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.

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.

Improvement in Infection Prevention and Control Performance Following Operational Research in Sierra Leone: A Before (2021) and After (2023) Study.

INTRODUCTION: Infection prevention and control (IPC) is crucial to limit health care-associated infections and antimicrobial resistance. An operational research study conducted in Sierra Leone in 2021 reported sub-optimal IPC performance and provided actionable recommendations for improvement. METHODS: This was a before-and-after study involving the national IPC unit and all twelve district-level secondary public hospitals. IPC performance in 2021 (before) and in 2023 (after) was assessed using standardized World Health Organization checklists. IPC performance was graded as: inadequate (0-25%), basic (25.1-50%), intermediate (50.1-75%), and advanced (75.1-100%). RESULTS: The overall IPC performance in the national IPC unit moved from intermediate (58%) to advanced (78%), with improvements in all six core components. Four out of six components achieved advanced levels when compared to the 2021 levels. The median score for hospitals moved from basic (50%) to intermediate (59%), with improvements in six of eight components. Three of four gaps identified in 2021 at the national IPC unit and four of seven at hospitals had been addressed by 2023. CONCLUSIONS: The study highlights the role of operational research in informing actions that improved IPC performance. There is a need to embed operational research as part of the routine monitoring of IPC programs.

Have Hand Hygiene Practices in Two Tertiary Care Hospitals, Freetown, Sierra Leone, Improved in 2023 following Operational Research in 2021?

In 2021, an operational research study in two tertiary hospitals in Freetown showed poor hand hygiene compliance. Recommended actions were taken to improve the situation. Between February-April 2023, a cross-sectional study was conducted in the same two hospitals using the World Health Organization hand hygiene tool to assess and compare hand hygiene compliance with that observed between June-August 2021. In Connaught hospital, overall hand hygiene compliance improved from 51% to 60% (p < 0.001), and this applied to both handwash actions with soap and water and alcohol-based hand rub. Significant improvements were found in all hospital departments and amongst all healthcare worker cadres. In 34 Military Hospital (34MH), overall hand hygiene compliance decreased from 40% to 32% (p < 0.001), with significant decreases observed in all departments and amongst nurses and nursing students. The improvements in Connaught Hospital were probably because of more hand hygiene reminders, better handwash infrastructure and more frequent supervision assessments, compared with 34MH where interventions were less well applied, possibly due to the extensive hospital reconstruction at the time. In conclusion, recommendations from operational research in 2021 contributed towards the improved distribution of hand hygiene reminders, better handwash infrastructure and frequent supervision assessments, which possibly led to improved hand hygiene compliance in one of the two hospitals. These actions need to be strengthened, scaled-up and guided by ongoing operational research to promote good hand hygiene practices elsewhere in the country.

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.

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.

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.

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.