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1 An Interdisciplinary Solution to the Drug Shortage Problem Kelli Kirkpatrick, PharmD – Mission Health, Asheville, NC Susan Mims, M.D. – Mission Health,

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Presentation on theme: "1 An Interdisciplinary Solution to the Drug Shortage Problem Kelli Kirkpatrick, PharmD – Mission Health, Asheville, NC Susan Mims, M.D. – Mission Health,"— Presentation transcript:

1 1 An Interdisciplinary Solution to the Drug Shortage Problem Kelli Kirkpatrick, PharmD – Mission Health, Asheville, NC Susan Mims, M.D. – Mission Health, Asheville, NC

2 Got Drugs? A Trans-disciplinary Model to Medication Shortages Susan Mims, MD, MPH Kelli Kirkpatrick, PharmD

3 Objectives Describe multi-disciplinary process of drug shortage management Provide resources to facilitate effective management and communication across many disciplines Share current challenges related to drug shortage manageme nt Provide updated information on advocacy efforts and opportunities

4 Mission Hospital: Who We Are Located in Asheville, NC Regional referral center for Western NC Service area population: 850,000 805 acute care beds Level II Trauma Center Surgeries/year: 40,000 Discharges/year: 40,000 Annual ED visits: 105,000 700 physicians on staff Cerner EMR Childrens Hospital 130 beds

5 Drug Shortages at Mission Hospital Volume of shortages Currently monitoring over 200 backordered medications Types of medications Sterile injectables with wide range of clinical applications Life-saving medications Complexity of shortage characteristics Classes of drugs vs one drug Extended duration of shortage Limited alternatives in some cases Need for alternative supplies increased

6 Newly Reported Medication Shortages in US Source: Fox E, Wheeler M. Drug Shortages in the US: Causes and What the FDA is Doing to Prevent New Shortages. http://www.medscape.com/viewarticle/780328_2. AccessMedicine from McGraw-Hill 2013 Data collected by the University of Utah Drug Information Service.

7 Active Medication Shortages in US Source: Source: Fox E, Wheeler M. Drug Shortages in the US: Causes and What the FDA is Doing to Prevent New Shortages. http://www.medscape.com/viewarticle/780328_2. AccessMedicine from McGraw- Hill 2013 Data collected by the University of Utah Drug Information Service

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9 Consequences Impacts on safety and quality of patient care –Increased risk of medication errors –Alternative treatment options may not be optimal Significant time shift for staff Increased cost Inventory -Capital -Regulatory -Overtime

10 What is the Impact? University of Michigan Health System – 2010 survey Directors of Pharmacy in U.S. Pharmacy, physician, and nursing input – Evaluated Impact of recent drug shortages Resource utilization to manage shortages – 253 responses (27% response rate) – 64% (n=192) community hospitals Source: Kaakeh R, Sweet BV, Reilly C et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm 2011;68:1811-9.

11 What is the impact? Time Spent Managing Drug Shortages Median (Interquartile Range) Annual Labor Cost 400 bed hospital Median (Interquartile Range) Pharmacist9 (5-20)32,629 (21,753-77,494) Pharmacy Technician 8 (3-17)9,153 (4,225-14,786) Physician0.5 (0-2)4,741 (0-18,965) Nurse0 (0-2)1,697 (0-7,635) Total17.548,220 (25,977-118,880) Source: Kaakeh R, Sweet BV, Reilly C et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm 2011;68:1811-9. Total U.S. Labor Cost $216 million annually

12 What is the impact? Patient Safety – 2010 ISMP National Survey – 1800 responses 35% - near miss occurred within last year 25% - medication errors occurred within last year 20% - adverse patient outcomes within last year Source: Institute for Safe Medication Practices. Drug shortages: national survey reveals high level of frustration, low levels of safety. ISMP Med Saf Alert. 2010;15 (19):1-4. http://www.ismp.org/Newsletters/acutecare/articles/20100923.asp. Accessed March 11, 2013. http://www.ismp.org/Newsletters/acutecare/articles/20100923.asp. Accessed March 11

13 What is the Impact? Quality of Care – 2011 American Hospital Association Survey – 820 hospital responses 82% hospitals reported delayed patient treatment 75% hospitals reports rationing or implementing restrictions for use Source: American Hospital Association. AHA Survey on Drug Shortages. July 12, 2011. http://www.aha.org/content/11/drugshortagesurvey.pdf. Accessed March 8, 2013. http://www.aha.org/content/11/drugshortagesurvey.pdf. Accessed March 8

14 What is the impact? December 2012 October 2012 Source: N Engl J Med 2012;267;26.; Pediatrics 2012;130;e1369;

15 Factors Affecting Drug Shortages FactorDetails Regulatory/Legislative Lack of FDA authority Time to approval of submitted drug applications Increase in FDA inspections/citations Raw Material Supplies Some sole source active product ingredient (API) Manufacturing Processes Good Manufacturing Practice requirements/changes Inability to quickly adjust production volumes Voluntary upgrades in production processes Business Market Factors Firm consolidations Product profitability Distribution Factors Just-in-Time inventories Senate Finance Committee Hearing on Drug Shortages:Why They Happen and What They Mean.Statement for the Record. American Society of Health System Pharmacists. December 7, 2011

