Additional Safeguards For Puberty Blockers

The Ministry of Health is today releasing an evidence brief and position statement on the use of puberty blockers for gender identity issues and outlining a more cautious approach to their use.

The evidence brief shows a lack of good quality evidence to back the effectiveness and safety of puberty blockers when used for this purpose.

A Ministry position statement underpinned by the evidence brief sets out expectations of a more precautionary approach for the care of adolescents with gender identity issues.

The Ministry’s assessment is that the starting point for treatment is a holistic assessment determining the full spectrum of needs a young person may have including social and mental health.

The new precautionary approach signals the need for clinicians to exercise caution in prescribing, including that prescribing should only be initiated by clinicians who are experienced in providing gender-affirming care, and are part of an interprofessional team offering a full range of supports to young people presenting with gender identity issues.

The Government has now tasked the Ministry with consulting on whether the new precautions should be backed by additional safeguards, such as regulations under the Medicines Act 1981 to strengthen changes in prescribing expectations.

These tighter controls reflect a level of concern both here and overseas about the increasing use of these medicines for the treatment of gender identity issues without sufficient evidence to support their safety and effectiveness both now and in the longer-term.

The appropriate and safe care for this group of young people is critically important.

Any additional safeguards in the form of regulations would be to protect against the risk of future harm to vulnerable individuals.

Other countries have also reported rises in recent years in the numbers of young people being treated for gender identity issues with puberty blockers. In New Zealand, in 2010, around 25 young people aged 11 and 17 years were typically started on treatment with these medicines and by 2021 the number had grown to around 140. In the last two years that number had fallen and in 2023 was 113.

The Ministry will be undertaking targeted consultation with organisations that are representative of those who may be affected by any potential regulations.

In addition, the Ministry will invite public submissions via survey questions on its Health Consultation Hub web page.

The consultation, open until late in January 2025, will be asking if further precautions are needed.

Other steps already underway include updated clinical guidelines on puberty blockers being commissioned by Health NZ and expected in coming months, better monitoring of usage in New Zealand and developing New Zealand’s own knowledge in this area to guide any further advice or safeguards.

The Ministry of Health will also commission research to determine the long-term clinical and mental health and wellbeing impacts of puberty blockers.

Material published by the Ministry of Health today is available here: https://www.health.govt.nz/publications/consultation-on-safety-measures-for-the-use-of-puberty-blockers-in-young-people

FAQ

What are puberty blockers?

Puberty blockers, or GnRH analogues, can be used to delay puberty by suppressing oestrogen and testosterone. They can be prescribed by appropriately experienced clinicians to young people experiencing gender identity issues.

How broad was the scope of the evidence being studied?

The evidence brief surveyed over 4,000 papers from international and national literature published up until 30 September 2023.

Of these, 20 papers examining clinical outcomes met the criteria for inclusion in the Evidence Brief: 12 from the Netherlands, three from the UK, two from the United States of America, one from Israel, one from Belgium, and one from Canada.

A total of 10 studies investigating mental health outcomes met the criterial for inclusion in the evidence brief: five from the United States two from the United Kingdom, and one each from Australia, the Netherlands and Spain.

An addendum to the evidence brief was developed covering from October 2023 to May 2024 which reviewed an additional 160 articles including the Cass Report.

What are the key findings?

The evidence brief found that the evidence supporting the effectiveness and safety was limited and of poor quality. There have been no significant New Zealand studies in this field.

Studies found that for those on puberty blockers, bone density is lower than expected for the individual’s stage of development, when compared with other young people.

Organ systems are often affected by hormone medication. However, for those on puberty blockers, there was no evidence of any potential significant effect on renal or liver function, or fertility or onset of diabetes.

What are the limitations of the evidence brief or the research it is based on?

It has become clearer that evidence about the impact of puberty blockers on clinical and mental health and wellbeing outcomes is scarce and of poor quality.

No New Zealand studies met the criteria for inclusion in the evidence brief. It is based on international studies.

Further, there is a limited diversity of people included in the studies.

When are puberty blockers prescribed, and by whom?

Currently, puberty blockers can be prescribed by clinicians as part of gender-affirming care once a young person reaches puberty onset (Tanner stage 2) and would otherwise start to develop secondary sex characteristics (physical characteristics that differ between the sexes and emerge at puberty).

Puberty onset is established by clinical assessment of an individual. The age ranges for onset of puberty are wide across the population – approximately 8-14 years for females, and 10-15 years in males.

When authorised prescribers first prescribe puberty blockers, they are expected to be working within their scope of practice – there is a clear expectation that the patient is aware that the medication is being used for an unapproved use and that there is an informed conversation about the potential risks and benefits.

What is changing?

The Ministry of Health has published its expectations setting out that prescriptions for puberty blockers for gender identity issues should only be initiated by clinicians who are experienced in providing gender-affirming care and are part of an interprofessional team offering a full range of supports to young people presenting with gender-related issues.

What mental health support is available?

It is important that young people feel confident that when they access healthcare they will be supported by an interprofessional team who are able to meet their physical, social and mental health needs.

Not all young people with issues relating to their gender identity have co-existing mental health illnesses. When there is a coexisting mental health illness this is likely to require specialist input to help with diagnosis and treatment.

Further support:

The Government has set a number of mental health targets with specific programmes focused on support for young people.

For example, Gumboot Friday is expanding its capacity to 15,000 young people per year through the additional funding of $6 million.

