BackgroundPrimary dysmenorrhoea occurs in up to 50% of menstruating females. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used therapeutic remedies for dysmenorrhoea in ...Uganda. However, NSAIDs are associated with a 3–5 fold increase in the risk of gastrointestinal (GI) adverse drug effects.ObjectivesWe aimed to determine the prevalence and associated factors of self-reported NSAID-related GI adverse effects in female students who use NSAIDs in managing dysmenorrhoea-associated pain at Makerere University.DesignA cross-sectional study.SettingMakerere University’s main campus, situated North of Kampala, Uganda.Participants314 female students pursuing an undergraduate programme at Makerere University and residing in different halls of residence and hostels.OutcomesSocial demographic data, menstrual history and treatment data.ResultsOverall, 314 valid responses were received from female students with a median age of 22 years (IQR: 18–29 years). The median age at menarche was 13 years (IQR: 9–18 years). 41% (n=129/314) of the respondents had used medication for dysmenorrhoea and 32% (n=41/129) of whom reported NSAID-associated GI adverse effects with nausea being the most frequently reported (44%, n=18/41)Factors independently associated with GI adverse effects were: age at menarche (p=0.026), duration of menstruation (p=0.030) and use of ibuprofen (p=0.005). Females taking ibuprofen for dysmenorrhoea were about four times as likely to have NSAID-associated GI adverse effects (adjusted OR 3.87, 95% CI 1.51 to 9.91) than those who did not receive ibuprofen. Logistic regression was used to determine factors associated with self-reported adverse effects of NSAIDs among the female students. A p<0.05 was considered statistically significant.ConclusionWe found a considerably high prevalence of NSAID-related GI adverse effects driven by factors such as age at menarche and ibuprofen use.
HIV is one of the most important risk factors of tuberculosis (TB)-related morbidity and mortality. Isoniazid preventive therapy (IPT) is recommended to prevent latent TB reactivation in patients ...with HIV. However, due to multiple therapies and comorbidities, these patients are predisposed to adverse drug reactions (ADRs) that lead to increased morbidity and mortality. The aim of this study was to determine the prevalence and associated factors of suspected IPT-linked ADRs in HIV-positive patients using IPT.
A cross-sectional study was conducted between February and March 2020 at 3 regional referral hospitals (RRHs) in central Uganda. We sampled 660 HIV-positive patients aged 10 years or older who received IPT between July and December 2019 inclusive. Patients were interviewed using a pretested structured questionnaire, and their treatment records were reviewed. A modified Poisson regression model with clustered robust standard errors was used to identify factors associated with suspected IPT-linked ADRs.
The prevalence of the suspected ADRs was 51% (334 of the 660; 95% confidence interval CI: 18% to 83%). Patients self-reported 7-fold the number of suspected ADRs documented in the clinical files by the health care workers. Musculoskeletal symptoms were the most frequently experienced reaction (14%), followed by dizziness (13%) and peripheral neuropathy (11%). Serious suspected ADRs were experienced by 12% of the study participants; the most common were hepatotoxicity (26%), dizziness (23%), and neuropathy (17%). Female sex (aPR adjusted prevalence ratio: 0.92, 95% CI: = 0.88 to 0.95), study site (aPR: 1.09, 95% CI: = 1.09 to 1.18), level of education (aPR: 0.94, 95% CI: = 0.94 to 0.99), history of TB (aPR: 0.93, 95% CI: = 0.87 to 0.99), good IPT adherence (aPR: 1.16, 95% CI: = 1.05 to 1.29), and use of protease inhibitor (PI)-based antiretroviral therapy (aPR: 1.01, 95% CI: = 1.00 to 1.02) were significantly associated with suspected IPT-linked ADRs.
The prevalence of suspected IPT-linked ADRs is high, and hepatotoxicity is the most commonly reported serious suspected ADR. Patients self-reported more suspected ADRs than those documented in clinical files by health care workers. Patient engagement could improve ADR detection and potentially strengthen the pharmacovigilance system. Patients with a high risk of ADR ought to be monitored regularly to enable early detection and management.
