OREANDA-NEWS. July 15, 2015. Fifty years on from its inception, the Yellow Card Scheme is moving into the digital age through a free-access mobile app that was launched today by Life Sciences Minister, Mr George Freeman MP.

The Yellow Card Scheme was introduced by Sir Derrick Dunlop, Chair of the Committee on the Safety of Drugs, in the wake of the Thalidomide disaster in 1964. The aim was to monitor the safety of UK medicines and act as an early warning system to identify potential side-effects and adverse reactions.

The Medicines and Healthcare products Regulatory Agency (MHRA), which runs the scheme, collates and reviews reports of suspected adverse drug reactions on all licensed and unlicensed medicines and vaccines.

It includes those issued on prescription as well as those bought over the counter from a pharmacist or supermarket.

Yellow Cards are used alongside other scientific safety information to help MHRA make changes, if necessary, to the warnings given to people taking a medicine or vaccine, or to the way they are used, to minimise potential risks.

The new Yellow Card smartphone app supplements an existing one-stop website and is the only app that allows patients, carers and healthcare professionals to report side effects directly to the Yellow Card Scheme to help MHRA ensure they are acceptably safe for patients.

Users can select specific medicines or vaccines to track and receive news and alerts about them.

See George Freeman talk about the benefits of the new app.

See George Freeman talk about the benefits of the new app.

The app has been created in collaboration with the Innovative Medicines Initiative WEB-RADR project, a large-scale public-private partnership between the European Commission, national regulatory authorities, academia, small and medium sized enterprises and the European Federation of Pharmaceutical Industry Associations (EFPIA) that aims to boost biopharmaceutical innovation.

The key features can be used by patients, carers and healthcare professionals and:

  • provide a convenient alternative to using paper Yellow Card forms or the Yellow Card website
  • the app is free to use for everyone on iOS and Android
  • is easy to use for reporting side effects directly to the Yellow Card Scheme
  • enables users to:
    • create a ‘watch list’ of medications to receive official news and alerts on
    • view numbers of Yellow Cards received by MHRA for medicines of interest
    • see immediate response that shows Yellow Card has been accepted
    • submit updates to Yellow Cards already submitted
    • view previous Yellow Cards submitted through the app

Mick Foy, Group Director for MHRA’s Vigilance and Risk Management of medicines division said:

The contribution of patients, careers and healthcare professionals alike in reporting suspected side effects to the Yellow Card Scheme is vital. The evidence helps MHRA detect safety issues and take the necessary action to keep the public safe.

Moving Yellow Card onto a mobile app is a logical progression in this digital age, allowing us to build on the existing website to improve user engagement.

It offers some good functionality to access further safety information, and it will continue to evolve over the course of the WEB-RADR project based on user feedback.

Life Sciences Minister George Freeman MP commented:

The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century.

By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people’s health and support research in the NHS.

You can download the app from the iTunes App Store and Google Play for your IOS or Android device.

Background

  1. The Medicines and Healthcare Products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The agency consists of three centres: MHRA, the Clinical Practice Research Datalink (CPRD), and the National Institute for Biological Standards and Control (NIBSC)
  2. The Vigilance and Risk Management of Medicines Division of MHRA is responsible for monitoring the safety of all medicines on the UK market. The Commission on Human Medicines is responsible for the Yellow Card Scheme, which is run on the Commission’s behalf by MHRA.
  3. The Yellow Card Scheme is MHRA’s system of monitoring the safety of medicines in the UK and it acts as an early warning system to identify new and strengthen existing safety information about medicines. Yellow Cards are used alongside other scientific safety information to help MHRA to take action, if necessary, to make changes to the warnings given to people taking a medicine or review the way the medicine is used to maximise benefit and minimise the risk to the patient.
  4. Yellow Cards are processed rapidly, according to tight timelines set out in legislation, in order to ensure that data from the reports are available in for analysis as quickly as possible for inclusion in the single detection process.
  5. The Yellow Card Scheme has been in existence for five decades. Despite its limitations, which are common to all spontaneous reporting schemes, it has a proven track record in the identification of previously unrecognised safety hazards. The Scheme has undergone continual evaluation and development over the years, and this will continue to fulfil its central role in the UK pharmacovigilance in the changing climate in which it operates. At the same time it will continue to adhere to the key principles defined by Sir Derrick Dunlop at the inception of the scheme: spontaneity and speed, confidentiality and above all the commitment of health professionals and patients to report their suspicions in the interest of protecting public health.
  6. The development of the Yellow Card app has been supported by the EU/EFPIA Innovative Medicines Initiative ‘WEB-RADR’ Joint Undertaking, grant number 115632. Visit the Innovative Medicines Initiative website and or the WEB-RADR website for further info.