasons unable operate vehiclevehicle

•• §§4507.20 Examination of licensee’s competency4507.20 Examination of licensee’s competency

Compare with Missouri LawCompare with Missouri LawProgressive!!Progressive!!

Compare with Missouri LawCompare with Missouri LawProgressive!!Progressive!!

•• Any physician, PT, OT, RN, DC, LSW, Any physician, PT, OT, RN, DC, LSW, psychologist, PA, NPpsychologist, PA, NP

•• Confidential, immunityConfidential, immunity, y, y•• ReportReport

-- Medical disorder impairing drivingMedical disorder impairing driving-- Expected duration impairmentExpected duration impairment

PennsylvaniaPennsylvaniaNext doorNext door-- bewarebeware

PennsylvaniaPennsylvaniaNext doorNext door-- bewarebeware

•• PENNDOTPENNDOT requiresrequires reporting w/in 10dreporting w/in 10d-- By any physician in any stateBy any physician in any state-- Also NP, PA, DC, etcAlso NP, PA, DC, etc-- Any condition impair driving abilityAny condition impair driving ability-- NeuromuscularNeuromuscular

•• Parkinson, alzheimer, convulsiveParkinson, alzheimer, convulsive•• Can be anonymousCan be anonymous•• Legal immunityLegal immunity

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States surrounding OHStates surrounding OHNo mandatory reporting for:No mandatory reporting for:

States surrounding OHStates surrounding OHNo mandatory reporting for:No mandatory reporting for:

•• KentuckyKentucky: + immunity, no clear legal : + immunity, no clear legal protection. protection. http://transportation.ky.gov/driverhttp://transportation.ky.gov/driver--

licensing/pages/kentuckylicensing/pages/kentucky--medicalmedical--reviewreview--boardboard--program.aspxprogram.aspx

ININ Rene al q6 r age < 75 q3 ears at 75 rsRene al q6 r age < 75 q3 ears at 75 rs•• ININ: Renewal q6 yr age < 75; q3 years at 75 yrs,: Renewal q6 yr age < 75; q3 years at 75 yrs,q2 at 85. Immunity for clinicians. q2 at 85. Immunity for clinicians.

•• No immunity or legal protectionNo immunity or legal protection inin-- W Virginia;W Virginia; not confidentialnot confidential-- MIMI: may report; form OC: may report; form OC--8888

http://www.michigan.gov/documents/OChttp://www.michigan.gov/documents/OC--88_16727_7.PDF88_16727_7.PDF

http://www.ama-assn.org/resources/doc/public-health/older-drivers-chapter8.pdf

SummarySummarySummarySummary•• If driving concerns arise:If driving concerns arise:

-- Office test vision, motor, cognitionOffice test vision, motor, cognition-- Refer appropriatelyRefer appropriately-- Reassess periodicallyReassess periodically

If dementia need to stageIf dementia need to stage•• If dementia need to stageIf dementia need to stage•• Algorithm for decisionAlgorithm for decision--makingmaking•• Reporting regs are inconsistentReporting regs are inconsistent

-- Within statesWithin states-- Between statesBetween states-- Watch out for PennsylvaniaWatch out for Pennsylvania

ReferencesReferencesReferencesReferences

• Iverson et al. Practice Parameter update: Evaluation and management of driving risk in dementia : Report of the Quality StandardsSubcommittee of the American Academy of Neurology. Neurology 2010;74;1316gy gy ; ;

• AMA Physician's Guide to Assessing and Counseling Older Drivers. 2010 edition. http://www.ama-assn.org/resources/doc/public-health/older-drivers-guide.pdf

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Floridagranddriver.comFloridagranddriver.comwww.flhsmv.gov/forms/72190www.flhsmv.gov/forms/72190

Floridagranddriver.comFloridagranddriver.comwww.flhsmv.gov/forms/72190www.flhsmv.gov/forms/72190

Gratuitous commentsGratuitous commentsSociety should do moreSociety should do moreGratuitous commentsGratuitous comments

Society should do moreSociety should do more

•• Physical safety of carsPhysical safety of cars•• CarfitCarfit•• SignageSignageSignageSignage

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Improving physical safetyImproving physical safetyImproving physical safetyImproving physical safety

•• Vehicle designVehicle design-- Head rests, shatterHead rests, shatter--resistantresistant

windshieldswindshields-- EnergyEnergy--absorbing steering wheel, absorbing steering wheel,

seat beltsseat belts-- Front, side air bag restraintsFront, side air bag restraints

•• Medical ConditionsMedical Conditions-- ATLS disseminationATLS dissemination

Car FitCar FitCar FitCar Fit

www.car-fit.org for AAA-sponsored listing of events

12 point CarFit Checklist12 point CarFit Checklist12 point CarFit Checklist12 point CarFit Checklist1. Who else drives car?1. Who else drives car?2. Uses safety belt?2. Uses safety belt?3. Steering wheel tilt/head 3. Steering wheel tilt/head

restraint devicerestraint device4. Distance between chest 4. Distance between chest

6. Positioning to gas pedal 6. Positioning to gas pedal 7. Positioning to brake 7. Positioning to brake

pedalpedal8. Mirror use8. Mirror use9 Neck mobility for blind9 Neck mobility for blind

and steering wheel and steering wheel (should be 10(should be 10--12")12")

5. Line of sight above 5. Line of sight above steering wheel (should be steering wheel (should be > 3")> 3")

9. Neck mobility for blind9. Neck mobility for blindspot checkspot check

10. Ignition key10. Ignition key11. Reach/operate vehicle 11. Reach/operate vehicle

controlscontrols12. Vehicle walk12. Vehicle walk--aroundaround

AAA, AARP

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Where to fit the car?Where to fit the car?Where to fit the car?Where to fit the car?

•• Isolated eventsIsolated events•• AARP, AAA have informationAARP, AAA have information•• Typically up to driver to make theTypically up to driver to make theTypically up to driver to make theTypically up to driver to make the

alterations in settingsalterations in settings•• www.carwww.car--fit.orgfit.org•• Can be part of a driver eval at CCF Can be part of a driver eval at CCF

Car/ Road SafetyCar/ Road Safetyre: Visionre: Vision

Car/ Road SafetyCar/ Road Safetyre: Visionre: Vision

•• Larger dials inside vehicleLarger dials inside vehicle•• IlluminationIllumination

-- Better on streetBetter on street-- Less glare within carLess glare within car

•• Better signageBetter signage-- clearview fontclearview font•• Protected turn lanesProtected turn lanes

-- LeftLeft--turn lanesturn lanes-- Protected turn signalsProtected turn signals-- Protected rightProtected right--turnturn

•• Signals over each laneSignals over each lane

Clearview fontClearview fontClearview fontClearview font

PurposePurpose•• Improve pattern Improve pattern

recognitionrecognition-- Mixed caseMixed case

•• Speed, accuracy, Speed, accuracy, and distance and distance legibility of word legibility of word recognitionrecognition

•• Recognition at nightRecognition at nightPennsylvania Transportation InstituteTexas Transportation InstituteApproval of FWHA

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Recent driver studyRecent driver studyRecent driver studyRecent driver study•• 45 persons: (no dementia)45 persons: (no dementia)

-- Mean age 73.5, MMSE 29.1Mean age 73.5, MMSE 29.1•• 84 patient with AD: 84 patient with AD:

-- 52 persons: (very early) 52 persons: (very early) Mean age 75 1 MMSE 25 4Mean age 75 1 MMSE 25 4•• Mean age 75.1, MMSE 25.4Mean age 75.1, MMSE 25.4

-- 32 persons: (mild dementia) 32 persons: (mild dementia) •• Mean age: 76, MMSE 21.8Mean age: 76, MMSE 21.8

•• All received baseline driver evaluationAll received baseline driver evaluation•• Reassessment q6 monthsReassessment q6 months

Rhode Island. Ott. Neurology. 2008

How did they do?How did they do?How did they do?How did they do?

25

Failure rate of on-the-road driver test at baseline

32

0

5

10

15

20

Per

cen

t

None Very early Mild

Clinical Dementia Rating

44

52

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Going Beyond Welcome To Medicare!

Peter A. DeGolia, MD, CMD

Learning Objective:

Cite two new expectations of the Medicare Medical Examination.

Speaker Disclosure:

Dr. DeGolia has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Going Beyond Welcome to Medicare!

October 15, 2011Salt Fork Ohio Geriatric Medicine Conference

Peter A. DeGolia, MDMedalie Professor for Home-Centered Health Care

CWRU School of MedicineUniversity Hospitals Center for Geriatric Medicine

CMS and Medicare

“Today, more than one year after the Affordable Care Act was enacted, we have made important improvements in Medicare to provide better care, lower costs, and improve the health of our beneficiaries.”

Donald M. Berwick, MDAdministratorJune 20, 2011

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What’s new in Medicare?Mr. M turned 65 years old on 1/2/2011. He went to

see his family physician two days later. He asked “What’s new Doc?” His doctor stated

A) You can now have your “Welcome to Medicare” Initial Preventive PhysicalMedicare Initial Preventive PhysicalExamination

B) Next year I can give see me for an Annual Wellness Visit without charge to you

C) You can get an Initial Preventive Physical Examination and an Annual Wellness Visit this year!

What is Medicare Part B?

• Government supported health insurance that helps cover medically-necessary services like doctors’ services, outpatient care home health services and othercare, home health services, and othermedical services.

• It now covers some preventive services.• Beneficiaries with Part B pay a monthly

premium.

What are Medicare Preventive Services?

• Health care to prevent illness or detect it at an early stage, when treatment is most likely to work best (e.g. pap tests, flu shots colorectal cancer screenings)shots, colorectal cancer screenings)

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New Benefits for People on Medicare

• Free Annual Wellness Visit• Free Preventive Services

L C t P i ti D• Lower Cost Prescription Drugs

Free Annual Wellness Visit

• Effective 1/1/2011• Builds on the one-time only preventive physical

examination (or “Welcome to Medicare Visit”)• Annual visit allows physicians and patients toAnnual visit allows physicians and patients to

develop and update a personalized prevention plan that considers both age-appropriate preventive services available to all Medicare beneficiaries and additional services that may be appropriate to the patient’s individual needs.

Free Annual Wellness Visit

• Annual wellness cannot be provided in the same 12 month period as the Welcome to Medicare visit, but can be provided annually thereafterannually thereafter.

• Visit is free for beneficiaries when provided by a Medicare participating health care provider.

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Free Preventive Services

• Effective 1/1/2011• May now receive many recommended

preventive services from Medicare participating health care provider withoutparticipating health care provider withoutpaying the Medicare Part B deductible and 20 percent coinsurance.

Lower Cost Prescription Drugs

• The Affordable Care Act phases out the Medicare Part D coverage gap, or “donut hole”, for Medicare beneficiaries by 2020. This year people on Medicare who do notThis year, people on Medicare who do notalready receive low-income subsidies will receive approximately a 50% discount on covered brand-name prescription drugs and biologics while they are in the donut hole.

Lower Cost Prescription Drugs

• Beneficiaries automatically will receive discounts at point-of-sale

• Beneficiaries will also receive greater coverage of generic drugs in the coveragecoverage of generic drugs in the coveragegap

• Assistance will increase until the coverage gap is closed in 2020

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What should providers know?• Medicare wants to encourage greater beneficiary

responsibility for the management of their health care• Know what services are now available to Medicare

beneficiaries– Welcome to Medicare Preventive Visit– Annual Wellness Visits– Preventive Services Checklist

• Beneficiaries are encouraged to– Go to the visits– Track the preventive services offered– Use a personal health record – Use the Drug & Pharmacy Manager tool to create, view, and

change their medication lists.

Top 10 diagnoses for people over age 50 years(by prescription)1. Hypertension2. Chronic heart disease3. Unspecified diabetes mellitus4. Disorders of lipoprotein metabolism5. Chronic obstructive pulmonary disease6. Heart failure7. Arthrosis8. Non–insulin-dependent diabetes mellitus9. Hypertensive heart disease10. Menopausal and peri-menopausal disorders

Data from The ‘‘boom’’ of baby boomers. Available at: http://www.ims-global.com/insight/news_story/0101/news_story_010123.htm. Accessed June 8, 2005.

Case Study

• Mr. M visits his family physician for his Welcome to Medicare! Visit. He reports that he is healthy except for osteoarthritis of his knee. His physician reviews his PMH, medications, and review of symptoms. He does not have cardiac disease and his examination is unremarkable. His physician recommends an EKG which is done and interpreted as normal.

• How is this billed by the provider and what, if anything, does the beneficiary pay?