Background:
Adverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions.
Objectives:
This study sought to determine the ...burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda.
Design:
We conducted a cross-sectional secondary analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda’s Mulago National Referral Hospital from November 2013 to April 2014.
Methods:
We reviewed clinical charts to identify inpatients with an ADR as one of the admitting diagnoses and, if so, whether or not the hospital admission was primarily attributed to the ADR. Logistic regression was used to determine factors associated with hospital admissions primarily attributed to ADRs.
Results:
Among 762 inpatients, 14% had ADRs at hospital admission and 7% were primarily hospitalized due to ADRs. A total of 235 ADRs occurred among all inpatients and 57% of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were attributed to antiretroviral drugs. HIV infection aOR (adjusted odds ratio) = 2.97, 95% confidence interval (CI): 1.30–6.77, use of antiretroviral therapy (aOR = 5.46, 95% CI: 2.56–11.68), self-medication (aOR = 2.27, 95% CI: 1.14–4.55) and higher number of drugs used (aOR = 1.13, 95% CI: 1.01–1.26) were independently associated with hospital admissions attributed to ADRs.
Conclusion:
Antiretroviral drugs were often implicated in ADR-related hospital admissions. HIV infection (whether managed by antiretroviral therapy or not), self-medication and high pill burden were associated with hospital admissions attributable to ADRs. The high HIV burden in Sub-Saharan Africa increases the risk of ADR-related hospitalization implying the need for emphasis on early detection, monitoring and appropriate management of ADRs associated with hospital admission in people living with HIV.
Plain language summary
Prevalence and contributing factors of hospital admissions attributed to adverse drug reactions in Uganda
Introduction: Adverse drug reactions (ADRs) are a big problem in many parts of the world and of particular concern is a situation where patients are admitted primarily because of an ADR. We sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission in Uganda.
Methods: We analysed data collected from a prospective cohort study of adult inpatients aged 18 years and older at Uganda’s Mulago National Referral Hospital from November 2013 to April 2014. We reviewed clinical charts to identify inpatients in whom an ADR was one of the admitting diagnoses and, if so, whether or not the ADR was the primary diagnosis linked to hospital admission. We used statistical tests to assess for contributing factors of hospital admissions attributable to ADRs.
Results: Among 762 inpatients, 108 had ADRs at admission and 56 were primarily admitted due to ADRs. A total of 235 ADRs occurred among all inpatients and 135 of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were linked to antiretroviral drugs. HIV infection, use of antiretroviral therapy, self-medication and higher number of drugs used were associated with hospital admissions primarily attributed to ADRs.
Conclusion: To prevent hospital admissions attributed to ADRs, patients need to be warned against self-medication, health workers and patients need to be reminded of the importance of early detection, monitoring and appropriate management of ADRs among the HIV-infected (whether managed by ART or not) and those patients taking many drugs.
Prompt detection and appropriate treatment of malaria prevents severe disease and death. The quality of care for adult malaria in-patients is not well documented in sub-Saharan Africa, particularly ...in Uganda. The study sought to describe the patterns of malaria diagnosis and treatment among adult in-patients admitted to the medical and gynaecological wards of Uganda's 1790-bed Mulago National Referral Hospital from December 2013 to April 2014.
A prospective cohort of 762 consented in-patients aged ≥ 18 years was assembled. Proportions of in-patients who received preadmission and in-hospital anti-malarials, missed Day 1 dosing of hospital-initiated anti-malarials and/or had malaria microscopy done were determined. Multivariable logistic regression was used to identify risk-factors for missed Day 1 dosing of anti-malarials.
