Knowledge, attitude and practice of pharmacists to pharmacovigilance and adverse drug reactions reporting process: a cross-sectional study in Kosovo

Selvete Shuleta Qehaja,Zorica Naumovska,Erblin Elezi,Ljubica Shuturkova,Aleksandra Kapedanovska,Zoran Sterjev,Virtyte Krasniqi

doi:10.33320/10.33320/maced.pharm.bull.2021.67.01.007

Abstract

Pharmacovigilance (PV) and drug safety monitoring have an essential role in protecting public health. A cross-sectional study evaluated pharmacist knowledge, attitude and practice toward PV and adverse drug reactions (ADRs) reporting. The structured validated questionnaire was distributed to 550 randomly selected pharmacists in the whole Kosovo region. 405 out of 550 pharmacists responded to the questionnaire. Most pharmacists have insufficient knowledge about pharmacovigilance and the ADRs reporting process. The main reasons for under-reporting were little knowledge of pharmacovigilance and adverse reporting process, lack of time, and lack of infrastructure. However, pharmacists showed a positive attitude and stated that they would practice pharmacovigilance if they receive the training. There is a necessity to intensify communication among all stakeholders involved in PV. In addition, continuous training and education are needed to increase pharmacist's awareness and knowledge of PV and their participation in the ADRs reporting process. Keywords: Pharmacovigilance, adverse drug reaction, knowledge, attitude, practice, pharmacists, Kosovo

Highlights

IntroductionPharmacovigilance (PV) is the “science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem” (WHO, 2002)
Pharmacovigilance (PV) is the “science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem” (WHO, 2002).As stated by the International Pharmaceutical Federation (FIP), the “safety monitoring of medicines is an integral part of clinical practice” (FIP, 2006).Kosovo is a lower-middle-income country withPV Department within Kosovo Medicines Agency (KMA) has been established since 2006, and legalS
67.9% of participants were community pharmacists, while 32.1 % were engaged in positions unrelated to community pharmacy

Summary

Introduction

Pharmacovigilance (PV) is the “science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem” (WHO, 2002). As stated by the International Pharmaceutical Federation (FIP), the “safety monitoring of medicines is an integral part of clinical practice” (FIP, 2006). PV Department within Kosovo Medicines Agency (KMA) has been established since 2006, and legal. Elezi provisions regarding PV have been updated according to the EU legislation (KMA, 2021). There is still a low number of reports on suspected adverse drug reactions (ADR) submitted by healthcare professionals, including pharmacists

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