Updates from MHRA

New online Yellow Card app to report medicines and devices on the go

An online Yellow Card Scheme is now available to report all adverse incidents related to medical devices, including performance concerns for diagnostics, defective medicines and counterfeit products. The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding physicians and surgeons that prompt reporting makes medicines and devices safer and is part of a healthcare professional’s responsibility to improving patient safety.

Only a suspicion that a medicine or vaccine might have caused a suspected adverse drug reaction (ADR) or that a medical device is performing outside its expected characteristics is needed to complete a Yellow Card. The card can be completed online or through the Yellow Card app. The app can be downloaded for free from iTunes Yellow Card or PlayStore Yellow Card and it allows physicians and surgeons to create a ‘watch list’ of medications to receive official alerts on or view the number of Yellow Cards received by the MHRA for medicines of interest.

Breast and Cosmetic Implant Registry (BCIR)

The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding all providers of breast implant surgery about the importance of participating in the Breast and Cosmetic Implant Registry (BCIR). The registry, launched in October 2016 in response to the Keogh Review of the regulation of cosmetic interventions, captures details of all breast implant procedures completed in England by the NHS and private providers.

The BCIR will help monitoring the safety and performance of breast implants by supporting the identification of possible trends and complications relating to specific implants and it will allow patients to be traced in the event that implants ever need to be recalled and removed. The MHRA expects providers to educate patients on the importance and benefits of being included in the registry and seek their written consent to add their details.