Black triangle (pharmacology)
Encyclopedia
Pharmacology
Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
(or vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
) indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.
Examples of how it might appear:
- NewDrugTradeName▼
- NewDrugTradeName▼
The black triangle also highlights the need for surveillance of any Adverse Drug Reactions
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
(ADRs) that might arise from the use of a new medication. The Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
(MHRA) encourage anyone to voluntarily report ADRs (however minor) via the Yellow Card Scheme
Yellow Card Scheme
The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
to gather more information and gain more understanding of a new medication.
After a new medicine (or vaccine) has been brought to the market there is still a lot that can be learned about the drug from its widespread use. Similarly, if an existing drug is being used in a situation where it was not used before or if it is being given by a different route of administration much can still be learned about its new or modified use.
The black triangle label generally stays with the new drug (or new use of an existing drug) for at least 2 years, when it is reviewed, and after this time the black triangle label may or may not be discontinued.