Prepared for: International Conference 1997
Comprehensive Cancer Care
"Focus on Cancer Pain"
Limassol, Cyprus
May 28 - May 31, 1997
Prepared by:
Pain & Policy Studies Group
World Health Organization Collaborating Center
for Policy and Communications in Cancer Care
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin USA
Your comments are welcome.
CITATION: This monograph is not copyrighted and may be quoted or reproduced using the
following citation:
Joranson DE, Gilson AM. Opioid availability: Diagnosis and treatment of regulatory barriers. University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center for Policy and Communications in Cancer Care: Madison, Wisconsin, USA, 1997 (Monograph)
TABLE OF CONTENTS
Purpose and introduction
Primary resources
Additional References
Selected Opioid Consumption Trends
CHARTS:
Consumption of morphine and pethidine in the world
Regional consumption of morphine and pethidine in the world
Consumption of morphine and pethidine in individual
countries
The purpose of this monograph is to provide informational resources that are directly
relevant to Europe to improve the availability of opioid analgesics for pain and
palliative care. The monograph includes references to key articles and reports. It has
been prepared especially for participants of the International Conference on Comprehensive
Cancer Care, Cyprus, 28-31 May, 1997. The monograph was prepared by the Pain & Policy
Studies Group/WHO Collaborating Center for Policy and Communication in Cancer Care in
Madison, Wisconsin, USA, in accordance with its WHO terms of reference which include
evaluation of barriers to cancer pain management and monitoring of opioid analgesic
consumption worldwide. Comments and suggestions are invited; please send them to David E.
Joranson, Pain & Policy Studies Group/WHO Collaborating Center, 1900 University
Avenue, Madison, Wisconsin 53705, USA; fax 1-608-263-0259.
There are several publications of international relevance with which participants should
be familiar. These are publications of the World Health Organization (WHO) and the
International Narcotics Control Board (INCB), and are listed in this section and in
Section II, below. There are also several publications which address regional opioid
availability issues in Europe and in Latin America; these are also listed in Section II.
Section III contains additional references, including those which are relevant to
individual countries. The following publications are of international significance and are
briefly summarized because they are particularly important for gaining an understanding
about how the international opioid distribution system is intended to work in order to
meet the needs of patients who need pain relief.
World Health Organization. Cancer Pain Relief: With A Guide to Opioid Availability.
Geneva: Author, 1996.
The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care has published a
second edition of Cancer Pain Relief, with a Guide to Opioid Availability. This Guide
explains the system that is used to make morphine and other opioids available for the
patients who need these medications for pain. The Guide is for the use of regulators and
health care professionals, and is intended to promote communication between them. It
briefly reviews the problem of cancer and pain, the necessity of having opioid analgesics
available to treat pain, and the WHO strategy for cancer pain relief. The Guide explains
how the opioid distribution system should work within the legal framework of international
treaty and national narcotic control laws. Particular attention is given to the role of
the national estimate of medical need for opioids, and the steps which are necessary to
obtain a supply of opioids either by domestic manufacture or by import. Finally, this
publication offers guidelines for appropriate regulation of health care professionals who
handle opioids, paying special attention to the need to balance concerns about drug abuse
with the needs of patients for pain relief.
World Health Organization publications can be obtained from Distribution and Sales, World
Health Organization, 1211 Geneva 27, Switzerland.
International Narcotics Control Board. Availability of Opiates for Medical Needs.
New York: United Nations, 1996.
The International Narcotics Control Board is the United Nations body responsible for
monitoring governments' compliance with the Single Convention on Narcotic Drugs, 1961. The
Board recognizes that the regulatory control of narcotics should not interfere with the
availability of opioids for medical purposes, including pain management. Further, the
Board recognizes its duty to ensure that opioids are sufficiently available to meet
medical needs, as defined by individual governments.
In 1995, the INCB surveyed all governments to find out if they have responded to its 1989
recommendations, and to learn what they are doing to identify and address barriers to
opioid availability for medical and scientific purposes. Sixty-five governments responded,
representing 50% of the worlds population. Only thirty-six of the 65 responding
governments (57% of the sample) reported having examined for presence of impediments; of
these 36 governments, 32 identified an average of five impediments in each country and
four said that no impediments had been found.
