1. A conceptual framework
   
2. Review of consumption data
   
3. Recommendations
   
4. Resources
   1. Purpose and introduction
   2. Interpretation of INCB consumption data
   3. Key publications of the United Nations on opioid availability
   4. Primary Resources
   5. Additional References
   6. Additional Consumption Data (Consumption Charts)
   7. Resolution by the Commission on Narcotic Drugs

Prepared for:

The Sertuerner Workshop
Einbeck, Germany
August, 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

www.medsch.wisc.edu/painpolicy

I. A Conceptual Framework

II. Review of Consumption Data

III. Proposed Recommendations for Action

1. Review and implement 1995 International Narcotics Control Board (INCB) recommendations

Whereas in 1989 the INCB, in cooperation with the World Health Organization (WHO), recognized that opiates are insufficiently available in the world and recommended that governments evaluate laws and regulations and health systems for impediments;⁽¹⁾ and

Whereas in 1995 the INCB, in cooperation with the WHO, re-evaluated the global situation with respect to opiate availability, finding that few governments had responded to the Board's recommendations, and that although there was progress in some countries, opiates continue to be less than adequately available for medical purposes throughout the world; and

Whereas the INCB, the WHO, and the U.N. International Drug Control Programme (UNDCP) have received little response to these recommendations from health organizations, despite the fact that NGOs throughout the world are keenly aware of the lack of availability of opiates and are working to improve the situation;

Therefore be it resolved that individuals gathered in Einbeck agree to immediately contact the NGOs with which they are associated to a) review the INCB recommendations and make them available to their memberships, and b) write to the INCB and the WHO, encouraging implementation of the recommendations, calling attention to the unmet need for opiates in their countries, and expressing a willingness to cooperate.

2. Balance the 1998 U.N. special session on international drug control

Whereas the United Nations will conduct a special session on international drug control in early 1998; and

Whereas this special session, in order to be balanced, should address not only the control of drugs which controlled under the international conventions, but also the availability of narcotic drugs for medical purposes according to the Single Convention on Narcotic Drugs, 1961, which specifies that national governments which are parties to the Single Convention are obligated to ensure the medical availability of opiates (narcotic drugs) which are indispensable for the relief of pain; and

Whereas the INCB has recently concluded that opiates are insufficiently available for medical purposes and has recommended to governments, the WHO, the UNDCP, and the U.N. Commission on Narcotic Drugs (CND) specific actions that should be taken to improve the availability of opiates; and

Whereas the agenda for the special session is being planned by the CND, which has representatives from many national governments, and which in 1997 adopted its own resolution strongly endorsing the recommendations of the INCB ⁽²⁾ (enclosed, pp. 27-28);

Therefore be it resolved that individuals gathered in Einbeck request their respective national NGOs to contact their national government's representatives to the Commission on Narcotic Drugs to (a) provide information about the unmet medical need for opiates in their countries, (b) call attention to the recommendations which have been made by the INCB and the CND, and (c) request the CND to include in the 1998 special session of the United Nations on drug abuse a resolution to

1. Request all governments to give their immediate and full consideration to the INCB and CND recommendations on opiate availability;

2. Create and fund a special cooperative program between the UNDCP, the INCB and the WHO to monitor and support implementation of the INCB recommendations on opiate availability; and

3. Reevaluate the situation in the year 2000.

3. Disseminate widely the WHO and INCB reports and recommendations; encourage national cooperation; promote education

Whereas the WHO Guide to Opioid Availability ⁽³⁾ and INCB special report make specific recommendations for how governments and pain and palliative care organizations should work together to satisfy unmet needs for opiates, and to address impediments to the adequate availability of opiates;

Therefore be it resolved that the WHO and INCB reports and the CND resolution should be made available to pain and palliative care organizations, professionals and regulatory authorities throughout the world; and

Be if further resolved, that in each country, pain and palliative care professionals and their respective NGOs are requested to take the initiative to establish communication with the narcotic regulators, the national cancer control program program in the Ministry of Health, and pharmaceutical manufacturers and suppliers in order to a) identify and satisfy unmet needs for drugs including needed opiates and adjuncts, to b) identify and address impediments to drug availability which may exist in the country's medical and drug regulatory system, and to c) periodically report progress and issues to their respective NGOs and to the WHO Collaborating Center for Policy and Communications in Cancer Care; and

Be if further resolved that, pursuant to the INCB recommendations, national NGOs on cancer, pain and palliative care are requested to increase their efforts to educate students and health professionals in the proper use of opiates, their adequate control, as well as in the correct use of terminology concerning drug dependence.

