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The Oncology Drug
Shortage
A Continuing Crisis
Karen Hagerty, MD
Director, Reimbursement Policy
National Drug Shortages
January 2001 to December 31, 2011
Note: Each column represents the # of new shortages identified
during that year
Source: University of Utah Drug Information Service
Service
Shortage Drugs in Oncology
(as of March 2012)
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Bleomycin
Cisplatin
Cytarabine*
Dacarbazine*
Daunorubicin
Doxorubicin
Doxorubicin, liposomal
Etoposide
Fludarabine*
*Listed on ASHP website only
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Fluorouracil
Leucovorin
Mesna
Methotrexate
Mitomycin
Mustargen
Ondansetron
Paclitaxel
Thiotepa
Vinblastine
Shortages by Drug Class
University of Utah Drug Information Service
Hospital Shortages
Percent of Hospitals Reporting the Number of Individual Drugs For Which the
Hospital Experienced a Drug Shortage in the Last Six Months
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Nearly half of hospitals reported experiencing a drug
shortage on a daily basis.
Percent of Hospitals Experiencing a Drug Shortage by Frequency
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Patient Impact
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 collected in June of 2011.
Three out of four hospitals report rationing or implementing restrictions for
drugs that are in short supply.
Percent of Hospitals That Have Implemented Rationing and/or Restrictions for Drugs
in Short Supply
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Three of 4 hospitals report that they rarely or never receive advance notice of
drug shortages…
Percent of Hospitals Reporting They Receive Advance Notice of Drug Shortages from
Drug Manufacturers, Wholesalers, Distributors, Group Purchasing Organizations or
the FDA
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
…and are often not informed of the cause or the expected duration of the
shortage.
Percent of Hospitals Reporting They Are Informed of
the Cause of the Drug Shortage
Percent of Hospitals Reporting They Are Informed of
the Expected Duration of the Drug Shortage
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Why Shortages, Why
Now?
Many Theories, and…it’s
Complicated
Causes of shortages
Unavailability
of raw
material
(API) 9%
Unavailability
of other
components
4%
Loss of site
5%
Production/
Capacity 18%
Reason for
shortage
0%
Other drug
shortages 4%
Product
Quality issues
42%
Product
discontinuation
18%
Source: FDA Drug Shortages Program
54% (as of 122010
Supply Chain/Manufacturing
Problems
• Single source API or raw materials
– Foreign sites major source of raw material
• Few manufacturers of sterile injections
– Industry consolidation
• Same production lines for multiple items
• Tighter inventories = less backup
• Major plant closings in 2009
Economic Issues
• Increased demand
• Pricing issues
• Move to other—more
favorable—product line
• Recalls
• Cost of plant
improvements vs.
profitability
• Regional issues
• Gray market
• Hoarding
• Unfavorable contract
arrangements
• MMA / ASP+6
• Role of other entities in
the supply chain:
wholesalers, distributors,
GPOs?
Potential Remedies
• Early notification of
potential problems
• Economic incentives
• Alternative sources of
shortage drug
• Clinical guidance on
alternatives
• Legislation