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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country.

BACKGROUND: Access to medical products of the required efficacy, quality and safety is essential for everyone's health and wellbeing. To achieve this milestone, every country needs a robust and strong performing National Regulatory Authority (NRA) that is independent and outcome oriented. With the help of the World Health Organization (WHO), the global benchmarking tool is the gold standard used to assess the regulatory capacity of NRAs. OBJECTIVES: This study assessed the capacity of the National Medicines Regulatory Authority in Sierra Leone to perform its regulatory functions. METHODS: This descriptive cross-sectional study used both qualitative and quantitative approaches. 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. RESULTS: The majority of the participants had a postgraduate degree (60%), and 72% had over 10 years of experience working at the NRA. Out of 251 sub-indicators assessed, 85 (34%) sub-indicators were fully implemented. Of the eight (8) functions assessed, sub-indicators related to clinical trial oversight and vigilance were the most implemented, with 67% and 62%, respectively. Of the 9 indicators assessed, 79% of the sub-indicators that are related to quality and risk management were implemented. The results of this study showed that PBSL operates at maturity level 1. The absence of laws and regulations that give PBSL the mandate to perform its regulatory functions was a major challenge even though other indicators were met. The study reported other challenges toward effective functioning, including but not limited to a lack of sufficient staff, weak enforcement of the sale of medicines and a poorly equipped quality control laboratory.

Assessment of antimicrobial stewardship programmes and antibiotic use among children admitted to two hospitals in Sierra Leone: a cross-sectional study.

INTRODUCTION: Antimicrobial resistance (AMR) is a global public health concern and irrational use of antibiotics in hospitals is a key driver of AMR. Even though it is not preventable, antimicrobial stewardship (AMS) programmes will reduce or slow it down. Research evidence from Sierra Leone has demonstrated the high use of antibiotics in hospitals, but no study has assessed hospital AMS programmes and antibiotic use specifically among children. We conducted the first-ever study to assess the AMS programmes and antibiotics use in two tertiary hospitals in Sierra Leone. METHODS: This was a hospital-based cross-sectional survey using the World Health Organization (WHO) point prevalence survey (PPS) methodology. Data was collected from the medical records of eligible patients at the Ola During Children's Hospital (ODCH) and Makeni Regional Hospital (MRH) using the WHO PPS hospital questionnaire; and required data collection forms. The prescribed antibiotics were classified according to the WHO Access, Watch, and Reserve (AWaRe) classification. Ethics approval was obtained from the Sierra Leone Ethics and Scientific Review Committee. Statistical analysis was conducted using the SPSS version 22. RESULTS: Both ODCH and MRH did not have the required AMS infrastructure; policy and practice; and monitoring and feedback mechanisms to ensure rational antibiotic prescribing. Of the 150 patients included in the survey, 116 (77.3%) were admitted at ODCH and 34 (22.7%) to MRH, 77 (51.3%) were males and 73 (48.7%) were females. The mean age was 2 years (SD=3.5). The overall prevalence of antibiotic use was 84.7% (95% CI: 77.9% - 90.0%) and 77 (83.8%) of the children aged less than one year received an antibiotic. The proportion of males that received antibiotics was higher than that of females. Most (58, 47.2 %) of the patients received at least two antibiotics. The top five antibiotics prescribed were gentamycin (100, 27.4%), ceftriaxone (76, 20.3%), ampicillin (71, 19.5%), metronidazole (44, 12.1%), and cefotaxime (31, 8.5%). Community-acquired infections were the primary diagnoses for antibiotic prescription. CONCLUSION: The non-existence of AMS programmes might have contributed to the high use of antibiotics at ODCH and MRH. This has the potential to increase antibiotic selection pressure and in turn the AMR burden in the country. There is need to establish hospital AMS teams and train health workers on the rational use of antibiotics.

Assessment of self-medication practices and safety profile of medicines utilisation among pregnant women attending antenatal clinics in Freetown, Sierra Leone: a multicentre cross-sectional study.