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IV. Resources

1. Purpose and introduction

The purpose of this monograph is to summarize work presented to the Sertuerner Workshop in Einbeck, Germany in August, 1997, by the Pain & Policy Studies Group/World Health Organization Collaborating Center at the University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, USA. The Sertuerner Workshop was an international meeting of pain and palliative care experts convened by Professor Michael Zenz. The monograph was prepared in accordance with the Collaborating Center's terms of reference which include evaluation of barriers to cancer pain management and monitoring of opioid analgesic consumption worldwide. The monograph also includes references to the articles and reports which are key to understanding opioid availability for cancer pain relief in the world. Comments and suggestions are invited; please send them to David E. Joranson, Director, Pain & Policy Studies Group/WHO Collaborating Center, 1900 University Avenue, Madison, Wisconsin 53705, USA; fax 1-608-263-0259. The Collaborating Center has a website at http://www.medsch.wisc.edu/painpolicy.

2. Interpretation of INCB consumption data

Morphine consumption statistics are used by the WHO as a broad indicator of progress to improve cancer pain relief. Morphine is on the WHO Ladder, and it is the most widely available strong opioid in the world. The consumption data come from the International Narcotics Control Board.⁽⁴⁾ Each year the INCB receives reports from national governments on narcotics consumed. For statistical purposes, "consumption" is that amount of a narcotic drug which has been distributed to the retail level, that is, to hospitals and pharmacies in a country for medical use, but is not necessarily all used by patients in a particular year. On these graphs, zero consumption could also be: (a) reported consumption of less than 1 kilograms, or (b) no report was provided by the government.

The statistics for morphine consumption may include amounts which are used for manufacturing combination products that contain a small amount of morphine but which are subject to less restrictive control than single-entity morphine. Some countries may consume a large amount of morphine for this purpose in a particular year. Where possible, these amounts have been subtracted.

Country statistics vary widely according to many medical, economic and social factors. There is no ideal consumption rate or amount which is implied to be ideal. Furthermore, there are a number of cautions that should be used in interpreting the data. In some countries, morphine is used for painful conditions other than cancer, such as surgery or chronic non cancer conditions. Increased consumption of morphine may not necessarily reflect greatly improved pain management, but rather more institutions using morphine and more patients being with less than effective doses; the use of opioid analgesics for cancer pain relief in the most economically advanced countries is still inadequate. The other opioids which are used in a country should also be taken into account, such as fentanyl, hydromorphone, oxycodone. Nevertheless, many countries' morphine consumption statistics are good general indicators of progress to improve cancer pain relief.

Additional information may be available from the competent national authority under the international drug control treaties; a directory is available which lists the names and addresses of these government agencies. ⁽⁵⁾

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3. Key publications of the United Nations on opioid availability

There are two authoritative publications which are relevant to health professionals and government regulators. These are publications of the World Health Organization (WHO) and the International Narcotics Control Board (INCB), and are summarized below. Section III contains a variety of publications relevant to national, regional, international and topical issues relating to opioid availability.

World Health Organization. Cancer Pain Relief: With A Guide to Opioid Availability. Geneva: Author, 1996. 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. 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. This document is published in English, French and Spanish.

International Narcotics Control Board. Availability of Opiates for Medical Needs. New York: United Nations, 1996. The International Narcotics Control Board is 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, and works with national governments to ensure that opioids are sufficiently available to meet medical needs, as defined by individual governments. In 1995, the INCB surveyed all governments in the world to find out how they responded to the Board's 1989 recommendations to identify and address barriers to opioid availability for medical and scientific purposes, and to collect data on the status of opioid availability world-wide. This publication reports the results of that survey, concluding 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. The INCB makes a number of recommendations that form a blueprint for national and international actions to improve the situation. 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.

