An Interdisciplinary Solution to the Drug Shortage Problem Kelli Kirkpatrick, PharmD – Mission Health, Asheville, N

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 management • Provide updated information on advocacy efforts and opportunities

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

8. 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

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

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-SystPharm 2011;68:1811-9.

11. What is the impact? Total U.S. Labor Cost $216 million annually Source: Kaakeh R, Sweet BV, Reilly C et al. Impact of drug shortages on U.S. health systems. Am J Health-SystPharm 2011;68:1811-9.

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.

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.

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 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, 13th -- <1 week supply • Communicated to Children’s 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

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

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

25. Systematic Communication PlanPoint of Care Notification Catalog Display 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 • Used for drugs with 7 days supply or less (Yellow, Orange , Red)

26. Color Based Actions ADCs - Automated dispensing cabinets

27. Color Based Actions ADCs - Automated dispensing cabinets

28. Color Based Actions

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

30. Med ShortageEthics 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 ActJuly 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.

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