the oncology drug shortage

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