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The Oncology Drug Shortage

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

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The Oncology Drug Shortage

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  1. The Oncology Drug Shortage A Continuing Crisis Karen Hagerty, MD Director, Reimbursement Policy

  2. 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

  3. 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

  4. Shortages by Drug Class University of Utah Drug Information Service

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. …and are often not informed of the cause or the expected duration of the shortage. Percent of Hospitals Reporting They Are Informed of the Expected Duration of the Drug Shortage Percent of Hospitals Reporting They Are Informed of the Cause of the Drug Shortage Source: AHA analysis of survey data from 820 non-federal, short-term acute care hospitals collected in June of 2011.

  11. Why Shortages, Why Now? Many Theories, and…it’s Complicated

  12. Causes of shortages 54% (as of 12-2010 Source: FDA Drug Shortages Program

  13. 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

  14. 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?

  15. Potential Remedies • Early notification of potential problems • Economic incentives • Alternative sources of shortage drug • Clinical guidance on alternatives • Legislation

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