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1
Proposal to the WHO Expert Committee on Selection of Medicines
A request to place medicines for palliative care in a
separate highest level section of the Model List of Essential Medicines for Children
Contents
1. Summary statement
2. Focal point
3. Consulted organizations
4. Current status of palliative care on the EMLc
5. Public-health rationale for this application
6. Disadvantages of current status
7. Technical corrections of inconsistencies
8. Timeliness of the application
9. Application/request
10. Acknowledgements
Additional reading
Annex 1
References
1. Summary statement
This proposal requests that the WHO Expert Committee on Selection of
Medicines changes the 3rd WHO Model List of Essential Medicines for Children dated
March 2011 (hereafter referred to as the "EMLc")1 so that medicines for palliative care
are located in a separate highest-level section of the list. Such a repositioning of the list
will help to end the lack of access, especially in low- and middle-income countries, to
essential medicines for palliative care and will avoid unequal and impaired access for
patients with a similar health status in other care settings.
The recently published WHO Guidelines on the Pharmacological Treatment of
Persisting Pain in Children with Medical Illnesses2 highlight the need for changes to the
EMLc and so do the WHO policy guidelines Ensuring Balance in National Policies on
Controlled Substances, Accessibility and Availability of Controlled Medicines3. Some of
the changes needed relate to individual preparations and will be addressed in separate
applications to the Expert Committee. This application relates to the structure of the list,
which needs improvement in order to advance availability and accessibility of opioid
analgesics and of palliative care medicines.
Currently the WHO has no analogue guideline for persisting pain in adults, but it
is obvious that the arguments presented in this application equally apply to the EML for
adults4, and the Committee may therefore want to draw similar conclusions for the latter.
2
Because this is not an application for the addition of specific medicines to the
EMLc, the standard format for applications did not seem suitable; therefore, this
application has a format deviating from the format provided by the Committee.
2. Focal point in WHO
Willem Scholten, WHO Team Leader, Access to Controlled Medicines,
Medicines Access and Rational Use, Department of Essential medicines and Health
Products, World Health Organization.
Correspondence after 31 October 2012: [email protected].
3. Name of the organization(s) consulted and/or supporting the application
The following organizations were requested to comment on the draft application and to
support the final application:
a. European Association of IASP Chapters, EFIC, Christel Geevels, Executive Secretary
([email protected]) (Please see letter of support)
b. Human Rights Watch, Mr Diederik Lohman ([email protected]) (Please see letter of
support)
c. International Association for Hospice and Palliative Care, Executive. Director, Dr
Liliana de Lima ([email protected]) (Please see letter of support)
d. International Association for the Study of Pain, Dr Kathy Kreiter, Executive Director,
([email protected]) (IASP Special Interest Group on Pain in Childhood, contact:
Dr Gary Walco, [email protected]) (Please see letter of support)
e. International Children’s Palliative Care Network, Dr Joan Marston, Executive
Director ([email protected]) (Please see letter of support)
f. International Union Against Cancer (UICC), Ms Julie Torode, Deputy CEO
([email protected]) (Please see letter of support)
g. World Institute of Pain, Dianne Willard, Executive Officer,
([email protected]) (Please see letter of support)
h. World Health Organization, Cancer Control Programme, Department of Chronic
Diseases Prevention and Management, Dr Cecilia Sepúlveda Bermedo, Senior
Adviser ([email protected]) (No reaction received) i. World Health Organization, Department of Child and Adolescent Health, Dr Lulu
Muhe, Technical Officer ([email protected]) (Please see e-mail of support)
j. World Wide Palliative Care Alliance, Dr Stephen R. Connor Ph. D., Senior Fellow
([email protected]) (Please see letter of support)
4. Current status of palliative care on the EMLc
Medicines for palliative care are currently included in the EMLc as
Subsection 8.4 in Section 8, titled: Antineoplastic, Immunosuppressives and Medicines
used in Palliative Care. Some of the medicines in Subsection 8.4 are also included in
3
other sections of the EMLc, according to their therapeutic use, e.g. opioid analgesics are
listed in Section 2.2. Other medicines are exclusively listed in Subsection 8.4.
