Government should consider ways to prevent ‘inappropriate overseas prescribing’ of hormone drugs, review recommends

The Cass review of gender identity services for children and young people has recommended the government work with the General Pharmaceutical Council to consider statutory solutions to prevent inappropriate overseas prescribing of hormone supplies.
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The final report of the Cass review of gender identity services (GIDS) has recommended that the Department of Health and Social Care (DHSC) should work with the General Pharmaceutical Council (GPhC) to look at how the law can prevent inappropriate overseas prescribing.

Led by Hilary Cass, former president of the Royal College of Paediatrics and Child Health, the ‘Independent review of gender identity services for children and young people’ was commissioned by NHS England to make recommendations to ensure that those accessing services for children and young people needing support around their gender identity receive a high standard of care.

The review’s final report, published on 10 April 2024, included feedback from focus groups that showed that some respondents reported seeking “private provision while on the waiting list for GIDS”, with “families trying to balance the risks of obtaining unregulated and potentially dangerous hormone supplies over the internet with the ongoing trauma of prolonged waits for assessment”.

The report says this is seen as “a forced choice (because the NHS provision is not accessible in a timely way) rather than a preference”, owing in part to the ongoing cost of treatment and the subsequent monitoring being “prohibitive for some”.

The report also says: “Any clinician who ascertains that a young person is being given drugs from an unregulated source should make the young person and their family aware of the risks of such treatment.”

As a result, the review recommends that “the DHSC should work with the GPhC to define the dispensing responsibilities of pharmacists of private prescriptions and consider other statutory solutions that would prevent inappropriate overseas prescribing”.

In response, the GPhC told The Pharmaceutical Journal that it “will carefully consider the report and identify any further communications or actions that we may need to take in response”.

On 21 March 2024, the GPhC published a statement warning that a lack of clear referral routes for people experiencing gender dysphoria could lead them to seek alternative options, such as sourcing unregulated products online or through private clinics outside of the UK.

This followed the publication on 12 March 2024 of an NHS England clinical policy which did not recommend the use of puberty-suppressing hormones, also known as puberty blockers, as a routine option for the treatment of children and young people who have gender incongruence or gender dysphoria.

In May 2021, the Care Quality Commission (CQC) proposed legislative changes to improve its ability to regulate independent primary care providers, including those which dispense medicines in England although they are prescribed abroad, which it said were “putting people’s lives at risk”.

In July 2023, a government response to a review of the CQC’s activities said that “the DHSC is working with CQC to discuss and identify whether there are activities being carried out by providers that are not included in the 2014 Regulations but may fall within CQC’s remit”.

Duncan Rudkin, chief executive of the GPhC, told the House of Commons Health and Social Care Select Committee inquiry into the future of pharmacy in January 2024 that the pharmacy regulator was looking again at this area, and was considering producing its own recommendations on legislative changes.

In a statement given to The Pharmaceutical Journal following the committee’s hearing, Rudkin said: “We understand that the CQC has sought legislative change, to enable them to effectively regulate independent providers of online primary care services and protect patients from harm.

“This includes proposals to bring into scope of CQC regulation providers who solely employ prescribing pharmacists to provide non-NHS prescribing services where they are not linked to the provision of pharmacy services at or from a registered pharmacy. 

“We support the extension of CQC’s remit in this respect, bearing in mind that our remit does not allow us to regulate and inspect a service provided by pharmacists without a registered pharmacy.”

Last updated
The Pharmaceutical Journal, PJ, April 2024, Vol 312, No 7984;312(7984)::DOI:10.1211/PJ.2024.1.308838

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