Literature DB >> 26240744

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

Jennifer L Cruz1, Jamie N Brown2.   

Abstract

OBJECTIVES: Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs.
METHODS: An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols.
RESULTS: Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed.
CONCLUSIONS: Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

Keywords:  clinical trials; investigational drugs; medication safety; pharmacy practice; research pharmacist

Year:  2015        PMID: 26240744      PMCID: PMC4519741          DOI: 10.1177/2042098615584924

Source DB:  PubMed          Journal:  Ther Adv Drug Saf        ISSN: 2042-0986


  4 in total

1.  Using preprinted medication order forms to improve the safety of investigational drug use.

Authors:  Helen Tamer; Nadine Shehab
Journal:  Am J Health Syst Pharm       Date:  2006-06-01       Impact factor: 2.637

2.  Reducing the potential for mistakes with investigational drugs.

Authors:  Matthew Grissinger
Journal:  P T       Date:  2011-03

3.  Investigational drug practices in Michigan hospitals.

Authors:  I A Cohen; M L Foote; D M Kirking; R M Tankanow; P F Conlon
Journal:  Am J Hosp Pharm       Date:  1989-07

4.  National survey of pharmacy-coordinated investigational drug services.

Authors:  L M Young; C M Haakenson; J H Weber; T J Tosch
Journal:  Am J Hosp Pharm       Date:  1984-09
  4 in total
  2 in total

Review 1.  Medication Safety in Clinical Trials: Role of the Pharmacist in Optimizing Practice, Collaboration, and Education to Reduce Errors.

Authors:  Jamie N Brown; Sara R Britnell; Andrew P Stivers; Jennifer L Cruz
Journal:  Yale J Biol Med       Date:  2017-03-29

2.  Economic outcomes associated with an investigational drug service within a Veterans Affairs health care system.

Authors:  Jamie N Brown; Frank Tillman; Sherin Jacob; Sara R Britnell
Journal:  Contemp Clin Trials Commun       Date:  2019-04-06
  2 in total

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