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Original Research ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pharmacol. | doi: 10.3389/fphar.2019.01004

The Role of an Interventional Program for Improving Pharmacovigilance at a Pediatric Facility

Nirit Kronenfeld1, Shirly Gamsu2, Rimona Keidar3, Ayelet Livneh3, Matitiahu Berkovitch4, Michael Goldman2, Hilla Bahat2, Miriam Shchory-Potlog5, Tomer Ziv-Baran6 and  Ibrahim Abu-Kishk7*
  • 1Pharmacy Department, Shamir Medical Center (Assaf Harofeh), Israel
  • 2Pediatric Department, Shamir Medical Center (Assaf Harofeh), Israel
  • 3Neonatal Intensive Care Unit, Shamir Medical Center (Assaf Harofeh), Israel
  • 4Clinical Pharmacology and Toxicology Unit, Shamir Medical Center (Assaf Harofeh), Israel
  • 5Shamir (Assaf Harofeh) Academic School of Nursing, Israel
  • 6Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Israel
  • 7Pediatric Intensive Care Unit, Shamir Medical Center (Assaf Harofeh), Israel

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 3753 admitted patients with 1323 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.

Keywords: Adverse druc reaction, Pharmacovigilance, Pharmacosurveillance, pediatric, intervention

Received: 29 May 2019; Accepted: 07 Aug 2019.

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.

* Correspondence: Dr. Ibrahim Abu-Kishk, Shamir Medical Center (Assaf Harofeh), Pediatric Intensive Care Unit, Zerifin, Israel, ibrahima@shamir.gov.il