Pharmaceutical Medicine

, Volume 32, Issue 5, pp 327–333 | Cite as

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

  • Michelle FoleyEmail author
  • Peter Kelly
  • Paolo Deluca
  • Andreas Kimergård
Short Communication



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

Ethical approval was not required for the study as this study met the criteria for service evaluation.


  1. 1.
    Nielsen S, Cameron J, Pahoki S. Opportunities and challenges: over-the-counter codeine supply from the codeine consumer’s perspective. Int J Pharm Pract. 2013;21(3):161–8.CrossRefPubMedGoogle Scholar
  2. 2.
    Tobin CL, Dobbin M, McAvoy B. Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom. Aust N Z J Public Health. 2013;37(5):483–8.CrossRefPubMedGoogle Scholar
  3. 3.
    Cooper R. Surveillance and uncertainty: community pharmacy responses to over-the-counter medicine abuse. Health Soc Care Commun. 2013;21(3):254–62.CrossRefGoogle Scholar
  4. 4.
    Kimergård A, Foley M, Davey Z, Dunne J, Drummond C, Deluca P. Codeine use, dependence and help-seeking behaviour in the UK and Ireland: an online cross-sectional survey. QJM. 2017;110(9):559–64. Scholar
  5. 5.
    Casati A, Sedefov R, Pfeiffer-Gerschel T. Misuse of medicines in the European Union: a systematic review of the literature. Eur Addict Res. 2012;18(5):228–45.CrossRefPubMedGoogle Scholar
  6. 6.
    Fredheim OM, Skurtveit S, Moroz A, Breivik H, Borchgrevink PC. Prescription pattern of codeine for non-malignant pain: a pharmacoepidemiological study from the Norwegian Prescription Database. Acta Anaesthesiol Scand. 2009;53(5):627–33.CrossRefPubMedGoogle Scholar
  7. 7.
    Roussin A, Bouyssi A, Pouché L, Pourcel L, Lapeyre-Mestre M. Misuse and dependence on non-prescription codeine analgesics or sedative H1 antihistamines by adults: a cross-sectional investigation in France. PLoS One. 2013;8(10):e76499.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Bergin M, Norman I, Foley M, Harris R, Rapca A, Rich E, et al. Practice implications and recommendations for managing codeine misuse and dependence. Acta Pharmaceutica. 2015;65(4):351–64.CrossRefPubMedGoogle Scholar
  9. 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
  10. 10.
    Barreto S, Tiong L, Williams R, Source, Department of Surgery MH, Modbury, South Australia, Australia. Drug-induced acute pancreatitis in a cohort of 328 patients. A single-centre experience from Australia. JOP. 2011;12(6):581–5.PubMedGoogle Scholar
  11. 11.
    Ng J, Morgan D, Loh N, Gan S, Coleman P, Ong G, et al. Life-threatening hypokalaemia associated with ibuprofen-induced renal tubular acidosis. Med J Aust. 2011;194(6):313–6.PubMedGoogle Scholar
  12. 12.
    Foley M, Harris R, Rich E, Rapca A, Bergin M, Norman I, et al. The availability of over-the-counter codeine medicines across the European Union. Public Health. 2015;129(11):1465–70.CrossRefPubMedGoogle Scholar
  13. 13.
    Fanning J, Glover-Thomas N. Take this medicine: the legality of prescription incentive schemes. Med Law Rev. 2010;18(3):417–26.CrossRefPubMedGoogle Scholar
  14. 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. 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. 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. Scholar
  17. 17.
    Hayes AF, Krippendorff K. Answering the call for a standard reliability measure for coding data. Commun Methods Meas. 2007;1(1):77–89.CrossRefGoogle Scholar
  18. 18.
    Cracknell C. Codeine now restricted to prescription only France: connexion France; 2017 [cited 2017 8th March]. Accessed 22 Mar 2018.
  19. 19.
    McCarthy M. Companies to pay $39.5 m in oxycontin and risperdal cases. BMJ. 2015;351:h7018. CrossRefPubMedGoogle Scholar
  20. 20.
    Aikin KJ, Betts KR, O’Donoghue AC, Rupert DJ, Lee PK, Amoozegar JB, Southwell BG. Correction of overstatement and omission in direct-to-consumer prescription drug advertising. J Commun. 2015;65:596–618. Scholar
  21. 21.
    Webster RK, Weinman J, Rubin GJ. People’s understanding of verbal risk descriptors in patient information leaflets: a cross-sectional national survey of 18-to 65-year-olds in England. Drug Saf. 2017;40(8):743–54.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Nielsen S, MacDonald T, Johnson JL. Identifying and treating codeine dependence: a systematic review. Med J Aust. 2018;208(10):451–61.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.School of Health ScienceWaterford Institute of TechnologyWaterfordIreland
  2. 2.National Addiction Centre, Institute of Psychiatry, Psychology and NeuroscienceKing’s College LondonLondonUnited Kingdom

Personalised recommendations