A comparative assessment of current and future pharmacovigilance in developed and developing countries - A case study of Ireland and Nigeria

Abstract

The thesis objectives are to compare and evaluate the factors about reporting Adverse Drug Reactions in the developed and developing countries among healthcare professionals (Medical doctors and Pharmacists) using Ireland and Nigeria as a case study. Which a questionnaire survey and phone interviews for quantitative and qualitative analysis are carried out respectively within the two regions (Ireland and Nigeria). The challenges faced by medical professionals concerning ADR reporting are achieved based on their knowledge and awareness to determine an effective recommendation to help improve both regions using the comparison results and works of literature gathered. From the author results and analysis, both groups of healthcare professionals from the two regions were compared to determine their opinion in respect to observation and reporting of ADRs under the categories of under-reporting, ADR reporting methods, regulations and guidelines pertaining ADR report in both Ireland and Nigeria as HPRA and NAFDAC are the regulatory body responsible for handling submitted ADR reports. An Overall total of 122 respondents from both Nigeria and Ireland are received which consists of 47 respondents from Ireland (12 medical doctors and 43 pharmacists) and 75 respondents from Nigeria (32 medical doctors and 43 pharmacists) showing a response rate of 60.0% and 87.5% from 20 and 45 medical doctors and pharmacist from Ireland and response rate of 71.1% and 95.5% out of 45 respondents respectively from both medical doctors and pharmacist from Nigeria. Surprisingly, 98.0% of the correspondents which consist of 12 medical doctors and 35 pharmacists from Ireland responded to knowing how to report ADRs to compare to 71.0% from Nigeria which is quite above average consisting of 26 medical doctors and 27 pharmacists responded to knowing how ADRs is being reported. However, it shows that pharmacists had better knowledge, awareness, understanding, and experience over the medical doctors regarding ADRs reporting. However, 92.0% and 96.0% of respondents of both groups from Nigeria and Ireland respectively opted to ADR reporting being made compulsory as a professional obligation towards achieving and improving pharmacovigilance. Furthermore, the challenges affecting ADR reporting in Nigeria are associated with the inaccessibility of ADR report forms when needed, complex reporting processes while too busy and lack of time remained the most common challenging factor among this too regions. The least common challenges reported at both regions are level of clinical trial knowledge, a concern that ADR report mighty is wrong among, fear of legal liabilities, and fear of exposure to legal liabilities from patient or drug manufacturer. Finally, after proper comparison and recommendation from both sides from the country it shows the need for better improvement in awareness among healthcare professionals in Nigeria been the country with the highest level of challenges compare to their counterpart healthcare professionals and this could be achieved by organizing pharmacovigilance conferences, continuous education programs included in their professional courses and training to improve knowledge of ADR reporting. Establishment of ADR departments in healthcare institutions headed by ADR specialists and offering professional recognition rather than financial rewards are the sustainable recommendation to put in practice in both regions to further improve the practice of ADR reporting in Nigeria and Ireland. To wrap it up, the need for the regulatory bodies from the developing countries to work in hand with the developed countries to better improves awareness, knowledge, and improvement towards ADRs reporting system.