title: Rare, serious, and comprehensively described suspected adverse drug reactions reported by surveyed healthcare professionals in Uganda.
abstract: BACKGROUND
  Lack of adequate detail compromises analysis of reported suspected adverse drug reactions (ADRs). We investigated how comprehensively Ugandan healthcare professionals (HCPs) described their most recent previous-month suspected ADR, and determined the characteristics of HCPs who provided comprehensive ADR descriptions. We also identified rare, serious, and unanticipated suspected ADR descriptions with medication safety-alerting potential.
  
  
  METHODS
  During 2012/13, this survey was conducted in purposively selected Ugandan health facilities (public/private) including the national referral and six regional referral hospitals representative of all regions. District hospitals, health centres II to IV, and private health facilities in the catchment areas of the regional referral hospitals were conveniently selected. Healthcare professionals involved in prescribing, transcribing, dispensing, and administration of medications were approached and invited to self-complete a questionnaire on ADR reporting. Two-thirds of issued questionnaires (1,345/2,000) were returned.
  
  
  RESULTS
  Ninety per cent (241/268) of HCPs who suspected ADRs in the previous month provided information on five higher-level descriptors as follows: body site (206), drug class (203), route of administration (127), patient age (133), and ADR severity (128). Comprehensiveness (explicit provision of at least four higher-level descriptors) was achieved by at least two-fifths (46%, 124/268) of HCPs. Received descriptions were more likely to be comprehensive from HCPs in private health facilities, regions other than central, and those not involved in teaching medical students. Overall, 106 serious and 51 rare previous-month suspected ADRs were described. The commonest serious and rare ADR was Stevens-Johnson syndrome (SJS); mostly associated with oral nevirapine or cotrimoxazole, but haemoptysis after diclofenac analgesia and paralysis after quinine injection were also described.
  
  
  CONCLUSIONS
  Surveyed Ugandan HCPs who had suspected at least one ADR in the previous month competently provided comprehensive ADR descriptions: more, indeed, than are received per annum nationally. Properly analyzed, and with local feed-back, voluntary ADR reports by HCPs could be an essential alerting tool for identifying rare and serious suspected ADRs in Uganda.
authors.affiliation: Department of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Ronald
authors.initials: R
authors.lastname: Kiguba
authors.affiliation: Clinical Epidemiology Unit, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Charles
authors.initials: C
authors.lastname: Karamagi
authors.affiliation: Department of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Paul
authors.initials: P
authors.lastname: Waako
authors.affiliation: National Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
authors.forename: Helen B
authors.initials: HB
authors.lastname: Ndagije
authors.affiliation: Medical Research Council Biostatistics Unit, Cambridge, United Kingdom.
authors.forename: Sheila M
authors.initials: SM
authors.lastname: Bird
mesh_terms: D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D006282:Health Personnel; D006801:Humans; D004364:Pharmaceutical Preparations / Q000145:classification; D011795:Surveys and Questionnaires; D014454:Uganda
chemical_list: D004364:Pharmaceutical Preparations