An Analysis on the Assessment and Reporting of Adverse Drug Reactions in Tertiary Hospitals in Lagos State, South-West Nigeria.

Abstract

Due to repeated occurrence of serious, unexpected ADR over the years, lots of professionals and public attention has been drawn to ADRs, and this has led to more focused attention on drug safety surveillance system. ADR incidence is associated with high rate of morbidity and mortality and this incidence cut across all age groups with a large number of hospitalisation, and huge financial burden on Nigeria healthcare system and the society. Unfortunately, the assessment, monitoring, and reporting system of ADR in Nigeria healthcare system still have lots of room for improvements, especially with the involvement of tertiary hospitals in Nigeria. Due to the above-stated problems, the assessment and analysis of ADR are critical to promptly detect the likely safety and security issues that might be associated with medicinal products; hence this research aims to analyse assessment and reporting of ADR in Tertiary Hospitals in Lagos State, South-West Nigeria”. The purpose of this research is to identify bottlenecks and loopholes in the system that hinders 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 of tertiary hospitals. It aims to interact with HCPs to determine their perception towards direct patient reporting of ADR. Also patients were considered in the study to determine their level of awareness/knowledge towards ADR reporting. 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 in which 2 were doctors, 2 were nurses, and 2 were pharmacist recording a response rate of (50%). From the analysis conducted a significant number of the 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, cumbersome procedures, 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 the HCPs also acknowledge that they are not aware that patients can report ADR directly neither do they think it is a good idea because they are of the perception that patients can’t generate a valid/quality ADR reports. Creating more awareness for both HCPs and general public, organising frequent training, workshop and seminars to update the knowledge of HCPs, providing adequate resources, incorporating ADR module into the curriculum of HCPs both 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 it is importance, are sustainable recommendations that will improve ADR practice and contribute invariable to pharmacovigilance system in Nigeria.