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Drug Shortages: Trends, Causes, and Mitigation Strategies

This presentation discusses the recent trends in drug shortages, explores the causes behind these shortages, and offers strategies to mitigate their impact on patient safety. The presentation also highlights the relationship between manufacturing and drug quality issues and their effect on drug shortages.

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Drug Shortages: Trends, Causes, and Mitigation Strategies

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  1. Drug Shortages Erin R. Fox, PharmD, BCPS, FASHP

  2. Disclosure • This presentation represents my own opinions • University of Utah Drug Information Service has a contract with Vizient (a GPO) to provide drug shortage information. The total amount is < 5% of total budget. • University of Utah Health is Vizient member @foxerinr

  3. Objectives • Explain the most recent trends in drug shortages and evaluate progress towards solutions • Describe how recent manufacturing and drug quality trends relate to drug shortages • Design drug shortage mitigation strategies to minimize patient safety concerns @foxerinr

  4. Current Trends

  5. National Drug Shortages - New Shortages by YearJanuary 2001 to March 31, 2019 Note: Each column represents the number of new shortages identified during that year. University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

  6. National Drug Shortages - New Shortages by Year January 2001 to march 31, 2019, % Injectable Note: Each column represents the number of new shortages identified during that year. Green = injectable, yellow = non-injectable University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

  7. National Drug Shortages – Active Shortages by Quarter Note: Each point represents the number of active shortages at the end of each quarter. University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

  8. Active Shortages Top 5 Drug Classes University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr Green = injectable, yellow = non-injectable

  9. What do these numbers mean? • New shortages increasing • Ongoing shortages not resolving • Basic products for patient care are short: local anesthetics, opioids, ketamine, antiemetics, sterile water https://www.aha.org/system/files/2019-01/aha-drug-pricing-study-report-01152019_1.pdf https://www.ashp.org/Drug-Shortages/Shortage-Resources/Roundtable-Report http://www.gao.gov/products/GAO-16-595 @foxerinr

  10. How did we get here? @foxerinr

  11. Cascade of Events Early 2000’s “Find production efficiencies” Heparin Warning letters, 483’s document serious quality problems Dr. Hamburg FDA increases scrutiny Irvine plant closes Ohio plant closes New York plant closes 30% manufacturing capacity is closed http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-Report-FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf

  12. Fragile supply chain for injectables • Few suppliers • Most products have just 1 or 2 • Limited capacity • “just in time” production • Multiple products manufactured on 1 line • No redundancy • No requirement to manufacture life-saving products • No business continuity plans required @foxerinr

  13. Drug Manufacturing Is a Business • Profitability • Manufacturing fixes • Capacity – most running 24/7 • Forecasting production – year+ schedules • Most shortages are due to some kind of quality problem at the factory @foxerinr

  14. Can you follow the quality data? • No! • Contract manufacturing means we don’t always know who makes the product • No requirement to disclose manufacturer (or location) in product label (or 483) • Drug makers consider proprietary - source of API, list of drugs made at a factory @foxerinr

  15. Transparency to incentivize Quality? ClinPharmacolTher. 2013;93:170–176 Mayo Clinic Proc.2014.89(3):361-373

  16. Quality Problems = Shortages • Factories with shortages in 2011, 2012 are same factories causing shortages beginning in 2017 - http://fortune.com/longform/pfizer-drug-problem-fortune-500/ • Fluid shortages began with company choosing not to fix quality issues for 4 years running….. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm560634.htm @foxerinr

  17. https://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-costhttps://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-cost https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631838.htm @foxerinr

  18. https://khn.org/news/how-tainted-drugs-reach-market-make-patients-sicker/https://khn.org/news/how-tainted-drugs-reach-market-make-patients-sicker/

  19. @foxerinr

  20. Mitigation Strategies @foxerinr

  21. What happens when a shortage occurs? • Pharmacy treats as emergency • How much do we have? • How long will it last? • Can we make it last longer? • What else can we buy? • Pharmacists + Physicians work together • Identify alternatives • Prioritize patients / ration • Risks • Medication errors • Delayed care • Patient harm @foxerinr

