E-DRUG: Improving Access to opioid analgesics
[One UN agency wants to control its illicit use (INCB), the other UN agency
wants to promote its licit use (WHO). Access to opioid analgesics like morphine
is essential for palliative care and terminal AIDS patients.
However, access to such essential medicines is extremely skewed towards
patients in rich countries.
WHO wants to improve access to opioid analgesics. The WHO "Access to Controlled
Medications Programme" is summarized at:
Below an excellent review of the situation from WHO's perspective. Copied as
fair use. WB]
Anesth Analg 2007;105:1-4
C 2007 International Anesthesia Research Society
The World Health Organization Paves the Way for Action to Free People from the
Shackles of Pain
Willem Scholten, PharmD, MPA*, Helena Nygren-Krug, LLB, LLM, LLM, and Howard A.
Zucker, MD, JD
>From the *Departments of Medicines Policy and Standards; Sustainable
>Development and Healthy Environments; and the Cluster of Health Technology and
>Pharmaceuticals, World Health Organization, Geneva, Switzerland.
Address correspondence to Willem Scholten, PharmD, MPA, Technical Officer,
Quality Assurance and Safety: Medicines, Department of Medicines Policy and
Standards, World Health Organization, 20 Avenue Appia, 1211 Geneva 27,
Switzerland. Address e-mail to email@example.com.
For about 80% of the world's population, pain relief when needed is a right yet
to be realized. If policies on opioid use were better balanced to enable access
to pain relief, rather than merely focusing on potential abuse, human suffering
could be significantly and readily alleviated.
Barriers that prevent people from accessing pain medications stem from efforts
to limit opium trade (mainly for nonmedical purposes) because of its
detrimental effects on the populations of many countries, especially in 19th
century Asia. The Shanghai conference of 1919 was a first step towards
international control of opium. In 1912, the first Opium Convention was signed
in The Hague, Netherlands. Since then, governments appear to be primarily
concerned about the possibility that people would become dependent on
psychoactive substances and about the harm that these could do to them. Often,
they seem to have forgotten about the medical benefit of these substances.
In the decades that followed, more international drug conventions and national
and local drug legislation were adopted. We can now see evidence that these
regulations have not sufficiently prevented people from taking drugs and
becoming dependent on them. Nevertheless, many countries have implemented the
treaties in their domestic laws more strictly than the conventions require,
impeding access to controlled medicines for legitimate medical purposes.
At the same time as the legislative process aimed at preventing drug abuse
evolved, the fear of drug dependence spread in society, both among health
professionals and ordinary people. Physicians started avoiding prescribing
opioids and lost the knowledge of how to use them. A number of medical schools
no longer teach opioid prescribing. Myths began to grow around opioid
medication. Doctors inexperienced in the use of opioids did not know how to
initiate, titrate, and withdraw the medication. Faced with undesirable outcomes
in patients (e.g., respiratory depression after a rapid increase in dose),
physicians became reluctant to prescribe these medicines. This led to further
mystification, including the widespread belief that morphine hastens death,
although this has been refuted (1). One may argue, conversely, that freedom
from pain prolongs life.
A few countries have good access to medicines that are controlled under
international drug conventions1 whereas a number of countries have mediocre
access. However, in most countries, controlled medicines, and especially
opioids, are hardly available, or not at all available. Figure 1 shows the
legal per capita consumption of morphine for each country. It clearly shows
that only 10-20 countries have good or reasonable access. In all other
countries, including in a number of rich countries, availability is a problem.
Admittedly, this graph does not show other opioids used in medicine, but
drafting a graph that would include those other opioids would not change the
[Figure omitted Figure 1. Global morphine consumption per capita, 2004.
The global mean (5.67 mg per capita) is calculated by adding the individual
mg/capita statistics for all countries and then dividing by the number of
countries. Data from 155 countries. Source: International Narcotics Control
Board. United Nations Demographic Yearbook. By: Pain and Policy Studies Group,
University of Wisconsin/WHO Collaborating Center, 2006.]
Drug control goes beyond opioids for analgesics. Controlled medicines also
include opioids for the treatment of opioid dependence, and some nonopioids.
