Virological Non-Suppression, Non-Adherence and the Associated Factors Among People Living with HIV on Dolutegravir-Based Regimens: A Retrospective Cohort Study.

Background: HIV is one of the leading causes of morbidity and mortality, with 39.0 million people living with HIV worldwide, 25.6 million of whom reside in the African region. Highly active anti-retroviral therapy (HAART) has improved survival and quality of life, yet some patients develop viral non-suppression. Dolutegravir (DTG) has been recommended since 2018 as a first-line treatment option in low- and middle-income countries owing to its effectiveness, low cost, and tolerability, but some studies have reported virological non-suppression with its use. This study aims to explore the prevalence and factors associated with virological non-suppression in adults taking DTG-based regimens in Mbarara Regional Referral Hospital. Methods: A retrospective cohort study was carried out among people living with HIV (PLWHIV) taking DTG-based HAART regimens by way of record review. SPSS was used for analysis, and both binary and multivariate logistic regression analyses were performed to test associated factors. Results: Among the 422 participants' records reviewed, 62.8% were female (median age 40 years, IQR=13). The prevalence of virological non-suppression was 4.2%. Poor adherence to HAART was significantly associated with virological non-suppression, with 100.3 increased adjusted odds (95% CI: 28.90-348.12, p<0.001) compared to those with a record of good adherence. The reasons for poor adherence included alcohol use, stigma, forgetting to take medication, transport problems, and irregular timing of swallowing. Conclusion: This study found poor adherence to be associated with a 4.2% prevalence of virological non-suppression among PLWHIV in a large public HIV care clinic. Despite the high suppression rates on DTG-based regimens, adherence counseling and viral load monitoring need to be emphasized at all HIV care centers to mark the trends of virological non-suppression.

Prevalence and factors associated with drug therapy problems among hypertensive patients at hypertension clinic of Mbarara Regional Referral Hospital, Uganda: a |cross-sectional study.

BACKGROUND: Despite the use of safe and effective conventional drugs, drug therapy problems (DTPs) pose a threat to the successful management of hypertension. DTPs are of a great concern in health care because of their serious consequences such as poor quality of life, increased health care costs, morbidity and mortality. However, there is no published information regarding the prevalence of DTPs and associated factors among hypertensive patients in Uganda. OBJECTIVE: The aim of the study was to determine the prevalence and factors associated with DTPs among hypertensive patients at the hypertension clinic of Mbarara Regional Referral Hospital (MRRH). METHOD: A cross-sectional study was conducted at the hypertension clinic, MRRH, Uganda among 228 hypertensive patients. Data were collected from medical records using a data abstraction tool and patients were interviewed using a structured questionnaire. Data analysis was done using Statistical Package for Social Sciences (SPSS) version 22.0. Descriptive analysis was used to determine the prevalence of DTPs. Logistic regression was used to determine the association between the independent and dependent variables. Variables were considered statistically significant at p-value <0.05. RESULTS: A total of 178 DTPs were identified among 141 hypertensive patients. The prevalence of antihypertensive-related DTPs was 61.8% (95% confidence interval [CI]: 55.3-67.5) with an average of 1.26 ± 0.52 DTPs per patient. Out of 141 participants with DTPs, 109 (77.3%) had one DTP, 27 (19.1%) had 2 DTPs, and 5 (3.5%) had 3 DTPs. The most common types of antihypertensive-related DTPs were 'dosage too low' which accounted for 53 (29.8%), followed by 'adverse drug reactions' which accounted for 48 (27%). Uncontrolled blood pressure (BP; adjusted odds ratio [AOR]: 4.17; 95% CI: 2.33-7.45, p < 0.001) and routine laboratory test results (AOR: 1.87; 95% CI: 1.04-3.36, p = 0.036) were significantly associated with antihypertensive-related DTPs among hypertensive patients. CONCLUSION: Almost two-thirds of study participants had antihypertensive-related DTPs. The most common DTPs were 'dosage too low' and 'adverse drug reactions' which both accounted for almost a third of the total DTPs each. Uncontrolled BP and routine laboratory test results were significantly associated with antihypertensive-related DTPs among the study participants. Our study emphasizes the need for improved patient care by clinical pharmacists to identify and prevent DTPs among hypertensive patients.

