Reprinted by permission of Elsevier Science Inc.: Opioid Availability in Latin America: The Declaration of
Jan Stjernswärd, et al. Journal of
Pain & Symptom Management, Volume 10(3): 233-236. Copyright 1995 by the U.S.
Cancer Pain Relief Committee.
|"Notice: this article appears on the PPSG website with the express
permission of the copyright holder, who should be consulted for
further permission to reproduce."
Opioid Availability in Latin America: The Declaration of
Jan Stjernswärd, MD (WHO), Eduardo Bruera, MD (Canada),
David Joranson, MSSW (USA), Silvia Allende, MD (Mexico),
Gustavo Montejo, MD (Mexico), Lisbeth Quesada Tristan, MD (Costa Rica),
Gloria Castillo, MD (Dominican Republic), Teresa Schoeller, MD (Brazil),
Maria Antonieta Rico Pazos, MD (Chile), Roberto Wenk, MD (Argentina),
Maria Pruvost, MD (Argentina), Liliana De Lima, PhD (Colombia),
Eduardo Mendez, MD (Uruguay), Juan Núñez Olarte, MD (Spain),
José Felix Olalla, MD (Spain), and Guillermo Vanegas, Jr., RN (Italy)
World Health Organization Palliative Care Program for Latin America, Florianopolis, Brazil
Between March 27 and 29, 1994, a group of representatives of 32 palliative care programs from eight Latin
American countries met under the auspices of the World Health Organization (WHO) Palliative Care Program for
Latin America in Florianopolis, Brazil. The participants included physicians, nurses, psychologists, volunteers,
drug regulators, hospital administrators, and representatives from the pharmaceutical industry. A comprehensive
report by David Joranson (University of Wisconsin-Madison) was followed by a general discussion moderated by
Jan Stjernswärd, Chief of the Cancer Unit, World Health Organization, and by Eduardo Bruera, Coordinator of
the WHO Cancer Pain and Palliative Care Program for Latin America. A number of issues related to opioid
availability were identified and discussed. This declaration summarizes the main conclusions of the meeting. The
attendants would like to encourage the widest possible distribution of this document. J Pain Symptom Manage
Opioid availability, Latin America, WHO, drug regulation
A significant increase in the utilization of opioid analgesics has been observed in most Latin American countries.
This is mostly the result of prescribing, preparation, and distribution of analgesics by a number of dedicated palliative
care groups. In some countries, such as Argentina and Colombia, the increases have been several-fold, as compared
to 1990, and reflect a much wider increase in the utilization of opioids into the general medical population. In most
countries, the increase in analgesic use has taken place mostly in the form of mild opioids (propoxiphen), partial
agonists or agonist-antagonists (buprenorphine, nalbuphine), meperidine, or pentazocine. These drugs are not highly
recommended for the management of cancer pain.
Unfortunately, the findings suggest that opioid use is still limited to a minority of physicians, and that most Latin American
cancer patients with pain continue to die without having received a single dose of a strong opioid agonist.
The main reasons identified for this pattern of utilization were (1) old national pharmacopeias oriented to a short-term
management of acute pain have predominantly parenteral preparation of mild opioids; (2) the cost of commercially available
preparations makes them unaffordable to most patients (this issue will be discussed in depth below); (3) physicians choose mild
opioids that do not require special prescription pads because of the severe bureaucratic limitations imposed by current prescription
regulation (this issue will also be addressed later); (4) there is severe lack of physicians and pharmacist education on cancer pain
management; physicians are frequently afraid of prescribing, and pharmacies frequently do not carry the opioids, forcing patients
and families to go long distances to fill an analgesic prescription; (5) existing legislation in most Latin American countries limits
the access of patients to analgesics without having substantial impact on the illegal drug markets (this issue will be addressed later
as well); and (6) clinicians, palliative care, pain, and cancer associations are not informed regularly by their government of their
patterns of opioid use in their countries.
Recommendations on Utilization
- The World Health Organization (WHO) Cancer Pain and Palliative Care Program for Latin America will regularly
report to members from different countries on patterns of opioid utilization. This will be coordinated by David Joranson, WHO
Collaborating Center for Symptom Evaluation at the University of Wisconsin Medical School in Madison.