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Case #1• Welcome to Medicare! Visit with an ECG which

was optional.• Billed using HCPCS/CPT code

– G0402 (IPPE)– G0403 (ECG for IPPE)( )– G0404 (ECG tracing for IPPE), and – G0405 (ECG interpret & report)

• G0402 = co-payment/coinsurance & deductible are waived.

• G0403, G0404, G0405 = co-payment /co-insurance applies; deductible applies

Welcome to Medicare visit• Medicare covers a one-time, comprehensive

Welcome to Medicare preventive visit for new beneficiaries within the first 12 months ofenrollment in Part B.

• This exam is now free. – G0402 = co-payment/coinsurance and deductible are

waived.• ECG is not required; if performed as part of the

evaluation, a deductible fee applies.• Comprehensive examination consists of 7

components

7 Components of the Welcome to Medicare visit

1. Review of an individual’s medical and social history with attention to modifiable risk factors

• PMH, FMHX, active medical problems, medications• Determine if the beneficiary is up-to-date with preventive

screenings and services2 Review of an individual’s potential risk factors for2. Review of an individual’s potential risk factors for

depression3. Review of an individual’s functional ability and level of

safety4. Perform a physical examination including obtaining an

individual's weight, height, blood pressure, visual acuity, and measurement of body mass index

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7 Components of the Welcome to Medicare visit

5. End-of-life planning6. Education, counseling, and referral based on

the results of the review and evaluation services described in the previous 5 componentsp

– Order further tests depending on the general health, preventive health status, and medical history of the beneficiary

7. Education, counseling, and referral, including a brief written plan such as a checklist for obtaining the appropriate screening and/or other Medicare Part B preventive services.

Classification of Older Adults

• Vigorous and stable (independent with life expectancy at least 5 years)

• Transitional (physical impairment with lifeTransitional (physical impairment with lifeexpectancy less than 5 years or moderate dementia with life expectancy 2–10 years)

• Supportive (life expectancy less than 2 years)

Effective 1/1/2011

• Medicare will cover an – annual wellness visit– personalized prevention plan

A b fi i t h M di f• A beneficiary must have Medicare forgreater than 12 months.

• The visit and prevention plan are free.

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New Annual Wellness Visits– Health risk assessment – Individual & family medical history– List of current providers providing care– List of prescription medications– Height, weight, body mass index or waist

circumference measurementscircumference measurements– BP measurements– Detection of cognitive impairments– Screening schedule for appropriate preventive

services over the next 5 to 10 years– List of risk factors and conditions for which

interventions are recommended or under way– Personalized health advice and referrals as

appropriate

Personalized Prevention Plan

• To prevent disease based on a beneficiaries current health and risk factors.

Preventive Services Checklist• Abdominal Aortic Aneurysm

Screening• Bone Mass Measurement• Cardiovascular Screening• Colorectal Cancer Screening• Fecal Occult Blood Test

Fl ibl Si id

• Glaucoma Test• Hepatitis B Shot• HIV Screening• Mammogram• Medical Nutrition Therapy

ServicesP T t d P l i E• Flexible Sigmoidoscopy

• Colonoscopy• Barium Enema• Diabetes Screening• Diabetes Self-management

training• Flu Shot

• Pap Test and Pelvic Exam• Welcome to Medicare

Preventive visit• Yearly Wellness Visit• Pneumococcal Shot• Prostate Cancer Screening• Smoking Cessation

Counseling

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Additional tests or services

• Additional tests or services provided during the yearly “wellness” visit that are not covered under these preventive benefits may result in co-payment/co-benefits may result in co payment/coinsurance and Part B deductible payments.

Case #2• 69 year old woman is seen for her annual

wellness visit. She has a PMH of HTN, DM, and CHF. She is sexually active and had an abnormal pap smear 1 year ago. Last year you spent 3 hours of one-on-one nutritional co nseling ith her specific to her h pertensioncounseling with her specific to her hypertensionand heart failure. No other evaluations were performed and you note that her blood sugar is elevated.

• What opportunities for preventive care exist at this visit?

Case #2• Repeat pelvic exam with Pap Smear • Annual mammogram• Cardiovascular disease screenings• Diabetes self-management training• 2 hours of subsequent medical nutrition therapy• Possibly Bone Mass Measurement • Fecal Occult Blood Test (at least)• Glaucoma screening• Seasonal influenza virus vaccine if appropriate• Pneumococcal vaccine if not previously given• Counseling to prevent tobacco use if she smokes and

wants to stop

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New codes• CMS established Healthcare Common

Procedure Coding System (HCPCS) codes that physicians are required to use to bill for AWV services. These agency-maintained HCPCS “G” codes are:

• G0438 – Annual wellness visit; includes a personalized prevention plan of service, first visit

• G0439 – Annual wellness visit; includes a personalized prevention plan of service, subsequent visit

• CMS decided to establish these HCPCS codes after determining that no existing code adequately describes the AWV services.

Billing and Coding for Services

• Refer to the Medicare Preventive Services Quick Reference Information handout

Physician reimbursement

• The 2011 Medicare payment—not adjusted for geography—is approximately $172 for G0438 and $111 for G0439.

• Medicare will pay the full amount meaning• Medicare will pay the full amount, meaningthat the beneficiary does not have to pay the typical 20 percent co-payment nor toward a yet-to-be reached deductible.

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Physician reimbursement

• Medicare will pay a physician for an AWV service and a medically necessary service, e.g. a mid-level established office visit, Current Procedural Terminology (CPT) code 99213, furnished during a single beneficiary encounter.

• Physicians must append modifier -25 (significant, separately identifiable service) to the medically necessary E/M service, e.g. 99213-25, to be reimbursed for both services.

Can I include elements when furnishing an AWV service beyond the elements that are

listed as required?• Yes. To illustrate, a review of a beneficiary’s risk for

depression and an assessment of functional ability and level of safety are only required elements for the first AWV service but a physician can continue to address these issues voluntarily in subsequent AWVs. CMS notes it would be appropriate to continue to screen fornotes it would be appropriate to continue to screen fordepression in subsequent AWVs for certain beneficiaries as evidence dictates that recurrent depression screening is indicated for a subgroup of patients. Continued screening for functional ability would be appropriate for those who it is determined a priority area.

• Voluntary advance care planning is another element in which you may engage a beneficiary even though it is not listed as a CMS-identified component.

Does a physician personally have to furnish an Annual

Wellness Visit service?• No. An AWV service can be furnished by a:

– Physician;y ;– Nurse practitioner (NP), physician assistant

(PA), or clinical nurse specialists (CNS); and – Medical professional (including a health

educator, registered dietitian, or\ nutrition professional) or a team of medical professionals, who are working under the direct supervision of a physician.

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Does the establishment of the AWV service benefit revoke the ability of a physician to bill a

beneficiary for a Medicare non-covered CPT comprehensive preventive medicine service,

CPT 99381-99397?• No. CMS states that a physician can continue to bill a beneficiary for a

non-covered comprehensive preventive medicine service, such as CPT 99387, which describes such a service to a new patient 65 years and older, as long as the service does not fit the description of the specific d i ti f AWV i th W l t M di i itdescription of an AWV service or the Welcome to Medicare visitservice.

• A physician can also continue to bill Medicare for a “medically necessary” service, e.g. CPT 99213, that addresses an acute or chronic problem during an encounter at which a CPT periodic comprehensive preventive service is furnished. The Medicare payment policy that directs the physician to bill the beneficiary the physician’s established charge for the CPT comprehensive preventive medicine service minus the established charge for the “medically necessary” service still applies.

Can a physician bill Medicare for a “medically necessary” service and an AWV service when

both are furnished during the same encounter?

• Yes. The physician should append the code indicating the medically necessary service, e.g. 99213, with modifier -25 (significant, separately identifiable evaluation and management service by the same physician on the same day of a procedure or other service), in addition to billing the appropriate AWV service.

• CMS states that it expects that “no component of an encounter attributable to the AWV would be used in determining the level of separate E/M service that would also be reported.”

Can CMS make changes to the required AWV elements in the future?

• CMS has the authority to add specific required elements to the initial and/or subsequent AWV service. One issue on the horizon is the pending addition of thethe horizon is the pending addition of thehealth risk assessment element, which CMS is likely to add as early as 2012. The agency is committed to seeking comments from the public before it changes AWV required elements.

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US Preventive Services Task ForceRecommendations for Older Adults

The following topics either include specific recommendations for adults ages 65 years and older or target preventive services primarily provided to older adults diseasesprimarily provided to older adults, diseasesthat carry a higher burden for older adults, or diseases that generally occur in older adults.

USPSTF Recommendations• A = The USPSTF recommends the service. There is high certainty that the net

benefit is substantial. Offer or provide this service.

• B = The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service.

• C = The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service in an individual patient. There is at l t d t t i t th t th t b fit i ll Off id thi ileast moderate certainty that the net benefit is small. Offer or provide this serviceonly if other considerations support the offering or providing the service in an individual patient.

• D = The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service.

• I Statement = The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.

Recommendations for Older AdultsAbdominal Aortic Aneurysm Screening

Summary of Recommendation• The USPSTF recommends one-time screening for

abdominal aortic aneurysm (AAA) by ultrasonography in men aged 65 to 75 who have ever smoked.Grade: B Recommendation. (Medicare will pay for this 1 ( p ytime for at risk beneficiaries.)

• The USPSTF makes no recommendation for or against screening for AAA in men aged 65 to 75 who have never smoked.Grade: C Recommendation.

• The USPSTF recommends against routine screening for AAA in women.Grade: D Recommendation.

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Recommendations for Older AdultsBreast Cancer Screening

Summary of Recommendation• The USPSTF recommends biennial screening mammography for women aged

50 to 74 years. Grade: B recommendation.

• The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. Grade: C recommendation.

• The USPSTF concludes that the current evidence is insufficient to assess the• The USPSTF concludes that the current evidence is insufficient to assess theadditional benefits and harms of screening mammography in women 75 years or older. Grade: I Statement.

• The USPSTF recommends against teaching breast self-examination (BSE).Grade: D recommendation.

• The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. Grade: I Statement.

• The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. Grade: I Statement.

Recommendations for Older AdultsCervical Cancer Screening

Summary of Recommendation• The USPSTF strongly recommends screening for cervical cancer in

women who have been sexually active and have a cervix.Grade: A Recommendation.

• The USPSTF recommends against routinely screening women older than age 65 for cervical cancer if they have had adequate recent screening with normal Pap smears and are not otherwise at high risk for cervical cancer (go to Clinical Considerations)for cervical cancer (go to Clinical Considerations).Grade: D Recommendation.

• The USPSTF recommends against routine Pap smear screening in women who have had a total hysterectomy for benign disease.Grade: D Recommendation.

• The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of new technologies to screen for cervical cancer. Grade: I Statement.

• The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of human papillomavirus (HPV) testing as a primary screening test for cervical cancer. Grade: I recommendation.

Recommendations for Older AdultsColorectal Cancer Screening

Summary of Recommendation• The USPSTF recommends screening for colorectal cancer

(CRC) using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary. Grade: A Recommendation.

• The USPSTF recommends against routine screening for colorectal cancer in adults age 76 to 85 years. There may be considerations that support colorectal cancer screening in an individual patient. Grade: C Recommendation.

• The USPSTF recommends against screening for colorectal cancer in adults older than age 85 years. Grade: D Recommendation.

• The USPSTF concludes that the evidence is insufficient to assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer. Grade: I Statement.

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Recommendations for Older AdultsCoronary Heart Disease Screening

Summary of Recommendation• The U.S. Preventive Services Task Force (USPSTF)

recommends against routine screening with resting electrocardiography (ECG), exercise treadmill test (ETT), or electron-beam computerized tomography (EBCT) scanning for coronary calcium for either the presence of severe coronary artery stenosis (CAS) or the prediction of coronary heart di (CHD) t i d lt t l i k f CHD tdisease (CHD) events in adults at low risk for CHD events.Grade: D Recommendation.

• The USPSTF found insufficient evidence to recommend for or against routine screening with ECG, ETT, or EBCT scanning for coronary calcium for either the presence of severe CAS or the prediction of CHD events in adults at increased risk for CHD events.Grade: I Statement.

Recommendations for Older AdultsDementia Screening

Summary of Recommendation• The U.S. Preventive Services Task

Force (USPSTF) concludes that the evidence is insufficient to recommendevidence is insufficient to recommendfor or against routine screening for dementia in older adults.Grade: I Statement.

Recommendations for 2011 Immunizations, Adult

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Recommendations for 2011 Immunizations, Adult

Recommendations for Older AdultsOsteoporosis Screening

Summary of Recommendation• The USPSTF recommends screening for

osteoporosis in women aged 65 years or older and in younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who h dditi l i k f thas no additional risk factors.Grade: B Recommendation.