Prevalence and factors associated with adverse drug reactions among heart failure patients hospitalized at Mbarara Regional Referral Hospital, Uganda.

BACKGROUND: Adverse drug reaction (ADR) of medications remains an obstacle to achieving optimal disease outcomes. This study aimed to assess the prevalence and associated factors of ADR among Heart failure (HF) patients hospitalized at Mbarara Regional and Referral Hospital. METHOD: A prospective observational study was conducted among hospitalized HF patients from November 2021 to January 2022. Univariate and multivariate logistic regression was employed to determine factors associated with the ADR. RESULT: Overall, 118 HF patients were included in the study with a median age of 43 years. A total of 164 ADRs were identified during the follow-up period of 1011 days. The incidence of new ADRs was 106 ADRs/1000 person-days. The prevalence of ADR was 59.3%. Of the 164 ADRs, 118(71.9%) were probable. The gastrointestinal system was the most frequently (27.5%) affected system. Over half (86, 52.4%) of the ADRs were mild and 96(58.5%) were preventable. Age group 19-59(AOR 0.15[0.03-0.35] at 95%CI, p = 0.013), herbal use (AOR 3.07[1.01-9.32] at 95%CI, p = 0.048), poly-pharmacy (AOR 8.7[2.4-15.77] at 95%CI, p < 0.001) and drug-drug interaction (AOR 6.06[2.79-12.5] at 95%CI, p = 0.004) were significantly associated with ADRs among HF patients. CONCLUSION: More than half of the hospitalized HF patients experienced at least one ADR during their hospital stay. The use of herbal medicines, poly-pharmacy, and drug-drug interaction were associated with a high risk of ARDs whereas the age group 19-59 years was less likely to experience ADRs.

Predictors of hospital-acquired adverse drug reactions: a cohort of Ugandan older adults.

BACKGROUND: Globally, it is estimated that the number of older adults will become 2 billion by 2050. The identification of the predictors of adverse drug reaction (ADR) in hospitalized older patients is crucial to the development of prediction tools and preventive strategies to mitigate the burden of ADRs. This study aimed to determine the predictors of hospital-acquired ADR occurrence among hospitalized older adults in a low-income country. METHODS: We conducted a prospective cohort of older adults admitted to medical, oncology, and surgery wards at Mbarara Regional Referral Hospital (MRRH) for a consecutive 6 months where each patient was followed up daily from admission to discharge. We used Edwards and Aronson's definition of ADR and the Naranjo ADR Causality Scale. We employed Beer's criteria and Lexicomp to determine potentially inappropriate medications, and drug interactions, respectively. We conducted univariate and multivariable logistic regression using Statistical Package for the Social Science (SPSS) Version 23.0. RESULTS: Out of 523 participants with median (Inter Quartile Range) age of 67 (62-76) years, 256 (48.9%) experienced at least one ADR. Independent predictors of occurrence of hospital acquired ADRs included age of 60-75 (Adjusted odds ratio (AOR) = 1.97, 95% C.I: 1.14-3.41; p value = 0.015) compared to > 75 years, previous ADR in 1 year (AOR = 2.43, 95% C.I: 1.42-4.17; p value = 0.001), potentially inappropriate medication (AOR = 4.56, 95% C.I: 2.70-7.70; p value< 0.001), polypharmacy (AOR = 3.29, 95% C.I: 1.98-5.46; p value< 0.001)), having a Charlison Comorbidity Index (CCI) ≥ 6 (AOR = 8.47, 95% C.I: 4.85-14.99; p value< 0.001), having heart failure (AOR = 2.83, 95% C.I: 1.34-6.02; p value = 0.007) or kidney disease (AOR = 1.95, 95% C.I: 1.05-3.61; p value = 0.034) and a hospital stay > 10 days (AOR = 3.53, 95% C.I: 1.89-6.61; p value< 0.001) compared to < 5 days. CONCLUSION: The current prevalence of ADR is higher than previously reported in high-income countries. Disease-related factors followed by medication-related factors were shown to be the most important predictors of hospital-acquired ADRs. CCI and PIM showed the strongest association with ADR. The predictors of ADRs identified in our study were generally comparable with those reported by previous studies. PLAIN LANGUAGE TITLE: Conditions that predispose older patients to experience harmful effects from their medications while in hospital. Identifying the conditions that predispose older adults to incur harmful effects of their medications helps to plan on how best to predict, take precautions and closely follow up on them and thus, to prevent these undesirable outcomes. This study aimed to identify these conditions which determine which older adults are higher risk to incur these harmful undesirable effects of medicines. Everydayduring their hospital stay, we closely followed older patients who were 60 years and above from their entry to the hospital wards until they left the hospital. We interviewed the participants, reviewed their medication files and we also examined them physically to identify any unwanted and harmful outcome from their current medications. Out of 523 participants, almost half of them experienced at least one harmful or undesired effect related to their medicine. Conditions which predisposed them to experience a harmful effect from their medicines included being in age bracket of 60-75 years, having a history of experiencing harmful outcomes from medicines in the previous 1 year, taking a medication which was listed as potentially inappropriate for older adults, taking 5 or more medications concurrently, having a lower 10 years survival chance, having heart or kidney disease and a hospital stay > 10 days.

Prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: a mixed design study.

BACKGROUND: In low income countries such as Uganda progress has been made towards achieving the United Nations AIDS programme 95-95-95 target however efforts are still impeded by pretreatment drug resistance and adverse drug events (ADEs) hence introduction of dolutegravir-based antiretroviral therapy as first-line treatment due to a higher genetic barrier to resistance, better tolerability and safety profile. However, recent studies have raised concerns regarding its safety in real-clinical settings due to ADEs and being a recently introduced drug there is need to actively monitor for ADEs, hence this study aimed to establish the prevalence and factors associated with ADEs among patients on dolutegravir-based regimen at the Immune Suppression Syndrome (ISS) Clinic- Mbarara Regional Referral Hospital (MRRH). METHODS: A mixed design study was conducted at ISS Clinic-MRRH among 375 randomly selected patients who had been exposed to DTG-based regimen for at-least 12 weeks. These were interviewed to obtain data on socio-demographics, dietary habits and their files reviewed for ADEs. Data entry was done using Epi-data 3.0 and exported to SPSS 25.0 for analysis. Prevalence was determined as a percentage, and ADE associated factors assessed using bivariate analysis, those found significant were further subjected to multivariate analysis and considered significant at P < 0.05. RESULTS: The prevalence of ADEs among patients on DTG-based regimen was found to be 33.1% (124/375) with 5.6% (7/124) participants discontinued from treatment due ADEs, 4 due to hyperglycemia and 3 liver toxicity. The commonly experienced ADE was allergy at 36.3%. Male sex (AOR 1.571, 95% CI 1.433-1.984), WHO stage one at entry to care (AOR 4.586, 95% CI 1.649-12.754), stage two (AOR 4.536, 95% CI 1.611-12.776), stage three (AOR 3.638, 95% CI 1.262-10.488), were significantly associated with ADEs. Patients with undetectable viral load at initiation of DTG-based regimen were 67.6% less likely to experience ADEs (AOR = 0.324, 95% CI 0.1167-0.629). CONCLUSION: This study reports a prevalence of 33.1% of ADEs among patients on DTG-based regimen. The most commonly experienced ADE was allergy. Male sex, early HIV disease stage at entry into care and detectable viral load at initiation of DTG-based regimen were significantly associated with ADEs. It is crucial to actively monitor patients with these characteristics for ADEs.

Development and Validation of 'Prediction of Adverse Drug Reactions in Older Inpatients (PADROI)' Risk Assessment Tool.

