Third World Shortages in a First World Country: Drug shortages and the impact on care

1. Third World Shortages in a First World Country:Drug shortages and the impact on care Timothy Lesar, Pharm.D. Director of Clinical Pharmacy Services Albany Medical Center Albany, New York

2. No drugs available- Hugs instead?

3. Learning Objectives • Describe the potential patient risks from drug shortages • Describe strategies to manage drug shortages

4. Discussion Outline • The scope of the drug shortage problem • The causes of drug shortages • The impact of drug shortages on patient care • Managing drug shortages

5. Drug Shortages: Scope of the Problem • In 2011 there were a reported 360 drug shortages

6. Drug Shortages:Disproportionate effect on critically ill patients • In 2010 there were a reported 178 drug shortages- 132 were injectables • Insert graph here

7. Drug Shortages • graph

8. Drug Shortages:Scope of the Problem • 2011-2012 Drug Shortage “Poster Children” • ADHD • Cytarabine • Methotrexate • Liposomal doxorubicin • Pentobarbital • Benzodiazepines • Local anesthetics • Opiates

9. Papaverine DDAVP Atracurium/ Pancuronium Norepinephrine Cytarabine Methotrexate Pentobarbital Leucovorin TPN components Proclorperazine Phentolamine Erythromycin TMP/SMX Lorazepam Diazepam Metoclopramide Fentanyl Preservative free morphine Hydromorphone Caffeine /Na benzoate Heparin Drug Shortages:Scope of the ProblemAMC 2011-12 Serious Outages and Shortages and on and on……..

10. Drug Shortages:Scope of the Problem • Primarily, but not only, injectables • Impacts almost all health care environments • Varies by area of country • Varies by facility • Varies over time as supply comes and goes • Can be unexpected (eg recalls)

11. Drug Shortages:Scope of the Problem • Considerable attention in lay media • Big enough problem to draw action from President, Congress and FDA • Appears to be a growing issue • Are shortages the new “norm” ?

12. The Pharmaceutical Supply Chain

13. Drug Shortages:Causes • Raw materials and Manufacturing issues • Quality issues • Drug recalls • Foreign sources of materials and products • Economic: • Low profit margins • Fewer manufacturers • Discontinuation for market reasons • Regulatory • DEA and FDA • “Secondary” shortages due to shift to alternative products

14. Drug Shortages:Causes • Just in time inventory practices by wholesalers and institutions • Little supply “buffer” • Free market forces • Purchasing contracts • “Specialty” and “gray” market distributors • Compounding pharmacies

16. Impact of Drug Shortages • Increased costs • Increased workload to manage • Impairs patient care • Safety concerns • Caregiver issues • Patient issues

17. Drug Shortages: Organizational Impact • Increased costs • Loss of “contract” costs • Loss of “generics” • Cisatracurium is 100x more expensive than atracurium • Dexmedtomidine is 7x more expensive than lorazepam • Use of more expensive forms • Use of alternative sources • “specialty and gray market” • “Compounders” • Personnel time for preparation • Waste

18. We live in a “Free Market” Economy

19. Drug Shortages: Organizational Impact • Increased workload to manage shortage • Involves multiple individuals • Clinical and operational • Involves multiple groups that must work together • Pharmacy • Nursing • Prescribers • Diverts from other activities

20. Drug Shortages: Impact on Care • Impairs patient care • Inability to treat • Treatment delays and disruption • Use of suboptimal therapies • >alternative to phentolamine for pressor extravasation? • Safety concerns • Use of less desirable drugs • Use of unfamiliar drugs • Switching medications • Loss of safety “systems” in general

21. Drug Shortages: The Care Provider • Lack of familiarity with alternative therapy • Little experience of “managing without” • Delayed medication availability • Additional workload • Miscommunication / confusion

22. Drug Shortages: The Patient • Suboptimal therapy • Increased adverse effects • Need to switch therapy • Confusion and errors • Increased costs

23. Managing Drug Shortages

24. AMC’s frontline warriors in the battle against drug shortages

25. Drug Shortages: Management • Have an updated and approved policy • Be aware of any supply issues • Start forming plans early • Find alternative sources of products • Critical role of pharmacy purchasing coordinator • Manage available supplies • Re-distribute • Be familiar with clinical and operational aspects • Consider all risks (FMEA) • Expect the unexpected

26. Drug Shortages: Management • Assess secondary effects of shortage • Communication plan • Identify all possible stakeholders • Use alternative forms of products • Size, concentration, dose form • Repackage • Determine possible alternative agents • May be patient/indication specific • Patient prioritization? • Requires Medical Staff input • Implementation plans • Monitor

27. Drug Shortages: Management AJHP 2009;66:1399-1406

28. Drug Shortages: RiskManagement AJHP 2009;66:1399-1406

29. Drug Shortages: Case: Atracurium • AMC not able to purchase atracurium • Identify individuals to manage shortage • Tracked use to predict date of outage • Developed management plan • Identify alternative: cisatracurium • Identify care and safety issues • Identify “system” changes needed • Inventory • Distribution of alternative agent • Computers • Protocols and order sheets • Drip rate sheets • Smart pump • Communication of changes • Who, What, When and How

30. Drug Shortages: Case: Atracurium • Implementation • “Starting” date chosen for switch • Purchase cisatracurium supply • Communication to caregivers of change • Computer system changes turned on • Uploaded altered AMC protocols / drip sheets • NOT able to change smart pumps • Change product preparation processes • Monitored issues

31. Drug Shortages: The nurse • Should expect… • Clear and timely communication • Appropriate education • Appropriate information resources • Appropriate “systems” support • Appropriate • Responsibilities…. • Be aware of communications • Attain appropriate knowledge • Appropriately alter practices if needed • Provide additional monitoring/ patient communication • If unsure… always get support • Provide feedback on entire process • “unsafe conditions”

32. Drug Shortages: Summary • Drug shortages are a growing problem • Drug shortages likely to continue • Drug shortages have multiple causes • Drug shortages present clear patient risks • Drug shortages must be managed systematically to assure patient safety • Each shortage is “unique” • Care givers must be actively involved to assure positive patient outcomes

33. Drug Shortages : FDA • Immediate actions • Requires more notification of shortages • Expedite approvals • Allow importation • Longer term actions • http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm277748.htm

34. Drug Shortages: Resources • FDA http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm • CDC (vaccines) • http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm • ASHP http://www.ashp.org/shortage • ISMP (safety issues) http://www.ismp.org

35. Drug Shortages: Additional References Mitka JAMA 2011;306:1069-70 Hill FDLI Food and Drug Policy Forum 2011;1(issue 16) http://www.ashp.org/DocLibrary/Policy/DrugShortages/FDLI-Article-on-Drug-Shortages.aspx Kaakh Am J Health Syst Pharm 2011;68:1811-1819 Lewin SCCM http://www.sccm.org/Publications/Critical_Connections/Archives/April-2011/Pages/DrugShortages.aspx Gesin SCCM http://www.sccm.org/Publications/Critical_Connections/Archives/February-2012/Pages/SettingofDrugShortages.aspx Grif- Aspach Crit Care Nurse 2012;32:8-13

36. Drug Shortages: Questions?