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Reprinted by permission
of Elsevier Science Inc.: Opioid Availability in Latin America: The Declaration
of Florianopolis, by Jan Stjernsw�rd, et al. Journal
of Pain & Symptom Management, Volume 10(3): 233-236. Copyright 1995
by the U.S. Cancer Pain Relief Committee.
Special Article
Opioid Availability in Latin America: The Declaration of
Florianopolis
Jan Stjernsw�rd, 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 N��ez Olarte, MD
(Spain), Jos� Felix Olalla, MD (Spain), and Guillermo Vanegas, Jr., RN (Italy)
World Health Organization Palliative Care Program for Latin America,
Florianopolis, Brazil
Abstract
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 Stjernsw�rd, 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
1995;10:233-236.
Key Words
Opioid availability, Latin America, WHO, drug regulation
Utilization
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.
Recommendations
The following recommendations were made on the
issue of cost:
- 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 available.
- 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 groups.
- 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 identified.
In a given country, a decrease in cost is only likely to be achieved as a
result of a combination of several of these recommendations. 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.
The results will be discussed in
2 years.
Legislation/Regulations
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. Jos� 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 2 years.
Conclusions
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.