1. International Narcotics Control Board. Availability of Opiates for Medical Needs. New York: United Nations, 1996.

2. Resolution 3 (XL) Availability of opiates for medical needs. Commission on Narcotic Drugs, Fortieth Session, Vienna, 18-27 March 1997.

3. World Health Organization. Cancer Pain Relief: With A Guide to Opioid Availability. Geneva: Author, 1996.

4. United Nations International Narcotics Control Board. Narcotics: Estimated World Requirements for 1997; statistics for 1995. Sales number E/F/S.97.XI.2 (This publication is in English, French, and Spanish.)

5. United Nations. Competent National Authorities Under the International Drug Control Treaties. Sales number ST/NAR.3/1994/1(E/NA). (This publication is in English, French, and Spanish.)

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4. Primary Resources

1. Joranson DE, Colleau SM. Medical need for opioids far from being met. Cancer Pain Relief, 1996; 9(Suppl.):1-3.

2. Colleau SM, Joranson DE. Highlights of the INCB report. Cancer Pain Relief, 1996; 9(Suppl.):1-3.

Subscriptions to Cancer Pain Release, a newsletter of the WHO, can be obtained by writing to the Pain & Policy Studies Group/WHO Collaborating Center, 1900 University Avenue, Madison, Wisconsin, 53705, USA; fax 608-263-0259.

3. Clausen TG, Eriksen J, Molke Borgbjerg F. Legal opioid consumption in Denmark 1981-1993. European Journal of Clinical Pharmacology, 1995; 48: 321-325.

4. Colleau SM (ed). Making opioids available to treat cancer pain: the international system. Cancer Pain Release, 1994; 7(2-3):1-4. [Explanation of how the international narcotic control system works.]

5. Coyne PJ. International efforts in cancer pain relief. Seminars in Oncology Nursing, 1997; 13(1): 57-62.

6. De Lima L, Bruera E, Joranson DE. Opioid availability in Latin America: The Santo-Domingo report- progress since the Declaration of Florianopolis. Journal of Pain and Symptom Management, 1997; 13(4): 213-219.

7. International Narcotics Control Board. Narcotic drugs: estimated world requirements for 1997, statistics for 1995. United Nations; New York, 1995. [This document is published annually and each report is in English, French and Spanish.]

8. International Narcotics Control Board. Report of the International Narcotics Control Board for 1989: Demand for and supply of opiates for medical and scientific needs. New York: United Nations, 1989. [Available in English, French, Spanish versions]

9. Lickiss JN. Indonesia: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):423-424.

10. Stjernsward J, Bruera E, Joranson DE, Allende S. et al. Opioid availability in Latin America: the Declaration of Florianopolis. Journal of Pain and Symptom Management, 1995; 10(3):233-236. [A summary of the findings and recommendations concerning opioid availability in Latin America.]

11. United Nations. Competent national authorities under the international drug control treaties. United Nations; New York, 1995. [Lists the address of the government agency in each country which is responsible for establishing the national estimate of medical need for opioids; each report is in English, French, Spanish, Russian, Chinese, and Arabic.]

12. Zenz M, Willweber-Strumpf A. Opiophobia and cancer pain in Europe. The Lancet, 1993; 341:1075-1076. [An overview of regulatory barriers to opioid availability in Europe.]

13. Zhang H, Gu W, Joranson DE, Cleeland CS. People's Republic of China: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1996; 12(2): 124-126.

The Journal of Pain and Symptom Management has devoted an entire issue to the topic of global progress in cancer pain relief and palliative care. See Journal of Pain and Symptom Management, 1993; 8(6).

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5. Additional References

1. Angarola RT. National and international regulation of opioid drugs: purpose, structures, benefits and risks. Journal of Pain and Symptom Management, 1990; 5(2) (Suppl.):S6-S11.

2. Bruera E. Palliative care in Latin America. Journal of Pain and Symptom Management, 1993; 8(6):365-368.

3. Caraceni A. Availability and use of opioids for cancer pain patients in Italy. [Letter] Journal of Pain and Symptom Management, 1987; 2(3):127-128.

