The Oncology Drug Shortage
A Continuing Crisis
Karen Hagerty, MDDirector, Reimbursement Policy
National Drug ShortagesJanuary 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)• Bleomycin• Cisplatin• Cytarabine*• Dacarbazine*• Daunorubicin• Doxorubicin• Doxorubicin, liposomal• Etoposide• Fludarabine*
• Fluorouracil• Leucovorin• Mesna• Methotrexate• Mitomycin• Mustargen• Ondansetron• Paclitaxel• Thiotepa• Vinblastine
*Listed on ASHP website only
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.
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
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
Three out of four hospitals report rationing or implementing restrictions for drugs that are in short supply.
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Percent of Hospitals That Have Implemented Rationing and/or Restrictions for Drugs in Short Supply
Three of 4 hospitals report that they rarely or never receive advance notice of drug shortages…
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
Percent of Hospitals Reporting They Receive Advance Notice of Drug Shortages from Drug Manufacturers, Wholesalers, Distributors, Group Purchasing Organizations or the FDA
…and are often not informed of the cause or the expected duration of the shortage.
Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.
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
Why Shortages, Why Now?
Many Theories, and…it’s Complicated
Causes of shortages
54% (as of 12-2010
Source: FDA Drug Shortages Program
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