• The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis in men.Grade: I Statement

Recommendations for Older AdultsProstate Cancer Screening

Summary of Recommendation• The USPSTF concludes that the current

evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 yearsscreening in men younger than age 75 years.Grade: I Statement.

• The USPSTF recommends against screening for prostate cancer in men age 75 years or older.Grade: D Recommendation.

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Recommendations for Older AdultsVision Screening

Summary of Recommendation• The USPSTF concludes that the current

evidence is insufficient to assess the balance of benefits and harms ofbalance of benefits and harms ofscreening for visual acuity for the improvement of outcomes in older adults.Grade: I statement.

US Preventive Services Task Force

USPSTF topics that focus on older adults and are currently under review include:

• Falls Prevention in Older Adults• Falls Prevention in Older Adults• Hearing Loss in Older Adults • Vitamin D for Osteoporosis Prevention • Multivitamins for Cardiovascular Disease

and Cancer Prevention • Dementia Screening

US Preventive Services Task Force

USPSTF other relevant topics that affect older adults:Tobacco use• The USPSTF recommends that clinicians ask all adults

about tobacco use and provide tobacco cessation interventions for those who use tobacco productsinterventions for those who use tobacco products.Grade: A recommendation.

Alcohol use• The U.S. Preventive Services Task Force (USPSTF)

recommends screening and behavioral counseling interventions to reduce alcohol misuse (go to Clinical Considerations) by adults in primary care settings.Grade: B Recommendation.

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Selected health maintenance activitiesActivity Vigorous Transitional Supportive

Breast examination Yearly Yearly YearlyMammography Every 1–2 y Consider every No

up to age 80 y 1–2 y up to age 75 y

Pap smear Consider 1–3 No NoPap smears if patient has never had one

Prostate-specific antigen Discuss pros Discuss pros Noand cons and cons

ith ti t ith ti twith patient with patient

Hemoccult testing Yearly Consider yearly No

Colonoscopy Every 5 y No No

Aspirin If history of If history of Nomyocardial myocardial infarction or R2infarction or R2 cardiovascular risk factorscardiovascular risk factors

Medication review Each visit Each visit Each visitData from Gerimed Software LLC. Clinical Guidepath tools. Heathrow (FL): Gerimed Software LLC; 2003.

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Foot Exam and Common Problems & Remedies for the Elderly

Brian J. Weiss, DPM

Learning Objectives:

Identify and explain treatment options to elderly patients regarding concerns about their foot situation.

Speaker Disclosure:

Dr. Weiss has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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NOTES

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Name That Lesion

Golara Honari, MD

Learning Objectives:

Recognize common clinical presentation of prevalent cutaneous conditions, specifically in adults and geriatric population.

Speaker Disclosure:

Dr. Honari has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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NOTES

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How To Set Up A QI Project In Your Practice That Is Meaningful

John R. Kues, PhD, CCMEP

Learning Objectives:

Develop and implement a QI project in practice that will improve patient care.

Speaker Disclosure:

Dr. Kues has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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NOTES

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No-monia and No-uria: Practical Recommendations for Using Fewer

Antibiotics

Robin L. P. Jump, MD, PhD

Learning Objectives:

Review the care and management of patients with appliances that contribute to the complexity of their care.

Speaker Disclosure:

Dr. Jump discloses she is a Consultant for GOJO and Pfizer.

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No�Monia and�No�UriaPractical�Recommendations�for�

Using�Fewer�AntbioticsOctober�15th,�2011

Robin�Jump,�M.D.,�Ph.D.Geriatric�Research,�Education�and�Clinical�Center

Louis�Stokes�VA�Medical�CenterCase�Western�Reserve�University

Disclosures• I�may�discuss�off�label�use�of�medications�(metronidazole�for�C.�difficile infection).

• Consultant�for�GOJO�Industries�and�Pfizer

• Research�funding�from�Merck�&�Sterisg

DisclaimerThe�opinions presented herein are my own and do not represent those of the Veterans Affairs system or the federal government.

Learning�Objectives

Discuss adverse effects of indiscriminant antibiotic use

Recognize opportunities for antimicrobialRecognize opportunities for antimicrobialstewardship at the bedside.

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Antimicrobials�Save�Lives

Courtesy�of�F.�Perez;�Armstrong�GL,�Conn�LA,�Pinner RW.�JAMA.�1999;281:61�66

Great�Influenza

Antimicrobials�Save�Lives

Penicillin

Sulfas

STR�INH�PZA HAART

AIDS

Courtesy�of�F.�Perez;�Armstrong�GL,�Conn�LA,�Pinner RW.�JAMA.�1999;281:61�66

Antimicrobial�Resistance�Takes�Lives

30

40

50

60

of s

ubje

cts

CRKPCSKPCarbapenem-Resistant Klebsiella pneumoniae

Carbapenem-Susceptible Klebsiella pneumoniae

0 001 0 001

0

10

20

30

Overall Mortality Attributable Mortality

Perc

ent o

Patel G et al. Infect Control Hosp Epidemiol 2008;29:1099-1106

OR 3.71 (1.97-7.01) OR 4.5 (2.16-9.35)

p<0.001 p<0.001

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Meta�analysis�of�31�studies�comparing�bacteremia due�methicillin resistant vs

Antimicrobial�Resistance�Takes�Lives

10

Increased�Risk�of�Death�with�MRSA�vs.�MSSA�

Bacteremia

methicillin�resistant�vs.methicillin�sensitive�Staphylococcus�aureus(MRSA�vs.MSSA,�respectively)

Cosgrove, S et al. Clin. Infect. Dis.36(1),53–59 (2003)

0.1

1

Odd

s�Ra

tio p<0.001

Improving antibiotic use is a public health imperative

• Antibiotics are the only drug where use in one patient can impact the effectiveness in another.

• If everyone does not use antibiotics well, we will all suffer the consequences.q

• Antibiotics are a shared resource (and becoming a scarce resource).

Only YOU can prevent antimicrobial resistance.

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How Not to Use Antibiotics• “Just in case”• “Well, the culture is negative but since

we’ve already started…” • “You’re feeling better? After just 1 day?

G ! 13 d f ibi i !”Great!—13 more days of antibiotics!”• “We’ll just keep these really powerful

antibiotics on board.”• “If 125mg is good, then 250mg must be

better!”

How to Reduce Antibiotic Use• All antibiotic orders need:

• Dose• Duration• Indication

• Get Cultures & Diagnostic Tests• Take an antibiotic time out

• When culture results come back• When the patient’s situation is more clear• Reassess need & Deescalate

http://blogs.cdc.gov/safeheatlhcare/?p=1026; accessed 3/2/11 Arjun Srinivasan M.D.

Pneumonia vs. No-monia

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History of Present Illness• 74 yo male LTCF resident

who fell.

• Diabetic, oxygen-dependent d/t COPD.

• Admitted via ED for “shortness of breath, change in mental status”

• Given ceftriaxone in ED

• “I fell trying to get to the bathroom.”• 3-4 weeks s/p CABG• Feels SOB when laying in bed; prefers

HPI, continued

y g ; pto sit in chair.

• Worsening cough, wet. White phlegm.• “I can’t walk well since the surgery.”

Pneumonia vs. No-moniaExam & Results from ER

• 98.4, 102, 152/94, 90% on 2L

• A&O to self. NAD.

• Coarse sounds b/l. Absent at L base

• 2-3+ leg edema. Poor wound healing

• WBC 8.0; 68% neutrophils

• Cr 1.6, otherwise nl labs

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Among LTCF residents:• Cough 75%• Fever 62%

• Sputum culture and Gram stain

• Streptococcus

Pneumonia vs. No-moniaEvaluation Diagnostic Testing

• Rales 55%• No symptoms 7.5%

Pulse oximetry:< 93% is 80% sensitive, 91% specific for pneumonia

Clinical�Infectious�Diseases�2009;�48:149�171

ppneumoniae urinaryantigen

• Legionella urinary Ag• Swab oropharynx for

influenza

Pneumonia vs. No-moniaDiagnostic Testing

Current2 weeks ago

Pneumonia vs. No-moniaManagement

• Lasix, iv then po• Improved BP managementmanagement

• Support hose• 14# weight loss; noted clinical improvement over next 3 days

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Pneumonia vs. No-monia

• Oxygen• Albuterol

Non-Antibiotic Management

• Cough syrup, Tessalon perles

• Incentive spirometry• Swallow evaluation if

concern for aspirationClinical�Infectious�Diseases�2009;�48:149�171

Pneumonia vs. No-monia

Community-Acquired Pneumonia • Minimum of 5 days• Afebrile for 48–72 hours• No more than 1 CAP-associated sign of clinical

Duration of Treatment

No more than 1 CAP associated sign of clinicalinstability:

HR < 100 RR < 24BP > 90mmHg 90% on RA, able to take po baseline mental status

Health Care-Acquired Pneumonia• 8 days (unless Pseudomonas or Acinetobacter spp.)

Clinical�Infectious�Diseases 2007;�44:S27�72;�Am�J�Respir Crit Care�Med�2005;�171:388�416

Pneumonia vs. No-monia

• Re-assess the need for antibiotics.

• CXR: “Cannot rule out infiltrate” may be radiologist-speak for “poor film and I can’t see the patient.”

• Elevated WBC or neutrophils (>~80%) suggests infection.

• Positive S. pneumo urinary antigen is really helpful.

• Candida, MRSA are common colonizers in sputum. People w/ pneumonia d/t S. aureus are usually quite ill.

• Stop dates for all antibiotics, especially for handoffs.

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Asymptomatic Bacteriuria

(ASB)

Urinary Tract Infection

(UTI)vs.

Urine�with�symptoms

UA & Culture

Gross Pus

Hold your nose

GrossSmell

Foley Trauma?Stone?

GrossBlood

Clinical�Infectious�Diseases�2009;�48:149�171;�CID�2010;�50:625�663

Urinalysis & Urine Culture

• Expect pyuria in catheterized patients and those with ASB

• A “dirty” UA may i di t d h d ti

• Candida in urine is rarely a pathogen

• Enterococcusfaecium is a

fi di dindicate dehydrationor poor bladder evacuation (BPH)

Clinical�Infectious�Diseases�2009;�48:149�171�and�CID�2000;�31:757�761

common finding andan uncommon pathogen

• Even multi-drug resistant pathogens may by mere colonizers

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Urinary Tract Infection Patients without a Catheter

• (Gross hematuria)*• Get a good urine sample• Encourage hydrationg y• Watchful waiting?If need to treat, then 3 days of • Nitrofurantoin or TMP-

Sulfamethoxazole• Cephalexin or amoxicillin• (Fluoroquinolone)

Clinical�Infectious�Diseases�2009;�48:149�171;��CID�2000;�31:757�761;�CID�2011;�52:�e103

Urinary Tract Infection

• Change (or remove) catheter• Good insertion technique• Good sample collection

Catheterized Patient

p• Watchful waiting?• Encourage hydration

• Treat for 7 days; 10-14 if slow to improve

• No “test of cure” culturesClinical�Infectious�Diseases�2009;�48:149�171;�CID�2010;�50:625�663

Asymptomatic Bacteriuria

• No symptoms

• Why was a culture sent?

• Talk to the patient….

• …then leave them alone!

Clinical�Infectious�Diseases�2009;�48:149�171�and�CID�2000;�31:757�761

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Asymptomatic Bacteriuria

• 15 – 50% of LTCF residents have asymptomatic bacteriuria, including pyuria

• No increased morbidity or mortality amongLTCF residents with asymptomatic bacteriuria.y p

Clinical�Infectious�Diseases�2000;�31:757�61

• Treatment increases resistant organisms, adverse events and cost

Positive�UA�&�Culture�� Infection

Asymptomatic Bacteriuria Infection?

Clinical Infectious Diseases 2000; 31:757-61

Do not treat Treat*

*Staphylococcus aureus

Clostridium difficile infection

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• Tube�feeds

• Laxatives

• Antibiotic�associated�diarrhea

• Obstruction

Reasons�to�have�diarrhea�that�are�not�Clostridium�difficile infection:

• Obstruction

• Food�poisoning

• Norovirus

• Rotavirus�and�other�enteroviruses

• Giardia and�Cryptosporidium

• Campylobacter,�Salmonella,�Shigella,�E.�coli

Clinical�Infectious�Diseases�2009;�48:14�71

Clostridium difficile

• Spores • Last for months on surfaces• Difficult to kill (10% bleach for 10 minutes)• Alcohol-based hand rubs DO NOT WORK• Soap & water is most effective

• Exposure to antibiotics is the single greatest risk factor C. difficile infection

Clinical Infectious Diseases 2007 Oct 15;45(8):992-8.

