Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?

被引:3
作者
de Jesus, Soraya Machado [1 ]
Santana, Rafael Santos [2 ]
Leite, Silvana Nair [3 ]
机构
[1] Univ Brasilia, Postgrad Program Pharmaceut Sci, Brasilia, DF, Brazil
[2] Univ Brasilia, Dept Pharm, Brasilia, DF, Brazil
[3] Univ Fed Santa Catarina, Dept Pharmaceut Sci, Florianopolis, SC, Brazil
关键词
Congenital abnormalities; contraceptive agents; drug; drug approval; guidelines; legislation; leprosy; pharmacovigilance; risk management; thalidomide; RISK-MANAGEMENT; BIRTH-DEFECTS; SURVEILLANCE; EMBRYOPATHY; LEPROSY; ACCESS; IMPLEMENTATION; LENALIDOMIDE; PROGRAMS; HISTORY;
D O I
10.1080/14740338.2021.1953467
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Introduction One of the biggest drug disasters in history has not prevented thalidomide from being used to treat various clinical conditions. Currently, Brazil has a worrying scenario: high consumption of the drug and, cases of pregnant women using thalidomide, even after adopting restrictive legislation. Areas covered This review of the literature and legislation sought to comparatively analyze the monitoring of thalidomide use in Brazil and other countries that use this drug. Finally, we discuss the differences between the countries. Expert opinion This analysis allows us to think beyond the safe use of thalidomide, but the safety provided by any type of monitoring system. It seems that out-patients that use unsafe drugs are exposed to some degree of risk. To improve safety, more extensive improvements are needed than monitoring systems related to the use of thalidomide. Its safe use depends on a drastic reduction in the incidence of leprosy and Erythema Nodosum Leprosum in the world; investment in research and development of safe and effective therapeutic alternatives to thalidomide; improvement of health systems and their health surveillance systems, particularly in primary health care; awareness of health professionals and patients for greater responsibility in the use of medicines, especially thalidomide.
引用
收藏
页码:67 / 81
页数:15
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