- The members from each country will jointly address the utilization issue with their Ministry of Health. Each report by
the national members will include the report on opioid availability prepared by the Wisconsin Collaborating Center, the new
guidelines for opioid availability produced by the WHO Cancer
Unit, (currently available in Spanish), and a copy of the report by the International Narcotics Control Board (INCB) to each
national government in 1989: "Demand for, and supply of opiates for medical and scientific needs." This report expresses the
concern of the INCB with the lack of opioid availability to patients and reminds governments that, as signatories of the Single
Convention on Narcotic Drugs, they are responsible for ensuring access to opioids for their patients. In addition, the Declaration
of Florianopolis and letters of support from the WHO Cancer Unit should be added.
- Drug regulators from different Latin American countries will be encouraged to contact David Joranson in order to consult
on problems associated with current legislation issues that limit access to opioids. It will also be suggested that these members
contact Dr. Jose Felix Olalla, the drug regulator from the Spanish Government, in order to inquire on the changes that the Spanish
Government has made in the area of utilization. These issues are discussed in depth below.
Cost of Opioids
The cost of most commercial preparations of opioids is much higher in Latin America than in North America and Europe. Using
Spain as a standard, the price of short-acting morphine (in US dollars), in those countries where it is available, is 5-10 times higher
than in Spain. Many countries do not have short-acting morphine, and patients are forced to use less-useful and more-expensive
opioids. This is a serious problem because the income of Latin American patients is 3-8 times lower than in Spain. Opioid
analgesics are drugs that are very inexpensive to produce. These drugs are produced from powders available from international
producers at a very low cost.
The reasons identified for the increased cost are the following: (1) In some countries, the more inexpensive forms of opioids are
not available (short-acting morphine or methadone). (2) Multinational pharmaceutical companies apply for licenses to sell the more
expensive drugs such as slow-release morphine, fentanyl patches, or buprenorphine. The main reason for this is the higher
overhead cost of these companies and the fact that these drugs are protected by a patent. (3) Smaller, local
companies are not applying for a license to sell inexpensive opioids. This is based on two factors: a) they have limited
awareness of the size of the potential market; and/or they are discouraged by governments with unreasonable
bureaucratic regulations for the production or distribution of opioids. (4) While simple capsules, oral solutions and
even parenteral solutions of morphine can be prepared by volunteers or hospital pharmacies using morphine powder,
most Latin American countries do not allow the entry of morphine powder. (5) The fear of legal consequences is
deterring a large number of pharmacies from preparing the drugs in their local pharmacies and also hospital
pharmacies from preparing and distributing opioids to the community. (6) Limited utilization of opioids by physicians
decreases the size of the market and the interest of companies to produce these drugs.
The following recommendations were made on the issue of cost:
The results will be discussed in 2 years.
- Availability of opioid analgesics. Opioids can be made available in the following ways:
- Multinational companies: They have the ability to manufacture, import, and distribute opioids. Their higher
overhead costs make it less interesting for them to produce cheaper drugs, but they can be very effective in introducing
more-expensive and modern drugs. These companies should be encouraged to bring drugs; to assist in the educational
process among physicians, nurses, and pharmacists; and to assist through their international and legal expertise in
updating the legislative and regulatory practices of each country.
- National companies: Because of their lower overhead and better knowledge of the local scene, these
companies can produce cheaper opioid preparations. These companies, however, have limited expertise in licensing
and distribution of opioids. These companies should be encouraged to produce useful simple commercial
preparations. Clinicians, nongovernmental organizations (cancer leagues, volunteer associations, and pain societies),
and drug regulators should assist these small companies in the process of making these commercial preparations
- State-owned or semiprivate companies:
These companies have as their main mandate to produce low-cost drugs. Many Latin American countries have these
companies, but they have not been interested in the production of opioid analgesics. In Spain, a semiprivate company
was helpful in keeping costs of opioids down when the demand was still low and commercial preparations were
limited. Some of these companies (e.g., in Spain and in the state of San Paulo, Brazil) have export capabilities. These
companies should be interested in the production and distribution of low-cost preparations of simple opioids.
- Importing of opioids: Several Latin American countries produce low-cost opioids that could easily be
imported and distributed for either local companies, governments, or nongovernmental organizations such as cancer
leagues. These companies do not have legal resources to maneuver in the complex bureaucracy of a country.
