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Helping to make medicine safer for children
Whether for a minor ailment or a serious condition, medicines are taken by millions of people every year without any problems. However adverse drug reactions (ADRs) can sometimes be an unwanted part of any effective treatment. Reporting of suspected ADRs is an important element of the system to monitor drug safety. Medicines and Healthcare products Regulatory Agency (MHRA) Group Manager for Pharmacovigilance, Mick Foy discusses the importance of reporting through the Yellow Card Scheme and the MHRA’s current focus on increasing the reporting of ADRs in children.
Many NHS professionals know about the Yellow Card Scheme, the voluntary reporting Scheme run by the UK’s medicines watchdog, the MHRA. The Scheme acts as an early warning system receiving reports of ADRs from healthcare professionals and patients from medicines and vaccines. The MHRA rely on healthcare professionals to report ADRs and they are recognised as key contributors to the Scheme making up 83 per cent of the total reports received.
However, as for all such reporting systems, there is significant underreporting of ADRs with some studies estimating that between 10-15% of serious cases are reported. The level of underreporting varies depending on a number of factors including whether the medicine is new and carries the black triangle symbol. With increasing workloads and demands on NHS staff something that is voluntary can often be forgotten despite it being a professional responsibility.
Medicine for children
A key area of concern is the safety of medicines used in children where use continues to rise. A recent survey undertaken on behalf of the MHRA found that 59 per cent of parents have self-medicated their child and that 75 per cent of parents would ask a doctor for advice if their children had suffered an ADR. Although increasing numbers of medicines specifically have a licensed indication for use in children, many are still used ‘off-label’. All medicines must undergo extensive testing and clinical trials to ensure that they are safe and effective, but it is more challenging to undertake pre‑market testing of medicines in children as they are vulnerable with developmental, physiological and psychological differences from adults. This means the collection of ADRs for medicines used in children is especially important as, at the time of licensing, there may be limited information available.
Information on key groups
Reporting to the Yellow Card Scheme helps provide important information about ADRs in such key groups as children as well as the general population. Now in its 50th year, the scheme has demonstrated its value on numerous occasions since it started in 1964, when it was conceived in response to the Thalidomide tragedy.
More recently Yellow Card data helped inform changes in advice on how to use medicines containing codeine. The review of evidence available included Yellow Cards and data from pharmaceutical companies and resulted in restrictions in the use of these medicines for children due to an increased risk of overdose, breathing difficulties or misuse.
Yellow Cards from NHS staff can help the MHRA identify new adverse drug reactions and also refine the understanding of factors affecting the clinical management of patients. The MHRA uses Yellow Card data alongside other scientific information to effectively monitor the safety of medicines. All Yellow Cards submitted are treated in the strictest confidence and are not used for any audit or disciplinary purposes. An extra five minutes taken by you or one of your colleagues to complete a Yellow Card can help to make medicines safer for everyone, especially in children.
What to report?
For medicines and vaccines in children under 18 years old you should report any suspected ADRs even if the reaction is well recognised, you are strongly encouraged to report all: serious reactions (fatal, life-threatening, a congenital abnormality, disabling or incapacitating, resulting in hospitalisation, or medically significant). You should also report any severe reactions (resulting in harm to the patient or more extreme in nature), as well as reactions to black triangle medicines and vaccines, unlicensed medicines and herbal products. What’s more, professionals should report medication errors resulting in harm to a child (including abuse, misuse and overdose), and reactions considered unusual for any reason including those not listed in the product information of a medicine.
How to report?
There are two methods for reporting, online and by using a paper form. It is easiest to report online (www.yellowcard.mhra.gov.uk) and if you choose to register, you can also keep track of any Yellow Cards that you send.
If you want to report by paper, forms are available at the back of the: British National Formulary for children (BNF-C) or BNF, and Monthly Index of Medicine Specialties (MIMS). You can also email email@example.com.
Yellow Card reports are evaluated alongside other data to determine whether any regulatory action is required to allow medicines to be used more safely and effectively. This can include restrictions in use, reclassification, refinement of dosage instructions or the introduction of specific warnings of side-effects in product information.