J. Mark Bailey, DO, PhDProfessor

Neurology and Anesthesiology

PAIN MEDICINE: STATE REGULATION AND

INTERPROFESSIONAL COLLABORATION

Disclosures

Dr. Bailey has nothing to disclose

OBJECTIVESAt the conclusion the learner will be able to:

Provide examples of how state pain regulations impact the practice of medicine

Effectively respond to new regulations, including state-mandated continuing medical education topics such as opioid-prescribing

Identify information resources available to practitioners regarding appropriate pain practice

Encourage a better understanding of state and federal laws/regulations for the prescribing and dispensing of controlled substance for all health care providers and promote interprofessional communication that helps address misuse and diversion.

CHRONIC PAIN DEFINITIONS

• Greater than 3 months  ”Classification of pain". In Weiner, R.S. Pain management: A practical guide for clinicians (6 ed)

• Greater than 12 months  Pain management: an interdisciplinary approach. Elsevier. p. 93

• Pain that extends beyond the expected period of healing Bonica's management of pain (3 ed.). Lippincott Williams & Wilkins. pp. 18–25.

PREVALENCE

Heart Disease

Stroke

Cancer

Diabetes

Total

Chronic Pain

25.8 million

16.3 million

7 million

11.7 million

60.8 million

116 million

http://www.painmed.org/patient/facts.html#incidence

COSTS

The total annual cost of health care due to chronic pain ranges from $560 billion to $635 billion which combines the medical costs of pain care and the economic costs related to disability days and lost wages and productivity.

Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.

PAIN TREATMENT HISTORY

Too Little?2000

Too Much?2014

THEN …• Prior to 2000, there was a growing public

perception that pain was being medically undertreated.

• In late 2000, Congress passed into law a provision that declared the ten-year period that began January 1, 2001, as the Decade of Pain Control and Research.

• Also in 2000, JCAHO released new standards for the assessment and management of pain in the facilities they accredit and certify. (5th vital sign)

… AND NOW

“Deaths from prescription painkillers have reached epidemic levels in the past decade. The number of overdose deaths is now greater than those of deaths from heroin and cocaine combined.”

CDC Vital Signs November 2011

OPIOIDS SOLD 2010

Automation of Reports and Consolidated Orders System of the DEA, 2010

OPIOID OVERDOSE DEATHS

National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System of the Drug Enforcement Administration, 1999-2010; Treatment Episode Data Set, 1999-2009

REGULATIONS IN THE TREATMENT OF CHRONIC

PAIN

Types of Regulations& Guidelines

Federal Regulations

State Regulations

Best Practices Guidelines

Federal Regulations

Risk Evaluation & Mitigation Strategy

Under the Food and Drug Administration Amendments Act of 2007, the FDA has the authority to require a manufacturer to develop a REMS when further measures are needed to ensure that the drug’s benefits outweigh its risks.

http://www.er-la-opioidrems.com/IwgUI/rems/home.action

Many Drugs have REMS

Opioids• Long-acting / Extended Release• Transmucosal IR Fentanyl Preps• Buprenorphine Oral Preps for Dependence

Androgel

Chantix

Vigabatrin

…many others.

Each REMS is Different

www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm#Current

ER/LA Opioid REMS

Components Include:• Prescriber Training• Patient Counseling Document • Medication Guides • Assessment and Auditing• Adverse Event Reporting

http://www.er-la-opioidrems.com/IwgUI/rems/home.action

Prescriber Training

Voluntary at present

Closely follows FDA ‘Blueprint’

Available at many professional / society meetings

AOA participation in CORE*REMS

State Regulations

24 | © CO*RE 2013

Office of the Inspector General. South Carolina Lacks a Statewide Drug Abuse Strategy. May 2013. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf

State of South Carolina. Executive Department. Office of the Governor. Executive Order No. 2014-22 (Establishing the Prescription Drug Abuse Prevention Council). March 2014. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf

In 2010

South Carolina ranked 23rd highest per capitaIN BOTH PRESCRIPTION OPIOID PRESCRIPTIONS & OVERDOSE DEATHSAs a result, the Governor’s Prescription Drug Abuse Prevention Council was established in 2014

SC Reporting & Identification Prescription Tracking System

(SCRIPTS)

25 | © CO*RE 2013

• Can provide prescribers w/ their patient’s prescription history to:

• Identify “doctor shoppers” who go to multiple doctors• Intervene to help abusers & keep excess prescription drugs off the street

• Prevent potential drug interactions

Office of the Inspector General. South Carolina Lacks a Statewide Drug Abuse Strategy. May 2013. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf

SCRIPTS is substantially underutilized• Use is voluntary• Only 22% of South Carolina physicians were registered in 2013 • Much fewer actually use it for prescribing decisions

New 2014 AL RegulationsWho is a Pain Specialist?

