Barriers to access to opioid medicines: a review of national legislation and regulations of 11 central and eastern European countries

Abstract

Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. Potential barriers were identified in all countries, ranging from 22 potential barriers (Cyprus) to 128 potential barriers (Lithuania). The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.

Trends in the consumption of opioids for the treatment of severe pain in Europe, 1990–2016

“…The lower availability of opioids in Southern and Eastern Europe, as in other areas of the world, can be attributed to several barriers, such as restrictive laws and governmental regulations, fears of possible addiction, lack of adequate training and awareness among healthcare professionals, limited economic resources and restricted formulary availability of opioids (Cherny, Baselga, de Conno, & Radbruch, ; Berterame et al., ; Vranken et al., ; O'Brien et al., ; Vranken et al., ; ESMO (Last accessed October, 5 2018)). Moreover, a recent investigation indicated that gross domestic product and human development index are the strongest determinants of access to opioid analgesics (Berterame et al., ).…”

The double opioid crisis: A call for balance

“…The issue is how to monitor and minimize potential unintended consequences for these patients. The Access to Opioid Medication in Europe (ATOME) project—aimed at the increase of access to opioid medicines in 12 countries with statistical evidence of low opioid consumption‐signaled clearly the importance of sustained investments in public health and education, and improved legal and regulatory systems to ensure safe and appropriate treatment of pain . Perhaps, one of the solutions for both crises lies in better education of health care professionals, patients and policymakers, in parallel with a more balanced view presented in the media.…”

Impact of Florida's prescription drug monitoring program and pill mill law on high‐risk patients: A comparative interrupted time series analysis

“…Many policies have been developed to address opioid‐related morbidity and mortality . In the United States, states have increasingly implemented prescription drug monitoring programs (PDMPs) and “pill mill” laws .…”