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Drug Shortages: Experiences in the U.S. and Abroad

International Summit on Medicines Shortages Toronto, Canada June 20-21, 2013. Drug Shortages: Experiences in the U.S. and Abroad. Kasey K. Thompson, Pharm.D., M.S. Vice President, Office of Policy, Planning and Communications American Society of Health-System Pharmacists

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Drug Shortages: Experiences in the U.S. and Abroad

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  1. International Summit on Medicines Shortages Toronto, Canada June 20-21, 2013 Drug Shortages:Experiences in the U.S. and Abroad Kasey K. Thompson, Pharm.D., M.S. Vice President, Office of Policy, Planning and Communications American Society of Health-System Pharmacists Bethesda, Maryland, U.S.A.

  2. Objectives • Define causes and current trends in drug shortages • Discuss implications of drug shortages • Describe lessons learned from efforts in the United States to address drug shortages.

  3. Drug Shortages in the United States: A Historical Perspective • Not a new issue • ASHP and others have been addressing drug shortages for almost 14 years • ASHP web resource center—Updated Daily (www.ashp.org/drugshortages) • Current challenge is the extent, duration, and type of drug shortages • Has a major impact on patient safety and pharmacy practice

  4. Drug Shortage Definition • A drug supply issue requiring a change • Impacts patient care • Requires use of an alternative agent American Society of Health-System Pharmacists. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. AJHP. 2009;66:1399-1406.

  5. U.S. Food and Drug Administration (FDA) • Policy is to “prevent or alleviate shortages of medically necessary products” • Shortages of “medically necessary” drugs are listed on FDA’s website Jensen V, Kimzey LM, Goldberger MJ. AJHP. 2002;59:1423-1425.

  6. FDA - Medical Necessity • Product treats or prevents a serious or life-threatening illness (off-label or labeled) • No reasonable alternatives exist (single-source) .

  7. Drug Shortage Data & Trends

  8. National Drug Shortages January 2001 to May 31, 2013 Note: Each column represents the # of new shortages identified during that year

  9. National Drug Shortages—Quarterly Note: Each column represents the # of active shortages at the end of each quarter. Q2-13 are data through 5/31/13. University of Utah Drug Information Service

  10. Active Shortages Top 5 Drug Classes University of Utah Drug Information Service

  11. Common Drug Classes in Short Supply – 2010, 2011, 2012 University of Utah Drug Information Service

  12. National Shortages vs. Chemotherapy ShortagesJanuary 2001 to December 31, 2012 University of Utah Drug Information Service

  13. Shortages – Dosage Forms 2012 University of Utah Drug Information Service

  14. Reasons for Shortages – 2012

  15. Reasons for Injectable Shortages – 2012

  16. Quality Problems

  17. Supply Chain Issues • Manufacturers and wholesalers typically have a 15 to 40 day inventory on hand • Pharmacies - 10 to 16 annual inventory turns The Pink Sheet. May 6, 2002:17-18 ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. AJHP. 2009;66:1399-1406.

  18. Manufacturing Problems • Sources • Sole source raw materials • Time to establish new source • Capacity • Few manufacturers of sterile injections • Same production lines for multiple items • Limited lyophilization capacity Provisional observations on drug product shortages: effects, causes, and potential solutions. AJHP. 2002;59:2173-2182

  19. Complex Manufacturing • Over 23 steps to manufacture meropenem • Starting materials (Italy, Japan) • Crude meropenem (Japan) • Purified meropenem (Italy, Japan) • Bulk Meropenem (Italy, Japan) • Vial Filling (Switzerland, US) • Packaged in boxes (US) • Biologic products • Take longer to produce • Any problems take longer to resolve

  20. Multifactorial Reasons • Multiple reasons can play a role in any particular shortage • A product may be recalled due to concern for microbial contamination or particulate matter in the vials (propofol) • 3 manufacturers of propofol, 2 had recalls, and the 3rd could not keep up with demand—U.S. imported product from Europe. • A product may be recalled and the manufacturer may have difficulty accessing raw materials (lipid emulsion)

  21. Business Decisions • Profitability • Manufacturing fixes • Capacity – most factories running 24/7

  22. Fragile Supply Chain Sterile Injectables • Few suppliers • Majority of the market supplied by 7 manufacturers • Contract manufacturers – the company that supplies the product didn’t always manufacture • Lack of redundancy • Multiple products made on existing manufacturing lines • Limited resiliency in manufacturing process • Complex manufacturing process • No simple fixes for quality problems • Problems typically affect multiple products http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml

  23. Raw Material Issues • Raw material availability • 20 years ago – 90% from US and Europe • Currently, 75 – 80% from China and India • Some materials are no longer accessible or only available as single source products Schweitzer SO. N Engl J Med. 2008;358:1773-1777 Provisional observations on drug product shortages: effects, causes, and potential solutions. AJHP. 2002;59:2173-2182 Fox ER, Tyler LS. AJHP. 2009;66:798-800

  24. Example – Fragile Supply Chain • Manufacturing plant closes April 2010. • Impacts 49 drugs – 18 are chemotherapy. • Problems occurred at the same time at other facilities. • Manufacturing resumed spring of 2011, but still not up to prior capacity for some agents.

