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.

The role of constraints and information gaps in driving risky medicine purchasing practices in four African countries.

Substandard and falsified (SF) medical products pose a major threat to public health and socioeconomic development, particularly in low- and middle-income countries. In response, public education campaigns have been developed to alert consumers about the risks of SF medicines and provide guidance on 'safer' practices, along with other demand- and supply-side measures. However, little is currently known about the potential effectiveness of such campaigns while structural constraints to accessing quality-assured medicines persist. This paper analyses survey data on medicine purchasing practices, information and constraints from four African countries (Ghana, Nigeria, Sierra Leone and Uganda; n > 1000 per country). Using multivariate regression and structural equation modelling, we present what we believe to be the first attempt to tease apart, statistically, the effects of an information gap vs structural constraints in driving potential public exposure to SF medicines. The analysis confirms that less privileged groups (including, variously, those in rural settlements, with low levels of formal education, not in paid employment, often women and households with a disability or long-term sickness) are disproportionately potentially exposed to SF medicines; these same demographic groups also tend to have lower levels of awareness and experience greater levels of constraint. Despite the constraints, our models suggest that public health education may have an important role to play in modifying some (but not all) risky practices. Appropriately targeted public messaging can thus be a useful part of the toolbox in the fight against SF medicines, but it can only work effectively in combination with wider-reaching reforms to address higher-level vulnerabilities in pharmaceutical supply chains in Africa and expand access to quality-assured public-sector health services.

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.

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.

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.