Paul Gavaza1, Bihn Bui. 1. Appalachian College of Pharmacy, Oakwood, VA 24631, USA. pgavaza@gmail.com
Abstract
OBJECTIVES: To determine pharmacy students' attitude toward and knowledge of reporting serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHOD: A 58-item survey questionnaire constructed to measure respondents' intention to report ADEs (3 items), attitude toward reporting ADEs (20 items), knowledge of ADE reporting (9 items), and demographic data was administered to all third-year (final-year) pharmacy students at the Appalachian College of Pharmacy. RESULTS: The majority of the 58 students who responded (91% response rate) intended (84%) and planned (85.3%) to report serious ADEs when they encounter them. Most respondents had favorable attitudes toward reporting serious ADEs to the FDA; respondents believed that reporting serious ADEs was valuable (5.6 ± 1.5, mean ± SD), good (3.0 ± 1.7), and beneficial (5.7 ± 1.5). Many students also believed that ADE reporting resulted in increased risk of malpractice, compromised relationships with physicians, broken trust with patients, disruption of the normal workflow, and was time consuming. Many students had inadequate knowledge on reporting ADEs. CONCLUSION: Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs.
OBJECTIVES: To determine pharmacy students' attitude toward and knowledge of reporting serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHOD: A 58-item survey questionnaire constructed to measure respondents' intention to report ADEs (3 items), attitude toward reporting ADEs (20 items), knowledge of ADE reporting (9 items), and demographic data was administered to all third-year (final-year) pharmacy students at the Appalachian College of Pharmacy. RESULTS: The majority of the 58 students who responded (91% response rate) intended (84%) and planned (85.3%) to report serious ADEs when they encounter them. Most respondents had favorable attitudes toward reporting serious ADEs to the FDA; respondents believed that reporting serious ADEs was valuable (5.6 ± 1.5, mean ± SD), good (3.0 ± 1.7), and beneficial (5.7 ± 1.5). Many students also believed that ADE reporting resulted in increased risk of malpractice, compromised relationships with physicians, broken trust with patients, disruption of the normal workflow, and was time consuming. Many students had inadequate knowledge on reporting ADEs. CONCLUSION: Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs.
Entities:
Keywords:
adverse drug event reporting; adverse drug events; drug safety; pharmacovigilance; theory of planned behavior
Authors: Paul Gavaza; Carolyn M Brown; Kenneth A Lawson; Karen L Rascati; James P Wilson; Mary Steinhardt Journal: Res Social Adm Pharm Date: 2010-11-05
Authors: Paul Gavaza; Carolyn M Brown; Kenneth A Lawson; Karen L Rascati; James P Wilson; Mary Steinhardt Journal: Br J Clin Pharmacol Date: 2011-07 Impact factor: 4.335
Authors: Tim Schutte; Jelle Tichelaar; Michael O Reumerman; Rike van Eekeren; Leàn Rolfes; Eugène P van Puijenbroek; Milan C Richir; Michiel A van Agtmael Journal: Drug Saf Date: 2017-05 Impact factor: 5.606
Authors: Tim Schutte; Rike van Eekeren; Milan Richir; Jojanneke van Staveren; Eugène van Puijenbroek; Jelle Tichelaar; Michiel van Agtmael Journal: Naunyn Schmiedebergs Arch Pharmacol Date: 2017-10-23 Impact factor: 3.000