FOI release

Freedom of Information request on the safety of sildenafil when supplied without medical prescription (FOI 21-389)

Published 28 June 2021

Thank you for your information request, dated 9th April 2021, where you asked for information regarding the safety of sildenafil when supplied without medical prescription. I am pleased to provide you with some of the information requested, see below. Unfortunately, some of the information is either not held or is exempt from release under section 21 – information accessible by other means and further explanation of this is provided below. The first sildenafil product licence approved in the UK with the legal category ‘Pharmacy’, was the product with brand name ‘Viagra Connect’. Medicines with the legal category ‘Pharmacy’ are supplied without prescription but only after discussion/consultation with the pharmacist. In order to support the safe provision of sildenafil as a Pharmacy medicine, additional risk minimisation measures were agreed with the marketing authorisation holder for Viagra Connect. These are available to view on the electronic Medicines Compendium website, at https://www.medicines.org.uk/emc/product/8725/rmms. The marketing authorisation holder agreed to conduct a survey-based study of pharmacists to assess the effectiveness of the additional risk minimisation measures. The study was titled “Survey of pharmacists to evaluate the effectiveness of the Viagra Connect national additional Risk Minimisation Measure (aRMM) in the United Kingdom (UK)”. The study has been included on the European Union electronic Register of Post-Authorisation Studies (EU PAS Register), a register of non-interventional post-authorisation studies. The study protocol and results are included on the register and can be found at: http://www.encepp.eu/encepp/viewResource.htm?id=32208. Unfortunately as this information is accessible by other means it is exempt from release under Section 21. The Act’s section 21 exemption states that there is no right of access to information via FOI if it is reasonably available to the applicant by another route. The marketing authorisation holder also agreed to conduct a survey-based study of patients receiving Viagra Connect, to assess the patients’ experience at the point of supply. However, the results of this study are not expected until the end of this year (i.e. are not held) and therefore cannot be provided. In addition, I have enclosed the Drug Analysis Print (DAP) for adverse reaction reports to the Yellow Card Scheme where sildenafil was the suspect drug and where the reporter has specified a brand name for a Pharmacy sildenafil product (i.e. either Viagra Connect or Aronix). No reports have been received with ‘Aronix’ specified as the suspect drug. Please see the accompanying sheet with explanatory information on the interpretation of DAPs. In addition, it is important to note that the provided DAP does not include any reports for Pharmacy sildenafil where the reporter has not specified the brand name. The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information. If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision. If you have a query about the information provided, please reply to this email. Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division