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

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.