The development of a pharmacovigilance system in Bahrain

Abstract

IntroductionThe pharmacovigilance system is playing a vital role in the process of patient safety through reporting of ADRs and other drug-related problems. Although, the.Pharmacovigilance system is well established in other Gulf Cooperation Countries (GCC). In Kingdom of Bahrain, the Pharmacovigilance system is still in its early stages. Establishing a successful Pharmacovigilance system in Bahrain requires a collective effort from various stakeholders such as the ministry of health and the National Health Regulatory Authority (NHRA). AimTo assess the current status of the Pharmacovigilance system in Bahrain and the feasibility of its development. ObjectivesTo investigate the current Pharmacovigilance activities in Bahrain, to explore the attitude / knowledge of healthcare providers towards PV systems and to identify the limitations, and barriers of the PV system in Bahrain. MethodologyThis was a descriptive cross-sectional study utilising an online survey composed of 24 questions. It was distributed to pharmacists, physicians, and nurses working at government and private hospitals in Bahrain through emails and social media. In addition, a telephone interview was performed with a pharmacist working for NHRA in Bahrain. Ethics approval was prior to commencing the study. ResultsMore than half of the respondents (69.8%) did not report any ADRs so far in their practice, whereas 30.2% had done so. A total of 95.8% of those who have never reported before were willing to report in the future. Participants who received training regarding reporting ADRs reported lower positive attitudes (3.3 ± 0.8 vs 3.6 ± 0.6). In addition, the participants were more knowledgeable about the ADRs reporting process than the PV system. The results showed the absence of an active PV program. The activity of PV in Bahrain is limited to receiving notifications and periodic safety update records from manufactures or the GHC. Conclusion: Despite the average level of knowledge of healthcare providers towards the PV system, the results indicated a negative attitude. Moreover, some barriers were reported. Establishing a specialised PV centre is the next step to improve the status of PV system in Bahrain.