UK MHRA mulls new incident reporting system

By Zachary Brennan

- Last updated on GMT

MHRA releases a new survey on the use of the current system
MHRA releases a new survey on the use of the current system
After nearly 50 years in use, UK’s MHRA is now looking into whether it should update and replace its system for reporting drug side effects to increase incident reporting and decrease confusion.

The downside of updating the current system is that because it’s well established, a significant portion of health professionals on the island already know how to use it.

The MHRA currently runs five reporting systems to collect reports of different types of incidents involving medicines, medical devices and blood and the idea would be to bring them all under the umbrella of the Yellow Card Scheme, which is currently how health professionals report adverse events from pharmaceuticals.

The MHRA currently enters the information from the Yellow Cards into a specialised database from which officials work on a weekly basis to identify potential hazards, and new information on recognised side effects. 

The cards may be the basis for MHRA contacting manufacturers on possible deficiencies if there are any trends when the data is compared with additional sources, such as medical literature, and data from a number of world-wide databases. The MHRA also puts out a monthly report on drug side effects.

New System

To make reporting simpler we are considering bringing all five systems together under the Yellow Card Scheme brand currently used for reporting side effects to medicines​,” the agency says.

In a questionnaire released earlier this week​ on whether to adopt a new system, the regulator asks health professionals about their understanding of the current system and the ways to report fake drugs, unknown side effects or other safety-related incidents.

The agency also asks how often the professional has reported certain types of events, what kind of an impact they think a new reporting system will have, and whether or not they would support a new system.

The survey will close on Oct. 9.

Related topics: Regulatory & Safety, Regulations, QA/QC

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