Montréal, Canada September 3, 2010

Contents

International Pain Summit Steering Committee Members

International Pain Summit Program

IASP Documents

Desirable Characteristics of National Pain Strategies: 3

Recommendations by the International Association for the Study of Pain

Declaration of Montréal 9

Summary Chart: 13

Examples of National Pain Care Strategies, Relevant Statements and Proposals, and Enacted Government Regulations/Laws

Survey Results: IASP National Pain Management Assessment Survey 15

Resources

Access to pain treatment as a human right 19

Diederik Lohman et al.

Access to Controlled Medications Programme 29

World Health Organization Briefing Note

National Pain Strategies

National Pain Strategy 35

Pain Management for all Australians

Chronic pain, negative affect and disability: 55

Preliminary data from the 2005 Statistics Norway Health Survey

National Program for Pain Management 63

Directorate-General for Health, Portugal

Designed for People with Chronic Conditions 73

Service Development and Commissioning Directives, Wales

International Pain Summit Steering Committee

Michael Cousins, AM MD DSc FRCA FANZCA FFPMANZCA FAChPM (RACP), Australia, Chair

Harald Breivik, MD, DMsc, FRCA, Norway

Mary Cardosa, MD, Malaysia

James Cleary, MB BS, USA

Beverly Collett, MB BS, United Kingdom

Amira Karkin-Tais, MD, Bosnia/Herzegovina

Liliana De Lima, MS, USA

Rollin M. Gallagher, MD, MPH, USA

Maija Haanpaa, MD, Finland

Philipp M Lippe, MD, FACS, FACPM, USA

Diederik Lohman, USA

Mary Lynch, MD, Canada

Henry Lu, MD, Philippines

Germán Ochoa, MD, Colombia

Catherine Price, MD, United Kingdom

M. R. Rajagopal, MD, India

Olaitan Soyannwo, MD, Nigeria

International Pain Summit Program September 3, 2010

Welcome IASP President – Eija Kalso, MD, PhD

Setting the Stage

Objectives for the Day Steering Committee Chair – Michael Cousins, MD, DSc

Video – The Problem of Pain Living with Pain

Establishing a Human Right to Pain Management Margaret Somerville, LLD, McGill University

Patient Perspectives

A Patient with Chronic Pain Andrea Crowe

Wife of a Cancer Patient Leslie Hickman

The Emerging Roles of People with Pain in Pain Care Lynn Cooper, Canadian Pain Coalition

Country Initiatives

Canada Honourable Marlene Jennings, Deputy House Leader for the Official Opposition and Liberal Critic for Government Ethics and Democratic Reform Malaysian Deputy Director General of Health, Ministry of Health Datuk Dr. Nor Hisham Abdullah

Pain Medicine in the United States Albert Osbahr, MD, American Medical Association

The First National Pain Strategy, Portugal Jose Romao, Dr. Med, President, Associaçao Portuguesa para o Estudo da Dor

The Chief Medical Officer’s Report: One Year On Benjamin Ellis, MD, Senior Policy Adviser, Arthritis Research Campaign, United Kingdom

Bogotá - a City with No Pain Project Germán Ochoa, MD, University Hospital, Bogotá

Paths to Progress in Pain Management: Patient-Provider Coalitions and the Medical Home Rollin M. Gallagher, MD, MPH, Board of Directors, American Pain Foundation Global Policy Making

IASP Medications Task Force Survey Response Beverly Collett, MB BS, IASP Executive Committee

Global Pain Initiatives James Cleary, MB BS, University of Wisconsin, USA

Human Rights Organizations: Pain Relief as a Human Right Diederik Lohman, Human Rights Watch, USA

Human Rights and “The Declaration of Montreal” Michael Cousins, MD, DSc

10:15 Break

The Problem of Pain Mary Lynch, MD, Canadian Pain Society

Desirable Characteristics of National Pain Strategies Cathy Price, MD, UK

Special Issues and Strategies in Developing Countries M.R. Rajagopal, MD, India

Special Issues of Pain in Children G. Allen Finley, MD, Canada

Panel Discussion of Presentations and Questions CHAIR: Mary Lynch, MD PANEL: Cathy Price, MD, Lynn Cooper, M.R. Rajagopal, MD, Mary Cardosa, MD, Philipp Lippe, MD, Germán Ochoa, MD, Harald Breivik, MD

12:20 Lunch (provided): 30 minutes

Objectives of Workshops/Round Table Discussions Michael Cousins, MD DSc

Round Table Discussions on Two Documents

Group Reports - #1 “Desirable Characteristics”

Group Reports - #2 “Declaration of Montréal”

Summary of Revisions

Discussion and Vote on Acceptance of Two Documents (subject to accepted modifications)

4:00 CLOSE

Refreshments available during afternoon session

IASP Documents

3

Desirable Characteristics of National Pain Strategies: Recommendations by the International Association for the Study of Pain

In the past four decades there have been significant advances in our understanding of the complexity of the nervous system and in our knowledge about the causes of pain. Research has established that there are essentially two types of pain (acute and chronic). There is both cancer-related and noncancer pain. Effective treatments exist; nevertheless, the best available evidence indicates a major gap between an increasingly sophisticated understanding of the pathophysiology of pain and the widespread inadequacy of its treatment.

In many nations, this gap is unnoticed and unmeasured. Many public health agencies seem unaware of the scale of the problem of unresolved pain, with the result that the population’s needs remain unaddressed, even though low-cost solutions may be available.

This gap has prompted a series of declarations and actions by national and international bodies advocating better pain control (see the Summary Chart for examples). These calls to action are based on three propositions:

• Pain, no matter which type, is inadequately treated for a variety of cultural, attitudinal, educational, political, religious, economic, and logistical reasons. • Inadequately treated pain has major physiological, psychological, economic, and social ramifications for patients, families, and society. • It is within the capacity of all developed and many developing countries to significantly improve the treatment of pain without incurring substantial costs, through addressing some of the barriers that exist.

The impact of inadequately treated pain appears remarkably similar, no matter where in the world it is measured [3,6,7,15,18,21,22,25].

• One in five people has moderate to severe chronic pain. • One-third of these people have experienced lost ability to perform wage-earning or other work.

Imaging studies have shown that persistent pain is associated with significant functional, structural, and chemical changes in the brain, thus putting such pain into the realm of a disease state [24]. Patients who have chronic pain disorders with known causes (e.g., osteoarthritis or cancer) or unknown causes (e.g., nonspecific low back pain) have altered cerebral pain processing and loss of gray matter, leading to impaired function [1,20,26]. Increasing evidence shows that chronic pain is in fact a separate disease entity with associated patterns of central nervous system abnormalities. Yet the considerable breakthroughs in scientific knowledge about the phenomenology, pathophysiological mechanisms, and related treatment advances for pain diseases and disorders are barely acknowledged in medical training, with the result that people with severe, poorly relieved pain are often stigmatized and disbelieved. The Declaration of Montreal highlights the need for people in pain to assert their rights to care. 4

Advances in medical knowledge have led to improved understanding of how to better manage pain, in terms of both primary and secondary prevention of chronic disability and improved multidisciplinary management of those most severely affected by chronic pain. However, studies [7,19] show that:

• Fewer than 50% of patients with cancer pain receive effective relief • Fewer than 50% of patients with acute pain receive effective relief • Fewer than 10% of patients with chronic noncancer pain gain access to effective management

Many institutions such as the National Institutes for Health (NIH) in the United States and the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom have published guidance on cost-effective interventions for the management of pain. Summarizing the literature [4,11,14,28], we now know that:

• 90% of acute pain can be successfully treated at low cost • 75% of cancer pain can be successfully treated at low cost • 80% of patients with chronic noncancer pain can now be effectively managed

Worldwide, if we continue to fail at effective pain management, we will continue to pay a staggering and unnecessary price [8].

The International Association for the Study of Pain (IASP) supports the view that every country should have a pain strategy that specifies the extent of the problem and what should be done about it. This document sets out recommendations for the essential elements of any national pain strategy and for the process of achieving a strategy. It accompanies the Declaration of Montreal, which asserts the human rights of those in pain. It is hoped that this document will act as an impetus to clinicians, educators, administrators, and governmental or professional organizations involved in the establishment and maintenance of standards for pain services to take action to prevent the continued waste of millions of lives and resources.

National Strategy Development

IASP members submitted health policies on pain in 19 countries to a review by a working party. Seven countries were found to have a comprehensive strategy to address the management of pain, and the remainder had strategies focusing mainly on opioid control. These strategies are contained within the Summary Chart.

Combined experience has demonstrated that several steps are helpful in developing a national strategy. The following points represent a distillation of these steps. 1. Understanding the scale of the problem posed by poorly managed pain

Excellent large-scale surveys in many countries have established that chronic noncancer pain ranks as the third most costly health care problem after cancer and cardiovascular disease and that the problem is costlier in developing countries [15,25]. Poorly relieved pain also leads to accelerated mortality [23]. 5

In spite of this information, the extent of the problem is poorly understood because pain and its effects are being hidden in other forms of measurement. As it is often initially associated with other disease processes, pain is often inadequately recorded, both in clinical records and in the administrative coding that is often used as a source for epidemiological studies. For example, the World Health Organization’s “Global Health Risks,” which aims to identify forthcoming major health risks to the world, mentions only the impact of low back pain on work [31]. Without generating new data, governments may fail to appreciate the size of the problem. Countries should carry out a basic health survey to understand this problem by asking questions specifically about pain, its management, and its impact. This information serves as a useful baseline from which to measure the impact of any interventions a government may introduce [12]. 2. Understanding the barriers to effective pain management

There may be professional, public, or system barriers. Common professional barriers include a lack of knowledge and skills, as well as inappropriate attitudes and behaviors that demonstrate a lack of understanding of the problem. System barriers may include a lack of resources, outmoded financial incentives, or poor coordination of care. Population health knowledge and awareness may be poor. Taboos may exist toward both those who seek treatment for their pain and some of the treatments that may benefit them. There may be problems with drug availability, training of health care workers, or gaps in policy development. A lack of resources to ensure coordination of pain management between both primary and secondary care and health care services and social services may exist [19].