  25. FDA’s Strategy • Prioritize medically necessary agents (determined on a case by case basis) • Evaluate risks and benefits for patients • Offer assistance and advice, but up to the manufacturer to fix • Success hinges on early notification • Jensen V, Kimzey L M, and Goldberger MJ. FDA’s role in responding to drug shortages. AJHP. 2002; 59:1423-5

  26. How Does FDA Prevent Shortages? • Regulatory discretion • Require filters (products with particulates, glass fragments) • Ask clinicians to double check volume (overfill) • Ask others to increase production • Expedite reviews (new product, longer expiration, new raw material, new manufacturing sites • A Review of FDA’s Approach to Medical Product Shortages. October, 2011. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm

  27. Imports • 12 different agents 2010-2013 • propofol, foscarnet, ethiodol, thiotepa, norepinephrine, capecitabine, leucovorin, levoleucovorin, methotrexate, doxorubicin liposomal, phentolamine, sodium bicarbonate • Limited by quantity available to share with US market • Importation is not a viable long-term solution for U.S. market

  28. Shortages Prevented by FDA 2010 - 2012 Source: CDER Drug Shortages

  29. FDA Can Only Do So Much…

  30. International Perspective on Drug Shortages • Drug shortages is a global issue! • Globalization of the pharmaceutical supply chain:1 • 40 percent of finished drug products are manufactured abroad • 80 percent of drug components (e.g., active pharmaceutical ingredients) are from foreign countries • Quality issues in the global supply chain contribute to drug shortages 1. www.prescriptionproject.org/assets/pdfs/Pew_Heparin_Round4b_SinglePgs_b.pdf

  31. European Association of Hospital Pharmacists—Drug Shortages Surveys • Surveyed 346 hospital pharmacists in 31 countries • Focus on the prevalence of drug shortages • Surveyed 266 hospital pharmacists in 29 countries • Focused on causes and impact on patients

  32. EAHP Survey Results • 98.8% of respondents had experienced a shortages in the past 12 months • 63.1% reported that problems associated with shortages occur at least weekly; 27%reported monthly problems.

  33. EAHP Survey Results Medicines in Short Supply Oncology 70.6% Emergency 43.8% Cardiovascular 35.1% Hematology 22.2% Respiratory 18.9% Pediatric 18.9% Other 31.4%

  34. EAHP Survey Results Originator Versus Generic Shortages Originator/Brand 42.9% Generic 57.1%

  35. EAHP Survey Results Root Causes of Shortages Single or Limited Suppliers 52.4% Raw Chemical Shortage 43.7% Manufacturing Quality Problem 43.7% *Small Country with Limited Market 41.7%

  36. Impact of Drug Shortages

  37. Practice Impact of Drug Shortages • No advance warning • Limited or no information • Significant increase in resources used to manage shortages • Personnel: pharmacists, pharmacy technicians, nurses, physicians • Financial: increased cost of alternative products/off-contract purchasing; gray market • Diverts health care providers from direct patient care activities • The resulting impact on patient safety and outcomes may be substantial but is difficult to quantify University of Michigan/ASHP Survey. AJHP. 2011;68:1811-9.

  38. Time Spent by Health Care Practitioners • AJHP. 2011;68:1811-9.

  39. Patient Care Impact • Patient care issues • Delayed or unavailable care • Safety implications • Adverse impact on patient outcomes

  40. Percent of Hospitals Reporting the Impact on Patient Care as a Result of a Drug Shortage Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals. Survey completed in June 2011

  41. Cause for Concern: Errors that May Be Caused by Drug Shortages • Clinicians may be less familiar with dosing, administration, or monitoring of the alternative therapy • Use of different package sizes can lead to over or under dosing • Compounding of unavailable therapies can lead to errors or sterility issues

  42. U.S Efforts to Prevent Shortages

  43. ASHP Guidelines on Managing Drug Shortages www.ashp.org/DocLibrary/BestPractices/ProcureGdlShortages.aspx

  44. Drug Shortages SummitBethesda, Maryland; November 2010 • Goals • Define the scope, causes, and potential patient harm from drug shortages • Discuss potential changes in public policy and stakeholder practices • Partner Organizations • ASHP • American Society of Anesthesiologists • American Society of Clinical Oncology • Institute for Safe Medication Practices • American Hospital Association (joined post summit) • 21 recommendations to improve communication and remove barriers faced by the FDA and drug manufacturers www.ashp.org/drugshortages/summitreport

  45. Addressing Drug Shortages in the U.S.: ASHP Advocacy • Early notification to FDA by manufacturers for all drugs regulated by FDA • Civil monetary penalties • Inter-agency coordination • Contingency plans • Generic user fee program

  46. Why Early Notification? Prevented shortages 2010 38 2011 195 2012 42

  47. Impact of New Law • A good first step – not a total solution • Increases scrutiny on shortages • Strengthens FDA’s Drug Shortages Program • Expedites approval of additional industry capacity and applications • Does not directly address capacity and economic factors

  48. Conclusions • Drug Shortages Remain a Major International Problem • There is No Single Cause of Shortages • The Reasons for Shortages May Differ From Country-to-Country, But there are also Likely Similarities • Communication is key between stakeholders (providers, government, manufacturers, and patients)

  49. Thank You

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