Study design and Period
This was a descriptive cross-sectional study using a mixed method approach of quantitative and qualitative components.
A self-administered questionnaire was used for the quantitative approach, and the qualitative aspect consisted of a desk review looking at key regulatory documents such as laws, regulations, policies, guidelines, standard operating procedures and reports.
The data collection tool used was the WHO global benchmarking tool (GBT) for “Evaluation of National Regulatory System of Medical Product Version VI. The date was collected from April 2023 - July 2023.
Study setting
The study was carried out at the Pharmacy Board of Sierra Leone Head Office in Freetown, Sierra Leone as well as the regional offices in Bo, Kenema, Makeni, and Kono Districts.
Specific setting
The Pharmacy Board of Sierra Leone, which is the National Medicines Regulatory Authority, is a semiautonomous institution situated at the Central Medical Stores New England Ville Freetown. The Pharmacy Board of Sierra Leone (PBSL) is the National Medicines Regulatory Agency, whose mandate is drawn from the Pharmacy and Drugs Act 2001; this is an act to regulate Pharmacy profession in Sierra Leone and to control manufacturing and supply, storage, distribution and transportation of medicines, including nutritional agents, cosmetics and chemicals, and to make provision for other related matters. The PBSL has an oversight board responsible for the oversight of regulatory activities
The PBSL consists of eleven (11) departments, namely, the drug evaluation and registration department, clinical trials and pharmacovigilance department, quality assurance department, quality control and laboratory department, complementary and alternative medicine department, factory and inspectorate department, distribution chain department, administration and finance departments, information and communication department, policy standards and practice department, and enforcement and narcotics department.
Study population
The targeted study participants were 43 employees of the Pharmacy Board of Sierra Leone who have expertise in medicine regulatory practices. This population included staff working in departments/units responsible for ensuring medicines quality, including the drug evaluation and registration department, pharmacovigilance and clinical trials department, quality assurance department, quality control and laboratory department, complementary and alternative medicines department, factory and inspectorate department, distribution chain department, policy standards and practice department. All 43 participants were part of this study.
Data collection tools
This included a self-administered questionnaire and a checklist for review during the desk review, which focused on key regulatory documents such as laws, regulations, policies, guidelines, procedures and reports.
The self-administered questionnaire included demographic data and information on the implementation of key regulatory functions as the independent variables. This was done in such a way that the research questions were answered and the objectives determined.
Data collection procedure
The method used was based on the nine indicators and nine functions as well as the 268 sub-indicators of the WHO/GBT for evaluating the capacity of any NRA [4].
For the purpose of this study, eight functions, nine indicators and 251 sub-indictors were assessed. One of the functions, National Regulatory Authority Lot Release, with 17 sub-indicators, were not assessed. Lot release is not applicable to PBSL, as it does not involve a large amount of release specific for biologicals, including vaccines (WHO, 2018).
The scale used for rating each sub-indicator in this assessment included implemented, which implies that the required document or process is already in place; partially implemented, which implies that the NRA has started the process; ongoing implementation, which implies that steps have been taken toward implementation; and not implemented, which implies no evidence of process or document.
A questionnaire and review of key regulatory documents were used to collect the data. The documents were retrieved from reports, databases and the PBSL website. After providing consent, the respondents completed the questionnaire.
Data analysis
The data were entered into Microsoft Excel and exported into the Statistical Package for the Social Sciences (SPSS) version 21 (International Business Machines Corporation, SPSS Statistics GradPack and Faculty Packs, New York, NY, USA).
Descriptive statistics were used to analyze the sociodemographic data. The functions and indicators used are presented in the tables and figures in the result section.
Ethical Considerations
For this study, ethical considerations were involved, as no harm was done to any of the participants.
The study was cleared by the research, innovation and publication committee at the Faculty of Pharmaceutical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone (RIPC-010-23). An Informed consent was obtained from all participants after explaining the purpose and procedures of the study.
The confidentiality of the participants who participated in the study was maintained.
Permission to conduct the study was also sought from the Registrar of Pharmacy Board of Sierra Leone. The respondents were also informed about the nature of the study