Knowledge, attitude and practice of hospital pharmacists towards pharmacovigilance and adverse drug reaction reporting in Najran, Saudi Arabia

Ali Mohamed Alshabi; Mohammed Ashique K Shaikh; Ibrahim Ahmed Shaikh; Saad Ahmed Alkahtani; Adel Aljadaan

doi:10.1016/j.jsps.2022.04.014

Knowledge, attitude and practice of hospital pharmacists towards pharmacovigilance and adverse drug reaction reporting in Najran, Saudi Arabia

Saudi Pharm J. 2022 Jul;30(7):1018-1026. doi: 10.1016/j.jsps.2022.04.014. Epub 2022 Apr 30.

Authors

Ali Mohamed Alshabi¹, Mohammed Ashique K Shaikh², Ibrahim Ahmed Shaikh³, Saad Ahmed Alkahtani¹, Adel Aljadaan³

Affiliations

¹ Department of Clinical Pharmacy, College of Pharmacy, Najran University, Najran, Saudi Arabia.
² Pharmacy Services Division, Najran University Hospital, Najran, Saudi Arabia.
³ Department of Pharmacology, College of Pharmacy, Najran University, Najran, Saudi Arabia.

Abstract

Introduction: Pharmacovigilance (PV) is critical in determining the risk-benefit ratio of medicines and encouraging their safe, rational, and effective use, hence enhancing patient safety and care. Pharmacists, as drug experts, share responsibility for ensuring that medicines remain safe.

Objective: The study aimed to assess the knowledge, attitude, and practice of hospital pharmacists towards PV and adverse drug reaction (ADR) reporting and to know factors that discourage them from reporting ADRs in Najran, Saudi Arabia.

Methods: A pre-tested self-administered questionnaire was distributed to all the pharmacists working in government hospitals who consented to participate in the study. Data was collected over three months, from 01 June 2018 to 31 Aug 2018. Data were analyzed using Statistical Package for Social Science (SPSS) software for Windows, version 23. Descriptive statistics such as frequency and percentages, mean ± standard deviation (SD) were calculated, and the Pearson's Chi-square test was used to examine the relationship between different variables.

Results: A total of 145 questionnaires were distributed, and the response rate obtained was 70.3%. The definition of PV and ADR were correctly identified by 42% and 68.3% of participants, respectively. A noteworthy finding is that 95% of participants were aware of the existence of the ADR reporting system, and 88.9% knew the responsible regulatory agency. Participants showed a positive attitude towards PV and ADR reporting; 90.1% considered ADR reporting a part of professional obligation, and 94.1% believed that there should be collaboration between pharmacists and other healthcare professionals. A majority of participants (86.1%) had identified an ADR during their practice, and 71.3% had reported an ADR. The unavailability of a professional environment to discuss ADR and insufficient pharmacotherapy/clinical knowledge was cited as the main factors discouraging from reporting ADRs.

Conclusions: Overall, the pharmacists had an average to good knowledge of and positive attitude towards PV and ADR reporting and a good ADR reporting practice. The concept of PV and ADR reporting should be further strengthened, and there is a vast potential for the same.

Keywords: ADR reporting; KAP; Najran; Pharmacists; Pharmacovigilance; Saudi Arabia.