Ceftriaxone has a high propensity for misuse because of its high rate of utilization. In this study, we aimed at assessing the appropriateness of the clinical utilization of ceftriaxone in nine health facilities in Uganda. Using the World Health Organization (WHO) Drug Use Evaluation indicators, we reviewed a systematic sample of 885 patients’ treatment records selected over a three (3)-month period. Our results showed that prescriptions were written mostly by medical officers at 53.3% (470/882). Ceftriaxone was prescribed mainly for surgical prophylaxis at 25.3% (154/609), respiratory tract infections at 17% (104/609), and sepsis at 11% (67/609), as well as for non-recommended indications such as malaria at 7% (43/609) and anemia at 8% (49/609). Ceftriaxone was mostly prescribed once daily (92.3%; 817/885), as a 2 g dose (50.1%; 443/885), and for 5 days (41%; 363/885). The average score of inappropriate use of ceftriaxone in the eight indicators was 32.1%. Only 58.3% (516/885) of the ceftriaxone doses prescribed were administered to completion. Complete blood count and culture and sensitivity testing rates were 38.8% (343/885) and 1.13% (10/885), respectively. Over 85.4% (756/885) of the patients improved and were discharged. Factors associated with appropriate ceftriaxone use were gender, pregnancy status, days of hospitalization, health facility level of care, health facility type, and type of prescriber.

Background: In Uganda, national tuberculosis (TB) treatment guidelines were revised to include the newer generation fluoroquinolones among the second-line treatment options for multidrug-resistant TB. This study was designed to analyze if the prescription of these quinolones is compliant with country recommendations. Methods: This was an observational retrospective study of consumption data for 2017 and 2018 across four selected regional referral hospitals. The sources of consumption data were hospital pharmacy stock cards and the dispensing register. The medical files of patients who had been prescribed fluoroquinolones were also assessed to study compliance with the Uganda Clinical Guidelines and the British National Formulary (BNF). Results: None of the 371 levofloxacin prescriptions analyzed complied with the Uganda Clinical Guidelines, although 250 (67.3%) were prescribed for indications included in the BNF. According to WHO prescription indicators, only 220 (59.3%) prescriptions were appropriate. Conclusion: The prescription of levofloxacin and moxifloxacin increased in the hospitals studied, but in a high proportion of cases, they were not compliant with country recommendations. The findings call for the strengthening of national antimicrobial stewardship programs.

Introduction Developing countries can improve their pharmacovigilance systems by analysing their own medication safety data. Objective The aims of this study were to characterize Uganda’s reported adverse drug reaction (ADR) onsets in 2012–2015 that were registered on VigiBase^® by 31 December 2017, to document delays in international visibility and the influence of covariates on this delay from ADR onsets in 2013 + 2014, to examine data quality, and to illustrate analytical approaches for safety data, particularly for patients receiving antiretroviral therapy (ART). Methods International delay was defined as elapsed time from complete ADR onset date to entry date on VigiBase^®, with covariates examined using Cox proportional hazards regression. Simple random sampling was used to locate the paper-based ADR forms for data quality assurance. Disproportionality for signal detection focused on serious singleton ADR onsets in patients receiving ART. Results Uganda’s VigiBase^® had 1018 patient entries with complete ADR onset dates: 260 in 2012, 293 in 2013, 305 in 2014 and 160 in 2015. Only 16% (154/953) of ADR onsets in 2012–2015 were in patients aged < 20 years for whom randomly sampled ADR forms were less fully completed; 87% (889/1018) comprised a singleton sign/symptom; half were serious. Median delay from ADR onset to international visibility was 11 months for ADR onsets in 2013 + 2014, and longest for healthcare professionals other than pharmacists and physicians. Disproportionality for serious ADR onsets in patients receiving ART included anaemia with zidovudine, renal impairment with tenofovir, Stevens–Johnson syndrome with nevirapine and skin rash with efavirenz. Conclusions Barely one ADR onset per day was registered on VigiBase^® from those submitted to Uganda’s National Pharmacovigilance Centre during 2012–2014; only one in six was from patients aged < 20 years. Paediatric pharmacovigilance requires more emphasis in Uganda. Delays from reported ADR onset to international visibility on VigiBase^® need to reduce dramatically. Quality assurance revealed rectifiable data entry deficits. Signal detection performed well for patients receiving ART.

