Evaluating the Glycemic Effects of Dolutegravir and Its Predictors Among People With Human Immunodeficiency Virus in Uganda: A Prospective Cohort Study.

Background: 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.

Methods: We conducted a prospective cohort study at 3 sites with 628 HIV-positive patients on tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD).

Navigating duplication in pharmacovigilance databases: a scoping review.

Objectives: Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive understanding of duplication in pharmacovigilance databases worldwide.

Novel Oral Poliovirus Vaccine 2 Safety Evaluation during Nationwide Supplemental Immunization Activity, Uganda, 2022.

Given its enhanced genetic stability, novel oral poliovirus vaccine type 2 was deployed for type 2 poliovirus outbreak responses under World Health Organization Emergency Use Listing. We evaluated the safety profile of this vaccine. No safety signals were identified using a multipronged approach of passive and active surveillance.

Cost and availability of selected medicines after implementation of increased import verification fees.

Background: Uganda imports approximately 90% of its medicines, with about 60% being distributed by the private sector. To discourage importation and promote local production of 37 selected locally manufactured medicines, the Ugandan government through the Ministry of Health in 2017 increased the import verification fees from 2 to 12%. The increase in verification fees ultimately affects cost and availability of these medicines.

Expanding regulatory science: Regulatory complementarity and reliance.

Drug regulatory institutions, infrastructures, and systems are becoming increasingly interconnected across national boundaries and increasingly global in outlook. This process is reflected in the broadening and deepening application of the principles and practice of Regulatory Reliance, and parallel initiatives to strengthen the capacities of regulatory institutions in low- and middle-income countries (LMICs). Although these developments are important and constructive, they have tended to be framed in terms of the transfer of systems, knowledge, and skills from relatively "mature" regulatory agencies in high-income countries (HICs) to less-well-resourced regulatory agencies in LMICs.

Antimicrobial consumption surveillance in Uganda: Results from an analysis of national import data for the human health sector, 2018-2021.

Background: The surveillance of antimicrobial consumption (AMC) is critical to developing appropriate antimicrobial stewardship interventions. It is a key component of World Health Organization's (WHO) Global Action Plan on Antimicrobial Resistance and the Uganda Antimicrobial Resistance National Action Plan 2018-2023. Our study's objective was to determine the national consumption of all antimicrobials.

Drug safety in Africa: a review of systems and resources for pharmacovigilance.

Introduction: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from long-term experience overcoming some of these challenges and proposes some solutions for implementing pharmacovigilance in resource-limited settings.

Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study.

Introduction: Adverse drug reactions (ADRs) are an important public health challenge worldwide; however, pharmacovigilance systems are plagued by under-reporting. Mobile technologies, including mobile applications such as Med Safety, could strengthen ADR reporting. We explored the acceptability, and factors that could influence uptake of, Med Safety for ADR reporting by health workers in Uganda.

The impact of the increase in import verification fees on local production capacity of selected medicines in Uganda.

Background: The local manufacture of pharmaceuticals is an opportunity to develop a broader manufacturing and knowledge-based economy and reduce over dependence on imports. To promote local production, the Ugandan government introduced Buy Uganda Build Uganda policy geared towards promoting use of locally manufactured goods. It also increased import verification fees in 2017 for 37 selected locally manufactured essential medicines from 2 to 12% to discourage importation of these medicines.

Patient experiences of sexual dysfunction after transition to dolutegravir-based HIV treatment in mid-Western Uganda: a qualitative study.

Background: The literature on dolutegravir (DTG)-based HIV treatment has focused on assessing therapeutic efficacy particularly with regard to viral load suppression. However, little empirical attention has been devoted to understanding the effects of DTG on quality of life, in particular sexual health and functioning in PLHIV. This study focused on understanding patient experiences of sexual dysfunction, after transition to DTG-based regimens in Rwenzori region in Mid-Western Uganda.

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.

Introduction: Combination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV).Pharmacovigilance-monitoring the effects of medicines-is essential for understanding real-world drug safety.

Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study.

Introduction: Patients have contributed <1% of spontaneous adverse drug reaction (ADR) reports in Uganda's pharmacovigilance database. Peer support combined with mobile technologies could empower people living with HIV (PLHIV) to report ADRs and improve ADR management through linkage to care. We seek to test the feasibility and effect of a peer support intervention on ADR reporting by PLHIV receiving combination antiretroviral therapy (cART) in Uganda; identify barriers and facilitators to the intervention; and characterise ADR reporting and management.

