title: Medication Safety in Clinical Trials: Role of the Pharmacist in Optimizing Practice, Collaboration, and Education to Reduce Errors.
abstract: Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates multiple mechanisms to promote safety and improve the quality of clinical research. This is accomplished through collaborating in the development of a research protocol, reviewing as a member of an advisory committee, developing mechanisms that contribute to safety, and assuring compliance with local and national regulations and standards. Ultimately, the profession of pharmacy has foundational responsibility for assuring the safe and effective use of medications, including investigational drugs in clinical research. It is through multidisciplinary collaboration that a research study will attain the highest standards for safety and maximize the quality and effectiveness of the data obtained in the clinical trial.
authors.affiliation: Durham VA Health Care System, Durham, NC.
authors.forename: Jamie N
authors.initials: JN
authors.lastname: Brown
authors.affiliation: Durham VA Health Care System, Durham, NC.
authors.forename: Sara R
authors.initials: SR
authors.lastname: Britnell
authors.affiliation: University of North Carolina Medical Center, Chapel Hill, NC.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Stivers
authors.affiliation: University of North Carolina Medical Center, Chapel Hill, NC.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Cruz
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D003299:Cooperative Behavior; D006801:Humans; D061214:Patient Safety; D010595:Pharmacists
keywords: clinical trials; investigational drug service; patient safety; pharmacy practice; research pharmacist