Advertising of Over-the-Counter Codeine-Containing Medicines in the EU: Differences in the Regulation of Advertising Between Member States
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.
AK was partly funded by the NIHR Collaboration for Leadership in Applied Health Research and Care South London. The views expressed are those of the author and not necessarily those of the NIHR. PD is supported by South London and Maudsley (SLaM) NHS Foundation Trust and by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) for Mental Health at King’s College London and SLaM’. The views expressed are those of the author and not necessarily of those organisations.
Compliance with Ethical Standards
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Conflicts of interest
MF, PK, AK and PD have no conflicts of interest to declare.
Ethical approval was not required for the study as this study met the criteria for service evaluation.
- 9.Evans C, Chalmers-Watson TA, Gearry RB. Combination NSAID-codeine preparations and gastrointestinal toxicity. 4 A summary of the original articles featured in this issue. N Zeal Med J. 2010;123(1324):92–3.Google Scholar
- 14.Weissman JS, Blumenthal D, Silk AJ, Newman M. Physicians report on patient encounters involving direct-to-consumer advertising. Health Affairs. 2004;23:292.Google Scholar
- 15.Limbu Y, Mukherjee A. Direct-to-consumer advertising: a review and agenda for future research. Thriving in a new world economy. Berlin: Springer; 2016. p. 177–80.Google Scholar
- 16.Southwell BG, Rupert DJ. Future challenges and opportunities in online prescription drug promotion research: Comment on “Trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters”. Int J Health Policy Manag. 2016;5(3):211–3. https://doi.org/10.15171/ijhpm.2016.05.CrossRefPubMedPubMedCentralGoogle Scholar
- 18.Cracknell C. Codeine now restricted to prescription only France: connexion France; 2017 [cited 2017 8th March]. https://www.connexionfrance.com/French-news/Codeine-now-restricted-to-prescription-only. Accessed 22 Mar 2018.