One in five (19%, 146/762) in-patients had an admission or discharge malaria diagnosis or both; with median age of 29 years (IQR, 22-42 years). Microscopy was requested in 77% (108/141) of in-patients with an admission malaria diagnosis; results were available for 46% (50/108), of whom 42% (21/50) tested positive for Plasmodium falciparum malaria parasitaemia. Only 13% (11/83) of in-patients who received in-hospital injectable artesunate (AS) or quinine (Q) received follow-up oral artemether-lumefantrine (AL); 2 of 18 severe malaria cases received follow-up oral AL. Injectable AS only (47%, 47/100) was the most frequent hospital-initiated anti-malarial treatment followed by injectable Q only (23%, 23/100) amongst in-patients who received in-hospital anti-malarials. A quarter (25%, 25/100; 95% CI: 17-35%) of in-patients missed Day 1 dosing of hospital-initiated anti-malarials. Each additional admission diagnosis was more than two-fold likely to increase the odds of missed Day 1 dosing of in-hospital anti-malarials (aOR = 2.6, 95% CI: 1.52-4.56; P-value = 0.001).
Half the malaria microscopy results were not available; yet, the rate of testing was high. The majority of in-patients initiated on injectable AS or Q did not receive the recommended follow-up oral AL. One in four in-patients delayed to initiate hospital anti-malarials by at least one calendar day. The hospital should encourage prompt availability of malaria test-results to promote the timely initiation and completion of anti-malarial treatment, thereby improving the quality of care for hospitalized malaria patients in Uganda.
IntroductionCoronovirus disease 2019 (COVID-19) misinformation has been reported globally and locally. This has the potential to influence public risk perception and reduce the acceptance of the ...COVID-19 vaccine. This study aims to determine the prevalence of COVID-19 misinformation and vaccine hesitancy in Buikwe district. The study will also pilot a social mobilisation intervention using community influencers and determine its effect on COVID-19 misinformation and vaccine hesitancy.Methods and analysisThe study will be conducted using a quasi-experimental study design, in which two villages will be assigned to the intervention arm and two villages assigned controls. A mixed-methods technique employing both quantitative and qualitative methods will be employed. Data will be collected from healthy men and women aged 18 years and older who reside in the selected villages. The study will be implemented in three phases. First, a baseline study of 12 in-depth interviews with key informants and 6 focus group discussions and a household survey among 632 participants will be done. Second, an intervention employing dialogue-based social mobilisation approach using 10-man community groups per village will be developed and implemented. These will be trained and facilitated to educate and sensitise their communities about COVID-19. Third, an end-line household survey done after 6-months of intervention implementation in the four villages to assess the effect of the intervention on COVID-19 misinformation and vaccine hesitancy. Post-intervention qualitative evaluation will be done after the endline quantitative assessment. Preliminary analysis of the endline quantitative analysis will inform any revisions of the discussion guides. Qualitative data collected will be analysed using thematic content analysis while quantitative data will be analysed using χ2 tests or logistic regression, by intention-to-treat analysis.Ethics and disseminationThe study was reviewed for ethics and approved by the Makerere University School of Health Sciences Research Ethics Committee, reference number MakSHSREC-2020-45 and the Uganda National Council of Science and Technology, reference number HS1140ES. Study finding shall be presented to the district and national COVID-19 task force and at scientific gatherings and published in a peer-reviewed journal.Trial registration numberPACTR202102846261362.
