FOI release

Freedom of Information request on prescriptions and ADR Data pertaining to Elmironin 2018-2020 (FOI-21-538)

Published 24 March 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-4-january-2021/freedom-of-information-request-on-prescriptions-and-adr-data-pertaining-to-elmironin-2018-2020-foi-21-538

Thank you for your email dated 08 December 2020, where you requested:

  1. How many patients were prescribed the drug Elmironin the UK between 01.01.2018 and 01.12.2020?
  2. How many cases of Elmironrelated eyesight defects were recorded in the same period?

It may be helpful if I firstly provide you some background information relating to the MHRA and the Yellow Card Scheme and the work we carry out. The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment are used safely and meet appropriate standards of safety, quality, performance and effectiveness. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM).

Unfortunately, prescription data falls outside the remit of work for the MHRA and we donot hold this information.While we do not hold the requested data, wecan refer you tohttps://www.nhsbsa.nhs.uk/prescription-data, where thedata may be held.

With regards to the number of cases of Elmiron and eyesight related defects, I can confirm that we do not haveany cases recorded in the period between 01.01.2018 and 01.12.2020.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division

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