Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative
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Abstract
Many patients in Europe do not receive adequate relief of pain because of excessive
regulatory restrictions on the availability and accessibility of opioids. This is
a major public health problem. The aim of the study is to evaluate and report on opioid
availability and the legal and regulatory barriers to accessibility across the countries
of Europe.
European Society for Medical Oncology and European Association for Palliative Care
national representatives reported data regarding survey of opioid availability and
accessibility. Formulary adequacy is evaluated relative to the World Health Organization
(WHO) essential drugs list and the International Association for Hospice and Palliative
Care list of essential medicines for palliative care. Overregulation is evaluated
according to the guidelines for assessment of national opioid regulations of the WHO.
Data were reported on the availability and accessibility of opioids for the management
of cancer pain in 21 Eastern European countries and 20 Western European countries.
Results are presented describing the availability and cost of opioids for cancer pain
in each surveyed country and nine forms of regulatory restrictions.
Using standards derived from the WHO and International Narcotics Control Board, this
survey has exposed formulary deficiencies and excessive regulatory barriers that interfere
with appropriate patient care in many European countries. There is an ethical and
public health imperative to address these issues.