Reprinted by permission
of Elsevier Science Inc.: Opioid Availability in Latin America: the Santo
Domingo Report Progress Since the Declaration of Florianopolis, by
Liliana De Lima, et al. Journal
of Pain & Symptom Management, Volume 13(4): 213-219. Copyright 1997
by the U.S. Cancer Pain Relief Committee.
article appears on the PPSG website with the express permission of the
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Opioid Availability in Latin America: the Santo Domingo
Progress Since the Declaration of FlorianopolisLiliana De
Lima, MS (USA), Eduardo Bruera, MD (Canada), David E. Joranson MSW (USA),
Guillermo Vanegas, RN (Italy), Soledad Cepeda, MD (Colombia) Lisbeth Quesada, MD
(Costa Rica), Roberto Wenk, MD (Argentina), Maria Claudia Pavajeau (Colombia),
Lea Derio, RN (Chile), Gustavo Montejo, MD (Mexico), Gloria Castillo, MD
(Dominican Republic), Franklin Ruiz, MD (Columbia), Ana Rocio Pupo, MD (Costa
Rica), Barbara Caries, MD (Venezuela), Eduardo Paredes, MD (Ecuador), and Teresa
Schoeller, MD (Brazil) The World Health Organization Palliative Care Program
for Latin America, Santo Domingo, Dominican Republic
The World Health Organization (WHO) has indicated that
opioid analgesics are insufficiently available, particularly in developing
countries, due to a variety of reasons, including legislative, educational and
policy issues. In its effort to promote the rational use of medical opioids and
the adequate treatment of patients with cancer, WHO has sponsored a meeting of
Latin American representatives every 2 years, which includes health
professionals and government regulators. During March 24-27, 1996, a group of 86
representatives of cancer pain relief and palliative care programs from nine
Latin American countries met in Santo Domingo under the auspices of the WHO
Palliative Care Program for Latin America. For the first time since the First
Latin American Meeting, government regulators were present to help address the
issue of opioid availability from their perspective. During the meeting, issues
pertaining to cancer pain, opioid availability, and palliative care were
discussed. This report summarizes some of the events and presents a summary of
the conclusions of an earlier meeting in 1994, as described in the
Declaration of Florianopolis, and presents its follow-up, The Santo
Domingo Report, generated following the 1996 meeting. J Pain Symptom
Man 1997;13:213-219. © U.S. Cancer Pain Relief Committee, 1997.
Latin America, opioid availability, legislation,
regulations, education, costs
The Declaration of FlorianopolisFollowing the Third Latin
American Meeting in 1994, the Declaration of Florianopolis1
was prepared. It summarized some of the events of the meeting and presented the
following conclusions concerning opioid-related issues.
Opioid UtilizationParticipants reported that opioid use was
still limited to a minority of physicians. The reasons stated were (a) old
pharmacopoeias oriented to short-term management of acute pain; (b) high costs
of commercial preparations; (c) bureaucratic requirements; (d) lack of physician
education; (e) restrictive legislation; and (f) lack of communication between
health professionals and institutions on the benefits of opioid use.
The WHO Cancer Pain Relief and Palliative Care Program for Latin America
asked Mr. David E. Joranson, Associate Director for Policy Studies, from the WHO
Collaborating Center, University of Wisconsin at Madison, to report the patterns
of opioid utilization across Latin America. Members of each country were asked
to address the issue directly with their Ministries of Health. It was
recommended that each member provide their regional regulator with the
consumption report prepared by Mr. Joranson, with the Spanish version of the WHO
publication Cancer Pain Relief: A Guide on Opioid Availability.2
Opioid CostsIt was reported that some commercial preparations
are too expensive for use in Latin America to treat patients with very low
incomes. In many countries, less expensive formulations were not available, and
companies, unaware of the needs in the market, were not applying for licenses to
manufacture or distribute opioid analgesics.
The Declaration of Florianopolis recommended that multinational
companies be encouraged to import new dosage forms, assist in the training of
physicians and health professionals, and assist in updating the legislative and
regulatory practices in their countries through their international and legal
expertise. Also, national companies were encouraged to prepare simple
immediate-release preparations with the assistance of clinicians and
nongovernmental organizations, and local pharmacists and local hospitals were
encouraged to prepare simple opioid solutions. The WHO Latin American Program
agreed to monitor the costs of opioid preparations.