Background: Despite the potential foetal and maternal risks of self-medication, studies on self-medication practice and the safety profile of medicines used during pregnancy are scarce in our setting. This study determined the self-medication practice and safety profile of medicines used among pregnant women. Methods: This cross-sectional study was conducted in face-to-face interviews among 345 pregnant women at three hospitals in Sierra Leone. Data were analysed using descriptive statistics and binary logistic regression to determine the prevalence and associated factors of self-medication. Results: A total of 345 pregnant women participated in the study. The prevalence of self-medication prevalence among pregnant women with conventional and/or herbal medicine was 132 (38.3%). Also, 93 (75%) of the conventional medicines (CMs) were categorised as probably safe, of which paracetamol 36 (29.0%) was commonly used, followed by amoxicillin 23 (18.5%) and antimalarials 22 (17.7%) for common illnesses such as headache 30 (25.4%), urinary tract infection 23 (19.4%) and malaria 22 (18.6%). The most common reason for self-medication was previous experience with the disease 24 (27.3%). Luffa acutangula 19 (30.2%) was the most used herbal medicine (HM), and Oedema 30 (47.6%) was the most reported ailment. Among the HM users, 34 (54.0%) believe they are more effective than CMs. Secondary school education (AOR = 2.128, 95%CI = 1.191-3.804, p = 0.011), tertiary education (AOR = 2.915, 95%CI = 1.104-7.693, p = 0.031), monthly income of greater than NLe 1,000 (AOR = 4.084, 95% CI = 1.269-13.144, p = 0.018), and perceived maternal illness (AOR = 0.367, CI = 0.213-0.632, p = <0.001) were predictors of self-medication. Conclusion: Self-medication practice was highly prevalent and was associated with educational status, monthly income, and perceived maternal illness during pregnancy. Therefore, intervention programmes should be designed and implemented to minimise the practice and risk associated with self-medication among pregnant women.

Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone.

Background: The manifestation and spread of neuroinvasive circulating vaccine-derived polioviruses (cVDPVs) across several countries, which led to the emergency use of the novel oral polio vaccine type 2 (nOPV2), raised concerns about adverse events following immunization (AEFI) surveillance. We assessed the attributes of AEFI with nOPV2 and examined stakeholder experiences and challenges in AEFI surveillance in Sierra Leone. Methods: Using a mixed method approach, we retrospectively reviewed passive data collected during a 2021 immunization campaign, and conducted semi-structured, interviews with vaccinators, district AEFI focal persons, and key stakeholders at the national Expanded Program on Immunization and the National Medicines Regulatory Authority. AEFI were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) and System Organ Class (SOC). Outcomes were stratified as recovered or not, with preventability and causality assessed using the Schumock and Thornton and World Health Organization (WHO) algorithms, respectively. Results: A total of 528 suspected AEFI were documented, predominantly affecting children aged 28 days to 23 months (63.3%). Most reported AEFI were administration site conditions and general disorders, with pyrexia being the predominant PT. Of 80 serious cases, 78 recovered, with 74 having an inconsistent causal relationship with the vaccine. Most serious cases (78) were deemed non-preventable, with only two being probably preventable. AEFI reporting was not routinely carried out across the group of people interviewed. AEFI reporting was not consistently performed, with discrepancies in defining reportable events and confusion over responsibility. Challenges with the open data kit (ODK) platform were noted, along with perceived inadequacies in training. Conclusion: While the nOPV2 is relatively new, the majority of AEFI were not serious, and most serious cases were not causally linked to the vaccine. Participants exhibited variations in experience and awareness of AEFI reporting.

An Assessment of Medication Errors Among Pediatric Patients in Three Hospitals in Freetown Sierra Leone: Findings and Implications for a Low-Income Country.

Background: Pediatric patients are prone to medicine-related problems like medication errors (MEs), which can potentially cause harm. Yet, this has not been studied in this population in Sierra Leone. Therefore, this study investigated the prevalence and nature of MEs, including potential drug-drug interactions (pDDIs), in pediatric patients. Methods: The study was conducted in three hospitals among pediatric patients in Freetown and consisted of two phases. Phase one was a cross-sectional retrospective review of prescriptions for completeness and accuracy based on the global accuracy score against standard prescription writing guidelines. Phase two was a point prevalence inpatient chart review of MEs categorized into prescription, administration, and dispensing errors and pDDIs. Data was analyzed using frequency, percentages, median, and interquartile range. Kruskal-Wallis H and Mann-Whitney U-tests were used to compare the prescription accuracy between the hospitals, with p<0.05 considered statistically significant. Results: Three hundred and sixty-six (366) pediatric prescriptions and 132 inpatient charts were reviewed in phases one and two of the study, respectively. In phase one, while no prescription attained the global accuracy score (GAS) gold standard of 100%, 106 (29.0%) achieved the 80-100% mark. The patient 63 (17.2%), treatment 228 (62.3%), and prescriber 33 (9.0%) identifiers achieved an overall GAS range of 80-100%. Although the total GAS was not statistically significant (p=0.065), the date (p=0.041), patient (p=<0.001), treatment (p=0.022), and prescriber (p=<0.001) identifiers were statistically significant across the different hospitals. For phase two, the prevalence of MEs was 74 (56.1%), while that of pDDIs was 54 (40.9%). There was a statistically positive correlation between the occurrence of pDDI and number of medicines prescribed (r=0.211, P=0.015). Conclusion: A Low GAS indicates poor compliance with prescription writing guidelines and high prescription errors. Medication errors were observed at each phase of the medication use cycle, while clinically significant pDDIs were also reported. Thus, there is a need for training on prescription writing guidelines and medication errors.

