Abstract
PurposeTo evaluate the association between spontaneous reporting (SR) and the knowledge, attitude, and needs of community pharmacists (CPs), using a questionnaire following a conceptual model known as the mixed model of knowledge-attitude-practices and the satisfaction of needs.MethodsSelf-administered questionnaires were used with a nationwide convenience sample of CPs between September 1, 2014 and November 25, 2014 in Korea. The association between SR and the predictive factors was evaluated using multivariate logistic regression analysis.ResultsIn total, 1,001 questionnaires were analyzed. The mean age of the respondents and the number of years spent in community pharmacy practice were 45.6 years and 15.3 years, respectively. CPs with experience of SR was 29.4%. Being older than 60 (ORadj, 0.16; 95% CI, 0.06–0.42), having prior experience with adverse drug reactions (ADR) (ORadj, 6.46; 95% CI, 2.46–16.98), having higher specific knowledge of SR (ORadj, 3.58; 95% CI, 1.96–6.56), and having less concern about the obstacles to SR (ORadj, 0.36; 95% CI, 0.23–0.57) were significant contributing factors to SR. The main obstacles to SR included perception of ADRs as ‘not serious ADR’ (77.9%), ‘already well known ADR’ (81.5%), and ‘uncertain about causality’ (73.3%). CPs without reporting experience had greater concerns related to the reporting method and the liability of the pharmacy than those with reporting experience (p<0.05).ConclusionsFindings from our study showed around one in three CPs had ADR reporting experience in Korea, while 87.1% had prior experience with ADR cases. The knowledge of SR, prior experience of ADR, and less concern about the obstacles to SR were contributing factors for reporting levels.
Highlights
When a new drug is reviewed on its efficacy and safety for its approval, all possible side effects of the drug cannot be anticipated based on preapproval studies because the studies include only several hundred to several thousand patients [1]
The mean age of the respondents and the number of years spent in community pharmacy practice were 45.6 years and 15.3 years, respectively
Being older than 60 (ORadj, 0.16; 95% CI, 0.06–0.42), having prior experience with adverse drug reactions (ADR) (ORadj, 6.46; 95% CI, 2.46–16.98), having higher specific knowledge of spontaneous reporting (SR) (ORadj, 3.58; 95% CI, 1.96–6.56), and having less concern about the obstacles to SR (ORadj, 0.36; 95% CI, 0.23–0.57) were significant contributing factors to SR
Summary
When a new drug is reviewed on its efficacy and safety for its approval, all possible side effects of the drug cannot be anticipated based on preapproval studies because the studies include only several hundred to several thousand patients [1]. The World Health Organization has set up the International Programme for Adverse Reaction Monitoring and played a leading role in global drug safety monitoring [2]. Other health authorities such as the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA) have worked collaboratively to improve pharmacovigilance as reflected by a recent report documenting an increased level of collaboration and sharing information between EMA and FDA to advance regulatory excellence in global community.[3]. The ADR reporting rate by CPs in these countries ranged from 12.0% to 28.9% [8]
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