Preliminary estimates show that, every year, 4.8 million people suffering from
moderate to severe pain caused by cancer do not receive treatment. For moderate
to severe pain experienced during end-stage Acquired Immuno Deficiency Syndrome
(AIDS), an estimated 1.4 million receive no treatment annually.2 For other
causes of pain, we can assume that those estimations are in the millions.
Substitution therapy of opioid dependence decreases the mortality rate of
opioid-dependent patients considerably. (In France, a reduction of more than
90% was observed after its introduction in the 1990s.)3 It also decreases the
transmission of blood-borne diseases like HIV and hepatitis C virus since it
reduces the use of contaminated needles. The use of injected drugs and
contaminated needles is known to be the cause of new infections in 30% of all
new HIV cases outside sub-Saharan Africa (420,000 cases annually)4 With regard
to the medicines used in emergency obstetric care no accurate figures have yet
been collected, but access to ephedrine and ergometrine are reportedly
The health impact of the lack of access to controlled medicines can be
expressed even more forthrightly: cancer causes 12% of all deaths and 80% of
terminal-stage cancer patients suffer moderate to severe pain. Of
terminal-stage patients, 80% will have no access to the analgesics they need.
This means that the lives of 7.75 of the world's population, or 576 million of
the roughly 6 billion people living today, will end without adequate analgesia.
Similar estimates suggest that a further 36 million HIV patients die in pain.6
In summary, of the people living now, at least 600 million will experience one
or more of the negative health impacts mentioned above during their lifetime as
a result of not being able to obtain medicines controlled under international
drug control treaties.
Although the drug conventions are often implemented in a way that hampers
access to these medicines, their stated objective includes the availability of
controlled medicines in medical practice. For example, the Preamble to the
Single Convention on Narcotic Drugs, i.e., the convention that regulates most
opioids, says "Recognizing that the medical use of narcotic drugs continues to
be indispensable for the relief of pain and suffering and that adequate
provision must be made to ensure the availability of narcotic drugs for such
purposes ...." The Preamble of the Convention on Psychotropic Substances uses
similar wording and adds " ... that their availability for such purposes should
not be unduly restricted ...."
Another important legal instrument, to which 193 states are parties, is the
constitution of the World Health Organization (WHO). It recognizes "the
enjoyment of the highest attainable standard of health [as] one of the
fundamental rights of every human being without distinction of race, religion,
political belief, economic or social condition."7 It defines health broadly as
including physical, social and mental well-being. Importantly, in this context,
when the United Nations Committee on Economic, Social, and Cultural Rights
issued its interpretation of the above, it included access to essential
medicines as part of the state parties' core obligations and referred
explicitly to the WHO Model List of Essential Medicines.8-10 This list includes
those medicines that satisfy the priority health care needs of the population
and are intended to be available within the context of functioning health
systems at all times, in adequate amounts, in the appropriate dosage forms,
with assured quality and adequate information, and at a price the individual
and the community can afford.
Another important development came in 2005, when the World Health Assembly, the
highest governing body of the WHO, adopted a resolution asking WHO and the
International Narcotics Control Board (INCB) to help countries to improve
access to opioid analgesics.11 A similar call was made by the Economic and
Social Council.12 In response, WHO developed the Access to Controlled
Medications Program (ACMP) in consultation with the INCB.13 With INCB, WHO
agreed that WHO will operate the program solely.
The program recognizes similar obstacles to access as those identified by
Brennan et al. in this issue of Anesthesia and Analgesia. (2) As a result, the
ACMP will address the broad range of the impediments to appropriate use of
controlled medications, including.14
improving access to effective treatment by reviewing legislation and
educating health care professionals, law enforcement staff and others regarding
current best practices and scientific evidence, and encouraging their adherence
developing normative clinical guidelines
promoting a better understanding of international drug control treaties
helping to ensure an uninterrupted supply of controlled medications at
assisting governments to make realistic estimates of future needs for opioid
analgesics and to compile reliable statistics on past consumption
performing surveys on the accessibility, availability, affordability and use of
the medicines and substances involved.
