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Are package inserts really necessary?

Abstract

In the United States control of drugs is more rigid than it is here. All dosage forms of all drugs (except a few very old-established preparations such as digitalis) must be accompanied by a package insert. However the leaflets probably have as little influence as they do at present in Britain. In both countries, the present content of the leaflet is qualitatively similar: the chemistry, pharmacology, indications for use and dosage, the precautions and side effects are summarised. American manufacturers may have to deal more fully with adverse effects of their drugs than do British manufacturers who are under no legal obligation to do so, although the Association of the British Pharmaceutical Industry Code of Practice requires mention of unwanted effects. However the pharmacists of both countries often remove the package insert before they hand over the medication. Even if this practice were prohibited, it would still be a problem to provide leaflets to accompany medicines dispensed from bulk packs.

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