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Patients are being signposted to an unregulated website where pre-exposure prophylaxis (PrEP) can be purchased with Bitcoin, in draft guidance published jointly by the British Association for Sexual Health and HIV and the British HIV Association.
The draft guidance, published in September 2024, is an update from guidelines issued in 2018 and was open for consultation until 26 November 2024.
The Royal Pharmaceutical Society (RPS) has voiced concerns around patient safety in its consultation response.
Under a section titled ‘Recommendations for buying generic PrEP online’, the guidance states: “Clinicians should signpost individuals to IWantPrEPnow, PrEPster or https://www.prep.global/getprep if they are unable or unwilling to access PrEP on the NHS. These sites offer support and advice and the ability to source [the] generic drug as safely as possible.”
However, in its consultation response, the RPS suggested a review of this section, noting that the suggested website “is not regulated by the [General Pharmaceutical Council], gives the option of purchasing PrEP via Bitcoin and the prescribing doctors section states that there are no updates to the website since 2019”.
“We are concerned for patient safety with this recommendation and would not want to set a precedent for patients buying [prescription-only] medication online,” it added.
“In addition, the quality of online purchased medicines can be highly variable and the presence of carcinogens and active product cannot be assured.”
In 2018, the guidance also recommended that “clinicians should signpost to IWantPrEPnow if they are unable to access PrEP on the NHS, as this site at least offers support and advice and the ability to source [the] generic drug as safely as possible”. At the time, the guidelines were accredited by the National Institute for Health and Care Excellence.
Analysis by The Pharmaceutical Journal of ‘Prevention of future deaths’ reports in 2023 revealed that coroners had raised concerns with government bodies 20 times over the regulation of the supply of drugs online since 2013.
The concerns included that many dangerous drugs are “freely marketed” online, with “no regulation” in their supply, with two coroners warning that the lives of vulnerable people are specifically at risk as “no protection is afforded” to them prior to making drug purchases online
The draft HIV guidance also says that community pharmacies could support greater equity around access to PrEP.
Under ‘Recommendations for PrEP Equity’, it states that “with clear governance connections to specialist level 3 GUM [genitourinary medicine] services, PrEP provision should be expanded, with evaluation, to settings outside of specialist sexual health services, including but not limited to, online services, in community pharmacies”.
The guidance adds that “local pharmacy collection services can also help to address geographical isolation”.
In its consultation response, the RPS said “we welcome the expansion of HIV PrEP eligibility”, and that PrEP should be available to collect from community pharmacies.
However, it criticised a guideline advising that children aged under 18 years should be treated with tenofovir alafenamide fumarate-emtricitabine (TAF/FTC).
“This is not a prophylactic option on the BNFc [British National Formulary for Children], which states to use TD-FTC [tenofovir disoproxil-emtricitabine]. The BNFc says that TAF/FTC is indicated for treatment not prophylaxis,” it said.
In February 2024, a government-commissioned report from the HIV Action Plan Implementation Steering Group recommended that “national health bodies, in partnership with local commissioners, should commission a series of pilots providing PrEP in a variety of settings outside specialist sexual health clinics”, including pharmacies.
However, the report said it was “concerning that the current proposal for PrEP pilots is marked as ‘possible future opportunities’, describes a single pharmacy pilot and does not include primary care”, adding that “PrEP pilots beyond sexual health services must be tailored to local need and capacity”.
