Drugs: Side Effects
Health
Written answers and statements, 5 November 2009
Jeremy Wright (Whip, Whips; Rugby & Kenilworth, Conservative)
To ask the Secretary of State for Health what information is available to GPs and pharmacists on the chemical composition of (a) generic and (b) branded drugs to enable risks of adverse reactions to be taken into account when prescribing.
Mike O'Brien (Minister of State (Health Services), Department of Health; North Warwickshire, Labour)
For both generic and branded medicines the composition, with respect to the primary active ingredient and any other ingredients which may have a pharmacological effect is declared on product labelling together with any appropriate warnings. The patient leaflet included in the packaging will also declare all ingredients in the composition and repeat any warnings necessary.
A full qualitative composition including all ingredients in the medicine is given in the patient leaflet and in the prescribers data sheet, otherwise know as a Summary of Product Characteristics, together with a description of any adverse reactions which have been observed with the medicine and others which may possibly occur. These reference documents for branded medicines are available in published compendia in book form and online.
Because generic medicines are licensed as therapeutically equivalent to the original branded versions then the risks of adverse reactions caused by the active ingredient should be the same.