ABSTRACT
BACKGROUND: There are limited data in South Africa (SA) on adverse drug reaction (ADR) patterns and common causative medicines, outside of HIV and tuberculosis treatment programmes. In SA, Western Cape Province has a pharmacovigilance programme that collects spontaneous reports of suspected ADRs from public sector healthcare facilities. OBJECTIVES: To describe reports received by the pharmacovigilance programme over a 4-year period (excluding those ascribed to medicines used to treat HIV and tuberculosis), as well as challenges faced in the implementation of such a system. METHODS: Reports of suspected ADRs and deaths possibly related to ADRs received between January 2015 and December 2018 were reviewed. Causality was assessed by a pharmacist, with multidisciplinary team involvement for all deaths and complicated cases. Causality was categorised according to the World Health Organization-Uppsala Monitoring Centre system. Preventability was assessed using Schumock and Thornton criteria. Observations on preventability and challenges faced in the operation of a spontaneous reporting system were also noted. RESULTS: We received 5 346 reports containing 6 023 suspected ADRs. There were 5 486 ADRs confirmed after causality assessment, in 5 103 reports. Cough, angio-oedema, movement disorders and uterine bleeding disorders were the most common ADRs. Enalapril, etonogestrel, amlodipine and hydrochlorothiazide were the most commonly implicated drugs. Seven deaths were reported; 3 of these reports of deaths had confirmed ADRs, and these ADRs were assessed as contributing to the deaths. Approximately 3.8% of commonly reported ADRs were preventable. CONCLUSIONS: Enalapril and etonogestrel were responsible for a significant proportion of ADRs reported to this provincial programme. Future work should include quantification of preventability aspects to better inform gaps in healthcare worker knowledge that can be addressed in order to improve patient care.
Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pharmacovigilance , Public Health , Adolescent , Adult , Child , Female , Humans , Infant , Male , Middle Aged , South Africa/epidemiology , Young AdultABSTRACT
OBJECTIVES: Renal dysfunction is a significant cause of morbidity and mortality among HIV-positive individuals. This study evaluated renal dysfunction in a cohort of adults who started antiretroviral treatment (ART) regardless of CD4 count at three Department of Health (DOH) clinics included in the HIV Prevention Trials Network 071 (HPTN 071) Population Effect of Antiretroviral Therapy to Reduce HIV Transmission (PopART) trial. METHODS: A retrospective cohort analysis of routine data for HIV-positive individuals starting ART between January 2014 and November 2015 was completed. Incident renal dysfunction was defined as an estimated glomerular filtration rate (eEGFR) < 60 mL/min after ART initiation among individuals with a baseline (pre-ART) eGFR ≥ 60 mL/min. RESULTS: Overall, 2423 individuals, with a median baseline CD4 count of 328 cells/µL [interquartile range (IQR) 195-468 cells/µL], were included in the analysis. Forty-seven individuals had a baseline eGFR < 60 mL/min. Among 1634 nonpregnant individuals started on a tenofovir-containing ART regimen and with a baseline eGFR ≥ 60 mL/min, 27 developed an eGFR < 60 mL/min on ART. Regression analysis showed lower odds of baseline eGFR < 60 mL/min at baseline CD4 counts of > 500 cells/µL [adjusted odds ratio (aOR) 0.29; 95% confidence interval (CI) 0.11-0.80], 351-500 cells/µL (aOR 0.22; 95% CI 0.08-0.59) and 201-350 (aOR 0.48; 95% CI: 0.24-0.97) compared with baseline CD4 counts < 200 cells/µL. CONCLUSIONS: This study showed low rates of renal dysfunction at baseline and on ART, with lower rates of baseline renal dysfunction among individuals with baseline CD4 counts > 200 cells/µL. Strategies that use baseline characteristics, such as age, to identify individuals at high risk of renal dysfunction on ART for enhanced eGFR monitoring may be effective and should be the subject of future research.
Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/complications , HIV Infections/drug therapy , Kidney Diseases/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , CD4 Lymphocyte Count , Female , Glomerular Filtration Rate , HIV Infections/pathology , HIV Infections/prevention & control , Humans , Male , Middle Aged , Retrospective Studies , South Africa , Surveys and Questionnaires , Young AdultABSTRACT
The serum anticholinergic activity (SAA) is used as a marker for cognitive impairment. Here, two studies have been performed characterizing the SAA profile. In Study 1 the endogenous SAA in relation to the total serum protein concentration was monitored for 24 h in five healthy individuals and compared with that in four inpatients following cardiac surgery. In Study 2 the SAA of seven healthy individuals was assessed following a single amitriptyline dose. In both studies SAA was assessed by an ex vivo assay. In Study 1, the absolute SAA varied in a wide range of 1.2 and 14.5 atropine equivalents (AEs) over 24 h. A circadian pattern was not observed. The mean total serum protein concentration, but not the SAA, was significantly lower in inpatients than in healthy individuals. In Study 2, the SAA increased following amitriptyline to a maximum. The mean SAA increased by 6.39 AE at the amitriptyline peak concentration. High SAA variability showed a low statistical relation to amitriptyline concentrations. Both studies characterize the SAA as an individual parameter not affected per se by surgery or clinical care and poorly correlated with the total serum protein concentration. The relation with amitriptyline concentration helps to quantify SAA values towards a better understanding of the clinical implications and limitations of SAA changes.
Subject(s)
Amitriptyline/pharmacokinetics , Cholinergic Antagonists/blood , Thoracic Surgery , Adult , Aged , Aged, 80 and over , Amitriptyline/blood , Animals , Humans , Male , Middle Aged , Radioligand Assay , Rats , Rats, Wistar , Receptors, Muscarinic/metabolismABSTRACT
La evaluación particulariza en el componente estratégico "formación de recursos humanos aplicado al componente programático salud materno-infantil", de acuerdo con la estrategia global de la atención primaria de salud, referida a los niveles de complejidad en la atención perinatal
Subject(s)
Education, Continuing , Gynecology , Prenatal Care , CurriculumABSTRACT
La evaluación particulariza en el componente estratégico "formación de recursos humanos aplicado al componente programático salud materno-infantil", de acuerdo con la estrategia global de la atención primaria de salud, referida a los niveles de complejidad en la atención perinatal
Subject(s)
Education, Continuing , Prenatal Care , Curriculum , Primary Health Care , Maternal and Child HealthABSTRACT
La evaluación particulariza en el componente estratégico "formación de recursos humanos aplicado al componente programático salud materno-infantil", de acuerdo con la estrategia global de la atención primaria de salud, referida a los niveles de complejidad en la atención perinatal
