Baxter IV Safety - Slides for handout€¦ · 4:50 p.m. Faculty Discussion and Audience Questions A...
Transcript of Baxter IV Safety - Slides for handout€¦ · 4:50 p.m. Faculty Discussion and Audience Questions A...
www.ashpadvantage.com/ivsafety
Provided by ASHP
Supported by an educational grant from Baxter Healthcare Corporation
AGENDA
2:00 p.m. Introductions and Announcements
Kevin Hansen, Pharm.D., M.S., BCPS, Activity Chair
2:10 p.m. Current State of Drug Shortages
Erin R. Fox, Pharm.D., BCPS
2:50 p.m. Back to Best Practices: Patient Safety and IV Preparation and Administration
Kevin Hansen, Pharm.D., M.S., BCPS
3:30 p.m. Stretch Break/Light Refreshments
3:45 p.m. How To of Data Generation and Interpretation from Smart Infusion Devices
Richard J. Zink, M.B.A.
4:10 p.m. Using Smart Infusion Device Data to Facilitate Clinical Practice Changes
Todd A. Walroth, Pharm.D., BCPS, BCCCP
4:50 p.m. Faculty Discussion and Audience Questions
A Sunday Symposium conducted at the 2018 ASHP Midyear Cinical Meeting and Exhibition
Sunday, December 2, 2018 2:00 p.m.–5:00 p.m. Pacific Ballroom B Hilton Anaheim Anaheim, California
Kevin Hansen, Pharm.D., M.S., BCPS
Assistant Director of Pharmacy ‐ Sterile Products, Special Formulations, Perioperative ServicesMoses H. Cone Memorial HospitalGreensboro, North Carolina
Erin R. Fox, Pharm.D., BCPS, FASHP
Senior Director, Drug Information and Support ServicesUniversity of Utah HealthSalt Lake City, Utah
Todd A. Walroth, Pharm.D., BCPS, BCCCP
Pharmacy Manager, Clinical ServicesClinical Pharmacy Specialist, Burn/Critical CareEskenazi HealthIndianapolis, Indiana
Richard J. Zink, MBA
Managing Director, REMEDI Operations Purdue University West Lafayette, Indiana
Provided by ASHPSupported by an educational grant from Baxter Healthcare Corporation
In accordance with ACCME and ACPE Standards for Commercial Support, ASHP policy requires that all faculty, planners, reviewers, staff, and others in a position to control the content of this presentation disclose their financial relationships. In this activity, only the individual below has disclosed a financial relationship. No other persons associated with this presentation have disclosed any relevant financial relationships.
• Kevin Hansen, Pharm.D., M.S., BCPS– Baxter, Acurity, and Pharmacy Purchasing & Products: Speakers
Bureau
Disclosures
Please be advised that this activity is being audio and/or video recorded for archival purposes and, in some cases,for repurposing of the content for enduring materials.
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• Review recent trends in drug shortages, including best practices for mitigating them.
• Explain best practices in IV preparation and administration that promote the safety of patients and healthcare personnel.
• Illustrate how to generate and interpret the continuous data provided by smart infusion devices.
• Demonstrate how data generated from smart infusion devices can be used to drive clinical practice changes.
Objectives
Current State of Drug ShortagesErin R. Fox, Pharm.D., BCPS, FASHP
Senior Director, Drug Information and Support ServicesUniversity of Utah Health
Salt Lake City, Utah
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Current Issues in IV Injectable Safety: Continuing the Conversation
• This presentation represents my own opinions. I am not speaking on behalf of the University of Utah
• University of Utah Drug Information Service has a contract with Vizient to provide drug shortage information. The total amount is < 5% of total budget.
Disclosure
• Review recent trends in drug shortages, including best practices for mitigating them.
Objective
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Current Issues in IV Injectable Safety: Continuing the Conversation
• UUDIS provides drug shortage content to ASHP• Public website at www.ashp.org/shortages
– Partners since 2001– Voluntary reports submitted via web– UUDIS investigates / confirms shortages with
manufacturers– Frequent communication with FDA Drug Shortage Team
National Shortages and University of Utah Drug Information Service (UUDIS)
Differences Between Websites
ASHPwww.ashp.org/shortage • Drugs impacting clinical
practice (biologics, devices, dosage forms)
• How to access• Frequent updates• Alternatives, safety
FDAwww.fda.gov/cder
• Fewer products• No biologics or
devices• Information from
manufacturerhttps://www.ashp.org/Drug‐Shortages/Current‐Shortages/FDA‐and‐ASHP‐Drug‐Shortages
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Current Issues in IV Injectable Safety: Continuing the Conversation
National Drug Shortages ‐ New Shortages by YearJanuary 2001 to September 30, 2018
Note: Each column represents the number of new shortages identified during that year.Data shared with permission from University of Utah Drug Information Service
12088 73 58 74 70
129149
166
211
267
204
140
185
142 154 146 139
0
50
100
150
200
250
300
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18
National Drug Shortages ‐ New Shortages by Year January 2001 to September 30, 2018, % Injectable
Note: Each column represents the number of new shortages identified during that year.Green = injectable, yellow = non‐injectable
Data shared with permission from University of Utah Drug Information Service
0
50
100
150
200
250
300
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18
7464 52
5664 60
61
46
46
63
57
5555 5045
45 63 58
56
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Current Issues in IV Injectable Safety: Continuing the Conversation
National Drug Shortages – Active Shortages by Quarter
Note: Each point represents the number of active shortages at the end of each quarter.Data shared with permission from University of Utah Drug Information Service
299 294 288305 306 320
301265
219190 185 195 191
174 176 176 174 174 183202
238
050
100150200250300350
Q2‐
13Q
3‐13
Q4‐
13Q
1‐14
Q2‐
14Q
3‐14
Q4‐
14Q
1‐15
Q2‐
15Q
3‐15
Q4‐
15Q
1‐16
Q2‐
16Q
3‐16
Q4‐
16Q
1‐17
Q2‐
17Q
3‐17
Q4‐
17Q
1‐18
Q2‐
18
Active Shortages – Top 5 Drug Classes
Green = injectable, yellow = non‐injectableUsed with permission from University of Utah Drug Information Service
82
8 132
22
1610
2334
0
10
20
30
40
Antimicrobials Chemotherapy Cardiovascular CNS E‐Lytes,Nutrition, Fluids
Number of Active Shortages September 30, 2018
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Current Issues in IV Injectable Safety: Continuing the Conversation
• The rate of new shortages is increasing and common shortages are severely impacting patient care and pharmacy operations
• Long‐term active and ongoing shortages are not resolving• The most basic products required for patient care are
short: bupivacaine, lidocaine, hydromorphone, morphine, fentanyl, ketamine, ondansetron, saline, and sterile water.
https://www.ashp.org/Drug‐Shortages/Shortage‐Resources/Roundtable‐Report http://www.nejm.org/doi/full/10.1056/NEJMp1800347
http://www.gao.gov/products/GAO‐16‐595
What do These Numbers Mean?
Why is this Happening?
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Profitability• Manufacturing fixes• Capacity – most factories running 24/7• Just in time production• Forecasting (contracts)• Aging facilities• Almost all shortages are due to some kind of quality problem at the manufacturing facility
Drug Manufacturing is a Business
• Contract manufacturing means we don’t always know who makes the product
• No requirement to disclose manufacturer (or location) in product label (or FDA form 483)
• No requirement to disclose source of active pharmaceutical ingredient (API)
• Why is the list of products made in a specific facility proprietary? No way to follow the quality data…
Lack of Transparency is a Problem
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Current Issues in IV Injectable Safety: Continuing the Conversation
Transparency to Incentivize Quality?
Woodcock J, Wosinska M. Clin Pharmacol Ther. 2013;93:170‐66Fox ER, et al. Mayo Clinic Proc. 2014.89(3):361‐73
Quality
Not Transparent
No Incentive
• Single firm often produces 90% of total supply – common to have sole source of raw materials – Capacity is limited, “just in time,” no redundancy
• What limits competition and new entrants?– Low use products – Manufacturing expense / return on investment
• Are FDA recommendations / public health considered during mergers?
• Are essential medications critical infrastructure?
