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Medicines and Healthcare Products Regulatory Agency: Standards

Volume 473: debated on Wednesday 12 March 2008

To ask the Secretary of State for Health (1) what recent steps the Government has taken to improve the reporting system of the Medicines and Healthcare Products Regulatory Agency; (192860)

(2) what recent steps the Government has taken to inform the public about unsafe medicines and medical equipment available on the market.

The Medicines and Healthcare products Regulatory Agency (MHRA) regularly publishes safety information on its website in relation to the safety of medicines and medical devices.

In August 2007, the MHRA launched a new monthly electronic bulletin, “Drug Safety Update”, which gives healthcare professionals the latest information and advice about medicines, including safety issues. The bulletin is available on the MHRA’s website at:

On 18 February 2008 the MHRA launched a new reporting form both on-line and in paper format to make it easier and more accessible for members of the public to report suspected adverse drug reactions (ADRs) to the Yellow Card Scheme. The online element allows important information to be entered directly onto the MHRA’s database. This is being publicised via a six week campaign in community pharmacies across the United Kingdom. The campaign aims to make members of the public aware of the potential for side effects to their medicines and inform them of what to do in such an event.

The MHRA’s Defective Medicine Report Centre also evaluates reports of defective or ineffective medicines and will take action to recall such products.

The MHRA has comprehensive systems in place to enable healthcare professionals, manufacturers and the public to report safety issues relating to medical devices. Reports can be made in writing, by telephone or electronically via the MHRA website. The online reporting system for healthcare professionals, patients and members of the public was launched in 2001.

In 2007 MHRA published a leaflet encouraging members of the public to report faulty medical equipment. These leaflets have been widely circulated in general practitioner surgeries and pharmacies.

The MHRA issues guidance to all national health service trusts at the beginning of each year, reminding them of their obligation to report safety issues relating to medical devices and NHS trusts and primary care trusts in England have designated medical device liaison officers to encourage and train staff and users to report adverse incidents.

The MHRA has recently upgraded the website to improve systems for manufacturer reporting. The Manufacturers Online Reporting Environment (MORE) was launched by the agency in October 2003 and an improved version was launched in February 2008. It is a simple tool provided by the agency for medical device manufacturers and their authorised representatives to report medical device adverse incidents online.

In 2005 the MHRA was designated as the UK Competent Authority for the Blood Safety and Quality Directives. In November 2005 MHRA launched Serious Adverse Blood Reactions and Events, the online reporting system for Blood Establishments and Blood Banks to report all serious adverse blood reactions and events occurring in the UK.