Oncology drug shortages have been faced by 83% of oncologists. These shortages delay treatments, force rationing and expensive drug substitutions, and slow enrollment in clinical trials. A study reflecting these findings was presented at the 2013 annual meeting of the American Society of Clinical Oncology in early June in Chicago, Illinois.
Among the affected oncologists, nearly all say their patients’ treatments have been impacted. A new study found that the shortages, which have hit especially hard among drugs to treat pediatric, gastrointestinal, and blood cancers, have left physicians unable to prescribe chemotherapies for a range of cancers.
A random sample of 500 board-certified US oncologists were surveyed in late 2012 and early 2013 to obtain information about the impact of drug shortages on their practice during the previous six months. The study’s findings were based on the 250 physicians who responded to the survey.
“Our results indicate that the vast majority of oncologists in the country are facing wrenching decisions about how to allocate lifesaving drugs when there aren’t enough to go around,” said Keerthi Gogineni, MD, MSHP, of the Abramson Cancer Center at the University of Pennsylvania in Philadelphia. “The potential impact of these drug shortages is vast: they’re putting patients at risk and driving up costs of cancer care.”
Oncologists have adapted in a variety of ways when preferred or recommended drugs are scarce. Their adaptations included 78% treating patients with a different drug or drug regimen, 77% substituting different drugs part way through therapy, 43% having to delay their patients’ treatments, 37% having to choose among patients who needed a particular drug, 29% omitting doses, 20% reducing doses, and 17% referring patients to another practice.
Right now, little is known about how these adaptations may impact clinical outcomes, but the authors said that the widespread treatment delays reported underscore the urgency of the problem. Gogineni said that the most risky types of modifications occur when physicians substitute drugs part way through the patients’ treatments, since there is often no established dose equivalence or known safety profile when the substitute is combined with other therapies. Clinical trials are also hampered when drugs necessary for properly testing new regimens are scarce.
The findings also illustrate the substantial cost burden imposed by drug shortages. Prices for both scarce drugs themselves as well as their common substitutions have risen in recent years. Generic drugs tend to be most difficult to obtain – sometimes due to manufacturing problems, but often, the authors noted, as a result of decisions by drug makers to deprioritize production of generics due to their slim profit margin.
Despite the prevalence of the shortage issues, 70% of doctors surveyed said their cancer centers or practices had no formal guidance for making allocation decisions. The scarcities raise difficult ethical questions that force doctors to weigh the needs of different but equally vulnerable patients against one another.