A pharmacy in the midst of a General Pharmaceutical Council investigation says it disputes contents of an ‘improvement notice’ issued over patient safety concerns.
Clear Chemist in Aintree, Liverpool came under the pharmacy regulator’s scanner in early October amidst media reports that it dispensed medication, including puberty blockers and cross-sex hormones, using online prescriptions issued by an overseas clinic that is not subject to British regulatory requirements.
The GPC said in a statement on Wednesday (Oct 28) that it had issued an improvement notice requiring multiple changes to be made by Clear Chemist including to assess risks to patients from its services and to update its safeguarding procedures.
A spokesperson for Clear Chemist told Pharmacy Business today that the GPhC notice “contains a number of factual inaccuracies and erroneous assumptions.”
“We are increasingly concerned that it contains a number of factual inaccuracies and erroneous assumptions that have in our opinion incorrectly formed the foundation of this disputed document. The culmination of which could wrongly impact the transgender community, a community we remain proud to support.”
Following an investigation, the GPhC concluded that Clear Chemist was found “not to be meeting” some of the standards for its registered pharmacies to ensure safe and effective care for patients and the public.
However, the pharmacy said it was “premature” on the part of GPhC to have issued a press statement on the improvement notice when concerns were raised over its accuracy.
“We have written to the GPhC providing examples of these inaccuracies and evidence supporting our position that standards are being met; and explaining we feel it is a waste of the GPhC and the Court’s resources to challenge this through their prescribed route.”
It further said: “There is also the important fact that the GPhC has been aware for some time of the patients to which the pharmacy dispenses and has not raised any previous concerns about standards not being met – importantly nor has any patient or patients representative.
“Indeed, the GPhC carried out an inspection and gave the pharmacy a satisfactory rating.
“Our last inspection by the GPhC which clearly noted the activities of GenderGP, stated that Clear Chemist met all the necessary standards set out in its regulations. More importantly it clearly stated no remedial actions were needed.
“It is important to note the standards have not changed since this last inspection. We have made the GPhC aware we are taking legal advice on our current position as the improvement notice is subject to appeal.”
The GPC said during an inspection on Oct 5 its inspectors found that the pharmacy had failed to meet some of the standards to ensure safe and effective care for patients and the public.
It added that the GPhC inspectors found “serious system-wide failures in the governance and management of risk” to patient safety at Clear Chemist.
“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.
Clear Chemist, owned by RB Healthcare, reportedly arranged home deliveries of ‘life-changing’ medication for transgender children based on prescriptions from a Hong Kong-registered private company which operates out of Malaga in Spain called GenderGP.
Significantly, the owner of GenderGP was fined £12,000 in December 2018 for running an unlicensed transgender clinic in south Wales and suspended by the General Medical Council.
The GPhC stipulates that pharmacies do not work with online providers who are trying to circumvent the regulatory oversight put in place within the UK to ensure patient safety throughout the healthcare system.
Duncan Rudkin, chief executive of the GPhC, said: “… 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.”
Claire Bryce-Smith, director of Insight, Intelligence and Inspection at the GPhC, today told Pharmacy Business: “We recognise pharmacies and pharmacy professionals are facing significant pressures, but reporting and reflecting on patient safety incidents is vital to help improve patient safety.
“During pharmacy inspections our inspectors look for evidence that appropriate action has been taken in response to any concerns or incidents within the pharmacy.”