Because access to controlled medicines is wider than access to opioid
analgesics only, the program will include all medicines controlled under the
drug conventions listed on the WHO Model List of Essential Medicines. These
include the medicines and medicine classes of opioid analgesics, opioids for
substitution therapy of opioid dependence, ephedrine and ergometrine,
benzodiazepines, and phenobarbital. These medicines are used in many areas of
medicine, including oncology, palliative care (for cancer, HIV patients, and
others), anesthesiology, surgery, trauma, treatment of dependence, neurology,
obstetrics, psychiatry, and general medicine. Basically, the obstacles to
address are the same for all these areas of medicine and therefore, the program
will cooperate with all these medical specializations and with many others
involved, including patients, pharmacists, and nurse associations.
As the numbers of affected patients make clear, impeded access is a huge
problem. Therefore, the ACMP will involve other organizations to enable the
work to take place on a scale that can make a real difference. WHO is currently
developing the operational plan for the first 6 yr of the program. However, it
is expected that it will take a much longer period to reach the more than 150
countries where access to controlled medicines is a problem. Initially, the
ACMP will work in countries where change has begun to take place in one way or
another, and will use the experience of countries, such as Romania, Uganda, and
some Indian states, that have made important improvements over the past year.
Gradually, the program will move on to other countries. If improvement were to
depend entirely on the actions of the ACMP, global change would take an
estimated 15-20 yr. It is hoped that, at a certain stage, countries will copy
the successful efforts of other countries on their own initiative.
For too long now, pain relief has remained a distant reality for millions of
people. The barriers are many, and stem mainly from the skewed focus on
limiting potential drug abuse rather than on relieving human suffering. But
there are also widespread myths that need to be dispelled, such as the idea
that newborns do not feel pain. Although the signals that children give when in
pain may be different from those of adults, thus making the diagnosis more
challenging, the best interests of the child must prevail15 and relief must be
The human suffering due to lack of pain relief is an affront to human dignity.
Every effort must be made to remedy this situation. WHO, through its ACMP, will
support governments in the realization of their obligation under the right to
"the enjoyment of the highest attainable standard of health, " to make
essential medicines accessible. WHO welcomes collaboration with others in this
1 Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol;
Convention on Psychotropic Substances, 1971; United Nations Convention against
Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.
2 Based on number of cancer and HIV/AIDS deaths in 2001, World Health Report
2002 and INCB statistics.
3 Information from Dr. Patrizia Carrieri, INSERM, Marseille, France.
4 UNAIDS Global Facts and Figures 2006.
5 0.12 multiplied by 0.8 multiplied by 0.8.
6 These are rough estimates, that would need to be adjusted for increasing
mortality from cancer and pain from other causes.
7 Off. Rec. Wld Hlth Org., 2, 100. (Accessed through
8 International Covenant on Economic, Social and Cultural Rights, Article 12.
(Accessed through www.ohchr.org/english/law/cescr.htm).
9 General Comment 14, on the right to the highest attainable standard of health
(art. 12), 2000. (Accessed through
10 WHO Model List of Essential Meds, 14th Edition, Geneva, 2005. (Accessed
11 Resolution WHA 58.22, 2005. (Accessed through
12 Resolution ECOSOC 2005/25. (Accessed through
13 WHO, Framework of the Access to Controlled Medications Program, 2007.
14 The ACMP often uses the word medications to include the whole process of
making medicines available from the beginning to the end, the administration of
15 The principle of the best interest of the child to be a primary
consideration and guide all actions is enshrined in the UN Convention on the
Rights of the Child (1990).
Accepted for publication April 5, 2007.
Porthenoy RK, Sibirceva U, Smout R, Horn S, Connor S, Blum RH, Spence C,
Fine PG. Opioid use and survival at the end of life: a survey of a hospice
population. J Pain Symptom Manage 2006;32:532-40.[ISI][Medline]
Brennan F, Carr DB, Cousins MJ. Pain management: a fundamental human right.
Anesth Analg 2007;105:205-21.[Abstract/Free Full Text]