5. Public-health rationale for this application
Introduction
From a public-health perspective, currently many patients are without access to
essential medicines for pain and palliative care. WHO policies and international drug
conventions require that countries make medicines controlled under these conventions
readily available to those in need. Opioid analgesics like morphine are among these
controlled medicines. Palliative care is promoted by WHO policies and is becoming more
important as the burden of NCDs increases. Positioning of the medicines for palliative
care on the Model List in a way that indicates secondary importance can negatively affect
access. The optimal positioning of the palliative care list is therefore of the utmost
importance.
Importance of improving access to opioid analgesics in global public health
It has been well documented that in most countries of the world, patients do not
have adequate access to opioid analgesics. The various barriers are described in the
World Medicines Report5 and in the WHO policy guidelines Ensuring Balance in
National Policies on Controlled Substances, Accessibility and Availability of Controlled
Medicines3. Legal and policy barriers are important reasons why these medicines are not
available in many countries. Seya et al. estimate that in 2006 only 464 million people had
adequate access to opioid analgesics, and 4.7 billion people had virtually no access6.
The World Health Assembly in its resolution 58.22 “On Cancer prevention and
control” (2005), called on WHO to address access to opioid analgesics7. Other
international bodies such as the International Narcotics Control Board (e.g. in a special
report on the availability of internationally controlled drugs)8 and the UN Commission on
Narcotic Drugs, have called for greater access for patients to these medicines.
In addition, the International Association for the Study of Pain adopted the World
Pain Declaration9, the Union for International Cancer Control published the World
Cancer Declaration10
and a consortium of 60 international and national organizations
initiated by Pallium India launched the Morphine Manifesto11
. All these declarations call
for adequate access to pain medicines and treatment of pain worldwide.
Importance of promoting palliative care in global public health
In recent years it has become clear that palliative care will become more and more
important12,13
. This is most clear for cancer control strategies, but palliative care is also
important to treat patients with HIV/AIDS14
, multiple and extensively drug resistant
tuberculosis (M/XDR TB)15,16
, severe congenital disease17
and many other conditions. In
WHA resolution 58.22 “On Cancer prevention and control”7, the Assembly called also on
WHO to establish cost-effective standards that include palliative care. WHO published in
2006 the WHO guide for effective programmes for Cancer control: Knowledge into
action18
. In this guide, consisting of a series of guidelines on various topics of cancer
4
control, it has been made clear that palliative care is an essential part of cancer control.
WHO strongly promotes that countries include palliative care as a part of their health care
systems.
A parallel development was that WHO added a section on medicines used in
palliative care to the EMLc. This was done at the request of the International Association
for Hospice and Palliative Care that initially organized a consensus meeting for the
drafting of a list19,20
. From this consensus list, several medicines were included in the
EMLc, but not all.
6. Disadvantages of current listing
Current listing is misleading
The purpose of the List is to be a guide for development of national and
institutional essential medicine lists and treatment policies. The current placement of
palliative care medicines together with antineoplastic and immunosuppressive medicines
gives the impression that palliative care medicines are intended for cancer patients only
and thereby validates laws and regulations in some countries that permit opioid
analgesics to be prescribed only for late-stage cancer patients.
Current listing lacks adequate guidance about indication
In Section 8.4, medicines are classified by the specialty of the health-care
workers. There is no other section exclusively bringing together medicines for a specific
type of care: the basic organizing principle used in the EMLc is to group medicines
according to their general effect on the body by organ system (e.g. cardiovascular
medicines, gastrointestinal medicines, dermatologic medicines) or by pharmacokinetic
activity (e.g. anaesthetics, analgesics, anti-neoplastic medicines). This structure permits
listing of sub-categories that identify specific indications. Because Medicines Used in
Palliative Care currently is a subsection, it does not give indications for any medicines.
For example, there is no sub-section on “medicines for nausea and vomiting” that would
include ondansetron. This lack of specific indications will result in reduced access to the
proper palliative medicines.
