In addition to a duty to report any serious adverse effect, times to be particularly vigilant include when a medicine has just been launched; when indications for use are changed – ie new patient groups are exposed to the medicine; special patient populations for whom experience of a medicine may be limited – e.g. children; new combinations with the treatment, with which unexpected drug interactions may occur.
The European Medicines Agency [EMA] notes these additional categories: “ it contains a new active substance authorised in the EU after 1 January 2011; it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), for which there is limited post-marketing experience; it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data); the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials.”
A Black Triangle logo has been used in the UK for many years “to signify medicines that are subject to intensive monitoring" [MHRA]. This inverted Black Triangle logo will now be used in all EU Member States, with a list of 'Black Triangle' medicines and vaccines agreed Europe-wide, the first version released in April 2013. The Black Triangle will start appearing in the package leaflets of medicines concerned from autumn 2013.
See more on the EMA website on the new European Union wide black triangle scheme for medicinal products and vaccines,
indicating that they should be subject to additional monitoring and reporting by health professionals and patients.