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Ethical Issues in New Drug Prescribing

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Abstract

We use the format of a hypothetical case study to review issues related to pharmaceutical product approval and physician prescribing practices. In this case, a new FDA-approved drug is recommended for a patient who subsequently experiences an adverse event that may or may not be related to the prescription. This case raises a number of ethical and legal considerations physicians routinely face when deciding whether to recommend such drugs for their patients. Despite the need for ongoing observation by the regulatory apparatus, physicians should be cognizant of the limitations of the drug approval system and the post-approval prescription drug surveillance system. We discuss physicians’ ethical obligations when faced with a newly approved drug, including seeking out independent sources of learning, reporting adverse effects, and notifying patients about limitations in available knowledge about therapeutic recommendations.

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Acknowledgements

Dr. Aaron Kesselheim is supported by a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01) and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. The authors report no potential conflicts of interest.

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Authors and Affiliations

  1. Harvard Medical School, Boston, MA, USA

    Lindsay W. Cole

  2. Division of Pediatric Hematology-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

    Jennifer C. Kesselheim

  3. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Aaron S. Kesselheim

  4. Division of Pharmacoepidemiology and Pharmacoeconomics, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA

    Aaron S. Kesselheim

Authors
  1. Lindsay W. Cole
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  2. Jennifer C. Kesselheim
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  3. Aaron S. Kesselheim
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Correspondence to Aaron S. Kesselheim.

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The case presented here is hypothetical, although it is based on common features of real-life cases.

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Cole, L.W., Kesselheim, J.C. & Kesselheim, A.S. Ethical Issues in New Drug Prescribing. Bioethical Inquiry 9, 77–83 (2012). https://doi.org/10.1007/s11673-011-9342-y

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  • DOI: https://doi.org/10.1007/s11673-011-9342-y

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