EXCLUSIVE Any enforcement of sanctions against pharmacists for 'inadvertent dispensing' of puberty blockers outside the terms of legislation 'will be considered on a proportionate and case-by-case basis', the government has promised.

This comes after the Royal Pharmaceutical Society (RPS) highlighted that pharmacists are the 'only' profession at risk of criminalisation in the government's changes to the availability of puberty blockers.

And it called for this 'inequitable' element of the legislation to be removed.

The RPS also said stronger referral pathways were 'urgently needed' to give patients timely access to specialist support.

'We would be in a better place to agree [with the government's proposals] if implementation was without criminalisation and if we were confident no patients were left without appropriate care and treatment,' the RPS said in its response to a consultation on making an emergency temporary ban of puberty blockers permanent.

Government considering making temporary ban permanent

An emergency ban currently prohibits the sale or supply of gonadotrophin-releasing hormone analogues for gender incongruence or dysphoria to under 18s not already taking them, when prescribed by UK-registered prescribers.

It prevents the sale and supply of these drugs from prescribers registered in the European Economic Area or Switzerland for any purposes to those under 18.

The ban makes it a criminal offence to supply puberty blockers outside the terms of the order.

However, the medicines can still be legitimately supplied to under-18s for very early onset of puberty (usually caused by another condition), to people under 18 with gender dysphoria already in treatment, and to people aged 18 and over.

The temporary ban is in place until late November. But The Pharmacist understands that between August and October, the government consulted with stakeholders including patients, representative charities, clinicians, academics and regulators, on whether the ban should be made permanent.

Pharmacists 'disproportionately' impacted by risk of criminalisation

In its response to that consultation, which has now closed, the RPS warned that the legislation 'exposes pharmacists to the risk of criminal charges if they supply these restricted medicines outside the specified conditions due to an inadvertent error or breach'.

'Pharmacists are the only healthcare profession impacted by the risk of criminalisation and this is a disproportionate risk for pharmacists when other professions are involved in the prescribing of these treatments and for the necessary checks and prescription annotations necessary,' the RPS added in its consultation response, published last week (4 October).

It said it was 'extremely concerned' about the potential for prosecution of pharmacists supplying puberty blockers, adding that it was 'not an equitable solution to the problem'.

The risk of criminalisation of a pharmacist for an inadvertent error or breach 'must be removed', the RPS said.

It also suggested that fear of prosecution 'may inadvertently result in pharmacists declining to supply these medicines at all', even where it is allowed.

'This will impact negatively on patient care', the RPS warned.

Enforcing sanctions 'will be considered on a proportionate and case-by-case basis'

In response to the RPS's concerns, a spokesperson for the Department of Health and Social Care (DHSC) told The Pharmacist that 'enforcement of any sanctions against pharmacists for inadvertent dispensing [of puberty blockers] will be considered on a proportionate and case-by-case basis'.

They added: 'We are committed to ensuring children questioning their gender receive the best possible care.

'Decisions on our children’s healthcare must follow the evidence at all times, and Dr Cass's review found there was insufficient evidence to show puberty blockers were safe for under 18s. That is why the government has extended the temporary ban and is consulting on making it permanent.'

Accessible specialist care pathways 'urgently needed'

In its consultation response, the RPS also highlighted the 'urgent' need for 'accessible specialist care pathways' for patients who have been awaiting treatment or have had it withdrawn.

'The absence of an identifiable, consistent referral pathway across England, Wales and Scotland 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,' the RPS said.

Pharmacists and pharmacy teams are under 'undue pressure' when faced with having to decline to supply treatment when this 'often means the child or young person has little chance of receiving necessary care', the RPS added.

'Accessible specialist care pathways are urgently needed including increased mental health support,' it said.

'Pharmacists need assurance of appropriate referral pathways so patients, including those already receiving treatment privately, are not suddenly left without treatment.'

In response to these concerns, NHS England highlighted to The Pharmacist its new referral pathway specification for children and young people with gender incongruence that was published in August and came into force in September.

Current wording 'overly complex'

The General Pharmaceutical Council (GPhC) also responded to the government's engagement with stakeholders on making the ban permanent.

It said the current regulation drafting was 'overly complex making it difficult to interpret'.

If a permanent order were to be introduced, the GPhC said that 'the drafting should support patients and healthcare professionals to easily understand the prohibition and the various requirements to be satisfied for a supply to be lawfully made'.

What defences would be available for supply 'in good faith'?

The GPhC also asked DHSC to clarify 'whether the offences are strict liability', or whether other defences could be available, such as a statutory defence which is currently available within the Medicines Act 1968 for pharmacy professionals involved in an assembly or dispensing error.

'Is it intended there should be no available defence in cases where a supply has been made in good faith believing the legal requirements to have been satisfied?' Louise Edwards, GPhC chief strategy officer and deputy registrar asked in the GPhC's response.

The regulator invited DHSC 'to provide clarity indicating the circumstances for when it would or would not be in the public interest to prosecute a pharmacy professional involved (perhaps unwittingly) in making a prohibited supply' of puberty blockers.

Consider impact on affected groups and mental health services

The GPhC also stressed the need for the government to 'consult fully and comprehensively' with groups most affected by the legislation, and to ensure that language used 'is appropriate and does not reinforce negative stereotypes or stigma'.

It highlighted the need to consider the potential impact of the order on NHS mental health services, particularly as the recently published Darzi report highlighted an increase in multiple long-term conditions including mental health in young people.