Interpreting adverse drug reaction (ADR) reports as hospital patient safety incidents.

British Journal of Clinical Pharmacology
Emma C DaviesM Pirmohamed

Abstract

Adverse drug reactions (ADRs) are a reporting category in the National Patient Safety Agency (NPSA) incident reporting system, though the Medicines and Healthcare Products Regulatory Agency (MHRA) pharmacovigilance system is the more established method for collecting ADR data. The majority of ADRs were shown to be of moderate risk to the patient, though some have a severe or catastrophic impact. Classification and reporting of ADRs according to NPSA guidance is possible but offers limited additional value to efforts to improve patient safety over and above the Yellow Card Scheme. In the UK, the National Patient Safety Agency (NPSA) includes adverse drug reactions as a reporting category, while the MHRA Yellow Card Scheme also collects data regarding adverse drug reactions (ADRs). In this study, we aimed to assess ADRs using NPSA criteria and discuss the resulting implications. ADRs identified in a 6-month prospective study of 3695 inpatient episodes were assessed according to their impact on the patient and on the organization, using tools developed by the NPSA. Seven hundred and thirty-three (100%) ADRs were assessed. In terms of impact on the patient, 537 (73.3%) were categorized as 'low' (minor treatment), 181 (24.7%) as 'mo...Continue Reading

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Citations

Dec 15, 2010·British Journal of Clinical Pharmacology·Yoon K LokeJames M Ritter
Nov 17, 2020·British Journal of Clinical Pharmacology·Rachel BryanSue Jordan
Dec 29, 2020·Journal of Medical Imaging and Radiation Sciences·Peranavi SarvananthanTaraneh Jorjany

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