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Pauline Rault
Dana Necsoiu
Isabelle Desjardins
Denis Lebel
Jean-François Bussières


Adverse drug reaction reporting systems, Clinical coding, Drug-related side effects and adverse reactions, Forms and records control, Medical records


Background and Objective

In the context of Vanessa’s Law, the medical records department and the pharmacy team of a mother-child hospital collaborated to create a system for coding adverse drug reactions (ADRs). This study was conducted to validate the coding of ADRs by the medical records team.

Material and Methods

This retrospective descriptive study covered 12 months of coding of hospitalization data by the medical records team (November 1, 2017, to October 31, 2018). The pharmacy team performed twice-monthly analysis to validate the ADR data, based on coded information for drugs and associated clinical manifestations.


Over the 12-month study period, a total of 755 ADRs were coded by the medical records department (i.e., 2.1 ADRs per day, corresponding to 7.1% of admissions). For 34 (4.5%) of these ADRs the pharmacy team made a change to the code originally assigned by the medical records department. Eighty-five (11.5%) of the coded ADRs were deemed serious, as defined by Health Canada, but only 13 (15%) of these serious ADRs were reported to the regulatory authority. The new process allowed clinical manifestation codes to be associated with individual drugs in the pharmacy’s Med-Echo-Plus® software, which facilitated interpretation of the data. Following this study, coding practices were reviewed, a coding algorithm was developed, and the codes for 18 drugs were clarified.


This study highlights the feasibility of establishing a link between the medical records and pharmacy departments to validate the coding of ADRs. At the study hospital, this linkage has identified serious ADRs, for which reporting will soon be required by Health Canada.

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