Fragile Supply Chain for Injectables
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Current Issues in IV Injectable Safety: Continuing the Conversation
A. Raw material supply shortagesB. CounterfeitingC. U.S. manufacturing moving overseasD. Quality and manufacturing problems
What are key causes of drug shortages?
Audience Poll
Best Practices to Minimize Impact
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Shortages can impact every step of the medication‐use process
• Pharmacists manage drug shortages every day • Goal – minimize any impact on patient care
– Unintended consequences? Shortages may be invisible to many on the healthcare team
Role of the Pharmacist
• Electronic health record (EHR), automation, smart pumps– All designed to require the use of the same product all of the time
• Large amounts of product needed • Uncertainty about syringes / stability
– FDA says cannot store drug in syringes, yet syringe pumps are approved. 503b outsourcing facilities also store drugs in syringes
• Uncertainty about compounding regulations• Unapproved drugs (manage price hikes like shortages)• Regulatory burden of USP chapters <797>, <800>, Drug Supply Chain
Security Act (DSCSA)
Current Challenges
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Current Issues in IV Injectable Safety: Continuing the Conversation
Fox ER, Am J Health‐Syst Pharm. 2018; 75:e593‐601.
Best Practice
• Team• Operational assessment• Therapeutic assessment• Impact analysis• Action plan
Disaster Planning Framework
• Mitigation• Preparedness• Response• Recovery
Hick JL. N Eng J Med. 2014; 370:1573‐1576.
N Eng J Med, March 19, 2014
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Current Issues in IV Injectable Safety: Continuing the Conversation
• IV fluids are both a supply and a treatment• Impact large numbers of inpatients and outpatients• Safety issues• Hospitals, infusion centers rely on specific volumes, solutions,
and concentrations• Changes to product concentrations may be high risk
– Stability issues– Administration errors– IV pump issues
Injectable Shortages – Unique Situation
• We can get some but….– It’s a different strength– It’s in different packaging – It’s a different size/volume– It’s from a different manufacturer– It’s imported– It’s not enough!
Most Common Situation
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Current Issues in IV Injectable Safety: Continuing the Conversation
Complex Problem Solving
Patient Impact
Clinical
Impact
Clinical
ImpactOperations
Impact
Operations
Impact
Gather data, monitor the shortage?Make purchasing decisions?Maintain contact with local reps? Make storage, preparation, and dispensing change
decisions?Make rationing decisions? Change technology? Communicate information?
Team Checklist – Who Will…..
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Current Issues in IV Injectable Safety: Continuing the Conversation
What if There’s not Enough?
Image from: Fink S. New York Times. January 29, 2016. Available at: https://www.nytimes.com/2016/01/29/us/drug‐shortages‐forcing‐hard‐decisions‐on‐rationing‐treatments.html.
• Don’t ration alone – develop a resource allocation committee
• Example tools available by drug class• Chemotherapy
Valgus J, J Oncol Pract. 2013;9:e21‐3Rosoff PM, Arch Intern Med. 2012;172:1494‐9.Jagsi R, Oncologist. 2014;19:186‐92.
• AntimicrobialsGriffith MM, Infect Control Hosp Epidemiol. 2012;33:745‐52
Rationing and Ethics
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Make sure each member understands his or her role and shares information
• Situations can change quickly• Efficient management relies on good team
communication• Timeliness is essential• Informatics / EHR changes!!!
Shortage Management Team Communications
Fixing the Problem
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Current Issues in IV Injectable Safety: Continuing the Conversation
A. YesB. No
Are shortages FDA’s fault?Audience Polling
Are Shortages FDA’s Fault?
NO • FDA shortage team is
extremely collaborative• Violations must be
extreme for a shut‐down (safety first!)
• Agency works diligently to prevent shortages
YES • Enforcement actions can
cause shortages• Manufacturers may have
trouble complying with regulations
• Regulatory discretion = unintended consequences?
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Prioritize medically necessary agents (determined on a case by case basis)
• Evaluate risks and benefits for patients• Offer assistance and advise, but up to the manufacturer to
fix• Success hinges on early notification• CANNOT require continued manufacturing or allocations – no matter how critical or life‐saving the product is
U.S. Food and Drug Administration. A Review of FDA's Approach to Medical Product Shortages. October 31, 2011. Available at: https://www.ipqpubs.com/wp‐
content/uploads/2012/02/FDA_drug_shortages_report.pdf
FDA’s Strategy
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm418347.htm
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Modernize drug quality oversight• Risk based inspection scheduling
– Predict drug shortages• Objective criteria including:
– Lot acceptance rate– Product quality complaint rate
• Star rating scale for manufacturers?
Quality Metrics Goals
• Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, advocates continuous manufacturing for:– Faster, improved quality, lower prices, fewer
shortages– Domestic plants – fully integrated from API to
finished product
Cox B. The Gold Sheet. July 29 2014: # 08140724006.
New Ideas for Manufacturing
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Traditional manufacturing = batch process– At every step, product is assessed and collected– Off‐line labs test finished product– Days to weeks processing time
• Continuous manufacturing = monitoring throughout– Minutes to hours processing time
Continuous Manufacturing
• National Academies of Sciences Engineering Medicine Workshop Sept 5‐6, 2018 http://nationalacademies.org/hmd/Reports/2018/medical‐product‐shortages‐during‐disasters‐brief.aspx
• AHA / ASA / ASCO / ASHP / ISMP – Drug Shortages as a Matter of National Security – Sept 20, 2018
• FDA Listening Sessions – invitation only (October 1, 2018)• FDA Public Meeting – November 27, 2018
Action?
© 2018 American Society of Health-System Pharmacists
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Pharmacists managing in crisis mode daily for basic injectable medications
• Continuing quality problems at manufacturing facilities
• No way to purchase based on quality• Devastating workload • Potential / actual patient harm
Key Points
Back to Best Practices: Patient Safety and IV Preparation and Administration
Kevin Hansen, Pharm.D., M.S., BCPS
Assistant Director of PharmacyMoses H. Cone Memorial Hospital | Cone Health
Greensboro, North Carolina
© 2018 American Society of Health-System Pharmacists
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Review recent trends in drug shortages, including best practices for mitigating them
• Explain best practices in IV preparation and administration that promote the safety of patients and healthcare personnel
Learning Objectives
Cone Health
• 6‐hospital health system• 1271 acute care beds • 6 cancer centers• 4 outpatient pharmacies• Stand alone emergency
center• Urgent care facilities• Specialty clinics
Photos used with permission from Cone Health
Moses H. Cone Memorial Hospital
Alamance Regional Medical Center
Wesley Long Hospital
Annie Penn Hospital
Women’s Hospital
Behavioral Health Hospital
236 beds
175 beds
110 beds
134 beds
80 Beds
536 beds
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Current Issues in IV Injectable Safety: Continuing the Conversation
Drug Shortage Impact on Compounding
X 12
Low High Error Potential
Ready‐to‐Administer (Premix)
Ready‐to‐Use Device
Low‐Risk Admixture
Medium‐Risk Admixture
IV Push
Graphics by K. Hansen
Drug Shortage Impact on Compounding
Patient Harm Potential Error Potential: Very High
High‐Risk Admixture
Graphics by K. Hansen
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Current Issues in IV Injectable Safety: Continuing the Conversation
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Current Issues in IV Injectable Safety: Continuing the Conversation
History of IV Compounding & Administration
Myers CE. Am J Health Syst Pharm. 2013; 70:1414‐27.
1955: First availability of disposable plastic syringes
1950: Nurses added potassium chloride to LVIS 1963:
Hospital based pharmacy IV admixture services began
Mid‐1960’s: Use of laminar airflow hoods / cleanrooms began
1971: Collapsible plastic LVIS containers introduced
2001 ‐ Today: DRUG SHORTAGES!!
Concerning Trend: some IV compounding transferred back to nursing with adoption of IV Push
Concerning Trend: some IV compounding transferred back to nursing with adoption of IV Push
19401940
20182018Mid‐1970’s: Y‐site attached sterile plastic chambers devised to add drugs to LVIS; later evolved to secondary infusion containers (i.e. piggybacks)
1999: Some pharmacies using barrier isolators, excluding workers from compounding environment
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Current Issues in IV Injectable Safety: Continuing the Conversation
“Unfortunately, there are too many people in health care who feel that if it hasn’t happened to them, the adverse experiences of others do not apply.”