Provider perspectives on the acceptability and tolerability of dolutegravir-based anti-retroviral therapy after national roll-out in Uganda: a qualitative study.

Background: The World Health Organization recommends dolutegravir (DTG) as the for first-line and second-line antiretroviral therapy (ART) worldwide. However, little is known about the acceptability and tolerability of DTG-based ART at routine points-of-care in Uganda. We set out to explore the perceptions of clinicians in ART clinics regarding the acceptability and tolerability of DTG-based ART since national roll-out in March 2018 in Uganda.

Evaluation of the Clinical Use of Ceftriaxone among In-Patients in Selected Health Facilities in Uganda.

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.

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting.

Background: Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.

Prescription of Levofloxacin and Moxifloxacin in Select Hospitals in Uganda: A Pilot Study to Assess Guideline Concordance.

: 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. : This was an observational retrospective study of consumption data for 2017 and 2018 across four selected regional referral hospitals.

Healthcare professionals' perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda.

Background: Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure.

Methods: A cross-sectional study of 685 HCP perspectives about the efficacy of ACT between June and July 2018 at selected health facilities in Uganda.

The effect of community dialogues and sensitization on patient reporting of adverse events in rural Uganda: Uncontrolled before-after study.

Background: Patients experiencing adverse drug events (ADE) in many developing countries are in the best position to report these events to the authorities but need to be empowered to do so. Systematic evaluation of community engagement and patient support especially in rural areas would provide evidence for a program to monitor potential harm from medicines. The aim of this study was to assess the effects of a community dialogue and sensitization (CDS) program on the knowledge, attitude and practises of community members for reporting ADE.

Adverse Drug Reaction Onsets in Uganda's VigiBase: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses.

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.

The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study.

Introduction: Uganda has rapidly increased access to antimalarial medicines in an effort to address the huge malaria disease burden. Pharmacovigilance information is important to guide policy decisions.

Objectives: The purpose of this study was to establish the burden of adverse drug reactions (ADRs) and associated risk factors for developing ADRs to artemisinin-based antimalarial treatment in Uganda.

Medication Error Disclosure and Attitudes to Reporting by Healthcare Professionals in a Sub-Saharan African Setting: A Survey in Uganda.

Background: Medication errors (MEs) are largely under-reported, which undermines quality improvement and medication risk management in healthcare.

Objectives: To assess attitudes of Ugandan healthcare professionals (HCPs) towards ME reporting, and identify characteristics of HCPs who endorsed integration of ME and adverse drug reaction (ADR) reporting, valued patient involvement in ME reporting, disclosed having ever made potentially harmful MEs, or observed possibly harmful MEs committed by other HCPs.

Methods: Healthcare professionals self-completed a questionnaire on their attitudes towards the occurrence and reporting of MEs in purposively selected Ugandan health facilities (public/private) including the national referral and six regional referral hospitals representative of all regions.

Rare, serious, and comprehensively described suspected adverse drug reactions reported by surveyed healthcare professionals in Uganda.

Background: Lack of adequate detail compromises analysis of reported suspected adverse drug reactions (ADRs). We investigated how comprehensively Ugandan healthcare professionals (HCPs) described their most recent previous-month suspected ADR, and determined the characteristics of HCPs who provided comprehensive ADR descriptions. We also identified rare, serious, and unanticipated suspected ADR descriptions with medication safety-alerting potential.

Targeted spontaneous reporting of suspected renal toxicity in patients undergoing highly active anti-retroviral therapy in two public health facilities in Uganda.

Background: Although the national HIV control programme in Uganda has a well-established system for monitoring disease progression and treatment outcomes, monitoring of adverse drug reactions (ADRs) is inadequate. In order to address under-reporting of ADRs, the National Pharmacovigilance Centre, in collaboration with the HIV control programme, piloted a targeted spontaneous reporting (TSR) system as a complementary method to traditional spontaneous reporting.

Methods: From April 2012 to March 2014, all cases of suspected renal toxicity in 10,225 patients on tenofovir-based regimens were monitored in the regional pharmacovigilance centres of Masaka and Mbale.