Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East.

BACKGROUND: Growing numbers of patients with diabetes mellitus in Africa and the Middle East on antidiabetic therapies necessitate understanding adverse event reporting in these regions. We assessed pharmaceutical industry insulin individual case safety report (ICSR) completeness and completeness-associated variables. RESEARCH DESIGN AND METHODS: The observational cross-sectional study, set in an insulin-manufacturing company's safety database, assessed vigiGrade® completeness scores of African and Middle Eastern post-marketing ICSRs from January to December 2018, and case variables effects on completeness. Low vigiGrade® scores indicated poorly documented ICSRs. RESULTS: We analyzed 4854 ICSRs; 59.8% from the Middle East. The mean vigiGrade® score was 0.58. Middle Eastern ICSRs had higher mean scores than African ICSRs (0.65 vs. 0.46, p<0.001). Scores peaked at 0.32, 0.70, and 1.00 for Middle Eastern ICSRs compared to 0.35 and 0.50 for African ICSRs. Middle Eastern serious (0.77 vs. 0.47; p<0.001) and solicited (0.70 vs. 0.48; p<0.001) ICSRs had higher mean scores than African ICSRs. Mean scores were highest for Middle Eastern physicians (0.89) and other healthcare professionals (0.82), whereas, in Africa, scores were highest for consumer- (0.47) and pharmacist-reported ICSRs (0.47) (p<0.001). CONCLUSIONS: Middle Eastern pharmaceutical industry insulin ICSRs were documented with greater detail than African ICSRs. Seriousness, report source, and reporter type significantly impacted ICSR completeness.

Adherence and clinical outcomes of HIV patients switching to a fixed-dose combination regimen.

Background: The efficacy of antiretroviral therapy (ART) is monitored using clinical markers such as viral load (VL) and CD4 counts. Adherence to ART has been associated with viral suppression and improved clinical outcomes. Objectives: To determine the relationship between adherence status with multiple-tablet regimens (MTR) and fixed-dose combination (FDC) regimens, to weight, CD4 count and VL of patients living with HIV. Method: An observational, descriptive study was conducted on a closed cohort of patients living with HIV and attending a primary health care clinic in Northern Cape in South Africa between 01 January 2013 and 31 December 2015. Patients were on an MTR and changed to an FDC regimen. Adherence was measured using the medicine possession ratio (MPR). Results: Statistically significant differences exist between the mean MPR of the 30-day (p = 0.0308) and 28-day supply (p < 0.0001) of the MTR when compared to FDC regimen. No statistically significant differences could be found between adherence and clinical outcomes such as weight, CD4 count and VL for either MTR or FDC regimens. The suppressed VL values measured for MTR were n = 299 (89.25%) and n = 415 (93.05%) for FDC regimen. Conclusion: Adherence improved when patients were switched to FDC, but no statistically significant differences in clinical outcomes measured as weight, CD4 count and VL between adherence status and regimen type could be found. Contribution: This study contributes to much-needed information about ART adherence and clinical outcomes (such as weight, CD4 count and VL) of adult HIV-positive patients in a public healthcare clinic in the Northern Cape, South Africa.

Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East.

BACKGROUND: The growing numbers of patients with diabetes mellitus in Africa and the Middle East on antidiabetic therapies necessitate an understanding of adverse event (AE) reporting in these regions. OBJECTIVE: The aim of the study was to provide an AE reporting overview in patients using insulin in Africa and the Middle East by characterizing and comparing individual case safety reports (ICSRs) features. METHODS: The cross-sectional study analyzed ICSR data from a global pharmaceutical company's pharmacovigilance database for January to December 2018 to describe and compare patient demographics, report sources, reporter types, ICSR seriousness, suspect products, indication for insulin use and AE preferred terms, by country. RESULTS: Overall 7076 ICSRs were analyzed, 63.6% from the Middle East. Most ICSRs were nonserious (91.5%), from solicited sources (83.5%), and reported by consumers (70.7%). Patients from the Middle East were, on average, 34.2 years of age, had gestational diabetes mellitus as indication (64.3%), insulin detemir as suspect product (76.5%), and exposure during pregnancy as AE preferred term (89.1%). Patients from Africa were 48.1 years old on average, a higher proportion of type 2 diabetes mellitus was observed (52.2%), human insulin was the suspect product (51.6%), and blood glucose increased the AE preferred term (23.1%). Few macrovascular and microvascular complications were reported (< 1% in both regions). Associations between the region and patient age, gender, report sources, reporter types, indications for insulin use, suspect products, and AE preferred term were significant (p < 0.001). CONCLUSION: ICSRs features were region-specific and dependent on patient age, gender, report sources, reporter types, suspect products, and AE preferred terms.

Standards of aminoglycoside therapeutic drug monitoring in a South African private hospital: perspectives and implications.

BACKGROUND: Therapeutic drug monitoring (TDM) is essential to ensure that aminoglycoside peak concentrations are high enough for effective antimicrobial treatment and trough levels are low enough to minimise toxicity. Inappropriate utilisation of TDM may lead to suboptimal therapy, toxicity and waste of resources. This study aimed to investigate the standard of aminoglycoside TDM performed in adult hospitalised patients. DESIGN: An observational, descriptive, cross-sectional study. SETTING: A 221-bed private hospital. PARTICIPANTS: All patients, older than 18 years, on intravenous aminoglycosides for more than 48 hours were included. INTERVENTIONS: None, was observational. A computerised database and patient files were used to obtain the information required for this study. Descriptive statistical analysis was used. MAIN OUTCOMES MEASURES: Aminoglycoside blood levels and estimated glomerular filtration rate (eGFR) in the patients. RESULTS: One hundred and three (103) patients were included: 65 on gentamicin and 38 on amikacin. Blood levels were performed in only 19 gentamicin (29.23%) and 22 amikacin (57.89%) patients. Trough levels were taken more than 2 hours before the next dose in 12 gentamicin (63.16%) and 12 amikacin (54.54%) patients. The majority of patients (96.92% on gentamicin and 84.21% on amikacin) received once daily doses. TDM was performed in all patients with an estimated glomerular filtration rate (eGFR) lower than 60 mL/min/1.73m2 and in 23.31% of gentamicin patients and 56.76% of amikacin patients with an eGFR higher than 60 mg/min/1.73m2. CONCLUSIONS: Incorrect sampling times and unnecessary levels taken in patients with normal renal function indicate a need for aminoglycoside treatment guidelines in the private hospital. FUNDING: None.