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Prospective cohort study on adverse drug reactions on all admissions to internal medicine: Incidence, risk factors and fatality
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  • Aduragbenro Adedapo,
  • Waheed Adedeji,
  • Ifetoluwanimi Adedapo,
  • Kayode Adedapo
Aduragbenro Adedapo
University of Ibadan College of Medicine
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Waheed Adedeji
University of Ibadan College of Medicine
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Ifetoluwanimi Adedapo
University of Ibadan College of Medicine
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Kayode Adedapo
University of Ibadan College of Medicine
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Abstract

Background Adverse drug reactions (ADRs) constitute major clinical burden of public health concern. Intensive adverse drug reactions monitoring in hospitals, though advocated are rare. Aims Intensive monitoring of medical patients for ADRs to assess incidence, risk factors and fatality of ADRs leading to hospital admission or occurring in the hospital. Research design and methods Prospective cohort study on 1280 adult patients admitted to the six medical wards of a tertiary institution over a 12-month period. Patients were assessed for ADRs during and throughout admission. Causality assessment and preventability of ADRs were assessed. Results Sixty-seven (5.2%) patients had ADRs, which was the cause of admission in 46 (3.6%), and majority 61(91%) of the ADRs were preventable. NSAIDs, 14 (20.3%), antidiabetics, 12 (17.4%) and antibacterial, 11 (15.8%) were the most suspected drugs. Gastrointestinal tract (37%), CNS (30.2%), and skin (24.7%) were the most affected organ/systems, while upper GI bleeding and hypoglycaemia were the most observed ADRs. ADRs led to deaths in 7(10.4%) patients, with overall case fatality rate of 0.5%. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis 3/7(42.9%) had the highest fatality rate. Risk factors, relative risk, 95% confidence interval for ADRs were alcohol intake, 1.7 (1.04, 2.80) and duration of hospital stay, 2.0 (1.16, 3.26). Conclusions Preventable ADRs are common and important cause of hospitalization and inpatients’ morbidity and mortality among medical patients in Nigeria. Upper GI bleeding and hypoglycaemia, resulting from NSAIDs and antidiabetic drugs were the most observed ADRs. Strategic planning for intensive follow up of ADRs in Nigeria is advocated.

Peer review status:ACCEPTED

11 May 2020Submitted to British Journal of Clinical Pharmacology
12 May 2020Submission Checks Completed
12 May 2020Assigned to Editor
14 May 2020Reviewer(s) Assigned
08 Jul 2020Review(s) Completed, Editorial Evaluation Pending
09 Jul 2020Editorial Decision: Revise Major
07 Sep 20201st Revision Received
08 Sep 2020Submission Checks Completed
08 Sep 2020Assigned to Editor
08 Sep 2020Review(s) Completed, Editorial Evaluation Pending
11 Sep 2020Editorial Decision: Revise Minor
14 Sep 20202nd Revision Received
16 Sep 2020Submission Checks Completed
16 Sep 2020Assigned to Editor
16 Sep 2020Review(s) Completed, Editorial Evaluation Pending
17 Sep 2020Editorial Decision: Accept