Impact of oncology drug shortages
Reporter: Saumil Gandhi, MD PhD
The Abramson Cancer Center at the University of Pennsylvania
Last Modified: June 7, 2013
Presenter: Keerthi Gogineni, MD, MSHP
Presenter's Affiliation: The Abramson Cancer Center at the University of Pennsylvania
Production of chemotherapeutics involves increasingly complex supply chain and quality assurance processes with many possible bottlenecks.
As a result, shortages of common chemotherapeutics are frequently reported and have been steadily increasing over the past 10 years.
The prevalence and consequences of these shortages on patient care is not understood.
This study aims to quantify the prevalence of these shortages and their effect on patient care.
A self-administered questionnaire was sent between 9/2012 and 1/2013 to a random sample of 455 board-certified U.S. oncologists selected from the American Society of Clinical Oncology directory.
245 responses were received (response rate 55%), of whom 210 were practicing medical oncologists/hematologists.
Oncologists were evenly distributed throughout all regions of the U.S.
There was no difference in the frequency of shortage based on the region of the country.
61% of respondents belonged to community-based private practices, while the remainder belonged to major academic medical centers.
There was no difference in the frequency of shortage at community-based private practices compared to university-based academic practices.
92% (163) of oncologists reported that they faced a drug shortage in the prior 6 months that ultimately affected a patient's treatment plan.
83% (174) of oncologists reported that they were unable to prescribe the standard chemotherapy for their patient's disease.
The five chemotherapy agents most commonly reported in shortage were: leucovorin (68%), liposomal doxorubicin (63%), 5-FU (19%), bleomycin (18%), and cytarabine (17%).
Physicians adapted in many ways.
Oncologists substituted more expensive branded drugs nearly 40% of the time. For example, Capecitabine costs ~140 time 5-FU for 1 cycle of colon cancer treatment.
Nearly 13% of the time, shortages prevented enrollment on to a clinical trial, delayed administration of a study drug, or suspended involvement of patients on clinical trials.
However, nearly 70% (146) of oncologists lacked any formal guidance for managing drug allocation during a shortage.
Chemotherapy shortages are very common across U.S. They compromise treatment of often curable malignancies, impede research, and lead to higher costs.
Oncologists also seem to lack formal guidance on how to address these shortages.
Oncologists across the U.S. face shortages of very common chemotherapy drugs at an alarmingly high rate.
Further studies are needed to determine the extent to which drug shortages lead to adverse outcomes for cancer patients.
National oncologic organizations need to work closely with drug manufacturers to streamline production and develop contingency plans to minimize interruptions in patient care.
In the interim, national organizations should provide general guideline to help individual physicians with optimal allocation of drugs that are in short supply.
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