UK concern at SPC and "black-triangle" advice

A survey by the UK Drug and Therapeutics Bulletin has found weaknessesin the safety aspects of the Summary of Product Characteristics system and accompanying flaws in the Black Triangle Scheme, which it says could be putting patients at unnecessary risk. The study appears in the DTB's latest issue (vol 39, no 4), in which it calls for an urgent review of the current position, with remedies sought and solutions implemented.

European Union legislation requires an SPC to be made available for every licensed medicine marketed in a member state, while a black triangle printed next to the product's name in the UK indicates that the Medicines Control Agency is monitoring it closely to increase understanding of its safety and identify quickly any previously-unrecognized unwanted effects, notes the DTB. The MCA asks, but cannot require in law, that the black triangle be displayed on all product information and advertising for such drugs, it adds.

The Bulletin's study analysed SPCs available in the eMedicines Compendium (eMC; www.emc.vhn.net) for products on the March 2001 Committee on Safety of Medicines/MCA list of black-triangle drugs. This list numbered 159 such brand-name products, but the DTB could not find SPCs in the eMC for 54 of these. Of the 119 SPCs found for the 105 medicines represented, 29 (24%) did not display a black triangle, prompting the researchers to ask individual companies for, and check for black triangles on, printed copies of current SPCs for such medicines. Of the 163 SPCs obtained by the researchers in this way, for a total of 144 brand-name medicines, 44 (27%) did not display a black triangle.