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Previous issue date: 2017-06-30 / INTRODU??O: Diversos estudos t?m mostrado que um n?mero significativo de medicamentos prescritos a pacientes pedi?tricos s?o off-label ou n?o licenciados, mas existe pouca informa??o sobre o uso destes medicamentos em unidades de terapia intensiva neonatal (UTIN), assim como estudos sobre fatores de risco para potenciais intera??es medicamento-medicamento (IMM). OBJETIVO: Identificar a prescri??o de medicamentos off-label e n?o licenciados utilizados em rec?m-nascidos (RN) hospitalizados em UTIN, al?m de avaliar frequ?ncia de IMM e seus fatores de risco. METODOLOGIA: Coorte prospectiva, no qual foram inclu?dos neonatos admitidos consecutivamente na UTIN da Maternidade Escola Janu?rio Cicco com pelo menos um medicamento prescrito e tempo de interna??o superior a 24 horas. Dados cl?nicos e farmacoterap?uticos dos neonatos foram coletados durante toda a interna??o, sendo a classifica??o dos medicamentos em off-label e n?o licenciados realizada de acordo com crit?rios da Food and Drug Administration atrav?s da base DrugDex-Micromedex?, a qual tamb?m foi utilizada na classifica??o das IMM, cujos fatores de risco foram identificados por regress?o log?stica. RESULTADOS: Entre agosto de 2015 e agosto de 2016 foram analisados 17421 itens medicamentosos em 3935 prescri??es de 220 neonatos, dos quais 96,4% foram expostos a medicamentos off-label e 66,8% a n?o licenciados. Mais de 70% dos prematuros e RN com menos de 2000g foram submetidos ? farmacoterapia com medicamentos off-label e mais de 50% aos n?o licenciados. Os anti-infecciosos para uso sist?mico foram o grupo farmacol?gico mais prescrito de forma off-label,sendo o fentanil (n=1358) e a gentamicina (n= 1197) os medicamentos com maior preval?ncia de uso off-label para RN. A cafe?na (n=1226) foi o medicamento n?o licenciado mais prescrito, seguido pelos agentes cardiovasculares (n=648) modificados pela enfermagem. Em 42,3% (n= 1665) das prescri??es foram detectadas IMM, cujos fatores de risco para IMM importantes foram o n?mero de medicamentos (OR 1,60, p<0,001), parto ces?reo (OR 2,68, p=0,06) e idade gestacional (OR 1,03, p= 0,002). CONCLUS?ES: RN em terapia intensiva ? submetido ? alta taxa de prescri??o e exposi??o a medicamentos off-label e n?o licenciados, sendo os mais frequentes os anti-infecciosos de uso sist?mico e os medicamentos atuantes no sistema nervoso, e tamb?m uma elevada incid?ncia de IMM, consistindo o n?mero de medicamentos prescritos, parto ces?reo e a idade gestacional os principais fatores de risco para IMM. / INTRODUCTION: Several studies have shown that a significant number of drugs prescribed to pediatric patients are off-label or unlicensed, but there is little information about the use of these drugs in neonatal intensive care units (NICUs), as well as studies about risk factors for drug-drug interactions (DDI). PURPOSE: To evaluate the use of off-label and unlicensed drugs in a Brazilian NICU of a teaching maternity hospital specialized in high risk pregnancy, and the frequency of DDI and associated risk factors. METHODS: A prospective cohort study was conducted between august 2015 and august 2016. All newborns admitted consecutively in the NICU of the Maternity School Janu?rio Cicco for over 24 hours and who had at least one medication prescribed were included. Demographic and clinical data were collected, as well as all medications prescribed during hospitalization. The classification of off-label and unlicensed drugs for the neonatal population according to the Food and Drug Administration criteria was done based on the DrugDex-Micromedex? database, which was also used for the classification of DDI. Logistic regression was used for the analysis of risk factors. RESULTS: A total of 17421 prescriptions items were analyzed in 3935 prescriptions of 220 newborns, of whom 96.4% were exposed to off-label medications and 66.8% to unlicensed drugs. More than 70% of premature and neonates with birth weight less than 2000g were submitted to off-label medicines and more than 50% to unlicensed. The anti-infectives for systemic use were the most prescribed off-label pharmacological group and the drugs most frequently classified as off-label for newborn were Fentanil (n= 1358) and gentamicin (n= 1197). Caffeine (n = 1226) was the most prescribed unlicensed drug, followed by cardiovascular agents (n= 648) modified by nursing. DDIs were found in 42,3% (n= 1665) of prescriptions , with number of drugs (OR 1.60, p<0,001), cesarean delivery (OR 2.68, p = 0,06) and gestational age (OR 1.03, p = 0,002) as risk factors for major DDI. CONCLUSION: Neonates in intensive care units have a high rate of prescriptions and exposure to off-label and unlicensed drugs, with antimicrobials for systemic use and drugs action on nervous system as the most frequently prescribed, as well as a high incidence of DDI, with number of medicines, cesarean delivery and gestational age being risk factors for major DDI.
| Identifer | oai:union.ndltd.org:IBICT/oai:repositorio.ufrn.br:123456789/24040 |
| Date | 30 June 2017 |
| Creators | Costa, Haline Tereza Matias de Lima |
| Contributors | 70573918465, Cornetta, Maria da Concei??o de Mesquita, 35303646491, Santos, Djanilson Barbosa dos, 91748526553, Martins, Rand Randall, Oliveira, Antonio Manuel Gouveia de |
| Publisher | PROGRAMA DE P?S-GRADUA??O EM CI?NCIAS FARMAC?UTICAS, UFRN, Brasil |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Source | reponame:Repositório Institucional da UFRN, instname:Universidade Federal do Rio Grande do Norte, instacron:UFRN |
| Rights | info:eu-repo/semantics/openAccess |
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