Royal Pharmaceutical Society (RPS) Position Statement in response to The Cass Review and The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) order 2024

Position Statement

Key Recommendations

Urgently address access to specialist care pathways

Pharmacist role: Facilitate referrals* to appropriate services including mental health support, and provide compassionate, informed support to children, young people and their families.

Call to Government / NHS: With the withdrawal of medication for many patients and the lack of medical treatment for those that have been awaiting consultation, accessible specialist care pathways are urgently needed including increased mental health support. Pharmacists need assurance of appropriate referral pathways so patients, including those already receiving treatment privately, are not suddenly left without treatment.

^{* In England, Wales and Scotland, current NHS advice is for pharmacists to refer patients back to their GP.  In England, GPs can then refer patients, if appropriate, to the National Referral Support Service for CYP Gender Services where patients should be able to access to mental health support if they wish while waiting to be seen by the specialist service. In Scotland, patients can be referred to gender identity services by their GP. These services are located within NHS Greater Glasgow & Clyde, NHS Lothian, NHS Highland and NHS Grampian. Further information and contact details can be found on the National Gender Identity Clinical Network for Scotland website. In Wales, GPs can refer patients into the Welsh Gender service.}

Facilitate seamless transition at all interfaces of care

Pharmacist role: Multidisciplinary teams for gender incongruence and gender dysphoria need specialist pharmacist input for expertise on medicines. Ensure that patients have appropriate education on medication options and uninterrupted access to necessary medications during any transition e.g. paediatric to adult services, primary care to mental health services.

Call to Government / NHS: Coordinate work with multidisciplinary teams to ensure continuity of care as patients transition between services at interfaces of care.

Stay informed and promote best practices

Pharmacist role: Regularly update knowledge on emerging evidence, legislation and best practices related to gender identity healthcare, including the latest guidelines on puberty blockers and hormone therapies. Ensure pharmacy teams have an awareness of gender identity healthcare and have the appropriate knowledge and skills for compassionate, person-centred care.

Call to Government / NHS Education providers: Include pharmacy teams in opportunities for continuous professional development and training programmes focused on gender identity healthcare.

Prioritise research

Pharmacist role: Participation in research initiatives to contribute to the evidence base on hormonal treatments and other pharmaceutical interventions for gender dysphoria.

Call to Government: Urgent prioritisation of further research for gender incongruence and gender dysphoria and the impact of medicines such as puberty blockers on child development. Evaluating the impact of the implementation of the Cass review on this population group should also be high priority and transparent.

Policy involvement

Pharmacist role: Collaborate with healthcare providers, policymakers, and researchers to shape and advocate for policies that ensure safe, effective and equitable pharmaceutical care for gender-diverse children and young people.

Call to Government / NHS: Early consideration of the role of pharmacy teams in multiprofessional gender identity healthcare; and inclusion in policy and subsequent service developments.

Protecting patients from unregulated providers without criminalising pharmacists

The emergency prohibition order makes it a criminal offence to supply medicines outside the terms of the order which may inadvertently result in pharmacists declining to supply these medicines at all for fear of prosecution. This will impact negatively on patient care.

The order may criminalise pharmacists who inadvertently supply gonadotrophin releasing hormone (GnRH) analogues believing it is not for puberty suppression. Therefore, they may be at risk of unwittingly breaking the law.

This is not an equitable solution to the problem.

Call to Government / NHS: To ensure, in the event of an extension of the emergency prohibition order or subsequent permanent solution, this does so without criminalising the clinical and professional role of a pharmacist.

Background

The Independent Review of Gender Identity Services for Children and Young People, chaired by Dr Hilary Cass made 28 recommendations about the provision of care for this patient population¹.

The review addresses the significant increase in referrals for gender identity support, noting changes in the demographics of these children and young people and the accompanying challenges. Dr Cass emphasises a compassionate, inclusive, and person-centred approach within legal and regulatory frameworks, while calling for better research and innovation. Recommendations include holistic assessments, expanded capacity through distributed service models, early intervention for pre-pubertal children, continuity of care from adolescence to adulthood, and careful consideration of medical treatments with robust oversight.

Impact on Services

Following the outcome of The Cass Review, puberty suppressing hormones are no longer available as a routine commissioning treatment option for treatment of children and young people in England who have gender incongruence and gender dysphoria².

NHS Wales commissions NHS England for these services, and therefore this policy extends to Wales.

NHS Greater Glasgow and Clyde and NHS Lothian, who host the Young People Gender Service in Scotland have paused new prescriptions of puberty hormone suppressants and gender-affirming hormones to young people under the age of 18 while more evidence is generated³.

The recent policy changes in the NHS surrounding prescription of puberty blockers may force young people and their families to seek healthcare from the independent healthcare setting, including overseas providers which operate outside of UK regulation. Prescriptions generated by prescribers operating outside the UK, precipitate complexity for pharmacists in undertaking the necessary due diligence to confirm the legality and safety of the prescription.

The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) order 2024, aims to mitigate some of these challenges, however, an as yet unquantified number of people established on treatment may continue to present private prescriptions generated in the European Economic Area to community pharmacies. Age verification for patients over the age of 18, presenting prescriptions for gonadotrophin-releasing hormone analogues may also present difficulties for both patients and pharmacy teams as national identity documents and birth certificates may be different from the prescription. These legal and safety checks may lead to ethical dilemmas for the pharmacist. Any delays due to the safety checks being undertaken may be misinterpreted by the patient as judgement or bias.

Impact on pharmacists and pharmacy teams

Over recent times, pharmacy teams have been utilising their professional judgment to support children and young people with gender incongruence and gender dysphoria to the best of their ability. This has been particularly challenging due to the lack of comprehensive regulatory or clinical guidelines before the publication of the final Cass Review and The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) order 2024.

Pharmacists and their teams must stay informed of best practices in the care of children, young people and their families, including compassionate communication and an awareness of the emerging evidence around the non-pharmacological interventions and prescription therapies. Initial education and training for pharmacists must adapt to accommodate knowledge and skills in cultural humility and compassionate communication, alongside the evidence base for hormonal treatments and pharmaceutical interventions in gender identity healthcare.

Until the model and infrastructure for multiprofessional gender identity healthcare is established, pharmacists lack a clear referral pathway when adhering to the final Cass recommendations and The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) order 2024. This absence of an identifiable, consistent referral pathway hampers the ability to provide optimal care, potentially leading to significant negative impacts on the mental health and well-being of children and young people. Additionally, pharmacists and pharmacy teams face undue pressure, as declining to supply treatment often means the child or young person has little chance of receiving necessary care.

The General Pharmaceutical Council (GPhC) has previously published information for pharmacists on the expected standards of pharmaceutical care for children and young people accessing gender identity healthcare^4,5. The RPS recognises that consistency in care practices for people accessing gender identity healthcare is vital. We are committed to collaborating with other professional bodies, regulators, independent providers and NHS organisations and patient groups across the devolved nations to achieve consistent, compassionate and high-quality standards of care for children and young people seeking support for gender incongruence and gender dysphoria and their families.