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Updated: May 9, 2026
06:59
A Novel Approach for the Administration of Medications and Fluids in Emergency Scenarios and Settings
Published on: November 9, 2016
[Off-label prescription: practice and problems].
António Vaz Carneiro1, João Costa
1Centro de Estudos de Medicina Baseada na Evidência, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.
Summary
Physicians sometimes prescribe approved drugs for unapproved uses, known as off-label prescription. This practice, while potentially beneficial, presents unique advantages and challenges in patient care.
Area of Science:
- Pharmacology
- Clinical Medicine
- Drug Regulation
Context:
- Drug approval relies on randomized controlled trials (RCTs) for specific indications.
- Approved indications define a drug's net clinical benefit for particular diseases.
- Post-approval, physicians may observe efficacy in unapproved conditions.
Purpose:
- To discuss the prevalence of off-label prescription.
- To explore the advantages of using medications for unapproved indications.
- To examine the inherent problems associated with off-label prescribing.
Summary:
- Off-label prescription involves using drugs for conditions not formally approved by regulatory authorities.
- This practice arises when physicians identify potential benefits beyond the drug's initial approved uses.
- The paper examines the frequency, benefits, and drawbacks of this common clinical scenario.
Impact:
- Highlights the gap between drug approval and real-world clinical application.
- Informs discussions on drug utilization, patient safety, and regulatory oversight.
- Provides insights into the complexities of evidence-based medicine and physician decision-making.
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