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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug shortages. Part 1. Definitions and harms.

Jeffrey K Aronson1, Carl Heneghan1, Robin E Ferner2,3

  • 1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Oxford, UK.

British Journal of Clinical Pharmacology
|July 17, 2023
PubMed
Summary
This summary is machine-generated.

Drug shortages pose significant risks to patient care, necessitating a clear operational definition. This review proposes a new definition to identify causes and guide solutions for drug supply chain disruptions.

Keywords:
adverse reactionsmedication errorspharmaceutical preparationsprescription drugsshortages

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Area of Science:

  • Pharmacoeconomics
  • Health Policy
  • Pharmaceutical Sciences

Background:

  • Drug shortages have increased significantly in recent years, impacting patient care.
  • Existing definitions of drug shortages are inadequate to address the complexity of the issue.
  • Localized shortages, termed stockouts, also contribute to the problem.

Purpose of the Study:

  • To critically review existing definitions of drug shortages and stockouts.
  • To propose a novel extensional operational definition for drug shortages.
  • To identify the harms associated with drug shortages and their management.

Main Methods:

  • Literature review of definitions and harms of drug shortages.
  • Analysis of manufacturing processes, causes, and contributing factors.
  • Development of an operational definition based on identified factors.

Main Results:

  • Current definitions are insufficient for understanding and addressing drug shortages.
  • An extensional operational definition is proposed, integrating manufacturing, causes, and contributing factors.
  • Drug shortages lead to adverse drug reactions, medication errors, undertreatment, and trial disruptions.

Conclusions:

  • A precise definition is crucial for identifying causes and developing effective solutions for drug shortages.
  • The proposed operational definition aids in pinpointing causes and guiding mitigation strategies.
  • Addressing drug shortages requires a comprehensive understanding of their multifaceted nature and impact.