A physician practice which advertises or holds itself out to the public as a provider of pain management services; OR

A physician practice which dispenses opioids; OR

A physician practice with greater than fifty percent of the patients being provided pain management services; OR

A physician practice in which any of the providers of pain management services are rated in the top ten percent of practitioners who prescribe controlled substances in Alabama, determined by the Alabama Prescription Drug Monitoring Database on an annual basis. (These physicians will receive a notification letter from the Board)

THESE DO NOT APPLY TO THE TREATMENT OF ACUTE PAIN

http://www.albme.org/painserv.html

New 2014 AL RegulationsRegistration as a Pain Specialist w/ State Board

A completed application

Proof of a current Drug Enforcement Administration (DEA) registration

Proof of an Alabama Controlled Substance Certificate (ACSC)

Proof of a current registration with the Alabama Prescription Drug Monitoring Program (PDMP)

The results of a criminal background check ($65)

The disclosure of any controlled substances certificate or registration denial, restriction or discipline imposed on the registrant, or any disciplinary act against any medical license of the registrant

 Payment of the initial registration fee ($100.00)

 A certification listing the current name of the physician who serves as the medical director

 The physical address of each location where pain management services are provided

A  list of all physicians who work at the practice location, including the name of the physician who will serve as the medical director

TN Pain RegulationsEffective January 1, 2012, all pain management clinics in Tennessee must be registered with the State.

Tennessee state law defines a pain management clinic as a privately-owned facility in which a medical doctor, an osteopathic physician, an advanced practice nurse or a physician assistant provides pain management services to patients, a majority of whom are issued a prescription for, or are dispensed, opioids, benzodiazepine, barbiturates, or carisoprodol, but not including suboxone, for more than 90 days within a 12-month period.

‘Pain management clinic’ shall also mean any privately-owned, facility or office which advertises in any medium for any type pain management services and in which one or more employees or contractors prescribe controlled substances.

TN Pain Regulations

TN law specifically limits pain clinics to accepting checks or credit cards. NO CASH! (except for co-pays)

Treatment of CA pain and benzos for mental health are excluded from pain clinic determinations.

Urine drug testing with confirmation is required prior to the outset of chronic opioid therapy and at least twice per year.

TN Non-Pain Medicine Specialist:All providers who wish to treat patients requiring less than 120 milligram morphine equivalent daily dose (MEDD) shall:

• Hold a valid Tennessee license issued by their respective board through the Department of Health and a current DEA certification.• Attend Continuing Education pertinent to pain management as directed by their governing board.

All providers who wish to treat patients requiring more than 120 MEDD for greater than nine months shall:

• Obtain at least one annual consultation with a Pain Medicine Specialist. Patients with more complicated cases may require more frequent consultation.

TN Pain Medicine Specialist:

Subspecialty certification in Pain Medicine under the boards of, Anesthesia, Neurology, Psychiatry and Physical Medicine & Rehabilitation OR diplomate status by 7/1/2016

An unencumbered Tennessee license

The minimum number of CME hours in pain management to satisfy retention of ABMS certification.

Any exceptions to this must be approved by the respective health related licensing and regulatory board.

Current pain medicine specialists who are qualified to take the specialty exam may continue to practice as a pain medicine specialist until 7/1/16, when diplomate status will be required.

FL Definition – Pain Clinic

Any publicly or privately owned facility that:• Advertises for pain-management services• In any month, the majority of patients seen

are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic non-malignant pain

FL Controlled Substance Prescribing

Amendment effective 7/1/12: a licensed physician under chapter...459(osteopathic),...who prescribes any controlled substance, as defined in §893.03, for the treatment of chronic nonmalignant pain must:

Designate himself or herself as a controlled substance prescribing practitioner on the physician’s practitioner profile

Comply with the requirements of the State Board

Use counterfeit-resistant prescription blanks

http://www.flsenate.gov/Laws/Statutes/2011/Chapter456/

FL Controlled Substance Prescribing

Report to State Board quarterly:

• How many new and return patients treated for chronic nonmalignant pain.

