"A comparative assessment of current and future pharmacovigilance in developed and developing countries - A case study of Ireland and Nigeria" by OLANREWAJU JIMOH
by
Finbarr Sheehy
| Oct 26, 2020
Medicine majorly constitutes the use of prescribing and administering drugs by healthcare professionals majorly the pharmacist and the medical doctors. The importance of these two professions is very paramount in fighting diseases and promoting good healthcare as well as the general well-being of humans. Also, the current drug discovery and research within the pharmaceutical industry have led to the will for the need for the safety and efficacy of drug products. The safety of the drug has been a major concern aftermarket authorization due to limited clinical trials which cannot prove the safety of the public health after consumption. Adverse drug reaction has always been a major challenge in the life of drug users and this cannot be avoided but rather can be prevented. The standard clinical trial phases include phase 1 which usually comprises a certain number of humans, mostly less than 20, and their safety with a lesser dosage of the drug, phase 2 is 50 to 100 towards the adequate dosage specifications. Phase 3 is usually carried towards a specific condition at which the drug is being produced for the effectiveness in treating a certain condition while phase 4 is conducted to identify the long term effects of the drug after the approval and enters the market. All these phases have led to pharmacovigilance activities of ADR reporting on how drug products are working after taking and the safety of the people using it.
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Objectives:
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.
Methodology:
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.
Findings:
An Overall total of 122 respondents from both Nigeria and Ireland are received which consists of 47 respondents from Ireland (12 medical doctors and 35 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.
Analysis:
It shows that 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.
Conclusions:
Proper comparison and recommendation from both sides from the country 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.