Subject: DOH:PATIENTS TO PLAY CENTRAL ROLE IN DRUG SAFETY DEPARTMENT OF HEALTH 2004/0163 4 May 2004 PATIENTS TO PLAY CENTRAL ROLE IN DRUG SAFETY For the first time patients will be able to directly report unexpected effects of drugs to the medicines watchdog, Lord Warner announced today. The Medicines Healthcare and products Regulatory Agency (MHRA) will pilot different methods of patient reporting, including using the internet and making forms available in GPs surgeries. The proposal is one of a series of recommendations made by experts reviewing the Yellow Card scheme, which were published today to coincide with the scheme's 40th anniversary. Each of the recommendations will be put out for consultation, with the exception of direct patient reporting which will be rolled out immediately. Lord Warner said: "Patients want and deserve to play their full part in making medicines safer. The Yellow Card System is recognised as of the best spontaneous reporting schemes for adverse drug reactions in the world. By introducing direct patient reporting we will improve the scheme even further. Systems will be set-up to allow patients to report any unexpected effects of their medication easily and quickly to the experts who monitor drug safety so that we can better protect public health". Chairman of the MHRA, Alasdair Breckenbridge said: "The Yellow Card Scheme has been the cornerstone of monitoring drug safety for 40 years. The data generated through the scheme can be used to further research and improve drug safety in the UK. These proposals will help to ensure that the full potential of this data is realised. I am grateful to Dr Jeremy Metters for carrying out this important piece of work which will help make sure that the scheme continues to identify potential issues of drug safety". The independent review, led by Dr Jeremy Metters, was set up last year to look at the implications of allowing greater access to Yellow Card data, as well as examining how better use could be made of the data itself. In addition to direct patient reporting, the expert group's recommendations include: Academics and researchers should be able to access Yellow Card data, providing their proposals are approved by scientific and ethics committee. MHRA should publish anonymous, aggregated data on the website on a regular basis. MHRA should further raise the awareness of health professionals about the importance of reporting adverse reactions. Notes to Editors: 1. The consultation document is available on the MHRA website www.mhra.gov.uk. Any comments should be sent to Kavita Chadda, MHRA, Market Towers, Nine Elms Lane, London by 28th July 2004. 2. The full report is published by the Stationary Office and is available online at www.tso.co.uk/bookshop. 3. Further details of the pilots, including where they will take place, will be released shortly. 4. The Yellow Card Scheme was set up in 1964 following the Thalidomide tragedy to provide a system for early detection of emerging drug safety hazards and the routine monitoring for all medicines in clinical use. Suspected adverse reactions to marketed medicinal products are reported to the Committee on Safety of Medicines (CSM)/MHRA, which are jointly responsible for running the scheme. Reports are primarily submitted voluntarily by GPs, hospital doctors, dentists, coroners, pharmacists and nurses. Reports are also received via the pharmaceutical industry, which has a statutory obligation to report suspected serious ADRs. 5. In July 2002 Health Minister Lord Warner announced the start of an independent review of the Medicines and Healthcare products Regulatory Agency's (MHRA's) drug side effect reporting system - the Yellow Card Scheme. 6. The CSM is an independent Committee of experts that advise Government on the safety, quality and effectiveness of medicines, including vaccines. It is also responsible for encouraging the collection and investigation of reports on suspected adverse reactions to medicines already on the market. The MHRA is the executive arm of the UK's Drug Licensing Authority and is responsible for all aspects of the regulation of medicines in the UK. 7. Media enquiries only to Vicky Wyatt on 020 7210 5656. [ENDS] -------------------------------------------------------------------- GNNREF: 94254 Issued by : DOH Press Office Contact : If you have any queries relating to this press release, please forward this e-mail to the Press Office e-mail address provided above, or alternatively contact the originating Press Office by telephone. (Media queries only) Please DO NOT attempt to reply to the sender of this e-mail. The sender is involved solely as a broadcasting agent and cannot process e-mailed queries. Any attached files with a .DOC extension should be read using a word processor capable of reading Word 97 files. If you believe that the originating body is sending you Word 2000 files that you are not yet capable of reading, ask them to save future files in an earlier version.