16 What, No Vitamin K? Feb, 13 th -- <1 week supply Communicated to Childrens Service line Pulled together team –Physicians –Pharmacists –Nurses –Educators –IT

17 Points for Consideration Stock management Therapeutic Evaluation Criteria for use Alternative therapy CPOE build/changes Education/Communication Internal Community

18 Drug Shortage Quality Team Purpose: Establish a proactive approach to drug shortage management and communication Trans-disciplinary Steering Committee –Administration –Physician Leadership –Pharmacist –Nursing –Performance Improvement –Information Technology

19 Requirements for Effective Management Drug Shortage Management Trans- disciplinary process Real-time Inventory Tracking Efficient use of available drug Ethical allocation of supplies Point of Care Communication Patient and Family Education State/Local Advocacy

20 Drug Shortage Sub-Teams Internal Logistics Physician Education Nurse Education Patient Education Clinical Decision Making and Ethics External Logistics

21 Systematic Communication Plan Drug Shortage List Color Identifiers: Red – None in Stock Orange – Less than 3 Day Supply Yellow – 3 to 7 Day Supply Purple – Chemotherapeutic agents in short supply Blue – More than 7 Day Supply, but of great concern Established color scheme to define Shortage Severity Estimated days supply based on historical usage Actions for each color to establish consistency

22 Systematic Communication Plan Hospital Intranet Updated Daily

23 Color Based Actions Blue (> 7 days supply, but of great concern) Add to Drug Shortage List and begin tracking inventory Remove supplies from low use ADCs (no use in 30 days) Initiate evidence-based literature assessment Drug specific team –Members identified by: Indications for use Electronic ordersets Utilization data (ADCs) Literature evaluated and summarized ADCs - Automated dispensing cabinets

24 Ethical Decision Making Process Alternative acquisition sources Substitute Meds Level of evidence for indications Use in PowerPlans Usage Reports Reimplementation Medication shortage Identified Designated Pharmacist: Researches using template Rapid Decision Team: Review & recommend distribution strategy Service Line Leaders: Review & provide feedback Implement Policy Pharmacist Physician Nurse Specialist MD Consultants

25 Systematic Communication Plan Point of Care Notification Catalog Display Used for drugs with 7 days supply or less (Yellow, Orange, Red) Physician Alerts Programmed in CPOE Primary goal – physician information at point of order –Yellow – alternative therapies –Orange – established criteria for use of shorted medication –Red – supply exhausted

26 Color Based Actions Yellow (3-7 day supply) ADC stock adjustments 5 to 7 day supply - assure 2-3 day pars in ADCs 3 to 5 day supply - unload from al l ADCs except top users High Alert order catalog display Physician alert Suggested alternative therapies (use optional) Consider addition of alternative therapies to ADCs ADCs - Automated dispensing cabinets

27 Color Based Actions Orange (less than 3 day supply) Centralize supplies/unload from ADCs Optimize availability of alternative therapies in ADCs Physician alert with criteria form Use restricted to patient- specific criteria Use of alternative therapy required if criteria not met ADCs - Automated dispensing cabinets

28 Color Based Actions Red (no supply) Physician alert Suggested alternative therapies (use required)

29 Appeals Process Final Decision: Apply Policy (original or revised) Yes Provider reviews policy Pharmacist: Explain rationale for policy P&T Chair: Review & rule on case P&T Chair: Review & rule on case Medication Shortage Ethics Committee: Review & rule on case Ok with decision? Apply Policy Apply Policy (original or revised) No Yes No

30 Med Shortage Ethics Committee Chief of Staff designee Physician Pharmacy and Therapeutics Member Nurse Pharmacist Ethicist Community Member Risk Management Administrative representative Board Member

31 Electronic Documentation

32 Inventory Management Proactive tracking system Electronic tracking database Supply Chain Pharmacist Minimize waste Unit dose preparation Manual draws (pharmacy tech) RIVA robot

33 Challenges Resources –Team Creation –Literature assessment –Point of Care Communications –Manual preparation of unit dose Timing of specific drug team creation Communication Patient/family education process

34 The Food and Drug Administration Safety and Innovation Act July 9, 2012

35 Merits of the Act Notification of FDA for planned production interruptions or discontinuations – 6 months required Broadens scope of early notification to include – biologic products – drugs used in emergency care and surgery FDA may expedite new application review Repackaging of medications for use within system

36 Current State Prevented drug shortages –195 in 2011 –282 in 2012 FDA - Drug Shortage Task Force –Strategic plan under development Enhanced coordination, communication, decision-making (internal) Enhanced communication (external) Evaluation of effect on research/clinical trials Evaluation of qualified manufacturing partner program Source: Federal Register. Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments. https://federalregister.gov/articles/2013/02/12/2013-03198/food-and-drug-administration. Accessed 3-9-2013.https://federalregister.gov/articles/2013/02/12/2013-03198/food-and-drug-administration

37 Continued Advocacy needed! Final, structured FDA monitoring plan Manufacturing redundancy for certain medications More stringent consequences for manufacturers not complying with notification requirements

38 Susan.Mims@msj.org Kelli.Kirkpatrick@msj.org Mission-Health.org


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