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Medicinal Products

Dáil Éireann Debate, Tuesday - 22 June 2021

Tuesday, 22 June 2021

Questions (607)

Peadar Tóibín

Question:

607. Deputy Peadar Tóibín asked the Minister for Health the regulations pertaining to the usage or prescription of puberty blockers by medical professionals. [25842/21]

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Written answers

Puberty blockers, also called puberty inhibitors, are drugs used to postpone puberty in children. The most commonly used puberty blockers are gonadotropin-releasing hormone (GnRH) agonists, which inhibit the release of sex hormones, including testosterone and oestrogen. In addition to their various other medical uses, puberty blockers are used off-label for transgender children to delay the development of unwanted sex characteristics. 

The use of a medicinal product outside of the specific terms of its marketing authorisation (MA) is often described as “off-label use”. It is the responsibility of the prescriber to satisfy him/herself that off-label use of a medicine is supported by good quality information from the scientific literature. Such off-label use therefore falls within the professional, clinical judgement of the prescriber.   

Where a product is used by a healthcare practitioner for patients under his care outside of the terms of the MA, such usage is not covered by, nor prohibited by, medicines legislation. The medical decision to prescribe or not prescribe a specific treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Department of Health has no role in this clinical decision-making process.

Question No. 608 answered with Question No. 606.
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