Medicamentos líquidos orais pediátricos contendo etanol: bases para o registro no Brasil

Abstract

The use of etanol as an excipient in oral liquid formulations was discussed in this work taking into account the aspect of the safety for the pediatric patient. The objective of this work was to offer bases to subsidize the norm elaboration that regulates the limits for the etanol use in pediatric liquid pharmaceutical dosage forms. For so much, a bibliographical revision concerning the etanol safety as an excipient in medicines of pediatric use occurred. Searches in data bases Academic Google, PubMed, Scielo, and Portal de Periódicos da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Capes) were proceeded. To have a wider vision of how many products registered in Brazil contains etanol, a rising of all of the synthetic medicines and herbal medicines in the liquid form, registered and published in Official Diary of the Union, until December of 2018 have been done. In order to assists the Anvisa’s guidelines on regulatory quality improvement a partial report of Regulatory Impact Analysis (AIR) have been elaborated. Concernig to international regulatory scenery, many countries have been adopting actions to reduce the risk associated to the etanol ingestion in medicines of pediatric use, these actions include, among other initiatives, to establish acceptance limits for the amount of etanol present in formulations, maximum use period of the medicine and the minimum information that should be included in package leaflet, as well as special cares with the packing material. In the rising of registrations of pediatric formulations was observed that now there are 498 valid registrations of medicines in the form oral liquid for pediatric use, of this total one, 127 registrations present etanol in their formulations. According to the elements gathered in Regulatory Impact Analysis (AIR) was possible to identify that the main regulatory problem is the possibility of damages and offences to the health of patient pediatric due to the etanol ingestion in medicines. Anvisa should regulate the etanol use in pediatric formulations, in order to avoid the unnecessary exhibition of patient pediatric to the etanol in formulations of medicines. The present work showed that the regulatories actions can be ruled with reasonableness and technical knowledge in way to face the problem with efficiency and regulatory quality, and this was possible taking in hands the AIR tool. In a future vision it necessary follow the next steps of AIR, in other words, wrapping up the several actors and with wide social participation, arriving to a complete AIR, for, thus, conclude the regulatory cycle.