Abstract

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects. Healthcare professionals (HCPs) have an important role in reporting Adverse Drug Reaction (ADR) cases. However under-reporting has been a major challenge in PV. Hence, we assessed the knowledge, attitude and practice (KAP) of HCPs about PV in a tertiary hospital of Kathmandu. A cross-sectional study was conducted using pretested questionnaire consisting of 21 closed ended questions (twelve on knowledge, five on attitude, four on practice and one open ended question to know the causes of under-reporting. Out of 520 HCPs, 448 (207 doctors and 241 nurses) participated in the study with the response rate of 86.2%. The mean KAP score for doctors was 10.38 ± 2.68 and 9.60 ± 2.32 for nurses. The major barriers for under-reporting were identified as the difficulty in deciding if it’s an ADR and lack of time to report ADRs. No significant correlation between knowledge and attitude of the HCPs was found (r=0, n=448, p< 0.01). However, there was a weak positive correlation between knowledge and practice (r= 0.05, n=448, p< 0.01) and also for attitude and practice (r= 0.09, n=448, p< 0.01). Hence, the HCPs had poor knowledge and practice but positive attitude towards PV. It is therefore strongly recommended to have an immediate educational intervention among the HCPs to improve the spontaneous ADR reporting.

Highlights

  • Drugs are a boon to the mankind but their use is often associated with unavoidable and undesirable adverse drug reactions (ADRs)

  • While assessing the healthcare professionals (HCPs)’ knowledge of PV, it was found that majority of the HCPs had knowledge

  • HCPs’ attitude towards PV The participants showed positive attitude towards PV. 94.4% of the participants thought that reporting an ADR is necessary while 81.5% opined that PV centre should be established in every hospital. 76.6% thought that reporting an ADR is a professional obligation for them so 84.6% felt that ADR reporting should be made mandatory

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Summary

INTRODUCTION

Drugs are a boon to the mankind but their use is often associated with unavoidable and undesirable adverse drug reactions (ADRs). The aims of PV are: assessing, collecting, monitoring, researching and evaluating ADRs related information; the ultimate goal being the safe use of drugs.[6,7] PV is important for reducing morbidity and mortality related to ADRs. The National Centre for PV in Nepal is regulated by the Department of Drug Administration since 2004 to liaison with WHO collaborating centre for International Drug Monitoring located in Sweden. As few as 40 reports of ADRs have been collected so far.[11] under-reporting of ADRs is a major problem in this reporting centre This can be due to gaps in the knowledge, attitude and practice (KAP) of PV among healthcare professionals (HCPs). Studies done to assess KAP of PV among HCPs had shown lack of awareness and knowledge as an important barrier in the reporting of ADR.[6,11,12].

MATERIALS AND METHODS
HCPs’ attitude towards PV
HCPs’ practice regarding PV
Factors causing under-reporting of ADR
Comparison of KAP scores among doctors and nurses
DISCUSSION
10. Department of
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