There are also initiatives underway to introduce peer support in EDs, expand specialist services for children and youth, and establish crisis recovery cafes to bolster the acute end of the continuum.

Mental health and addiction targets:

80% of people accessing specialist mental health and addiction services seen within three weeks

80% of people accessing primary mental health and addiction services through the Access and Choice programme seen within one week

95% of mental health and addiction-related ED presentations admitted, discharged or transferred from ED within 6 hours

500 mental health and addiction professionals trained each year

25% of mental health and addiction investment allocated towards prevention and early intervention.

What is your message for people who may be suffering mental distress?

We want to reassure anyone who may be experiencing gender identity issues that their wellbeing remains our top priority. This is why the Director-General of Health’s position statement reflects a holistic approach to gender-affirming care with access to wrap-around support. We would encourage anyone who is experiencing mental distress to talk to their healthcare provider or call or text 1737.

What gender affirming care (aside from puberty blockers) are available for those aged 11-17 experiencing gender identity issues?

Supporting young people experiencing gender identity issues requires a developmentally appropriate and holistic approach.

Care should be managed through a multi-disciplinary team (MDT) approach, working with patients, family and whānau.

Gender affirming care available for people in this age group can involve non-medical options, including support with social affirmation, health education, or psychological support. Medical gender affirming care (aside from puberty blockers) may include gender affirming hormone therapy.

Gender affirming surgery is not available in Aotearoa New Zealand for people under 18 years of age.

Not all young people will want or needmedicalsupport, and the initiation of puberty blockers is just one potential outcome of the pathways of interdisciplinary care providing holistic care.

Are puberty blockers safe and reversible? 

The evidence brief concluded that there is not yet enough quality evidence to definitively assess the safety and reversibility of puberty blockers.

Clinicians will continue to provide careful advice on gender affirming options for individuals and their families, and subsequent interprofessional clinical follow-up and support. Note that no medical treatment is entirely without risk.

What happens next?

A more precautionary approach to prescribing is now in place as set out in the position statement. The Ministry of Health will be consulting on additional safeguards, including whether to make regulations.

Clinicians can continue to provide the most appropriate advice and care to young people experiencing gender identity issues. Prescriptions for puberty blockers will only be initiated by clinicians who are experienced in providing gender-affirming care, and who are part of an interprofessional team offering a full range of supports to young people presenting with gender-related issues.

The Director-General of Health has set the expectation that puberty blockers are initiated by clinicians that have expertise in this area and are part of an interdisciplinary team to ensure appropriate support is provided to those seeking care and advice.

Over time we expect there will be a clearer understanding of gender-affirming care, including the impact of treatment and care have on the individual’s physical and mental wellbeing including the use of puberty blockers.

Health New Zealand – Te Whatu Ora has commissioned updated clinical guidance for gender-affirming care, which will cover the use of puberty blockers, expected to be available in current months.

The Ministry will continue to seek expert advice that considers system wide issues relating to gender-affirming care.

An Expert Advisory Group has been established to provide the Ministry with advice on gender affirming care and providing a broader scope.

The Ministry will continue to monitor developments in overseas jurisdictions.

How will Health NZ’s guidelines be enforced?

The Ministry of Health is working with Health New Zealand to establish a clinical governance structure to enable active monitoring of all aspects of gender identity services including prescribing of puberty blockers. Peer review, which is part of standard clinical practice, will provide assurance that clinicians are working to the guidelines.

Why was the release of the position statement and evidence brief delayed?

A: This is a complex area, and the Ministry has taken the time needed to ensure that our response is appropriate for the New Zealand context.

There have been significant new publications internationally relating to puberty blockers that needed to be considered, and we are continuing to monitor developments overseas, including any new emerging evidence.

The evidence brief, and addendum, covers relevant publications and articles through to May 2024. Since then, there have been additional 43 articles published in the scientific literature that have been reviewed by the Ministry. The outcome of this preliminary assessment, at a high level, is that none of these studies change the key findings of the evidence brief which is that the available evidence supporting the effectiveness and safety of puberty blockers is limited and of poor quality.

The Ministry has also been monitoring significant regulatory changes, particularly in the UK. In March 2024, NHS England published clinical guidance in March 2024 halting the routine use of puberty blockers for treatment of gender identity issues a month prior to the release of the final Cass Review. In May 2024, stronger curbs on the use of puberty blockers for gender identity issues were announced by the UK government and which remain in place after a legal challenge in July 2024 was dismissed. In August 2024, NHS England announced a two-year action plan to implement the recommendations from the Cass Review:

https://www.england.nhs.uk/long-read/children-and-young-peoples-gender-services-implementing-the-cass-review-recommendations/

The position statement and evidence brief were important considerations in the Ministry’s advice and recommendations about next steps and additional safeguards provided to Ministers.

What were the studies being considered or the additional work requiring active consideration by the Ministry of Health?

The Evidence Brief included articles and studies up until 30 September 2023. In the eight months from then to May 2024, an additional 160 articles, including the final Cass Report, were published. These articles have since been screened by the Ministry and those deemed eligible have been included in an addendum to the Evidence Brief.

The Cass Review, published in April 2024, is a comprehensive 388 review, which was accompanied by nine studies, eight of which were systematic reviews of evidence supporting the Cass Review’s recommendations.

The Cass Review prompted a change to prescribing in substantive parts of the UK. Both the review itself, and other studies in the evidence brief have been actively considered by the Ministry as part of the release of the Evidence Brief and Position Statement.

© Scoop Media