Antibiotic use among hospitalised patients in Sierra Leone: a national point prevalence survey using the WHO survey methodology.

OBJECTIVE: Inappropriate use of antibiotics is a major driver of antibiotic resistance. A few studies conducted in Africa have documented that about half of hospitalised patients who receive antibiotics should not have received them. A few hospital-based studies that have been conducted in Sierra Leone have documented a high usage of antibiotics in hospitals. Therefore, we conducted a nationwide point prevalence survey on antibiotic use among hospitalised patients in Sierra Leone. DESIGN: We conducted a hospital-based, cross-sectional survey on the use of antibiotics using the WHO point prevalence survey methodology. SETTING: The study was conducted in 26 public and private hospitals that are providing inpatient healthcare services. PARTICIPANTS: All patients admitted to paediatric and adult inpatient wards before or at 08:00 on the survey date were enrolled. OUTCOME MEASURES: Prevalence of antibiotic use, antibiotics Access, Watch and Reserve (AWaRe) categorisation, indication for antibiotic use prevalence and proportion of bacteria culture done. RESULTS: Of the 1198 patient records reviewed, 883 (73.7%, 95% CI 71.1% to 76.2%) were on antibiotics. Antibiotic use was highest in the paediatric wards (306, 85.7%), followed by medical wards (158, 71.2%), surgical wards (146, 69.5%), mixed wards (97, 68.8%) and lowest in the obstetrics and gynaecology wards (176, 65.7%). The most widely prescribed antibiotics were metronidazole (404, 22.2%), ceftriaxone (373, 20.5%), ampicillin (337, 18.5%), gentamicin (221, 12.1%) and amoxicillin (90, 5.0%). Blood culture was only done for one patient and antibiotic treatments were given empirically. The most common indication for antibiotic use was community-acquired infection (484, 51.9%) followed by surgical prophylaxis (222, 23.8%). CONCLUSION: There was high usage of antibiotics in hospitals in Sierra Leone as the majority of patients admitted received an antibiotic. This has the potential to increase the burden of antibiotic resistance in the country. We, therefore, recommend the establishment of hospital antimicrobial stewardship programmes according to the WHO core components.

Quality of Reporting of Adverse Drug Reactions to Antimicrobials Improved Following Operational Research: A before-and-after Study in Sierra Leone (2017-2023).

Background: The quality of pharmacovigilance data is important for guiding medicine safety and clinical practice. In baseline and follow-up studies after introducing interventions to improve the quality of reporting of Individual Case Safety Reports (ICSRs) in Sierra Leone, we compared (a) timeliness and completeness of reporting and (b) patient outcomes classified as 'recovering'. Methods: Baseline (January 2017-December 2021) and follow-up (June 2022-April 2023) studies of ICSRs in the national pharmacovigilance database. Interventions introduced following recommendations from the baseline study included: updating standard operating procedures and guidelines, setting performance targets follow-up of patient outcomes, and training. Results: There were 566 ICSRs in the baseline study and 59 in the follow-up study. Timelines (reporting < 30 days) improved by five-fold (10% at baseline to 47% in follow-up). For the completeness of variables in ICSRs (desired threshold ≥ 90%),this was 44% at baseline and increased to 80% in the follow-up study. 'Recovering' outcomes reduced from 36% (baseline study) to 3% (follow-up study, p < 0.001). Conclusions: Significant improvements in timeliness, completeness, and validation of ICSRs were observed following operational research in Sierra Leone. While enhancing pharmacovigilance and patient safety, this study highlights the important synergistic role operational research can play in improving monitoring and evaluation systems.

