Sales of over-the-counter products containing codeine in 31 countries, 2013-2019: a retrospective observational study

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Opioid prescribing trends have been well investigated in many countries. However, the patterns of opioids purchased over-the-counter (OTC) without a prescription are mostly unknown. Codeine is an opioid that is widely available OTC in many countries. We aimed to assess national sales and public expenditure of OTC codeine-containing products purchased in 31 countries between 2013 and 2019.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a retrospective observational study using electronic point-of-sale data from IQVIA. Countries included Argentina, Belgium, Brazil, Bulgaria, Canada, Croatia, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Japan, Latvia, Lithuania, Mexico, The Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, the UK, and the USA. We calculated the annual mean volume of sales per 1000 of the population and public expenditure (GBP, £ per 1000) between April 2013 and March 2019. We quantified changes over time and the types of products sold.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>31.5 billion units of codeine, costing £2.55 billion, were sold OTC in 31 countries between April 2013 and March 2019. Total sales increased by 3% (3025 units/1000 in 2013 to 3111 in 2019) and public expenditure doubled (£196/1000 in 2013 to £301 in 2019). Sales were not equally distributed across the 31 countries. South Africa accounted for the largest mean volume of sales (31 units/person), followed by Ireland (24 units/person), France (16 units/person), Latvia (15 units/person), and the UK (11 units/person). The types of products (n=569) and formulations (n=12) varied.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In many parts of the world, a substantial number of people may be purchasing and consuming codeine from OTC products. Clinicians should ask patients about their use of OTC products. Public health measures are required to identify and prevent codeine misuse and abuse, increase awareness and education about the harms of codeine, and review medicines legislation to improve the collection of such data.</jats:p></jats:sec><jats:sec><jats:title>Pre-registration</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://doi.org/10.17605/OSF.IO/AY4MC">https://doi.org/10.17605/OSF.IO/AY4MC</jats:ext-link></jats:p></jats:sec>