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

Vranken, Marjolein J. M. and Lisman, John A. and Mantel-Teeuwisse, Aukje K and Jünger, Saskia and Scholten, Willem and Radbruch, Lukas and Payne, Sheila Alison and Schutjens, Marie-Hélène D. B. (2016) Barriers to access to opioid medicines : a review of national legislation and regulations of 11 central and eastern European countries. Lancet Oncology, 17 (1). e13-e22. ISSN 1470-2045

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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.

Item Type:
Journal Article
Journal or Publication Title:
Lancet Oncology
Additional Information:
This is the author’s version of a work that was accepted for publication in The Lancet Oncology. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in The Lancet Oncology, 17, 1, 2016 DOI: 10.1016/S1470-2045(15)00365-4
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?? oncology ??
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Deposited On:
09 Aug 2016 15:06
Last Modified:
10 Nov 2023 00:18