Daniel L Hertz1, Rivka Siden2, Jessie Modlin3, Linda Lee Gabel4, Siu Fun Wong5. 1. Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI dlhertz@med.umich.edu. 2. Oncology Clinical Trials Support Unit, University of Michigan, Ann Arbor, MI. 3. St. Luke's Mountain States Tumor Institute, Boise, ID. 4. Smilow Hospital at Yale New Haven Hospital, New Haven, CT. 5. Chapman University School of Pharmacy, Irvine, CA.
Abstract
PURPOSE: The frequency and process for drug interaction (DI) screening at sites enrolling patients into SWOG clinical trials were studied. METHODS: Survey invitations were e-mailed to 180 SWOG head clinical research associates to determine the frequency of and personnel involved in DI assessment in subjects who were screened for and enrolled in clinical trials at their sites. Descriptive statistics were performed to evaluate the data. RESULTS: A total of 83 surveys recorded a response to at least 1 question, yielding an overall response rate of 46.1%. At least 72 completed surveys were submitted, for a completion rate of 40.0%. The majority of sites (51%) reported that DI screening only occurred during eligibility assessment when a DI was included in the protocol exclusion criteria. The pharmacist was "always" involved in DI screening during eligibility assessment at 17% of sites. Clinical research coordinators (56%) and research nurses (45%) were the predominant personnel who performed DI screening to assess eligibility for trial enrollment. A subset of sites (3-6%) reported not having access to a pharmacist. Fewer than 10% of sites reported that they "always" use drug information services, websites, resources, or literature searches, though many tools were used "often" or "sometimes" by more than 20% of sites. CONCLUSION: A survey revealed that DI screening was not being systematically conducted within SWOG clinical trials. When DI screening did occur, it was primarily conducted by clinical research coordinators or study nurses. Pharmacist-led DI screening was not the current practice within SWOG sites surveyed and was precluded by a lack of pharmacists' availability or involvement.
PURPOSE: The frequency and process for drug interaction (DI) screening at sites enrolling patients into SWOG clinical trials were studied. METHODS: Survey invitations were e-mailed to 180 SWOG head clinical research associates to determine the frequency of and personnel involved in DI assessment in subjects who were screened for and enrolled in clinical trials at their sites. Descriptive statistics were performed to evaluate the data. RESULTS: A total of 83 surveys recorded a response to at least 1 question, yielding an overall response rate of 46.1%. At least 72 completed surveys were submitted, for a completion rate of 40.0%. The majority of sites (51%) reported that DI screening only occurred during eligibility assessment when a DI was included in the protocol exclusion criteria. The pharmacist was "always" involved in DI screening during eligibility assessment at 17% of sites. Clinical research coordinators (56%) and research nurses (45%) were the predominant personnel who performed DI screening to assess eligibility for trial enrollment. A subset of sites (3-6%) reported not having access to a pharmacist. Fewer than 10% of sites reported that they "always" use drug information services, websites, resources, or literature searches, though many tools were used "often" or "sometimes" by more than 20% of sites. CONCLUSION: A survey revealed that DI screening was not being systematically conducted within SWOG clinical trials. When DI screening did occur, it was primarily conducted by clinical research coordinators or study nurses. Pharmacist-led DI screening was not the current practice within SWOG sites surveyed and was precluded by a lack of pharmacists' availability or involvement.
Authors: Lauren A Marcath; Taylor D Coe; Faisal Shakeel; Edward Reynolds; Mike Bayuk; Steven Haas; Bruce G Redman; Siu-Fun Wong; Daniel L Hertz Journal: J Patient Saf Date: 2021-01-01 Impact factor: 2.243