• Number of patients discharged due to drug abuse

• Number of patients discharged due to drug diversion

• Number of patients treated from out of stateAnnual Onsite Inspection

Best PracticesStandard of Care

Federation of State Medical Boards

State Medical Board Recommendations• Closely follow FSMB

Pain Organizations Recommendations

FSMB Model Policy

• Pain management is important and integral to the practice of medicine

• Use of opioids may be necessary for pain relief• Use of opioids for other than a legitimate medical purpose

poses a threat to the individual and society• Physicians have a responsibility to minimize the potential for

abuse and diversion• Physicians may deviate from the recommended treatment

steps based on good cause• Not meant to constrain or dictate medical decision-making

FSMB, Federation of State Medical Boards

Recommended ElementsPatient Information about Opioids

Medication Agreement

Opioid Consent Form

Intake forms with appropriate elements

Documented Abnormality

Opioid Risk Assessment

Rx Drug Monitoring Program Use

Documented Treatment Plan

Drug Screening Policy / Practices

Discharge letter (when/if necessary)

PRINCIPALS FOR SAFE OPIOID PRESCRIBING

Risk assessment for misuse

Assess for comorbid mental disease

Addiction referral if indicated

Caution with opioid conversions

Avoid combining opioids and benzos

Start methadone at very low doses

Assess for sleep apnea

Reduce dose during respiratory illness

Avoid using ER/LA for acute or post-op

Webster, L.W. Pain Medicine 2013: 14: 959 – 961.

41

PDMPs: Requirements for Prescribers to Register

YesNo

1

2

3

4

1Alabama: only physicians w/ or seeking pain management registration required to register. 2Virginia: effective 7/1/2015. 3Ohio: effective 1/1/2015. 4Maine: automatically registered upon obtaining/renewing professional license.

PDMPs: Substances Monitored

Schedule IISchedule II-IIISchedule II-IVSchedule II-V

PHARMACY ISSUES

PHARMACY ISSUES

In 2013, physicians were becoming aware that Rx they had written (usually opioids) were not being filled.

Some pharmacies required ‘medical information’ (diagnosis codes, imaging / lab results, date of last exam) or even direct physician communication before filling Rx.

This resulted in some patients not getting the medications they required in a timely fashion – even though they had an entirely proper Rx.

PHARMACY ISSUESThe AMA House of Delegates adopted policy stating that a pharmacist who makes inappropriate queries on a physician's rationale behind a prescription, diagnosis or treatment plan is interfering with the practice of medicine.

AOA asked to participate in a stakeholders workgroup, led by the NABP, and included representatives from the AMA, several large pharmacy chains and the DEA

Guidelines currently being formulated for both prescribers and dispensers

SHARED RESPONSIBILITYPharmacists also accountable for improperly prescribed / dispensed medications

DEA mandates on pharmacies “include assessing whether prescriptions for controlled substances were written for a legitimate medical purpose in the usual course of professional practice”

A pharmacist cannot dispense a controlled substance unless he/she concludes that the prescription meets these criteria

PHARMACY ISSUES

The U.S. DEA has reached an $80 million settlement with Walgreens Pharmacies after the company violated rules about dispensing analgesics. According to the DEA, Walgreens pharmacies in Florida violated record-keeping and dispensing rules. The pharmacies continued to fill suspicious oxycodone orders and Rx that were not for legitimate medical use.

2014 AMA HOD

“If the problem isn't resolved, the AMA will advocate for regulatory and legislative solutions to prohibit pharmacies from denying medically necessary treatments, the policy states.”

“There are doctors, and there are pharmacists. My responsibility is to write a prescription; it's

the pharmacist's responsibility to fill it” comment from one of the participants

STAKEHOLDERSAmerican Academy of Family Physicians 

American College of Emergency Physicians 

American Medical Association

American Osteopathic AssociationAmerican Pharmacists Association

American Society of Anesthesiologists 

American Society of Health-System Pharmacists 

Cardinal Health

CVS Health

Healthcare Distribution Management Association 

National Association of Boards of Pharmacy 

National Association of Chain Drug Stores 

National Community Pharmacists Association Pharmaceutical Care Management Association 

Purdue Pharma L.P.

Rite Aid

Walgreen Co 

POSSIBLE ACTIONS

Education for physicians / pharmacists concerning mutual roles

Development of clinical ‘vignettes’ for appropriate physician / pharmacists interactions

Expansion of PDMP Interconnect program to ALL states

Naloxone kits to patients prescribed chronic opioids and their families

SUMMARYChronic pain is a widespread, and expensive medical problem.

Because of skyrocketing opioid overdose deaths, many new regulations are in place.

It’s getting harder to comply with the plethora of recommendations / regulations; particularly when writing ER/LA opioids.

There are unexpected ramifications of these regulations. The AOA is actively involved in finding appropriate solutions.

CONTACT INFORMATION

UAB Highlands1201 11th Avenue SouthSuite 400Birmingham, AL 35205

(205) 930-8300 office(205) 930-8301 fax

markbailey@uab.eduwww.uab.edu/neuropain