Support Yellow Card: improve the safety of medicines in pregnancy and breastfeeding, and in babies and children

Reporting suspected adverse drug reactions to the Yellow Card Scheme helps to support the safe use of medicines in babies, children, and pregnant and breastfeeding women. Show your support for this year’s EU-wide ADR awareness week campaign from 19–23 November 2018, by sharing material on social media and discussing the importance of reporting suspected side effects with colleagues and parents and caregivers.

From:
Medicines and Healthcare products Regulatory Agency
Published
14 November 2018
Therapeutic area:
Obstetrics, gynaecology and fertility, Paediatrics and neonatology

What can healthcare professionals and their organisations do?

  • follow us on our social media channels and show your support for the importance of reporting suspected adverse drug reactions (ADRs) by retweeting, commenting, liking, and sharing material with your social media contacts. You can follow us via:

  • encourage dialogue between your colleagues and patients, parents, and caregivers about the importance of reporting suspected ADRs, particularly those that occur during pregnancy and breastfeeding or in infants and children

  • don’t delay in reporting any suspected ADRs to the Yellow Card Scheme or via the Yellow Card app (download from the Apple App Store or Google Play Store)

  • engage locally with your regional Yellow Card Centre or your local Medication Safety Officer (MSO) in England at your hospital trust

Reporting improves medicines safety

The MHRA continually reviews the safety of all medicines. Some adverse drug reactions can only be identified when medicines are used for a long time in a wide range of different people, so it is very important that suspected adverse drug reactions are reported to the Yellow Card Scheme.

Every report made by a healthcare professional or a patient or caregiver plays a critical role in understanding the benefits and risks of medicines in clinical use, allowing action to be taken to minimise risks. Reporting helps to improve the safety of medicines for all patients and, in some cases, can result in better tailored prescribing advice, which can help improve adherence to treatment.

Medicines in pregnancy and breastfeeding

Medicines should not typically be taken in pregnancy and during breastfeeding. However, some women will need to take medicines to protect their health and that of the baby.

When a medicine is licensed, there is often limited information on effects from use in pregnancy and breastfeeding. Therefore, information about any suspected adverse drug reactions in the mother or child is essential to improve understanding of a medicine’s effects and to ensure that healthcare professionals have the best available information on risks. For more about what key elements to include when reporting a suspected adverse drug reaction during pregnancy or breastfeeding, see article in Drug Safety Update, July 2018.

Risks in infants and children exposed to medicines during pregnancy have been identified with the help of healthcare professionals reporting to spontaneous reporting schemes like Yellow Card and to registries. One example of this is mycophenolate mofetil and risk of serious birth defects and spontaneous abortion.

Encourage women who are pregnant or breastfeeding, or who are planning a pregnancy, to talk to their healthcare professional about medicines they are taking. This includes any over-the-counter or herbal or complementary medicines.

It is very important that women who are pregnant do not stop taking prescribed medicines without talking to their doctor. Stopping some medicines suddenly can cause harm to mother and baby.

If a woman needs to take a medicine during pregnancy or breastfeeding, make sure they are fully aware of the benefits and risks of medicines they are taking, are provided with a patient information leaflet, and that they know how to report suspected side effects.

Medicines in babies and children

There has been an increase in the number of medicines licensed for use in children, including more complex medicines, as a result of EU legislation. Many medicines are also used off-label in children without evidence to support efficacy and safety, although there are many instances where there is sufficient clinical knowledge for such medicines to be used safely. Children can also react to medicines very differently from adults. Despite these factors, there is under-reporting of suspected ADRs in children.[footnote 1][footnote 2][footnote 3]

All healthcare professionals involved in the care of paediatric patients should not only report suspected ADRs including those associated with off-label use, but also encourage parents and caregivers to report suspected ADRs in their child – they know their child best and can raise concerns about medicines that might not be otherwise identified. The MHRA systems handle any duplicate reports so this need not be a deterrent. All Yellow Card reports are confidential.

Medicines for Children is a partnership that produces information for parents and caregivers about medicines their child may be using. A leaflet from this organisation is available to assist discussion with parents and caregivers about side effects in children and the importance of reporting to the Yellow Card Scheme.

All Yellow Card reports related to suspected medicines-related harms in children are analysed alongside other safety information to assess medicines safety. Safety issues in children that were identified, in part, from reporting of adverse drug reactions include:

About the Yellow Card Scheme

All healthcare professionals, parents, and caregivers can report any suspected adverse reactions to the Yellow Card Scheme to medicines including:

  • vaccines
  • blood factors and immunoglobulins
  • herbal medicines
  • homeopathic remedies

It is easy to report on the Yellow Card website or via the Yellow Card app. Download the app today via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices.

You can also use the app to access the latest safety information from the MHRA about medicines and medical devices on the Newsfeed. Search for medicines to see details of Yellow Card reports others have made. Medicines of interest can also be added to a Watch List to receive news and alerts about new side effects and safety advice as it emerges.

We also have dedicated guidance on the Yellow Card Scheme for healthcare professionals including accredited CPD e-learning modules.

About the EU-wide ADR campaign

Campaign material freely available for reuse includes a general animation about reporting and infographics, which are also available on the Yellow Card reporting website.

The reporting of suspected ADRs is the key to patient safety. This year’s campaign builds on the first and second award-winning EU wide campaigns, to help encourage greater local and national awareness about the importance of reporting to support the earlier detection of safety issues.

Article citation: Drug Safety Update volume 12, issue 4: November 2018: 4.

  1. Hawcutt DB, et al. Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis. Br J Clin Pharmacol 2016; 82: 1601–12. ↩

  2. Heeley E, et al. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 358: 1872–73. ↩

  3. Thiesen S, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children – a prospective observational cohort study of 6,601 admissions. BMC Med 2013; 11: 237. ↩

Updates to this page

Published 14 November 2018
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