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Pharmacy-coordinated investigational drug services
American Journal of Hospital Pharmacy
|March 1, 1982
Summary
A pharmacy-coordinated investigational drug service (IDS) improves control over investigational drugs. This service ensures safe, effective, and efficient execution of clinical drug studies within hospitals.
Area of Science:
- Pharmaceutical Sciences
- Clinical Pharmacy
- Health Services Research
Background:
- Investigational drugs require careful management in hospital settings.
- Existing drug control mechanisms may not adequately address the complexities of clinical research.
Purpose of the Study:
- To propose and define the concept of a pharmacy-coordinated investigational drug service (IDS).
- To outline the essential functions and operational requirements for an effective IDS.
- To highlight the benefits of an IDS for various stakeholders in clinical research.
Main Methods:
- Conceptualization of the IDS as a set of coordinated service functions.
- Identification of key functions: drug distribution, clinical services, research activities, and study management.
- Emphasis on planning, resource allocation (personnel, financial, facilities), and management.
Main Results:
- An IDS requires dedicated personnel (estimated 80% of costs), clear job descriptions, and standard operating procedures.
- Successful implementation necessitates institutional approvals, authority, and resources.
- An ongoing quality assurance program and periodic reporting are crucial for operation.
Conclusions:
- A pharmacy-coordinated IDS enhances the safety, efficacy, and efficiency of investigational drug studies.
- The structure and scope of an IDS should be tailored to individual hospital needs and research involvement.
- Establishing an IDS requires strategic planning, resource commitment, and effective management for sustained success.