Prepared for:
V. Congreso Latinoamericano de Cuidados Paliativos
Concepción, Chile
March, 1998.
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
CITATION: This monograph is not copyrighted and may be quoted or reproduced using the following citation:
Joranson DE, Gilson AM, Monterroso M, Nelson JM. Opioid Analgesics in Latin America: Legal Requirements, Trends, Recommendations. University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center for Policy and Communications in Cancer Care: Madison, Wisconsin, USA, March, 1998 (Monograph).
In Latin America, palliative care groups have been meeting every two years in cooperation with WHO and narcotic regulators. This group has also published conclusions and recommendations for improving opioid availability.3 One of these recommendations was for the WHO Collaborating Center in Madison, Wisconsin, to continue reporting opioid consumption trends for the Latin American region and other relevant developments. This monograph is the Center's response to those recommendations.
The purpose of this monograph is to provide informational resources that are directly relevant to Latin America to improve the availability of opioid analgesics for pain and palliative care. The monograph includes references to key articles and reports. It has two purposes: 1) to share information throughout the region, and 2) to encourage further study and discussion of ways to improve the availability of opioid analgesics to cancer patients for the relief of pain, while preventing diversion and abuse. It has been prepared especially for participants of the V Congreso de Cuidados Paliativos, Concepcion, Chile, March, 1998. This 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. The Collaborating Center has a website at http://www.medsch.wisc.edu/painpolicy.
[Back to the top]
II. REVIEW OF CONSUMPTION DATA
One indicator of progress to improve availability of opioid analgesics for cancer pain
relief and palliative care in a country is the medical use and therefore the consumption statistics
of drugs like morphine. 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. However morphine statistics alone do not
reflect the complete picture in countries where other strong opioids are also being used. 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 not necessarily used by
patients in a particular year. On these graphs, zero consumption could also be: (a) reported
consumption of less than 1 kilogram, 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, and methadone. Nevertheless, many countries' morphine consumption statistics are good, although 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
Consumption Charts and Data
Morphine Consumption: Latin America and the World, 1996
Consumption of Morphine and Pethidine: Argentina
Consumption of Morphine and Pethidine: Bolivia
Consumption of Morphine and Pethidine: Brazil
Consumption of Morphine and Pethidine: Chile
Consumption of Morphine and Pethidine: Colombia
Consumption of Morphine and Pethidine: Costa Rica
Consumption of Morphine and Pethidine: Cuba
Consumption of Morphine and Pethidine: Dominican Republic
Consumption of Morphine and Pethidine: Ecuador
Consumption of Morphine and Pethidine: El Salvador
Consumption of Morphine and Pethidine: Guatemala
Consumption of Morphine and Pethidine: Guyana
Consumption of Morphine and Pethidine: Honduras
Consumption of Morphine and Pethidine: Mexico
Consumption of Morphine and Pethidine: Nicaragua
Consumption of Morphine and Pethidine: Panama
Consumption of Morphine and Pethidine: Paraguay
Consumption of Morphine and Pethidine: Peru
Consumption of Morphine and Pethidine: Suriname
Consumption of Morphine and Pethidine: Uruguay
Consumption of Morphine and Pethidine: Venezuela
[Back to the top]
III. LEGAL REQUIREMENTS
In 1995, INCB conducted a survey of governments, in cooperation with the WHO, to
obtain information about opiate availability and impediments.6 Impediments to availability of
opioid analgesics involve many factors related to knowledge, attitudes, resources and policy,
including restrictive narcotics laws and regulations. Partial data from the INCB's survey relating
to legal restrictions on prescribing opioids such as morphine are summarized in the table.