Clinical Indications of C. difficile infection

• Mild to moderate diarrhea; may progress to fulminant colitis � death

• >3 watery/unformed stools/day x 2 daysI ti• Incontinence

• Fever, crampy abdominal pain• nausea, dehydration

• WBC > 14

Infection Control & Hospital Epidemiology 2002;23:696-703

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Treatment of C. difficile InfectionInitial Disease• *Metronidazole 500mg po q8h x 10 days• Should see response in 2-4 days, resolution in 6-7 days

Recurrent Disease• Repeat metronidazole x 10 days• Oral vancomycin 125mg po q6h x 10 days• Repeat vancomcyin x 10 days• Vancomycin taper

(q6h to q12 to qday to q3day over 6 weeks)• Ask for help There is insufficient evidence to support the use of

probiotics as therapeutic agents.*Start with oral vanco for patients on warfarin or with severe symptoms.

On�Line�Resources

• http://www.cdc.gov/drugresistance/campaigns.html

• http://www.cdc.gov/getsmart/healthcare/resources/

• www.idsociety.org

• http://www idsociety org/content aspx?id=4434#fev• http://www.idsociety.org/content.aspx?id=4434#fever_and_infection

• http://www.idsociety.org/content.aspx?id=4428#as

• http://www.innovations.ahrq.gov/content.aspx?id=2968

• http://www.cdc.gov/getsmart/healthcare/support-efforts/asp-int-costs.html

Thank�you

Questions�or�Comments?

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Sunday October 16, 20117:15 am Breakfast (4th level)

7:45am Registration/sign in (2th level)

8:00-9:15 am Symposium IV: Special Issues for Geriatricians Moderator: Allison J. Batchelor, MD, CMD

8:00-8:30am Travel Medicine for Seniors Jeffrey D. Schlaudecker, MD

8:30-9:00am No Risks! Know Risks! Larry Lawhorne, MD

9:00-9:15am Discussion & Questions

9:15-9:30am Break

9:30-11:30 am Symposium V: Mental Health Concerns for Older Patients Moderator: Allison J. Batchelor, MD, CMD

9:30-10:00 am Anxiety Spectrum Disorders in the Elderly Alina Rais MD

10:00-10:30 am Update on Alzheimer’s Disease Brendan Kelley, MD

10:30-11:00 am Determining Decision Making Capacity: Who Wants Ice Cream? A John McSweeny, JD, PhD

11:00-11:30 am Discussion & Questions

11:30 a.m. Adjournment

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Symposium IV

Special Issues for Geriatricians

Moderator:

Allison J. Batchelor, MD, CMD Associate Professor

Geriatric Medicine and Gerontology Ohio University Heritage College of Osteopathic

Medicine

Moderator Disclosure:

Dr. Batrchelor has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Travel Medicine for Seniors

Jeffrey D. Schlaudecker, MD

Learning Objectives:

List pre travel guidelines for the older adult traveling internationally.

Speaker Disclosure:

Dr. Schlaudecker has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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General�Travel�Health�Resources��Prepared�by�Dr.�Jeff�Schlaudecker� � � September�26,�2011��

����������� �� ��������� � ������������������

���������Yellow�Book������������������������������������������������� �

� !"�����������"���������������������������������������������

Know�Before�You�Go� � � �����#"����$"��������������������%#&���

'(��) �� �����*�����+��������

� !����������������������������������������������

���� "�������(��)���&�,����� ��������������� �����

Travelers�with�Disabilities�and�Medical�Conditions�� !����������� "������"")����� �

��������������-������� � �������""��"����

� !�������� ����������������������"������ �#&����&� ������)���&�����

� �)���&� "�����������������"������ �����"������ �.���/�

(�������������$� � � ���������$����

� !"��������� )����.��0)��� ���/�"��������������������������� �����

� "�� ����1�#�������)� ���"������ 2�����)�������������� ��%�������#��� �

������($� � � � ���������� $����

� !��"�� ��� �% ����������� �

SHOTS�� � � � �������)��1����������

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'�(����"���������(������ � ���� ��������

� !�)���&� "�������� �������������� ��� 2������ � 2�����'�(��5�#� &�

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+� "����������������������� � ����"� "��������) �����

� !�� �������������������������� ����'�(�2�-���

,��� �,���������������� )������ � �������� ������������

6����������"����������������������������)������� )������

4��7���, � ���� � � � ���7��� � �����

4�������5���)�������� "�����������&��������

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No Risks! Know Risks!

Larry Lawhorne, MD

Learning Objective:

List the most common areas of medical liability risk and regulatory risk across the continuum of care for clinicians caring for older adults.

Speaker Disclosure:

Dr. Lawhorne has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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10/3/2011

1

Larry Lawhorne MDLarry�Lawhorne,�MDProfessor�and�Chair,�Department�of�GeriatricsBoonshoft�School�of�MedicineWright�State�University

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3�Areas�of�FocusClinical�liability�risk�across�the�continuum�of�care�(driving�and�falls).�

R l i k h i f (hRegulatory�risk�across�the�continuum�of�care�(home�health,�CMN,�and�nursing�home�care).

Approaches�to�decreasing�risks�in�both�areas.

The�Crux�of�the�MatterIf�we�knew�or�should�have�known�a�person�was�at�risk�for�(fill�in�the�blank)�and�did�nothing�to�attempt�to�decrease�g pthat�risk,�then�are�we�ourselves�at�risk�for�action�by�a�licensing�board�or�a�plaintiff�attorney�or�even�an�attorney�general?

…clinical�liability.

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The�Crux�of�the�MatterIf�we�knew�or�should�have�known�a�person�was�at�risk�for�(an�automobile�accident�in�which�people�are�injured�or�killed)�and�did�nothing�to�attempt�to�decrease�that�risk,�then�are�we�ourselves�at�risk�for�action�by�a�licensing�board�or�a�plaintiff�attorney�or�even�an�attorney�general?

What�should�you�do�when�you�i i i llsuspect�your�patient�is�potentially�

an�unsafe�driver?

Case:�79�year�old�man� Lives�with�his�wife�of�59�years�on�the�family�farm�� Son�calls�you�day�before�father’s�routine�appt�for�hypertension�and�arthritis�W i d b d l d i i i d d’� Worried�about�a�gradual�deterioration�in��dad’s�driving.��

� Trouble�reading�road�signs�but�recently�had�a�check�up�with�eye�doctor�that�showed�no�significant�problems�with�his�vision.��

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Case�(Continued)�General�physical�and�detailed�neurological�exams�are�normal.��

�Scores 27 out of a perfect score of 30�Scores�27�out�of�a�perfect�score�of�30�on�the�MMSE�with�2�points�off�for�recall�and�1�point�off�for�inability�to�copy�intersecting�pentagons.��

Performed�poorly�on�Trails�B�

What�should�you�do�next?�A.�Do�not�bring�up�the�issue�of�driving�because�it�would�be�a�HIPAA�violation.

B.�Recommend�that�he�only�drive�when�someone�is�in�the�car�with�him�in�case�he�has�way�finding�problemsproblems.

C.�Recommend�that�he�have�a�driving�evaluation�at�the�local�office�of�the�Ohio�Bureau�of�Motor�Vehicles.�

D.�Order�brain�imaging�studies�and�neuropsychological�testing.�

E.�Tell�him�to�stop�driving�until�you�can�do�a�more�thorough�evaluation.�

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Important�functional�abilities:

�Vision�Cognition��Motor�function

Assessment�of�Driving�Related�Skills

Vision Visual�fields�by�confrontation�testingSnellen�Chart

Motor�Function Postural�swayRapid�pace�walkMotor�strength,�ROM

Cognition Trail-Making Test, Part BClock Drawing Test

Trails�B�(TMT�B)

�Tests�visual�conceptual�and�pvisuomotor�tracking

�Involves�motor�speed�and�attention�functions

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Trails�B

Trails�B� Letters:�� A�� L� Numbers:� 1�� 12� 75�seconds�

…or�the�patient�performs�poorly�in�d i ? ione�or�more�domains?��2�options.

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� Targeted�clinical�assessment� Functional�on�road�assessment� P ibi d t i i li t i th

1. Certified Driver Rehabilitation Specialists have expertise in:

� Prescribing�and�training�clients�in�the�use�of�adaptive�equipment

� Counseling�and�advising�on�driving�concerns�and�mobility�alternatives

2.�Letter�to�BMVThe�person�referenced�above�should�be�re�evaluated�for�driving�safety�based�on�my�examination�and�observations.��His�insight�and�judgment are impaired and he is currently takingjudgment�are�impaired�and�he�is�currently�taking�pain�medication�that�may�further�impair�his�ability�to�drive�safely.��I�have�asked�him�not�to�drive�until�he�is�re�evaluated�by�Ohio�BMV.��You�may�disclose�my�name�to�this�person.

Will�be�sent�to�you�after�your�letter�or�sometimes just shows up generatedsometimes�just�shows�up…generated�from�another�source.

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Form�2310A�(2�pages)yes�or�no�items yes�or�no�items

� Vision�abnormalities� Musculoskeletal,�including�

loss of limb

� Neurological� Alcohol�or�drugs

P hi t iloss�of�limb� Cardiovascular� Respiratory� Diabetes�or�other�

endocrine

� Psychiatric�� Other��medical�disorders�

that�could�interfere�with�driving

Form�2310A�(2�pages)For�all�“yes”�answers:

1. How�long�has�condition�existed?Gi d f l i d2.�� Give�date�of�last�episode�or�exacerbation.

3. Is�medication�prescribed?4. If�medication�prescribed,�does�

patient�take�medication�regularly�and�as�instructed?�

Form�2310A�(2�pages)A.�This�patient�should�be�permitted�to�retain�driving�privileges.

B.�This�patient�should�be�permitted�to�retain�driving privileges only if they can pass a partialdriving�privileges�only�if�they�can�pass�a�partial�driver�license�exam�which�consists�of�a�vision�screening�and�a�road�test�for�driving�and�maneuverability.

C.�This�patient�should�be�permitted�to�retain�driving�privileges�only�if�they�can�pass�a�vision�exam.

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Form�2310A�(2�pages)D.�This�patient�should�be�permitted�to�retain�driving�privileges�only�if�they�can�pass�a�complete�driver�license�exam�which�consists�of�a�vision�screening, written test of Ohio’s laws and signs,screening,�written�test�of�Ohios�laws�and�signs,�and�a�road�test�for�driving�and�maneuverability.

E.�This�patient�should�not�be�permitted�to�retain�driving�privileges.

The�Crux�of�the�MatterIf�we�knew�or�should�have�known�a�person�was�at�risk�for�(a�fall�resulting�in�a�hip�fracture�and�permanent�placement�in�a�nursing�facility)�and�did�nothing�to�attempt�to�decrease�that�risk,�then�are�we�ourselves�at�risk�for�action�by�a�licensing�board�or�a�plaintiff�attorney�or�even�an�attorney�general?

What�should�you�do�when�you�i i i k fsuspect�your�patient�is�at�risk�for�

falls?

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“The�Patient�who�Falls.”JAMA.��2010;�303(3):�258�266.

Regulatory�Liability� Signing�home�health�orders� Prescribing�medical�equipment� Hanging�out�in�the�nursing�home

Form�CMS�485,�“Home�Health�Certification�and�Plan�of�Care”

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Signing�Home�Health�Orders� How�many�485�forms�and�orders�do�you�receive�in�a�week?

� What’s�on�each�form�and�in�each�order?Did f i ll i h� Did�you�or�one�of�your�associates�actually�give�the�verbal�order?��Are�you�sure?

� How�do�you�manage�the�cellulose�or�electronic�load?

� What�about�that�face�to�face�(F2F)�visit?

Face�to�Face�Visit� No�more�than�90�days�before�or�within�30�days�of�start�of�Home�Health.

� Date�of�the�visit�and�why�the�clinical�findings�support that the patient is homebound and insupport�that�the�patient�is�homebound�and�in�need�of�either�intermittent�skilled�nursing�services�or�therapy�services.

� Visits�may�be�performed�by�the�certifying�physician�or�by�an�APN�in�consultation�with�the�physician.

Face�to�Face�Visit� Documentation�of�the�face�to�face�visit�must�be�a�separate�and�distinct�section�of,�or�an�addendum�to�the�certification,�and�must�be�clearly�titled,�dated and signed by the certifying physiciandated�and�signed�by�the�certifying�physician.

