Background Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Good PV practice is associated with better patient care, increased safety in medication use and better public health via continuous benefit/risk assessment of drugs.
Purpose This study aimed to assess the knowledge and awareness of adverse drug reactions (ADRs) reporting and PV system among hospital pharmacists in Macedonia and identification of the cause of under-reporting.
Material and methods Non-interventional, questionnaire-based study was conducted for a period of 3 months in order to evaluate hospital pharmacist knowledge and attitude towards PV. A total of 54 pharmacists from different secondary and tertiary healthcare organisations in Macedonia participated in the study. A validated and predesigned questionnaire comprised of 19 questions that covered three main topics: assessment of pharmacist awareness and knowledge regarding PV and ADRs reporting, pharmacists’ attitude, practice and reason for under-reporting, and pharmacists’ recommendations and suggestions to improve PV.
Results A high percentage of awareness (95%) is detected for the necessity of ADR reporting and the need for PV education among hospital pharmacists. They had a good PV knowledge and presented a positive attitude towards ADR reporting. Unfortunately PV practice is not implemented in hospitals at a satisfactory level. The factors that discourage pharmacists from reporting ADRs, include inadequate information available from the patient, need for additional PV education, as well as reinforcement of the PV system in the hospitals. These results point to the need for building proper infrastructure and a legal framework as major determinants for awareness of PV in the future.
Conclusion xA satisfactory level of knowledge and awareness of PV and ADRs reporting was demonstrated among clinical pharmacists in hospitals. The poor ADR reporting practice emphasised the urgent need for implementation of the appropriate strategies for improving the awareness of PV practices in hospitals and at the national level. It addresses the need for implementation of educational and training programmes for the hospital pharmacists in order to encourage them to actively participate in ADR reporting and raising the levels of patient safety.
No conflict of interest
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