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PJ Online homeHospital Pharmacist
Vol 12 No 2 p46
February 2005

Hospital Pharmacist back issues

News summary


Patients to report suspected ADRs

Yello card scheme

Yellow card scheme is to be extended to patients, with wider access to data for independent researchers as well

Patients, along with parents or carers of patients, are now able to report suspected adverse drug reactions (ADRs) directly to the Medicines and Healthcare products Regulatory Agency. This is one of the changes introduced in response to recommendations made in the MHRA’s “Report of the independent review of access to the yellow card scheme”. Patients can submit information online (www.yellowcard.gov.uk) or on forms that have been made available at 4,000 GP surgeries across the UK.

Anthony Cox, ADR pharmacist at Sandwell and West Birmingham Hospitals NHS Trust said: “Public access to the scheme’s data is indicative of the general move towards transparency in society.” He pointed out, however, that people should be aware of the limitations of the data held by the MHRA. Mr Cox continued: “Patient reporting of ADRs will allow individual patients to play their role in drug safety, and also give a real opportunity to evaluate the usefulness of such reports … Reports from health professionals will continue to be of the utmost importance to drug safety in the UK, and the start of patient reporting does not reduce the professional responsibility on pharmacists, nursing staff and doctors to report to the scheme any qualifying reactions they observe.”

Other changes to the yellow card scheme announced include wider access to data. Anonymised data about suspected ADRs will be published on the MHRA website and will therefore be available to the general public. Researchers will be able to access more detailed data. Safeguards will be in place, with each request to do so being reviewed by an independent committee, to make sure that it is ethically and scientifically sound and protects patient confidentiality.

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