Intended for healthcare professionals


Over the counter medicines: proceed with caution

BMJ 2008; 336 doi: (Published 27 March 2008) Cite this as: BMJ 2008;336:694
  1. Robin E Ferner, director1,
  2. Keith Beard, consultant physician2
  1. 1West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham B18 7QH
  2. 2Mansionhouse Unit, Victoria Infirmary, Glasgow G41 3DX
  1. Correspondence to: R E Ferner r.e.ferner{at}
  • Accepted 22 February 2008

Robin Ferner and Keith Beard caution that the risks of increasing people’s access to over the counter medicines may outweigh the benefits

An all party parliamentary group in England is currently assessing whether there is a case for banning over the counter access to analgesics containing weak opioids.1 Recent coroner’s inquests found that a 41 year old man died from respiratory depression after taking an over the counter analgesic containing paracetamol and dihydrocodeine2 and attributed the death of a 49 year old woman to renal failure from addiction to an over the counter preparation containing ibuprofen and codeine.3 Here we consider what determines whether a medicine is available over the counter and whether changes are needed.

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.

View this table:
Table 1

European and UK legislative controls on over-the-counter drugs

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 …

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