  22. Increased labor • Can lose entire supply with a single recall • Devastating EHR changes • Switching to IV push due to minibag shortage required review and changes to 700 electronic treatment plans (for just 2 drugs) Photo credit: Erin Fox Kaakeh R et al. AJHP. 2011;68:1811-1819

  23. Patient Harm 448 shortage related errors 2004 – 2018 • 71% reached patient • Most common error types: • Dose omission • Rx / refill delayed • Wrong dose • Wrong drug Top drug classes related to drug shortage errors • Analgesics • Antibiotics • Electrolytes • Antidotes • Benzodiazepines @foxerinr

  24. Best Practice Team • Operational Assessment • Therapeutic Assessment • Impact Analysis • Action Plan • Review and repeat https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.ashx @foxerinr

  25. Most common situation • We can get *some* but… • It’s a different strength • It’s in different packaging • It’s a different size • It’s from a different manufacturer • It’s imported • It’s not enough! @foxerinr

  26. Fixing the problem?

  27. FDA’s Strategy • Prioritize medically necessary agents (determined on a case by case basis) • Evaluate risks and benefits for patients • Offer assistance and advise, but up to the manufacturer to fix • Success hinges on early notification • CANNOT require continued manufacturing or allocations – no matter how critical or life-saving • A Review of FDA's Approach to Medical Product Shortages. October 31, 2011. @foxerinr

  28. Quality metrics goals • Modernize drug quality oversight • Risk based inspection scheduling • Predict drug shortages? • Objective criteria including: • Lot acceptance rate • Product quality complaint rate • Star rating scale for manufacturers? @foxerinr

  29. Modernize manufacturing? • Janet Woodcock advocates continuous manufacturing for: • Faster, improved quality, lower prices, fewer shortages • Domestic plants – fully integrated from API to finished product • Cox B. FDA Talks Up Continuous Manufacturing, Offers Assistance. The Gold Sheet. July 29 2014: # 08140724006. @foxerinr

  30. Lots of talking – action??? • Media attention • Congressional staff briefing • New FDA Commissioner / new approvals • FTC interest • Dept. Homeland Security, DOD • Publications • Sept 5-6 - Workshop on Medical Product Shortages During Disasters (National Academies of Sciences, Engineering, Medicine) • Sept 20 – Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Healthcare Critical Infrastructure (ASHP, ASA, AHA, ASCO, ISMP) • Ongoing - FDA / Interagency Drug Shortage Task Force – public meeting November 27, 2018 @foxerinr

  31. Takeaways from fda public meeting • FDA interest in risk assessments • Move API production to US • No quick resolution for current API contamination crisis (“sartan” class) • Gaps in knowledge vs. other industries • Market share, actual manufacturer, source of raw materials • Gaps for FDA • Amount made at manufacturing site • Source of API (if more than 1 approved) • Reason for shortage • If product will be marketed post approval https://healthpolicy.duke.edu/events/drug-shortage-task-force @foxerinr

  32. Advocacy – changes for Fda Strengthen Title X of FDASIA ∆ Provide reason for shortage to FDA with notification Contingency planning ∆ FDA includes as part of inspection / approval process @foxerinr

  33. Critical infrastructure ∆ Consider drug shortages as a national security threat ∆ Support shortage prevention efforts by HHS / DHS ∆ Incentives for US production of API @foxerinr

  34. New ventures? • CivicaRx / others • Improve supplies • Stabilize market • Long term contracts • Guaranteed volumes • Will it work? Will it be enough? @foxerinr

  35. Key points • Continuing quality problems at manufacturing facilities • Pharmacists managing in crisis mode daily for basic injectable medications • Devastating workload • Work together to mitigate potential / actual patient harm @foxerinr

  36. contact Erin R. Fox, PharmD, BCPS, FASHP Senior Director, Drug Information & Support Svcs. University of Utah Health 801-587-3621 erin.fox@hsc.utah.edu Twitter: @foxerinr

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