‐ Michael Cohen, MS, FASHP (ISMP)
3.375 g Doses~100/day = 337.5 g
Drug9 * 40.5 g vials = 364.5 g
Sterile Water9 * 152 mL = 1,368 mL
NS 50 mL Bags100 bags
Graphics: K. Hansen
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Current Issues in IV Injectable Safety: Continuing the Conversation
Dear Health Care Provider…
Graphics: K. HansenHospira (Letter to Health Care Providers) May 2018;
https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/ucm608319.pdf
One of the factors associated with an increased potential for error with IV
medications is the number of complex manipulations required when preparing
and administering these drugsHertig JB et al. J Patient Saf. 2018; 14:60‐5.
Proactive strategies
Vest TA, et al. PPPMag. 2018;15:2.
Drug Standard Shortage
Ceftriaxone 1 g Frozen IVPB(refrigerated)
1. RTU vial/bag (room temp)2. Manual Admix (refrigerated)
Norepinephrine Infusions 503B Premix (room temp)
1. Manual admixture D5W (refrigerated)
2. Manual admixture NS (refrigerated)
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Current Issues in IV Injectable Safety: Continuing the Conversation
Assistant Director: Operations
Assistant Director: Clinical
System‐Wide Director:Operations
Site Pharmacy Managers
Ope
ratio
nal
PurchasingDRUG
SHORTAGETEAM
Materials Management Coordinator
Interdisciplinary involvement with specific active roles
on the team.
ADC: automated dispensing cabinetMEC: medical executive committeeGraphic: K. Hansen
A. DailyB. More than once per weekC. Once weeklyD. More than once per monthE. Monthly
How frequently does your drug shortage management team meet?
Audience Polling
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Current Issues in IV Injectable Safety: Continuing the Conversation
Drug Shortage Tracker
Cone Health Drug Shortage Tracker. Image used with permission
Document operational and clinical changes with effective dates. Routinely review list for resolved
drug shortages so clinical/operational changes can be reverted to ‘normal state’
Drug Shortage Mitigation
• In most markets, shortages/surpluses are rare. Price changes keep quantity of products supply and demand in balance
• Elasticity– Measure of a variable’s sensitivity to
change in another variable (i.e.; price)– Acute care drug supply and demand are
INELASTIC• Opportunity
– Shift demand to different product– Preserve on‐hand supply
Department of Health and Human Services. 2011. Yeung K, et al. National Bureau of Economic Research. June 2016. URL: https://www.nber.org/papers/w22308
Mitigation: the action of reducing the severity, seriousness, or painfulness of somethingMitigation: the action of reducing the severity, seriousness, or painfulness of something
Pric
e
Quantity
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Current Issues in IV Injectable Safety: Continuing the Conversation
Hierarchy of Controls
National Institute for Occupational Safety and Health. Hierarchy of controls. https://www.cdc.gov/niosh/topics/hierarchy/default.html
Hazardous DrugsElimination• Shift use to clinical alternativeSubstitution• Outsource to 503B• Alternative
• Package size• Manufacturer• Brand• Strength• Dosage form
Pharmacy Controls• Operational modifications• Insource compoundingAdministrative Controls• Dosing restrictions• Patient group restrictionsCommunication• Communicate shortage
Drug ShortagesMost time consuming
Least time consuming
Most effective
Least time consumingLeast
effective
STAT
“If everything is STAT, everything is routine…”
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Current Issues in IV Injectable Safety: Continuing the Conversation
Sterile Water for Injection Vial Shortage
Graphics: K. Hansen
Scenario: Sterile water for injection (SWFI) vials commonly used for drug reconstitution in the pharmacy and on nursing units are completely unavailable. Certain medications do not have any information available to safely dilute in alternative diluents. How do we continue to reconstitute these medications?
Alteplase 2 mg
?
Graphics: K. Hansen.Wjernikowski JT, et al. Lancet. 2000; 355:2221‐2.
Sterile Water for Injection Vial ShortageStrategy• To the maximal extent possible, preserve use of
SWFI 10 mL vials for nursing units only• Only use pharmacy bulk packages of SWFI in
pharmacy for drug reconstitution where appropriate
• Batch 2 mg alteplase vials and freeze syringes
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Current Issues in IV Injectable Safety: Continuing the Conversation
Sterile Water for Injection Bag Shortage
Graphic & photo: K Hansen, Illustration: Package Insert; B. Braun 2015.
Scenario: SWFI 1000 mL bags are completely unavailable. These are used routinely for sodium bicarbonate infusions. 2000 mL bags are available from two manufacturers, however they either do not have an injection port or the additive port is sealed by the manufacturer. How do we continue to provide sodium bicarbonate infusions to patients?
Compounding sodium bicarbonate infusions in 2000 mL SWFI bags using closed‐system transfer device (CSTD)
Photos & graphics: K. Hansen
Sodium Bicarbonate 300 mEq / 2000 mL Sterile Water for Injection
Strategy:Mitigating drug shortages may
require creative solutions using available tools
Closed‐System Transfer Device
Adapters
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Current Issues in IV Injectable Safety: Continuing the Conversation
Potassium Chloride Injection Shortage
Photos: K. Hansen
Potassium Chloride Injection Shortage
Photo: K. Hansen
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Current Issues in IV Injectable Safety: Continuing the Conversation
Potassium Chloride Injection Shortage
Photos: K. Hansen
Potassium Chloride Injection Shortage
Photos: K. Hansen
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Current Issues in IV Injectable Safety: Continuing the Conversation
Potassium Chloride Injection ShortagePharmacy Dispenses
~42 dispenses/day
~25 dispenses/day
Potassium Chloride Injection Shortage
Graphics: K. Hansen
Potassium Chloride
10mEq
10 mEq/50 mL
Premix
Potassium Chloride
30mEq
30 mEq/265 mL
Compounded Strategy:Compounded alternative that considers:• Ease of compounding• Frequency of compounding• Stability• Beyond‐use date• Pump settings• Clinical ordering• Preservation of stock• Minimization of fluid bag use• Turn‐around‐time
42 per day 14 per day
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Current Issues in IV Injectable Safety: Continuing the Conversation
Automated Compounder
Graphics and photo: K. Hansen
• Barcode verification• Volumetric pumping• Gravimetric verification• Batch mode
Sodium Phosphate Injection Shortage
Graphics: K. Hansen
Scenario: Sodium phosphate injection vials are completely unavailable and not expected to be in stock for months. Potassium phosphate is not a viable option for certain renal patients for phosphate replacement. How do we continue to provide intravenous phosphate to these patients?
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Current Issues in IV Injectable Safety: Continuing the Conversation
Sodium Phosphate Injection Shortage
Graphic: K. Hansen.https://www.nutritioncare.org/uploadedFiles/Documents/
Newsletter/Glycophos%20Dear%20Healthcare%20Professional%20letter%20Jan%202018.pdf
Sodium glycerophosphate• Phosphate: 1 mmol/mL• Sodium: 2 mmol/mL• Organic phosphate
MacKay M, et al. J Parenter Enteral Nutr 2015 Aug; 39(6):725‐8
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Modify TPN ordering process from salt (i.e. sodium chloride) to ion (i.e., Na, Cl)
• Use salt priority list to determine proper product dispensed
• Can modify priority list as shortages change
• If sodium phosphate is needed in TPN, only use as a manual add (don’t add to automated compounder) to prevent waste.
TPN Clinical Ordering
Salt priority1. Sodium Chloride2. Sodium Acetate3. Potassium Chloride4. Potassium Acetate5. Potassium Phosphate6. Calcium Gluconate7. Magnesium Sulfate8. Sodium Glycerophosphate9. Sodium Phosphate
Strategy:Sodium phosphate prioritized last so potassium phosphate and sodium glycerophosphate will be maximized before any sodium phosphate will be needed.
Spinal Bupivacaine Injection Shortage
Graphic: K. Hansen
Scenario: An anesthesiologist calls your office and states that the spinal trays no longer contain ‘heavy bupivacaine’ and a dose is needed for a ‘patient on the table’. Spinal bupivacaine is currently on national backorder and is completely unavailable. How do we continue to provide spinal medications for patients?
