Proposal for deletion - WHO · ([email protected]) (IASP Special Interest Group on Pain in...

12
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 Illnesses 2 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 Medicines 3 . 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 adults 4 , and the Committee may therefore want to draw similar conclusions for the latter.

Transcript of Proposal for deletion - WHO · ([email protected]) (IASP Special Interest Group on Pain in...

Page 1: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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.

Page 2: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 3: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 4: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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.

Page 5: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 6: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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.

Page 7: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 8: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 9: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 10: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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

Page 11: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

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.

References 1 WHO Model List of Essential Medicines for children, 3rd list (March 2011), World Health

Organization, Geneva 2011. Accessible at: http://whqlibdoc.who.int/hq/2011/a95054_eng.pdf 2 World Health Organization, WHO Guidelines for the Pharmacological Treatment of Persisting

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

accessibility of controlled medicines, World Health Organization, Geneva, 2011. ISBN 978 92 4

156417 5 Accessible at: http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html 4 WHO Model List of Essential Medicines, 17th list (March 2011), World Health Organization,

Geneva 2011. Accessible at: http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf 5 Milani B, Scholten W, Access to Controlled Medicines. In: The World Medicines Situation

2011, 3rd Edition, World Health Organization, Geneva 2011 (Chapter released April 2011).

Accessible at:

http://www.who.int/entity/medicines/areas/policy/world_medicines_situation/WMS_ch19_wAcc

ess.pdf 6 Seya MJ, Gelders SFAM, Achara UA, Milani B, Scholten WK. A First Comparison between the

Consumption of and the Need for Opioid Analgesics at Country, Regional and Global Level. J

Pain and Palliative Care Pharmacotherapy, 2011; 25: 6-18. Accessible at:

http://informahealthcare.com/doi/pdf/10.3109/15360288.2010.536307 7 Resolution WHA58.22. Cancer prevention and control. In: Fifty-eighth World Health Assembly,

Geneva, 25 May 2005. A copy of the resolution can be found in:

http://www.who.int/entity/medicines/areas/quality_safety/Framework_ACMP_withcover.pdf 8 Report of the International Narcotics Control Board on the Availability of Internationally

Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes. New York,

2011, E/INCB/2010/1/Supp.1, ISBN: 978-92-1-148260-7 http://www.incb.org/pdf/annual-

report/2010/en/supp/AR10_Supp_E.pdf 9 Declaration of Montréal, Declaration that Access to Pain Management Is a Fundamental Human

Right http://www.iasp-

pain.org/Content/NavigationMenu/Advocacy/DeclarationofMontr233al/default.htm), 10

World Cancer Declaration. Clin J Oncol Nurs. 2006 Dec;10(6):721-2. 11

A morphine manifesto. J Pain Palliat Care Pharmacother. 2012 Jun;26(2):144-5.

Page 12: Proposal for deletion - WHO · (Kreiter@iasp-pain.org) (IASP Special Interest Group on Pain in Childhood, contact: Dr Gary Walco, gary.walco@seattlechildrens.org) (Please see letter

12

12

Meier DE. The development, status and future of palliative care. Robert Wood Johnson

Foundation Health Policy Series , 2010. http://www.rwjf.org/pr/product.jsp?id=58708 13

Ahmedzai SH, Costa A, Blengini C, Bosch A, Sanz-Ortiz J, Ventafridda V, Verhagen SC; A

new international framework for palliative care. International working group convened by the

European School of Oncology. Eur J Cancer. 2004 Oct;40(15):2192-200. 14

Harding R, Selman L, Agupio G, Dinat N, Downing J, Gwyther L, Mashao T, Mmoledi K,

Moll T, Sebuyira LM, Ikin B, Higginson IJ. Prevalence, Burden, and Correlates of Physical and

Psychological Symptoms Among HIV Palliative Care Patients in Sub-Saharan Africa: An

International Multicenter Study. J Pain Symptom Manage. 2012 Jun 1. [Epub ahead of print] 15

Harding R, Foley KM, Connor SR, Jaramillo E. Palliative and end-of-life care in the global

response to multidrug-resistant tuberculosis. Lancet Infect Dis. 2012 Jun 8. [Epub ahead of print] 16

Simms VM, Higginson IJ, Harding R. What palliative care-related problems do patients

experience at HIV diagnosis? A systematic review of the evidence. J Pain Symptom Manage.

2011 Nov;42(5):734-53. Epub 2011 May 26. 17

Pediatric palliative care-when quality of life becomes the main focus of treatment.

Bergstraesser E. Eur J Pediatr. 2012 Apr 3. [Epub ahead of print] 18

Cancer Control: Knowledge in Action. World Health Organization, Geneva, 2007.

ISBN: 92 4 154734 5 http://www.who.int/cancer/modules/en/index.html 19

The International Association for Hospice and Palliative Care list of Essential Medicines for

Palliative Care (background document), accessible at:

http://www.hospicecare.com/resources/pdf-docs/iahpc-em-summary.pdf 20

The International Association for Hospice and Palliative Care list of Essential Medicines for

Palliative Care (list), accessible at: http://www.hospicecare.com/resources/pdf-docs/iahpc-

essential-meds-en.pdf 21 The WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with

Medical Illnesses. Geneva, 2011.

http://www.who.int/medicines/areas/quality_safety/guide_on_pain/en/index.html 22

Forzley M, Gardner C, Voytivich Y. Discrimination and Access to Medical Treatment in

General Comment 14. Informal paper July 2012. On file with Prof. Forzley. 23 WHO Policy Guidelines Ensuring Balance in National Policies on Controlled Substances,

Guidance for Availability and Accessibility for Controlled Medicines.

http://whqlibdoc.who.int/publications/2011/9789241564175_eng.pdf 24

Cancer Pain Relief and Palliative Care in Children, World Health Organization, Geneva 1997.

ISBN 92 4 154512 7. 25 Lynch, T., Connor, S., and Clark, D. 2012. Mapping levels of palliative care development: a

global update. Journal of Pain and Symptom Management (forthcoming).