Detection of serious adverse drug reactions using diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems

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Ariane Gosselin
Claire Chabut
Amélie Duhamel
Isabelle Desjardins
Denis Lebel
Jean-François Bussières


diagnostic codes, International Statistical Classification of Diseases and Related Health Problems, hospital, pharmacovigilance, serious adverse drug reactions


Canadian hospitals are legally required to report serious adverse drug reactions (ADRs). This study aimed to assess the ability to detect serious ADRs from diagnostic codes and the potential benefit of adding stand-alone diagnostic codes to the regular process for detecting serious ADRs. In this descriptive study, clinical pharmacists and a reference work on drug-induced diseases allowed to identify diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada (ICD-10 CA), reflecting clinical manifestations related to an ADR. Records for admissions to a large urban mother–child hospital in the fiscal year 2018–2019, as coded by medical archivists, were analysed. Of 69 ICD-10-CA diagnostic codes reflecting an ADR identified, 38 were included in the detailed analysis of patient records and 18 (which appeared in 130 admissions) deemed to indicate a serious ADR. Among the 130 admissions analysed, 70 serious ADRs were identified, of which 52 were previously detected by the regular process and 18 were not, increasing the detection of serious ADRs by 34.6% (18/52). These 18 serious ADRs were newly identified from 11 of the 18 codes reflecting clinical manifestation of a serious ADR. Adding ICD-10-CA diagnostic codes not associated with external cause codes can increase the capacity to detect serious ADRs in hospitals. Over a 12-month period, the use of 11 such diagnostic codes increased the detection capacity for serious ADRs by 34.6%.
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