Although the WHO has recommended that oral opioids be available for cancer patients in
hospitals and in the community, the INCB survey results indicate that the recommended
opioids were considerably less available than injectable preparations. Further, less than
50% of the governments reported that morphine, in any dosage form, was stocked in all
country s hospitals with cancer programs.
Results of the INCB survey also suggest that legal restrictions are prevalent. Many
responding governments indicated that they: (1) require special government-issued forms
and other special permissions for the prescription of opioid analgesics, (2) have maximum
prison sentences and fines for physicians who fail to comply with prescribing
requirements, (3) require physicians to report patients who receive opioid prescriptions,
and (4) regulate the maximum dose of opioid analgesics that can be prescribed for
outpatients. Moreover, less than half of the governments reported having a national law
that reflects the treaty provision from the Single Convention recognizing that narcotic
drugs are indispensable for the treatment of pain and suffering.
Another important result of the INCB survey was that a majority of the governments
indicated that they have national policies to improve medical use of opioids, as well as
anticipate significant further increases in consumption of opioids. Based on these
studies, the INCB concluded that a small but significant number of governments are making
efforts to improve the availability of opioids for medical use, but that a number of
problems remain which governments must address.
NOTE: INCB reports are United Nations publications and may be obtained from bookstores and
distributors throughout the world. Consult your bookstore or write to: United Nations,
Sales Section, New York or Geneva. (If there is difficulty obtaining a publication,
contact the INCB at Vienna International Centre, P.O. Box 500, A-1400, Vienna, Austria,
Fax 43 1 21345-5867) [This document is published in English, French and Spanish.]
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The graphs on the following pages describe the consumption of morphine and pethidine in
the world, as well as in selected countries. "Consumption" means that amount of
drug which has been supplied to physicians, pharmacies and hospitals for retail
distribution, i.e., patient care. Consumption also includes drugs supplied for scientific
research, although these amounts are typically quite small. Over time, consumption is a
good indicator of patient use, except for exceptions which are noted below. These data are
furnished by governments to the International Narcotics Control Board in accordance with
their obligations as parties to the Single Convention on Narcotic Drugs, 1961. The reader
should consult the INCB reports for the official statistics. Statistics on each country's
estimate of medical need for opioids, the country's status of treaty adherence, and
consumption of principal opioids for the last five years are reported in an annual
publication of the Board.
The purpose of the consumption graphs is to communicate data on the global, regional and
country consumption of selected opioids to health care professionals and regulators so
they can see what the trends have been. 1994 data for individual countries was included
where available; global and regional data for 1994 was not included since a number of
countries have not yet reported to the INCB, making the global totals incomplete. Absence
of data for a country's consumption for a particular year means either that a) the
government did not report the information, or b) the amount reported was less than 1
kilogram.
Morphine was selected since the WHO recommends use of this analgesic, and because it uses
these consumption data as a rough indicator of progress to relieve cancer pain. (It should
be noted that the INCB morphine consumption data also includes the amounts of morphine
that are converted to non-analgesic drug products. Consequently, the global morphine
consumption statistic is inflated by several per cent; this inflation may be much more
significant in certain countries for particular years where amounts of morphine for
conversion are actually greater than the amount of morphine consumed as an analgesic for
patient needs; for example, this has occurred in Italy and Argentina.)
Pethidine is used for comparison purposes because of its wide-spread use as an analgesic.
Codeine trends are not reported here since it is used for medical purposes other than
analgesia, such as cough and diarrhea. Other important opioid agonists are not reported
here, although they are increasingly being used in some countries; these include
dihydrocodeine, fentanyl, levorphanol, hydrocodone, hydromorphone, methadone and
oxycodone. Also not reported is the use of other less potent and lesser-controlled
analgesics such as dextropropoxyphene and pentazocine.
The following pages contain the consumption trends for the world, regions of Europe and
individual countries in the European region.
Global Consumption of Morphine
Consumption of Morphine in Europe
Consumption of Morphine and Pethidine: Albania