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Related Experiment Video

Updated: Aug 30, 2025

Primer-Free Aptamer Selection Using A Random DNA Library

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Published on: July 26, 2010

Single-patient expanded access: A primer for pharmacists.

Andrew J F Smith¹, Kimberly A Redic¹

¹Department of Pharmacy Services, Michigan Medicine, Ann Arbor, MI, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists

|September 3, 2022

Summary

This summary is machine-generated.

Expanded access provides investigational drugs for serious conditions when other treatments fail. Pharmacists play a key role in navigating this pathway, ensuring safe and compliant patient care.

Keywords:

compassionate use expanded access investigational drugs research pharmacy right to try

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Area of Science:

Pharmacology
Regulatory Science
Clinical Pharmacy

Background:

Expanded access is a regulatory pathway for investigational drugs.
It is used for serious or life-threatening diseases when no other therapies exist or patients are ineligible for clinical trials.
Key stakeholders include drug manufacturers, the Food and Drug Administration (FDA), and institutional review boards.

Purpose of the Study:

To explain the process of expanded access for investigational drugs.
To discuss the roles and informational resources available for pharmacists in expanded access programs.

Main Methods:

Review of the expanded access regulatory framework.
Identification of pharmacist responsibilities and resources.

Main Results:

Expanded access allows treatment with non-FDA-approved agents outside of clinical trials.
Pharmacists can contribute to therapy identification, risk-benefit assessment, preparation, administration, supportive care, transitions of care, and regulatory compliance.
Various resources, including websites, publications, and organizations, can assist in navigating expanded access.

Conclusions:

Expanded access bridges clinical care and research by providing investigational treatments.
Healthcare providers should consider expanded access when approved treatment options are exhausted.