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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug Administration and Therapy Phases: Overview01:26

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Evaluation of a pharmacist-led workflow for the FDA Expanded Access Program.

Blake T Barta1, Ann McGee2, Beth McLendon Arvik2

  • 1Duke University Hospital, Durham, NC, and University of North Carolina at Chapel Hill Eshelman School of Pharmacy, Chapel Hill, NC, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|March 25, 2024
PubMed
Summary

Pharmacists require significant resources to manage Expanded Access Programs (EAP). This study found that unreimbursed EAP services cost approximately $196,500 annually, highlighting the need for financial sustainability in compassionate use drug programs.

Keywords:
compassionate useexpanded accessinvestigational drugspharmacy servicesresearch pharmacy

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Area of Science:

  • Pharmacy Practice
  • Investigational Drug Management
  • Expanded Access Programs

Background:

  • Expanded Access Programs (EAP) facilitate patient access to investigational drugs outside of clinical trials.
  • Limited data exists on the pharmacist-led workflows and resource requirements for managing EAP requests.
  • Healthcare systems face challenges in sustaining EAP services due to a lack of reimbursement for associated labor costs.

Purpose of the Study:

  • To characterize the resources pharmacists need to manage investigational drugs for individual patient and small population EAP.
  • To identify the types of EAP requests received by a healthcare institution.
  • To share a pharmacist-led workflow for managing EAP requests.

Main Methods:

  • Retrospective, single-center, observational study.
  • Review of EAP requests submitted to Duke University Hospital (DUH) between August 1, 2017, and February 11, 2023.
  • Analysis of institutional policy impact on EAP approval rates.

Main Results:

  • Of 168 EAP requests submitted after the institutional policy requiring Pharmacy and Therapeutics (P&T) committee approval, 162 (96.4%) were approved.
  • The projected annualized cost of unreimbursed EAP services at DUH for 2023 was approximately $196,500.
  • The study identified significant labor resource requirements for EAP management.

Conclusions:

  • A pharmacist-led workflow for EAP services is essential but resource-intensive.
  • The lack of reimbursement for EAP services poses a financial challenge for healthcare systems.
  • Further strategies are needed to ensure the financial sustainability of compassionate use programs.