Banca de DEFESA: AMANDA MARIA DE PAIVA

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : AMANDA MARIA DE PAIVA
DATE: 29/04/2022
TIME: 09:10
LOCAL: Plataforma on line
TITLE:

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

KEY WORDS:

Pediatrics; Drug Therapy; Medicine Package Inserts; Critical Care; Drug-Related Side Effects; Adverse Reactions.

PAGES: 105
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUMMARY:

Background: The use of medication in pediatrics should be performed with caution. The
shortage of studies in the area and of specific medicines formulated for children and adolescents
that address the physiological needs of this population make the occurrence of adverse drugrelated events more common in this population when they’re compared to adults. The
medication package inserts are legal documents that provide information about the use of
medicines to patients and health professionals and must contain data that guide the
administration and inform the potential risks associated with medicines. Based on the above,
this study aims to perform the technical and legal analysis of package inserts for medicines used
in pediatrics, verifying whether the package inserts include technical and legal aspects and
corroborate the recommendations of clinical protocols and legal provisions. Methods: A
documental study of medication package inserts analysis was carried out, divided into two
substudies. The search of the medication package inserts was carried out through the electronic
portal of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária
– ANVISA). Substudy 1 consists of the technical and legal analysis of drug inserts commonly
used via continuous infusion (CI) pump in neopediatric intensive care units (ICU). Thirteen
drugs used via IC were selected and information on the use in neonatal and pediatric patients
was searched in the package inserts. In order to compare the technical information, the
Micromedex Neofax®, Micromedex Pediatrics® and Lexicomp® databases were consulted.
To analyze the legal aspects, ANVISA's Resolution of the Collegiate Board (Resolução da
diretoria colegiada - RDC)47/2009 was used. Substudy 2 consists of the search for
recommendations on adverse drug reactions (ADR) in pediatrics contained in the Guideline
Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List in the package inserts of drugs
sold in Brazil. Results: substudy 1 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 CI in pediatrics. Substudy 2 showed that, of the drugs indicated for pediatric
use, only 26% (n=6) presented the risks of ADRs similar to the Guideline KIDs List and the
same recommendations on the package inserts. The others (74%) showed some disagreement.
Conclusions: The package inserts are technical and legal documents that provide essential
information for the safe use of medications and, as noted, they have deficiencies that can
compromise the safety of medication use, especially when dealing with neonatal and pediatric
patients.

BANKING MEMBERS:
Presidente - 1039964 - ANDRE DE OLIVEIRA BALDONI
Externa ao Programa - 1680498 - MARCIA CHRISTINA CAETANO ROMANO
Externo à Instituição - ADRIANO MAX MOREIRA REIS - UFMG