Yellow Card reporting for healthcare professionals

Black Triangle drugs and vaccines
Please report all suspected ADRs to drugs marked with an inverted black triangle (▼) (i.e. new drugs on the market). The list of medicines under additional monitoring gives details of all black triangle drugs.

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

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

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

• Adverse reactions in children
  We ask you to be particularly alert for suspected ADRs in children, and to report them according to the guidelines. 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
  The MHRA 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 the MHRA 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 to 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 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.

Please note that you can also report suspected ADRs that arise as a result of error, misuse, abuse or off-label use.

There are four methods for reporting a suspected adverse drug reactions (ADRs) to the Yellow Card scheme.

1: Reporting online
It is easiest and quickest to report ADRs online at http://www.mhra.gov.uk/yellowcard

Full instructions are given on the website. If you chose to register, you can also keep track of any Yellow Cards that you send.

The new dedicated COVID-19 reporting website should be used to report any suspected side effects from medicines, vaccines or medical devices relating to COVID-19 treatment and prevention.

2: Yellow Card mobile app
You can receive news updates from the MHRA and report side effects to medicines via the Yellow Card app. Please download it from the Apple App Store or Google Play Store.

Key features of the app include the ability to create a ‘watch list’ of medications for which you can receive news and alerts from the MHRA. You can view numbers of Yellow Cards reported to the MHRA for medicines of interest and see previous Yellow Cards you have submitted through the app.

At the moment account details are not synchronised between this website and the app, so you need to create separate accounts. The MHRA are also considering ways to report medical device adverse incidents, defective medicines and counterfeit products through the app.

3: Reporting directly from clinical systems
Electronic Yellow Card reporting is available in the Medicines Information system, MiDatabank, used by Medicines Information pharmacist throughout the UK.

Health professionals using the clinical systems SystmOne and Vision can also transmit Yellow Cards to the MHRA directly from the software.

4: Reporting by post
Yellow Card forms are available:

• by downloading a Healthcare professional Yellow Card form to print out
• by writing to: FREEPOST YELLOW CARD (no other address details necessary)
• by emailing: yellowcard@mhra.gov.uk

There are four critical pieces of information required for a Yellow Card report:

1: Suspect drug(s)
The name of the drug(s) suspected to have caused the reaction. If known, it is helpful to have the following:

• route of administration
• daily dose, dose frequency and schedule
• dates of administration
• if it is a vaccine, please quote brand and batch number

2: Suspect reaction(s)
Describe the suspected reaction(s) including a diagnosis if relevant. Include:

• when the reaction occurred
• seriousness of the reaction
• any treatment given
• outcome of reaction

If the reaction has already been reported (e.g. by another healthcare professional or the patient) but you have additional information to report, please submit a Yellow Card as duplicate reports will be detected and the information linked.

3: Patient details
Basic information about the patient is vital in assessing reports and obtaining further information. Please provide at least one of the following:

• Patient sex
• Patient age at the time of the reaction
• If known, please provide the patient’s weight
• Patient initials and a local identification number (hospital or practice reference number) to help you identify the patient in any future correspondence

Providing this information does not breach confidentiality agreements between you and your patient.

For the identification number, you can use any number or code that will identify the patient to you, but not to the MHRA. For instance, you could use the patient's local practice or hospital number or you may wish to set up a file specifically for Yellow Cards.

We consider that it is vital that a copy of the Yellow Card report is included on the patient's notes for future reference.

4: Reporter details
This field must be completed in all cases. Please include your name and full address so that the MHRA can acknowledge receipt of the report and follow up for further information if necessary.

Any additional information
We would be grateful for any additional information in the report that you think might be relevant such as:

• Other drugs taken in the last three months prior to the reaction, including over-the-counter (OTC) and herbal medicines
• Any information on re-challenge with the suspect drug(s)
• Relevant medical history, including allergies
• Relevant test results
• For congenital abnormalities, please state all other drugs taken during the pregnancy and the date of the last menstrual period
• Attach additional pages (including print-outs of test results) if necessary

If the patient was not taking any other drugs, or if no other information is available, please indicate this.

All the information that you provide helps to interpret the case and evaluate safety issues. Please provide as much relevant information as is readily available to reduce the need for follow-up. However, please do not delay reporting just because some details are not known. The MHRA will contact you if they require additional information.

Nature of reaction
Some clinical events are commonly caused by medicines. For example:

• acute dystonias
• blood dyscrasias
• skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis
• neuroleptic malignant syndrome.

When such conditions are seen, the possibility that they have been caused by a medicine should be considered.

Timing of reaction
The time period from when treatment with the medicine was started to when the reaction developed may be characteristic of the reaction. For example:

• anaphylaxis usually develops within a few minutes of parenteral drug administration
• some reactions develop months or years later and may be related to a cumulative effect of the drug or even have an effect on the next generation e.g. diethylstilbestrol and vaginal cancer.

Relationship to dose
Adverse reactions are often dose-related and may be minimised by reducing the dose of the medicine being taken. If the symptoms resolve when the medicine is stopped, this suggests that they are associated with the medicine, although the symptom resolution may be coincidental.

If the medicine is re-introduced and the symptoms recur, this strongly suggests that the medicine is responsible, although deliberate re-challenge with the drug may not be justifiable following serious adverse reactions.

Other possible causes
You may also need to consider other possible causes for the reactions being experienced. For instance:

• the reaction(s) may be a manifestations of the patient's underlying illness or another disease
• other medicines (including self-medication and herbal remedies) that the patient may be taking could be responsible for the reaction
• an interaction between two medicines may have caused the ADR
• for some reactions, specific investigations and test results may help in making a diagnosis, for instance, measuring plasma drug concentrations or performing a liver biopsy where drug-induced hepatitis is suspected.

By filling in a Yellow Card you are simply reporting your suspicion. The report will be looked at in the context of any other information that is available about that particular reaction, and can therefore add to our knowledge and understanding of the reaction.