Over the counter medicines: proceed with caution

admin March 28th, 2008

Our director has an editorial in the BMJ this week on the subject of over the counter medication.

Both overuse and underuse of effective medicines can cause serious harms. The benefits of self treatment probably apply to only a small subset of medicines. There is little evidence in the UK that the current policy governing the change from prescription-only to over the counter medicines has exacerbated the harm of overuse. Although we can take heart from the fact that major disasters such as thalidomide have been avoided by stringent licensing regulations, the global outlook is rather more sombre. Much of the world has little or no effective regulation of medicines once licensed, and the internet makes these medicines, or counterfeit versions of them, available worldwide. The Royal Pharmaceutical Society proposes a “seal of approval” for legitimate internet pharmacies, but many people seem prepared to risk fake drugs, often for erectile dysfunction or obesity, rather than confide in a prescriber and present the prescription at a recognised pharmacy. The society’s initiative is unlikely to plug the internet loophole, and we face the uninviting prospect that medicines regulation will become ineffective everywhere.

The safety of over the counter medicines has to be continually reviewed, even though this is difficult in practice. Since healthcare professionals may not be involved, we have to rely on patients to report adverse effects. The UK regulatory agency’s new simplified yellow card system inviting patients to report adverse drug reactions could therefore be helpful. When safety concerns are raised regulators should investigate. Since efficacy is also important, regulators should ask for clearer evidence of benefit at the over the counter dose if this is lower than the dose usually prescribed. Given the concerns, it would be wise to avoid any wholesale rush to reclassify medicines. Whole communities might lose out in the long run if indiscriminate overuse of widely available medicines were to lead to large numbers of avoidable but irreversible adverse effects.

Also reported at the BBC.

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