Do we have sufficient information to optimally inform regulatory or other policy decisions about medications containing codeine?

Codeine is the most commonly consumed opiate world-wide, with demand having risen 27% during the last decade and with global purchasing peaking at 269 tonnes in 2011 1. Although its effects are milder than heroin, its opiate effect means it has misuse and dependence potential 2. Codeine is formulated commonly in analgesic products with paracetamol or ibuprofen, and there are increasing reports of harms from these. Public health polices such as up-scheduling of over-the-counter (OTC) codeine, packaging addiction warnings and health professional education have been implemented, but these vary widely by country 3. South Africa has recently given notice of its intention to reduce the amount of codeine in a single tablet to 10 mg and to up-schedule norcodeine and acetylcodeine 4. Despite these concerns, and a perception that the misuse of products containing codeine is widespread and linked to trends of increasing patient self-care, the prevalence of codeine misuse and dependence is not known, and may be exacerbated by the hidden nature of misuse. Disproportionate attention to harms from opiates such as tramadol and oxycodone has unfortunately overshadowed the importance of harms associated with codeine misuse and dependence 5, and we argue that governments, health-care professionals and the public must respond appropriately to this. To address the lack of epidemiological data on codeine misuse and dependence, we obtained previously unreported formal drug treatment data involving codeine misuse and dependence from the UK National Drug Treatment Monitoring System (NDTMS), the Irish National Drug Treatment Reporting System (NDTRS) and the South African Community Epidemiology Network on Drug Use (SACENDU). We ascertained that 1.9% of people in drug treatment in Ireland (2008–12) had codeine as a primary or secondary drug of abuse compared to 2.2% in the United Kingdom (2013/14) and 2.5% in South Africa (2014). While the percentages are low, the denominators are substantial and this amounts to 4248 individuals in the United Kingdom and a stepped increase over time percentagewise from 1.47% in 2008/9 (and 2.07% in 2012/13). The treatment demand data, however, present only one side of the problem 6, and the European Union (EU)-funded CODEMISUSED Project, a 3-year multi-country study/exchange between academics and the pharmacy trade in the United Kingdom, Ireland and South Africa, which started in September 2013, aims to understand more clearly the nature and extent of codeine misuse and dependence. It will triangulate data from surveys of general practitioners, pharmacists, pharmacy customers, addiction treatment providers, individuals in treatment and internet codeine purchasers. An additional study planned in South Africa focuses on estimating the extent of codeine misuse at a population level through undertaking a national household survey in 2016 and using indirect estimation techniques. These studies and the resulting data will be used to inform policy decisions around optimally managing pain medication access, and suggest possible innovations to control codeine misuse through enhanced pharmacy surveillance, detection and assessment, patient information and adverse effects prevention. In the absence of good information, we urge caution in making regulatory or other policy responses that might reduce access to weaker OTC pain medications. The EU FP7 (Marie Curie) funding for the CODEMISUSED project required an exchange between sectors involving secondments of 2 months or longer. The two sectors are the academic sector (Waterford Institute of Technology, the South African MRC and King's College London) and the retail pharmacy sector (Cara Pharmacy in Ireland, Weldricks Pharmacy in the United Kingdom and The Local Choice Pharmacy in South Africa). Three of the authors (C.P., P.D. and M.C.v.H.) have all spent time on secondment with one or more of these pharmacy chains. While on secondment we have research, local travel and training costs covered by the hosting organizations (with the funding coming from the EU and clearly demarcated for specific expenses). We do not believe that this has influenced what we have written in the letter. For secondments of more than 9 months the salary for the secondees under the EU funding mechanism goes to the hosting organization, which pays the salary during the secondment period. This applies only to M.C.v.H., who has a long-term secondment to Cara Pharmacy in Ireland. Her salary comes from the EU but is paid to Cara Pharmacy, who pays it to M.C.v.H. We do not believe that this has influenced what we have written in the letter. We acknowledge the contributions of the UK NDTMS, the Irish NDTRS and SACENDU in providing data on treatment demand data relating to codeine. C.P., M.C.v.H. and P.D. were on secondment on thle CODEMISUSED Project during the writing of this letter, and acknowledge that project's funding from the European Community's Seventh Framework Programme FP7/2007-2013 under grant agreement number 611736.