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.

 Objectives:

The study objectives are follows:

- To identify the key regulations on drug importation and its impact on Local Manufacturing in Nigeria

- Identify the impact (positive and/or negative) of foreign contract manufacturing on local drug manufacturing

- Identify the key challenges faced by local drug manufacturers in Nigeria

- Provide recommendations to improve the local drug manufacturing in Nigeria.

Methodology:

To determine the impacts of drug importation regulations on local pharmaceutical manufacturing in Lagos Nigeria, the author adopted a quantitative and qualitative research method by using questionnaire surveys and zoom meeting interviews. The survey was distributed electronically to the local pharmaceutical manufacturing industries in Lagos Nigeria, who are also key importers of drugs in Nigeria. They are the main research group and were asked to fill the survey through the cooperation and assistance of the union (PMGMAN) that made their contacts available to the author. The cooperation between the local pharmaceutical unions in Nigeria assisted the author in gathering the required information and data used for the statistical analysis. The questions asked was specifically meant to get the general perception of the key players in the Nigeria pharmaceutical industry. Most importantly, to determine the impacts of drug importation regulations on local pharmaceutical industry in Lagos Nigeria. Along the same lines to get the challenges and recommendation for the growth of the industry that have depended so much on CMOs from India and China for 70% of their drugs. The qualitative approach of this research was via zoom meeting interviews to understand personal experience of the local drug manufacture’s and importers who have been in the business for more than one decade.
 
Findings:

The thesis aims at evaluating the impacts of drug Importation regulation on local pharmaceutical manufacturers in Lagos Nigeria by carrying out a questionnaire-based surrey and zoom interviews for quantitative and qualitative analysis respectively. In achieving the objectives of the study, the knowledge, awareness, and drawbacks faced by the local pharmaceutical industry were appropriately considered in order to derive at effective recommendations to improve local drug manufacturing in Lagos Nigeria. Both groups (local drug manufacturers/importers) in the pharmaceutical industry were compared to derive at their perspective on the impacts of drug importation regulations on their business. A total of 77 out of the 117 participated actively in the survey, of whom they combine pharmaceutical importation and local pharmaceutical manufacturing. Interesting, 83% of the participants admitted that the importation regulations in Nigeria are outdated and ineffective/inconsistent and have impacted negatively to the growth of the industry. However, an overwhelmingly majority of the local drug manufactures/importers also attributed the frequent taxation from state and non-state regulators as a major draw backs to local drug manufacturing that have yielded to the 25% capacity production of the Nigeria local drug manufacturing.
 
Analysis:

As evidenced by the analysis, most of the local manufacturer’s combines local drug manufacturing with its importation for the sustenance of their business since it is more expensive to manufacture drugs than its importation in Nigeria. The local manufacturers, PSN and PMGMAN admitted that the inability of the government in providing the enabling environment for local pharmaceutical manufacturing is among the factor that have discouraged local manufacturing of drugs. In addition to this they admitted that government regulations like high taxes and complex drug regulations have negatively affected the industry.

Conclusions:

In concluding this research work and its analysis on the impacts of drug importation regulations on local pharmaceutical manufacturing in Nigeria and after reviewing relevant literatures on the topic within the Nigeria pharmaceutical industry, the author found the process very informative and needful in solving the problem associated with the poor performance of the local pharmaceutical industry that have yielded to the 25% production capacity of the industry. Finally, the growth of the pharmaceutical manufacturing industry depends on the intervention of the Federal Government of Nigeria in providing the infrastructure’s, funds, policies and regulations which remains the key catalyst for the development of the industry and reducing the dependency on CMOs chiefly from India.