Specific examples of barriers include:

• Educational gaps: national surveys in Canada and the United Kingdom have identified that veterinarians receive more training in pain management than do health care professionals who care for people [9,30]. • Best-practice pain management often requires coordinated interdisciplinary assessment and management, yet current reimbursement and insurance arrangements mean that treatments with limited evidence of efficacy, including some surgeries and invasive medical treatments that carry the risk of complications or dependency, are often favored over a combination of less invasive and less costly approaches that promote independence. • Excessive waiting times for treatment in chronic pain can lead to a deterioration in health [16,29], risking aggravation of the pain condition and further decreases in quality of life, eventually requiring more expensive interventions. • Pain research is grossly underfunded, considering the burden of illness [5,17]. • There is a lack of public health focus on pain as a priority [10]. 3. Developing a clear plan to deliver change

Desirable characteristics of any plan, as recommended by the International Association for the Study of Pain, have been classified into four broad areas:

• Pain research 6

• Pain education • Patient access and care coordination • Monitoring and quality improvement

It is essential to

• Identify those who have the capacity to deliver change • Establish a timeline for achieving change • Measure the impact of change on a health system and on the society in which it operates

Desirable Characteristics of National Pain Strategies Characteristics Examples Responsible Parties Pain Research ƒEpidemiological A national health survey. Public health services, health economists ƒTranslational/ Prioritization of pain for funding opportunities that Federal health research funding bodies basic science target gaps in pain treatment, knowledge transfer, education, and policy. Pain Education ƒUndergraduate/ At an early stage in training to equip trainees with Centers of learning, regulatory bodies medical school both the knowledge and skills to address all types of pain. The IASP Core Curriculum sets out standards for education in pain. ƒGME-primary All primary care practitioners to have the Commissioners of health care care knowledge and skills to perform a basic pain assessment and develop a management plan. ƒGME-specialists There should be physicians trained to a specialist Centers of learning, regulatory bodies level in pain medicine. ƒCME-physicians All physicians should have ongoing education in Commissioners of health care pain. ƒAllied health Allied health professionals should all have parts of Centers of learning, regulatory bodies their core curricula dedicated to pain management ƒPublic awareness The population needs education to understand that Providers of health care, patient people may be in pain and thus struggle to organizations, and health educator maintain their lives without wanting to programs communicate their vulnerabilities for fear of discrimination. Patient Access and Care Coordination ƒTo care Rapid access to pain care to prevent deterioration Health care policy makers, providers and to poor function. commissioners of health care Hospitals should have at least one doctor and one nurse with training in pain assessment and management. ƒTo medicines The WHO list of essential medicines should be Government regulatory agencies, drug available. Ensure access to oral morphine for enforcement agencies, and key clinical cancer pain by identifying barriers to its access and staff by taking steps to overcome them. 7

Characteristics Examples Responsible Parties ƒTo information Accurate signposting to the right help as early as Providers and commissioners of health possible with a fully informed choice of options. care Any pain management program must engage the community both in advocacy and in use of trained volunteers in the care program. ƒSpecialist referral Pain networks can ensure excellent relationships Commissioners of health care between providers. Where secondary care exists, there should be a vertical system for escalation of referrals of difficult problems from primary, through secondary, to tertiary care centers. All tertiary care centers should have specialized pain clinics with facilities for expert psychosocial support and interventional procedures. ƒInterdisciplinary A biopsychosocial approach to assessment and Providers of health care approach management. ƒSelf-care Care should be in partnership with family and/or caregivers. Adoption of approaches that support self-care. Monitoring/Quality Improvement ƒTime to care Setting standards for access times and work plans that allow sufficient time. ƒQuality of service Patient experience should be routinely sought; there should be a reduction in waiting times for treatments. ƒQuality of life Improvements in the individual patient’s quality of life, according to both generic and disease-specific measures. ƒEconomic burden Monitoring should include work absence due to pain, prescription costs, urgent care, and use of other services. ƒSpecial needs Special populations include the very young and Providers and commissioners of health very old, victims of torture, those with learning care difficulties, ethnic minorities, and impaired persons.

References [1] Apkarian AV, Sosa Y, Krauss BR, Thomas PS, Fredrickson BE, Levy RE, Harden RN, Chialvo DR. Chronic pain patients are impaired on an emotional decision-making task. Pain 2004;108:129–36. [2] Australian and New Zealand Anaesthetists Association. Acute pain scientific evidence. 2009. Available at: http: www.anzca.edu.au/resources/booksandpublications. [3] Blyth FM, March LM, Brnabic AJ, Jorm LR, Williamson M, Cousins MJ. Chronic pain in Australia: a prevalence study. Pain 2001;89:127–34. [4] Boswell MV, Cole BE, editors.Weiner’s pain management: a practical guide for clinicians, 7th ed. 2006. CRC Press: Boca Raton; 2006. [5] Bradshaw DH, Empy C, Davis P, Lipschitz D, Nakamura Y, Chapman CR. Trends in funding for research on pain: a report on the National Institutes of Health grant awards over the years 2003 to 2007. J Pain 2008;9:1077–87. [6] Breivik H, Bond M. Why pain control matters in a world full of killer diseases. Pain: Clin Updates 2004;12(4):1–4. [7] Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life and treatment. Eur J Pain 2006;10:287–333. 8

[8] Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg 2007;105:205–21. [9] British Pain Society Educational Special Interest Group. Survey of undergraduate curricula. Available at: www.britishpainsociety.org/members_sig_edu_short_report_survey.pdf. [10] Chief Medical Officer for England’s report on the health of the nation. 150th annual report. 2008: Pain: breaking through the barrier. [11] Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pan: time to back off? J Am Board Fam Med 2009;22:62–8. [12] Elliott AM, Smith BH, Penny KI, Smith WC, Chambers WA. The epidemiology of chronic pain in the community. Lancet 1999;354:1248–52. [13] European Federation of IASP Chapters. Declaration 2002: Pain is a disease in its own right. [14] Henry JL. The need for knowledge translation in chronic pain. Pain Res Manag 2008;13:465–76. [15] Huijer Abu-Saad H. Chronic pain: a review. J Med Liban 2010;58:21–7. [16] Lynch ME, Campbell FA. A systematic review of the effect of waiting for treatment for chronic pain. Pain 2008;136:97– 116. [17] Lynch ME, Schopflocher D, Taenzer P, Sinclair C. Research funding for pain in Canada. Pain Res Manage 2009;14:113–5. [18] Moulin DE, Clark AJ, Speechley M, Morley-Forster PK. Chronic pain in Canada, prevalence, treatment, impact and the role of opioid analgesia. Pain Res Manage 2001;7:179–84. [19] Phillips C, Main C, Buck R, Aylward M, Wynne-Jones G, Farr A. Prioritising pain in policy making: the need for a whole systems perspective. Health Policy 2008;88:168–75. [20] Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Brain gray matter decreases in chronic pain is the consequence and not the cause of pain. J Neurosci 2009;29:13746–50. [21] Sjøgren P, Ekholm O, Peuckmann V, Grønbaek M. Epidemiology of chronic pain in Denmark: an update. Eur J Pain 2009;13:272–9. [22] Thomsen AB, Sørensen J, Sjøgren P, Eriksen J. Chronic non-malignant pain patients and health economic consequences. Eur J Pain 2002;6:341–52. [23] Torrance N, Elliott AM, Lee AJ, Smith BH. Severe chronic pain is associated with increased 10 year mortality. A cohort record linkage study. Eur J Pain 2010;14:380–6. [24] Tracey I, Bushnell MC. How neuroimaging studies have challenged us to rethink: is chronic pain a disease? J Pain 2009;10:1113–20. [25] Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, Borges GL, Bromet EJ, Demytteneare K, de Girolamo G, de Graaf R, Gureje O, Lepine JP, Haro JM, Levinson D, Oakley Browne MA, Posada-Villa J, Seedat S, Watanabe M. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain 2008;9:883–91. [26] Valet M, Gündel H, Sprenger T, Sorg C, Mühlau M, Zimmer C, Henningsen P, Tölle TR. Patients with pain disorder show gray matter loss in pain processing structures: a voxel based morphometric study. Psychosom Med 2009;71:49–56. [27] Ventafridda, Tamburini M, Caraceni A, De Conno F, Naldi F. A validation study of the WHO method of pain relief. Cancer 1987;59:850–6. [28] Walsh NE, Brooks P, Hazes JM, Walsh RM, Dreinhofer K, Woolf AD, Akesson K, Lidgren L; Bone and Joint Decade Task Force for Standards of Care for Acute and Chronic Musculoskeletal Pain. Standards of care for acute and chronic musculoskeletal pain: the Bone and Joint Decade (2000–2010). Arch Phys Med Rehabil 2008;89:1830–45. [29] Walseth Hara K, Brochgrevink P. National guidelines for evaluating pain: patients’ legal right to prioritised health care at multidisciplinary pain clinics in Norway implemented 2009. Scand J Pain 2010;1:60–3. [30] Watt-Watson J, McGillion M, Hunter J, Choiniere M, Clark AJ, Dewar A, Johnston C, Lynch M, Morley-Forster P, Moulin D, Thie N, von Baeyer CL, Webber K. A survey of pre-licensure pain curricula in health science faculties in Canadian universities. Pain Res Manag 2009;14:439–44. [31] World Health Organization. Global health risks: mortality and burden of disease attributable to selected major risks. 2009. Available at: www.who.int/healthinfo/global_burden_disease/GlobalHealthRisks_report_full.pdf. [32] Zech DF, Grond S, Lynch J, Hertel D, Lehmann KA. Validation of World Health Organization guidelines for cancer pain relief: a 10-year prospective study. Pain 1995;63:65–76.

