During the week beginning 7th November, the Medicines and Healthcare products Regulatory Agency (MHRA) is running a social media campaign to promote the reporting of suspected side effects. This initiative is part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. One of its main aims is to raise awareness of national reporting systems for suspected side effects in medicines. Over 20 member states are taking part in the combined cross-European social media campaign.
All medicines have the potential to cause side effects. The reporting of adverse reactions is vital to ensure the associated risks of medicines are identified and understood. Regulatory authorities and pharmaceutical companies rely on the reporting of suspected side effects to make sure medicines on the market are as safe as possible and that they carry the most up-to-date safety information. Unfortunately, all adverse reaction reporting systems suffer from a level of underreporting. Hence, the MHRA campaign is important as a reminder of reporting obligations, raising awareness and helping strengthen the existing system.
At the centre of the campaign is an animation showing the story of a patient who has a suspected adverse reaction. It shows the medicine being taken, a suspected side effect being experienced, how reports are made by patients or healthcare professionals to the medicines regulator, and how this benefits future patients.
Over the years, reporting has contributed to a number of product withdrawals where it was determined that the risks outweighed the benefits, improved product labelling, e.g., the warning that patients taking warfarin should limit or avoid drinking cranberry juice, and, in many EU countries, the advice not to prescribe aspirin to children virtually eliminated cases of Reye’s syndrome, a serious and often fatal condition that causes swelling in the liver and brain.
Mick Foy, group manager for MHRA’s Vigilance and Risk Management of Medicines division said:
“Our campaign will help the public, patients and healthcare professionals report potential side effects and have confidence that their reports are making a difference.
“You can help make medicines safer by reporting any suspected side effects easily and quickly through our Yellow Card Scheme online or via the mobile app.”
The Yellow Card Scheme was originally set up in 1964 after the thalidomide disaster to collect information on suspected adverse drug reactions (ADRs) to medicines. The Yellow Card Scheme allows the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market. In May of this year, the MHRA extended The Yellow Card Scheme to cover safety concerns associated with e-cigarette products.
Thus, the Scheme collects information on suspected problems or incidents involving:
1. Side effects (also known as adverse drug reactions or ADRs)
2. Medical device adverse incidents
3. Defective medicines (those that are not of an acceptable quality)
4. Counterfeit or fake medicines or medical devices
5. Safety concerns for e-cigarettes or their refill containers (e-liquids)