� Non�physician�practitioners�performing�the�face�to�face�visit�must�document�the�clinical�findings�of�that�face�to�face�patient�visit�in�the�medical�record�and�communicate�those�findings�to�the�physician�who�certifies�the�encounter.�

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The�F2F�visit�should�make�it�easier�for�you�to�be�able�to…�Clarify�what�the�patient�really�needs.�Read�the�forms�and�orders�more�efficiently to confirm that the orderedefficiently��to�confirm�that�the�ordered�services�make�sense.Caveat:�You�should�not�assume�that�all�of�the�services�provided�by�the�HHA��are�necessary,��but�you�are�not�expected�to�confirm�each�order�with�each�patient!

Operationally� Set�aside�time�to�review�(read!)�and�sign�Home�Health�forms�and�orders�and�submit�bills�to�Medicare

� Workwith your billers or consultants to properly� Work�with�your�billers�or�consultants�to�properly�use:

> POC�codes�(G0180�and�G0179)> CPO�code(G0181)

Prescribing�Mobility�Assistive�Equipment�(MAE)

� What�are�the�existing�criteria�for�an�individual�patient�to�qualify�for�MAE…especially�motorized�devices?

� Have you documented in themedical record that� Have�you�documented�in�the�medical�record�that�the�individual�meets�criteria�for�and�will�benefit�from�a�motorized�device?

� How�do�you�address�the�after�the�fact�request�to�certify�the�medical�necessity�of�a�scooter?

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Motorized�Scooter

Motorized�Scooter� Takes�more�room�to�maneuver�than�a�motorized�wheelchair.

� May�demand�two�hands�to�control.Th i i l i d l d bl� The�seating�is�less�supportive,�and�less�adaptable�for�patients,�as�compared�to�the�motorized�wheelchair.

� Less�expensive.� Easier�to�transport.

Medicare�Guidelines�for�MAE�(overview)

� Basis�for�prescription�must�be�logical;�documentation�of�why�less�expensive�and�less�technical�equipment�is�not�appropriate�must�be�includedincluded.

� MAE�can�only�be�ordered�to�enhance�Mobility�Related�ADLs�in�the�home,�and�cannot�be�prescribed�for�community�needs.��

� Mobility�outside�of�home�is�not�considered�a�medical�necessity.

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http://www.cms.hhs.gov/MLNGenInfo

WBT�in�CMNUpon�completion�of�this�course�you�should�be�able�to:� List�the�items�that�require�a�Certificate�of�Medical�Necessity�(CMN)

� Identify the responsibilities of Physicians Physician� Identify�the�responsibilities�of�Physicians,�Physician�Assistants,�Nurse�Practitioners,�or�Clinical�Nurse�Specialists�as�they�relate�to�the�CMN

� Define�medical�record�documentation� Identify�the�sections�of�a�CMN� List�CMN�common�Errors� Identify�CMN�completion�resources

…nursing�home�issues.

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2009�survey�by�the�AMDA� 28%�have�been�sued�in�their�capacity�as�attending�physicians.

� 9%�have�been�sued�in�their�capacity�as�medical�directorsdirectors.

� Majority�either�successfully�defended�the�care�or�administrative�supervision�they�had�provided�and�won�the�lawsuit�or�were�dismissed�from�it.

� But,�economic�and�emotional�costs�of�enduring�lengthy�lawsuits�cannot�be�understated.�

More�from�2009�AMDA�SurveyFor�attending�physicians,�11%�reported�problems�obtaining�or�renewing�professional�liability�insurance�for�patient�care,�with�more�than�a�third�of those reporting that the problemswere due toof�those�reporting�that�the�problems�were�due�to�their�work�in�nursing�facilities�(33%)�or�the�percent�of�nursing�facility�work�(14%).

Things�that�keep�me�awake…� Anticoagulation� Medication�errors� Falls� Pressure�ulcers� Resident�on�resident�violence� Elopement

These�and�others�have�both�clinical�and�regulatory�components.

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SummaryWe�know�the�risks…providing�care�for�older�adults�is�not�for�the�faint�of�heart:

� Our�patients�are�at�risk�for�any�number�of�serious�clinical�conditions,�and�we�are�at�risk�if�we�don’t�address�them�appropriately.

� The�regulatory�world�we�inhabit�is�one�in�which�even�innocent�mistakes�may�be�construed�as�fraud.

The�best�response…� Identify�the�areas�in�your�own�practice�that�are�high�risk…both�clinical�and�regulatory.

� Develop�strategies�for�delivering�the�best�evidence based clinical careevidence�based�clinical�care.

� Keep�up�with�the�regulatory�issues�you�face�most�often�(consider�CMS�WBT).

� Remember�why�we�provide�services�for�older�adults…it’s�what�we�do,�and�we�are�good�at�it.

� Illegitimis�non�carborundum�(DLTBGYD).

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Symposium V

Management Issues for Better Patient Care

Moderator:

Allison J. Batchelor, MD, CMD Associate Professor

Geriatric Medicine and Gerontology Ohio University Heritage College of Osteopathic

Medicine

Moderator Disclosure:

Dr. Batchelor has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Anxiety Spectrum Disorders of the Elderly

Alina Rais, MD

Learning Objectives:

Discuss the biopsychosocial etiology of anxiety disorders.

Speaker Disclosure:

Dr. Rais has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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ALINA�RAIS,�M.D.ASSOCIATE�PROFESSOR

DEPARTMENT�OF�PSYCHIATRY�

ANXIETY�DISORDERS�IN�THE�ELDERLY

“Anxiety is a thin stream of fear trickling through the mind. If encouraged, it cuts a channel into which all other thoughts are drained”~ Robert Albert Block

� Anxiety�disorders�are�the�most�common�mental�disorders.

� They�share�extreme�anxiety�as�the�principal�di t b f ti l tdisturbance�of�emotional�tone.

� Anxiety�is�manifested�by�disturbance�of�mood,�thinking,�behaviors�and�physiological�activity.

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Normal�Anxiety

� Every�one�experiences�anxiety:�a�diffuse,�unpleasant,�vague�sense�of�apprehension�often�with�the�occurrence�of�somatic�symptoms.

Disorders Features

Generalized�anxiety�disorder

Somatic�tension,�hyperarousal,�excessive�worry�(egosyntonic) in�multiple�areas�of�life�that�is�primarily�future�oriented,�persistent�anxiety,�non�[phobic�avoidance,�many�unexplained�physical�complaints,�lack�of�severe�depressed�mood�or�anhedonia,�infrequent�panic�attacks,�possible�

fhistory�of�trauma�and�abuse.

Major�depressive�disorder

Severe�depressed�mood, anhedonia,�ruminations�about�loss�and�past�failures,�global�erosion�of�self�esteem,�prominent�vegetative�symptoms

Social�anxiety�disorder

Fear�of�being�judged�unfavorably�or�humiliated,�significant�avoidance�of�social�situations�due�to�worries,�and�fears,�performance�anxiety�in�public

Adapted with permission from Informa Health Care: Nutt D. Rickels A. Stein DJ eds. Generalized Anxiety Disorder: Symptomatology Pathogenesis and Management. London, UK 2002:36

Disorders Features

Obsessive�compulsive�disorder Intrusive�and�unwanted thoughts,�egodystonic�obsessions�surrounding�symmetry,�contamination,�aggressive,�sexual�urges�compulsive�rituals�to�neutralize�the�obsessions

Posttraumatic�stress disorder A�trauma�is�reexperienced,�symptoms�of�avoidance,�numbing�is�common,�

Features of Different Types of Anxiety

hypervigilance, often�the�presence�of�nightmares

Panic�disorder Discrete,�self�limiting,�unexpected�anxiety�attacks�that�include�heightened�autonomic�arousal,�preoccupation�with�having�another�panic�attack,�misperception�of�bodily�symptoms.

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Disorders Features

Hypocondriasis Strongly�held�conviction�that�one�has�a�disease,�excessive�reassurance seeking�that�does�little�to�assuage�these�fears.

Personality�disorders Longstanding�and�marked�patterns of maladaptive

Features of Different Types of Anxiety

patterns�of�maladaptive�functioning,�less�symptom�focused,�more�global�impairments�in�interpersonal�relationships.

� Anxiety�is�a�signal:�alerts[warns]�of�an�impeding�danger.

� Enables�a�person�to�take�a�measure�to�deal�with the threatwith�the�threat.

� Anxiety�is�a�response�to�an�unknown�[unconscious]�,conflictual�,internal�threat.

� Anxiety�does�not�equal�fear.� Fear�is�a�response�to�an�known,�external,�nonconflictual�threat.

Epidemiology�of�Anxiety�Disorders

� In�the�USA,�1�year�prevalence�for�all�anxiety�disorders�among�adults�18�54�exceeds�16%.

� Women have a higher prevalence of 30%,Women�have�a�higher�prevalence�of�30%,whereas�men�have�a�prevalence�of�19%.

� More�frequent�in�lower�socioeconomic�status.� Have�an�early�age�of�onset,�chronic�,relapsing�or�

recurrent�course�often�leading�to�disability.� Significant�overlap[comorbidity�]with�mood�and�

substance�abuse�disorders.

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Psychological�Theories

� Three�major�schools�of�psychology�contributed�to�the�understanding�of�anxiety:

� Psychoanalytical�theory� Behavioral�theory� Existential�theory

Psychoanalytical�Theory

� Sigmund�Freud�hundred�years�ago�coined�the�term�“anxiety�neurosis”.

� He defined anxiety as a signal of a dangerous� He�defined�anxiety�as�a�signal�of�a�dangerous�drive�stemming�from�the�unconscious.

� Anxiety�was�viewed�as�the�result�of�a�conflict�between�unconscious�sexual�or�aggressive�wishes�and�superego�or�external�reality.

� Three�types�of�anxiety:

� Reality�anxiety:�ego�becomes�overwhelmed�by�threats of external nature{earthquake}.threats�of�external�nature{earthquake}.

� Neurotic�anxiety:�unconscious�fear�of�loosing�control�over�id�urges.

� Moral�anxiety:�fear�of�doing�something�against�our�moral�code.

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Behavioral�Theories

� Anxiety�is�a�conditioned�response�to�specific�environmental�stimuli.

� Anxiety�can�be�a�learned�behavior{imitating�an�observed�behavior}.P ti t t d t ti t th d f� Patients�tend�to�overestimate�the�degree�of�danger�and�to�underestimate�their�capacity�to�cope�with�the�perceived�threat.

� Distorted,�counterproductive,�faulty�thinking�proceed�the�maladaptive�behaviors.

� Based�on�this�theory�one�of�the�most�effective�therapies�spawned.

Existential�Theory

� Based�on�this�theory�,people�became�aware�of�feeling�of�nothingness�in�their�lives.

� Those�feelings�are�more�disturbing�than�the�acknowledgement�of�their�own�death.

� Anxiety�is�a�response�to�the�perceived�void�in�their�existence�and�meaning.

Biological�Theories

� The�cost�of�the�evolution�is�that�the�brain�functions�as�a�pain�machine.

� Amygdale�suffers�from�an�evolutionary�hangover�from�the�days�that�people�needed�to�avoid�saber�toothed�tigers�to�survive.

� A�security�system�that�is�firing�when�there�is�no�intruder�.

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Neuro�Anatomical�Considerations

� Limbic�system:�two�important�regions� Amygdala�and�the�HippocamusR i d i d t i� Receive�noradrenergic�and�sertonergic�innervetions.

� Contains�high�concentration�of�GABA�receptors.

� Locus�ceruleus�and�Raphe�nuclei�project�to�both�Limbic�system�and�the�Cortex.

� Cerebral�cortex:

� The�frontal�cortex�is�connected�with�the�parahippocampal�region,�the�cingulate�gyrus�and�hypothalamus�hence�implication�in�anxiety�symptoms

� Some�implication�attributed�also�to�the�temporal�lobe{also�part�of�the�limbic�system}

Neurotransmitters

� Norepinephrine�{locus�ceruleus�in�the�rostral�pons}

� Serotonin�[Raphe�nuclei�in�the�rostral�brainstem].

