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Pharmaceut ical Shortages:Impact on Pat ien ts,
Profess ionals and the Publ ic
Bernadette Belgado, Pharm.D.
UF Health at Jacksonville
West Paul, M.D., Ph.D.
Wake Med Health
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Drug Shortages: causes &
solutionsBernadette Belgado, Pharm.D.
Director, Drug Information CenterManager, Department of Pharmacy
Shands Jacksonville Department of PharmacyClinical Assistant ProfessorUF College of Pharmacy
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Objectives
Explain the reasons for medication shortages
Discuss drug shortage legislation
No disclosures
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Keuhn BM. JAMA. 2013;309(6):532-533
New Drug Shortages by Year
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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 theFDA
Foreign markets supply 80% of raw materials
Increased quality awareness and regular inspection of
foreign raw materials plants mandated by FDA
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This family-owned workshop in Xinwangzhuang, a village in Juangsu
Province, China, processes pig intestines for heparin
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Drug Supply Chain
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
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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.
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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
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Regulatory Issues
New FDA Commissioner in 2009
Enforcement and regulatory activities spiked from 2009-
2011
Warning letters to pharmaceutical manufacturersregarding 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.
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FDA Warning letters 2004-2011
FDA Fiscal Year 2011 Enforcement Statistics
Numberofletters
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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
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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 Med2011 365:2147-49
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340B Pricing Program
Provides nominal pricing for outpatientmedications
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
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Drug Supply Chain
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
G P h i
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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
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Drug Supply Chain
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm
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Health Systems
Just in time inventory practices
Pharmacy inventory turns short 30 days
Hoarding and stockpiling
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Keuhn BM. JAMA. 2013;309(6):532-533
New FDA
Commissioner
Heparin recallMedicare
Modernization Act
Unapproved
drugs initiative
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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
FDA Safety & Innovation
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FDA Safety & Innovation
Act (FDASIA)
Executive presidential order October 2011
FDASIA July 2012
Requires at least 6 month notification to FDA and othermanufacturers 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
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Keuhn BM. JAMA. 2013;309(6):532-533
New FDA
Commissioner
Heparin recallMedicare
Modernization Act
Presidential
Executive order
FDASIA
Unapproved
drugs initiative
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Keuhn BM. JAMA. 2013;309(6):532-533
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