Bupivacaine 0.75% inDextrose 8.25%
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Current Issues in IV Injectable Safety: Continuing the Conversation
Memo, 2018; Hospira Inc. / Pfizer
Lesson:Know all sources of medication use/procurement throughout your practice setting
Spinal Anesthetics
Hadzic, A. Hadzic's Textbook of Regional Anesthesia and Acute Pain Management 2nd edition (2017) McGraw‐Hill Education
Onset(minutes)
Duration(minutes)
Commonly used:
Bupivacaine 0.75% 5 – 8 90 – 110
Lidocaine 5% 3 – 5 60 – 70
Less commonly used:
Tetracaine 0.5% 3 – 5 70 – 90
Mepivacaine 2% 2 – 4 140 – 160
Ropivacaine 0.75% 3 – 5 140 – 200
Levobupivacaine 0.5% 4 – 8 135 – 170
Chloroprocaine 3% 2 – 4 80 ‐ 120
Lesson:Understand and communicate key differences in alternative medications that are available
HyperbaricIso‐/ hypo‐baric
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Current Issues in IV Injectable Safety: Continuing the Conversation
Baricity
Uppal V, et al. Anesth Analg. Nov 2017. 125(5): 1627‐37.Graphics: K. Hansen
IsobaricSame density as CSF
Hypobaric Less dense than CSF
HyperbaricMore dense than CSF
Affects:• Diffusion pattern• Effectiveness• Spread (dermatome height
or block height)• Side‐effect profile of drug
“plain”
“heavy”
Baricity:The density of a substance in comparison with the density of human cerebrospinal fluid (CSF).
Distilled Water
• For planned cesarean delivery: a spinal anesthetic with hyperbaric bupivacaine 0.75% (1.6 – 2 mL) may be substituted with:
– Isobaric PF bupivacaine 0.5% at a dose between 2.5 – 2.6 mL (12 – 13 mg), if being administered with supplemental opioids. Higher doses of bupivacaine (up to 3 mL [15 mg]) may be required if supplemental opioids are not available.
• For epidural labor analgesia:– Ropivacaine may be used as an alternative to bupivacaine. Ropivacaine is 40% less
potent than bupivacaine.• If possible, request that all bupivacaine solutions be primarily made available
to OB anesthesia, and other divisions be mindful of shortage and use other local anesthetics whenever feasible.
URL: https://soap.org/2018‐bupivacaine‐shortage‐statement.pdf
Spinal Bupivacaine Injection ShortageSociety for Obstetric Anesthesia and Perinatology (SOAP) Advisory in Response to Shortages of Local Anesthetics in North America
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Current Issues in IV Injectable Safety: Continuing the Conversation
Drug Concentration Size Availability*
SpinalFormulationsBupivacaine / Dextrose
0.75%/8.25% 2 mL No
Lidocaine / Dextrose 5% /7.5% 2 mL NoPlainFormulations
Bupivacaine 0.25% 10 mL, 30 mL Yes0.5% 10 mL, 30 mL No
0.75% 10 mL Very LimitedRopivacaine 0.2% 10 mL, 20 mL Yes
0.5% 20 mL, 30 mL Yes0.75% 20 mL No
1% 10 mL, 20 mL YesLidocaine 1% 2 mL, 5 mL, 30
mLYes
2% 2 mL, 5 mL, 10 mL
Yes
Tetracaine 1% 2 mL YesChloroprocaine 1% 20 mL, 30 mL Very Limited
2% 20 mL, 30 mL Very Limited3% 20 mL No
Mepivacaine 1% 30 mL, 50 mL Yes1.5% 30 mL Yes2% 20 mL, 50 mL Yes
FormulationswithEpinephrineBupivacaine / Epinephrine
0.25% / 1:200K 10 mL, 30 mL No0.5% / 1:200K 10 mL, 30 mL No
Lidocaine / Epinephrine
1% / 1:100K 30 mL No1% / 1:200K 30 mL Yes
1.5% / 1:200K 5 mL Yes2% / 1:100K 10 mL Yes2% / 1:200K 10 mL, 20 mL Yes
Local Anesthetic Availability
… As of April 25 @ 10:32 AM EST
Lesson:Drug shortage availability may be extremely fluid; constant monitoring of availability and backorders is required
Single‐Dose (SDV) vs. Multiple‐Dose Vial (MDV)
Graphics: K.HansenHodgson PS, et al. Anesth Analg. 1999;88:797‐809.
Lesson:Avoid preservative containing injections in the central nervous system. Pay close attention to SDV vs. MDV when purchasing alternative products
Single‐doseSingle‐dose
Multiple‐doseMultiple‐dose
Neurotoxic preservatives:• Benzyl alcohol• Formaldehyde salts• Parabens• Phenol• Polyethylene glycol• Sodium sulfites
Administration of drugs containing preservatives (MDVs) has been linked to adverse effects when administered in the CNS.
Bupivacaine 0.5%
Bupivacaine 0.5%
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Current Issues in IV Injectable Safety: Continuing the Conversation
ISMP Reported Errors during opioid shortages:• IV HYDROmorphone prescribed at the intended dose for
morphine and administered, resulting in death of two patients• HYDROmorphone 0.5 mg IV was supposed to be substituted
for morphine 4 mg IV, but HYDROmorphone 4 mg IV was given in error
• Administered 4 mg of morphine IV believing the vial held 2 mg• Administered 8 mg of morphine IV instead of 2 mg; only 8 mg
syringes available from manufacturer• Misfilled an automated dispensing cabinet pocket for 2 mg
morphine vials with 10 mg morphine vials• Wrong dose of morphine administered after 4 mg/mL prefilled
syringes were replaced with 5 mg/mL vials; bar‐coding system overridden due to the emergent switch in strengths, which had not yet been entered into the bar‐coding system
ISMP Medication Safety Alert Sept. 2010
Injectable Opioid Shortages Result in Patient Harm
Lesson:1.) Don’t underestimate importance of communication, education, trainingwhen using alternative projects
2.) Don’t bypass safety steps during drug shortage mitigation
Sound‐Alike, Look‐Alike Drugs
Graphics: K. Hansen
Morphine5 mg/mL
Hydromorphone 2 mg/mL
Morphine10 mg/mL
Naloxone0.4 mg/mL
Morphine50 mg/mL
Morphine 25 mg/mL
1 mg/mL2 mg/mL4 mg/mL
Hydromorphone Syringe Cartridges
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Maximize use of oral therapy whenever possible• Non‐opioid pharmacologic alternatives• Nonpharmacologic alternatives• Reserve certain opioids for specific patient
populations (i.e., OR)• Use uniform opioid conversion tool across health
system ASHP. Injectable Opioid Shortage FAQ. 2018. Available at: https://www.ashp.org/Drug‐
Shortages/Shortage‐Resources/Injectable‐Opioid‐Shortages‐FAQ.
Injectable Opioids: Shortage Mitigation
• Determine which PCA/syringe sizes are compatible with your institution’s infusion pumps
• Research evidence‐based data to ensure appropriate stability, container, and storage conditions
• Take stock of what vial sizes and concentrations are available.
• Determine whether will prepare in batches or on demand• Consider plunger vs. plunger‐less PCA syringes and need
to stock appropriate materials
Compounding for Patient‐Controlled Analgesia (PCA)
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Current Issues in IV Injectable Safety: Continuing the Conversation
• For State‐licensed Hospital Pharmacies, consider:– USP <797> Pharmaceutical Compounding – Sterile Preparations– USP <1079> Good Storage and Distribution Practices for Drug Products– USP <1136> Packaging Unit‐of‐Use– USP <1178> Good Repackaging Practices– USP <1191> Stability Considerations in Dispensing Practice– FDA Guidance Document (final): Repackaging of certain Human Drug Products by Pharmacies and
Outsourcing Facilities• Current interpretation: treat sterile repackaging as current USP <797> defined
‘medium‐risk’ compounding when assigning a beyond‐use date. Ensure stability testing has been performed for the exact storage container with no adverse findings (i.e., leaching of materials or precipitation)
– Room temperature: 30 hours– Refrigerated: 9 days– Frozen: 45 days– Note: in the absence of appropriate sterility testing
USP <797> 2008.Loyd A, Int J Pharm Compd. 2013. 17(1): 54‐61
Repackaging Sterile Products
How to determine Beyond‐Use Date
Considerations: Chemical degradation Physical compatibility Sterility Permeability of packaging Storage container Storage conditions Compounding risk‐level
Note: ‘Spiking’ a compounded sterile preparation bag for administration is the last aseptic manipulation. Administration is not in scope of the current USP <797>. Need to consider other organizations’ best practices (i.e., Infusion Nurses Society (INS)).
