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

2. 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

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 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.

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

12. Causes of shortages 54% (as of 12-2010
Quality problems
GMP requirements for complex process, numerous risk points, strict quality control
Scientific advances in quality tests
Recalls initiated by firm
Business decisions
Discontinuation
Closing of sites
Market consolidations – limited sources of drug
Upgrade of facilities
Problems with raw materials or API
Hoarding or stockpiling
54% (as of
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
1 year is not enough time to establish a new source.

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?
A combination of contract arrangements or constraints, downward pressure on prices, shifting demand and overall economic pressures can create a “tipping point” below which it is no longer feasible for a company to continue producing the drug. If a company is in a tenuous position relative to a particular drug—and a quality issue surfaces—the cost of correcting that problem may outweigh any benefit the company will derive from doing so. That may be cause to shift production lines to a more lucrative product.
This very complicated environment has also given rise to the so-called “gray market” in which shortage drugs—which may have been hoarded in anticipation of problems—are offered at substantial mark-ups. In some cases, these markups have been in the neighborhood of 1000%.
There are competing theories about which of the economic forces—and to what extent—are the culprit, which is why the solution is evasive.

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