9

DECLARATION OF MONTRÉAL Declaration that Access to Pain Management Is a Fundamental Human Right

We, as delegates to the International Pain Summit (IPS) of the International Association for the Study of Pain (IASP) (comprising IASP representatives from Chapters in 84 countries plus members in 126 countries, as well as members of the community), have given in-depth attention to the unrelieved pain in the world,

Finding that pain management is inadequate in most of the world because:

• The World Health Organization (WHO) estimates that 5 billion people live in countries with low or no access to controlled medicines and have no or insufficient access to treatment for moderate to severe pain.

• There are major deficits in knowledge of health care professionals regarding the mechanisms and management of pain.

• There are severe restrictions on the availability of opioid medication, which is critical to the management of pain.

• Most countries have no national policy at all or very inadequate policies regarding the management of pain as a health problem, including an inadequate level of research and education.

And, recognizing the intrinsic dignity of all persons and that suffering is harmful and should be avoided, we declare that: The following human rights must be recognized throughout the world.

Article 1. The right of all people to have access to pain management without discrimination, in particular, on the basis of age, sex, gender, medical diagnosis, race, religion, culture, marital status, or political or other opinion (Footnotes 1-3).

Article 2. The right of people in pain to be informed about how their pain can be assessed and the possibilities for treatment (Footnote 4). Recording the results of assessment, e.g. as the ‘5th vital sign’, can focus attention on unrelieved pain, triggering appropriate treatment interventions and adjustments.

Article 3. The right to access an appropriate range of effective pain management strategies (Footnote 5), supported by policies and procedures that must be appropriate for the particular setting of health care and the health professionals employing them. 10

Article 4. The right of people with pain to have access to all appropriate medicines, including but not limited to opioids, and to have access to health professionals skilled in the use of such medicines (Footnote 6). In resource-poor countries it is important to at least ensure access to oral immediate- release morphine.

Article 5. The right of people with pain to assessment and treatment by an appropriately educated and trained interdisciplinary team at all levels of care. (In resource-poor countries the team should include, at a minimum, a doctor and a nurse with training in pain management).

Article 6. The right of people with pain to treatment under a health policy framework that is compassionate, empathetic, and well-informed. This includes legal systems (including laws relating to opioids), the conditions of employment that employers impose on employees, compensation systems, insurance bodies, and government agencies.

Article 7. The right of people with pain to have access to best practice nonmedication methods of pain management (ranging from relaxation and physiotherapy methods to more complex cognitive behavioral treatment) and to specialist-performed interventional methods, depending upon the resources of the country.

Article 8. The right of people with chronic pain to be recognized as having a disease entity, requiring access to management akin to other chronic diseases.

Article 9. The obligation of all health care professionals in a treatment relationship with a patient, within the scope of the legal limits of their professional practice and taking into account the treatment resources reasonably available, to offer to a patient in pain the management that would be offered by a reasonably careful and competent health care professional in that field of practice. Failure to offer such management is a breach of the patient's human rights.

Article 10. The obligations of governments and all health care institutions, especially hospitals, within the scope of the legal limits of their authority and taking into account the health care resources reasonably available, to establish laws, policies, and systems that will help to promote, and will certainly not inhibit, the access of people in pain to fully adequate pain management. Failure to establish such laws, policies, and systems is unethical and a breach of the human rights of people harmed as a result.

Note: This Declaration has been prepared having due regard to current general circumstances and modes of health care delivery in the developed and developing world. Nevertheless, it is the responsibility of: governments, of those involved at every level of health care administration, and health professionals to update the modes of implementation of the Articles of this Declaration as new frameworks for pain management are developed. 11

Footnotes

1. International Covenant on Economic, Social and Cultural Rights (ICESCR) (1966). The State parties of the ICESCR recognize “the right of everyone to the highest attainable standard of physical and mental health” (Art. 12), creating the “conditions which would assure to all medical service and medical attention in the event of sickness.” 2. Universal Declaration of Human Rights (1948): Rights to Health (Article 25); Convention on the Rights of a Child (Article 24); Convention on the Elimination of All Forms of Discrimination Against Women (Article 12); Convention on the Elimination of All Forms of Racial Discrimination (Article 5(e)(iv)). 3. The Committee on Economic, Social and Cultural Rights. General Comment No.14, 22nd Session, April-May 2000 E/C 12/2000/4. “Core obligations” of all signatory nations included an obligation to ensure access to health facilities, goods, and services without discrimination, to provide essential drugs as defined by WHO, and to adopt and implement a national health strategy. 4. Committee on Economic, Social and Cultural Rights. General Comment No.14, 22nd Session, April-May 2000, E/C 12/2000/4, para. 12. General Comment No. 14 stated that health accessibility “includes the right to seek, receive and impart information and ideas concerning health issues.” 5. The UN Universal Declaration of Human Rights (1948) (Article 5) states: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment…” Comment: Deliberately ignoring a patient’s need for pain management or failing to call for specialized help if unable to achieve pain relief may represent a violation of Article 5. 6. The UN Special Rapporteur on the Right to Health and the UN Special Rapporteur on the question of torture and other cruel, inhuman, and degrading treatment stated: “The failure to ensure access to controlled medicines for the relief of pain and suffering threatens fundamental rights to health and to protection against cruel, inhuman and degrading treatment.”

References

ANZCA. Statement on patients’ rights to pain management. ANZCA PS 45; 2001. Available at: www.anzca.edu.au. Brennan F, Carr DB, Cousins MJ. Pain management: a fundamental human right. Anesth Analg 2007;105:205– 21. Scholten W, Nygren-Krug H, Zucker HA. The World Health Organization paves the way for action to free people from the shackles of pain. Anesth Analg 2007;105:1–4. Somerville M. Death of pain: pain, suffering, and ethics. In Gebhart GF, Hammond DL, Jensen TS, editors. Proceedings of the 7th World Congress on Pain. Progress in Pain Research and Management, Vol. 2. Seattle: IASP Press; 1994. p. 41–58.

Summary Chart - Examples of National Pain Care Strategies, Relevant Statements and Proposals, and Enacted Government Regulations/Laws

Country USA CAN AUS ENG PRT NOR WAL SCO CRI BIH LBN CHL IND ROM MEX COL VNM UGA Pain Research ƒ Epidemiologic „„ „„ „„ „„ „„ „„ „„ ƒ Translational/ „„ „„ „„ „„ Basic Science Pain Education ƒUndergraduate/ „„ „„ „„ „„ „„ „„ „„ „„ „„ Medical School ƒ GME‐Primary „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ Care ƒ GME‐Specialists „„ „„ „„ „„ „„ „„ „„ „„ „„ ƒ CME‐Physicians „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ ƒ Allied Health „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ ƒ Public „„ „„ „„ „„ „„ Awareness Patient Access & Care Coordination ƒ To Care „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ ƒ To Medicines „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ ƒ To Information „„ „„ „„ „„ ƒ Specialist „„ „„ „„ „„ „„ „„ „„ „„ „„ Referral ƒ Interdisciplinary „„ „„ „„ „„ Approach ƒ Self‐Care „„ Monitoring ‐ Quality Improvement ƒ Time to Care „„ ƒ Quality of „„ „„ „„ „„ „„ „„ „„ „„ „„ „„ Service ƒ Quality of Life „„ „„ „„ „„ „„ ƒ Economic „„ „„ „„ Burden ƒ Special Needs „„ „„ „„ „„

„„ = Recommended by non‐governmental organizations „„ = Proposed by national governmental organizations „„ = Enacted into national law, national regulations, or national statute Prepared for IASP by: John P. Ney, MD

15

Survey Results: IASP National Pain Management Assessment Survey

Purpose

To obtain information on an international scale regarding the state of pain medicine at the primary care and specialist level, and on obstacles to improvement in pain management through policy initiatives and government interventions.

Methods

A link to an online questionnaire was sent to 84 International Association for the Study of Pain (IASP) chapter presidents, each representing the pain medicine faculty for a particular country. The questionnaire consisted of 29 largely multiple-choice questions in three areas: (1) Pain treatment by primary care providers, (2) pain treatment by specialists, and (3) the role of the government in regulation and oversight of pain management. Several open-ended questions were also asked. The respondents were encouraged to answer all questions to the best of their knowledge, although they were allowed to skip individual questions.

Results

As of 12 August, 29 of 85 responses (response rate of 34%) representing 28 different countries were collected. The majority of respondents were from developing nations, although nations with developed health care systems, such as Canada, Australia, and the UK were also represented. The response rate per multiple-choice question ranged from 62% to 76%. The response rates below were based on respondents who actually answered the relevant question in the survey.