The exclusive listing of medicines in this section can lead to the denial of access
for patients with an identical or similar health status as patients in palliative care and who
equally qualify for these medicines, but who are treated by other specialties. Therefore,
there should be a clear justification for exclusively listing any medicine in this (sub)-
section of the EMLc only. For instance, for opioid analgesics the WHO Guidelines on the
Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses2 point
out that the clinically correct manner of treating pain does not depend on etiology but on
the pathophysiological mechanism of the pain.21
Therefore, pain patients with a similar
type and level of pain should be treated equally, regardless of the type of service
providing the treatment. The current differences between Section 8.4 and other sections
related to pain treatment are therefore unjustified.
5
Another negative consequence of the current structure of the EMLc is that
medicines listed in other sections of the EMLc do not appear in the section on palliative
care (e.g. essential medicines listed as anti-neoplastics, anti-retrovirals and anti-
tuberculosis medicines). This may cause the misunderstanding that patients in palliative
care do not qualify for access to these other medicines, and policy makers may conclude
that hospices and palliative care institutions do not need these medicines.
Principle of Non-Discrimination
Non-discrimination in health services is one of the core principles of the World
Health Organization’s Constitution, as well as of the international legal regime.
Regretfully, the current structure of the EMLc may unintentionally lead to violations of
this principle, as health policy makers may erroneously conclude that palliative care
medicines are intended for cancer patients only. This could lead to unjustifiable failure to
treat non-cancer patients with medicines listed in the section—especially controlled
medicines—despite a medical need. United Nations and WHO policies indicate clearly
that access to controlled substances should not be restricted to certain groups only.
Furthermore, in the case of pain treatment, not treating patients for their pain by
neglect, is a violation of the right to the highest attainable standards of health and
wellbeing as illustrated in the memorandum on the right to health and access to medicines
for pain and palliative care.22
WHO policy as enunciated in its policy guidelines Ensuring balance in national
policies on controlled substances3 is found in Guideline 7. It states:
“Guideline 7: Governments should include the availability and accessibility of
controlled medicines for all relevant medical uses in their national pharmaceutical policy
plans. They should also include the relevant controlled medicines and relevant services
in specific national disease control programmes and other public health policies.
Planning for availability through the formulation of policy plans is
essential for defining and realizing the health policy objectives of a country. It is
also essential for the realization of a country’s international obligations with
respect to the international drug conventions and human rights conventions.
The objective to make controlled medicines available and accessible for
all medical and scientific purposes in the national medicines policy plan should
be stipulated at the outset. Policies should also address availability of controlled
medicines for scientific purposes, as research with these substances may be
necessary for such use.
Only after establishing this general policy should specific policy plans be
developed for individual diseases. As a minimum, countries should ensure that
availability and accessibility of controlled medicines is addressed for the
following disease-specific policies:.. [the table that follows includes cancer
6
control, HIV/AIDS, mental health including substance abuse or other disorders,
and maternal health.]” 23
Thus clearly, medicines for palliative care are not only for cancer patients, but
also for HIV/AIDS patients, M/XDR TB, severe congenital disease and other conditions.
The Guidelines clearly recommend that countries adopt a general policy on accessibility
of controlled medicines before developing policies for specific conditions. The current
EMLc is organized the opposite way. It only lists palliative care medicines as related to
cancer, without providing a general list of essential palliative care medicines for all
conditions that require such health services. Thus, for patients with exactly the same pain,
the structure of the essential medicines list may result in negligence of their pain, a result
that cannot be justified medically nor under the Guidelines. This could constitute
discrimination by health status, and thus a violation of international human rights norms.
Examples of countries where discrimination of pain patients occurs in practice
It is important to avoid introducing rights for certain groups that could be
construed as withholding this right to other patient groups. Indeed in practice this is
happening. For example in the Russian Federation and Japan, it is not allowed to
prescribe strong opioid analgesics for patients other than terminal cancer patients. In the
State of Kerala, India, after the introduction of a state policy to make strong opioids
available to cancer patients, access was denied to patients suffering severe pain from
HIV, because the policy did not state such use. Even recently in Kerala, a non-cancer
patient in pain was requested to present a biopsy report.