| Country | Argentina | Chile | Colombia | Cuba | Mexico | Peru | Uruguay | Venezuela |
| Does the national drug control law recognize that opiates are indispensable for the relief of pain and suffering? | No | No | No | Not in the national legislation, but in the technical rules of each medical specialty | Yes | Yes | Yes, in the norms implementing the national law | Yes |
| Does the national drug control law ensure availability of opiates for the relief of pain and suffering? | Yes | No | No | Yes | Yes | Yes | Yes, in the norms implementing the national law | Yes, in the Ley de Sanidad Nacional and in the Ley de Ejercicio de la Farmacia |
| Can a physician prescribe opiates for a patient in a hospital? If so, what are the special requirements? | Yes, special government prescription form | Yes, special government and hospital prescription forms | Yes, special license, special government prescription form, special training | Yes, permission from the hospital or the medical supervisor (for long term patients), duplicate prescription form for internal use | Yes, special license, permission from the hospital or the medical supervisor, special government and hospital prescription forms | Yes, special hospital prescription form | Data not available | Yes, special government and hospital prescription form |
| Is there a maximum quantity that physicians can prescribe for a patient in a hospital? (Each time) | 20 mg each time
80 mg per day |
No | 200 mg | Yes, maximum of 20 mg per day of chlorhydrate of morphine (ampules) in case of emergency and for no more than three consecutive prescriptions | No | Yes, 20 mg every four hours | Data not available | No |
| Is there a maximum length of time that a patient can receive opiates in a hospital? | No | No | No | No | No | No | Data not available | No |
| Can a physician prescribe opiates for a patient at home? If so, what are the special requirements? | Yes, special government prescription form | Yes, special government and hospital prescription forms | Yes, special license, special government prescription form | Yes, permission from the hospital or the medical supervisor, duplicate prescription form for authorized professionals | Yes, special prescription form | Yes, special hospital prescription form (under the social security system) | Data not available | Yes, special government and hospital prescription form. |
| Is there a maximum
amount that
physicians can
prescribe for patient
at home?
(Each time) |
20 mg each time
80 mg per day |
No | Dose for ten calendar days | Yes, maximum of 20 mg per day of chlorhydrate of morphine (ampules) in case of emergency and for no more than three consecutive prescriptions | Yes | According to the physician's orders | Data not available | No |
| Is there a maximum length of time that a patient can receive opiates at home? | No | No | Up to 20 calendar days with the authorization of the Fondo Nacional de Estupefacientes | No, the treatment is subject to periodic review | No | For up to seven days, renewable | Data not available | No |
| Are there provisions regarding disposal of leftover opiate medications? | Requires (or allows) return of unused opiates to hospital or pharmacy, depending on the instructions given to the family | No | Requires return to the Fondos Rotatorios Seccionales or the Fondo Nacional de Estupefacientes | Requires (or allows) return of unused opiates to hospital or pharmacy | Requires (or allows) return of unused opiates to hospital or pharmacy | Requires return to the corresponding health authority | No, but the family can be asked to return them | Yes |
| Is there a legal requirement to report to the government the name of patients who receive opiates? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Does the national drug law define "Addiction" or "Drug Dependence" | No | No answer | Yes | No | Yes | Yes | No | Yes |
| What is the maximum penalty if a physician fails to comply with laws that govern opiate prescribing? | Jail/prison up to ten years | Jail | No answer | Jail/prison up to 8 years | Physician will not be able to practice for 3 to 5 years | Jail/prison five years, prohibition to exercise one's profession | Jail/prison up to 20 years | Temporary suspension of license from 6 to 12 months |
| What is the minimum mandatory penalty if a physician fails to comply with laws that govern opiate prescribing? | Fine from 1,000-1,200,000 pesos, prohibition to exercise one's profession | Jail, fine, other penalty | Prison for a minimum of three years; minimum of five years suspension to exercise one's profession | Jail/prison for a minimum of 3 years | Temporary suspension of medical license | Prison for a minimum of 2 years, prohibition to exercise one's profession | Suspension of license to practice, after the third time withdrawal of license | Fine corresponding to 2-300 days of minimum wage |
[Back to the top]
IV. INCB RECOMMENDATIONS
Based on its survey of governments, the INCB developed a set of recommendations;
those which were directed to national governments and health professionals are summarized
here, and presented verbatim in this monograph.
