Banca de QUALIFICAÇÃO: AMANDA MARIA DE PAIVA

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : AMANDA MARIA DE PAIVA
DATE: 18/01/2022
TIME: 09:00
LOCAL: Plataforma on
TITLE:

Use of medicines in pediatrics: an analysis of the technical and legal aspects of package inserts

KEY WORDS:

Medicines; drug labeling ; Pediatrics; Evidence-Based Health.

PAGES: 80
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUMMARY:

The use of medication in pediatrics should be cautious. The scarcity of studies in the area and of specific medicines formulated for children and adolescents that address the physiological needs of this population makes the occurrence of adverse drug-related events more common in this population when compared to adults. Drug package inserts are legal documents that provide information about the use of drugs to patients and health professionals and must contain complete information that guides administration, informing the potential risks associated with the risks of drugs. This study aims to analyze whether the package inserts for medicines used in pediatrics include technical and legal aspects and corroborate the recommendations of clinical protocols and legal provisions. A documentary study was carried out, carried out in three stages, in which technical and legal information contained in the package inserts of drugs commonly used via continuous infusion pump in neopediatric intensive care units were analyzed and the recommendations of an international Guideline contained in the package inserts were verified. of medicines. The consultation of the leaflets was carried out through the electronic portal of the National Health Surveillance Agency (ANVISA). The package inserts sought information on the use of medications in neonatal and pediatric populations. To analyze the legal aspects, ANVISA's RDC No. 47/2009 was used. In order to compare the technical information, the databases Micromedex NeoFax®, Micromedex Pediatrics® and Lexicomp® were consulted, in addition to the guideline “The Kids List”. The first stage of the study showed that of the 13 drugs analyzed, 46% (n=6) showed some non-compliance with RDC 47/2009. Only 46% (n=6) of the drugs are indicated for pediatric use and only the midazolam package insert (7.7%) contained information considered essential for use via BIC in pediatrics. Regarding the analysis of the recommendations contained in the package inserts regarding adverse drug reactions (ADRs) in pediatrics, of the medicines indicated for pediatric use, only 26% (n=6) presented in the package inserts the risks of the occurrence of ADRs similar to those of The KIDs List and the same recommendations. The others (74%) showed some disagreement.

BANKING MEMBERS:
Presidente - 1039964 - ANDRE DE OLIVEIRA BALDONI
Externa ao Programa - 1680498 - MARCIA CHRISTINA CAETANO ROMANO
Externa à Instituição - CARINA CARVALHO SILVESTRE - UFJF