7. Technical corrections for inconsistencies
If the Expert Committee decides to reorganize the list, this may be an opportune
time to address the following items for technical correction:
Updating to new guidelines
There is a question as to whether the analgesics on the list are adequate to meet
the needs of the growing demand that will result from NCDs. The EML and EMLc
should be aligned with pharmacological treatment guidelines for adults and children.
(Based on the new persisting pediatric pain guidelines, separate preparation-specific
applications for the EMLc will be submitted)
Lack of listing the indication or intended use in the palliative care list
The intended use of the medicines in the palliative care section is not specified.
Unjustified differences between the general part and the palliative care list
- Some medicines in the palliative care subsection are not listed in the general part
In principle every preparation on the palliative care list should also be on the main
list, unless there is a sound justification why patients with a similar symptom should not
receive the treatment outside a palliative care setting. There are 13 medicines in the
palliative care list but only 7 appear elsewhere. Examples are the laxatives docusate
sodium and lactulose.
7
- Some medicines needed in palliative care not listed in the specific PC section
The existence of a section with a limited number of medicines for palliative care
can easily lead to misinterpretation. There is a risk that policy makers will withhold
medicines not on the list to palliative care services and hospices (e.g. essential medicines
listed as anti-neoplastics, anti-retrovirals and anti-tuberculosis medicines). Being
admitted to palliative care does not necessarily mean that the treatment of the patient’s
specific disease should be interrupted. Antiretrovirals, antituberculosis medicines and
many other treatments should be continued and in many cases the treatment can be
provided by the palliative care service.
Examples of the problems mentioned above:
Issues with laxatives
Together with any opioid administration, laxatives should be given concurrently.
This is a ”mandatory” treatment approach that goes back for decades. It was already
mentioned in the WHO guidelines Cancer Pain Relief in 1986. The WHO guidelines
Cancer Pain Relief in Children (p 40)24
mention: “constipation is an expected side-effect
of opioid administration and it does not resolve. It can be avoided by giving a suitable
diet (increased fluids and bulk) and by the daily administration of stool softeners, such as
docusate, combined with a stimulant, such as senna.” The WHO guidelines on the
Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses,
mention “Long-term opioid use is usually associated with constipation and patients
should also receive a combination of a stimulant laxative and a stool softener
prophylactically.” (p 41)2 Therefore, laxatives are essential medicines in any treatment
with opioid analgesics, regardless whether the patient is treated in a palliative care setting
or in any other setting. However, in the EMLc, laxatives are only mentioned in Section
8.4 (Palliative Care), which section lists docusate sodium, lactulose and senna. As a
result, patients treated with opioids in a different setting than a palliative care setting may
not receive the treatment they need.
Issues with morphine
The EMLc lists morphine for palliative care. Although not mentioned in the
EMLc, the listing of morphine in Section 8.4 is obviously intended for the treatment of
pain and not as a pre-operative agent. It is not clear that oral morphine solution is also
intended for the palliation of dyspnoea.
Issues with ibuprofen and morphine
The WHO guidelines on the Pharmacological Treatment of Persisting Pain in
Children with Medical Illnesses2 do not make any distinction between the treatment of
pain in a palliative care setting or in another setting. However, several dosage forms and
strengths are exclusively mentioned in Section 8.4 of the EMLc: ibuprofen tablet 600 mg,
and morphine granules (modified release; to mix with water): 20 mg; 30 mg; 60 mg; 100
mg; and 200 mg. This range of granule capsules gives access to children who cannot
swallow solid preparations and to children who can swallow but who have a need for
8
higher strengths, as the highest slow release tablet on the EMLc is only 60 mg. As a
result, patients treated for pain with ibuprofen or morphine in a different setting than a
palliative care setting may not receive the treatment they need.