U.S. Pharmacopeial Convention. Pharmaceutical Compounding – Sterile Preparations. USP31–NF26 2nd Supplement, 2008.
Note: the shortest time should always be used
A beyond‐use date (BUD) identifies the time after which a compounded product should not be administered.
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Current Issues in IV Injectable Safety: Continuing the Conversation
ISMP Guidelines; 2015. Available at: https://www.ismp.org/guidelines/iv‐push.
Adult IV Push MedicationsSafe Practice Guidelines1. Acquisition and distribution2. Aseptic technique3. Clinician preparation4. Labeling5. Clinician administration6. Drug information resources7. Competency assessment8. Error reporting
ISMP Guidelines for Safe Practice of Adult IV Push Medications
To the greatest extent possible, provide adult IV push medications in a ready‐to‐administer form
A. We have not added additional personnelB. Drug shortage coordinator or managerC. PharmacistsD. TechniciansE. Students/Interns
What additional personnel have you added due to drug shortages?
Audience Polling
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Current Issues in IV Injectable Safety: Continuing the Conversation
Help!• Pharmacy students/interns can be deployed to help
meet the increased workload due to drug shortages• At our institution, 3 pharmacy interns were added
to the sterile compounding team• They perform sterile compound batch preparation
of shortage drugs• Focus efforts on non‐time critical activities to
balance availability with school schedule (i.e., evenings, weekends)
• Trained in LEAN methodologies throughout organization to minimize waste, and maximize production
• Excellent experience for students
INTERNS WANTED
• Key Takeaway #1: An effective drug shortage management team requires interprofessional involvement with clearly defined active roles for all members.
• Key Takeaway #2: While drug shortage communication is important, implementing workflow streamlined changes/alternatives is most effective.
• Key Takeaway #3: Each drug shortage for injectable products is unique and requires careful analysis to ensure safe, effective, and reasonable alternative practices
Key Takeaways
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Current Issues in IV Injectable Safety: Continuing the Conversation
How To of Data Generation and Interpretation from Smart Infusion
Devices Richard A. Zink, M.B.A.
Managing Director, REMEDI OperationsRegenstrief Center for Healthcare Engineering
Purdue UniversityWest Lafayette, Indiana
• Discuss the importance of analyzing pump data• Identify types of infusion pump data• Illustrate examples of analyzing infusion pump
data• List recommended infusion pump analysis
reports
Section Objectives
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Current Issues in IV Injectable Safety: Continuing the Conversation
• 2 million large volume pumps (LVPs) delivering 300 million infusions / year
• 90% of hospital patients receive infusions• Error prone• NPSG.06.01.01, Association for the Advancement of
Medical Instrumentation (AAMI)/FDA Infusion Device Summit, and other calls to action
• Patient safetyAAMI. Go with the Flow Webinar. https://vimeo.com/283045057. (accessed October 23, 2018).
Hedlund N et al. J Infus Nurs. 2017; 40: 206‐14.
Why Look at Smart Pump Data?
• Alerts: Captured when programming the pump • Compliance: Leveraging Dose Error Reduction System (DERS)?• Alarms: Air‐in‐line, patient side occlusion, etc.• Infusion details: Actual doses and concentrations used• Drug libraries: Concentrations, limits, care areas, etc.• Pump status: Are all pumps up‐to‐date?• Adverse Drug Events (ADEs): Have we caused harm using a
smart pump?
ISMP. Medication Safety Alert! July 12, 2018 Vol 23. Issue 14.
Which Data to Analyze?
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Current Issues in IV Injectable Safety: Continuing the Conversation
A. Alert dataB. Compliance dataC. Drug library benchmarking dataD. Infusion details
Which type of smart infusion pump data is evaluated most frequently at your organization?
Audience Response Question
Data Sources and Analysis Tools
SystemDataSource
AnalysisTools
Pump vendorSigma Gateway (Baxter)DoseTrac (B. Braun)Knowledge Portal (BD)MedNet (ICU Medical)PharmGuard (Smiths Medical)
Electronic Health Record (EHR) Vendor ( w/ interoperability)
Custom reporting
Excel
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Current Issues in IV Injectable Safety: Continuing the Conversation
How to draw Archie
Step 1: Draw some circles. Step 2: Draw the rest.
Images used with permission from R. Zink
• Looks at the alert details• Used to reinforce use of smart pump features • Identifies unexpected practice at the pump• Workflow based off most popular report
Workflow 1: Identify Problematic Alerts
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Current Issues in IV Injectable Safety: Continuing the Conversation
Alert Data
• Times (the) Limit = Programmed valueLimit value
– Over the maximum limit > 1– Under the minimum limit < 1
• Example: Adult continuous dose fentaNYL– Drug library soft maximum = 250 mcg/h– Programmed value = 1000 mcg/h– Times Limit = 1000/250 = 4
“Times” Limit
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Current Issues in IV Injectable Safety: Continuing the Conversation
0
2341
1
2042
117
606
74
705
2.4
176
14.57.5
1 2 3 4 5
Insulin
Dose Units/hour
Patients
Upper Hard Limit Edits‐Insulin December n=5 patients
Initial Final
Insulin Analysis
Image courtesy of Pharmfusion Consulting. Used with permission.
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Current Issues in IV Injectable Safety: Continuing the Conversation
Example reports and Analysis2341
1
2341
1
0 4000 8000 12000 16000 20000
• Good catch: programmed value is more/less than X times the library limit and the resulting clinician response is to REPROGRAM
• Missed catch: programmed value is more/less than X times the library limit and the resulting clinician response is to OVERRIDE
• Other: Most often CANCEL
Good Catch / Missed Catch
790
1
2 200 400 600 800 1000 1200 1400ABOVE LIMIT
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Focus on highest (lowest) Times Limit alerts• Drugs – high alert medication (HAM) list and
reduce alert fatigue• Date/time ‐ Same patient and shift effects• Cancels – Exited the DERS to give the infusion?• Look at both over and under dosing “catches”
Examining the Alert Data Summary
A. The maximum duration of the infusionB. The ratio of the programmed pump value to the limit
defined in the smart pump drug libraryC. A hard limit defined in the smart pump drug library
In infusion pump data analysis, “times limit” refers to?
Outcome Question
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Current Issues in IV Injectable Safety: Continuing the Conversation
Used to reinforce use of smart pump features and identify areas for improvement
Compliance* = # of infusions using DERS# of infusions
*As reported by the vendor
Workflow 2: Improving Compliance
View Compliance Trend
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
90%
85%
80%
75%
70%
65%
Com
plia
nce
Rate (%
)
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Current Issues in IV Injectable Safety: Continuing the Conversation
View by Facility / Care Area
66%67%71%76%81%86%93%
59% AVG 70% AVG 74% AVG 74% AVG
75% AVG 81% AVG 83% AVG 84% AVG
100
50
0
100
50
0
Hospital Average
View by Care Area100
50
078% AVG
64%67%67%71%
Hospital Average
75%82%100%
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Current Issues in IV Injectable Safety: Continuing the Conversation
View Volumes by Care AreaPROFILE TREND LAST MONTHNumber of Infusions
DERS Compliant Total
Monitor the Change
100%
95%
90%
85%
80%
75%
70%Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct
Com
plia
nce
Rate (%
)
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Used to address alert fatigue• Good place to start alert analysis• Initial focus on highest alerting drugs, then
specific medications (e.g. HAM list, chemo drugs, highest alerting in ICU, etc.)
