Abstract

Aim To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective. Methods A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses' knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included. Results Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint. Conclusion Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses' knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.

Highlights

  • Adverse drug reaction (ADR) is defined by the World Health Organization (WHO) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function” [1]

  • This review identified that 53.6% of nurses told patients about possible ADR

  • Nurses have a positive attitude toward PV and ADR reporting, their knowledge and practice in pharmacovigilance activities and ADR reporting were not at a suitable level of competence

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Summary

Introduction

Adverse drug reaction (ADR) is defined by the World Health Organization (WHO) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function” [1]. Pharmacovigilance (PV) refers to ADR reporting, defined by the WHO as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems” [1]. National PV systems were developed by many countries after the thalidomide disaster in the 1960s [9]. These systems allow continuous monitoring of all drugs used in clinical settings and enable the creation of alerts for identifying new ADRs. These systems allow continuous monitoring of all drugs used in clinical settings and enable the creation of alerts for identifying new ADRs Their strength is entirely related to the actual rate reported by healthcare practitioners [10]

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