Patients to report suspected ADRs

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. |