HPRA concerns about patients sourcing PrEP meds online

HPRA concerns about patients sourcing PrEP meds online

Dr Fiona Lyons, National Clinical Lead for Sexual Health, has highlighted concerns expressed by the HPRA about patients sourcing pre-exposure prophylaxis (PrEP) medicines online and made recommendations for GPs.

Pre-exposure prophylaxis (PrEP) is the pre-emptive use of oral antiretroviral therapy (ART) in HIV negative people to reduce the risk of HIV infection. In July 2016, the European Medicines Agency (EMA) licensed TRUVADA® for use as PrEP in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults, making it the first medicine licensed for HIV prevention in Europe. TRUVADA® is a co-formulation of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC).

The HSE Sexual Health and Crisis Pregnancy Programme is currently developing recommendations around HIV PrEP in Ireland in line with implementation of the national sexual health strategy. TRUVADA® is currently being assessed by the National Centre for Pharmacoeconomics for the PrEP indication and it is likely to be a number of months before a decision around reimbursement is reached.

Clinicians and community representatives are aware that individuals are accessing generic PrEP preparations on line. Sourcing generic PrEP online is often referred to as "informal PrEP use". Within Irish law it is illegal to supply medicines via the internet and it is illegal for an individual to source prescription medicine without a prescription. This law is in place to protect the public from counterfeit and bogus meds. The Health Products Regulatory Authority (HPRA) works with customs and excise to intercept suspected medicines sourced over the internet. The HPRA are also aware of generic PrEP being sourced over the internet and have expressed concerns about medicines that have been seized in the recent past.

The HPRA is has expressed concerns about:

1) The authenticity of some of the websites that are listed on the iwantprepnow.co.uk website as suppliers of PrEP medication.

2) The origin and authenticity of a supply of the PrEP generic preparation Ricovir EM from Mylan which was seized by customs and excise in the recent past. They are working with Mylan to determine the legitimacy of the origin and supply of the medicine.

GPs might come across patients who are ordering these medications on line and we have been asked to raise awareness as follows:

If a patient discloses to a GP that they are sourcing PrEP online, you should:

• Highlight HPRA concerns about sourcing medicines over the internet and direct patients to the HPRA website for further information.
• Encourage the patient to attend STI services and continue to attend STI services for monitoring whilst taking PrEP.
• For patients who do not wish to attend STI services, HIV and STI testing should be performed at least once every three months. Guidance on monitoring patients taking PrEP is being developed.
• Reassure patients who are approached by the HPRA, if their PrEP is seized, that the HPRA is only interested in gaining information on suppliers to protect the public and is not seeking to take action against those who are sourcing medicines.