ObjectivesPharmacovigilance 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.DesignA scoping review.Data sourcesReviewers comprehensively searched the literature in PubMed, Web of Science, Wiley Online Library, EBSCOhost, Google Scholar and other relevant websites.Eligibility criteriaPeer-reviewed publications and grey literature, without language restriction, describing duplication and/or methods relevant to duplication in pharmacovigilance databases from inception to 1 September 2023.Data extraction and synthesisWe used the Joanna Briggs Institute guidelines for scoping reviews and conformed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Two reviewers independently screened titles, abstracts and full texts. One reviewer extracted the data and performed descriptive analysis, which the second reviewer assessed. Disagreements were resolved by discussion and consensus or in consultation with a third reviewer.ResultsWe screened 22 745 unique titles and 156 were eligible for full-text review. Of the 156 titles, 58 (47 peer-reviewed; 11 grey literature) fulfilled the inclusion criteria for the scoping review. Included titles addressed the extent (5 papers), prevention strategies (15 papers), causes (32 papers), detection methods (25 papers), management strategies (24 papers) and implications (14 papers) of duplication in pharmacovigilance databases. The papers overlapped, discussing more than one field. Advances in artificial intelligence, particularly natural language processing, hold promise in enhancing the efficiency and precision of deduplication of large and complex pharmacovigilance databases.ConclusionDuplication in pharmacovigilance databases compromises risk assessment and decision-making, potentially threatening patient safety. Therefore, efficient duplicate prevention, detection and management are essential for more reliable pharmacovigilance data. To minimise duplication, consistent use of worldwide unique identifiers as the key case identifiers is recommended alongside recent advances in artificial intelligence.
Understanding the burden of dyslipidemia and its associated factors among adult people living with HIV on dolutegravir (DTG) based anti-retroviral therapy (ART) is critical to provide clinical ...guidance and risk reduction strategies in our setting.
We conducted a cross-sectional study on adult people living with HIV on DTG based ART between July and August 2022 at Mengo Hospital, a private not for profit missionary hospital owned by the Church of Uganda. Dyslipidemia was defined as: Total cholesterol (TC) ≥ 5.2 mmol/l, or high-density lipoprotein (HDL) < 1 mmol/l for men and < 1.3 mmol/l for women, or triglycerides (TG) ≥ 1.7 mmol/l, and low-density lipoprotein (LDL) ≥ 3.4 mmol/l. A participant was considered to have dyslipidemia if they had any of the lipid profile parameters in the above ranges. Socio-demographic information, clinical data and behavioral characteristics were collected. Fasting lipid profile and fasting blood glucose levels were also measured. Bivariate and multivariate analyses were done using a generalized linear model regression of the Poisson family with a log link (modified Poisson) using robust standard errors since the prevalence of dyslipidemia was more than 10%. Adjusted prevalence ratios (PR) were reported with their 95% confidence intervals (CI). A p-value of less than 0.05 was considered statistically significant.
A total of 341 participants were included. The prevalence of dyslipidemia was 78.0%, (95%CI:73.3-82.1). The highest prevalence was for low HDL (72.1%, 95%CI 67.1-76.7) followed by high TG (20.2%, 95%CI: 16.3-24.9), high TC (12.0%, 95%CI: 9.0-15.9) and high LDL (6.5%, 95%CI: 4.3-9.6). Female sex (aPR:1.55, 95%CI: 1.32-1.84, p < 0.001) and previous use of protease inhibitor (PI) based ART regimen (aPR:1.26, 95%CI: 1.04-1.53, p = 0.018) were significantly associated with dyslipidemia.
We demonstrate that the prevalence of dyslipidemia is very high as it was present in more than three quarters of the study participants. Female sex and previous use of PI based ART regimen were significantly associated with dyslipidemia. Management of dyslipidemia should be integrated in the HIV treatment package and we recommend further inquiry into the temporal relationship between dyslipidemia and DTG among ART patients, if any.
The Uganda ministry of Health recommends frequent blood glucose monitoring for the first six months on dolutegravir, in people with HIV (PWH) having pre-diabetes mellitus (pre-DM). We sought to ...determine if indeed PWH with pre-diabetes started on dolutegravir had worse blood glucose outcomes at 48 weeks compared to those with normal blood glucose. In this matched cohort study, we compared 44 PWH with pre-DM and 88 PWH with normal blood glucose at baseline. The primary outcome was change in mean fasting blood glucose (FBG) from baseline to week 48 and 2-hour blood glucose (2hBG) from baseline to week 36 compared between the two groups. There was significant increase in FBG in PWH with normal blood glucose (mean change in FBG(FBG): 3.9 mg/dl, 95% confidence interval (95% CI): (2.2, 5.7), p value (p) = < 0.0001) and decrease in those with pre-DM (FBG: -6.1 mg/dl, 95%CI (-9.1, -3.2), p = < 0.0001) at 48 weeks. 2hBG was significantly lower than at baseline in both groups with the magnitude of reduction larger in those with pre-DM at 12 weeks (adjusted differences in mean drop in 2hBG (a2hBG): -19.69 mg/dl, 95%CI (-30.19, -9.19), p = < 0.0001) and 36 weeks (a2hBG: -19.97 mg/dl, 95%CI (-30.56, -9.39), p = < 0.0001). We demonstrated that Ugandan ART naïve PWH with pre-diabetes at enrollment have consistent improvement in both fasting blood glucose and glucose tolerance over 48 weeks on dolutegravir. Intensified blood glucose monitoring of these patients in the first six months of dolutegravir may be unnecessary.
