Press release: Help make medicines safer by reporting suspected side effects: MHRA launches campaign

From 20-24 November, MHRA is running a social media campaign to promote recognition and reporting of suspected side effects from over-the-counter medicines, as part of an EU-wide awareness week.

While medicines are safe and effective, side effects can happen, even with over-the-counter medicines. It is important the risks associated with all medicines are understood and communicated to health professionals and patients.

Potential side effects may range from a headache or sore stomach, to flu-like symptoms or just ‘feeling a bit off’ and reporting these can help regulators monitor medicines on the market and take action as appropriate.

Regulators such as MHRA rely on the reporting of suspected side effects to make sure medicines on the market are acceptably safe. Unfortunately, all reporting systems suffer from under reporting – this is why our campaign is important to both raise awareness and help strengthen the system.

SCOPE ADR Campaign

Mick Foy, Group Manager for MHRA’s Vigilance and Risk Management of Medicines division, said

The most important part of our work is making sure the medicines you and your family take are effective and acceptably safe.

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 online through the Yellow Card Scheme.

The campaign 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.

Notes to Editor

1. National reporting systems for the collection of suspected adverse drug reactions (commonly known as side effects) have acted as early warning systems to help identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until reports were received by medicines regulators.

2. 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: CPRD, NIBSC and MHRA.

3. The public is advised that they should take prescription-only medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

4. To report a counterfeit medicine or device contact MHRA’s dedicated 24-hour hotline on 020 3080 6701, or email counterfeit@mhra.gov.uk, or write to: Counterfeits, The Intelligence Unit, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ.

5. To report a suspected side effect from an unlicensed medicine visit the Yellow Card Scheme

6. The SCOPE Joint Action project (scopejointaction.eu) social media campaign is being taken forward through the Heads of Medicines Agencies Working Group for Communications Professionals.