Opioid LegislationThe Declaration of Florianopolis
addressed the issue of opioid legislation and regulations in the different Latin
American countries. Most of the problems described derived from legislation or
regulations that restrict the medical use of opioids, limiting the dosages, the
concentrations, or the duration of therapy, and requiring triplicate
prescription pads. Physicians and health professionals, as well as regulators
from Latin American countries, were advised to contact Mr. Joranson, for
consultation concerning problems related to legislative and regulatory issues
that limit opioid use for medical needs.
The Santo Domingo ReportDuring March 24-27, 1996, a group of 86
representatives of cancer pain relief and palliative care programs from nine
Latin American countries met in Santo Domingo under the auspices of the WHO
Palliative Care Program for Latin America, coordinated by Dr. Eduardo Bruera,
Professor of Oncology, Chair in Palliative Medicine, Alberta Cancer Foundation,
Edmonton, Alberta, Canada. Among the participants were health professionals from
different fields, including physicians, social workers, psychologists, and
nurses. For the first time since the First Latin American Meeting, government
regulators were present to help address the issue of opioid availability from
During the 1996 Santo Domingo meeting, many improvements were recorded that
had occurred in the 2 years since the Declaration of Florianopolis. The
following summarizes the main points.
Opioid ConsumptionA report3
on consumption of morphine and meperidine (pethidine), using data from the
International Narcotics Control Board (INCB), was presented by Mr. Joranson,
from the Pain Research Group, WHO Collaborating Center, Madison, Wisconsin. The
data demonstrated that since the Declaration of Florianopolis, some
improvement in the consumption of opioids has occurred within the countries that
have participated in the Latin American meetings. The picture that emerged is
one with a distinct difference between those countries that presently have
palliative care programs and those that do not. The trend in countries having
programs shows an increase in morphine consumption, whereas the ones that do not
have programs have very low levels of consumption, sometimes none. This pattern
of opioid utilization does not seem to reflect any political or social situation
within a given country; rather, it demonstrates the impact of the efforts of the
different professionals working in the field of palliative care to create a
medical demand for opioid analgesics.
The data show that countries such as Argentina, Costa Rica, Mexico, and
Dominican Republic had a significant decrease in meperidine (pethidine)
consumption along with a significant increase in morphine consumption.
(Meperidine, although widely used for postsurgical pain management, is not
preferred for chronic cancer pain management, due to toxicity from accumulation
Although some countries such as Colombia, Chile, and Brazil show an increase in
the levels of consumption of morphine, they still have higher consumption levels
of meperidine than of morphine. Some countries such as the Bahamas, Barbados,
Bolivia, Guatemala, Panama, Peru, and Venezuela show little, if any, consumption
of morphine, with only meperidine consumption reported. It is even worse in
other countries that do not show any consumption of either morphine or
meperidine, such as Honduras, El Salvador, Ecuador, Haiti, Jamaica, and
Opioid AvailabilityThe reasons cited for the increase in use of
morphine in some countries were as follows:
- More opioids are available, in different concentrations and formulations.
Some countries have started importing opioid analgesics that were not
available 2 years ago. Colombia is importing methadone and transdermal
fentanyl patches; Venezuela and Dominican Republic, transdermal fentanyl
patches; and Ecuador, slow-release morphine. Other countries in which morphine
is now available in concentrations that were not previously available are
Costa Rica, Chile, Mexico, and Argentina.
- Health authorities in some countries have become interested in palliative
care and cancer pain relief issues and have either created national programs
or are helping existing programs to develop. Since the Declaration of
Florianopolis, Chile and Colombia have adopted a National Palliative Care
and Cancer Pain Relief Program, endorsed by their Ministries of Health.
Some of the following reasons, which were cited as barriers to improving
morphine use, were the same as those given in the Declaration of
- High costs of commercial preparations, slow-release morphine and
transdermal patches costs still remain too high for the majority of the
population (see below).
- Restrictive legislation and regulations interfere with the adequate use of
opioids (see below).
- Distribution of morphine is limited to big centers and hospitals in
cities. Many rural areas do not have enough supplies of opioids to satisfy the
needs of the population.
- There is a lack of education for health professionals about the medical
uses of opioids (see below).
Recommendations About Availability. It was recommended that Mr.
Joranson continue to coordinate the monitoring of opioid use and consumption
trends. He will provide members with the data reported annually by the INCB.
- Members of each country were encouraged to contact the regional and
national health authorities and to provide them copies of the report on
morphine consumption in their country.
- In the summer of 1996, the INCB was to release a new report and
to improve opioid availability. It was intended that a copy be sent to each
member, who in turn would send a copy to the regional and national authorities
in his or her country.
- It is intended that regulators from different countries will work together
to help each other and will recommend ways to enhance the distribution and
access of opioids for the patients, while preventing diversion.