Antibiotic use and consumption in Freetown, Sierra Leone: A baseline report of prescription stewardship in outpatient clinics of three tertiary hospitals.

Objective: As there are no country-representative data on bacterial sensitivities to guide antimicrobial stewardship (AMS) interventions, an AMS programme was established in the outpatient clinics of three tertiary hospitals in Freetown, Sierra Leone. Methods: The study employed a cross-sectional design to collect antibiotic prescribing data from 370 pregnant women and lactating mothers, 314 children and 229 regular patients in the outpatient clinics of the Princess Christian Maternity Hospital (PCMH), Ola During Children's Hospital and Connaught Hospital (CH), respectively, in April 2022. All data were analysed using Stata Version 16. Results: Of 913 patients, most were female (n=635, 69.5%), treated at PCMH (n=370, 40.5%) and had a bacterial infection (n=661, 72.4%). The indication for prescribing antibiotics was inappropriate in 252 (27.6%) patients. Of the 1236 prescriptions, 393 (31.8%) were made at CH. The duration of antibiotic use was not stated in 230 (18.6%) prescriptions. Overall antibiotic consumption was 55.3 defined daily doses per 1000 outpatient-days. Conclusion: Gaps in antibiotic prescriptions were identified in the outpatient clinics of three national referral hospitals in Sierra Leone. In order to combat antimicrobial resistance, AMS interventions are needed to reduce the prescription of antibiotics for inappropriate indications or without specified duration.

Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone.

Clinical trials during public health emergencies of novel medical products such as therapeutics and vaccines in resource-limited settings are daunting due to the limited capacity for regulatory assessment. Regulating clinical trials during the Ebola outbreak in Sierra Leone required expedited evaluation to identify medical products that could be promptly introduced to combat the epidemic in the absence of approved treatment or prevention. This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10-15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. In addition, the Agency-ensured structures and systems were in place for reporting and reviewing adverse events and serious adverse events, management of biological samples, submission and review of progress reports, and good clinical practice inspections. Unfortunately, the Ebola epidemic revealed many weaknesses in the country's clinical trials regulatory structure and processes. Government and partners should further offer more resources to build the clinical trial structures and systems so that the Agency will be better poised to handle future public health emergencies.

Leveraging WHO's Global Benchmarking Tool to strengthen capacity in clinical trials oversight for public health emergencies: the GHPP VaccTrain model.

BACKGROUND: A stable, well-functioning and integrated national medicines regulatory system is a core component of health systems resilient against infectious disease outbreaks. In many low- and middle-income countries, however, sizable gaps exist in the emergency preparedness framework of national regulatory authorities (NRAs). RegTrain-VaccTrain is a project of Germany Ministry of Health's Global Health Protection Programme that contributes to global efforts aimed at strengthening such regulatory systems by providing technical support and advice to partner NRAs. In this study, we probed the outputs of our capacity-strengthening activities for clinical trials oversight (CTO) to take stock of progress made and examine remaining priorities in order to provide specialized technical assistance in addressing them to improve operational readiness for emergencies. METHOD: Data validated from NRA self-benchmarking results in 2017 and worksheet records of November 2021 were utilized to assess the emergency preparedness capacity for CTO in three VaccTrain partner NRAs (Liberia, Sierra Leone, The Gambia) before and after interventional capacity-strengthening partnership, using specific public health emergency-related (sub-)indicators of the WHO Global Benchmarking Tool. RESULTS: A generally weak and vulnerable structural framework for CTO characterized the emergency preparedness capacity in all three partner NRAs at baseline, thus putting their operational readiness for public health emergencies at risk. VaccTrain's collaborative work was successful at supporting individual NRAs to develop the full spectrum of operational structures (including (draft) regulations, guidelines, and standard operating procedures) required to improve regulatory preparedness. A gap in the formal approval and implementation of developed legal documents in two of three NRAs still remains. Notwithstanding, a robust emergency framework now exists and the NRAs stand better prepared to respond to (future) locally-concerning health emergencies, during which time clinical trials activity was observed to heighten. CONCLUSIONS: These results exemplify a north-south capacity-strengthening partnership model that effectively contributes in developing structures to enhance regulatory oversight and support expeditious product development in response to crises. They further underscore the equally critical role local/national processes play in facilitating the full implementation of developed structures.

The burden of renal admissions in a tertiary Hospital in Sierra Leone.

