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Adverse drug reactions - Management
Additional information
- For information on how to decide whether a person could be experiencing a suspected adverse drug reaction (ADR), see Assessment.
- The Medicines and Healthcare product Regulatory Agency (MHRA, www.mhra.gov.uk) collects Yellow Card reports from both health professionals and members of the public on:
- Prescription medicines
- Herbal remedies
- Over the counter (OTC) medicines (available on sale from pharmacies only)
- Unlicensed medicines in cosmetic treatments
- The MHRA is particularly interested in receiving ADR reports (via the Yellow Card scheme — www.yellowcard.gov.uk) from health care professionals on the following:
- Adverse reactions in children:
- Very little is known about the safe use of medicines in children because they are generally not exposed to medicines in clinical trials.
- In addition, many drugs that are routinely used to treat children are not licensed for use in this age group.
- Adverse reactions in elderly people:
- Elderly people may be more susceptible to developing reactions because they may metabolize or excrete medicines less effectively and may be more sensitive to their effects.
- Black Triangle products:
- These are new drugs and vaccines that are being intensively monitored to confirm their risk/benefit profile. In addition, they also cover new combinations of drugs, new routes of administration for established drugs and established drugs with significant new indications.
- These drugs are marked with an inverted Black Triangle in the British National Formulary (BNF) and also in the Summaries of Product Characteristics (SPCs).
- The MHRA and the Commission on Human Medicines are interested in all reports of suspected adverse reaction associated with these products. This is to confirm the risk/benefit profile established during the pre-marketing phase as well to increase understanding of the safety profile of these new medicines. In addition, previously unrecognized adverse effects will be identified as quickly as possible.
- There is no standard time for a product to retain Black Triangle status. However, an assessment is usually made following two years of post-marketing experience and the Black Triangle symbol is not removed until the safety of the drug is well established.
- The list of Black Triangle drugs are updated monthly and can found on the MHRA website.
- Serious reactions with established medicines:
- These include reactions that are fatal, life threatening, disabling, or incapacitating; those that result in hospitalization, increased duration of hospitalization, or congenital abnormalities; and those that are medically significant.
- Serious reactions differ from severe reactions.
- A severe reaction might not be life threatening or disabling, but in the individual patient, it is extreme. An example would be a headache, which would not normally be considered serious but may be very severe.
- A comprehensive list of serious reactions can be found on the MHRA website.
- Established drugs and vaccines no longer require intensive monitoring because the safety of the products has been well established. However, previously unrecognized adverse effects, in particular rare or delayed effects, may still be identified when a medicine has been available for many years.
- Delayed drug effects:
- These reactions may appear months or years after exposure (e.g. cancers or retroperitoneal fibrosis).
- These adverse reactions are not likely to be identified in short-term clinical studies and may become apparent only after extensive and long-term use of the drug.
- Report any suspicion of such an association.
- Congenital anomalies:
- Information on these adverse reactions is very limited, given that clinical trials do not generally involve pregnant women.
- Report to the MHRA instances of babies born with a congenital abnormality and pregnancies that result in a malformed aborted fetus if a drug is thought to be implicated. Include information about any medicine taken during the pregnancy, including self medication.
- Herbal remedies:
- Although some herbal medicines are licensed for use, many unlicensed herbal remedies available from outlets other than pharmacies or are supplied by herbal practitioners.
- It is important for the MHRA to monitor all herbal products to ensure their safety. For example, Yellow Card reporting identified hepatotoxicity associated with Kava-Kava which resulted in its supply being prohibited in the UK in 2003 [Independent Steering Committee, 2004].
- Include as much information as possible about the herbal remedy, including its ingredients, source or supplier (if known), and what the product was being used for. If the remedy was supplied by a herbal practitioner, try to obtain their name and address.
- Consider retaining a sample of the product if the reaction is severe, in case the MHRA needs to investigate further.
- Reports from the general public:
- The MHRA is especially interested in any suspected adverse reactions that are:
- Not mentioned in the patient information leaflet.
- Have caused problems serious enough to interfere with everyday activities.
- Further information on reporting suspected adverse drug reactions can be found online for health care professionals and members of the public or via www.yellowcard.gov.uk.
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