Black triangle symbol (▼) in Patient Information Leaflets

[helvella]

The MHRA has issued the following which may be of interest to those here:

Black triangle symbol (▼) in Patient Information Leaflets

Article date: October 2013

For the first time, patients and the public will start to see information in Patient Information Leaflets about how to report suspected side effects via the Yellow Card Scheme.

The Yellow Card Scheme is a vital early-warning system, collecting information from healthcare professionals and the wider public to help monitor the safety of medicines. It helps us take action to make changes to the warnings for a medicine, or review the way a medicine is used to maximise benefit and minimise risk.

In the UK, the black triangle (▼) has been in place for many years to aid the monitoring of new medicines through encouraging the reporting of suspected adverse reactions; it has now been adopted for use in Europe (see Drug Safety Update May 2013). A list of black triangle medicines can be found at: mhra.gov.uk/blacktriangle.

For the first time, patients will start to see the black triangle (▼) in the Patient Information Leaflet for relevant medicines. The leaflet will explain that the medicine is subject to additional monitoring to allow quick identification of new safety information, and that patients can help by reporting any side effects.

Patients, parents, or carers may ask you questions about the black triangle (▼) symbol or reporting of side effects. Please encourage these enquirers to report any suspected side effects via the Yellow Card Scheme, reiterating the guidance in the Patient Information Leaflet about potential side effects of the medicine (and what to do). It may be important to explain that: the symbol means that the medicine is being monitored particularly closely; this is generally because there is less information available about it compared with other medicines (eg, because it is new to the market or there is limited data on its long-term use); and that the symbol does not mean the medicine is unsafe.

Do not worry about duplicate reports if a Yellow Card is submitted by both a professional and a patient (or carer) for the same suspected adverse reaction. We are able to detect duplicate reports and use the combined information provided when assessing each case.

Remember that guidelines remain the same for healthcare professionals: any suspected adverse drug reaction can be reported on a Yellow Card. We are particularly interested in hearing about all those that are associated with black triangle (▼) medicines.

How to report

For healthcare professionals and the wider public alike, it is easiest and quickest to report online at

mhra.gov.uk/yellowcard

If you choose to register, you can also keep track of any Yellow Cards that you send.

mhra.gov.uk/Safetyinformati...

Rod

[Glynisrose]

Please remember that even if the medication is on general prescription and has been for years that you can still register side effects. Or even that the medication does not work for you,

[sarahstevenson]

Medicines information dept at our nearest city hospital have been really helpful and supportive too, as I have completed yellow card reports. Thanks Rod for posting.