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. We adopted a qualitative exploratory research design. Between August and September 2021, we conducted sixteen in-depth interviews and six focus group discussions (48 participants) with patients reporting 'new' sexual dysfunction after transition to DTG-based regimens at seven health facilities in mid-Western Uganda. Data were analyzed by thematic approach. Decreased libido was reported in both sexes of patients within weeks of transition to DTG-based regimens. Diminished interest in sex was more frequently reported among women while men complained of a marked reduction in the frequency of sex. Women reported loss of psycho-social attraction to their long-term male partners. Erectile dysfunction was common among men in this sample of patients. Patients described their experiences of sexual dysfunction as an affront to their socially-constructed gender identities. Patients described tolerating sexual adverse drug reactions (ADRs) as a necessary tradeoff for the extension in life granted through antiretroviral therapy. A number of women reported that they had separated from their spouses as a result of perceived drug-induced sexual dysfunction. Marital strife and conflict arising from frustration with sexual-partner dysfunction was frequently reported by participants in both sexes. Several participants indicated experiencing insecurity in their heterosexual relationships due to difficulties in sexual functioning. Sexual dysfunction following transition to DTG-based regimens is common in both sexes of PLHIV, who indicated that they had no prior experience of difficulties in sexual health. Our findings demonstrate that sexual ADRs negatively impact self-esteem, overall quality of life and impair gender relations. DTG-related sexual health problems merit increased attention from HIV clinicians. Further research is warranted to assess the prevalence of DTG-associated sexual dysfunction in patients in Uganda.
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.
We adopted a qualitative exploratory design involving 49 participants. Between September 2020 and February 2021, we conducted 22 in-depth interviews with clinicians in the ART clinics of 12 purposively selected health facilities across Uganda. The selection of study sites ensured diversity in facility ownership-type (public/private), level of service delivery (tertiary/secondary/primary) and the four major geographic sub-regions of Uganda. We conducted three focus group discussions with 27 clinicians in the participating facilities. Data were analyzed by thematic approach.
Clinicians in ART clinics acknowledged that DTG-based ART is well tolerated by the majority of their patients who appreciate the reduced pill burden, perceived less side effects and superior viral load suppression. However, they reported that a number of their patients experience adverse drug reactions (ADRs) after being transitioned to DTG. Hyperglycemia is, by far, the most commonly reported suspected ADR associated with DTG-based regimens and was cited in all but two participating facilities. Insomnia, weight gain and reduced libido are among the other frequently cited suspected ADRs. In addition, clinicians in ART clinics perceived some of the suspected ADRs as resulting from drug interactions between dolutegravir and isoniazid. Weak diagnostic capacities and shortage of associated commodities (e.g. glucometers and test kits) were reported as impediments to understanding the full extent of ADRs associated DTG-based ART.
While DTG-based regimens were perceived by clinicians in ART clinics to be well tolerated by the majority of their patients, they also reported that a number of patients experience suspected ADRs key among which were hyperglycemia, insomnia and reduced libido. Based on the perspectives of clinicians, we recommend that future studies examine the prevalence of dolutegravir-induced hyperglycemia in patients in Uganda.
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