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Objectives:
This research aims to identify bottlenecks and loopholes that hinder effective ADR practice in tertiary hospitals in Lagos state Nigeria. The research involved major stakeholder of pharmacovigilance activities which includes; HCPs (Doctors, Nurses, and pharmacists) and patients.
1) To assess the knowledge, attitude, and practice of HCPs towards Pharmacovigilance and ADR in Lagos state tertiary hospitals.
2) Determine HCPs' perception towards direct patient reporting of ADR.
3) To elicit patients' experience regarding ADR reporting and evaluate its impacts on pharmacovigilance structure.
4) To make sustainable recommendations which invariably will contribute to the overall pharmacovigilance system in place in the hospitals.
Methodology:
This research was modelled on a mixed-method approach that was underlined by a deductive approach and positivist philosophy. The primary data was collected using an online survey and phone interview. The survey was targeted at 450 participants, and a total of 405 respondents were obtained in return in which 270 were patients, and 135 were HCPs (doctors, nurses, and pharmacists) recording a response rate of 90%. For the interview, 12 people were scheduled to be interviewed but 6 responses were obtained which includes 2 doctors, 2 nurses, and 2 pharmacists recording a response rate of (50%).
Findings:
From the analysis conducted a significant number of HCPs participants have basic understanding of ADR but have no knowledge of causality assessment and they established that they are not sufficiently trained on how to assess and report ADR. Several bottlenecks such as lack of knowledge/awareness, lack of feedback from NPC, unavailability of ADR reporting forms, insufficient staffs, and excessive workload were established as most challenging issues. However, a highly significant number 92% are willing to update their knowledge on ADR practice and opted to make it a mandatory obligation to help resolve underreporting issues faced by the country. A significant number of Patients participants established they are not familiar with ADR and the importance of reporting, while HCPs acknowledged they are not aware that patients can report ADR directly neither do they think it’s a good idea because they are of the perception that patients can’t generate valid/quality ADR reports.
Analysis:
Although the regulatory agency in Nigeria (NAFDAC) has set in place the ideal models needed for reporting, however, their performance towards awareness and publicity of ADR was rated poorly and this in turn is a huge barrier in promoting drug safety practice and pharmacovigilance system in Nigeria. However, from reviewed literature and findings obtained from the study, it can be deduced that global underreporting issues are significantly associated with lack of knowledge and adequate resources dedicated to identify, assess, monitor, and report potential ADRs effectively. The reporting and assessing medium in Nigeria tertiary hospitals are inadequately efficient and somehow being underutilized by Nigerians including its HCPs and healthcare providers due to lack of dedicated resources to the process, and persistent focus on knowledge acquisition instead of its implementation and feasibility. The resulting effect of this act is the burden of ADR faced by the country and inability to achieve required ADR reported cases despite the high mortality and morbidity rate associated with ADR cases in the country.
Conclusions:
Nigeria is earmarked as a fast developing country and a leading nation in the future, therefore the country has to be established in all aspects especially the healthcare system starting with its HCPs and regulatory agency. Patients should be educated, encouraged, and actively involved on ADR reporting because they have the potential to add value to generated reports by providing more detailed reports which can help detect likely causality and impact on patients’ lives. Creating more awareness, organising frequent training, workshop, and seminars to update the knowledge of HCP, dedicating adequate resources, incorporating ADR module into the curriculum of HCPs during their undergraduate and orientation program when newly employed, establishing an active pharmacovigilance centres in tertiary hospitals to help monitor and guide ADR practice, educating and encouraging patients on ADR reporting and its importance, are sustainable recommendations that will improve ADR practice and contribute invariably to pharmacovigilance system in Nigeria.