Presentation Transcript

1. Pharmaceutical Shortages: Impact on Patients, Professionals and the Public Bernadette Belgado, Pharm.D. – UF Health at Jacksonville West Paul, M.D., Ph.D. – Wake Med Health

2. Drug Shortages: causes & solutions

   Bernadette Belgado, Pharm.D. Director, Drug Information Center Manager, Department of Pharmacy Shands Jacksonville Department of Pharmacy Clinical Assistant Professor UF College of Pharmacy
3. Objectives Explain the reasons for medication shortages Discuss drug shortage legislation No disclosures
4. New Drug Shortages by Year Keuhn BM. JAMA. 2013;309(6):532-533
5. Reported reasons for sterile injectable drug shortages in 2011 Woodcock J, Wosinska M. Clin Pharmacol Ther 2013;92:170-6.
6. Drug Supply Chain Raw materials http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
7. Raw Materials 2008 – heparin recall Over 200 patients died as a result of contaminated heparin with over-sulfated chondroitin Raw materials plant in China was never inspected by the FDA Foreign markets supply 80% of raw materials Increased quality awareness and regular inspection of foreign raw materials plants mandated by FDA
8. This family-owned workshop in Xinwangzhuang, a village in Juangsu Province, China, processes pig intestinesfor heparin http://www.nytimes.com/2008/03/30/weekinreview/30bogdanich.html?ref=heparindrug&_r=0
9. Drug Supply Chain http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
10. Drug Manufacturers Generic injectable drugs (73%) Lack of redundancy in manufacturing processes 71% of market controlled by 3 manufacturers Routine facility maintenance Business decisions to discontinue drug Unable to support demand Woodcock J, Wosinska M. Clin Pharmacol Ther 2013;92:170-6.
11. Drug Manufacturers Lack of sterility Particulates of foreign matter Crystallization of the active ingredient Precipitates New/unintended impurities or degradation Equipment breakdown Woodcock J, Wosinska M. Clin Pharmacol Ther 2013;92:170-6
12. Drug Supply Chain http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
13. Regulatory Issues New FDA Commissioner in 2009 Enforcement and regulatory activities spiked from 2009-2011 Warning letters to pharmaceutical manufacturers regarding quality increased 42% in 2009 and up 156% in 2010. Simultaneously shutting down 4 major generic manufacturers of generic medications 30% of decrease in manufacturing capacity 112th Congress 2012. http://oversight.house.gov/report/fdas-contribution-to-the-drug-shortage-crisis.
14. FDA Warning letters 2004-2011 Number of letters FDA Fiscal Year 2011 Enforcement Statistics
15. Regulatory Issues FDA increased enforcement of Unapproved Drugs Drug Evaluation & Safety Initiative (DESI) Drugs approved or deemed identical, related, or similar (IRS) between 1938 – 1962 Pre-1938 drugs grandfathered No change to the formulation, dosage form, potency, route of administration, indication, or intended patient population FDA requests NDA for any unapproved drug http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf http://www.ashp.org/DrugShortages/NotAvailable/Bulletin.aspx?id=602
16. Regulatory Issues - MMA Medicare Modernization Act (MMA) 2003 Changed pricing formula for reimbursement in outpatient setting Originally average wholesale price (AWP) Generic availability erodes selling prices by ~ 85-90% after a year Average selling price (ASP) + 6% MMA limits - Manufacturers only allowed to increase prices by 6% biannually Cabner BA. N Engl J Med 2011 365:2147-49
17. 340B Pricing Program Provides nominal pricing for outpatient medications One-third of all hospitals are eligible for 340B prices Unintended consequence of MMA and 340B New manufacturers are not entering the marketplace to produce generic medications Only 7 generic companies make sterile injectables
18. Drug Supply Chain http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
19. Group Purchasing Organizations GPOs – 98% of hospitals Negotiate price and volume contracts with drug manufacturers Six GPOs control about 90% of drugs purchased Contract awarded on multiple factors lowest cost, returns, rebates, stipulations for “failure to supply” Speculation that fewer generic manufacturers are a direct result of the GPO structure Nelson R. Medscape. http://www.medscape.com/viewarticle/778146
20. Drug Supply Chain http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
21. Health Systems “Just in time” inventory practices Pharmacy inventory turns short 30 days Hoarding and stockpiling
22. Medicare Modernization Act Heparin recall Unapproved drugs initiative New FDA Commissioner Keuhn BM. JAMA. 2013;309(6):532-533
23. FDA Solutions Allow temporary importation of foreign equivalent Propoven from UK for propofol shortage Phenylephrine from UK Sodium Bicarbonate from Australia Allow affected drug with conditions – safety considered Potassium Phosphate – double filtration required Mannitol – heat medication to dissolve crystals Alteplase – rubber stopper particles – filtering required
24. FDA Safety & Innovation Act (FDASIA) Executive presidential order – October 2011 FDASIA – July 2012 Requires at least 6 month notification to FDA and other manufacturers of potential shortages or ASAP No civil or monetary penalties for industry noncompliance FDA required to keep updated list of drugs and reasons Expedited review of new generics
25. Presidential Executive order Medicare Modernization Act Heparin recall Unapproved drugs initiative FDASIA New FDA Commissioner Keuhn BM. JAMA. 2013;309(6):532-533
26. Keuhn BM. JAMA. 2013;309(6):532-533