� Gamma�aminobutyric�acid[GABA]

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Neurotransmitter�Abnormality Effect

GABA Decreased�GABA�A�receptor�density�in�GAD, GABA�A�predicts�efficacy�of�benzodiazepines

Serotonin Decreased CSF�SHIAA�concentrations

Serotonin�transporter Platelet,�PET, postmortem�brain�studies�show�density�correlates�negatively�with�anxiety�symptoms�in�GAD

SHT1A Agonists�are�anxiolytic

SHT2A Agonists�are�anxiolytic

Source: Schienle A. et al

Case�#1

� 80�year�old�women�presents�with�complaints�of�increased�worries

� On�a�daily�basis,�feels�antsy,�restless,�not�able�t l t i ht f li f dto�sleep�at�night,�feelings�of�_and�overwhelmed

� Decreased�appetite�and�impaired�sleep�at�night

� Depressed�mood�and�inability�to�function

� Patient�lives�by�herself� She�lost�her�husband�2�years�ago� Overwhelmed�by�financial�worries

� Selling�her�previous�home� Has�to�pay�all�her�bills\� Not�driving� Medical�problems�(pain)� Poor�social�support�from�her�family� Social�isolation

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Case�#2

� 72�year�old�male,�married� Retired�but�still�working�as�a�chauffeur�(driver)�� Anxiety�symptoms�for�all�his�life� Described�himself�as�a�worrier,�about�almost�

every�aspect�of�his�life� Worsening�of�symptoms�for�past�few�years,�as�a�

result�of�some�minor�medical�problems� Poor�response�to�multiple�medication�trials� Poor�response�to�CBT

Anxiety�in�the�Elderly

� The�current�literature�suggest�that:

� Anxiety�disorders�are�common�among�older�individuals�but�less�common�than�in�younger�ones.

� Overlap�exists�between�the�symptoms�with�somed ff d ldifferences�and�assessment�limitations.

� Anxiety�disorders�are�highly�comorbid�with�other�psychiatric��conditions[depression]�and�medical�disorders.

� Strong�association�between�anxiety�and�cognitive�disorders.

� Both�pharmacotherapy�and�CBT�demonstrated�efficacy�for�older�adults�with�anxiety.

� Estimated�prevalence�of�anxiety�in�the�older�adult�groups�ranges�from�3.2�14.2%.

� One�study�that�included�GAD,�and�using�a�ti l l f d % lnational�sample�found�a�12.2%prevalence.

� The�Epidemiological�Catchment�Area[ECA]�,found�1�month�prevalence�of�5%.

� The�national�Comorbidity�Survey�Replication�found�a�7%�prevalence�over�12�months.

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10/4/2011

9

Risk�factors

� Being�a�female�.� Having�several�medical�problems� Being�single,�divorced,�separated� Lower�education� Impaired�subjective�health� Stressful�life�events� Physical�limitation� Adverse�events�in�childhood�and�neuroticism

� Older�adults�experience�life�transitions:� Retirement� Physical�health�problemsC i f h i� Caregivers�for�their�spouses

� Loss�of�loved�ones� Reduced�economic�resources� Fears�of�being�a�burden�for�others

Medical�conditions

� Parkinson’s�disease[45%]� Cardiovascular�problems[36�45%]� Pulmonary�disorders[18�50%�of�COPD�patients]

� Endocrine�problems� Medications� Cognitive�decline�including�dementia[5�21%]

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Treatment��options

� Pharmacological�treatment� Preliminary�evidence�suggests�that�antidepressant�medications�are�effective�in�the treatment of GAD and PD in olderthe�treatment�of�GAD�and�PD�in�older�population.

� Only�3.8%�of�patients�were�prescribed�antidepressants.

� Still�the�benzodiazepine�group�is�the�most�prescribed�[25.30%]

Psychosocial�treatments

� Review�of�17�studies�of�evidence�based�treatment�found�that�CBT,�relaxation�therapy,�supportive�therapy�and�cognitive�therapy all demonstrated efficacytherapy�all�demonstrated�efficacy

� The�review�also�showed�that�they�are�less�efficient�in�older�patients.

Summary

� The�overall�literature�shows�lower�incidence�of�anxiety�in�older�adults

� In�the�clinical�practice�we�see�anxiety�mostly�as�a�comorbid�symptom�related�to�depression,�neurodegenerative disorder (dementia Parkinson’sneurodegenerative�disorder�(dementia,�Parkinson s�disease

� Some�time�over�diagnosed�and�mistreated

� GAD�is�the�most�commonly�seen�and�the�most�challenging�in�terms�of�treatment�approaches..

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Dementia Overview

Brendan Kelley, MD

Learning Objective:

Provide an update on current research to better diagnose and treat Alzheimer’s disease and dementia.

Speaker Disclosure:

Dr. Kelley has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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Dementia�Overview�Brendan�Kelley,�MD�Director,�Memory�Disorders�Center�Department�of�Neurology�University�of�Cincinnati���Scope�of�the�problem�Alzheimer’s�disease�and�other�dementias�affect�over�5�million�Americans�and�providing�appropriate�care�for�people�with�dementia�constitutes�an�impending�healthcare�crisis.��Statistics�related�to�Alzheimer’s�disease��National:�About�5million�Americans�are�afflicted�with�Alzheimer’s�disease�Over�435,000�unpaid�caregivers�provide�over�12.5�billion�hours�of�unpaid�care,�with�an�estimated�value�of�$144�billion�($11.50�per�hour)�By�2050,�it�is�estimated�that�annual�costs�associated�with�care�of�people�having�dementia�will�exceed�$2�trillion��In�Ohio:�About�230,000�Ohioans�are�afflicted�with�Alzheimer’s�disease�Over�435,000�unpaid�caregivers�provide�over�495�million�hours�of�unpaid�care,�with�an�estimated�value�of�$5.7�billion���Emerging�conceptualizations�of�dementia�Dementias�are�typically�characterized�by�their�clinical�manifestations.�This�approach�has�resulted�in�substantial�increase�in�our�understanding�of�the�pathological�substrates�responsible�for�dementia,�and�has�provided�the�basis�for�systematically�studying�the�clinical�manifestations�of�the�disease.��Increasingly,�it�is�recognized�that�understanding�of�the�clinicopathological�correlations�relevant�to�dementia�provides�a�critical�link�to�advance�our�development�of�therapeutic�and�diagnostic�research�strategies.��Several�proteins�have�been�identified�that�are�implicated�in�the�pathological�processes�associated�with�dementia.�Similar�changes�are�seen�in�some�individuals�who�remain�cognitively�normal.�Thus,�while�categorization�by�protein�provides�an�important�step�towards�diagnostic�and�therapeutic�breakthroughs,�it�is�still�based�in�what�must�be�regarded�as�circumstantial�evidence.��Alpha�synuclein�–�“synucleinopathies”�Parkinson’s�disease�is�characterized�by�deposition�of�aggregated�synuclein�(Lewy�bodies)�in�the�brainstem,�basal�ganglia�and�in�the�cerebral�cortex.�The�pathological�hallmark�of�neuronal�dropout�in�the�substantia�nigra�is�felt�to�result�from�these�pathological�processes.���Braak�et�al.�published�a�paper�in�2004�proposing�a�staging�of�these�pathological�changes.�In�this�staging�scheme,�substantia�nigra�pathology�occurs�at�midstage�disease,�while�involvement�of�anterior�olfactory�nucleus,�medulla,�and�pontine�tegmentum�occur�earlier.�Thus,�Lewy�body�pathology�appears�to�begin�in�

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the�lower�brainstem,�proceed�rostral�to�the�substantia�nigra�and�in�later�stages�of�Parkinson’s�disease�Lewy�body�deposition�in�the�neocortex�is�evident.�This�pattern�fits�well�with�the�symptomatology�of�Parkinson’s�disease.��Lewy�body�dementia�is�also�characterized�by�abnormal�deposition�of�alpha�synuclein.�Pathological�evidence�suggests�the�pattern�of�progression�differs�from�that�of�Parkinson’s�disease,�with�neocortical�deposition�occurring�much�earlier�in�the�clinical�course.�This�would�provide�a�theoretical�explanation�for�the�occurrence�of�cognitive�decline�much�earlier�in�the�clinical�course�of�people�having�Lewy�body�dementia.���TDP�43�In�2006,�mutations�in�PGRN�were�identified�to�account�for�roughly�half�of�people�having�frontotemporal�dementia�linked�to�chromosome�17�(FTDP�17).�The�pathological�finding�in�these�cases�was�that�of�frontotemporal�lobar�degeneration�with�ubiquitinated�inclusions�(FTLD�U),�and�the�ubiquitinated�protein�has�since�been�identified�to�be�a�previously�described�protein,�TDP�43.�Its�role�in�normal�brain�function�has�not�yet�been�described.��Tau�The�other�half�of�patients�having�FTDP�17�were�previously�identified�to�have�mutations�in�MAPT.�In�these�people,�the�pathological�hallmark�was�that�of�FTLD�with�deposition�of�hyperphosphorylated�tau�aggregates.���Alzheimer’s�disease�Alzheimer’s�disease�is�characterized�by�deposition�of�amyloid�plaques�and�neurofibrillary�tangles�of�the�protein�tau.�Braak�et�al.�have�staged�the�pathological�changes�of�Alzheimer’s�disease,�and�this�construct�has�been�used�to�understand�the�relationship�between�the�progression�of�these�pathological�changes�and�the�clinical�manifestations�of�the�disease.����Relevance�of�this�model�Increasingly,�it�is�recognized�that�early�intervention�at�an�asymptomatic�or�minimally�symptomatic�stage�provides�the�best�hope�for�effective�treatments�of�Alzheimer’s�disease�and�other�neurodegenerative�conditions.�Changes�relevant�to�the�pathological�processes�implicated�in�Alzheimer’s�disease�are�felt�to�happen�decades�before�the�emergence�of�clinical�symptoms,�suggesting�that�this�is�a�viable�strategy.�We�will�discuss�research�efforts�focused�on�early�diagnosis�and�potentially�disease�modifying�treatment�interventions�as�a�model�of�how�this�conceptual�framework�can�be�employed.���Alzheimer’s�disease�can�be�detected�early�

�We�will�discuss�the�hypothetical�framework�outlined�in�Jack�CR,�et�al.�Lancet�Neurology�2010��Current�understanding�suggests�that�abnormal�processing�of�A�(�amyloid)�represents�one�of�the�earliest�events�in�a�pathological�cascade�that�leads�to�clinical�Alzheimer’s�disease.�Changes�in�CSF�levels�of�A�may�be�detectable�a�decade�or�more�prior�to�clinical�symptoms.�Strategies�to�detect�these�changes�include�ligand�bound�FDG�PET�and�direct�measurement�of�CSF�levels�of�A,�total�tau�(t�tau)�and�phosphorylated�tau�(p�tau).�Alterations�in�these�protein�levels�precede�detectable�changes�in�brain�volumes�by�several�years.�Thus,�while�structural�brain�MRI�may�provide�a�useful�biomarker�in�some�

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clinical�trials�of�people�already�having�mild�cognitive�impairment�(MCI)�or�AD,�it�is�unlikely�to�be�useful�in�this�presymptomatic�state.���Potential�treatment�strategies�Utilizing�this�understanding,�several�lines�of�research�has�produced�potential�treatment�strategies.�We�will�review�several�of�these�treatment�strategies,�including:��Partial�inhibition�of��secretase�Enhance�clearance�(or�interfere�with�formation)�of�A�oligomers�A�aggregation�depends�upon�Cu�and�Zn�Target�cellular�inflammatory�response�to�A�Cholesterol�modulation�Various�substances�target�the�synaptotoxic/neurodegenerative�effects�of�A�or�tau���However,�this�model�has�limitations:�A�critical�review�of�the�amyloid�hypothesis�Amyloid�hypothesis���basis�Accumulation�of�A�proposed�in�the�early�1990s�as�the�pathogenesis�of�AD�In�early�1980s,�A�isolated�from�meningeal�blood�vessels�in�Downs�syndrome�and�AD�Shortly�thereafter,�A�isolated�in�AD�plaques����APP�(APP)�coded�on�x�some�21�Mutations�in�APP�responsible�for�some�genetic�AD�–�most�near����,��,�and���secretase�(favor�cleavage�by��,�and���secretase)��Amyloid�hypothesis���strengths�Bolstered�by�cloning�of�PS1�and�PS2�and�by�pathogenic�mutations�which�act�by�modulating��secretase�activity�Mutations�in�MAPT�causes�FTD�–�severe�tau�pathology�does�not�induce�amyloid�deposition�Transgenic�mice�overexpressing�BOTH�mutant�human�APP�and�mutant�human�tau�exhibit�increased�formation�of�tau�positive�tangles�(NOT�in�those�with�mutant�human�tau�alone)�Genetic�variability�in�A�catabolism�and�clearance�may�contribute�to�the�risk�of�late�onset�AD�APP�transgenic�mice�crossed�with�apoE�deficient�mice�markedly�reduces�cerebral�A�deposition�in�offspring���Amyloid�hypothesis���concerns�Number�of�amyloid�deposits�in�the�brain�does�not�correlate�well�with�the�degree�of�cognitive�impairment��

Diffuse�plaques�–�often�no�glial�or�neuritic�pathology�Specific�neurotoxic�species�of�A�and�its�effects�on�neuronal�function�have�not�been�defined�in�vivo��

Synaptic�effects�seem�to�involve�A�oligomers��PS1�mutations�increase�A,�but�degree�of�increase�does�not�correlate�with�age�of�onset�AND�what�about�those�weird�symptoms?�

PS1�mutations�may�be�poor�model�–�PIB�radically�differs�from�LOAD�Transgenic�mice�undergoing�progressive�A�deposition�but�do�not�exhibit�neuronal�loss���Conclusions�

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Alzheimer’s�disease�and�other�dementias�have�a�dramatic�cost�to�society�in�terms�of�death,�lost�quality�of�life�and�cost�of�providing�care�Decades�of�clinical�study�of�dementia�has�dramatically�improved�our�awareness�of�these�diseases�and�that�they�do�not�represent�normal�aging�Advances�in�clinicopathological�correlations�continue�to�advance�our�understanding�of�the�pathological�substrates�of�neurodegenerative�disease�This�understanding�will�provide�the�basis�for�future�advances�in�diagnosis�and�treatment��

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Determining Decision Making Capacity: Who Wants Ice Cream?

