Dataset Information

Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey.

ABSTRACT:

Aims

Fatal adverse drug reactions (ADRs) are important causes of death, but data from resource-limited settings are scarce. We determined the proportion of deaths in South African medical inpatients attributable to ADRs, and their preventability, stratified by human immunodeficiency virus (HIV) status.

Methods

We reviewed the folders of all patients who died over a 30 day period in the medical wards of four hospitals. We identified ADR-related deaths (deaths where an ADR was 'possible', 'probable' or 'certain' using WHO-UMC criteria and where the ADR contributed to death). We determined preventability according to previously published criteria.

Results

ADRs contributed to the death of 2.9% of medical admissions and 56 of 357 deaths (16%) were ADR-related. Tenofovir, rifampicin and co-trimoxazole were the most commonly implicated drugs. 43% of ADRs were considered preventable. The following factors were independently associated with ADR-related death: HIV-infected patients on antiretroviral therapy (adjusted odds ratio (aOR) 4.4, 95% confidence interval (CI) 1.6, 12), exposure to more than seven drugs (aOR 2.5, 95% CI 1.3, 4.8) and increasing comorbidity score (aOR 1.3, 95% CI 1.1, 1.7).

Conclusions

In our setting, where HIV and tuberculosis are highly prevalent, fatal in-hospital ADRs were more common than reported in high income settings. Most deaths were attributed to drugs used in managing HIV and tuberculosis. A large proportion of the ADRs were preventable, highlighting the need to strengthen systems for health care worker training and support.

SUBMITTER: Mouton JP

PROVIDER: S-EPMC4594724 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Publications

Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey.

Mouton Johannes P JP Mehta Ushma U Parrish Andy G AG Wilson Douglas P K DP Stewart Annemie A Njuguna Christine W CW Kramer Nicole N Maartens Gary G Blockman Marc M Cohen Karen K

British journal of clinical pharmacology 20150706 4

<h4>Aims</h4>Fatal adverse drug reactions (ADRs) are important causes of death, but data from resource-limited settings are scarce. We determined the proportion of deaths in South African medical inpatients attributable to ADRs, and their preventability, stratified by human immunodeficiency virus (HIV) status.<h4>Methods</h4>We reviewed the folders of all patients who died over a 30 day period in the medical wards of four hospitals. We identified ADR-related deaths (deaths where an ADR was 'poss ...[more]

PMID: 25475751

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Project description:Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions.We prospectively followed patients admitted to 4 hospitals' medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission.There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34-65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06-2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09-1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07-1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17-3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable.In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect South Africa's high HIV and tuberculosis burden. Identification and management of these ADRs should be considered in HIV and tuberculosis care and treatment programs and should be emphasized in health care worker training programmes.

Project description:BackgroundElectronic continuous surveillance databases are ideal for monitoring antibiotic use (ABU) in hospitalised patients for antibiotic stewardship programmes (ASP). However, such databases are scarce in low-resource settings. Point prevalence surveys (PPS) are viable alternatives. This report describes ABU and identifies ASP implementation improvement areas in Limpopo Province, South Africa.MethodsThis cross-sectional descriptive study extracted patient-level ABU data from patients' files using a modified global PPS tool. Data were collected between September and November 2021 at five regional hospitals in Limpopo Province, South Africa. All patients in the wards before 8 a.m. on study days with an antibiotic prescription were included. Antibiotic use was stratified by Anatomic Therapeutic Chemical and Access, Watch, Reserve classifications and presented as frequencies and proportions with 95% confidence intervals (CI). Associations between categorical variables were assessed using the chi-square test. Cramér's V was used to assess the strength of these associations.ResultsOf 804 inpatients surveyed, 261 (32.5%) (95% CI 29.2-35.7) were prescribed 416 antibiotics, 137 were female (52.5%) and 198 adults (75.9%). One hundred and twenty-two (46.7%) patients received one antibiotic, 47.5% (124/261) received two, and 5.7% (15/261) received three or more antibiotics. The intensive care units had a higher ABU (68.6%, 35/51) compared to medical (31.3%, 120/384) and surgical (28.5%, 105/369) wards (p = 0.005, Cramér's V = 0.2). Lower respiratory tract infection (27.4%, 104/379), skin and soft tissue infections (SST) (23.5%, 89/379), and obstetrics and gynaecology prophylaxis (14.0%, 53/379) were the common diagnoses for antibiotic prescriptions. The three most prescribed antibiotic classes were imidazoles (21.9%, 91/416), third-generation cephalosporins (20.7%, 86/416) and combination penicillin (18.5%, 79/416). Access antibiotics accounted for 70.2% (292/416) of prescriptions and Watch antibiotics for 29.6% (123/416) (p = 0.110, Cramér's V = 0.1). Reasons for prescribing and treatment plans were documented in 64.9% (270/416) (95% CI 60.3-69.5) and 21.4% (89/416) (95% CI 17.3-25.3) of prescriptions, respectively.ConclusionsThe study serves as a baseline for ABU surveillance at the five regional hospitals in Limpopo Province. Lack of documentation indicates poor prescribing practices; ASP should address gaps by deploying evidence-based, multifaceted and stepwise interventions.

Project description:BackgroundAdverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study's objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable.MethodsThis was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded.ResultsA total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4-6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5-25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively.ConclusionThis feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

Dataset Information

Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey.

Aims

Methods

Results

Conclusions

Publications

Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey.

Similar Datasets

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