1257/2012 - Clinical use and control on thalidomide dispensing in Brasilia-DF, Brazil, from 2001 to 2012 Uso clínico e controle sobre a dispensação de talidomida em Brasilia-DF, Brasil, de 2001 a 2012.
A talidomida, medicamento sedativo e teratógeno humano, havia sido banida nos anos 1960 e voltou a ser comercializada com novas indicações na década de 1990. Diferente de outros países, o uso da talidomida nunca foi interrompido no Brasil, onde ela é prescrita para tratar a reação tipo 2 da hanseníase. Inúmeras crianças com defeitos congênitos compatíveis com o fenótipo da embriopatia causada pela talidomida nasceram após 1965, uma evidência de que o controle sobre o uso e dispensação do medicamento falhou no país. Nova regulamentação sobre a dispensação e prescrição da talidomida foi introduzida em 2001. Este artigo relata dados sobre a dispensação e usos clínicos da talidomida no Distrito federal em 211/12, quando a nova regulamentação passou a vigorar, e dados sobre a dispensação e uso do medicamento 10 anos antes (2001). Os resultados mostraram que o número de pacientes que usaram talidomida decresceu de 819 em 2001 para 369 em 2011/12. A hanseníase foi indicação clínica para mais de 70% das prescrições em ambos os períodos analisados no estudo. No mesmo período, entretanto, o uso para lupus eritematoso diminuiu de 13,7 para 4,9%, enquanto o uso para mieloma múltiplo cresceu de 2.9 para 20,3% de todas as prescrições. A prescrição de talidomida para as outras indicações aprovadas foi muito menos frequente, enquanto o uso para indicações não aprovadas correspondeu a <1% das prescrições em 2001 e 2011/12. O cadastro dos prescritores, pacientes e unidades dispensadoras na secretaria estadual de saúde, introduzida pela regulamentação que entrou em vigor em 2011, aparentemente tornou o controle sobre a dispensação e uso da talidomida mais eficiente e confiável.
Palavras-chave:
talidomida
uso para indicações não aprovadas
hanseníase
controle de medicamentos
mieloma múltiplo
lupus eritematoso
Abstract:
Thalidomide, a sedative drug and human teratogen, had been banned in the 1960s and re-entered the market with new clinical indications in mid 1990s. Contrasting to most countries, use of thalidomide has never been discontinued in Brazil where it is prescribed for Hansen disease type 2- reaction. A number of babies with birth defects compatible with thalidomide embryopathy phenotype were born after 1965, an indication that control on drug dispensing and use failed in the country. New rules on thalidomide dispensing and prescription were introduced in 2011. This article reports data on thalidomide dispensing and clinical uses in the Federal District in 2011/12, when new rules were put into effect, and data on drug dispensing and use obtained ten years earlier (2001). It was found that the number of patients making use of thalidomide declined from 819 in 2001 to 369 in 2011/12. Hansen disease accounted for over 70% of prescriptions in both time periods analyzed in this study. In the same time interval, however, use for lupus erythematosus decreased from 13.7 to 4.9%, while that for multiple myeloma increased from 2.9 to 20.3% of all prescriptions. Thalidomide prescription for remaining approved indications was far less frequent, and so was the use for off label indications that accounted for <1% of prescriptions in 2001 and 2011/12. Registration of prescribing doctors, patients and dispensing units at the state department of health, introduced by regulation put into effect in 2011, apparently turned control on thalidomide dispensing and clinical use more effective and reliable.
Keywords:
thalidomide
off label uses
Hansen disease
drug control
multiple myeloma
lupus erythematosus
Uso clínico e controle sobre a dispensação de talidomida em Brasilia-DF, Brasil, de 2001 a 2012.
Resumo (abstract):
Thalidomide, a sedative drug and human teratogen, had been banned in the 1960s and re-entered the market with new clinical indications in mid 1990s. Contrasting to most countries, use of thalidomide has never been discontinued in Brazil where it is prescribed for Hansen disease type 2- reaction. A number of babies with birth defects compatible with thalidomide embryopathy phenotype were born after 1965, an indication that control on drug dispensing and use failed in the country. New rules on thalidomide dispensing and prescription were introduced in 2011. This article reports data on thalidomide dispensing and clinical uses in the Federal District in 2011/12, when new rules were put into effect, and data on drug dispensing and use obtained ten years earlier (2001). It was found that the number of patients making use of thalidomide declined from 819 in 2001 to 369 in 2011/12. Hansen disease accounted for over 70% of prescriptions in both time periods analyzed in this study. In the same time interval, however, use for lupus erythematosus decreased from 13.7 to 4.9%, while that for multiple myeloma increased from 2.9 to 20.3% of all prescriptions. Thalidomide prescription for remaining approved indications was far less frequent, and so was the use for off label indications that accounted for <1% of prescriptions in 2001 and 2011/12. Registration of prescribing doctors, patients and dispensing units at the state department of health, introduced by regulation put into effect in 2011, apparently turned control on thalidomide dispensing and clinical use more effective and reliable.
Palavras-chave (keywords):
thalidomide
off label uses
Hansen disease
drug control
multiple myeloma
lupus erythematosus
Paumgartten, F.J.R., Souza, N.R.. Clinical use and control on thalidomide dispensing in Brasilia-DF, Brazil, from 2001 to 2012. Cien Saude Colet [periódico na internet] (2012/Ago). [Citado em 28/09/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/clinical-use-and-control-on-thalidomide-dispensing-in-brasiliadf-brazil-from-2001-to-2012/11057
