The Enterprise Risk of Drug Shortages in Hospitals

1. AHLA = Enterprise Risk Management Task Force The Enterprise Risk of Drug Shortages in Hospitals Karen D. Gurwitch, Pharm.D Lynn Sessions, Esq.

2. Objectives • Understand nature of current drug shortage • Describe impact of drug shortages on patient safety/cost of healthcare • Describe a specific hospital experience • Explore enterprise risk of drug shortages

4. Backorders and The Press

5. Publications by the American Journal of Health System Pharmacy

6. National Drug Shortages January 2001 – June 2011 Projected 2011 annual shortage 77% Injectables 211 166 156 149 129 120 88 73 74 70 58 Drug Information Services, University of Utah, 2010

7. Causes • Fewer suppliers • Manufacturer financial decisions • Enforcement of FDA standards/regulations • Leaner inventory levels • Gray market distributors • Stockpiling by end-users • Unexpected increases in demand • Quality/availability raw material

8. Reasons for Shortages (Injectables)

9. Enterprise Risk Issues • Clinical impact • Financial impact • Ethical considerations • Regulatory impact • Potential legal threat

10. Clinical Impact of Drug Shortages • Adversely affect drug therapy • Compromise or delay medical treatment/procedures • Failure to treat /progression of disease • Medication errors/adverse patient outcomes

11. Near Misses, Errors and Adverse Outcomes [National Report] • Dosing • EPINEPHrine 1:1,000 overdose in substitution for 1:10,000 • Wrong dose of levoleucovorin substituted for leucovorin • IV etoposide converted to oral dosing without doubling dose • Concentration • Cytarabine dosing error using 1000mg vial instead of 500mg vial • Alternative Drug • Thrombophlebitis from Phenytoin administration • No Therapy/Delayed Therapy • Treatment of PCP due to no IV Bactrim • Death from Untreated resistant pseudomonas: no amikacin • Clinically significant delay in treating a patient with PCP due to IV Bactrim shortage • Death from resistant pseudomonas infection due to amikacin shortage

12. Drug Shortage Survey - Impact 98% 89% 80%

13. Other Effects of Drug Shortages • Financial effects • High cost associated with alternative medications • Additional costs associated with treatment of adverse outcomes • Time and resources spent to address shortages • Emotional effects • Frustration, anger, mistrust • Strained professional relationships

14. Cost of Drug Shortages (Jan-Dec 2010)

15. FDA’s Approach During Shortage • Address manufacturing /quality problems • Encourage other manufacturer’s to “ramp up” • Expedite issues related to shortages • Temporary importation

16. Limitation of FDA’s Authority • Inability to force a manufacturer to produce a product “Manufacturers are not required to report plans to discontinue a product unless they are the sole manufacturer of a drug that is life-supporting; life-sustaining; or intended for use in the prevention of a debilitating disease or condition…” (21 CFR 314.81 FR published 10/07) • No penalty for not notifying FDA of a discontinuation

17. “Preserving Access to Life-Saving Medications Act” (S.296) • Manufacturer’srequirement: • Notify the FDA of any manufacturing “discontinuance, interruption, or other adjustment” that would “likely” result in a shortage of the product • Incur fine for not notifying the government about a likely shortage

18. “Preserving Access to Life-Saving Medications Act” (S.296) • FDA requirement: • Use evidence-based criteria to identify drugs that may be vulnerable to a shortage • Collaborate with manufacturers for “continuity of operations plans” for “medically necessary drugs” and include in those plans a process for addressing drug shortages

19. “Preserving Access to Life-Saving Medications Act” (S.296) • FDA requirement: • Put a priority on inspecting facilities that manufacture, propagate, compound, or process a drug involved in a drug shortage and that also have recently corrected a problem • Distribute, “to the maximum extent practicable,” information on actual drug shortages to health care provider and patient organizations

20. Guidelines for Managing Drug Shortages • Assessment of duration of shortage • Analysis of threat to patient care and cost • Exploration of therapeutic alternatives • Effective/Timely communication • Patient prioritization • Ensure external relationships

21. Steps Taken ASHP GUIDELINE HOSPITAL PHARMACY Effective collaboration to develop tactics around a specific drug/patient population Compound and repackage drugs/Minimize waste Ensure routine/updated communication Engage area hospitals to share supply Work with vendors and distributors • Validate details of shortage • Identify primary patient population • Determine: • stock on hand • supply from alternative sources • purchase history and/or true history • Identify alternative drug product supply

22. Specific Experience • Communication • Appropriate timing • Target audience • Method of communication • Ethical dilemma • Patient prioritization • System Limitation • Complexity of the system • Increased costs

23. Specific Experience • Compromise of safety measures • Look-A-Like drugs • Standard concentrations • Preparation of products • Increased workload • Compounding and repackaging • Finding drug supply • Establishing guidelines or identifying alternatives

24. Backorder Management: Multidisciplinary Team Approach

25. Shortages in Short • Problems • Difficult to impossible to predict • Little to no information from manufacturers • Increased cost and emotions • No evidence of relief from shortages • Solutions • Work together as a multidisciplinary team to create guidelines for use, when possible • Use cost-saving and resource-sparing measures when appropriate

26. Additional considerations • Ensure legal and/or risk management involvement • Develop and sustain process for treatment decision • Explore creative alternatives • Communicate consistently with stakeholders