The role of an interventional program for improving pharmacovigilance at a pediatric facility

Nirit Kronenfeld; Shirly Gamsu; Rimona Keidar; Ayelet Livneh; Matitiahu Berkovitch; Michael Goldman; Hilla Bahat; Miriam Shchory-Potlog; Tomer Ziv-Baran; Ibrahim Abu-Kishk

doi:10.3389/fphar.2019.01004

The role of an interventional program for improving pharmacovigilance at a pediatric facility

Nirit Kronenfeld, Shirly Gamsu, Rimona Keidar, Ayelet Livneh, Matitiahu Berkovitch, Michael Goldman, Hilla Bahat, Miriam Shchory-Potlog, Tomer Ziv-Baran, Ibrahim Abu-Kishk

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The reporting rate of adverse drug reactions (ADRs) by healthcare professionals is low. ADR interventional programs may improve the reporting rate by the medical team. Our literature search revealed that only a few interventional studies among the pediatric population have been published. Objective: We aimed to create an interventional program in order to improve the reporting rate of ADRs during the interventional period compared to the control period, detect which drugs frequently lead to ADRs and determine the most serious ADRs. Design: A 3-month prospective intervention study compared with one year prior to the intervention (control period). ADR data was also collected for the year following the study period. Healthcare professionals were encouraged to report ADRs and an ADR reporting system was created for them. Setting: Pediatric Division at Shamir Medical Center (Assaf Harofeh), a tertiary care medical center. Results: The study population included 3,753 admitted patients with 1,323 prescriptions during the study period. During the period before the intervention was started, the ADR reporting rate was null. During the study period, 46 reports were collected: 46% from the general pediatric department, 26% from the pediatric neurology department, and 22% and 6% from the pediatric and neonatal intensive care units, respectively. Antiepileptic medications, IVIG, steroids and antibiotics were frequently reported to induce ADRs. Serious ADRs were also reported in 5 cases. One year of follow up after the intervention revealed a significant decline in the reporting rate. Conclusion: It is important to periodically encourage healthcare professionals to report any ADRs in order to increase knowledge about medication safety and prevent fatal harm.

Original language	English
Article number	1004
Journal	Frontiers in Pharmacology
Volume	10
Issue number	SEP
DOIs	https://doi.org/10.3389/fphar.2019.01004
State	Published - 2019
Externally published	Yes

Bibliographical note

Publisher Copyright:
Copyright © 2019 Kronenfeld, Gamsu, Keidar, Livneh, Berkovitch, Goldman, Bahat, Shchory-Potlog, Ziv-Baran and Abu-Kishk. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

Keywords

Adverse drug reactions
Intervention
Pediatric
Pharmacovigilance
Reporting
Sides effects

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.3389/fphar.2019.01004

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abstract = "Background: The reporting rate of adverse drug reactions (ADRs) by healthcare professionals is low. ADR interventional programs may improve the reporting rate by the medical team. Our literature search revealed that only a few interventional studies among the pediatric population have been published. Objective: We aimed to create an interventional program in order to improve the reporting rate of ADRs during the interventional period compared to the control period, detect which drugs frequently lead to ADRs and determine the most serious ADRs. Design: A 3-month prospective intervention study compared with one year prior to the intervention (control period). ADR data was also collected for the year following the study period. Healthcare professionals were encouraged to report ADRs and an ADR reporting system was created for them. Setting: Pediatric Division at Shamir Medical Center (Assaf Harofeh), a tertiary care medical center. Results: The study population included 3,753 admitted patients with 1,323 prescriptions during the study period. During the period before the intervention was started, the ADR reporting rate was null. During the study period, 46 reports were collected: 46% from the general pediatric department, 26% from the pediatric neurology department, and 22% and 6% from the pediatric and neonatal intensive care units, respectively. Antiepileptic medications, IVIG, steroids and antibiotics were frequently reported to induce ADRs. Serious ADRs were also reported in 5 cases. One year of follow up after the intervention revealed a significant decline in the reporting rate. Conclusion: It is important to periodically encourage healthcare professionals to report any ADRs in order to increase knowledge about medication safety and prevent fatal harm.",

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AU - Gamsu, Shirly

AU - Keidar, Rimona

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AU - Berkovitch, Matitiahu

AU - Goldman, Michael

AU - Bahat, Hilla

AU - Shchory-Potlog, Miriam

AU - Ziv-Baran, Tomer

AU - Abu-Kishk, Ibrahim

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PY - 2019

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The role of an interventional program for improving pharmacovigilance at a pediatric facility

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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