Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation

• Published in: BMC health services research Vol. 24; no. 1; pp. 1020 - 9
• Main Authors: Lahai, Michael, Lake, Laurie, Vandy, Ahmed, Sebba, Bondu, Sesay, Mohamed, Abiri, Onome T, Johnson, Joy, Buffa, Tamba, Kanu, Abdulai, Bawoh, Mohamed, Komeh, James P, Johnson, Wiltshire C N
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 03.09.2024; BioMed Central; BMC
• Subjects: Certification; Clinical trials; Data collection; Data entry; Drug and Narcotic Control - legislation & jurisprudence; Drugs; Drugstores; Economic indicators; Humans; Internal auditing; International economic relations; ISO standards; Laboratories; Laws, regulations and rules; Licenses; Logistics; Medicines regulation; Narcotics; National medicines regulatory authorities; Pharmaceutical industry; Pharmacovigilance; Pharmacy; Pharmacy board of Sierra Leone; Quality assurance; Quality control; Quality Improvement; Quality management; Registration; Regulation; Retrospective Studies; Self evaluation; Sierra Leone; Substandard and falsified medicines; World health; Sierra Leone; Sub-Saharan Africa; Africa; National medicines regulatory authorities; Quality assurance; Pharmacy board of Sierra Leone; Substandard and falsified medicines; Medicines regulation
• ISSN: 1472-6963; 1472-6963
• DOI: 10.1186/s12913-024-11452-8

National Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the identification of substandard and falsified medicines, the changes in the functions and key indicators of assessment, and the quality improvement changes of the Pharmacy Board of Sierra Leone. Data was obtained from 2013 to 2021 records using a data collection tool to collate and review all relevant information to address the different objectives. All data were sourced from the Department of Quality Assurance and the Department of Enforcement and Narcotics at the Pharmacy Board of Sierra Leone. The review also included, identified substandard and falsified medicines, the World Health Organisation Global benchmarking self-assessment tool, and internal and external audit records of the quality management system of all twelve departments of the Pharmacy Board of Sierra Leone. The study showed marked changes in identifying substandard and falsified medicines by the Pharmacy Board of Sierra Leone during ISO 9001:2015 implementation (2017- 2020) compared to Pre-ISO 9001:2015 implementation (2013- 2016). Critical functions of the Pharmacy Board of Sierra Leone from the assessment of the WHO GBT ML in 2016 and 2021 showed that several indicators had been addressed during ISO 9001:2015 certification with improvement in the level of maturity for the quality management systems and Pharmacovigilance functions. There was also an improvement in identifying non-conformances and a commitment to continuous improvement of processes during ISO 9001:2015 implementation. This study revealed that regular checks through standard assessment, internal audits, and standard management review processes that generate follow-up actions, timelines, and a commitment to identifying correction, and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of an institution (Pharmacy Board of Sierra Leone). Our study revealed that commitment to continuous implementation of proper quality management system could significantly improve institutional efficiency, thereby improving service delivery and customer satisfaction.