Impact of oncology drug shortages

Reporter: Saumil Gandhi, MD PhD
The Abramson Cancer Center at the University of Pennsylvania
Last Modified: June 7, 2013

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Presenter: Keerthi Gogineni, MD, MSHP
Presenter's Affiliation: The Abramson Cancer Center at the University of Pennsylvania

Background

  • 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.

Methods

  • 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.

Results

  • 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.

Author's Conclusions

  • 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.

Clinical Implications

  • 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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