A. Recommendations for consideration by Governments
51. Governments are invited to consider the following recommendations:
F. Recommendations for consideration by educational institutions and non-governmental health-care organizations, including the International Association for the Study of Pain and other health-care representatives
56. Educational institutions and non-governmental health-care organizations are encouraged to consider the following recommendations:
[Back to the top]
V. KEY REFERENCES
There are two authoritative publications which are relevant to health professionals and
government regulators. These publications from the WHO and the INCB, 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. Section VI 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. 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 Center, P.O. Box 500, A-1400, Vienna, Austria, Fax 43 1 21345-5867) [This document is published in English, French and Spanish.]
[Back to the top]
VI. BIBLIOGRAPHY
There are several publications of international relevance with which participants should
be familiar. Besides the publications of the WHO and the INCB, which where referenced in
section V, there are also several publications which address international opioid availability
issues as well as those relevant to Latin America; these are listed below.
Agreda RF. Basic elements for a national comprehensive plan for drug abuse control in Peru. Bulletin on Narcotics, 1987; 39(2):37-49.
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.
Bruera E. Palliative care in Latin America. Journal of Pain and Symptom Management, 1993; 8(6):365-368.
Cagliotti CN. Co-operation between South American countries in the struggle against drug abuse and illicit drug trafficking. Bulletin on Narcotics 1987; 39(1):61-67.
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.
Clausen TG, Eriksen J, Molke Borgbjerg F. Legal opioid consumption in Denmark 1981-1993. European Journal of Clinical Pharmacology, 1995; 48:321-325.
Colleau SM (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.]
Colleau SM (ed). Dedication, volunteers: key ingredients to initiate cancer pain relief program in Argentina. Cancer Pain Release , 1989; 3(2):1.
Colleau SM (ed). Dominican Cancer Institute starts pain relief program in Santo Domingo. Cancer Pain Release, 1989; 3(2):1.
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.]
Colleau SM (ed). Mexico adopts national cancer pain policy. Cancer Pain Release, 1990; 4(2-3):1.
Colleau SM (ed). Mexican NCI receives morphine sulfate, starts training program in cancer pain relief. Cancer Pain Release, 1989; 3(1):1.
Colleau SM (ed), Bruera E. Cancer pain relief in Central and South America: a progress report. Cancer Pain Release, 1993; 6(2-3):1-6. [Contains reports on Argentina, Brazil, Colombia, Costa Rica, the Dominican Republic, Mexico, Uruguay and Ecuador, and is also available in Spanish.]
Colleau SM (ed), Joranson DE. Highlights of the INCB report. Cancer Pain Release, 1996; 9(Suppl.):1-4.
Coyne PJ. International efforts in cancer pain relief. Seminars in Oncology Nursing, 1997; 13(1): 57-62.
De Lima L, Bruera E, Joranson DE, et al. 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.
De Lima L. Colombia: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):404-406.
Galduroz JCF, Masur J. The unofficial history of drug use: a study in a Brazilian sample. British Journal of Addiction, 1990; 85:1577-81.
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.
International Narcotics Control Board. Narcotic drugs: Estimated world requirements for 1997, statistics for 1995. New York: United Nations, 1995. [This document is published annually and each report is in English, French and Spanish.]
International Narcotics Control Board. Report of the International Narcotics Control Board for 1995: Availability of opiates for medical needs. New York: United Nations, 1996.
Junta Internacional de Fiscalización de Estupefacientes. Informe de la Junta Internacional de Fiscalización de Estupefacientes correspondiente a 1995: Disponibilidad de opiáceos para las necesidades médicas y científicas. Nueva York, Naciones Unidas, 1996.
Organe International de Contrôle des Stupéfiants. Rapport de l'Organe international de contrôle des stupéfiants pour 1995: Disponibilité des opiacés pour les besoins médicaux. New York: Nations Unies, 1996.