A. John McSweeny, JD, PhD

Learning Objective:

Define the concepts of clinical capacity and legal capacity.

Speaker Disclosure:

Dr. McSweeny has no financial interest or other relationship with any manufacturer of commercial product or service to disclose.

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A Neuropsychologist/Attorney’s PerspectiveA�Neuropsychologist/Attorney s��PerspectiveA.�John�McSweeny,�J.D.,�Ph.D.

Professor�Emeritus�of�Psychiatry�and�NeurologyUniversity�of�Toledo

Although�I�am�an�attorney�licensed�in�Ohio,�this�presentation�is�not�legal�advice�and�you�should�not�rely�on�it�for�legal�purposes.��If�you�require�legal�advice�you�should�contact�an�attorney�licensed�in�Ohio�or�the�jurisdiction�in�which�you�practice.

•Basic�Concepts�of�Capacity�and�Competence•Examples�of�Legal�Capacities•Basic�Issues�in�the�Clinical�Assessment�of�Capacity•Clinicians�who�perform�assessments�of�capacity.•Problems�in�the�Assessment�of�Clinical�Capacity•Models�and�Strategies�in�the�Clinical�Assessment�of�Capacity•Case�Example

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•Criminal�Competence/Capacity• Right�or�ability�to�make�self�directed�decisions�and�execute�acts�in�criminal�proceedings�or�to�be�subjected�to�certain�legal�proceedings�and�decisions.

• Examples�– Competency�to�stand�trial,�capacity�for�pro�se�representation,�capacity�to�receive�a�capital�sentence.�

•Civil�Competence/Capacity• Right�or�ability�to�make�self�directed�decisions�and�execute�acts�of�a�civil,�non�criminal�nature.

• Examples�� Testamentary�Capacity,�Contractual�Capacity

•Competence

• The�legal�right�to�make�self�directed�decisions�or�perform�self�

directed�legal�acts.

• Presumed�in�adults

• Assumption�could�be�challenged�based�on�evidence�presented�to�a�

probate�court�judge.

•Capacity

• Clinical�status�assessed�by�a�health�care�professional�in�response�to��questions�raised�a�person’s�ability�to�make�p q p ydecisions�or�perform�acts.

• Capacity�information�was��provided�to�a�probate�court�judge�who�made�legal�decisions�regarding�competence.

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•Competence�and�capacity�have�been�used�inconsistently�as�legal�or�clinical�terms.

•Examples:

• “Physician judgments of competency”Physician�judgments�of�competency.

• Testamentary�Capacity

•No�universal�agreement�on�terminology

•“Capacity”�is�used�to�cover�both�legal�and�clinical�judgments�of�a��person’s�abilities.�

•Legal�Capacity�– A�legal�judgment�is�at�issue.

•Clinical�Capacity�– A�clinical�judgment,�usually�in�the�service�of�a�probate�court’s�judgment�of�legal�capacity.

•Adopted�by�the�Joint�Working�Group�of�the�American�Bar�Association�Commission�(ABA)�on�Law�and�Aging�and�the�American�Psychological�Association�(APA)�on�the�Assessment�of Capacity in Older Adultsof�Capacity�in�Older�Adults

•Employed�in�handbooks�developed�by�the�ABA/APA�Joint�Working��Group�for�lawyers,�judges,�and�clinicians.

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•Legal�capacity�is�assumed�for�adults�but�can�be�challenged�in�probate�court.

•Court�may�exercise�the�state’s�protective�powers�� parens�patriae�– and�appoint�a�substitute�decision�maker:�a�guardian�or�conservator.

•Clinical�capacity�evidence�is�persuasive but�not�dispositive.�

•Other�considerations• Individual’s�Life�Situation• Legal�standards• General�principles�of�justice�and�equity

• General�vs.�Specific�Legal�Capacity• General�legal�capacity�– General�legal�right�to�make�decisions�

about�one’s�legal�affairs.

• Example:�Guardianship�hearings.

• Specific�legal�capacity��� Right�to�make�decisions�about�specific�

legal�affairs.

• Examples:��Contractual�Capacity,�Sexual�Consent�Capacity,�

testamentary�capacity.

• Not�recognized�in�all�states

• Limited�Legal�Capacity• A�person�has�the�authority�to�make�certain�decisions�but�not�others�within�a�general�or�specific�legal�capacity.

• Defined�by��a�limiting�order�issued�by�a�probate�judge.

• Example�– A�person�is�declared�to�lack�financial�capacity�with�regard�to�financial�transactions�of��over�$500.

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• Intermittent�Legal�capacity• Legal�incapacity�can�be�temporary�or�intermittent��in�individuals�whose�cognitive�abilities�fluctuate�or�improve�due�to�treatment�or�natural�course�of�events.

• A�judge�may�restore�legal�capacity��at�a�hearing�subsequent�to�removing�it.�

• Consent�to�Medical�Treatment

• Contractual�Capacity

• Donative��Capacity

• Capacity to Convey Real PropertyCapacity�to�Convey�Real�Property

• Capacity�to�Consent�to�Sexual�Relations

• Driving�Capacity

• Financial�Capacity

• Testamentary�Capacity

•Right�to�refuse�Treatment

• Common�law�battery* rationale�

• “Every�human�being�of�adult�years�and�sound�mind�has�

h d h h ll b d h ha�right�to�determine�what�shall�be�done�with�his�own�

body”�– Justice�Benjamin�Cardozo�(Schloendorff�v.�The�

Society�of�the�New�York�Hospital,�N.Y.,�1914).

• * “A�harmful�or�offensive�intentional�touching�.�.�.”

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•An�“umbrella”�capacity:�It�encompasses�more�specific�forms�of�capacity�including�contractual�capacity,�donative�capacity�and�testamentary�capacity.

•Includes• The�ability�to�manage�one’s�financial�affairs�in�a�fashion�consistent�with�personal�self�interest�and�values.�

• The�ability�to�manage�one’s�estate.

•Often�at�issue�when�probate�courts�consider�appointing�a�guardian�or�conservator�for�all�or�part�of�one’s�estate.��

•Traditional�common�law�standard:��“capacity�to�manage�in�a�reasonable�manner�all�of�one’s�financial�affairs.”�(ABA/�APA��Joint�Working�Group,�2008).�

•Uniform�Guardianship�and�Protective�Proceedings�Act�(NCCUSL,��1997)

• Model�Act�with�Two�pronged�test

1. The�ability�or�inability�of�the�individual�to�manage�his�or�her�financial�affairs�due�to�“an�impairment�in�the�ability�to�receive�or�evaluate�information�or�make�decisions,�even�with�appropriate�technological�assistance.”�

2. The�need�for�management�of�the�individual’s�financial�resources�needed�“for�support,�care,�education�and�welfare�of�the�individual”�as�well�as�persons�who�may�depend�on�him�or�her.

• Concerns�clinical�status�as�assessed�by�a�healthcare�professional,�usually�a�physician�or�clinical�psychologist.

• The�extensiveness�of�clinical�capacity�exams�and�the�expertise�of�the�examiner�vary�considerably.

• Extensive�and�detailed�examinations�conducted�by�specialists�are�atypical.

• Often�based�on�a�subjective�judgment�of�a�generalist�physician.�

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• Multiple�Clinical�Capacities

• Ask�“capacity�for�what?”

• Focus�on�relevant�clinical�capacities.

• Decisional�vs.�Executional�Capacities

• Decisional�– Involve��making�a�decision

• Executional��� Involve�the�ability�to�implement�a�decision.�

• Clinical�Capacity�as�Continuous�vs.�Dichotomous�

• Dichotomous�view�� Lawyers,�judges,�some�clinicians.

• Continuous�view�– Psychologists�and�other�clinicians.

• Clinical�Capacity�and�the�Diagnosis�of�Dementia

• Dementia����Loss�of�Clinical�Capacity

• Relevant�but�insufficient�evidence�of�lack�of�capacity.

• A�functional�analysis�of�the�abilities�inherent�in�the�transactions�in�a�legal�capacity�is�necessary.

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• Permanent�vs.�Temporary�Incapacity�:��Relationship�to�

three�categories�of�dementia.

• Progressive�Dementia����������������

• Arrestable��Dementia��with�persisting�deficits.

• Reversible�Dementia��without�persisting�deficits.

Some�Representative�Causes�of�the�Dementia�SyndromeReversible Dementia Reversible Dementia Without Persisting Without Persisting

DeficitsDeficits

Arrestable Dementia with Arrestable Dementia with Persisting DeficitsPersisting Deficits

Progressive DementiaProgressive Dementia

DepressionDepression Vascular dementiaVascular dementia Alzheimer’s DiseaseAlzheimer’s Disease

Hypoxia (e.g., from Hypoxia (e.g., from anemia, decreased anemia, decreased cardiac output, lung cardiac output, lung disease)disease)

Alcoholic dementiaAlcoholic dementiaTrauma (e.g., dementia pugilistica)Trauma (e.g., dementia pugilistica)

Frontotemporal Frontotemporal DementiasDementias

Electrolyte imbalance Electrolyte imbalance (e.g., hyponatremia)(e.g., hyponatremia)

Syphilis (I.e., general paresis)Syphilis (I.e., general paresis)Some intoxications (e.g., lead)Some intoxications (e.g., lead)

Huntington’s diseaseHuntington’s diseaseParkinson’s diseaseParkinson’s disease

Hepatic insufficiencyHepatic insufficiency BB1212 deficiency (e.g., longdeficiency (e.g., long--standing)standing) Diffuse Lewy BodyDiffuse Lewy BodyDiseaseDisease

Endocrine disease (e.g., Endocrine disease (e.g., hyperthyroidism, Addison’s hyperthyroidism, Addison’s disease, Cushing’s disease, Cushing’s disease)disease)

Normal pressure hydrocephaulus Normal pressure hydrocephaulus (e.g., long(e.g., long--standing)standing)Postencephalitic dementiaPostencephalitic dementia

Multiple sclerosisMultiple sclerosis

CreutzfeldtCreutzfeldt--JakobJakobdiseasedisease

Some intoxications (e.g., Some intoxications (e.g., therapeutic drugs)therapeutic drugs)

Anoxic dementiaAnoxic dementia Human Human Immunodeficiency Immunodeficiency virus dementiavirus dementia

BB1212 deficiency (e.g. of deficiency (e.g. of short duration)short duration) Progressive Progressive

Supranuclear palsySupranuclear palsyAmyotrophic lateral Amyotrophic lateral sclerosissclerosis

Normal pressure Normal pressure hydrocephalushydrocephalus(e g of short duration)(e g of short duration)

23

Permanent�vs.�Temporary�Incapacity

Progressive�Dementia����������������������Permanent/dynamic�Incapacity

Arrestable��Dementia�����������������������Permanent/static�Incapacity

Reversible�Dementia������������������������Temporary�Incapacity

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• May�be�determined�by�statute�or�probate�court�rules• Example�1�� ORC�§2111.031�

• Refers�to�expert�opinion�for�the�determination�of�guardianship

• General�in�scope�– “Licensed�physicians�and�other�”persons.”

• Example�2�� Ohio�Rule�of�Superintendence�66�for�probate�courts• Specifies�two�classes�of�experts�who�may�provide�opinions�on�the�need�for�guardianship

PhysiciansClinical�Psychologists

• Example�3��� ORC�§2111.49(A)(1)(i)�– Specifies�five�classes�of�experts�who�may�provide�opinions�on�the�need�for�continuation�of�a�guardianship�1. Licensed�Physician2. Licensed�Clinical�Psychologist3. Licensed�Independent�Social�Worker4. Licensed�Professional�Clinical�Counselor5. Mental�Retardation�Team

• Physicians• Primary�Care�or�Generalist�Physicians

• Often�an�individual’s�personal�physician

• Specialist�physicians��� Board�Certified�Specialties• Psychiatrists• Neurologists• Geriatricians

• Professional�Psychologists�– Board�Certified�Specialties• Clinical�Psychologists• Clinical�Neuropsychologists• Forensic�Psychologists

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•Inter�rater�reliability�of�physician�capacity�judgments�is�low

•Overall�agreement�of�56%�in�one�study�of�mildly�demented individuals (Marson et al 1997a)demented�individuals�(Marson�et�al.,�1997a).