BACKGROUND: Adverse drug reactions (ADR) detection and prediction methods in hospitalized older adults remain imprecise. The identification of the risk factors for ADRs in this group of patients is crucial to develop plausible prediction models. OBJECTIVE: This study aimed at developing and validating a "Prediction of ADR in Older Inpatients (PADROI)" risk assessment tool in hospitalized older adults. METHODS AND MATERIALS: We had previously conducted a derivational study that aimed to determine the risk factors of ADRs in hospitalized older adults. We developed the PADROI model as a potential ADR risk assessment tool incorporating 8 predictors each given a score by rounding off the respective adjusted odds ratios (AORs) to the nearest whole number. Subsequently, we conducted another prospective cohort among adults aged 60 years and older admitted to Gynecology and Obstetrics, Medical, Oncology, Surgery, and Psychiatry wards at Mbarara Regional Referral Hospital (MRRH) from July 5 to September 17, 2021. RESULTS: A total of 124 participants, 70 females and 54 males aged 60-95 years, were included in this validation cohort; 62 of them experienced 90 ADRs. When applied to the derivational cohort, the area under receiver operating characteristic curve (AUROC) for the PADROI model was shown to be 0.896 (0.869-0.923; at 95% CI). In the validation study, AUROC of PADROI was 0.917 (0.864-0.971 at 95% CI; p < 0.001). Overall, PADROI correctly predicted 91.7% of those who experienced an ADR. CONCLUSION: Using the adjusted odds ratios from our derivational cohort, we developed an ADR prediction tool (PADROI) that achieved an excellent AUROC (0.917), high sensitivity (87.1%) and specificity (90.3%). The current model demonstrated a high potential for clinical applicability which can be strengthened if similar results are reproduced in larger and multi-centered studies.

Prevalence, Incidence, and Characteristics of Adverse Drug Reactions Among Older Adults Hospitalized at Mbarara Regional Referral Hospital, Uganda: A Prospective Cohort Study.

BACKGROUND: Adverse drug reactions (ADRs) are associated with significant clinical and economic effects. Among the elderly population, the risk for ADRs is even higher. Data of ADR prevalence and incidence among the elderly population in Uganda and many low- and middle-income countries are lacking. OBJECTIVE: This study determined the prevalence, incidence, and characteristics of ADRs among hospitalized elderly patients at Mbarara Regional Referral Hospital (MRRH), Uganda. METHODS AND MATERIALS: We conducted a prospective cohort of older adults admitted to medical, oncology, and surgery wards at MRRH for consecutive 6 months. The primary data were obtained by interviewing patients and caregivers and reviewing patient medication charts, taking vital signs, and physical examinations. We used Edwards and Aronson's definition of ADR and the Naranjo ADR Causality Scale. We conducted descriptive statistics and the Kolmogorov-Smirnov test using SPSS Version 23.0. RESULTS: We studied a total of 523 older adults 60 to 103 years of age. During their hospital stay, 256 (48.9%) of the patients experienced at least one ADR. A total of 365 ADRs were identified during 4702 person-days of follow-up. The incidence of ADRs was 78 ADRs/1000 person-days. ADRs affecting the gastrointestinal tract were the most frequently (40.6%) identified categories. Probable and type A ADRs accounted for 260 (71.2%) and 305 (83.6%) of the total incidents, respectively. Overall, 237 (64.9%) of the ADRs were rated as mild, whereas 10 (2.8%) of them as severe. Lastly, 165 (45.2%) of the ADRs were categorized as preventable. CONCLUSION: Almost half of the hospitalized patients aged 60 to 103 years experienced at least one ADR during their hospital stay, which is higher than has been previously documented. Almost three-thirds of the ADRs were probable, about 4 out of 5 were type A and almost two-thirds were mild. Nearly half of the ADRs were preventable.

Prevalence, characteristics and predicting risk factors of adverse drug reactions among hospitalized older adults: A systematic review and meta-analysis.

