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Medications used in paediatric intensive care by continuous infusion: Do the technical aspects of the package inserts
Amanda Maria de Paiva1,2, Marlon Silva Tinoco2,3, Júlio César Veloso4,5
1Farmacêutica especialista em Cuidado Humanizado da Criança e do Adolescente pelo Programa de Residência Multiprofissional Integrada em Saúde no Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Insights
Medication errors are common in pediatric intensive care. This study found many drug labels lack crucial information and legal compliance, increasing risks for children. Improvements are needed for safer pediatric care.
Area of Science:
- Pediatric Pharmacology
- Medication Safety
- Health Law Compliance
Background:
- Hospitalized children face higher risks of medication errors than adults.
- Limited research exists on pediatric medication safety and efficacy.
- Package inserts are critical for safe medication use in pediatric intensive care units (ICUs).
Purpose of the Study:
- To evaluate technical and legal compliance of drug package inserts for continuous infusion (CI) medications in pediatric ICUs.
- To determine if package insert information aligns with clinical protocols and legal standards.
- To identify gaps in pediatric medication information for CI administration.
Main Methods:
- Documentary analysis of drug package inserts for CI use in neonatal and pediatric ICUs.
- Utilized the National Health Surveillance Agency (ANVISA) electronic portal for data collection.
- Compared technical data with Micromedex NeoFax®, Micromedex Paediatrics®, and Lexicomp® databases.
- Assessed legal compliance using ANVISA's RDC no. 47/2009.
Main Results:
- 46% of analyzed medications showed non-compliance with RDC 47/2009.
- Only 46% of medications were indicated for pediatric use.
- Specific CI information for pediatrics was found in only one drug's (midazolam) package insert (7.7%).
Conclusions:
- Significant weaknesses exist in pediatric ICU medication package inserts for CI use.
- Non-compliance and missing technical data increase medication administration difficulties and patient safety risks.
- Regulatory oversight and healthcare professional input are vital for correcting deficiencies and ensuring safe pediatric care.
What Is Known And Objective:
Hospitalized paediatric patients are three times more likely to experience medication errors with the potential to cause harm, when they are compared to adults. The lack of research in paediatrics, difficulties that are derived as indications and the parameters of safety and effectiveness of pharmacological therapy in children. To analyse whether the technical and legal aspects of the package insert for medicines used in paediatric intensive care units (ICU) using a continuous infusion (CI) pump corroborate the recommendations of clinical protocols and legal provisions.
Methods:
A documentary study, in which technical and legal information contained in the package inserts of medications commonly used via CI in neopediatric ICUs was analysed. The consultation of the medication package insert was carried out through the electronic portal of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA). Information on the use of medications in the neonatal and paediatric populations via CI was sought in the medication package insert. To analyse the legal aspects, ANVISA's RDC no. 47/2009 was used. In order to compare the technical information, the Micromedex NeoFax®, Micromedex Paediatrics®, and Lexicomp® databases were consulted.
Results And Discussion:
Of the 13 medications analysed, 46% (n = 6) had some non-compliance with RDC 47/2009. Only 46% (n = 6) of the medications are indicated for paediatric use and only the medication package insert for midazolam (7.7%) contained the information considered essential for use via CI in paediatrics.
What Is New And Conclusion:
This is an innovative study that identifies the weaknesses of the medication package inserts for medications used by CI in paediatric ICUs. Failure to comply with legal recommendations can make medication administration difficult and increase the probability that errors will occur; and the absence of specific technical information can make care difficult and compromise patient safety. It is important that there is supervision by regulatory agencies and the contribution of health professionals so that non-conformities are reported and corrected, to guarantee safe care for paediatric patients in intensive care.
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