Introduction: Opioid prescribing trends have been investigated in many countries. However, the patterns of over-the-counter purchases of opioids without a prescription, such as codeine combinations, are mostly unknown. Objective: We aimed to assess national sales and expenditure of over-the-counter codeine-containing products purchased in 31 countries over six years. Methods: We conducted a retrospective observational study using electronic point-of-sales data from the human data science company, IQVIA, for 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 annual mean sales (units per 1000 of the population) and public expenditure (GBP per 1000) for each country between April 2013 and March 2019. We quantified changes over time and the types of products sold. Results: 31.5 billion units of codeine, costing 2.55 billion GBP, were sold over-the-counter 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 301/1000 in 2019). Sales were not equally distributed; South Africa sold the most (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) sold varied. Conclusion: In many parts of the world, substantial numbers of people may be purchasing and consuming codeine from over-the-counter products. Clinicians should ask patients about their use of over-the-counter products and public health measures are required to improve the collection of sales data and safety of such products. Study protocol pre-registration: https://doi.org/10.17605/OSF.IO/AY4MC

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