Patients to report drug side-effects to NHS
pharmafile | October 21, 2003 | News story | |
Patients will be able to report adverse reactions to medicines direct to the NHS from next year, the Government has revealed.
The plans are part of a radical overhaul of the Yellow Card scheme, which will also allow nurses to report side-effects from today.
The voluntary Yellow Card scheme, established in 1964 following the thalidomide tragedy, now allows nurses, midwives and health visitors along with GPs, pharmacists, hospital doctors, dentists and coroners to submit suspected adverse drug reactions to the MCA and the Committee on Safety of Medicines.
Also for the first time, health professionals will be able to send in reports to the Medicines Control Agency on-line, making reporting of adverse drug reactions quicker and easier.
"Today heralds a new era for a scheme which has been at the cornerstone of improving drug safety for nearly 40 years" ,said Health Minister Lord Hunt. "Just as nurses are the backbone of the NHS, so the reporting of adverse drug reaction has saved countless lives and improved our knowledge about how we use drugs for the benefit of all of us.
During the meningitis C immunisation scheme in 1999-2000, nurses were allowed to report suspected adverse reactions the vaccine. Lord Hunt said that this proved nurses could play a vital role in drug monitoring.
Patients will be able to report adverse reactions via NHS Direct and NHS Direct Online by the New Year.
"I want to see the new scheme rolled out across the country during 2003. NHS Direct plays a key role in the way patients access healthcare and it must be right that we use this point of access to be able to access information from patients," Lord Hunt said.
The updating of the Yellow Card scheme pre-empts plans to develop a European-wide database of suspected unexpected adverse reactions (SUSARs), as required by the European Clinical Trials Directive.
The system aims to co-ordinate the reporting and analysis of adverse reactions across EU member states and link to the central EUDRACT clinical trials database.
As part of its ongoing reform of pharmaceutical legislation, the European Parliament has recently adopted provisional plans for the "intense supervision" of undesirable side-effects. The goal is to facilitate the rapid withdrawal of any licensed product with a "negative benefit/risk balance". but exactly what measures will be taken to implement these plans has yet to be decided.