1) Primary care: With regard to primary care, the majority of respondents noted that their nation’s populace had access to primary care providers (PCPs) (67.3% of question respondents). Most PCPs were medical doctors (65% of respondents), although nurses also played a significant role (>25% of primary care in respective nations) for a quarter of respondents. 44% of respondents indicated that less than half of PCPs in their nation did not have residency training, and 48% of respondents noted that less than 5% of PCPs had supervised clinical rotations in a pain-related medical specialty. Indeed, lack of supervised clinical training in pain for primary care was cited as one of the top three national challenges in pain management by 42% of respondents. However, pain diagnosis and management was felt to be a significant portion (>1/4 of practice) for 45% of respondents. Sixty percent of respondents noted some barrier to PCP prescription of opiates, 45% noted some restriction on the prescription of expensive adjunctive pain medications (anticonvulsants and antidepressants) by PCPs, and 70% indicated some limitation on PCPs performing pain-related procedures, such as joint injections. Greater than 70% of respondents indicated that PCPs in their nation were able to refer to an allied health provider (physical therapist, counselor, nurse, or pharmacist) to help manage pain disorders. 16

2) Pain specialist care: In assessing challenges to improving pain management on a national level, lack of pain specialists was cited by 100% of respondents. Ninety percent of respondents indicated that pain specialists represented 5% or less of the health care providers in their nation, with 47% of respondents indicating that 5% or less of pain specialists were MDs. Insufficient formal supervised clinical training for pain specialists was noted by 37% of those surveyed. For 69% of respondents indicated that only one-fourth or less of the total practice of pain specialists was related to the diagnosis or treatment of pain. Nearly 40% of respondents indicated that at least a quarter of pain specialist time was spend managing chronic pain with oral medications, while only 17% indicated that pain specialists in their nation spent greater than one-fourth of their practice performing procedures. A significant portion of respondents (21%) indicated that more than one-fourth of pain specialists’ practice was spent educating nonspecialists. For types of pain (cancer-related, neuropathic, postprocedure, other chronic pain), chronic non-neuropathic/noncancer pain was the most commonly seen (39% of respondents indicating >25% of pain specialist practice). Respondents indicate that patients were more likely to be referred to a pain specialist by a PCP or other medical specialist than to be self-referred.

3) Government role in pain management: Eighty-four percent of respondents indicated that the government was responsible for health care for all of its citizens. A government entity specifically tasked with pain management was noted by only eleven percent of respondents, while 26% indicated that their government had published referral guidelines to pain specialists, and there was no government involvement in pain specialist training and certification according to 68% of respondents. Ninety-five percent of survey respondents indicated at least moderate difficulty in contacting government legislators, administrators and political figures regarding health care and pain management. Of 18 possible challenges for national pain management strategies, lack of government prioritization of pain management was cited by 58% of respondents.

Conclusions

Our survey of IASP chapter presidents provides a description of some of the major problems facing pain management on a global scale. The shortage of pain specialists, insufficient training for specialists and primary care providers in pain management, and the minimal role of national governments were each noted as prominent challenges in reforming pain management in their respective nations. Although our results should not be interpreted as definitive, they point to the need for greater education of health care providers and involvement of government in pain practice.

Supporting Materials

Lohman et al. BMC Medicine 2010, 8:8 19 http://www.biomedcentral.com/1741-7015/8/8

DEBATE Open Access Access to pain treatment as a human right Diederik Lohman, Rebecca Schleifer, Joseph J Amon*

Abstract Background: Almost five decades ago, governments around the world adopted the 1961 Single Convention on Narcotic Drugs which, in addition to addressing the control of illicit narcotics, obligated countries to work towards universal access to the narcotic drugs necessary to alleviate pain and suffering. Yet, despite the existence of inexpensive and effective pain relief medicines, tens of millions of people around the world continue to suffer from moderate to severe pain each year without treatment. Discussion: Significant barriers to effective pain treatment include: the failure of many governments to put in place functioning drug supply systems; the failure to enact policies on pain treatment and palliative care; poor training of healthcare workers; the existence of unnecessarily restrictive drug control regulations and practices; fear among healthcare workers of legal sanctions for legitimate medical practice; and the inflated cost of pain treatment. These barriers can be understood not only as a failure to provide essential medicines and relieve suffering but also as human rights abuses. Summary: According to international human rights law, countries have to provide pain treatment medications as part of their core obligations under the right to health; failure to take reasonable steps to ensure that people who suffer pain have access to adequate pain treatment may result in the violation of the obligation to protect against cruel, inhuman and degrading treatment.

Background Organization (WHO) study found that people who live Chronic pain is a one of the most significant causes of with chronic pain are four times more likely to suffer suffering and disability worldwide, and a common symp- from depression or anxiety [24,25]. The physical and tom of both cancer and HIV/AIDS. Up to 70% of cancer psychological effects of chronic pain influence the patients suffer from pain [1] and, among individuals liv- course of disease [26]. Chronic pain can indirectly influ- ing with HIV/AIDS, wide estimates of pain prevalence ence disease outcomes by reducing treatment adherence. at all stages of infection have been reported [2-18]. The WHO Pain Relief Ladder recommends the While pain prevalence is diminished among individuals administration of different types of pain medications, on antiretroviral therapy [16], studies continue to docu- depending on the severity of pain, and is the basis of ment the under-recognition and under-treatment of modern pain management [27]. For mild pain, the pain, even among individuals being treated for HIV WHO calls for basic pain relievers, usually widely avail- infection [19-22]. Pain treatment is also related to gen- able without prescription. For mild to moderate pain, it der, as HIV-infected women with pain are twice as likely recommends a combination of basic pain relievers and a to be under-treated as their male counterparts [21]. weak opioid, such as codeine. For moderate to severe Pain has a profound impact on the quality of life and pain, the WHO has recognized that strong opioids, such can have physical, psychological and social conse- as morphine, are ‘absolutely necessary’ [28]. quences. It can lead to reduced mobility and a conse- The WHO’s recognition of the absolute necessity of quent loss of strength, compromise the immune system opioid analgesics has reflected the consensus among and interfere with a person’s ability to eat, concentrate, health experts for decades. Almost 50 years ago, the sleep, or interact with others [23]. A World Health United Nations (UN) member states adopted the 1961 Single Convention on Narcotic Drugs, declaring the med- * Correspondence: [email protected] ical use of narcotic drugs indispensable for the relief of Health and Human Rights Division, Human Rights Watch, 350 Fifth Avenue, pain and mandating an adequate provision of narcotic 34th Floor, NY 10118, USA

© 2010 Lohman et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Lohman et al. BMC Medicine 2010, 8:8 Page 2 of 9 20 http://www.biomedcentral.com/1741-7015/8/8

