Published: 19 November 2018

Publications

Help make medicines safer: report suspected side effects in children and during pregnancy

25 October 2018

Medsafe is pleased to be part of the third annual social media campaign to promote the importance of reporting suspected side effects from medicines.

Taking place from 19-23 November, the campaign forms part of an awareness week involving 32 medicines regulators, including those in the EU, Australia, Mexico and New Zealand. Regulators will jointly focus on raising reporting numbers for suspected side effects in infants and children, and during pregnancy, including when breastfeeding.

Any suspicions of an adverse reaction to a medicine should be reported to the Centre for Adverse Reactions Monitoring (CARM).

While medicines are safe and effective, side effects can happen. It is important the risks associated with all medicines are understood and communicated to healthcare professionals and their patients, including parents and carers, people planning for or expecting a baby.

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

Regulators such as Medsafe 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 the campaign is important to both raise awareness and help strengthen the system.

This year the United Nations’ Universal Children’s Day falls within the awareness week and both campaigns seek to promote international togetherness and improve children's welfare.

The campaign is supported by Uppsala Monitoring Centre, the World Health Organisation Collaborating Centre for International Drug Monitoring, who have developed the campaign animations to encourage reporting.

A number of organisations, including the European Medicines Agency, the European Commission and patient organisations such as EURORDIS, a non-governmental patient-driven alliance of patient organisations representing rare disease patient organisations in 70 countries, have also pledged their support.

Medsafe Group Manager Chris James 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 raise awareness with parents and carers, including expectant mothers and those planning to have a baby. It’s important for them and healthcare professionals to report potential side effects and have confidence their reports are making a difference.

“Children and infants can react differently to medicines than adults. It’s important for parents and carers to read the medicine’s consumer information leaflet and ensure they are giving the medicine in the right dose.

“Medicines you take while pregnant or breastfeeding can sometimes affect your baby. If you need to take medicine during pregnancy or breastfeeding, or if you are planning on having a baby, it’s essential you discuss your treatment, including any potential side effects, with your doctor or healthcare professional.

“Everyone can help make medicines safer by reporting any suspected side effects easily and quickly online to CARM.”

Ends

Notes:

1. To report a suspected side effect from a medicine, visit the Centre for Adverse Reactions Monitoring (CARM) .
2. Medicines regulators cannot give individual medical advice. If you are worried about your health or suspected side effects, talk to your doctor, pharmacist or nurse.
3. 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.
4. Data from adverse reaction reports sent to CARM is important and is used alongside other scientific safety information to help medicines regulators 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.
5. This campaign forms part of a wider social media campaign that is being taken forward through the Heads of Medicines Agencies Working Group for Communications Professionals and the International Coalition of Medicines Regulatory Authorities to raise awareness and encourage the reporting of suspected ADRs. In 2017, the second ADR awareness campaign resulted in an increase of 16% ADR reporting and 11% overall in EU.