Legal barriers in accessing opioid medicines: results of the ATOME quick scan of national legislation of eastern European countries.
BACKGROUND
Overregulation of controlled medicines is one of the factors contributing to limited access to opioid medicines.


OBJECTIVE
The purpose of this study was to identify legal barriers to access to opioid medicines in 12 Eastern European countries participating in the Access to Opioid Medication in Europa project, using a quick scan method.


METHODS
A quick scan method to identify legal barriers was developed focusing on eight different categories of barriers. Key experts in 12 European countries were requested to send relevant legislation. Legislation was quick scanned using World Health Organization guidelines. Overly restrictive provisions and provisions that contain stigmatizing language and incorrect definitions were identified. The selected provisions were scored into two categories: 1) barrier and 2) uncertain, and reviewed by two authors. A barrier was recorded if both authors agreed the selected provision to be a barrier (Category 1).


RESULTS
National legislation was obtained from 11 of 12 countries. All 11 countries showed legal barriers in the areas of prescribing (most frequently observed barrier). Ten countries showed barriers in the areas of dispensing and showed stigmatizing language and incorrect use of definitions in their legislation. Most barriers were identified in the legislation of Bulgaria, Greece, Lithuania, Serbia, and Slovenia. The Cypriot legislation showed the fewest total number of barriers.


CONCLUSIONS
The selected countries have in common as main barriers prescribing and dispensing restrictions, the use of stigmatizing language, and incorrect use of definitions. The practical impact of these barriers identified using a quick scan method needs to be validated by other means.
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
Marjolein J M
MJ
Vranken
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands. Electronic address: A.K.Mantel@uu.nl.
Aukje K
AK
Mantel-Teeuwisse
Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany.
Saskia
S
Jünger
Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany; Centre for Palliative Care, Malteser Hospital Bonn, Bonn, Germany.
Lukas
L
Radbruch
Lisman Legal Life sciences, Nieuwerbrug, The Netherlands.
John
J
Lisman
Consultant, Medicines and Controlled Substances, Lopik, The Netherlands.
Willem
W
Scholten
International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, United Kingdom.
Sheila
S
Payne
International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, United Kingdom.
Tom
T
Lynch
Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands; Schutjens de Bruin, Tilburg, The Netherlands.
Marie-Hélène D B
MH
Schutjens
D000701:Analgesics, Opioid / Q000627:therapeutic use*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005060:Europe; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D010166:Palliative Care / Q000331:legislation & jurisprudence
D000701:Analgesics, Opioid
ATOME; Opioids; access; barriers; harm reduction; legislation; medicines; morphine; pain treatment; palliative care; regulations