title: Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross-sectional survey.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Johannes P
authors.initials: JP
authors.lastname: Mouton
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.|Independent Pharmacovigilance Consultant, Cape Town.
authors.forename: Ushma
authors.initials: U
authors.lastname: Mehta
authors.affiliation: Department of Medicine, Cecilia Makiwane Hospital and Walter Sisulu University, East London.
authors.forename: Andy G
authors.initials: AG
authors.lastname: Parrish
authors.affiliation: Department of Medicine, Edendale Hospital, Pietermaritzburg, South Africa.
authors.forename: Douglas P K
authors.initials: DP
authors.lastname: Wilson
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Annemie
authors.initials: A
authors.lastname: Stewart
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Christine W
authors.initials: CW
authors.lastname: Njuguna
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Nicole
authors.initials: N
authors.lastname: Kramer
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Gary
authors.initials: G
authors.lastname: Maartens
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Marc
authors.initials: M
authors.lastname: Blockman
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
authors.forename: Karen
authors.initials: K
authors.lastname: Cohen
mesh_terms: D000328:Adult; D000368:Aged; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000401:mortality* / Q000517:prevention & control*; D005260:Female; D006761:Hospitals / Q000706:statistics & numerical data*; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
keywords: South Africa; adverse drug reaction; anti-tuberculosis therapy; antiretroviral therapy; in-hospital death; preventability