International Narcotics Control Board. Report of the International Narcotics Control Board for 1985: Demand for and supply of opiates for medical and scientific needs. New York: United Nations, 1985.
Junta Internacional de Fiscalización de Estupefacientes. Informe de la Junta Internacional de Fiscalización de Estupefacientes correspondiente a 1985: Disponibilidad de opiáceos para las necesidades médicas y cientîficas. Nueva York, Naciones Unidas, 1985.
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.
Jage J. Opioids and the fear of addiction in Germany. Cancer Pain Release, 1991; 5(2):1,1.
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.]
Joranson DE. Guiding principles of international and federal laws pertaining to medical use and diversion of controlled substances. In: Cooper JR, et al. Evaluation of the Impact of prescription drug diversion control systems on medical practice and patient care: Possible implications for future research. National Institute on Drug Abuse Technical Research Monograph 131. Rockville, MD: NIDA, 1993.
Joranson DE. New international efforts to ensure availability of opioids for medical purposes. Journal of Pain and Symptom Management, 1996; 12(2):85-86.
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.
Joranson DE, Colleau SM (ed). Medical need for opioids far from being met. Cancer Pain Release, 1996; 9(Suppl.):1-3.
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]
Joranson DE, Gilson AM. Opioid availability: Diagnosis and treatment of regulatory barriers. 1997 (Monograph).
Joranson DE, Gilson AM. U.N. Agency: Global action needed to improve opioid availability. APS Bulletin, 1997; 7(2):10-11.
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).
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.
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.
Lickiss JN. Indonesia: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):423-424.
Luczak J. Palliative/hospice care in Poland. Palliative Medicine, 1993; 7:67-75. [Discusses opioid policy, progress and issues in Poland.]
Murad JE. The role of the pharmacist in drug abuse in developing countries. Pharmacy International, 1982; (October):311-313.
Ortiz A, Romano M, Soriano A. Development of an information reporting system on illicit drug use in Mexico. Bulletin on Narcotics, 1989; 41(1-2):41-52.
Portenoy RK. Opioid therapy for chronic nonmalignant pain: Clinicians' perspective. Journal of Law, Medicine, & Ethics, 1996; 24(4):296-309.
Quesada L. Costa Rica: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):407-408.
Selva C. International control of opioids for medical use. European Journal of Palliative Care, 1997; 4(6):194-198.
Stjernsward J, Joranson DE. Opioid availability and cancer pain-an unnecessary tragedy. Supportive Care in Cancer, 1995; 3:157-158.
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.]
Tragen IG. Co-operation of countries within the Organization of American States to combat drug problems. Bulletin on Narcotics, 1987; 39(1):57-60.
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.]
Wenk R. Argentina: status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):385-387.
Wenk, R. Availability of opioid analgesics in Argentina. Journal of Pain and Symptom Management, 1987; 2(4):191-192.
World Health Organization. Cancer pain relief: With a guide to opioid availability (second edition). World Health Organization, Geneva, 1996.
Organización Mundial de la Salud. Alivio del dolor en el cancer: Con una guía sobre la disponibilidad de opioides (segunda edicion). Organización Mundial de la Salud, Ginebra, 1996.
World Health Organization. Cancer pain relief and palliative care (Technical Report Series 804), World Health Organization, Geneva, 1990.
Organización Mundial de la Salud. Alivio del dolor y tratamiento paliativo en el cancer (Serie de Informes Técnicos 804), Organización Mundial de la Salud, Ginebra, 1990.
World Health Organization. Cancer pain relief. World Health Organization, Geneva, 1986.
Organización Mundial de la Salud. Alivio del dolor en el cáncer. Organización Mundial de la Salud, Ginebra, 1986.
Zenz M. Germany: Status of cancer pain and palliative care. Journal of Pain and Symptom Management, 1993; 8(6):416-418.
Zenz M. Treatment for cancer pain in France. [Letter] British Medical Journal, 1995; 311:387.
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.
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.]
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.