CWB is promising for treating EVD in resource-poor settings, especially in the early phases of outbreaks when resource-mobilization is done. Even though our sample size was small and the evaluation was not randomised, our results contribute to existing evidence that convalescent whole blood could be considered as a useful candidate for treating EVD. Further studies that are randomised will be required to further assess the efficacy of CWB as treatment option during any EVD outbreak.

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. Electronic supplementary material The online version of this article (10.1186/s40545-019-0173-2) contains supplementary material, which is available to authorized users.

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.

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.

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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.

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.

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.