Objectives:

The author explored the knowledge, attitude and experience of ADR spontaneous reporting among medical doctors and pharmacists in line with established guidelines and regulations by the relevant authorities in Nigeria. Although current spontaneous reporting practices are less than optimal, this research dissertation was aimed at articulating effective strategies that could be optimally leveraged to improve the frequency and quality of reporting while driving better positive health outcomes for patients across Nigeria. An outline of the research objectives include:

1. To evaluate the knowledge and awareness of ADR reporting among healthcare professionals in Nigeria

2. To assess challenges among healthcare professionals in the practice of ADR reporting in Nigeria.

3. To make sustainable recommendations to improve ADR reporting among healthcare professionals in Nigeria.

Methodology:

Primary and secondary research methods were utilised by the author through the electronic dissemination of questionnaires, phone interviews and literature reviews. The secondary research was first carried out to explore relevant current literature from reputable research databases and journals on ADR reporting to determine the gaps as it pertains to the established research objectives. Attempts to fill these gaps were subsequently carried out through primary research by distributing questionnaires to 140 medical doctors and pharmacists (74.3% response rate), which constituted the approach for quantitative analysis. Phone interviews were further conducted for qualitative analysis with 10 highly experienced healthcare professionals (over 10 years of experience). The author applied the positivism and interpretivism philosophies to analyse the questionnaire and phone interview findings respectively.

Findings:

Both groups of healthcare professionals were compared to determine their opinions on frequency of observed and reported ADRs, reasons for high underreporting rates, awareness of ADR reporting methods, guidelines and regulations as well as the NAFDAC regulatory body responsible for handling submitted ADR reports. A total of 104 out of 140 responded to the survey, of whom 53 (75.7%) were medical doctors and 51 (72.9%) were pharmacists. 34.0% of medical doctors who responded did not know how to report ADRs compared to just 5.9% of pharmacists who responded. In ascertaining familiar ADR reporting method, 39.0% of respondents selected yellow cards/ADR forms, 11.0% of respondents selected the ADR e-reporting form while 25.0% of respondents were familiar with both methods. 25.0% of respondents were unfamiliar with any of the methods for reporting ADRs in Nigeria. 36.0% of respondents admitted having reported an ADR within the past 12 months. The majority 57.0% of respondents indicated not to have reported an ADR in the past 12 months while 7.0% of respondents were unsure if they did. An overwhelming 90.0% of respondents opted for ADR reporting being made compulsory as a professional obligation towards pharmacovigilance.

Analysis:

Analysis showed that medical doctors and pharmacists have only an average knowledge and awareness of ADR reporting in Nigeria. They can correctly identify ADRs and the criteria for reporting but effective reporting remains a challenge. Pharmacists had better knowledge, awareness and experience over medical doctors regarding ADR reporting in Nigeria. However, despite overall poor attitudes to reporting ADRs, both groups exhibited a willingness to do better if proper continuous education and training is made available. NAFDAC performed poorly in raising awareness, providing training and encouraging better drug safety practices and pharmacovigilance. Very few healthcare professionals are aware of the guidelines or regulations governing the ADR reporting system in Nigeria. The authorities rarely acknowledge or follow up on reported ADRs which results in poor reporting rates. Factors varied among both groups as the challenges faced by medical doctors does not translate to the same challenge faced by pharmacists. However, both groups of HCPs agree that ADR reporting should be made a professional obligation to improve ADR reporting in Nigeria. Despite an overwhelming acceptance of the authors' recommendations, some opposed extra remunerations for every ADR reports made as it might distract from the ideal purpose of ADR reporting and pharmacovigilance- improving drug and patient safety in Nigeria.

Conclusions:

Factors ranging from indifference to ADR reporting, poor knowledge and accessibility of reporting methods, poor awareness of guidelines surrounding the reporting procedures are to great extent the same as observed from other studies in Nigeria and other countries. While few studies on ADR reporting in Nigeria compare multiple groups of healthcare professionals, this study demonstrates that pharmacists are more predisposed to favorable outcomes regarding ADR reporting than their medical doctor counterparts. Improving ADR reporting in Nigeria would greatly reduce the healthcare costs and mortality rates and further reduce the incidence of ADRs observed. As suggested by both groups of healthcare professionals, a review of regulations to make ADR reporting compulsory as a professional obligation towards patient safety bears great potential. The course content of the medical and pharmaceutical students should be reviewed to include modules on ADR reporting and tutorials on pharmacovigilance and drug safety practices prior to graduation. Health institutions should establish ADR departments headed by ADR specialists to improve reporting rates in Nigeria and foster liaison with the National Pharmacovigilance centers.