– Assistant Professor, Taif University, Taif, Makkah, Saudi Arabia
Background: Under-reporting is a significant challenge experienced in pharmacovigilance programs worldwide. In Saudi Arabia, it considered as a significant concern, attributed to a lack of knowledge and training in healthcare providers about pharmacovigilance and maintaining the safety of medication. There are limited studies available with community pharmacists, attributed to the lack of understanding of ADR reporting and pharmacovigilance awareness in Saudi Arabia.
Objectives: The study assessed the knowledge, attitude, and practice of community pharmacists of the pharmacovigilance and adverse drug reactions (ADRs) reporting system in Saudi Arabia.
Methods: A survey-based cross-sectional study was conducted from November 2020 to January 2021 with a convenient sample of community pharmacists from the different regions of Saudi Arabia to assess their knowledge, attitude, and practice to pharmacovigilance and ADR reporting. Descriptive statistics were used and are presented as frequency (N) and percentage (%) to describe the knowledge, attitude, and practice of the sample related to pharmacovigilance and ADR reporting.
Results: Responses were received from 1172 community pharmacists. Most of the respondents (86.7%) were familiar with the National Pharmacovigilance and Drug Safety Center, and 830 (70.8%) knew about the ADR reporting form. The majority (94%) of the sample agreed with the importance of ADR reporting for patient care and national health. Although 92.2% of the participants asked their patients about ADRs, 90.2% agreed that more training programs is required by the Saudi Food and Drug Authority (SFDA) for healthcare professionals on ADRs detection and the reporting system. Analgesic agents were highest category in which ADRs were reported (67.4%). The majority (92.1%) of the ADRs reported occurred in patients with chronic diseases.
Conclusions: The present study illustrated the improvement of the knowledge, attitude, and practice of community pharmacists regarding pharmacovigilance and ADR reporting. The Saudi Food and Drug Authority (SFDA) is advised to implement good pharmacy practice guidelines and standards, and continuous educational programs to enhance the current practices of community pharmacists regarding pharmacovigilance and ADR reporting.