Workflow 3: Reducing Alerts
View Alert Trend and Top 10
2.99k
2.79k
576
567
445
396
250
191
189
159
3.0k
2.5k
2.0k
1.5k
1.0k
0.5k
0
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Current Issues in IV Injectable Safety: Continuing the Conversation
View Alert Trend by Care Area3.0k
2.5k
2.0k
1.5k
1.0k
0.5k
0
50%
12%
38%
Examine the Trend
43%
20%
16%
15%
92%90%77%
17%
99%
10.41k120
8.01k1.80k
470753618
111
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Current Issues in IV Injectable Safety: Continuing the Conversation
Take a Deeper Look900
800
700
600
500
400
300
200
100
0
98%
2.72k66
Monitor the Change900
800
700
600
500
400
300
200
100
0
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Current Issues in IV Injectable Safety: Continuing the Conversation
Suggested Reports
1. Alert details2. Compliance trend 3. Compliance by profile4. Compliance by volume5. Alert trend
• All reports shown in prior examples• See supplement for additional examples of suggested reports• In order of most frequently used*
*Data courtesy of the REMEDI infusion pump collaborative
6. Top 10 alerts7. Alerts by profile8. Alerts by infusion type9. Alerts by action taken10. Alerts by type
Report Usage
Data courtesy of the REMEDI infusion pump collaborative. Used with permission.
Category ReportFrequency
Notes
Alerts 67% Top 2 alert reports;‐ Alert details (40%)‐ Alert trend + Top 10 (28%)
Compliance 18% All reports ‐ graphs & tables
Drug library benchmarking
15% Comparison & analysis of concentrations, limits, etc.
100%
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Align pump library design to practice at the pump
• Examine your smart pump data monthly• Focus initial analysis on outliers, drugs/fluids
with high volume of alerts and compliance data• Drill down into the data for better understanding
Key Takeaways
Using Smart Infusion Device Data to Facilitate Clinical Practice Changes
Todd A. Walroth, Pharm.D., BCPS, BCCCP
Pharmacy Manager – Clinical ServicesClinical Pharmacy Specialist – Burn/Critical Care
Eskenazi HealthIndianapolis, Indiana
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Illustrate how to generate and interpret the continuous data provided by smart infusion devices.
• Demonstrate how data generated from smart infusion devices can be used to drive clinical practice changes.
Objectives (Re‐visited)
• Drug Error Reduction Software (DERS)• Drug library limits (min/max)
– Dose– Rate– Duration– Concentration– Patient weight
• Hard limit cannot override• Soft limit able to override• Alerts• Alarms
Shah PK. Pharmacotherapy. 2018;38:842‐50.
Smart Pump “Lingo”
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Searched PubMed, Scopus, and CINAHL for peer‐reviewed literature on managing smart pump alerts, alarms, and related fatigue
• 29 articles met inclusion criteria (1/1/04 – 8/31/17)• Two main categories of alerts:
– Mechanical alarms (occur more frequently)– Clinical alerts (several causes are actionable)
• Proposed strategies: – Development of interdisciplinary teams to oversee continuous quality
improvement (CQI) involving end users– Standardization of medication administration practices– Widening of drug limits when clinically appropriate– Maintaining up‐to‐date drug limit libraries– Interoperability
Shah PK. Pharmacotherapy. 2018;38:842‐50.
Strategies for Managing Smart Pump Alarm & Alert Fatigue
Continuous Quality Improvement Using Data Analysis
Breland BD. Am J Health‐Syst Pharm. 2010;67:1446‐55.
ObjectiveDescribe the use of CQI process in the implementation of smart pumps in a community teaching hospital
Summary
• 413‐bed, community teaching hospital• Post‐implementation CQI allowed refinement of clinically important safety limits• Minimization of inappropriate, meaningless soft limit alerts on select agents• Assigning individual clinical profiles to specific patient care areas allowed
customization of libraries and identification of specific compliance concerns• Seven library updates over the first 12 months• Compliance with safety software improved from 33% to 98% over a 3‐year period• 4‐6% of soft limit alerts prompted edits to drug library limits
Conclusion• Compliance rates improved over time• Education, auditing, and refinement of drug libraries led to improved compliance in
most clinical profiles
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Current Issues in IV Injectable Safety: Continuing the Conversation
Quality‐Improvement Analytics & Metrics
Skledar SJ. Am J Health‐Syst Pharm. 2013;70:680‐6.
ObjectiveDescribe implementation of a smart pump CQI program across a large health‐system, with an emphasis on key metrics for outcomes analysis and program refinement
Summary
• 6000 pumps across 14 inpatient facilities • Centralized team responsible for retrieval and interpretation of smart pump data • Metrics:
• Compliance with programmed limits• Top 20 Drugs involved in alerts• Drugs with alert‐override rates > 90%• Alerts by infusion type• Nurse response to alerts• Alert rate per drug library update• Four system‐wide updates over 18 months
Conclusion
• Reduction in “nuisance alerts” by about 10%• Targeted interventions to reduce adverse drug events (ADEs), rapid‐infusion errors,
and workarounds• Nurses reprogrammed or canceled infusion average of 400 times/month• Smart pump CQI program effective tool for enhancing IV medication safety
• Total number of alerts or alarms• Number of clinically irrelevant alerts• Alerts overridden• Low drug library limits compliance• Nurse perceptions through survey• Time to override• Workarounds
Shah PK. Pharmacotherapy. 2018;38:842‐50.
Additional Metrics for Smart Pump Alert and Alarm Fatigue
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Minimum
• Maximum
• Standard concentrations
• Wildcards
• Adults vs. Pediatrics
Types of Clinical Alerts
• Deviation from standards
• Bolus doses
• Concentration limits
• Soft min
• Soft max
• Hard max
Dosing Duration
Rate Concentration
General Problem Solving
Question Example
Correct profile? Med/Surg vs. ICUCorrect medication name? Piperacillin vs. piperacillin/tazobactam
Intermittent vs. continuous dosing? Nafcillin, cefepime, etc.Bolus vs. continuous dosing? Pantoprazole
Correct therapy? Argatroban, alteplase, etc.Correct weight? Kg vs. lbs
Correct dosing units? Gram vs. mg
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Current Issues in IV Injectable Safety: Continuing the Conversation
ICPS Smart Pump Alert Fatigue Workgroup
TJC NPSG 06.01.01: “Improve the safety of clinical alarm systems”
Dulling effect causes end users to ignore potential safety issues
False Alert = “Clinically Insignificant Alert”
Alert Fatigue
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900. Joint Commission. https://www.jointcommission.org/assets/1/6/2018_HAP_NPSG_goals_final.pdf (accessed 2018 Nov 9).
GOAL: Shared vision and challenge of making Indianapolis the safest city for healthcare
Used with permission from ICPS (J. Fuller).
Indianapolis Coalition for Patient Safety, Inc. (ICPS)
Community Health Network
Eskenazi HealthFranciscan Health
Indianapolis
Indiana University Health
Richard L. RoudebushVA Medical Center
St. Vincent
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Current Issues in IV Injectable Safety: Continuing the Conversation
• 315 bed academic medical center• Safety‐net health system in Indianapolis, IN• Level I Trauma Center (>100,000 ED visits/year)• 21,680 inpatient admissions• 217,924 Primary Care visits• 100,644 Specialty Care visits• 603,340 Mental Health visits
Image used with permission from Eskenazi Health
Eskenazi Health
ProblemVariability within and lack of consistent process for managing smart pump drug libraries across institutions
GoalTo minimize the number of clinically insignificant alerts presented to end users through development of a Consensus Statement
Methods• Interdisciplinary group (i.e., pharmacists, nurses, engineers)• Lean/Six Sigma methodologies to achieve process standardization• Prioritized current state needs and barriers
Results
• ICPS Consensus Statement• Crosswalk of terminology between manufacturers• Clinical Advisories guidelines• Policy template• Culture of shared learning
ICPS Smart Pump Workgroup
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
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Current Issues in IV Injectable Safety: Continuing the Conversation
Targets for Optimization
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Drug Limits & Libraries
Types of Alerts
PoliciesSafety Items
Learning Activity: Think/Pair/Share
• Consider current state practices at your institution for reviewing alerts and managing drug libraries
• Collaborate with a partner• Share processes for
reviewing each of these targeted areas
• Discuss gaps and areas for improvement
Drug Limits & Libraries
Types of Alerts
PoliciesSafety Items
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Standardized, city‐wide process for managing smart pump drug libraries
• Clinical advisories • Visual cue project/data set updates• Overfill/flush bag project • Top ten lists• Pump integration subgroup • Interoperability metrics and reports
ICPS Smart Pump Safety Workgroup
• Identify best practices to establish specific, actionable safety items related to smart pump drug library optimization
Project Objective
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Current Issues in IV Injectable Safety: Continuing the Conversation
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
• Multi‐site project
• Interdisciplinary approach
• All six ICPS health‐systems represented
• June 15, 2018
ICPS Final Consensus Statement – Drug Dosing Libraries Review Process
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Individuals Involved
Timeline/Schedule
Content for Review
Approval Process
Communication & Education
Follow‐up
1.
