Sales of over-the-counter (OTC) codeine-containing products in 31 countries, 2013-2019

The prescribing of opioids has increased [1], but it is not known whether codeine-containing medicines sold over-the-counter (OTC) are following similar trends to prescribed opioids. Products containing codeine, an opioid related to morphine, have been associated with dependence, death, and collateral toxicity from combinations with paracetamol and ibuprofen [2,3]. However, access to granular data on OTC sales is limited. The full picture of the growing opioid problem will not be known until both prescription and OTC data on opioid sales are evaluated. Regulation of codeine-containing products varies across the world. In the UK, combination products called co-codamol, containing 8 mg of codeine (a low dose) and 500 mg of paracetamol, can be purchased without a prescription from pharmacies. However, 15 of the 28 European Union member countries do not allow codeine to be sold OTC [4]. More recently, Australia and Manitoba, Canada, changed the status of codeine-containing medicines to prescription-only [5,6]. Thus, there is building pressure to upregulate and restrict access to OTC codeine products. To the best of our knowledge, data on sales of OTC codeine medicines have not been described before. Thus, the aim of our repeat cross-sectional observational study is to describe national sales of over-the-counter (OTC) codeine-containing products purchased from pharmacies across 31 countries between 2013 and 2019. Our objectives are: 1. to determine the total volume (e.g. number of tablets) of OTC codeine-containing products purchased nationally each year, adjusted for population; 2. to determine the total public expenditure (converted to GBP, £ sterling as of 20/09/3019) of OTC codeine-containing products purchased nationally each year; and 3. to assess trends in volume and public expenditure nationally from 2013 to 2019.