drugs for medical use [29]. The International Narcotics drug supply systems; (2) the failure to enact policies on Control Board (INCB), charged with monitoring the pain treatment and palliative care; (3) poor training of implementation of the UN drug conventions, clarified in healthcare workers; (4) the existence of unnecessarily 1995 that the Convention ‘establishes a dual drug con- restrictive drug control regulations and practices; (5) trol obligation: to ensure adequate availability of narco- fear among healthcare workers of legal sanctions for tic drugs, including opiates, for medical and scientific legitimate medical practice; and (6) the unnecessarily purposes, while at the same time preventing illicit pro- high cost of pain treatment. duction of, trafficking in and use of such drug’ [30]. The Failure to ensure functioning and effective supply system WHO has included both morphine and codeine in its Opioid analgesics are controlled medicines and, as such, Model List of Essential Medicines [31]. Various other their manufacture, distribution and prescription are international bodies, such as the UN Economic and strictly regulated. The 1961 Single Convention on Narco- Social Council and the World Health Assembly, have tic Drugs has created a system for the regulation of sup- also called on countries to ensure an adequate availabil- ply and demand, overseen internationally by INCB and ity of opioid analgesics [32-35]. nationally by special drug control agencies. Every year, Yet, despite this clear consensus that pain treatment countries submit estimates of their need for morphine medications should be available, approximately 80% of and other controlled medications to INCB, which the world population has either no, or insufficient, access approves each country’s supply. Cross-border transac- to treatment for moderate to severe pain [36]. Millions of tions must be authorized and registered by INCB. people living with cancer and HIV - including 1 million As the production, distribution and dispensation of end-stage HIV/AIDS patients - suffer from moderate to controlled medicines are under exclusive government severe pain each year without treatment [36]. control, governments must also put in place an effective Pain treatment medications are not evenly distributed system of distribution in order to provide healthcare worldwide. Approximately 89% of the total world con- providers and pharmacies with a continuous and ade- sumption of morphine occurs in North America and quate supply of the medications. Yet, many govern- Europe [37]. Low and middle income countries consume ments, as a result of resource limitations or lack of only 6% of the morphine used worldwide [38], even political will, have failed to put in place effective supply though they are home to about half of all cancer systems for controlled medicines [41]. More fundamen- patients [26] and more than 90% of HIV infections [39]. tally, there is a lack of a common understanding of opi- However, inadequate pain management is also prevalent ate pain relief needs and accessibility. A 2006 African in developed countries. In the USA, the lack of the Palliative Care Association survey found that, while drug availability of pain medication in pharmacies, misinfor- control agencies in Kenya, Tanzania and Ethiopia mation about addiction on the part of both patients and believed the regulatory system worked well, morphine providers and fear of criminal sanctions for prescribing consumption in each of these countries was far below pain medicines are significant limiting factors [40]. Stu- the estimated need and the palliative care providers sur- dies in Western Europe also document an under-estima- veyed identified myriad problems with the regulatory tion of pain severity and under-treatment of pain [17]. system [42]. This article outlines the common obstacles to the pro- While UN drug conventions require countries to sub- vision of pain treatment and palliative care and calls for mit estimates of their need for controlled substances the reform of laws and policies inhibiting access to pain based on a careful assessment of population needs, treatment worldwide. It also examines access to pain some countries either submit no estimates or submit relief medicine in relation to the obligations of states only symbolic estimates. For example, the West African under international human rights law. Identifying state nation of Burkina Faso estimated that it would need 49 obligations in the context of the HIV/AIDS epidemic g of morphine in 2009 [43]. Based on an estimate for a has been a powerful mechanism for mobilizing attention terminal cancer or end-stage AIDS patient of a daily and compelling response. By developing a human rights need for 70 mg of morphine for an average of 90 days, framework related to access to pain relief medicines, this amount would be sufficient for about eight patients. individuals living with HIV, as well as those with cancer Even in countries that estimate a need for considerably or other causes of pain, can more effectively unite to greater absolute quantities of morphine, population demand the accountability of governments to respect, needs are vastly underestimated (Table 1). protect and fulfill their rights. Without an effective distribution system, sufficient supply does not ensure accessibility. As controlled medi- Discussion cations may only be transferred between parties that Barriers to access to pain treatment globally include: (1) have been authorized under national law, governments the failure of governments to put in place functioning must ensure that a sufficient number of pharmacies are Lohman et al. 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Table 1 Morphine estimates, mortality and pain treatment need. Country Cancer AIDS No. of individuals Estimated Estimate of morphine No. of Percentage of those deaths deaths expected to need total need provided by individuals needing treatment who 2002 2005 pain treatment in morphine country to INCB for estimate is would be covered by estimate estimate 2009 need in 2009 2009 (kg) sufficient for estimate (kg) Countries that estimate almost no need for morphine Benin 13490 9986 15786 96 0.5 83 0.50% Senegal 17625 5432 16816 102 0.6 99 0.60% Rwanda 14196 21956 22335 136 0.8 132 0.60% Gambia 2395 1430 2631 16 0.18 31 1.20% Bhutan 727 >10 per 582 3.5 0.08 14 2.30% 100,000 Burkina 23262 13067 25143 153 0.05 8 0.03% Faso Eritrea 6240 5959 7972 48 0.075 12 0.15% Gabon 2071 4457 3886 24 0.088 14 0.40% Swaziland 1837 17577 10258 62 0.5 82 0.80% Selected other countries Egypt 62299 >10 per 49840 303 10 1646 3% 100,000 Philippines 78500 >10 per 62800 382 31 5103 8% 100,000 Kenya 50809 149502 115398 701 30 4938 4% Russian 217696 N/A 174157 1058 200 32922 15% Federation Mexico 92701 6321 77321 470 180 29630 38% Projection for the numbers of people requiring pain treatment does not include those with acute pain or pain related to non-terminal cancer or HIV and do not include pain control medications other than morphine. The table is based on an estimate by Foley and others that 80% of terminal cancer patients and 50% of terminal AIDS patients will require an average of 90 days of pain treatment with 60 mg to 75 mg of morphine per day [16]. Country estimates were obtained from INCB website [43]; projections for annual cancer and AIDS deaths are based on the most recent cancer and AIDS mortality figures reported by the WHO [79]. licensed to handle morphine and that the procedures for comprehensive strategy [47], most countries do not have procuring, stocking and dispensing it are practical. palliative care and pain treatment policies, either as Yet, in some cases, government regulations allow only stand-alone policies or as part of cancer or HIV/AIDS a few institutions to stock the medication, sharply limit- control efforts [47,48]. Many countries have even failed ing accessibility [42]. In other countries, excessively bur- to add oral morphine and other opioid-based medicines densome procedures for procurement, dispensing and to their list of essential medicines or to issue guidelines accounting effectively discourage health institutions on pain management for healthcare workers [42]. from procuring the required morphine [44]. Where hos- The INCB has recommended that national drug con- pitals and pharmacies do stock morphine, interruptions trol laws recognize the indispensible nature of narcotic in stock are common [42,45]. drugs for the relief of pain and suffering as well as the Failure to enact palliative care and pain treatment obligation to ensure their availability for medical pur- policies poses. However, in 1995 only 48% of the governments In 1996, the WHO identified the absence of national responding to a survey had laws reflecting the former policies on cancer pain relief and palliative care as one and 63% the latter [30]. It is not known exactly how of the reasons that cancer pain is not adequately treated many countries still do not use the relevant language in [46]. In 2000, the organization noted that pain treatment their legislation and even recent model laws and regula- continued to be a low priority in healthcare systems [28] tions on drug control from the UN Office on Drugs and and, again, in 2002 it noted that there was a wide gap Crime themselves do not contain these provisions between the rhetoric and the reality when integrating [49-52] (Appendix 1). palliative care principles into public health and disease Lack of training for healthcare workers control programmes [26]. One of the biggest obstacles to the provision of good Although the WHO and leading experts on palliative palliative and pain treatment services in many countries care have stressed the importance of having a is the lack of training for healthcare workers. Lohman et al. BMC Medicine 2010, 8:8 Page 4 of 9 22 http://www.biomedcentral.com/1741-7015/8/8

Misinformation about oral morphine is still extremely cumbersome dispensing procedures; and limitations on common among healthcare workers and knowledge of the formulation and quantity of medicine that can be how to assess and treat pain is often very inadequate. prescribed [55]. In some cases, drug control authorities Some of the most common myths maintain that: treat- or health systems adopt even more restrictive measures ment with opioids leads to addiction; that pain is neces- than those required in the formal regulations. Although sary because it is enables diagnosis; that pain is the diversion of medical opiods from its proper use is unavoidable; and that pain has negligible consequences. frequently cited as the explanation for such policies, the Each of these myths is inaccurate. Numerous studies INCB has noted that, in practice, diversion is relatively have shown that treatment of pain with opioids very rare [56] and the WHO has observed that ‘this right [to rarely leads to addiction [28]; most pain can be treated impose additional requirements] must be continually well [28]; pain is not necessary for diagnosis [23]; and balanced against the responsibility to ensure opioid pain has considerable social, economic and psychologi- availability for medical purposes’ [46]. cal consequences as it prevents people who suffer from An example of overly restrictive policies adopted by it, and often their caregivers, from living a productive many countries is to limit the prescription of narcotic life [23]. pain medicines to medical professionals who qualify for Throughout much of the world, including some indus- specific licenses. The 1961 the Single Convention on trialized countries, ignorance of the use of opioid medi- Narcotic Drugs does not require healthcare workers to cations is the result of a failure to provide healthcare obtain a special license to handle opioids and the WHO workers with adequate training in palliative care and has recommended that ‘physicians, nurses and pharma- pain management. A survey by the Worldwide Palliative cists should be legally empowered to prescribe, dispense Care Alliance of healthcare workers in 69 countries in and administer opioids to patients in accordance with Latin America, Asia and Africa found that 82% in Latin local needs’ [46]. Yet special licenses are common, and America, 71% in Asia and 39% in Africa had not nurses and pharmacists are rarely able to prescribe pain received any instruction on pain management or opioids medicines. For example, the Worldwide Palliative Care during their undergraduate medical studies [53]. Addi- Alliance reported that, in 2007, in Mongolia, Peru, Hon- tional studies have documented the significant number duras, Kyrgyzstan and a state in India only palliative of healthcare providers in Africa who report inadequate care specialists and oncologists are authorized to pre- opportunities for training in palliative care and pain scribe oral morphine [53]. In Russia, an AIDS doctor treatment [42]. Even in industrialized countries instruc- reported that he could not treat a patient who suffered tion on palliative care and pain treatment remains a from severe pain because he was not licensed to pre- considerable challenge. A 1999 review found that con- scribe morphine and that those oncologists who are siderable numbers of healthcare workers had insufficient would not provide treatment because the patient did factual knowledge about pain management among can- not have cancer [57]. cer patients in the industrialized countries [54] (Appen- Another common obstacle is the special prescription dix 2). procedures for opioids - for example the use of specific Excessively restrictive drug control regulations or prescription forms and the insistence that multiple enforcement practices copies of the prescription be maintained. The WHO The 1961 the Single Convention on Narcotic Drugs lays Expert Committee on Cancer Pain Relief has observed out three minimum criteria that countries must observe that these practices often reduce prescription of opioid when developing national regulations governing the pain medicines by 50% or more [46]. In 1995, INCB handling of opioids. First, individuals must be author- found that 65% of countries that participated in its sur- ized to dispense opioids by their professional license to vey had special prescription procedures [30]. practice or be specially licensed to do so. Secondly, Another special practice is the requirement that pre- movement of opioids may only occur between institu- scriptions by healthcare workers be approved by collea- tions or individuals so authorized under national law. gues or superiors and that dispensing must be witnessed Finally, a medical prescription is required before opioids by multiple healthcare workers. In Ukraine, for example, may be dispensed to a patient. Governments may, under the decision to prescribe morphine has to be made by a the Convention, impose additional requirements if group of at least three doctors, one of whom must be deemed necessary [29]. an oncologist [58]. In South Africa, two nurses must However, many countries have regulations that go well observe the dispensing of opioids [42]. beyond these restrictions, creating complex procedures While the WHO has recommended that ‘decisions for procurement, stocking and dispensing of controlled concerning the type of drug to be used, the amount of medications, including: restrictive licensing requirements the prescription and the duration of therapy are best for health care providers prescribing medicines; made by medical professionals on the basis of the Lohman et al. BMC Medicine 2010, 8:8 Page 5 of 9 23 http://www.biomedcentral.com/1741-7015/8/8