•Physicians�differ�in�terms�of�which�cognitive�process�they�focus�on�when�making�judgments�of�clinical�capacity�(Marson�et�al.,�1997b).

•2008�� ABA�Commission�on�Aging�and�American�Psychological�Association�Manual�for�clinical�capacity�evaluations�published.�

• Developed�by��ABA/APA�Joint�Working�Group�on�Assessment�of Capacity in Older Adults to address shortcomings in clinicalof�Capacity�in�Older�Adults�to�address�shortcomings�in�clinical�capacity�evaluations.

• Provides�detailed�guidelines�for�conducting�clinical�capacity�exams�for�six�different�capacities.�

• Companion�manuals�were�published�for�lawyers�and�judges.

Nine�components�of�ABA/APA�Model

1. Legal�Standards2. Functional�Elements3. Diagnoses

C iti d i i4. Cognitive�underpinnings5. Psychiatric�or�Emotional�Issues6. Values�and�preferences�7. Risk�of�Harm�and�Level�of�Supervision�Needed8. Means�to�Enhance�Capacity9. Clinical�judgment�

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• Determining�and�understanding�the�legal�standard�

• The�first�step�in�any�capacity�evaluation• Key�given�that�the�ultimate�consumer�is�a�probate�

djudge• Consultation�with�an�attorney�may�be�helpful�at�this�

stage

• Functional�Elements• Derived�from�the�legal�standard.• What�activities,�decisions�are�involved

• General�medical,�neurological�and�psychiatric�diagnoses• Provide�information�regarding�the�cause�of�incapacity

• Cognitive�Underpinnings• Underlie�decision�making�and�other�functional�elements

Aff d b l i l hi i d i di• Affected�by�neurological,�psychiatric�and�systemic�diseases• Neuropsychologists�specialize�in�this�area

• Psychiatric�or�emotional�factors

• Psychiatric�Illness�affects�cognitive�underpinnings�and�functional�elements�in�clinical�capacity

• However,�emotional�disturbance���cognitive�dysfunction.

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• Values�and�Preferences• Values�� “[The]�underlying�set�of�beliefs,�concerns,�and�

approaches�that�guide�personal�decisions.”�

• Preferences�– “the�preferred�option�of�various�choices�p pthat�is�informed�by�values.”

• Important�in�financial�capacity,�especially�testamentary�capacity

• Values�and�Preferences• Consistency�of�recent�decisions�with�long�held�values�

and�preferences�may�serve�as�an�indication�of�capacity.

• Recent�choices�may�indicate�a�maturing�value�system.• An�individual’s�values�may�be�outside�the�norm�and�

inconsistent�with�the�evaluator’s.�• Persons�with�cognitive�dysfunction�may�be�able�to�

express�deeply�held�beliefs�that�affect�decisions.

• Risk�of�harm�and�Level�of�Supervision�Needed• Includes�physical�and�economic�harm• May�not�be�entirely�personal;�others�may�depend�on�person�

assessed.

• Assessment�includes• Cognitive�and�other�deficits• Environmental�and�social�support�systems• Social�,�economic�and�physical�demands�placed�on�individual

• Level�of�supervision�recommended�should�be�logically�connected�to

• Risk�of�harm• Level�of�supervision�required�to�mitigate�the�harm.�

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• Recommendations�of�means�to�enhance�capacity

• Medical,�Rehabilitative�and/or�psychological�treatment

• Accommodation�of��sensory�and/or�motor�impairment

• Recommended�time�for�re�hearing�of�a�negative�capacity�decision.

• Clinical�judgment�concerning�capacity• Binary�judgment�in�most�jurisdictions.�• Continuous�judgment�allowed�in�some�jurisdictions.

Assessing Clinical Capacity:Case Example “L.T.”

� Background� 78�year�old�widowed�female�referred�by�UTMC�neurologist�for�an�additional�opinion�regarding�necessity�for�continuation�of�guardianship.

� Recent�Medical�History� Memory�decline�reported�by�daughter� Diagnosed�with�Mild�Cognitive�Impairment�six�months�prior�to�exam.

� Poor�compliance�with�insulin�regimen�for�diabetes�for�preceding�three�years.

� Weight�loss�of�21�lbs.�over�three�years�(current�weight�=�118�lbs.,��height�=�5’�6”.)

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Assessing Clinical Capacity:Case Example “L.T.”

� Past/current�Medical�History� Diabetes�I�since�birth� Hypercholesteremia� Hypertension�� Breast�cancer�12�years�prior,�treated�surgically,�no�reoccurrence.

� 60�year�hx�of�smoking,�currently�1�pack/day� No�hx�of�ETOH�or�other�substance�abuse/dependence.

� Radiologic�Findings� MRI�– 8�months�prior�– “Significant�subcortical�arteriosclerotic�white�matter�leukoencephalopathy.”

Assessing Clinical Capacity:Case Example “L.T.”

� Psychiatric�history� No�formal�psychiatric�history� Evidence�of�recent�delusional�thinking�

� Bank�gave�her�a�“phony”�cashier’s�check.� Someone�stole�her�insulin�from�her�refrigerator.�

� Medications� Warfarin�(Anti�Coagulant)� Enapril�(Anti�hypertensive)� Gabapentin�(Controls�diabetic�foot�pain)� Atenolol�(Anti�hypertensive)� Lovastatin�(Controls�Cholesterol)� Aspirin�(Anti�Coagulant)� Humalog�(Insulin)� Novolin�(Insulin)

Assessing Clinical Capacity:Case Example “L.T.”

� Physical�Functioning� WNL�for�ambulation,�using�stairs,�etc.� Vision�and�hearing�WNL�when�corrected� No�chronic�pain�or�weakness

S i l/ d ti l hi t� Social/educational�history� H.S.�degree�+�1�year�of�college� Retired�church�office�worker� Widowed�13�years�prior�(Ms.�T�reported�9�years�prior)� Adopted�two�children

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Assessing Clinical Capacity:Case Example “L.T.”

� Legal�History� Daughter�granted�emergency�guardianship.

� Adult�Protective�Services�in�her�county�petitioned�Probate�Court�at�the�request�of�L.T.’s�PCP.�

� PCP�completed�Ohio�Statement�of�Expert�Opinion�(SEO)�supporting APC’s petition for appointment of a guardian.supporting�APC s�petition�for�appointment�of�a�guardian.

� Ms.�T�petitioned�court�for�termination�of�guardianship.� Submitted�SEO�completed�by�a�local�neurologist�supporting�termination�of�guardianship.

� Petition�supported�by�daughter.

� Judge�asked�for�a�third�SEO� L.T.�consulted�UTMC�neurologist�who�referred�L.T.�to�UTMC�clinical�neuropsychologist.

Assessing Clinical Capacity:Case Example “L.T.”

� Assessment�� Review�of�medical�records� Interview�of�L.T.�and�L.T.’s�daughter� Neuropsychological�test�battery�including�tests�of�orientation,�attention,�spatial�abilities,�language,�general�i ll l f i i ll id ifi iintellectual�functioning,�memory,�smell�identification�and�mood.

� Adaptive�Behavior�checklists�completed�by�L.T.�and�L.T’s�daughter�covering�conceptual,�social�and�practical�everyday�life�functioning.

� Legal�Capacity�Questionnaire�– Assesses�ability�to�understand�financial�transactions.

Assessing Clinical Capacity:Case Example “L.T.”

� Legal�Standard�– Ohio�Revised�Code�(O.R.C.)�2111.01(D):�Definition�of�Incompetent� “‘Incompetent’�means�any�person�who�is�so�mentally�impaired as a result of a mental or physical illness orimpaired�as�a�result�of�a�mental�or�physical�illness�or�disability,�or�mental�retardation,�or�as�a�result�of�chronic�substance�abuse,�that�the�person�is�incapable�of�taking�proper�care�of�the�person’s�self�or�property�or�fails�to�provide�for�the�person’s�family�or�other�persons�for�whom�the�person�is�charged�by�law�to�provide,�or�any�person�confined�to�a�correctional�institution�within�this�State.”

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Assessing Clinical Capacity:Case Example “L.T.”

� Functional�Elements�� Financial

� Understanding�and�being�able�to�complete�financial�transactions�– Normal�

� Communicating�with�persons�at�financial�institutions�–Mildly�impairedR b i i h d l d i� Remembering�to�engage�in�scheduled�transactions�or�arranging�for�these�to�take�place�– Appears�to�be�normal

� Self�care� Managing�medical�treatment�regimens�– Definitely�Impaired� Managing�hygiene�– Normal�� Diet�management�� Questionable� Using�transportation�to�obtain�needed�goods�– Normal�� Shopping�and�selecting�needed�items�� Questionable

Assessing Clinical Capacity:Case Example “L.T.”

� Medical�Diagnoses

� General�medical�history�including�DM�I,�hypertension,�hypercholesteremia�and�cerebrovascular�disease.

� Mild dementia based on history and neuropsychological test� Mild�dementia�based�on�history�and�neuropsychological�test�results.��Likely�a�combination�of�early�Alzheimer�disease�and�cerebrovascular�disease.�

Assessing Clinical Capacity:Case Example “L.T.”

� Cognitive�underpinnings

� Significant�memory�deficits�with�marked�deficits�in�delayed�memory�(suggestive�of�AD)

� Mildly impaired orientation� Mildly�impaired�orientation� Deficits�in�olfactory�identification�(suggestive�of�AD)� Low�normal�general�intellectual�functioning�(FSIQ�=�89)� Mild�moderately�impaired�cognitive�flexibility� Borderline�spatial�and�language�abilities�� Normal�attention�and�concentration

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Assessing Clinical Capacity:Case Example “L.T.”

� Psychiatric�and�emotional�factors� Mild�but�clinically�significant�depression�based�on�depression��questionnaire�results,�self�rating�of�mood,�daughter’s�rating�of�mood,�and�clinical�interview.�

� Thought�disorder�as�evident�from�delusional�thinking�pattern,�g g p ,may�be�secondary�to�and/or�exacerbated�by�memory�deficits.

� Values�and�preferences� L.T.�expresses�strong,�long�held,�preference�for�personal,�economic,�and�physical�independence�and�self�directed�behavior.

� Daughter�supports�these�values.�

Assessing Clinical Capacity:Case Example “L.T.”

� Risk�of�harm� Medical/personal�–

� Significant�and�probable�risk�of�harm�given�Ms.�T’s�known�failure�to�adhere�to�insulin�regimen�and�possibly�other�medication�schedules.�

� Memory�deficits�and�other�cognitive�deficits�present�additional�i k f lf i jrisks�of�self�injury

� Economic�–� Lower�risk�due�to�L.T.’s��good�comprehension�of�financial�transactions�and�previously�existing�financial�arrangements.

� Supervision�required� Medical�– Daily�supervision�required� Economic�– Periodic�but�regular�supervision�

Assessing Clinical Capacity:Case Example “L.T.”

� Recommendations�for�enhancing�capacity� Evaluation�for�neurological�treatment�including�the�possibility�of�a�cholinesterase�inhibitor.

� Referral�to�geropsychiatrist�for�further�assessment�and�treatment�of�depression,�thought�disorder�and�cognitive�difficultiesdifficulties.

� Organization�and�regular�checking�of�L.T.’s�self�care�in�general�and�medication�usage�in�particular.

� Execution�of�voluntary�Power�of�Attorney�for�health�care�and�for�financial�affairs.

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Assessing Clinical Capacity:Case Example “L.T.”

� Clinical�judgments�concerning�capacity1) Ms.�T�has�general�financial�capacity.2) Ms.�T�does�not have�capacity�for�care�of�her�person.�3) Ms.�T’s�clinical�incapacity�is�consistent�with�

incompetence�under�O.R.C.�2111.01(D).4) The�guardianship�should�be�continued.5) Ms.�T�should�be�re�evaluated�in�6�12�months�to�

determine�change�in�status�given�implementation�of��treatment�and�other�recommendations�for�enhancing�capacity.

6) Re�hearing�of�competency�and�guardianship�may�be�considered�post�re�assessment.�

Questions?

UT�College�of�Law�Graduation�- May�9,�2010

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NOTES