Dolutegravir (DTG), a key component of the recommended human immunodeficiency virus (HIV) treatment regimens in Uganda, has been associated with hyperglycemia. We evaluated its influence on hyperglycemia risk to create a hyperglycemia risk stratification tool for patient monitoring. We conducted a prospective cohort study at 3 sites with 628 HIV-positive patients on tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD). Participants included both nucleoside reverse transcriptase inhibitor–experienced (exposed) and antiretroviral therapy (ART)–naive (nonexposed) groups. Follow-up occurred every 6 months with random blood sugar (RBS) testing every 3 months. Participants with RBS ≥7 mmol/L were classified as hyperglycemic and underwent glycated hemoglobin (HbA1c) testing, confirming diabetes with a 6.5% cut-off. The study found a hyperglycemia incidence rate of 24.5 (95% confidence interval [CI], 19.3–31.1) cases per 100 person-years (PY) and a diabetes incidence rate of 5.8 cases (95% CI, 3.6–9.3) per 100 PY. Hyperglycemia incidence was slightly lower in nonexposed (20.8 cases per 100 PY) versus exposed groups (25.2 cases per 100 PY). Multivariable analysis indicated a trend toward lower hyperglycemia risk (adjusted hazard ratio [aHR], 0.78 [95% CI, .37–1.66]; P = .52) and substantially lower diabetes incidence (aHR, 0.34 [95% CI, .04–2.82]; P = .32) in the nonexposed group. Significant factors for hyperglycemia included age (P < .001), study site (P < .001), and DTG-based ART duration (P = .02). Our study showed an increased incidence of hyperglycemia with age, study site, and duration of DTG exposure in people with HIV on TLD. We suggest integrated screening and care for hyperglycemia and diabetes in HIV services, especially when initiating DTG regimens.

Background: Despite the effectiveness of maternal vaccines, low- and middle-income countries grapple with inadequate safety monitoring systems. Robust safety surveillance is crucial to increasing vaccine confidence and timely identifying any potential safety signal that could put pregnant women and children at risk following vaccination. This study assessed the pharmacovigilance (PV) systems for vaccines used in pregnancy in Uganda. Methods: A qualitative study involves 13 key informant interviews and 8 focus group discussions among key stakeholders. Purposive sampling was used to select study participants. Data analysis was done using Miles and Huberman’s matrices approach and conducted in Atlas.ti software. Findings: A passive system involving multistakeholders at various levels of the healthcare structure existed but was inadequate for monitoring adverse events following maternal immunization. The existence of parallel reporting systems for vaccines was noted. Heavy workload, lack of feedback, inadequate knowledge to recognize and report adverse events following maternal immunizations and logistical challenges impeding reporting and follow-up were among the barriers to reporting. Electronic medical records, though underutilized for safety surveillance, offer promising potential. Conclusions: To address the specific needs of maternal vaccination, the PV system in Uganda needs improvement. A multipronged approach, including policy coherence, embracing active surveillance and leveraging existing birth outcome surveillance and electronic medical records, is essential. Harnessing healthcare provider knowledge and advisory committee capacity in causality assessment is also necessary. The study findings can inform priority interventions to enhance PV for existing and new maternal vaccines.

Active vaccine pharmacovigilance complements the standard passive or spontaneous surveillance system, which suffers from low reporting rates. This study aimed at utilizing population-based structures to report and profile adverse events following immunization (AEFI) with the measles and rubella vaccine (MR), or MR in combination with the bivalent oral polio vaccine (bOPV 1&3) (MR & bOPV), during mass vaccination in Uganda. Caretakers of children at home (less than 5 years) and schoolgoing children were followed up on and encouraged to report any AEFIs on day one, 2–3 days, 10 days, and 14 days after vaccination at school by their teachers and at-home, community-based village health teams. Out of 9798 children followed up on, 382 (3.9%) reported at least one AEFI, and in total, 517 AEFIs were reported. For MR, high temperature (21%), general feeling of weakness (19.3%), and headache (13%) were the most reported AEFIs, though there were variations on the days when they were reported. For the combination dose of MR & bOPV, high temperature (44%), rash (17%), general feeling of weakness (13%), and diarrhoea (8%) were the most common adverse events following immunization reported by caretakers. All 382 children cleared the AEFIs within 2 days, with 343 (90%) children reporting mild or moderate AEFIs and only 39 (10%) reporting severe AEFIs. The reported AEFIs are known and are mentioned in the vaccine leaflets with similar severity classification. Rates of AEFIs differed with the number of days after receiving the immunization. Conclusion: Active surveillance for AEFIs provides additional important information to national vaccine regulatory bodies. It reassures the public that vaccines are safe and that their safety is being taken seriously in Uganda, which would improve vaccine acceptability and confidence in the health system. Piggybacking on existing structures such as village health team members (for children at home) and teachers (for schoolgoing children) facilitates reaching vaccine recipients and increases reporting rates. Therefore, studies using active reporting of AEFIs should be conducted at regular intervals to report the overall incidence of AEs and to monitor trends and changes.