Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process

Abstract

Purpose Patients' safety is a public concern in healthcare systems across the world and should be ensured, among others, by pharmacovigilance based on spontaneous reports of adverse drug reactions (ADRs). Spontaneous ADRs reporting is an important component of the pharmacovigilance system. The role of pharmacists in spontaneous ADRs reporting is crucial in the pharmacovigilance system since it helps to monitor the patients' treatment in real‐life conditions. The aim of the study was to evaluate the pharmacists' attitudes to and knowledge on spontaneous ADRs reporting in Poland and to identify the reasons for underreporting of ADRs. Methods The study was conducted between January 2016 and January 2018. A self‐administered questionnaire was designed and distributed to pharmacists. The pharmacists were randomly selected from the official database kept by the chief pharmaceutical inspectorate in Poland. Results Only 16% (n = 84) of the respondents have ever attended a training on pharmacovigilance. Eighty‐one percent (N = 422) of pharmacists believe that not all synthetic drugs available on the market were safe. Twenty‐eight percent (n = 146) of the respondents were certain about safety of drugs of natural origin, and 16% (n = 84) were of an opinion that adverse reactions following administration of such drugs should not be reported at all. Conclusions To conclude, there is an increasing awareness of the need to develop pharmacovigilance practices. The current (not fully adhered to in practice) model of pharmacovigilance and its associated tools have been developed for synthetic drugs, and applying these methods to monitor safety of herbal medicines presents unique challenges.

Adverse drug event reporting by pharmacists: a systematic literature review

“…More working experience as a pharmacist was found to increase the odds of reporting in three studies [32,38,39] but was not significant in other studies [47,62] and was associated with better knowledge and attitude towards ADE and ADE reporting in one study [63] and with reduced knowledge in other two studies [56,59] . Increasing years of experience (10-14 years) increased the awareness about the presence of the national ADE reporting system.…”

“…Many studies included in this review lacked a theoretical framework. In papers in which a theoretical framework was utilized, Inmans’ seven deadly sins for not reporting ADEs; Knowledge‐Attitude‐Practice Model (KAP); and theory of planned behaviour were the most frequently used theories to understand pharmacists' reporting of ADEs …”

“…[24,[36][37][38] Many studies included in this review lacked a theoretical framework. In papers in which a theoretical framework was utilized, Inmans' seven deadly sins for not reporting ADEs [32,33,35,39,40] ; Knowledge-Attitude-Practice Model (KAP) [29][30][31]34,[41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56] ; and theory of planned behaviour were the most frequently used theories to understand pharmacists' reporting of ADEs. [57] reporting [58] and knowledge [59] of ADEs in two studies.…”

“…(2019) [56] 2019 Poland NA To evaluate the pharmacists' attitudes to and knowledge on spontaneous ADR reporting in Poland and to identify the reasons for underreporting of ADRs Pharmacists NM…”

Pharmacy‐led pharmacovigilance: Ready for use or missed opportunity?

“…In this issue of the journal, two different perspectives from Europe, ie, from Wales in the United Kingdom and Poland, are presented on the increasing, but also challenging, role of pharmacists in pharmacovigilance . This is not a new voice, and also in other regions (eg, United States, Saudi Arabia, and China) in the world, similar experiences on the potential contribution of pharmacists to pharmacovigilance are flagged and shared.…”