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Pharmacology and therapeutics
Research
Incidence, risk factors and risk prediction of hospital-acquired suspected adverse drug reactions: a prospective cohort of Ugandan inpatients
  1. Ronald Kiguba1,
  2. Charles Karamagi2,
  3. Sheila M Bird3
  1. 1Department of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda
  2. 2Clinical Epidemiology Unit, Makerere University College of Health Sciences, Kampala, Uganda
  3. 3Medical Research Council Biostatistics Unit, Cambridge, UK
  1. Correspondence to Ronald Kiguba; kiguba{at}gmail.com

Abstract

Objectives To determine the incidence and risk factors of hospital-acquired suspected adverse drug reactions (ADRs) among Ugandan inpatients. We also constructed risk scores to predict and qualitatively assess for peculiarities between low-risk and high-risk ADR patients.

Methods Prospective cohort of consented adults admitted on medical and gynaecological wards of the 1790-bed Mulago National Referral Hospital. Hospital-acquired suspected ADRs were dichotomised as possible (possible/probable/definite) or not and probable (probable/definite) or not, using the Naranjo scale. Risk scores were generated from coefficients of ADR risk-factor logistic regression models.

Results The incidence of possible hospital-acquired suspected ADRs was 25% (194/762, 95% CI: 22% to 29%): 44% (85/194) experienced serious possible ADRs. The risk of probable ADRs was 11% (87/762, 95% CI 9% to 14%): 46% (40/87) had serious probable ADRs. Antibacterials-only (51/194), uterotonics-only (21/194), cardiovascular drugs-only (16/194), antimalarials-only (12/194) and analgesics-only (10/194) were the most frequently implicated. Treatment with six or more conventional medicines during hospitalisation (OR=2.31, 95% CI 1.29 to 4.15) and self-reported herbal medicine use during the 4 weeks preadmission (OR=1.96, 95% CI 1.22 to 3.13) were the risk factors for probable hospital-acquired ADRs. Risk factors for possible hospital-acquired ADRs were: treatment with six or more conventional medicines (OR=2.72, 95% CI 1.79 to 4.13), herbal medicine use during the 4 weeks preadmission (OR=1.68, 95% CI 1.16 to 2.43), prior 3 months hospitalisation (OR=1.57, 95% CI 1.09 to 2.26) and being on gynaecological ward (OR=2.16, 95% CI 1.36 to 3.44). More drug classes were implicated among high-risk ADR-patients, with cardiovascular drugs being the most frequently linked to possible ADRs.

Conclusions The risk of hospital-acquired suspected ADRs was higher with preadmission herbal medicine use and treatment with six or more conventional medicines during hospitalisation. Our risk scores should be validated in large-scale studies and tested in routine clinical care.

  • CLINICAL PHARMACOLOGY
  • EPIDEMIOLOGY
  • GENERAL MEDICINE (see Internal Medicine)
  • GYNAECOLOGY

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2015-010568

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    Footnotes

    • Contributors RK conceived of the study and drafted the manuscript and, in conjunction with SMB, participated in its design, implementation, statistical analysis and drawing of inferences. CK participated in study design and, together with SMB, took part in the manuscript writing process. All authors approved the final manuscript.

    • Funding RK gratefully acknowledges funding support provided by the Training Health Researchers into Vocational Excellence (THRiVE) in East Africa grant number 087540, funded by the Wellcome Trust; and an African Doctoral Dissertation Research Fellowship (ADDRF) award 2013–2015 ADF 006 offered by the African Population and Health Research Centre (APHRC) in partnership with the International Development Research Centre (IDRC). In UK, SMB is funded by Medical Research Council programme number, MC_U105260794.

    • Disclaimer The work here reported is solely the responsibility of the authors and does not necessarily represent the official views of the supporting offices. The funders had no role in the decisions on what and where to publish.

    • Competing interests SMB holds GSK shares.

    • Ethics approval Ethical approval for the study was obtained from the School of Medicine Research and Ethics Committee, Makerere University College of Health Sciences (REC REF No. 2011-113), the Mulago Hospital Research and Ethics Committee (MREC 253) and the Uganda National Council for Science and Technology (HS 1151).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The data are available from the lead author, RK, by email request to kiguba@gmail.com