Perspectives of Oncology Nursing and Investigational Pharmacy in Oncology Research.

OBJECTIVES: This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process. DATA SOURCES: Government regulations, professional guidelines, and best practices. CONCLUSION: ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse's role in the process of clinical trial ID management is dependent on each institution's expectations of clinical research nurses and the scope of their role. IMPLICATIONS FOR NURSING PRACTICE: Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse's involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research.

Compounding pharmacies: before and after an inspection.

Recent events have directed the U.S. Food and Drug Administration's attention to compounding pharmacies and have increased the frequency and vigorousness of pharmacy inspections. It is critical for compounding pharmacists to be prepared for such inspections and to understand their responsibilities after an inspection is over.