2.
3.
4.
5.
6.
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Current Issues in IV Injectable Safety: Continuing the Conversation
Recommendation 1: Individuals involved in the review process
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Pharmacy NursingMedication
Safety
Recommendation 2: Timeline/schedule for review
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
• All profiles reviewed at least once per yearAnnuallyAnnually• Individual/grouped profiles facility‐specific• Not every profile reviewed each quarterQuarterlyQuarterly• Additional reviews as needed• Follow‐up on medication incidents, etc.MonthlyMonthly
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•• Top Ten Drugs• Formulary updates
• Bedside audits• Compliance with dosing limits
• Compliance per profile
At aminimum
Recommendation 3:Content for review
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
••Good‐catches•Patient outliers•ISMP Action Alerts
•Medication errors
When available
Recommendation 4: Approval process for recommended changes
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Interdisciplinary Committee Approval
Medication SafetyPatient Safety
Smart Pump Committee
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Current Issues in IV Injectable Safety: Continuing the Conversation
Safety Huddle
One Page Sheet
Audits EMS
Supply ChainEmails
CPOE Alerts
Central Supply
Pump Safety Day
BioMed
Morning ReportFacilities
Recommendation 5: Communication & Education
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Safety Huddle
One Page Sheet
Audits EMS
Supply ChainEmails
CPOE Alerts
Central Supply
Pump Safety Day
BioMed
Morning ReportFacilities
Recommendation 5: Communication & Education
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
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Current Issues in IV Injectable Safety: Continuing the Conversation
Safety Huddle
One Page Sheet
Audits EMS
Supply ChainEmails
CPOE Alerts
Central Supply
Pump Safety Day
BioMed
Morning ReportFacilities
Recommendation 5: Communication & Education
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Recommendation 6: Follow‐up and continued review
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
Previous Top Ten Drugs
Changes from previous quarter
Assess for improvements
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Current Issues in IV Injectable Safety: Continuing the Conversation
Alert Review: Lorazepam
Override (n = 203)Reprogram (n = 14)Cancel (n = 7)Other (n = 8)
Alert Review: Lorazepam
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Current Issues in IV Injectable Safety: Continuing the Conversation
Total Lorazepam Alerts (Critical Care/Emergency Department)
232
60
50
100
150
200
250
3Q2011 1Q2012
Zero alerts remaining after two revisions
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
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Current Issues in IV Injectable Safety: Continuing the Conversation
50% decrease in alerts per device per month over 5 years
7.2
3.6
Walroth TA. Am J Health Syst Pharm. 2018;75:893‐900.
• Standardized, city‐wide process for managing smart pump drug libraries
• Clinical advisories • Visual cue project/data set updates• Overfill/flush bag project • Top ten lists• Pump integration subgroup • Interoperability metrics and reports
ICPS Smart Pump Safety Workgroup
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Current Issues in IV Injectable Safety: Continuing the Conversation
CLINICAL ADVISORIES
Rules for Creating Advisories1. Operations focused (not clinically focused)2. Descriptive – make sure it includes quantitative or objective values (actual cutoffs,
values, etc.) not open for interpretation3. Must be actionable at the time of programming the pump, or focus on special
techniques4. Contain a specific strategy to alert a different user (volume to be infused for
amiodarone)5. In general, monitoring, vitals, etc. should be general knowledge for the drug and
should not be included as an advisory6. Remove any lab related alerts7. Error prevention, ISMP recommendations, or response to multiple drug
errors/sentinel event reviews may warrant a specific advisory8. If independent nursing double‐check required, indicate that upon programming9. Any new advisories should be approved through Med Safety, Smart Pump
Committee, or equivalent
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VISUAL CUE PROJECT/DATA SET UPDATES
Drug Library Wireless Update Delays
DeLaurentis P. Am J Health Syst Pharm. 2018;75:1140‐4.
PurposeTo estimate the prevalence and severity of delays in wireless updates of smart pump drug libraries across a large group of US hospitals
Methods
• Retrospective study using REMEDI database• 49 hospitals, 12 health‐systems, across 5 states• Update delay defined as interval from time of drug library versions
replaced to time of last infusion alert triggered by previous version during the study
Results• 11 of 12 health‐systems were found to have drug library update delays• Update delay medians ranged from 22 to 192 days • Overall delay min and max durations were 0 and 661 days
ConclusionSubstantial delays in completion of wireless updates of smart pump drug libraries were common across a large group of hospitals over various sizes
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• Two‐phase study:– End user perceptions– Implementing visual cues for pump updates
• Project Partners:– ICPS – RCHE/Purdue University – Eskenazi Health
Visual Cues Project
Preliminary Data
Used with permission from P. DeLaurentis.
Study Unit shows ~30%
higher update rate
than Control Unit
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Current Issues in IV Injectable Safety: Continuing the Conversation
FLUSH BAG PROJECT
• Goal to minimize amount of drug remaining in the bag at the end of the infusion due to: – Manufacturer overfill– Pharmacy overfill/drug additives
• Developed standardized approach to addressing the infusion of intermittent IV medications in adults– ICPS Consensus Statement for Flushing Intermittent IV Medications – Policy template– Standardized education/competencies
• ↓ workarounds required = ↓ clinically insignificant alerts
Flush Bag Project
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Current Issues in IV Injectable Safety: Continuing the Conversation
Protocol Recommendations
• Ordering instructions• Size of bag• Product• Administration• Volume to be infused• Rate of infusion• Out of scope meds
Used with permission from ICPS (J. Fuller).
• Standardized, city‐wide process for managing smart pump drug libraries
• Clinical advisories • Visual cue project/data set updates• Overfill/flush bag project • Top ten lists• Pump integration subgroup • Interoperability metrics and reports
ICPS Smart Pump Safety Workgroup
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Current Issues in IV Injectable Safety: Continuing the Conversation
TOP TEN LISTS
NS‐normal saline
• One site reviewed workflow, drug library limits, screen shots of electronic health record (EHR), and alerts fired
• Group discussion, comments, and questions• Focus points for follow‐up:
– Workflow– Bolus doses– Therapies
Deeper Dive Into Insulin
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Current Issues in IV Injectable Safety: Continuing the Conversation
• When (and why) in practice do you allow insulin bolus doses for patients (excluding hyperkalemia)?
• How are insulin bolus doses ordered (e.g., within an order set, part of a protocol, one time doses when needed)?
• Does every site have a bolus option built in the pump? If so, how much?
• Is this limited to certain therapies and/or areas? • Are nurses bolus dosing from the bag/pump? • Are nurses using 999 mL/hr to bolus insulin?• Do you have a hard max for your insulin infusion rates?
