| アブストラクト | OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. |
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| ジャーナル名 | Archives de pediatrie : organe officiel de la Societe francaise de pediatrie |
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| 投稿日 | 2019/10/16 |
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| 投稿者 | Soyer, J; Necsoiu, D; Desjardins, I; Lebel, D; Bussieres, J-F |
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| 組織名 | Departement de pharmacie et unite de recherche en pratique pharmaceutique, Centre;Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.;Service des archives medicales, Centre Hospitalier Universitaire Sainte-Justine,;Montreal, Quebec, Canada.;Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada; Faculte de;pharmacie, Universite de Montreal, Montreal, Quebec, Canada. Electronic address:;jf.bussieres@ssss.gouv.qc.ca. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31611146/ |
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