MHRA must engage more with public, say MPs
pharmafile | October 29, 2003 | News story | |Â Â Â
The MHRA has come under criticism from MPs over its efforts to communicate with the public and lead improvements in medicines safety.
The MHRA has a statutory duty to promote the safe and effective use of drugs, but the House of Commons Committee of Public Accounts (CPA) says the agency has failed to develop awareness among the public and doctors about its role.
The CPA's investigation was prompted by a National Audit Office report published in January, and backed its conclusion that important safety messages were not being communicated effectively between the Agency, doctors and patients.
"The Agency has been one of the leaders in its field internationally, but, at home, efforts to improve the reporting of adverse reactions by health professionals have had limited success", said the CPA.
"The quality of many information leaflets and labels, designed to alert patients and doctors to potential risks, is poor".
The Agency has admitted that patient information leaflets need to be improved but stressed that current practice was governed by EU law, with change still several years away.
New voluntary labelling guidelines have already been introduced in the UK this year in a bid to cut medication errors, but the MPs said the agency must do more to ensure industry compliance.
The pharmaceutical industry welcomed the CPA report, but said it was currently unable to provide more information for patients.
"We readily accept that more and better information could be provided to patients about medicines, but the fact is that the law prevents us from doing this", said ABPI Director General Dr Trevor Jones. "It is high time that patients were allowed to access good quality information about the medicines they have been prescribed".
The ABPI added that given the increasing range of activities undertaken by the MHRA, it may be "no longer appropriate" for the Agency be entirely funded by industry fees, though the Committee for the Safety of Medicines, which reviews marketing applications, is independent.
The MPs also concluded that the MHRA's Yellow Card system for collecting adverse drug reactions also needed to improve, though it was judged to have a "good record" in ensuring the safety of medicines licensed in the UK.
The MHRA's practices were most recently called into serious doubt by heavy criticism from mental health charity Mind, over an inquiry into Seroxat and other SSRI antidepressants.
It is estimated only between 10% and 25% of adverse events are currently reported by doctors through the Yellow Card scheme. Common reasons cited by doctors for failing to report include lack of time, inconvenience of the scheme and a belief that it is not their responsibility.
The scheme has now been made available to doctors on-line, and extended to nurses and patients through NHS Direct.
Both the MHRA and Department of Health have acknowledged the system needs to change, with suggestions that the importance of medicines safety should be incorporated into medical training with assistance from the Royal Colleges and universities.
The CPA also warned that warnings given to MHRA about prescribing habits that may lead to adverse reactions and drug interactions are not being passed on to doctors.
It cited the case of GlaxoSmithKline's smoking cessation therapy Zyban where the success of the MHRA's safety campaign on revised dosing was confirmed by monitoring prescribing habits as an example of good practice.