individual needs of each patient, not by regulation’ [46], the discrepancy: medication subsidies by industrialized regulations imposing limitations on the dose of oral countries; industrialized government regulation of the morphine that can be prescribed per day or the number price of opioids; taxes, licenses and other costs related of days for which it can be prescribed are common. The to import of finished product; large overhead of local 1995 INCB survey found that 40% of countries partici- production; poorly developed distribution systems; low pating set a maximum amount of morphine that could demand; and regulatory requirements that drive up cost. be prescribed at one time to a hospitalized patient and Further, a 2007 report also found that the promotion of 50% of countries surveyed set limits for patients who non-generic - and costly - forms of opioid analgesics lived at home [30]. Limits for home-based patients were has made pain treatment medications unaffordable in frequently less than those for hospitalized patients - in some areas, as inexpensive formulations are withdrawn some cases half of the typical daily doses [16]. The sur- when more expensive opioids appear on the market vey also found that 20% of participating countries [64]. imposed a maximum length of time that a hospitalized A number of countries have successfully sought ways patient could receive morphine and 28% had such to create a capacity for the local production of basic restrictions for patients at home. In some cases, pre- oral morphine, in tablet or liquid form, at low cost. For scriptions for morphine could not exceed a week’ssup- example, in India, a small manufacturing unit has been ply; in some countries this was non-renewable [30]. set up at a hospital that produces low cost immediate Although no recent comprehensive overview of coun- release morphine tablets from morphine powder [64]. In tries that impose these kinds of limitations is available, Uganda, the ministry of health commissioned charitable they continue to be widespread [53,59]. procurement and manufacturing facility to produce Fears of legal sanction morphine solution which could be distributed to hospi- Although the INCB has recommended that healthcare tals, health centres and palliative care providers [65]. In workers be able to provide opiates without unnecessary Vietnam, a new opioid prescription regulation allows fear of legal action for unintended violations which the ministry of health to mandate state and para-state would inhibit provision or dispensation [60], ambiguity pharmaceutical companies to produce oral and injectible in regulations, poor communication by drug regulators opioids [66]. These examples illustrate the potential for to healthcare workers about the rules for handling creating locally manufactured, low-cost oral morphine. opioids, the existence of harsh sanctions (including Health as a human right mandatory minimum sentences) and, in some countries, Health is a fundamental human right enshrined in prosecutions of healthcare workers for unintentional numerous international human rights instruments. The mishandling of opioids, lead to fear among medical pro- International Covenant on Economic Social and Cultural fessionals. Little research has been published that docu- Rights (ICESCR) specifies that everyone has a right ‘to ments the extent and impact of fears by healthcare the enjoyment of the highest attainable standard of phy- providers on the prescription practice globally. A recent sical and mental health’ [67]. The Committee on Eco- survey in the USA of criminal and administrative cases nomic, Social and Cultural Rights, the treaty’s against physicians related to opiod prescription found monitoring body, has held that states must make avail- an increasing trend in prosecutions which has a chilling able and accessible in sufficient quantity ‘functioning effect on physician practice [61]. Some authors argue public health and health-care facilities, goods and ser- that physicians have an individual obligation to treat vices, as well as programmes’ [68]. patients for severe pain and should be held accountable As states have different levels of resources, interna- forafailuretotreatpainviaachargeofmedicalmal- tional law does not mandate the kind of health care to practice and, in extreme cases, criminal negligence [62]. be provided and, instead, demands ‘progressive realiza- Cost tion’. By committing to the international agreements, a Although basic oral morphine is inexpensive [16], cost is state agrees ‘to take steps... to the maximum of its avail- a frequently cited impediment to improving access to able resources’ to achieve the full realization of the right pain treatment and palliative care services, particularly to health. High income countries will generally have to for low and middle income countries. A 2003 study provide healthcare services at a higher level than those found that the average retail cost of a monthly mor- with limited resources, but all countries will be expected phine supply ranged from US$10 in India to US$254 in to take concrete steps toward increased services. Argentina [63]. Paradoxically, the study found that med- The Committee on Economic, Social and Cultural ian cost of a month’s supply of morphine was more Rights has also held that there are certain core obliga- than twice as high in low and middle income countries tions that are so fundamental that states must fulfill (US$112) as in industrialized countries (US$53). The them. While resource constraints may justify only partial study suggested that a number of factors might explain fulfillment of some aspects of the right to health, the Lohman et al. BMC Medicine 2010, 8:8 Page 6 of 9 24 http://www.biomedcentral.com/1741-7015/8/8

Committee has observed that ‘a State party cannot, Countries also have an obligation to progressively under any circumstances whatsoever, justify its non- implement palliative care services, which, according to compliance with the core obligations...which are nonder- the WHO, must have ‘priority status within public health ogable’. The Committee has identified, among others, and disease control programmes’ [26]. Countries must the following core obligations: to ensure the right of ensure an adequate policy and regulatory framework, access to health facilities, goods and services on a non- develop a plan for the implementation of these services discriminatory basis, especially for vulnerable or margin- and take all steps that are reasonable within available alized groups; to provide essential drugs, as from time resources to execute the plan. Failure to attach adequate to time defined under the WHO Action Programme on priority to developing palliative care services within Essential Drugs; to ensure the equitable distribution of healthcare services will violate the right to health [55]. all health facilities, goods and services; and to adopt and Pain treatment and the right to be free from cruel, implement a national public health strategy and plan of inhuman and degrading treatment action, on the basis of epidemiological evidence, addres- The right to be free from torture, cruel, inhuman and sing the health concerns of the whole population [68]. degrading treatment or punishment is also a fundamen- Pain treatment and the right to health tal human right that is recognized in numerous interna- As morphine and codeine are on the WHO List of tional human rights instruments [69-75]. This right Essential Medicines [31], countries have to provide these creates a positive obligation for states to protect persons medications as part of their core obligations under the in their jurisdiction from torture, cruel, inhuman and right to health, regardless of whether or not they have degrading treatment or punishment. In a letter to the been included on their domestic essential medicines lists Chairperson of the 52nd Session of the Commission on [68]. Countries must ensure that they are both available Narcotic Drugs, the UN Special Rapporteur on Torture, in adequate quantities and physically and financially Cruel, Inhuman and Degrading Treatment and Punish- accessible for those who need them. ment and the UN Special Rapporteur on the Right to Since manufacturing and distribution of controlled Health noted that governments’ failure to take measures medicines, such as morphine and codeine, are comple- to ensure the accessibility of pain treatment threatens tely in government hands, states must put in place an this fundamental right [75]. effective procurement and distribution system and cre- Summary ate a legal and regulatory framework that enables The lack of pain treatment medicine is both perplexing healthcare providers in both the public and private sec- and inexcusable. Pain causes terrible suffering yet the tors to obtain, prescribe and dispense these medications. medications to treat it are cheap, safe, effective and gen- Any regulations that arbitrarily impede the procurement erally straightforward to administer. Furthermore, inter- and dispensing of these medications will violate the national law obliges countries to make adequate pain right to health. States must adopt and implement a medications available. Over the last 20 years, the WHO strategy and plan of action for the roll out of pain treat- and the INCB have repeatedly reminded states of this ment and palliative care services. Such a strategy and obligation. However, little progress has been made and plan of action should identify obstacles to improved ser- tens of millions of people continue to suffer - both vices as well as take steps to eliminate them. directly from untreated pain and from its consequences. States should also regularly measure progress made in Under international human rights law, governments ensuring the availability and accessibility of pain relief must take steps to ensure that people have adequate medications. The requirement of physical accessibility access to treatment for their pain. At a minimum, states means that these medications must be ‘within safe phy- must ensure the availability of morphine, the mainstay sical reach for all sections of the population, especially medication for the treatment of moderate to severe vulnerable or marginalized groups, such as...persons pain. Failure to make essential medicines such as mor- with HIV/AIDS’ [68]. This means that states must phine available or, more broadly, to take reasonable ensure that a sufficient number of healthcare providers steps to make pain management and palliative care ser- or pharmacies stock and dispense morphine and codeine vices accessible to all, results in a violation of the right and that an adequate number of healthcare workers are to health. In some cases, failure to ensure patients have trained and authorized to prescribe these medications. access to treatment for severe pain will also give rise to Financial accessibility means that, while the right to a violation of the prohibition of cruel, inhuman and health does not require states to offer medications free degrading treatment. of charge, they must be ‘affordable for all’. According to Therearemanyreasonsfortheenormityofthegap the Committee, payment for healthcare services must be between pain treatment needs and what is delivered, but based on equity and poorer households should not be the chief among them is a willingness by many govern- disproportionately burdened by cost [68]. ments around the world to passively stand by as people Lohman et al. BMC Medicine 2010, 8:8 Page 7 of 9 25 http://www.biomedcentral.com/1741-7015/8/8

