The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review

Abstract

The drug thalidomide has resurged in the world market under restrictive conditions for marketing and use. In Brazil, there are still cases of pregnant women using thalidomide even after the implementation of laws that regulate the control of use (Law No. 10.651/2003 and Collegiate Board Resolution No. 11/2011). The objective of this study was to discuss the control of thalidomide use in Brazil, based on a scoping review of the scientific literature, documents, and data from the Ministry of Health. A total of 51 studies and documents related to the following subthemes were selected: (1) organization of access and use of thalidomide in the health system; (2) epidemiological and population characteristics of people affected by leprosy; and (3) occurrence of pregnancy and cases of embryopathy with the use of thalidomide. The results showed that Brazil has no unified information database about thalidomide patients. Furthermore, there is inconsistency in the accreditation of public health centers that dispense this medicine, in a country that has a high consumption of thalidomide in the Unified Health System. A large part of this amount of dispensed medicine is intended for the treatment of erythema nodosum leprosum, mainly in the North, Northeast, and Central-West regions of the country, which are endemic for leprosy. This disease is the only one among the clinical indications of the medicine approved in Brazil that does not have a Clinical Protocol and Therapeutic Guidelines. The control of thalidomide use in Brazil presents historical regulatory failures. These are currently linked to the organization and structure of primary healthcare in the country, as well as to the lack of leadership of the Ministry of Health and National Health Surveillance Agency when it comes to managing the process of control of this use.

Access to thalidomide

“…However, in each suspected case a thorough investigation should be done to exclude other causes of the "Thalidomide embryopathy phenotype". [32][33][34] A scoping review of access to thalidomide in Brazil suggested a need for a national Clinical Protocol and Therapeutic Guidelines for use of thalidomide in ENL cases, uniform accreditation of health centres approved for supply of thalidomide and for a national database of patients treated with it. Brazilian law requires women of childbearing age to use contraceptive precautions when they are prescribed thalidomide.…”

The dark side of drug repurposing. From clinical trial challenges to antimicrobial resistance: analysis based on three major fields

“…The drug, infamously recognized in its devastating original form as a sedative and curative for morning sickness, returned to the medical world for the treatment of leprosy and, subsequently, multiple myeloma ( 5 ). It is worth noting that the discovery of thalidomide’s efficacy in treating leprosy, specifically erythema nodosum leprosum, was a serendipitous occurrence ( 6 ). The story behind this accidental discovery is recounted in the book Dark Remedy .…”