Advertising of Over-the-Counter Codeine-Containing Medicines in the EU: Differences in the Regulation of Advertising Between Member States

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The availability of over-the-counter (OTC) medicines containing codeine has generated worldwide debate with increased focus on its safe use. Medicine agencies across the European Union (EU) have responded to the public health concern by placing restrictions and warnings on codeine medicines sold OTC in High Street and internet pharmacies. These restrictions include direct-to-consumer advertising; however, there are few published studies examining conditions of advertising across member states. A review of the conditions of advertising was conducted by accessing information pertaining to each medicine’s regulatory agency allowing the sale of codeine in the EU. Each agency was asked to respond to three topics: (1) level and type of restrictions placed on all forms of direct-to-consumer advertising of OTC medicines containing codeine; (2) labelling criteria on packaging including indication related to the risk of addiction and any other patient information specific to codeine; and (3) complaints received by the medicines agency related to direct consumer advertising of OTC medicines containing codeine. Data were collated and tabulated in Excel to demonstrate its position on OTC codeine advertising. In the EU, 12 countries allow the sale of OTC codeine, while 16 do not. Of the 12 countries permitting its sale OTC, 4 countries prohibited direct-to-consumer advertising of codeine. The majority of the countries permitting advertisements did not have any additional or special restrictions or warnings for codeine-containing products with the exception of the UK where advertising codeine was only permitted under certain restrictions including product endorsement and special warnings including its indication of use for a maximum of 3 days. There is wide disparity in advertising of OTC codeine in the EU. Safeguards for OTC codeine use are likely to continue to remain a priority in the interest of public safety.