Healthcare professional reporting: What to report

Reporting
Please complete a Yellow Card if you have a suspicion that a drug has caused an adverse reaction. Do not delay reporting, even if you are in doubt about causality.

Please submit reports for the following:

- Black Triangle drugs and vaccines
Please report all suspected ADRs to drugs marked with an inverted black triangle (▼) (ie new drugs on the market).The Intensive monitoring list gives details of all black triangle drugs and is updated monthly.

- Established drugs and vaccines
For established drugs and vaccines (including over-the-counter and herbal medicines), report all suspected adverse reactions that you consider to be SERIOUS. They should be reported even if the effect is well recognised.

Serious reactions are those which are:

• fatal
• life-threatening
• disabling
• incapacitating
• have resulted in, or prolonged, hospitalisation
• medically significant
• congenital abnormalities
• examples of serious reactions

However, if you are unsure about the seriousness of a reaction please report it anyway.

Other areas of specific interest
Although we monitor adverse reactions associated with all medicines on the market, we have a number of areas in which we are particularly interested in receiving reports:

• Adverse reactions in children
  We ask you to report all suspected adverse reactions in children, even if they occurred with an established drug and regardless of whether or not the medicine is licensed for use in children. This is because the nature and course of illness and ADRs may differ between adults and children. In general, children are not exposed to medicines in clinical trials, therefore very little is known about the safe use of medicines in this group. Furthermore, many drugs which are routinely used to treat children are not actually licensed for their use, so it is particularly important to focus on their safety in children.
• Adverse reactions in elderly individuals
  We ask you to be particularly alert for suspected ADRs in elderly individuals, and to report them according to the guidelines. It is important to monitor the safety of medicines in this group, as older individuals may be more susceptible to developing reactions as they may metabolise medicines less effectively, and be more sensitive to their effects. For both pharmacokinetic and pharmacodynamic reasons, they may be more susceptible to developing reactions.
• Delayed drug effects
  We are interested in reports of ADRs which may appear months or even years after drug exposure, e.g. cancers, retroperitoneal fibrosis. We would like you to report any suspicion of such an association.
• Congenital anomalies
  If a baby is born with a congenital abnormality, or if a pregnancy results in a malformed aborted foetus, please consider whether this might have resulted from an adverse reaction to a medicine, and report it to us if appropriate. In the report, please give information about any medicine taken during the pregnancy, including self medication and the date of the last menstrual period.
• Herbal remedies
  There are many herbal remedies available over-the-counter from outlets other than pharmacies, or supplied by herbal practitioners, and only some of these are actually licensed for use. It is important that we monitor both licensed and unlicensed herbal products to ensure their safety; therefore we ask you to report suspected adverse reactions to any herbal remedy.

It is important that you provide us with as much information as possible about the remedy, including its ingredients, the source or supplier, if known, and the condition that the product was being used for. If the remedy was supplied by a herbal practitioner, it would be useful to receive their name and address. You should also retain a sample of the product if the reaction is severe, in case further investigations are required.

Reporting reminder