WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: 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. WHAT THIS STUDY ADDS: 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. AIM: 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. METHODS: 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. RESULTS: 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 'moderate' (moderate increase in treatment, no permanent harm), 14 (1.91%) as 'severe' (permanent harm) and 1 (0.14%) was categorized as 'catastrophic' (direct cause of death). In terms of impact on the organization, none was categorized as 'no harm/no risk', 508 (69.3%) as 'insignificant', 188 (25.6%) as 'minor', 25 (3.4%) as 'moderate', 12 (1.6%) as 'major' and none was classed as 'catastrophic'. Less than 2% of ADRs would be eligible for detailed analysis according to the NPSA guidance. The ADRs that cause incidents of greater significance relate to bleeding, renal impairment and Clostridium difficile infection. CONCLUSIONS: Classification of ADRs according to NPSA guidance offers limited additional value over and above that offered by the Yellow Card System. A consistent message needs to be sent to prospective reporters of ADRs; the availability of more than one system is likely to confuse reporters and does not aid patient safety.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: 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. WHAT THIS STUDY ADDS: 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. AIM: 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. METHODS: 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. RESULTS: 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 'moderate' (moderate increase in treatment, no permanent harm), 14 (1.91%) as 'severe' (permanent harm) and 1 (0.14%) was categorized as 'catastrophic' (direct cause of death). In terms of impact on the organization, none was categorized as 'no harm/no risk', 508 (69.3%) as 'insignificant', 188 (25.6%) as 'minor', 25 (3.4%) as 'moderate', 12 (1.6%) as 'major' and none was classed as 'catastrophic'. Less than 2% of ADRs would be eligible for detailed analysis according to the NPSA guidance. The ADRs that cause incidents of greater significance relate to bleeding, renal impairment and Clostridium difficile infection. CONCLUSIONS: Classification of ADRs according to NPSA guidance offers limited additional value over and above that offered by the Yellow Card System. A consistent message needs to be sent to prospective reporters of ADRs; the availability of more than one system is likely to confuse reporters and does not aid patient safety.
Authors: Munir Pirmohamed; Sally James; Shaun Meakin; Chris Green; Andrew K Scott; Thomas J Walley; Keith Farrar; B Kevin Park; Alasdair M Breckenridge Journal: BMJ Date: 2004-07-03
Authors: Emma C Davies; Christopher F Green; Stephen Taylor; Paula R Williamson; David R Mottram; Munir Pirmohamed Journal: PLoS One Date: 2009-02-11 Impact factor: 3.240
Authors: Yoon K Loke; Albert Ferro; Lionel D Lewis; Adam F Cohen; Andrew Somogyi; James M Ritter Journal: Br J Clin Pharmacol Date: 2011-01 Impact factor: 4.335
Authors: Clint Mizzi; Eleni Dalabira; Judit Kumuthini; Nduna Dzimiri; Istvan Balogh; Nazli Başak; Ruwen Böhm; Joseph Borg; Paola Borgiani; Nada Bozina; Henrike Bruckmueller; Beata Burzynska; Angel Carracedo; Ingolf Cascorbi; Constantinos Deltas; Vita Dolzan; Anthony Fenech; Godfrey Grech; Vytautas Kasiulevicius; Ľudevít Kádaši; Vaidutis Kučinskas; Elza Khusnutdinova; Yiannis L Loukas; Milan Macek; Halyna Makukh; Ron Mathijssen; Konstantinos Mitropoulos; Christina Mitropoulou; Giuseppe Novelli; Ioanna Papantoni; Sonja Pavlovic; Giuseppe Saglio; Jadranka Setric; Maja Stojiljkovic; Andrew P Stubbs; Alessio Squassina; Maria Torres; Marek Turnovec; Ron H van Schaik; Konstantinos Voskarides; Salma M Wakil; Anneke Werk; Maria Del Zompo; Branka Zukic; Theodora Katsila; Ming Ta Michael Lee; Alison Motsinger-Rief; Howard L Mc Leod; Peter J van der Spek; George P Patrinos Journal: PLoS One Date: 2016-09-16 Impact factor: 3.240