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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.

Special Report

Opioid Availability in Latin America: the Santo Domingo Report

Progress Since the Declaration of Florianopolis

Liliana 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
Abstract:
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.

Key Words
Latin America, opioid availability, legislation, regulations, education, costs

The Declaration of Florianopolis

Following 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 Utilization

Participants 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 Costs

It 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 Legislation

The 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 Report

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, 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 their perspective.

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 Consumption

A 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 of metabolites).4 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 Guatemala.

Opioid Availability

The reasons cited for the increase in use of morphine in some countries were as follows:
  1. 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.
  2. 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 Florianopolis:

  1. High costs of commercial preparations, slow-release morphine and transdermal patches costs still remain too high for the majority of the population (see below).
  2. Restrictive legislation and regulations interfere with the adequate use of opioids (see below).
  3. 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.
  4. 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.

  1. 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.
  2. In the summer of 1996, the INCB was to release a new report and recommendations5 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.
  3. 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 criteria:

  1. 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.
  2. Increases in the number of imported or domestically manufactured opioids available, in different concentrations and formulations.
  3. 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 countries.
  4. The number of physicians actively prescribing opioids and the number of institutions that provide palliative care and cancer pain relief.

Opioid Costs

Many 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.
  1. Pharmaceutical companies have to pay large overhead costs for the import and distribution of the drugs, which are then transfered to the patient.
  2. In some countries, such as Venezuela, morphine powder is not imported, and the only products available are expensive formulations of opioid analgesics.
  3. 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.
Recommendations About Costs. The members recommended the following:
  1. 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.
  2. Pharmaceutical companies were encouraged to import commercial opioid preparations that are not otherwise available.
  3. 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 country.
  4. 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:

    1. The availability of simple and inexpensive preparations
    2. The decrease in the costs of the presently available preparations
    3. The increase in the access of the patient population to these preparations

    Education

    Participants 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 education:

    1. Old pharmacopoeias still call for use of nonopioid analgesics or low doses of opioids for short periods.
    2. 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.

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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 criteria:

    1. The number of multidisciplinary seminars promoted in a given country and the number of health professionals who attended
    2. Any changes in curriculum within the health-related careers

    Legislation and Regulations

    Mr. 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.

    1. 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.
    2. 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.
    3. 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.
    4. 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 patients.

    Recommendations About National Narcotic Legislation.

    1. Members of different countries were encouraged to read their national narcotics law thoroughly and to know the regulations and prescribing requirements.
    2. 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 regulatory modifications.
    3. 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 sudden increases.
    4. Pharmaceutical companies were to encourage meetings between the regulators and physicians to identify the preparations that best suit the needs of the population.
    5. 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.
    6. 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 up.

    Monitoring Legislation. Although changes in legislation are slower to achieve, success will be judged by the following criteria:

    1. How much health professionals know about their own legislation.
    2. 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.

    Conclusions

    The 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.

    References

    1. Stjernsward J. Bruera E, Joranson D, et al. Opioid availability in Latin America: the Declaration of Florianopolis. J Pain and Symptom Manage 1995;10:3, 233-236.

    2. World Health Organization Collaborating Center on Symptom Evaluation, Madison, Wisconsin. Cancer Pain Relief: A Guide to Opioid Availability. Preprinted with authorization from WHO, 1992.
    Alivio del Dolor en el Cancer: Guia sobre la Disponibilidad de Opioides [Ruiz F. Cepeda S,Jairo M, De Lima, L, Trans]. Printed with previous authorization from WHO by the Fondo Nacional de Estupefacientes del Ministerio de Salud de Colombia, Bogota, Colombia, 1994.

    3. Joranson DE, Smokowski PR. Opioid Consumption Trends in Latin America: Division of Policy Studies. University of Wisconsin Pain Research Group/WHO Collaborating Center, Madison, Wisconsin, March 1996 (Monograph).

    4. Teoh N. Vainio A. The status of pethidine in the WHO model list of essential drugs. Palliat Med 1991;5:185-186.

    5. International Narcotics Control Board. Availability of Opiates for Medical and Scientific Needs: Special Report Prepared Pursuant to Economic and Social Council Resolutions 1990/31 and 1991/43. World Health Organization (WHO) Cancer Pain Relief: With a Guide to Availability, 2nd ed. Geneva: WHO, 1996.