title: 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.
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, Netherlands.
authors.forename: Marjolein J M
authors.initials: MJ
authors.lastname: Vranken
authors.affiliation: Lisman Legal Life sciences, Nieuwerbrug, Netherlands.
authors.forename: John A
authors.initials: JA
authors.lastname: Lisman
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, Netherlands. Electronic address: A.K.Mantel@uu.nl.
authors.forename: Aukje K
authors.initials: AK
authors.lastname: Mantel-Teeuwisse
authors.affiliation: Institute of General Practice, Hannover Medical School, Hannover, Germany.
authors.forename: Saskia
authors.initials: S
authors.lastname: Jünger
authors.affiliation: Willem Scholten, Willem Scholten Consultancy, Lopik, Netherlands.
authors.forename: Willem
authors.initials: W
authors.lastname: Scholten
authors.affiliation: Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany; Centre for Palliative Care, Malteser Hospital Bonn, Bonn, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Radbruch
authors.affiliation: International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, UK.
authors.forename: Sheila
authors.initials: S
authors.lastname: Payne
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, Netherlands; Schutjens de Bruin, Tilburg, Netherlands.
authors.forename: Marie-Hélène D B
authors.initials: MH
authors.lastname: Schutjens
mesh_terms: D000701:Analgesics, Opioid; D061891:Controlled Substances; D003535:Cyprus; D005061:Europe, Eastern; D006115:Greece; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D009369:Neoplasms / Q000150:complications*; D009293:Opioid-Related Disorders / Q000517:prevention & control; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D017410:Practice Guidelines as Topic; D063487:Prescription Drug Misuse / Q000331:legislation & jurisprudence* / Q000517:prevention & control; D014421:Turkey; D014944:World Health Organization
chemical_list: D000701:Analgesics, Opioid; D061891:Controlled Substances