Clinicians, nongovernmental organizations, and drug regulators should help these companies in the process of importing opioid analgesics. Companies have been identified in Argentina and Mexico and can be contacted through the
local palliative care physicians.
- Production of opioid preparation by other
- Local pharmacists: Drug regulators and clinical groups should provide simple guidelines for the effective
preparation of liquid solutions and capsules of opioids. These guidelines could be distributed through the local
colleges of pharmacy to empower pharmacists to produce analgesics in the community. Local drug regulators should
be educated on the importance of making these drugs available to cancer patients.
- Volunteer groups: Volunteer groups, under the supervision of pharmacists, have been effective in producing
high-quality opioids in San Nicolas, Argentina. Volunteer groups have also been highly effective in importing and
distributing commercial preparations of opioids in Santo Domingo, Dominican Republic. This model of community
involvement should be encouraged using existing nongovernmental organizations such as cancer societies or pain
societies. Drug regulators and pharmaceutical companies should assist these organizations in making the drugs
available to patients.
- Local hospitals: Local hospitals, through
their pharmacies, have been highly effective in the production and distribution of opioids in the city of Cordoba, Argentina. This
model is highly effective because of the ability of these large pharmacies to produce high volumes and, therefore, decrease the cost
of the drugs. Hospital pharmacies that could take over the production and distribution of opioids in each region should be
In a given country, a decrease in cost is only likely to be achieved as a result of a combination of several of these
Each individual government should outline the strategy chosen for cost reduction. WHO Cancer Pain and Palliative Care
Programs will support and advise clinicians, governments and companies in this regard.
- Monitoring of costs. The WHO Latin American Program will monitor the cost of opioids
with the help of different local programs. Success in cost containment will be judged by (a)
availability of simple opioid preparations; (b) increase in the access of the population to these preparations; and (c) decrease in
the cost of these preparations to the level of cost currently existing in North America and Europe.
A large variation exists in the drug legislation and regulation in different Latin American countries. Unfortunately, these
regulations reflect more the concern with diversion of opioids than genuine concern for the well-being of dying cancer patients.
A large body of evidence suggests that an increase in opioid availability for patients does not result in increased illegal diversion.
The following findings were made regarding legislation/regulations: The bureaucratic burden is too high on physicians and
pharmacists for the adequate prescription of opioids. (a) Triplicate prescription pads are difficult to obtain and expensive, often
requiring the physician to personally pick them up from a government office. (b) The maximal amount/ duration of prescriptions
is too small, resulting in physicians and patients being required to falsify information in order to avoid frequent visits to the
physician's office and the pharmacy. (c) Pharmacy regulations regarding storage of opioids are so restrictive that, in many
Latin American cities, there are no pharmacists carrying opioid analgesics. (d) The regulatory aspects discourage pharmaceutical
companies from producing or importing new opioid preparations.
The following recommendations were made: (a) Governments should be presented with a detailed list of the local
legislative/regulatory obstacles to opioid availability. This list will be generated by the local physicians, ideally with input from
pharmacists and pharmaceutical companies. (b) Latin American regulators should be presented with the information package
describing utilization. (c) Latin American regulators will be encouraged to meet the representatives of the Spanish Minister of
Health during their annual meeting. Dr. José Felix Olalla has expressed an interest in sharing the Spanish experience with
legislative and regulatory changes. (d) Governments will be encouraged to seek advice from the Division of Policy Research, WHO
Collaborating Center for Symptom Evaluation, University of Wisconsin. David Joranson has offered support in this area. (e) The
WHO Cancer Pain and Palliative Care Program will monitor legislative and regulatory improvements. This will be reported in
This declaration has identified the main issues related to utilization, cost, and legislation/regulation with regards to cancer pain
management in Latin America. A number of specific recommendations have been issued that are simple and low cost. These
recommendations should result in a rapid improvement in the access to adequate analgesia by cancer patients.
The recommendations require the cooperation of professionals (physicians, nurses, and pharmacists), governments (ministers
of health and drug regulators), and pharmaceutical companies (multinational, national, and state owned). Volunteer organizations,
political organizations, and the press should assist in increasing awareness of the seriousness of the problem and the simplicity of
the solutions required.
Regular monitoring will take place in order to assess the degree of implementation of these recommendations in each country
and the success of these recommendations in producing the necessary changes.