학술논문
Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods
Document Type
Report
Author
Source
Drug Safety. September 1, 2011, Vol. 34 Issue 9, p755, 8 p.
Subject
Language
English
ISSN
0114-5916
Abstract
Background When a new drug is licensed, data on the drug's safety are incomplete. The information acquired from preclinical trials is limited because of small sizes and short study periods. [...]
Background: Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented in medical education over the last decade, with a shift in training methods from those aimed predominantly at the transfer of knowledge towards those that are more practice based and skill oriented. It is conceivable that these changes have an impact on pharmacovigilance training in vocational training programmes. Therefore, this study compares the effectiveness of a skill-oriented, practice-based pharmacovigilance training method, with a traditional, lecture-based pharmacovigilance training method in the vocational training of general practitioners (GPs). The traditional, lecture-based method is common practice in the Netherlands. Objective: The purpose of this study was to establish whether the use of a practice-based, skill-oriented method in pharmacovigilance training during GP traineeship leads to an increase of reported ADRs after completion of this traineeship, compared with a lecture-based method. We also investigated whether the applied training method has an impact on the documentation level of the reports and on the number of unlabelled events reported. Study Design: A retrospective cohort study. The number of ADR reports submitted to the Netherlands Pharmacovigilance Centre Lareb (between January 2006 and October 2010) after completion of GP vocational training was compared between the two groups. Documentation level of the reports and the number of labelled/unlabelled events reported were also compared. Results: The practice-based cohort reported 32 times after completion of training (124 subjects, 6.8 reports per 1000 months of follow-up; total follow-up of 4704 months). The lecture-based cohort reported 12 times after training (135 subjects, 2.1 reports per 1000 months of follow-up; total follow-up of 5824 months) [odds ratio 2.9; 95% CI 1.4, 6.1]. Reports from GPs with practice-based training had a better documentation grade than those from GPs with lecture-based training, and more often concerned unlabelled events. Conclusions: The practice-based method resulted in significantly more and better-documented reports and more often concerned unlabelled events than the lecture-based method. This effect persisted and did not appear to diminish over time.
Background: Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented in medical education over the last decade, with a shift in training methods from those aimed predominantly at the transfer of knowledge towards those that are more practice based and skill oriented. It is conceivable that these changes have an impact on pharmacovigilance training in vocational training programmes. Therefore, this study compares the effectiveness of a skill-oriented, practice-based pharmacovigilance training method, with a traditional, lecture-based pharmacovigilance training method in the vocational training of general practitioners (GPs). The traditional, lecture-based method is common practice in the Netherlands. Objective: The purpose of this study was to establish whether the use of a practice-based, skill-oriented method in pharmacovigilance training during GP traineeship leads to an increase of reported ADRs after completion of this traineeship, compared with a lecture-based method. We also investigated whether the applied training method has an impact on the documentation level of the reports and on the number of unlabelled events reported. Study Design: A retrospective cohort study. The number of ADR reports submitted to the Netherlands Pharmacovigilance Centre Lareb (between January 2006 and October 2010) after completion of GP vocational training was compared between the two groups. Documentation level of the reports and the number of labelled/unlabelled events reported were also compared. Results: The practice-based cohort reported 32 times after completion of training (124 subjects, 6.8 reports per 1000 months of follow-up; total follow-up of 4704 months). The lecture-based cohort reported 12 times after training (135 subjects, 2.1 reports per 1000 months of follow-up; total follow-up of 5824 months) [odds ratio 2.9; 95% CI 1.4, 6.1]. Reports from GPs with practice-based training had a better documentation grade than those from GPs with lecture-based training, and more often concerned unlabelled events. Conclusions: The practice-based method resulted in significantly more and better-documented reports and more often concerned unlabelled events than the lecture-based method. This effect persisted and did not appear to diminish over time.