Adolescents with gender dysphoria. The National Bioethics Committee says yes to the use of triptorelin

The opinion with the recommendations inspired by the warning and the evaluation, on a case-by-case basis, of the prescription of the drug currently administrable according to the modality of "indications other than those authorized", off -label, was approved during the plenary of the last days of the National Bioethics Committee that answered a question from the AIFA. THE DOCUMENT

30 JUL – From the diagnosis and proposed treatment that must come only from a multidisciplinary and specialized team, moving to the possibility that the treatment be limited to cases in which other psychiatric and psychotherapeutic interventions are obtained ineffective, up to adequate training of the pediatrician, the basic social and health network and the educational institutions concerned.

The "opinion" of the National Bioethics Committee on the ethics of the use of the drug triptorelin for the treatment of adolescents with gender dysphoria came in response to a question submitted by l & # 39; AIFA. Published on the CNB website, and approved at the plenary session on July 13, the opinion gives recommendations inspired by the caution and the evaluation, on a case-by-case basis, of the use of the drug in adolescents with a condition frequently accompanied by psychiatric disorders, disorders of emotion and behavior, with self-injury and high incidence of suicide.

The prescription of triptorelin for gender dysphoria is currently possible according to the method of "indications other than those authorized" (off label). On the basis of this clbadification, except in cases where the individual local authorities do not otherwise, the therapeutic decision, preparation and informed consent are exclusively the responsibility of the physician, without verification by an ethics committee. .

The recommendations. The CNB document, after highlighting the benefits and risks of using the drug, makes recommendations based on prudence and on a case-by-case basis
The NBC recalls the need: [19659007] – diagnosis and treatment proposal comes from a multidisciplinary and specialized team
– treatment is limited to cases where other psychiatric and psychotherapeutic interventions are ineffective;
– the treatment provides for a voluntary and conscious consent of the information received in the specific physical and psychological conditions;
– adequate training is provided for the pediatrician, the basic social health network and the educational institutions concerned with these subjects.

The Committee also recommends:
1) the preparation of studies on the safety, efficacy and physical-psychological follow-up of treated cases
2) the establishment of a fair and homogeneous access policy to triptorelin
Finally, the Committee recommends that IAAFs regulate the special conditions of administration of drugs in the diagnosis of gender dysphoria in adolescence
.

The document, written by Laura Palazzani and Lorenzo of Avack was voted by the majority of the members of the CNB present at the Plenary (other memberships were received later), with the contrary vote of Assunta Morresi (who subsequently sent an annotation) and abstention from Carlo Petrini (delegate representative of Iss) and Maria Teresa Palamara (representative of the Css

30 July 2018
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