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YELLOW CARD REPORTING SYSTEM

All drugs can cause side effects, also described as adverse events or adverse reactions. Some may not yet be known so it is essential that you report all adverse events that are reported to you. Advrse events include pregnancy in women using contraception. It is not necessary to be certain that an adverse reaction was caused by a drug – suspicion that it may be associated with the drug is sufficient. Report suspected adverse drug reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) by completing and sending a yellow card (at the back of BNF) or via http://yellowcard.mhra.gov.uk/

In 2015, the scheme was extended to include defective medicines (not of an acceptable quality) and counterfeit or fake medicines or medical devices. 

Black triangle drugs

Newly launched drugs are monitored intensively. They are denoted by an inverted black triangle, which appears on the Summary of Product Characteristics, prescribing information, patient information leaflet and all promotional material. Typically, a medicine will be assigned black triangle status for 5 years after they are licensed. Medicines removed from the list may be reinstated if new safety concerns emerge. A list of ‘black triangle’ medicines is available at www.mhra.gov.uk/blacktriangle.

  • For black triangle drugs (intensively monitored medicines) report any suspected reactions
  • In children (under 18 years) report all suspected adverse reactions, whether from established or newly launched medicines, and whether from licensed or ‘off-label’ use.
  • For established drugs (those without black-triangle status) there is no need to report well-known non-serious adverse effects e.g. constipation with opioid analgesics

If in doubt: report

Yellow Card Scheme http://yellowcard.mhra.gov.uk

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