The recent publication of the guidelines on persisting paediatric pain leads to the
need for making the EMLc consistent with the new guidelines. There will be new dosage
forms and new opioid analgesics. The additions need to be accurately added in the same
manner to all parts that relate to pain control, both in the general part and the palliative
care section in order not to create new inconsistencies. Based on the new persisting
pediatric pain guidelines, several separate applications for the addition of preparations of
opioid analgesics to the EMLc will be submitted.
8. Timeliness of this application
The Committee noted in its 2011 report that the WHO guidelines for palliative
care are in need of update. The guidelines for Cancer pain relief and Palliative Care in
Children have been replaced now by the new pediatric guidelines on persisting pain2 and
WHO has issued numerous policy statements with reference to chronic and other specific
diseases. This proposal offers an opportunity to bring the EMLc in alignment with WHO
treatment and policy guidelines and with human rights practice.
This request makes no suggestion on the particular content of the palliative care
part of the EMLc; the precise content of the list is not what this application is about.
Rather this application refers to the headings under which these medicines are grouped
and the system in use. It is hoped this application may assist the Committee in
organizing medicines for pain and palliative care in an up-to-date, user friendly manner.
All that is needed is to group all medicines for palliative care under one highest-level
section with appropriate subsections and as deletions and additions are made these
changes would be included in the new section and subsequent subsections the Committee
deems appropriate. Unlike for other sections, the section title does not indicate the use of
the medicines in the palliative care section and therefore such an indication needs to be
added. By creating a highest-level section for medicines for palliative care, the
Committee will highlight the importance of palliative care and avoid the impression that
other patients are not entitled to be relieved of avoidable.
9. Application/Request Today, palliative care is not (yet) integrated in the health care system in many
countries and does not exist in other countries.25
Given the great importance of palliative
care in current global public health, a special position in the EMLc is justified, as already
explained above under Importance of promoting palliative care in global public health.
Such a positioning of the palliative care section should not lead to discriminate against
any patients with similar or identical medical needs for the medicines listed on this list
and it should also not impede access to other medicines listed for patients admitted to
palliative care.
We request that an appropriate separate highest-level section is created for the
content of Section 8.4. A short introduction in the explanatory notes of the EMLc will be
9
needed to clearly define the meaning of this highest-level section. An example of how
such an introduction may look like is presented in Annex 1.
By the creation of a separate highest-level section on medicines for palliative
care, the full impact of WHO policy can be made clear, and the availability of these
medicines improved. Highlighting such medicines in this manner will provide an up-to-
date presentation of medicines for palliative care reflecting best medical practices, human
rights, and WHO policies. By establishing a new highest-level section in the EMLc, and
possibly also in the EML, the utility of the EML(c) to serve as a guide for the
development of national and institutional essential medicine lists will be strengthened and
provide robust guidance to national medicines policies.
10. Acknowledgements
Dr Willem Scholten has been assisted by Michele Forzley, JD, MPH, Professor of
Global Public Health Law Widener School of Law, USA when drafting this application.
Mr Diederik Lohman (Human Rights Watch) and Dr Erik Krakauer (Harvard Medical
School; on behalf of UICC) reviewed the manuscript.
Additional Reading
Bond M. Pain education issues in developing countries and responses to them by
the International Association for the Study of Pain. Pain Res Manag. 2011 Nov-
Dec;16(6):404-6. Review. http://www.ncbi.nlm.nih.gov/pubmed/22184547
Cheng SY, Dy S, Hu WY, Chen CY, Chiu TY. Factors Affecting the
Improvement of Quality of Dying of Terminally Ill Patients with Cancer through
Palliative Care: A Ten-Year Experience. J Palliat Med. 2012 Jun 27. [Epub ahead
of print]
Emanuel N, Simon MA, Burt M, Joseph A, Sreekumar N, Kundu T, Khemka V,
Biswas B, Rajagopal MR, Emanuel L. Economic impact of terminal illness and
the willingness to change it. J Palliat Med. 2010 Aug;13(8):941-4.