suffer. Excessive over-regulation by governments and the healthcare practitioners - also a first in Africa - and ignorance of healthcare providers conspire to create a authorized the prescribing of morphine by nurses who vicious cycle of under-treatment. As pain treatment and have been trained in palliative care. By early 2009, 79 palliative care are not priorities for the government, nurses and clinical officers had received training in pain healthcare workers do not receive the necessary training management and been authorized to prescribe oral mor- in order to assess and treat pain. This leads to wide- phine, several thousand healthcare workers had attended spread under-treatment and to a low demand for mor- a short course on pain and symptom management and phine. Similarly, complex procurement and prescription 34 out of 56 districts in Uganda had oral morphine regulations, and the threat of harsh punishment for mis- available and in use [65]. Despite this impressive pro- handling morphine, discourage pharmacies and hospitals gress, many challenges remain, including: ensuring the from stocking and healthcare workers from prescribing availability of oral morphine throughout Uganda; keep- it, which again results in low demand. A lack of the ing it affordable; preventing stockouts; and training all prioritization of opioid pain medicine is not a result of relevant healthcare workers. the low prevalence of pain but of the invisibility of its sufferers. Appendix 2: Vietnam case study To break out of this vicious cycle, individual govern- Since 2005, Vietnam has made considerable progress in ments and the international community must fulfill expanding access to palliative and pain treatment ser- their obligations under international human rights law. vices. A working group on palliative care, including Governments must take action to eliminate barriers that health officials, physicians and NGOs, conducted a rapid impede the availability of pain treatment medications. situation analysis devised to assess the availability of, They must develop policies on pain management and and need for, palliative care in Vietnam. This rapid ana- palliative care; introduce instruction for healthcare lysis found severe chronic pain to be common among workers, including for those already practicing; reform cancer and HIV/AIDS patients, while the availability of regulations that unnecessarily impede the accessibility of opioid analgesics was severely limited, palliative care ser- pain medications; and take action to ensure their afford- vices were not readily available and clinicians lacked ability. While this is a considerable task, various coun- adequate training [78]. The working group recom- tries, such as Uganda and Vietnam, have shown that mended that national palliative care guidelines be devel- such a comprehensive approach is feasible in low and oped, a balanced national opioid control policy be middle-income countries. Other nations must learn designed, training for healthcare workers be expanded from these experiences and work towards the realization and that the availability and quality of palliative care ser- of full access to pain relief medicines. vices be improved. In 2006, the Ministry of Health issued detailed guide- Appendix 1: Uganda case study lines to practitioners on palliative care and pain man- In 1998, Ugandan government officials, representatives agement and, in 2008, it issued new guidelines on of non-governmental organizations and the WHO opioid prescription which have eased a number of key agreed on ways in which pain treatment could be made regulatory barriers. The Ministry has also approved a available to the population. These steps included: devel- package of training courses for practicing physicians and oping national palliative care, cancer and AIDS pain two medical colleges now offer instruction on palliative relief policies; implementing a training course to com- care to undergraduate medical and nursing students. plement existing palliative medicine teaching and However, only a few hundred healthcare workers have increasing the number of skilled providers; developing received training so far, understanding of palliative care new drug regulations: updating the essential drug list; among healthcare officials continues to be limited, var- conducting estimates of the medical need for morphine; ious regulatory barriers persist and few pharmacies and and requests from the drug control authority for an hospitals stock oral morphine. increased national allowance from the INCB [77]. Following this agreement, Uganda has made consider- Acknowledgements able progress in reducing or eliminating barriers that The authors would like to thank Katherine Todrys, Seth Davis, Olena Baev, have traditionally impeded access to pain treatment Emily Dauria and Mignon Lamia for their help with the development of the medications. In its 5-year Strategic Health Plan for article and all those working to provide palliative care worldwide for their dedication and compassion. 2000-2005, the government noted that palliative care was an essential clinical service for all Ugandans and so Authors’ contributions became the first nation in Africa to do so. It also added DL and JJA conceived the article and reviewed the existing literature. DL wrote the article and RS and JJA reviewed and contributed to a revised liquid morphine to its essential drug list, adopted a new version. All authors reviewed and approved the final text. set of guidelines for the handling of class A drugs for Lohman et al. BMC Medicine 2010, 8:8 Page 8 of 9 26 http://www.biomedcentral.com/1741-7015/8/8

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Larue F, Fontaine A, Colleau SM: Underestimation and under-treatment of Availability. Geneva: WHO, 2 1996. pain in HIV disease: a multicentre study. BMJ 1997, 314:23. 47. Stjernsward J, Clark D: Palliative medicine: a global perspective. Oxford 18. Dalakas MC: Peripheral neuropathy and antiretroviral drugs. J Periph 2001, Textbook of Palliative Medicine New York: Oxford University PressDoyle G, 6:14-20. Hanks WC, Cherny N, Calman K 2003, 1199-222. 19. Breitbart W, Patt RB, Passik SD, Reddy KS, Lefkowitz M: Pain: clinical 48. DFID Health Resource Center: Review of Global Policy Architecture and updates. IASP 2006, 4:1-8. Country Level Practice on HIV/AIDS and Palliative Care. DFID 2007. 20. Harding R, Easterbrook P, Dinat N, Higginson IJ: Pain and symptom control 49. United Nations Office on Drugs and Crime: Model Drug Laws Designed in HIV disease: under-researched and poorly managed. Clin Infect Dis For Civil Law Countries: Document A - Model Law On The Classification 2005, 40:491-492. of Narcotic Drugs, Psychotropic Substances and Precursors and on the 21. Hewitt D, McDonald M, Portenoy R, Rosenfeld B, Passik S, Breitbart W: Pain Regulation of the Licit Cultivation, Production, Manufacture and Trading syndromes and etiologies in ambulatory AIDS patients. Pain 1997, of Drugs. UN 2003. 70:117-123. Lohman et al. BMC Medicine 2010, 8:8 Page 9 of 9 27 http://www.biomedcentral.com/1741-7015/8/8

50. United Nations Office on Drugs and Crime: Model Regulation Establishing Pre-publication history an Interministerial Commission for the Coordination of Drug Control. UN The pre-publication history for this paper can be accessed here:http://www. 2002. biomedcentral.com/1741-7015/8/8/prepub 51. Model Drug Abuse Bill. http://www.unodc.org/unodc/en/legal-tools/Model. html. doi:10.1186/1741-7015-8-8 52. Do international model drug control laws provide for drug availability?. Cite this article as: Lohman et al.: Access to pain treatment as a human http://www.painpolicy.wisc.edu/internat/model_law_eval.pdf. right. BMC Medicine 2010 8:8. 53. Adams V: Access to pain relief - an essential human right. J Pain Palliat Care Pharmacother 2008, 22:101-129. 54. Green K, Kinh LN, Khue LN: Palliative Care in Vietnam: Findings from a Rapid Situation Analysis in Five Provinces. Hanoi: Vietnam Ministry of Health 2006. 55. Human Rights Watch: Unbearable Pain: India’s Obligation to Ensure Palliative Care. HRW 2009http://www.hrw.org/en/node/86153. 56. International Narcotics Control Board: Report of the International Narcotic Control Board for 2008. United Nations 2009. 57. Proceedings of the 2nd Eastern Europe and Central Asia AIDS Conference: 3-5 May 2008. Moscow 2008. 58. The Ministry of Health of Ukraine: Order No. 356.. 59. Anderson E, Beletsky L, Burris S, Davis C, Kresina T, eds: Closing the gap: case studies of opioid access reform in China, India, Romania and Vietnam. Report for the UK Department of International Development. DID 2008. 60. International Narcotics Control Board: Demand For and Supply of Opiates for Medical and Scientific Needs. INCB 1989. 61. Goldenbaum DM, Christopher M, Gallagher RM, Fishman S, Payne R, Joranson D, Edmondson D, McKee J, Thexton A: Physicians charged with opioid analgesic-prescribing offenses. Pain Medicine 2008, 9:737-47. 62. Margaret Somerville: Death of pain: pain, suffering and ethics. Progress in Pain Research and Management, Proceedings of the 7th World Congress on Pain, International Association for the Study of Pain Washington: IASP PressGerald F Gebhart, Donna L Hammond, Troels S Jensen 1994, 2:41-58. 63. De Lima L, Sweeney C, Palmer JL, Bruera E: Potent analgesics are more expensive for patients in developing countries: a comparative study. J Pain Palliat Care Pharmacother 2004, 18:63. 64. Joransen DE, Rajagopal MR, Gilson AM: Improving access to opioid analgesics for palliative care in India. J Pain Symptom Manage 2002, 24:152-59. 65. Email correspondence with Anne Merriman, Hospice Uganda 2009. 66. Email correspondence with Kimberly Green, Family Health International Vietnam 2009. 67. International Covenant on Economic, Social and Cultural Rights. GA Res. 2200A (XXI). 21 U.N. GAOR Supp. No. 16 at 49. U.N. Doc. A/6316. 993 U.N.T.S. 3. art. 11 1966. 68. UN Committee on Economic, Social and Cultural Rights: General Comment No. 14: The Right To The Highest Attainable Standard Of Health. UN 2000. 69. International Covenant on Civil and Political Rights: GA Res. 2200A (XXI). 21 UN GAOR Supp. No. 16 at 52. . UN Doc. A/6316. art. 7. UN 1966. 70. UN: Universal Declaration of Human Rights. UN Doc A/810. UN 1948. 71. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment: GA Res. 39/46, Annex. 39 UN GAOR Supp. No. 51 at 197. UN Doc. A/39/51. art. 16. UN 1984. 72. Inter-American convention to prevent and punish torture. OAS Treaty Series No. 67. OAS 1987. 73. European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment: ETS 126 1987. 74. African [Banjul] Charter on Human and Peoples’ Rights: OAU Doc. CAB/LEG/ 67/3 rev. 5. 21 I.L.M. 58 1981. 75. Z v. United Kingdom. 4 EHRR 97 2001. Publish with BioMed Central and every 76. Letter from Special Rapporteur on the question of torture and Special scientist can read your work free of charge Rapporteur on the right of everyone to the enjoyment of the highest "BioMed Central will be the most significant development for attainable standard of physical and mental health to Ms. Selma Ashipala- disseminating the results of biomedical research in our lifetime." Musavyi, Chairperson of the 52nd Session of the Commission on Narcotic Drugs 2008. Sir Paul Nurse, Cancer Research UK 77. Stjernsward J: Uganda: initiating a government public health approach Your research papers will be: to pain relief and palliative care. J Pain Symptom Manage 2002, 24. available free of charge to the entire biomedical community 78. Green K, Kinh LN, Khue LN: Palliative care in Vietnam: Findings from a rapid situation assessment in five provinces. Hanoi: Vietnam Ministry of peer reviewed and published immediately upon acceptance Health 2006. cited in PubMed and archived on PubMed Central 79. WHO Statistical Information System. http://www.who.int/whosis/en/. yours — you keep the copyright

