‘Safety failure’ by chemist selling hormones for trans children The Times 29.10.20

The original article is here.

A pharmacy that arranged home deliveries of life-changing medication for transgender children which bypassed NHS safeguards has been found to have “system-wide failures” by its regulator.

Clear Chemist dispensed medication, including puberty blockers and cross-sex hormones, using online prescriptions issued by a clinic overseas that is not subject to British regulatory requirements.

The pharmacy, which is based in Aintree, Merseyside, offered “quick, discreet delivery” to the patient’s home as part of its service.

The prescriptions were from GenderGP, a private company founded by Helen Webberley, who was fined in 2018 for running an unlicensed transgender clinic in south Wales and suspended by the General Medical Council. She initially moved the clinic to Spain and last year it was acquired by Harland International, which is registered in Hong Kong.

When The Times reported earlier this month that parents of transgender children could bypass safeguards by paying for online prescriptions dispensed by Clear Chemist it prompted an immediate inspection by the General Pharmaceutical Council (GPC).

The regulator has now announced the outcome, saying Clear Chemist was found not to be meeting some of the standards for registered pharmacies to ensure safe and effective care for patients and the public.

Inspectors found serious system-wide failures in the governance and management of risk at the pharmacy and a lack of safeguarding which presents a risk to patient safety, the regulator said.

“Inspectors considered the volume and type of medicines supplied, the age range and potential vulnerability of the patients, and the additional risks of working with prescribers based in the EEA [European Economic Area] and working outside UK regulatory oversight,” the GPC said.

The GPC issued an improvement notice requiring multiple changes to be made by the pharmacy, including to assess risks to patients from its services and to update its safeguarding procedures.

Clear Chemist’s arrangement for dispensing online prescriptions issued from an overseas clinic appeared to take advantage of a loophole that allows prescriptions for certain medicines written in a country within the EEA or Switzerland to be dispensed in Britain.

But guidelines from the GPC last year said pharmacies must not work with online providers who are trying to circumvent the regulatory oversight in place within the UK.

Children treated for gender dysphoria within the NHS must be referred by their GP, have a telephone assessment and between three and six therapy sessions, as well as two sessions with an endocrinology team before they can proceed. The NHS guidelines are being reviewed.

Duncan Rudkin, chief executive of the GPC, said: “We know that people receiving medicines from Clear Chemist have been concerned about how our actions may affect them.

“We want to reassure everyone that we have not asked the pharmacy to stop supplying medicines to patients undergoing treatment for gender dysphoria. We have directed the pharmacy to make improvements to make sure that people receive medicines that are safe and effective for them.

“Our inspectors will continue to work with the superintendent pharmacist to make the improvements needed and to support continuity of care for the pharmacy’s patients.”

Clear Chemist, owned by RB Healthcare, told The Times earlier this month that it sought to ensure that patients gave consent to notify their GP about their private treatment. It said it wrote to patients’ doctors as an additional safeguard, saying GPs could contact the company if they had concerns about treatment.