title: Barriers to access to opioid medicines for patients with opioid dependence: a review of legislation and regulations in eleven central and eastern European countries.
abstract: OBJECTIVE
  Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify specific access barriers for patients with opioid dependence in legislation and regulations of 11 central and eastern European countries.
  
  
  METHODS
  This study builds on a previous analysis of legislation and regulations as part of the EU 7th Framework Access To Opioid Medication in Europe (ATOME) project. An in-depth analysis was undertaken to determine specific barriers for patients with opioid dependence in need of opioid analgesics or opioid agonist therapy (OAT). For each country, the number and nature of specific potential barriers for these patients were assessed according to eight categories: prescribing; dispensing; manufacturing; usage; trade and distribution; affordability; penalties; and other. An additional keyword search was conducted to minimize the omission of barriers. Barriers in an additional category, language, were recorded qualitatively. Countries included Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia and Turkey.
  
  
  RESULTS
  Ten of the 11 countries (all except Estonia) showed specific potential barriers in their legislation and regulations. The total number of barriers varied from two (Slovenia) to 46 (Lithuania); the number of categories varied from one (Slovenia) to five (Lithuania). Most specific potential barriers were shown in the categories 'prescribing', 'usage' and 'other'. The total number in a single category varied from one to 18 (Lithuania, prescribing). Individual differences between countries in the same specific potential barrier were shown; for example, variation in minimum age criteria for admission to OAT ranging from 15 (Lithuania, in special cases) to 20 years (Greece). All countries had stigmatizing language in their legislation.
  
  
  CONCLUSIONS
  Patients with opioid dependence are likely to experience specific barriers to accessing opioids in addition to those experienced by other non-dependent patients.
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
authors.forename: Marjolein J M
authors.initials: MJM
authors.lastname: Vranken
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
authors.forename: Aukje K
authors.initials: AK
authors.lastname: Mantel-Teeuwisse
authors.affiliation: Institute of General Practice, Hannover Medical School, Hannover, Germany.|Research Unit Ethics, University Hospital Cologne, Cologne, Germany.
authors.forename: Saskia
authors.initials: S
authors.lastname: Jünger
authors.affiliation: Department of Palliative Medicine, University Hospital, Bonn, Germany.|Centre for Palliative Care, Malteser Hospital, Bonn, Bonn, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Radbruch
authors.affiliation: Willem Scholten Consultancy, Medicines and Controlled Substances, Lopik, The Netherlands.
authors.forename: Willem
authors.initials: W
authors.lastname: Scholten
authors.affiliation: Lisman Legal Life sciences, Nieuwerbrug, The Netherlands.
authors.forename: John A
authors.initials: JA
authors.lastname: Lisman
authors.affiliation: Eurasian Harm Reduction Network, Vilnius, Lithuania.
authors.forename: Marija
authors.initials: M
authors.lastname: Subataite
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.|Schutjens de Bruin, Tilburg, The Netherlands.
authors.forename: Marie-Hélène D B
authors.initials: MDB
authors.lastname: Schutjens
mesh_terms: D000701:Analgesics, Opioid / Q000627:therapeutic use*; D005060:Europe; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D009293:Opioid-Related Disorders / Q000150:complications*; D010146:Pain / Q000150:complications* / Q000188:drug therapy*
chemical_list: D000701:Analgesics, Opioid
keywords: Access; OAT; OST; addiction; barriers; buprenorphine; legal; methadone; opioid dependence; regulatory