Monitoring Availability. Success will be judged by the following
- Increases in opioid consumption, as recorded in the INCB consumption
reports, increases in total morphine consumption per country, total morphine
consumption per capita, or consumption trends in individual hospitals,
depending on the data available.
- Increases in the number of imported or domestically manufactured opioids
available, in different concentrations and formulations.
- Improved coverage of cancer pain patients who need opioid analgesics.
Members were encouraged to contact Dr. Eduardo Bruera and Dr. Charles Cleeland
in order to design questionnaires and evaluation forms to assess the
prevalence of cancer pain and the treatments available within the different
- The number of physicians actively prescribing opioids and the number of
institutions that provide palliative care and cancer pain relief.
Opioid CostsMany members reported a decrease in the costs of
some commercial preparations. For example, the cost of immediate-release
morphine in Argentina and Mexico has decreased 10 times, as compared with that
of 1994. In addition, new and less-expensive preparations are available in
Brazil, Costa Rica, Argentina, Chile, and Colombia; however, there are countries
in which the costs of some preparations are still too high for many patients.
Recommendations About Costs.
The members recommended the following:
- Pharmaceutical companies have to pay large overhead costs for the import
and distribution of the drugs, which are then transfered to the patient.
- In some countries, such as Venezuela, morphine powder is not imported, and
the only products available are expensive formulations of opioid analgesics.
- The small quantities of drugs that reach the rural areas are sometimes
charged the extra costs of the distribution process. In Brazil, patients in
rural areas may be charged an extra 15%-20% of the original price of morphine
analgesics found in major cities.
- Governments were encouraged to import morphine powder for domestic
manufacture of simple formulations of morphine. The formulation should be done
in approved laboratories, under the supervision of licensed pharmacists.
- Pharmaceutical companies were encouraged to import commercial opioid
preparations that are not otherwise available.
- Governments were encouraged to revise the taxes and the paperwork
procedures imposed on imported preparations of opioid analgesics so that these
are not so burdensome as to discourage the importation of analgesics to a
- Because some inexpensive preparations of opioids are manufactured in
different Latin American countries, members were encouraged to provide
information to drug regulators about these.
Monitoring Costs. Success will be judged by the following criteria:
- The availability of simple and inexpensive preparations
- The decrease in the costs of the presently available preparations
- The increase in the access of the patient population to these
EducationParticipants reported that some progress has been
made in physician education regarding pain assessment, pain evaluation, and
rational use of opioid analgesics. Countries such as Argentina and Colombia
have adopted formal training programs for residents and undergraduates. The
following were the reasons reported as accounting for the barriers in
- Old pharmacopoeias still call for use of nonopioid analgesics or low
doses of opioids for short periods.
- Although some improvement has been made in the education of physicians
since the Declaration of Florianopolis, there has been very little,
if any, improvement in the education of nurses, pharmacists, and hospital
administrators on the issues of palliative care, cancer pain relief, and the
rational use of analgesic opioids.
Recommendations About Education.
- Members were encouraged to participate in seminars with palliative care
and cancer pain relief lectures. Educational seminars and workshops should
include health professionals from different areas, including physicians,
nurses, administrators, and pharmacists.
- Members who hold teaching positions within medical and health teaching
facilities were encouraged to promote changes in the curriculum in which
palliative care and cancer pain relief are taught starting from
undergraduate levels. The International Association for the Study of Pain
Core Curriculum for Professional Education in Pain and the Canadian
Palliative Care Curriculum can serve as guides.
- Efforts should be made to include cancer pain relief and palliative care
as part of the Cancer Control Strategy within every country, and this should
be regarded as important as the Cancer Prevention and Cancer Treatment
Programs. The mechanism by which members can do so is by contacting national
health authorities, cancer leagues, and volunteer organizations.
- Pharmaceutical companies were encouraged to promote seminars and
distribute publications on palliative care and cancer pain relief to educate
the health professionals and the general public. Pharmaceutical companies
should promote the education of all health professionals, including nurses,
social workers, therapists, psychologists, and other professionals who work
as part of the team care group.
- Health professionals possessing Spanish copies of books, documents,
articles, and/or reports were to make these available to other members by
informing them about titles, costs, and shipping procedures. Dr. Roberto
Wenk, from Argentina, and Dr. Franklin Ruiz, from Colombia, were available
to provide valuable literature support.
- Members were to encourage nurses to participate in educational programs,
research, publication of materials, and management and care of terminal
patients. Mr. Guillermo Vanegas, RN, was available to provide support and to
act as an advisor in this area.