4. Colleau S, and Bruera E. (eds.) Cancer pain relief in Central and South America: A progress report. Cancer Pain Release, 1993; 6(2-3):1-8.

5. Colleau S. (ed.) Cancer Pain Release. 1995; 8(2);19-20. [This issue contains up to date reports on palliative care and use of morphine in Catalonia and Colombia.]

6. Gomez-Batiste X, Fontanals de Nadal MD, Via JM, Roca J, Trelis J, Porta J, Stjernsward J, Trias X. Catalonia's five-year plan: preliminary results. European Journal of Palliative Care, 1994; 1:98-101.

7. Jage J. Opioids and the fear of addiction in Germany. Cancer Pain Release, 1991; 5(2): 1,1.

8. Joranson DE, Gilson AM, Krchnavek K. Opioid analgesics for cancer pain relief: A review of consumption trends and the literature relating to Latin American countries, 1994 (Monograph).

9. Joranson DE, Gilson AM. Controlled substances, medical practice and the law. In: Schwartz HI. Psychiatric Practice Under Fire: The Influence of Government, the Media and Special Interests on Somatic Therapies. Washington, DC: American Psychiatric Press, Inc., 1994:173-194. [Barriers to opioid availability in the USA]

10. Joranson DE. Prescribing for cancer pain (in Netherlands): reflections on progress and directions. Journal of Pharmaceutical Care in Pain & Symptom Control, 1994; 2(2): 1-4.

11. Joranson DE. Availability of opioids for cancer pain: recent trends, assessment of system barriers, new WHO guidelines, and the risk of diversion. Journal of Pain and Symptom Management, 1993; 8:353-360. [Contains a survey instrument for assessing barriers to opioid availability.]

12. Larue F, Colleau SM, Fontaine A, Brasseur L. Oncologists and primary care physicians' attitudes toward pain control and morphine prescribing in France. Cancer, 1995; 76(11):2375-2382.

13. Larue F, Colleau SM, Brasseur L, Cleeland CS. Multicentre study of cancer pain and its treatment in France. British Medical Journal, 1995;310:1034-1037.

14. Luczak J. Palliative/hospice care in Poland. Palliative Medicine, 1993; 7:67-75. [Discusses opioid policy, progress and issues in Poland.]

15. Stjernsward J, Joranson DE. Opioid availability and cancer pain-an unnecessary tragedy. Supportive Care in Cancer, 1995; 3:157-158.

16. Wenk R. Argentina: status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):385-387.

17. World Health Organization. Cancer pain relief and palliative care (Technical Report Series 804), Geneva: WHO, 1990.

18. Zenz M, Zenz T, Tribe M, Strumpf M. Severe under treatment of cancer pain: a year survey of the German situation. Journal of Pain and Symptom Management, 1995; 10(3):187-191.

19. Zenz M. Treatment for cancer pain in France. [Letter] British Medical Journal, 1995; 311:387.

20. Zenz M. Germany: status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):416-418.

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6. Additional Consumption Data

Consumption of Morphine and Pethidine: Australia
Consumption of Morphine and Pethidine: Canada
Consumption of Morphine and Pethidine: China
Consumption of Morphine and Pethidine: Denmark
Consumption of Morphine and Pethidine: Egypt
Consumption of Morphine and Pethidine: France
Consumption of Morphine and Pethidine: Germany
Consumption of Morphine and Pethidine: India
Consumption of Morphine and Pethidine: Italy
Consumption of Morphine and Pethidine: Japan
Consumption of Morphine and Pethidine: Norway
Consumption of Morphine and Pethidine: Poland
Consumption of Morphine and Pethidine: South Africa
Consumption of Morphine and Pethidine: Sweden
Consumption of Morphine and Pethidine: United Kingdom
Consumption of Morphine and Pethidine: United States

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7. Resolution by the Commission on Narcotic Drugs

Resolution 3 (XL)
Availability of opiates for medical needs
The Commission on Narcotic Drugs.