Greater access to ADR data and Patient Reporting

admin January 18th, 2005

The MHRA have announced that Yellow Card data will now be publically available on their website.

Patients and researchers will be able to look at data on the safety of different medicines announced Health Minister, Lord Warner today. The move is part of a series of measures to further improve the drug side effect reporting system – theYellow Card Scheme, which is used by the medicines watchdog (MHRA) to monitor the safety of medicines in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) will publish anonymous data on suspected adverse drug reactions on their website. Researchers will also be able to access more detailed data and measures will be put in place to prevent potential abuse of the information. Every request will be reviewed by an independent commitee to make sure it is ethically and scientifically sound and protects patient confidentiality.

As well as this patient reports will now be accepted:

The first pilots of patients directly reporting unexpected effects of drugs to the regulator were also launched. Forms to report unexpected drug reactions will available in 4000 GP surgeries across the UK and patients will also be able to make reports online.

Links:
Drug analysis printouts (DAPs) - these data are up to January 2004

Patient reporting form

Patient reporting launched.

Questions and Answers. [PDF]

Response to consultation on Yellow Card Scheme. [PDF]

Yellow Card Scheme review. [PDF]

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