BACKGROUND: Occurrence of adverse drug reactions is a major global health problem mostly affecting older adults. Identifying the magnitude and predictors of adverse drug reactions is crucial to developing strategies to mitigate the burden of adverse drug reactions. This study's objectives were to estimate and compare the prevalences of adverse drug reactions, to characterize them and to identify the predictors among hospitalized older adults. METHODS: A comprehensive systematic literature search including both prevalence and risk factors of adverse drug reactions in hospitalized older adults was conducted using PubMed, Scopus and Google Scholar, involving all articles published in English. Descriptive statistics and comparison of means was performed using SPSS version 20.0 and metaprop command was performed in STATA version 13.0. Heterogeneity was assessed using I 2 statistic. RESULTS: A total of 18 studies, involving 80,695 participants with a median age of 77 years, were included in this study. The pooled prevalence of adverse drug reaction was 22% (95% confidence interval: 17%, 28%; I 2 = 99.23%). Among high-income countries, the prevalence of adverse drug reactions was 29% (95% confidence interval: 16%, 42%) as compared to 19% (95% confidence interval: 14%-25%) in low and middle-income countries (p value = 0.176). Of the 620 adverse drug reactions categorized, most were type A (89%), which are generally predictable and preventable. Two-thirds (795, 67%) of the adverse drug reactions were probable and most (1194, 69%) were mild or moderate. The majority (60%) of the categorized adverse drug reactions were preventable and less than one-third (31%) were severe. The most consistently reported predictors of adverse drug reactions in hospitalized older patients were medication-related factors, including polypharmacy and potentially inappropriate medications followed by disease-related factors-renal failure, complex comorbidity, heart failure and liver failure. CONCLUSION: Almost one-quarter of all hospitalized older adults experienced at least one adverse drug reaction during their hospital stay. The majority of the adverse drug reactions were preventable. Medication-related factors were the most consistently reported predictors of adverse drug reactions followed by disease-related factors.

Predictors of Medication-Related Emergency Department Admissions Among Patients with Cardiovascular Diseases at Mbarara Regional Referral Hospital, South-Western Uganda.

BACKGROUND: Medication-related emergency department admissions impose a huge and unnecessary burden on the healthcare system. We sought to determine the prevalence and predictors of medication-related emergency department admissions, among patients with cardiovascular diseases at Mbarara Regional Referral Hospital, Uganda. METHODS: Institutional research ethics approval was secured to conduct a cross-sectional study at the Mbarara Regional Referral Hospital emergency department, between February and September, 2020. All eligible and consenting patients were enrolled in a consecutive manner after a preliminary diagnosis was made by the attending physician. Structured questionnaire interview and comprehensive medication history reviews were used to identify medication therapy problems, in collaboration with a resident physician present on duty. We used sequential categorization for medication therapy problem(s). Descriptive and logistic regression analyses were used to determine prevalence and predictors of medication-related emergency department admissions. RESULTS: Out of the 128 patients interviewed, 105 (82%) patient admissions were associated with a medication therapy problem: ineffectiveness of drug therapy (53.3%, 56), medication non-adherence (42.9%, 45), and adverse drug reactions (3.8%, 4). Out of a total of 90 incidences of medication non-adherence, 34.4% (31/90) were due to lack of understanding of patient medication regimen, and 27.8% (25/90) due to unaffordable cost of medicines. Female gender (AOR = 4.31 [1.43, 13.03 at 95% CI]; P-value = 0.010]) and a history of tobacco use (AOR = 9.58 [1.14, 80.28 at 95% CI]; P-value = 0.037) were statistically significant predictors of medication-related emergency department admissions in adjusted analysis. CONCLUSION: Four in five emergency department admissions were associated with medication-related causes, majorly due to ineffectiveness of drug therapy. Knowledge gap on patient medication regimens was the most prevalent cause for medication non-adherence. Female gender and previous or current tobacco use was an independent risk factor for medication-related admissions.

An Ethics-based Approach to Global Health Research Part 2: Strategies for Overcoming Logistic and Implementation Challenges.

With the growth of global pharmacy partnerships and collaborative research, particularly between high-income countries and low- or middle-income countries, it is necessary to establish best practices for fair and ethical collaboration and research. There is a gap in the pharmacy literature in this regard. Through this commentary, authors will present a pathway for future global health researchers including generating ideas based on mutual needs of the partnership and the community; exploring the importance of regulations including the need to conduct research and partnership projects within the confines of each participant's professional scope of practice, expertise, and licensure; describing the need to develop agreements and the components that should be included in such an agreement; discussing ethical guidelines for research planning, obtaining ethical approval, and planning for adverse events; and illustrating ethical considerations for research implementation with considerations around consent, data collection, linking patients to care after the completion of the study, and dissemination. Global examples, with a pharmacy-specific approach where applicable, within each section highlight the importance of discussion and action around ethics and equity when pursuing collaborative research, recognizing that many of these situations involve difficult decisions.