Identification of discrepancies between adverse drug reactions coded by medical records technicians and those reported by the pharmacovigilance team in pediatrics: An intervention to improve identification, reporting, and coding

To identify the discrepancies between the adverse drug reactions (ADRs) identified by medical records technicians and the ADRs identified by the pharmacovigilance team, and to validate the quality of the information collected by the medical records technicians. To propose improvements to the method...

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Bibliographic Details
Published in:Archives de pédiatrie : organe officiel de la Société française de pédiatrie 2019-10, Vol.26 (7), p.400-406
Main Authors: Soyer, J., Necsoiu, D., Desjardins, I., Lebel, D., Bussières, J.-F.
Format: Article
Language:English
Subjects:
Adolescent
Adverse drug reaction reporting system
Adverse Drug Reaction Reporting Systems - standards
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Canada
Child
Child, Preschool
Clinical coding
Clinical Coding - standards
Clinical Coding - statistics & numerical data
Drug-Related Side Effects and Adverse Reactions - diagnosis
Hospitals, University - standards
Hospitals, University - statistics & numerical data
Humans
Infant
Infant, Newborn
Medical Records - standards
Medical Records - statistics & numerical data
Medical records administrators
Pediatrics - standards
Pharmacovigilance
Quality Assurance, Health Care
Quality Improvement
Quality Indicators, Health Care - standards
Quality Indicators, Health Care - statistics & numerical data
Retrospective Studies
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Summary:To identify the discrepancies between the adverse drug reactions (ADRs) identified by medical records technicians and the ADRs identified by the pharmacovigilance team, and to validate the quality of the information collected by the medical records technicians. To propose improvements to the method for detection of serious ADRs by medical records technicians and the pharmacovigilance team to meet the new requirements of Canada's amended Food and Drug Act (Vanessa's Law) and its regulations. This was a descriptive and retrospective study. We included all ADRs identified by medical records technicians in the coding of records after hospitalization, including active ADRs present at admission or identified during hospitalization between 1 April 2017 and 31 October 2017, and all ADRs identified and reported by the pharmacy through its pharmacovigilance program during the same period. We identified the discrepancies between the two identification systems and revised all cases from patient records. In addition, we identified improvements in the method for detecting and reporting serious ADRs. This study identified 343 ADRs, 322 of which were coded by the medical records technicians and 21 identified by the pharmacovigilance team for a period of 7 months in a mother–child university hospital center. Only 1.5% of the ADRs were identified by both medical records technicians and the pharmacovigilance team. The code Y43, which corresponds to the largest number of identified ADRs, mainly includes anticancer drugs and immunosuppressant drugs. Three corrective actions were set up: 1) implementation of a form to explain the addition and coding of an ADR to a patient's file, 2) weekly transmission of a working file between the medical records technicians and the pharmacovigilance team so that the files would be reviewed and a declaration made to the regulatory authority, and 3) creation of a standardized pharmacist's note to add to the patient file. It is possible to increase the reporting of ADRs, improve the quality of coding, and reduce discrepancies between the ADRs coded by these two teams through a structured intervention.
ISSN:0929-693X
1769-664X
DOI:10.1016/j.arcped.2019.09.004