BACKGROUND: The burden of both acute kidney injury and chronic kidney disease is on the rise globally. In sierra Leone, there has been no data on renal patients or admissions. This study intends to close this gap in knowledge and give preliminary data on the burden of renal disease in this country. METHODS: The study was a retrospective review of the case notes of patients admitted at Connaught Hospital, Freetown over a 2 year period. Data extraction was done using a well- structured proforma. RESULTS: A 2.7% renal admission burden was obtained; mean duration of hospital stay was 15.1 ± 14.7; mean age of patients was 47.2 ± 17.5 with a female preponderance. The common risk factors for chronic kidney disease were systemic hypertension (43%) and diabetes mellitus (24%). The common risk factors for acute kidney injury were sepsis (77%) and hypovolemia (15%). The in- hospital mortality rate was 47% and 73% were non-compliant with haemodialysis probably due to financial reasons. CONCLUSION: There is a significant burden of kidney disease in our environment, affecting mainly our young and middle-aged population. A rational approach is to embark on kidney disease prevention programs.

Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017-2021): A Wake-Up Call to Improve Reporting.

Background: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. Methods: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017−2021. Results: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2−420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of 'recovering' outcomes. Conclusions: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets.

National Antibiotic Consumption for Human Use in Sierra Leone (2017-2019): A Cross-Sectional Study.

Monitoring antibiotic consumption is crucial to tackling antimicrobial resistance. However, currently there is no system in Sierra Leone for recording and reporting on antibiotic consumption. We therefore conducted a cross-sectional study to assess national antibiotic consumption expressed as defined daily dose (DDD) per 1000 inhabitants per day using all registered and imported antibiotics (categorized under the subgroup J01 under the anatomical and therapeutic classification (ATC) system) as a proxy. Between 2017-2019, total cumulative consumption of antibiotics was 19 DDD per 1000 inhabitants per day. The vast majority consisted of oral antibiotics (98.4%), while parenteral antibiotics made up 1.6%. According to therapeutic/pharmacological subgroups (ATC level 3), beta-lactam/penicillins, quinolones, and other antibacterials (mainly oral metronidazole) comprised 65% of total consumption. According to WHO Access, Watch, and Reserve (AWaRe), 65% of antibiotics consumed were Access, 31% were Watch, and no Reserve antibiotics were reported. The top ten oral antibiotics represented 97% of total oral antibiotics consumed, with metronidazole (35%) and ciprofloxacin (15%) together constituting half of the total. Of parenteral antibiotics consumed, procaine penicillin (32%) and ceftriaxone (19%) together comprised half of the total. Policy recommendations at global and national levels have been made to improve monitoring of antibiotic consumption and antibiotic stewardship.

Pharmacovigilance systems in resource-limited settings: an evaluative case study of Sierra Leone.

Few low and middle-income countries (LMIC) have fully operational pharmacovigilance structures, systems and legal framework to collect and collate safety data and evaluate the risks and benefits by active and passive approaches. However, in a LMIC such as Sierra Leone, the capacity to manage the risks by taking appropriate preventative actions to help inform therapeutic decisions, promote rational use of medicines, guide risk management and communications is gradually growing but yet to be fully optimized. This study sought to assess the current status of pharmacovigilance in Sierra Leone since it became the 87th member of the World Health Organisation International Drug Monitoring Programme. This study evaluated the pharmacovigilance system in Sierra Leone through a comprehensive and system-based approach that covered the national medicines regulatory authority, health facilities and public health programmes. A descriptive cross-sectional study design was employed. Using a convenience sampling method, 14 respondents from the national medicines regulatory authority, six health facilities and six public health programmes were interviewed. Data were collected using a validated metric instrument: Indicator-Based Pharmacovigilance Assessment Tool. A scoring system was used for the quantification of assessment results with a score greater than 60% indicating that an organization has structural and policy frameworks to collect and collate safety data in a national database and evaluate the risks and benefits by both active and passive approaches. The study findings showed that the national medicines regulatory authority scored 79% and thus met the standard requirements of pharmacovigilance. On the other hand, the health facilities and public health programmes scored less than 60% indicating the need to fully operationalise pharmacovigilance frameworks at these levels. The study further demonstrated that the national medicine regulatory authority which hosts the national pharmacovigilance centre had functional pharmacovigilance structures and processes with potential to providing leadership in the implementation of pharmacovigilance in Sierra Leone.