The Addiction readership may be interested in the developing discussion on the pressing need to respond to the challenge of dependence on prescribed medicines in Europe, as elsewhere. Dependence is a risk with medicines containing narcotic and psychotrophic substances, many of which are controlled by international, European and domestic provisions. A growing body of evidence on the impact in health and economic terms of misuse of and dependence on such medicines led the United Nations Office of Drugs and Crime (UNODC) to refer to it as ‘a global health concern’ 1. Later, in 2011, the Executive Office of the President of the USA referred to prescription drug abuse as an ‘epidemic’ 2. European data showed that in 2012, in 17 European Union (EU) countries, more than 10% of first-time treatment entrants were misusing an opioid other than heroin as their primary drug 3. The need to address systematically dependence on prescribed medicines is referenced in the European Drugs Strategy 2013–2020 4 and the EU Action Plan on Drugs 2013–2016 5, as a result of which policy bodies at the European level have begun to discuss their role in framing the response. Such a discussion has been brought about gradually. Addressing dependence on medicines raises a different set of challenges from dependence on illicitly obtained drugs, challenges to which most European policy bodies are only beginning to be exposed. Traditionally, criminal justice bodies were called upon to manage the increasing supply of illicit drugs through the black market and that affected the understanding of, and response to, dependence ensuing from them. Conversely, dependence on controlled medicines, available on prescription in health-care settings from physicians and other prescribers, brings a need to base a response within health-care institutions which are better equipped to manage it. Additionally, policy bodies are faced with a lack of solid data on the extent and characteristics of dependence on prescribed medicines. Such data as exist up to now point to a heterogeneity across Europe in terms of the types of medicines involved and in how dependence on them is understood. Lack of harmonized data across countries confuses the picture further and contributes to the gap in the understanding of which medicines are misused, how these are misused, by whom, why and how such a dependence can be addressed systematically. Drug dependence monitoring systems have not been able to address such questions: to date, they have tended to focus only on the diversion of methadone and buprenorphine prescribed as treatment for dependence, ‘allowing’ people dependent on prescribed opioids who do not use illicit drugs to fall through the cracks. European health-care systems are in need of an accurate picture of dependence on prescribed medicines that is based on consistent, harmonized data, produced by prescription monitoring systems, including pharmacoepidemiology, pharmacovigilance and illicit drug monitoring systems, and reported against shared indicators. This need is pressing; otherwise, there will continue to be a lack of shared, comparable indicators to inform detection, validation, evaluation, prioritization and evidence-based responses to growing signals of dependence on prescribed medicines. It is essential that in Europe, as elsewhere, a framework for monitoring misuse of medicines and any ensuing dependence is defined in cooperation with competent bodies in the fields of pharmaceutical use, misuse and dependence. This framework will help to ensure that policy and service delivery responses are appropriate and this will, in turn, support prescribers and policymakers in their task of ensuring the safe delivery of effective health care to all in need. G.F., C.G., T.G., J.McC. and E.S. have no conflicts of interest; M.L.K. is a member of the Advisory Board and Speaker for Reckitt Benckiser and a member of the Advisory Board and Speaker for BioDelivery Systems International.