The Yellow Card Scheme is run by the MHRA and the Commission on Human Medicines (CHM), and is used to collect information from both health professionals and the general public on suspected side effects or ADRs to a medicine. Its continued success depends on the willingness of people to report suspected ADRs.
The Yellow Card scheme is used to collate reports from anyone from the UK on both licensed and unlicensed medicines including:
For new drugs (i.e. black triangle drugs) the MHRA want you to report ANY side effects you encounter. For more well established drugs, the MHRA only want to know whether the reaction is serious, these are reactions which are:
In addition, the MHRA has specific areas of interest which they ask all medical professionals dealing with medicines to keep in mind…
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.
Biologicals and vaccines
Please include in your report the brand name and batch number.
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.
The Yellow Card scheme is used to collate reports from anyone from the UK on both licensed and unlicensed medicines including:
- Prescription medicines
- Vaccines
- Over-the-counter (OTC) medicines
- Herbal remedies
- Swine flu medicines
For new drugs (i.e. black triangle drugs) the MHRA want you to report ANY side effects you encounter. For more well established drugs, the MHRA only want to know whether the reaction is serious, these are reactions which are:
- fatal
- life-threatening
- disabling
- incapacitating
- have resulted in, or prolonged, hospitalisation
- medically significant
- congenital abnormalities
In addition, the MHRA has specific areas of interest which they ask all medical professionals dealing with medicines to keep in mind…
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.
Biologicals and vaccines
Please include in your report the brand name and batch number.
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.
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