Monitoring Education. Success will be judged by the following
- The number of multidisciplinary seminars promoted in a given country and
the number of health professionals who attended
- Any changes in curriculum within the health-related careers
Legislation and RegulationsMr. Joranson invited drug
regulators from four countries - Costa Rica, the Dominican Republic, Colombia,
and Chile - to participate. They worked together to discuss the issues of
opioid availability in their countries. The regulators participated in a
panel, during which they discussed how to achieve a balance between opioid
availability and measures to stop illegal use.
A preliminary analysis of the Colombian law was presented by Mr. Joranson
and Liliana De Lima, Fellow in Policy Studies, Pain Research Group, WHO
Collaborating Center, Madison, Wisconsin. The legislation analysis, which uses
criteria based on international treaties and WHO guidelines, serves to enable
members from the different countries to identify positive provisions, as well
as barriers, within the laws, and the regulations that interfere with the
medical use of opioids, and develop recommendations for change.
- Some of the barriers identified in the legislation and regulations of
Latin American countries include limits on the dosage amounts, amounts of
prescription, the duration of therapy, and the concentrations of the drugs.
Often these limitations interfere with the treatment of chronic cancer pain.
- Pharmacies and health institutions have limits to the amount of morphine
they can store, which are sometimes inadequate to satisfy the medical needs
of the patients in that community.
- Although special prescription forms may be necessary, they are difficult
to obtain, and in some countries such as the Dominican Republic, Costa Rica,
and Venezuela, physicians are charged for them.
- Volunteers in countries such as Chile have proved to be of valuable help
in the control of diversion of the "leftover" drugs following the death of
the patient. Volunteers are distributed geographically and then are required
to visit the patients, providing assistance and guidance in the use of
opioids. After the patient dies, the volunteer takes back any leftover drugs
to the drug system, and if appropriate, these are made available for other
Recommendations About National Narcotic Legislation.
- Members of different countries were encouraged to read their national
narcotics law thoroughly and to know the regulations and prescribing
- Regulators and government representatives were encouraged to seek advice
from Mr. David Joranson, Director of Policy Studies, WHO Collaborating
Center in Madison, Wisconsin, about issues concerning legislative and
- Members of different countries were encouraged to meet their regulators
and establish a dialogue, identify issues, and prepare a work plan.
Regulators were requested to avoid setting limits on the dosages, the
potency, or the duration of the therapy, as these are medical decisions that
should be made by the physician, depending on the patient's condition. The
amounts allowed for storage in health institutions and pharmacies should be
enough to satisfy the needs of the patients, including large doses and
- Pharmaceutical companies were to encourage meetings between the
regulators and physicians to identify the preparations that best suit the
needs of the population.
- The information required on the triplicate prescription forms should be
limited to reasonable information, as recommended in the WHO Publication Guide on
Opioid Availability. Prescription pads should be free and be easily
available for the physicians throughout the country.
- Volunteers should be trained to help reduce the risk of diversion.
Members were encouraged to contact Mrs. Lea Derio, from the Ministry of
Health of Chile, in order to gain information on how the system is set
Monitoring Legislation. Although changes in legislation are slower
to achieve, success will be judged by the following criteria:
- How much health professionals know about their own legislation.
- Any legislative changes in which articles and regulations that impede
the adequate use of opioids have been affected. Countries in which
legislation changes have been adopted will be used as positive examples, and
other members should know how the process was conducted in order to initiate
such a process in their countries.
ConclusionsThe Santo Domingo Report has identified the
progress in opioid utilization, costs, and legislation that has taken place in
some Latin American countries since the 1994 Declaration of
Florianopolis. The reports from different members indicate that there has
been significant progress in the areas of new opioid formulations, physician
education, and reduction of costs. Significant improvement is still needed in
the areas of legislation, distribution, and education of other health
professionals, including nurses and pharmacists.
There appears to be a sharp contrast in the region between countries where
opioids are accessible for pain patients and those in which there is almost no
access. This contrast does not seem to follow socioeconomic patterns, as can
be seen by some wealthier countries in the region having less patterns of
utilization than do much poorer countries.
As in the Declaration of Florianopolis, the success of the
recommendations made in this report depends on the cooperation of all health
professionals, including physicians, nurses, pharmacists, government
regulators, pharmaceutical companies, volunteers, political organizations, and
health administrators. Regular monitoring will take place to assess the degree
of implementation of these recommendations in each country and the success of
these recommendations in producing the necessary changes. The results will be
discussed again in 1998.
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