Insulin Follow‐up Questions
• BB/CCB order set recommend including bolus doses• All other current state bolus dose orders are one time orders
(no bolus option in the Hyperglycemia or DKA order sets)• Change bolus admin rate soft min to 1 unit/min and soft max
to 20 unit/min• Consider having a hard max on bolus doses• Recommend therapies for high dose insulin usage (i.e., BB/CCB
overdose) • Add hard max infusion rate for Toxicology therapies
BB‐beta blocker; CCB‐calcium channel blocker
Insulin Recommendations
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Most alerts are primary intermittent duration• Well known issue (overfill/volume in bag)• No changes needed in general at this time• Recommended to review ICPS IV Flush Bag
Protocol
Deeper Dive into Vancomycin
Upcoming Reviews of Top Ten Drugs
• Oxytocin• Heparin• Rituximab• Propofol• Potassium• Piperacillin/
tazobactam
NS‐normal saline
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Standardized, city‐wide process for managing smart pump drug libraries
• Clinical advisories • Visual cue project/data set updates• Overfill/flush bag project • Top ten lists• Pump integration subgroup • Interoperability metrics and reports
ICPS Smart Pump Safety Workgroup
• Four ICPS health‐systems represented• Pump integration projects – sharing & brainstorming• Alert standardization• Gap analysis of reporting:
– EHR– Vendors – Online database
• Crosswalk of appropriate reports based on need and discipline• Goal is to identify standard metrics and associated benchmarks
Pump Integration & Interoperability
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Implementing and optimizing interoperability • Standardized approach to managing occlusion and air‐in‐
line alarms• Evaluation of specific, replicable alert and alarm reduction
strategies • Aligning and leveraging reports (EHR vs. vendors vs. online
databases)• Greater emphasis on benchmarking quantitative metrics
Future Directions
• Key Takeaway #1– A standardized, consensus‐driven process should be used for smart
pump drug library data review and optimization • Key Takeaway #2
– The ICPS approach can help other health‐systems to reduce the number of clinically insignificant alerts presented to end users
• Key Takeaway #3– Interdisciplinary idea‐sharing can yield additional projects aimed at
reducing alert fatigue and opportunities to leverage smart pump data
Key Takeaways
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Current Issues in IV Injectable Safety: Continuing the Conversation
• Implement a standardized process for drug library data review and optimization
• Use an interdisciplinary approach to reviewing smart pump data• Review Top Ten Drug lists on a regular basis to identify
opportunities for improvement• Consider addressing additional projects that can result in
decreased smart pump alerts (e.g., PCA, wireless drug library updates lag times, flush bag/overfill standardization, interoperability, identifying and reporting key metrics, etc.)
Which of these practice changes will you consider making?
Audience Reflection
ASHP CE Processing Deadline: January 31 elearning.ashp.org Code: ____________ Complete evaluation Additional instructions in
handout
• Archive of today’s symposium will be released March 2018
Thank You for Joining Us
www.ashpadvantagemedia.com/ivsafety
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Current Issues in IV Injectable Safety: Continuing the Conversation
Top 10 Reports Used in Smart Pump Data Analysis
Presented as a supplement to the ASHP Advantage Pre-Meeting Symposium, Current Issues in I.V. Injectable Safety: Continuing the Conversation, Sunday, December 2, 2018.
Rich Zink, MBA Managing Director, REMEDI Operations
Regenstrief Center for Healthcare Engineering Purdue University
West Lafayette, Indiana This document contains sample reports used in the analysis of smart infusion pump data. These reports are limited to alert data (warnings generated while the clinician is programming the pump) and compliance data (measurement of the frequency of use of smart pump features). Reports and analyses of other smart infusion pump data (e.g., operational alarms, pump update status, variation in concentrations and doses, etc.) are out of scope for this document.
Current Issues in Injectable Safety: Continuing the Conversation
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Report title: Alert Details
Critical question answered: What are the details for each alert?
Suggested attributes: Drug, Profile, Therapy, Dataset, Facility, Hard/Soft, Type, Above/Below Limit, Drug Limit, Programmed Value, Amount Exceeded, Units,% Exceeded, Times Limit, Field Limit Type, Date, Device ID, Action Taken, Drug Amount, Diluent Vol, Concentration, Infusion Rate, Volume to be infused (VTBI), Infusion Duration.
Comment(s):
• If desired, export from vendor software to Excel and leverage pivot tables
• Sorting by Times Limit is often helpful
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Compliance Trend
Critical question answered: How well are we using our smart infusion pump features?
Suggested attribute: Compliance percentage (as defined by the vendor)
Comment(s):
• Line graphs or histograms make it easier to detect trends
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Compliance by Profile
Critical question answered: What percentage of infusions use the smart pump features and what percentage do not use the features (often called BASIC)?
Suggested attributes: Compliance percentage (as defined by the vendor)
Comment(s):
• Blue bar indicates infusion percentage using smart pump features
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Compliance by Number of Infusions
Critical question answered: Number of compliant and non-compliant (BASIC) infusions delivered by unit.
Suggested attributes: Compliance percentage (as defined by the vendor)
Comment(s):
• Compliments percentage by profile reports
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Alert trends (by month)
Critical question answered by the report: What is the total volume of alerts and how are they trending?
Comment(s):
• Line graphs or histograms make it easier to detect trends
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Top 10 Alerts
Critical question answered: Which drugs or fluids get the most alerts?
Suggested attributes: Number of alerts by drug
Comment(s):
• The top 10 list provides a list of candidate drugs or fluids for addressing alertfatigue
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Alerts by Profile
Critical question answered: What is the profile breakdown of all alerts by month?
Suggested attributes: Number of alerts by profile
Comment(s):
• Line graphs or histograms make it easier to detect trends
• Identifies which care areas have more issues with alerts
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Alerts by Infusion Type
Critical question answered: Which methods of infusing medications are generating the most alerts?
Suggested attributes: Number of alerts by infusion type
Comment(s):
• Vendor terminology differs in naming the infusion types
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Alerts by Type
Critical question answered: What type of alerts are generated when programming the pump?
Suggested attributes: Number of alerts by type
Comment(s):
• Different vendors have different types of programming alerts
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Report title: Alerts by Action Taken
Critical question answered: How do clinicians respond to alerts?
Suggested attributes: Number of alerts
Comment(s):
• Can be run on all drugs, high alert medications, or selected drugs
Example report(s):
Current Issues in IV Injectable Safety: Continuing the Conversatin
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Claiming CE Credit 1. Log in to the ASHP eLearning Portal at elearning.ashp.org with the
email address and password that you used when registering for the Midyear.The system validates your meeting registration to grant you access to claim credit.
2. Click on Process CE for the Midyear Clinical Meeting and Exhibition.3. Enter the Attendance Codes that were announced during the sessions and click Submit.4. Click Claim for any session.5. Complete the Evaluation.6. Once all requirements are complete, click Claim Credit for the appropriate profession.
Pharmacists and Pharmacy Technicians: Be prepared to provide your NABP eProfile ID, birthmonth and date (required in order for ASHP to submit your credits to CPE Monitor).Others (International, students, etc.). Select ASHP Statement of Completion.
All continuing pharmacy education credits must be claimed within 60 days of the live session you attend. To be sure your CE is accepted inside of ACPE's 60-day
window, plan to process your CE before January 31, 2019.
Exhibitors Exhibitors should complete the steps below first. If you encounter any issues with the process, please stop by the Meeting Info Desk onsite or email [email protected].
1. Log in to www.ashp.org/ExhibitorCE with your ASHP username and password.2. Click on the Get Started button.3. Select the 2018 Midyear Clinical Meeting and Exhibition from the dropdown menu.4. Select your Exhibiting Company from the list of exhibitors. Your screen will change and you will
then be logged into the ASHP eLearning Portal.5. Follow the instructions in the section above this, starting with Step Two.
Questions? Contact [email protected]!
About the Faculty
www.ashpadvantagemedia.com/ivsafety
Accreditation
The American Society of Health-System Pharmacists (ASHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
n ACPE #0204-0000-18-445-L05-P
n 3.0 contact hours I Application-based
n Qualifies for Patient Safety CE
Kevin Hansen, Pharm.D., M.S., BCPS, Activity ChairAssistant Director of Pharmacy Sterile Products, Special Formulations, Perioperative ServicesMoses H. Cone Memorial Hospital Greensboro, North Carolina
View full faculty bios at
Richard J. Zink, MBAManaging Director, REMEDI Operations Purdue University West Lafayette, Indiana
Erin Fox, Pharm.D., BCPS, FASHPSenior Director, Drug Information Service University of Utah Health Salt Lake City, Utah
Todd Walroth, Pharm.D., BCPS, BCCCPPharmacy Manager, Clinical ServicesClinical Pharmacy Specialist Burn/Critical Care, Eskenazi Health Indianapolis, Indiana