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[e-drug] Improving Access to opioid analgesics

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:
http://www.who.int/medicines/areas/quality_safety/Impaired_Access/en/index.html
http://www.who.int/medicines/areas/quality_safety/AccessControlledMedicationsBrNote.pdf
http://www.who.int/medicines/areas/quality_safety/Framework_ACMP_withcover.pdf

Below an excellent review of the situation from WHO's perspective. Copied as 
fair use. WB]

http://www.anesthesia-analgesia.org/cgi/content/full/105/1/1

Anesth Analg 2007;105:1-4
C 2007 International Anesthesia Research Society
doi: 10.1213/01.ane.0000267542.72315.34 

EDITORIAL

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 scholtenw@who.int.

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 
essence. 

[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 
problematic. 

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 
administrative procedures 

educating health care professionals, law enforcement staff and others regarding 
current best practices and scientific evidence, and encouraging their adherence 
to these 

developing normative clinical guidelines 

promoting a better understanding of international drug control treaties 

helping to ensure an uninterrupted supply of controlled medications at 
affordable prices 

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 
provided. 

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 
important endeavor. 


Footnotes  
 
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 
www.who.int/governance/eb/constitution/en/index.html). 

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 
www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915005090be?Opendocu
ment). 

10 WHO Model List of Essential Meds, 14th Edition, Geneva, 2005. (Accessed 
through
www.who.int/medicines/publications/essentialmedicines/en/index.html). 

11 Resolution WHA 58.22, 2005. (Accessed through 
www.w9ho.int/gb/ebwha/pdf_files/WHA58/WHA58_22-en.pdf). 

12 Resolution ECOSOC 2005/25. (Accessed through 
www.un.org/docs/ecosoc/documents/2005/resolutions/Resolution%202005-25.pdf).


13 WHO, Framework of the Access to Controlled Medications Program, 2007.
(Accessed through 
www.who.int/medicines/areas/quality_safety/AccessControlledMedicinesProgr.Fr
amework.pdf). 

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 
medicines inclusive. 

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. 

REFERENCES

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]

 

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