GPhC inspectors have forced a London-based online pharmacy to cease much of its business activity after “system-wide failures” were identified in the way it was producing and supplying its core range of products – sildenafil-based compound medicines marketed as a treatment for low libido in women. 

GPhC inspectors visited the Pimlico offices of She Can Health Ltd on May 23 this year, discovering serious and wide-ranging issues in how the company operates and failing the business on six of the regulator’s criteria for registered pharmacies.

The company’s business model involves issuing private prescriptions to female patients after an online questionnaire is completed and then preparing unlicensed topical medicines to order.

The questionnaire is used to exclude pregnant women and those with certain medical conditions. Three products were available at the time of the inspection, including one targeting women who had been diagnosed with genital herpes.

Supplies were “not made lawfully” as the prescribing pharmacist “did not produce a legally valid prescription”, the inspector found.

Lack of documentation

“The pharmacy had not conducted any external assays to assure itself of the quality or stability of the unlicensed medicines to inform its compounding techniques,” said the GPhC inspector, adding that it also sourced most of its raw ingredients from the US without having the necessary MHRA authorisation and that “key steps of preparation were not documented”.

The superintendent pharmacist – who had completed dermatology training and could not demonstrate competence to prescribe low libido treatments – based her prescribing decisions “solely on the questionnaire” and “could not recollect refusing to make a supply” since starting with the company.

“The pharmacy didn’t have a clear process for follow-up and monitoring, which was relevant given the medicine was unlicensed, and the efficacy and side-effects were largely unknown,” said the inspector. Company director Lisa Henderson claimed her clinical lead, a “women's sexual health expert”, had experience with similar sildenafil-based products while lliving in the United States.

GPhC slams brakes on business                                    .

On June 7 this year, the GPhC imposed conditions on She Can Health that place severe restrictions on its activities. The pharmacy must not supply medicines against private prescriptions, must not sell or supply any medicines without a marketing authorisation and must not provide a prescribing service of any kind.

Currently, the website lists one product for sale: a Low Libido Treatment Arousal Cream that is available on prescription and sells for £75. She Can Health’s accounts for the year to January 31 2023 show that it made a loss of almost £17,000.

Lisa Henderson has been approached for comment.