Uso de medicamentos off-label e não licenciados em unidade de tratamento intensivo neonatal e sua associação com escores de gravidade / Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores

OBJETIVO: Avaliar a frequência da prescrição de medicamentos de uso não licenciado (UL) e off-label (OL) em recém-nascidos internados em unidade de tratamento intensivo neonatal de hospital de nível terciário e verificar a associação do seu uso com a gravidade dos pacientes. MÉTODOS: Estudo observacional de coorte dos medicamentos prescritos no período de 6 semanas da internação de neonatos, entre julho e agosto de 2011. Os medicamentos foram classificados em UL e OL para dose, frequência, apresentação, faixa etária e indicação, de acordo com bulário eletrônico aprovado pela Food and Drug Administration. Os pacientes foram acompanhados até alta hospitalar ou 31 dias de internação, com registro diário do Neonatal Therapeutic Intervention Scoring System. RESULTADOS: Foram identificados 318 itens de prescrição para 61 pacientes (média de cinco itens/paciente) e apenas 13 pacientes com uso de medicamentos adequados (21%). Identificaram-se prevalências de 7,5% para prescrições UL e de 27,7% para OL. O uso OL mais prevalente foi para medicamentos não padronizados para faixa etária - 19,5%. Computaram-se 57 medicações - um paciente recebeu 10 fármacos UL/OL na internação. A prevalência de usos OL foi maior em prematuros < 35 semanas e nos com escores de gravidade mais elevados (p = 0,00). CONCLUSÕES: A prevalência de neonatos expostos a medicamentos UL/OL durante a internação hospitalar foi elevada, especialmente naqueles com maior escore de gravidade no Neonatal Therapeutic Intervention Scoring System. Embora haja apreciação geral de que neonatos, especialmente pré-termo, tenham alta taxa de uso de medicamentos, uma avaliação incluindo diferentes culturas e países é necessária para priorizar áreas de pesquisa futura na farmacoterapêutica dessa população vulnerável.

OBJECTIVE: To analyze the frequency of unlicensed (UL) and off-label (OL) prescriptions in neonates admitted to the neonatal intensive care unit of a tertiary care hospital and to determine their association with patients' severity. METHODS: Observational cohort study including drugs prescribed during hospitalization of neonates over a 6-week period between July and August 2011. The drugs were classified as UL and OL for dose, frequency, presentation, age group, or indication, according to an electronic list of drugs approved by the Food and Drug Administration. Patients were followed until hospital discharge or 31 days of hospitalization, with daily records of the Neonatal Therapeutic Intervention Scoring System (NTISS). RESULTS: We identified 318 prescription items for 61 patients (average of five items/patient); there were only 13 patients with appropriate use of medications (21%). A prevalence of 7.5% was identified for UL prescriptions and 27.7% for OL, and the most prevalent OL use was that related to age group - 19.5%. Fifty-seven medications were computed - one patient received 10 UL/OL drugs during hospitalization. The prevalence of OL uses was higher in preterm infants < 35 weeks and in those with higher severity scores (p = 0.00). CONCLUSIONS: The prevalence of neonates exposed to UL/OL drugs during hospitalization was high, especially for those with higher NTISS scores. Although there is general appreciation that neonates, especially preterm infants, have a high rate of drug use, an assessment including different cultures and countries is still needed to prioritize areas for future research in the pharmacotherapy of this vulnerable population.

The drug lag: new drug introductions in India in comparison to United States.

CONTEXT: Important drugs become available late in India, some much later, than in the United States. The prevailing trends in new drug introduction in India as compared to USA have been looked into this study. OBJECTIVES: To determine the trends in new drug introduction, both qualitative and quantitative, during the period, 1988 to 1999, in India. DESIGN: Data search, compilation and analysis. SOURCE: Various issues (1982-1997) of "Journal of the American Pharmaceutical Association" and "Indian Drug Manufacturers Association" Bulletin (1988-2000). MAIN OUTCOME MEASURES: Average drug lag, trends in drug lag over years (1988-1999), drug lag by therapeutic categories, drug lag by FDA classification of drugs. RESULTS: Average drug lag in India during the years 1988 to 1999 was 4.02 +/- 2.77 years. It has shown a decreasing trend over the years. Gastrointestinal drugs have the least drug lag (1.2 +/- 2 years). Cardiovascular drugs suffer the highest drug lag among therapeutic categories (5.21 +/- 2.2 years). 1AA drugs and 1P drugs (FDA classification) are priority drugs in India also. 1A drugs, which are important new therapeutics agents have been unfortunately neglected by drug developers and regulatory authorities in India. CONCLUSION: Important new drugs become available in India with a drug lag. This 'drug lag' has declined over the years. Qualitative analysis show that 1A class drugs, supposedly the most important category, has been the worst affected.