Posted by ed_uk on January 23, 2005, at 16:50:00
For the first time ever, patients in the UK can report drug side effects direct to the Medicines and Healthcare products Regulatory Agency (our 'FDA'). Side effects are reported on Yellow Cards. In addition, from now on, reported side effects will be published online.
From the Pharmaceutical Journal..........
Patients are now able to report suspected adverse drug reactions direct to the Medicines and Healthcare products Regulatory Agency, which will also publish anonymised data on suspected ADRs online, it was announced this week.Yellow card forms for patients are now available in 4,000 GP surgeries across the UK and can be ordered by telephone from the MHRA (020 7084 2000). Patients can also make reports online (www.yellowcard.gov.uk). The move has been welcomed but has led to a warning that patient reports should not replace those of pharmacists and other health care professionals.
In addition to being able to access the adverse drug reaction (ADR) data being published on the MHRA’s website, researchers will also be able to ask for access to more detailed reports. These requests will be reviewed by an independent committee to ensure that they are ethically and scientifically sound and that patient confidentiality is protected.
The changes, which come in response to recommendations made in the “Report of the independent review of access to the yellow card scheme”, have been welcomed. “The Association of the British Pharmaceutical Industry is fully supportive of the MHRA’s move to publish data on suspected adverse drug reactions,” an ABPI spokesman said.
Anthony Cox, adverse drug reaction pharmacist at Sandwell and West Birmingham Hospitals NHS Trust, said: “The opening up of the yellow card scheme data to expert independent researchers is welcome and may in future lead to valuable insights into drug safety.” However, he warned that patient reports should not replace those of health professionals. “Reports from health professionals will continue to be of the utmost importance to drug safety in the UK,” he said.
The MHRA working group responsible for patient reporting of ADRs is still in the process of designing the best systems to enable patients to report suspected ADR experiences, but expects to have final systems in place by 2006.
poster:ed_uk
thread:446344
URL: http://www.dr-bob.org/babble/20050119/msgs/446344.html