Gardiner C, Gott M, Ingleton C, Hughes P, Winslow M, Bennett MI. Attitudes of
Health Care Professionals to Opioid Prescribing in End-of-Life Care:
A Qualitative Focus Group Study. J Pain Symptom Manage. 2012 Jun 5. [Epub
ahead of print]
Human Right Watch, Uncontrolled Pain, Ukraine’s Obligation to Ensure
Evidence-Based Palliative Care. New York, 2011. ISBN 1-56432-768-X.
accessible at:
http://www.hrw.org/sites/default/files/reports/ukraine0511WebRevised.pdf
Lynch T, S Payne, W Scholten, S Juenger, L Radbruch. ATOME training of
lawyers and national counterparts workshop: a report. European Journal of
Palliative Care 2011; 18 (6), 293-297
10
Malloy P, Paice JA, Ferrell BR, Ali Z, Munyoro E, Coyne P, Smith T. Advancing
palliative care in Kenya. Cancer Nurs. 2011 Jan-Feb;34(1):E10-3.
http://www.ncbi.nlm.nih.gov/pubmed/20921889
Namukwaya E, Leng M, Downing J, Katabira E. Cancer pain management in
resource-limited settings: a practice review. Pain Res Treat. 2011;2011:393404.
Epub 2011 Dec 11. http://www.ncbi.nlm.nih.gov/pubmed/22191020
Pergolizzi J, Böger RH, Budd K, Dahan A, Erdine S, Hans G, Kress HG,
Langford R, Likar R, Raffa RB, Sacerdote P. Opioids and the management of
chronic severe pain in the elderly: consensus statement of an International Expert
Panel with focus on the six clinically most often used World Health Organization
Step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine,
oxycodone). Pain Pract. 2008 Jul-Aug;8(4):287-313. Epub 2008 May 23.
http://www.ncbi.nlm.nih.gov/pubmed/18503626
Radbruch L, S Juenger, S Payne, W Scholten. Access to opioid medication in
Europe. Journal of Pain and Palliative Care Pharmacotherapy 2012; 26 (2)
Rajagopal M. Disease, dignity and palliative care. Indian J Palliat Care. 2010
May;16(2):59-60.
Scholten W, Nygren-Krug H, Zucker HA: The World Health Organization Paves
the Way for Action to Free People from the Shackles of Pain, Anesthesia &
Analgesia, 105, 1 (July 2007) 1-4. Accessible at: http://www.anesthesia-
analgesia.org/cgi/content/full/105/1/1
Simone CB 2nd, Vapiwala N, Hampshire MK, Metz JM. Palliative care in the
management of lung cancer: analgesic utilization and barriers to optimal pain
management. J Opioid Manag. 2012 Jan-Feb;8(1):9-16.
http://www.ncbi.nlm.nih.gov/pubmed/22479880
Zuccaro SM, Vellucci R, Sarzi-Puttini P, Cherubino P, Labianca R, Fornasari D.
Barriers to pain management: focus on opioid therapy. Clin Drug Investig. 2012
Feb 22;32 Suppl 1:11-9. doi: 10.2165/11630040-000000000-00000.
http://www.ncbi.nlm.nih.gov/pubmed/22356220
11
Annex 1
Proposed text for the Explanatory Notes (to be inserted after the 2nd paragraph on the
complementary list):
The palliative care list (Section [X]) contains those medicines that are essential for
palliative care. With the increasing burden of non-communicable diseases, the
importance of providing adequate palliative care services is rising around the world. This
list highlights those medicines that are always needed for palliative care. In addition,
palliative care services may need additional essential medicines from other sections to
treat the specific diseases of the patients cared for by palliative care services.
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Pain in Children with Medical Illness World Health Organization, Geneva 2012, ISBN 978 92 4
154812 0. http://www.who.int/medicines/areas/quality_safety/guide_on_pain/en/index.html and
http://whqlibdoc.who.int/publications/2012/9789241548120_Guidelines.pdf (permanent URL) 3 Ensuring Balance in National Policies on Controlled Substances, Guidance for availability and
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The International Association for Hospice and Palliative Care list of Essential Medicines for
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