Rumors of an impending shortage also may cause stockpiling (ie, providers buy drugs in excess of current patient demand) before supplies diminish. Or, generic drugs may be discontinued in favor of producing more profitable cancer drugs. The FDA does not have the authority to require a company to continue manufacturing generic drugs. Some of the oncology-related drugs reported to be currently in shortest supply include bleomycin, cisplatin, doxorubicin, etoposide and leucovorin. For additional information and a full list of drug shortages, see the FDA and the American Society of Health-System Pharmacists (ASHP) Web sites.
Impacts of the Shortage
Negative effects of the chemotherapy drug shortage tend to vary by facility type, with infusion centers and small hospitals suffering more than health systems and hospitals with large volumes. Smaller infusion centers typically have less buying power and lack the advantage of sharing resources across multiple sites. Oncology practitioners have faced a range of challenges in dealing with the chemotherapy drug shortage, including:
- Lack of suitable alternative drugs—Although alternative drugs can be used during a shortage, alternative drugs are not always available. In a 2010 survey by the Institute for Safe Medication Practices (ISMP), 80% of respondents reported difficulty obtaining a suitable alternative product.
- Higher cost of alternative drugs—Alternative drugs are often more expensive than their generic alternatives, but reimbursement levels do not always reflect cost. For instance, the alternative for leucovorin, Fusilev™, may cost a medical oncology practice 10 times more, yet Medicare reimbursement is only 65% of this cost. In many cases, practices have absorbed the additional cost, although this is not a sustainable practice.
- Higher rates of errors and adverse outcomes—Alternative drug use can increase the potential for medical and dosing errors. In the ISMP survey, 1 in 4 respondents reported medication or dosing errors, 1 in 5 reported adverse patient outcomes and 1 in 3 reported near misses in the past year due to the current drug shortage.
- Drug administration to patients based on clinical need and/or outcome—Dr Michael Neuss, former chair of the ASCO, says it is not uncommon for patients to be prioritized based on whether or not administration of a chemotherapy drug could be curative. He says providers make such decisions every day based on the available drugs.
- Delayed patient treatments—As a result of the shortage, some patients at affected organizations have had to delay or change their treatment protocols based on available drugs.