Current legislation

UK legislation to regulate the supply of medicines dates back 40 years. It stems from the disastrous consequences of prescribing the teratogenic drug thalidomide to pregnant women after inadequate safety checks.4 The ensuing inquiries led to the UK Medicines Act 19685 and European Economic Community Directive 65/65/EEC.6 Broadly, these divide medicines into classes that do or do not require prescription (table 1⇓). In Europe and the United States, a newly licensed medicine will usually be available only on prescription. In much of the developing world, however, licensed medicines are available without prescription.

Regulation by prescription is no guarantee of prudent use. For example, an especially virulent strain of methicillin resistant Staphylococcus aureus is now common in patients presenting to emergency rooms in the United States7—a probable consequence of widespread overuse of antibiotics—and the emergence of a resistant Streptococcus has led to calls to restrict the use of levofloxacin.8 Nevertheless, prescription only medicines are subject to a range of controls that are relaxed when medicines are made …