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World Health Organization Briefing Note — February 2009 29 Access to Controlled Medications Programme Improving access to medications controlled under international drug conventions x Providing normative guidance relating to the use of controlled medications x Policy analysis and review of legislation to identify possible means for improving access x Training and practical assistance to governments and healthcare workers

ccess to many medicines controlled frequently unavailable. A under international drug control treaties There are 16 million people who inject is lacking around the world, with the drugs in the world.2 Of the new HIV exception of a few industrialized countries. infections in Eastern Europe and Central Even in some highly industrialized countries Asia in 2005, 67% were due to injection drug access is limited. The realization of the use.3 It is estimated that if pharmacological Millennium Development Goal 8e,"Provide treatment of opioid dependence was to be access to affordable essential drugs in made readily available, such access could developing countries", is likely to be further result in the prevention of up to 130,000 new away for opioid analgesics than for any other HIV infections from needle sharing outside class of medicines. sub-Saharan Africa annually. A meta These controlled medicines are used analysis of four studies showed a reduction to treat conditions including: of annual HIV-seroconversion by 64% (C.I. 34 - 81 %).4 Such treatment would also reduce the spread of hepatitis C and other Moderate to severe pain x blood-borne diseases as well as decrease Opioid dependence x deaths from opioid overdose by 90%.5 Obstetric complications x Finally, it is estimated that every dollar invested in treatment of opioid dependence Pain Management has a 3 to 13-fold return to society. The World Health Organization (WHO) estimates that 5 billion people live in Maternal death countries with low or no access to controlled Each year, half a million women die medicines and have no or insufficient access during childbirth6, about 120,000 of them to treatment for moderate to severe pain.1 from post-partum bleeding.7 Many of these In these countries, each year tens of lives could have been saved if medicines to millions of patients are suffering without stop the bleeding were available. adequate treatment: Treatment is simple and x 1 million end-stage HIV/AIDS patients inexpensive x 5.5 million terminal cancer patients Moderate to severe pain can be easily x 0.8 million patients suffering injuries, controlled with opioid analgesics such as caused by accidents and violence morphine. Opioid dependence can be x Patients with chronic illnesses effectively treated with oral substitution x Patients recovering from surgery therapy using methadone or buprenorphine. x Women in labour (110 million births each While post-partum bleeding can be treated year) by either ergometrine or oxytocin, these x Paediatric patients medicines are both not readily available. Of the two medicines, ergometrine is a Opioid dependence treatment controlled substance. and HIV-prevention Lack of access affects all controlled Despite strong evidence of efficacy, medicines on the WHO Model List of adequate treatment of opioid dependence Essential Medicines. Because of their status such as oral substitution therapy is as essential medicines, their availability for

Medicines Access and Rational Use, Department of Essential Medicines and Pharmaceutical Policies Health Systems and Services, World Health Organization Contact: Dr Willem Scholten Tel.: +41 22 791 5540 Email: [email protected] 30 Access to Controlled Medications Programme — Page 2

medical treatment is a human right, as lifting these barriers and started the defined in the International Covenant on development of pain treatment guidelines. Economic, Social and Cultural Rights (article Over the past years, ACMP has raised 12, the Right to Health). awareness about the problem of access to these medicines through presentations at Balancing prevention and conferences, publications and the media. medical availability Many factors contribute to the lack of What needs to be done? access to controlled medicines. There is a The ACMP will address all aspects need for greater awareness among policy that act as barriers to obtaining controlled makers, healthcare professionals and the medicines for medical treatment including: general public to dispel the myth that opioid legislative and administrative procedures, as analgesics (i.e. pain killers derived from well as knowledge among policy makers, opium, such as morphine) will do harm to healthcare workers, patients and their patients and cause dependence. The fear of families. dependence upon pain treatment is largely During the first phase (six years) of unfounded, as almost all patients are able to its implementation, the ACMP focus is on stop their opioid medication at the end of identifying the most effective assistance their treatment with no long-lasting effects. mechanisms and further developing tools to Although substitution treatment does not be used in the programme. The ACMP's terminate dependence, it removes most of the activities will include: detrimental health effects for the patient as well as the harmful impact of drug dependency on a society. Ergometrine, a Normative guidance medicine used in obstetrics, is often x Development and dissemination of unavailable for use in childbirth. Although internationally recognized standards for not a drug of abuse it can be used as a treatment and policy guidelines starting material for the synthesis of such Policy analysis drugs. x Workshops for healthcare professionals, Of course, the risk of dependence legislators and law enforcers to analyse and discuss the problem and draft through non-medical use is real and society needs to protect against these drugs being national action plans for its resolution diverted from appropriate medical use. This x Improving access to effective treatment by reviewing legislation and can and should be done in a balanced way that does not affect their availability for administrative procedures appropriate medical treatment. Training and practical assistance x Supporting implementation of action What has been done so far? plans at the national level x Training healthcare professionals In response to the World Health through workshops on rational Assembly and the United Nations' Economic prescribing, provision of information 8 and Social Council in 2005 , WHO developed materials and curriculum review support the Access to Controlled Medications to universities Programme (ACMP) in consultation with the x Training workshops for civil servants to International Narcotics Control Board and a make realistic estimates of future needs number of NGOs. The strategy was presented for opioid analgesics and to compile to and accepted by the UN's Commission on reliable statistics, and Narcotic Drugs and the World Health x Training workshops on procurement for Assembly in 2007. The ACMP focuses on pharmaceutical inspectors and law lifting barriers that impede access to enforcement controlled medicines, including opioids - the Further study most important category of these medicines. x Performing surveys on accessibility, The ACMP has participated in availability, affordability and use of the activities of other organizations directed at medicines and substances involved.

Medicines Access and Rational Use, Department of Essential Medicines and Pharmaceutical Policies Health Systems and Services, World Health Organization Contact: Dr Willem Scholten Tel.: +41 22 791 5540 Email: [email protected] Access to Controlled Medications Programme — Page 3 31

To develop activities in twelve East European countries, ACMP formed the Who are our partners? ATOME-consortium (Access to Opioid The ACMP supports governments in Medicines in Europe) which includes: the identifying and overcoming obstacles that European Association for Palliative Care (EAPC), the Eurasian Harm Reduction hinder the procurement and distribution of controlled medication to help ensure Network, Help the Hospices UK, Hospice adequate availability of opioid analgesics for Casa Sperantei, the International Observatory for End of Life Care at the pain treatment and opioid dependence. WHO will work with national authorities, including University of Lancaster, Ministry of Interior regulatory authorities, public health and Administrative Reform - Government of Romania, National Anti-Drugs Agency and administrators and law enforcement officials. WHO will also draw on the expertise of NautaDutilh NV. relevant WHO departments and units The governments of France and the involved in diseases related to pain, Netherlands as well as the US Cancer Pain international and national experts in the Relief Committee, the Open Society Institute area of opioid medication, WHO and IASP, are donors to the Programme. The Collaborating Centers, the International European Commission (Directorate-General Narcotics Control Board and healthcare for Research) is a donor to the ATOME professionals, such as medical practitioners, consortium through its 7th Framework nurses with special training and Programme. pharmacists. Work in countries will be implemented in close collaboration with What will happen as a result? WHO regional offices and WHO Expected outputs of the ACMP Representatives in the countries. include internationally recognized standards for clinical treatment with controlled " The ACMP is an extremely medications, tools and national capacity to assess trends in opioid availability and important development which will future needs of controlled medicines, a have a similar major impact on the review of national policy and legislation on management of severe unrelieved pain controlled medicines, national healthcare workers trained in rational use of controlled world wide as the 1986 WHO medicines, and curriculum developed on the initiatives on the management of use of controlled medications. cancer pain." The direct beneficiaries of the ACMP International Association for the Study of Pain will be national authorities such as regulatory authorities, national healthcare administrators, healthcare professionals and The ACMP's current partners and law enforcement officials in developing endorsers include national and international countries where access to pain medication is healthcare experts, WHO Collaborating severely limited. The indirect and ultimate Centre for Policy and Communications in beneficiaries of the ACMP will be people in Cancer Care at the University of Wisconsin need of controlled medication, particularly and national and international professional patients suffering from cancer, chronic pain, associations, such as the United States' diabetic neuropathy, HIV neuropathy, sickle- Cancer Pain Relief Committee, the cell disease, pre-and post-operative surgery International Harm Reduction Association pain, traumatic pain, women in delivery, (IHRA), the International Association for the neonates, children, particularly paediatric Study of Pain (IASP), the European patients in developing countries, as well as Association for Palliative Care (EAPC), the patients with opioid dependence and their African Palliative Care Association (APCA), communities. the International Association for Hospice and Palliative Care (IAHPC) and the International The ACMP is the first and only global Observatory for End of Life Care.9 initiative in this field adding value to national

Medicines Access and Rational Use, Department of Essential Medicines and Pharmaceutical Policies Health Systems and Services, World Health Organization Contact: Dr Willem Scholten Tel.: +41 22 791 5540 Email: [email protected] 32 Access to Controlled Medications Programme — Page 4

processes through the provision of evidence- based guidelines, policy analysis, training and practical assistance. The clinical 4 World Health Organization, Guidelines for the Pharmacologically Assisted Treatment of Opioid guidelines, tools and training materials Dependence, Geneva 2009. developed under the programme will provide 5 Dr Patrizia Carrieri, INSERM, Marseille, France (oral universal and internationally recognized communication, 28 March 2006)

standards for the clinical use of controlled 6 Maternal Mortality in 2005, Estimates developed by, medicines for use by national governments. WHO, UNICEF, UNFPA and The World Bank, Geneva 2007, ISBN 978 92 4 159621 3, accessed at http://www.who.int/reproductive- Proposed budget health/publications/maternal_mortality_2005/mme_20 The ACMP's action plan has a 05.pdf projected budget of US$ 55.5 million for its 7 WHO, Emergency and surgical procedures at the first referral health facility, accessed at: first six years (inclusive 13% Programme www.who.int/eht/en/SurgicalProcedure.pdf Support Cost). Two-thirds of the budget will 8 Resolutions WHA58.22 and ECOSOC 2005/25 focus on policy development and support activities to improve access to opioids for 9 Many of these organizations have written letters of support. to the ACMP pain management. The remaining third will 10 The ACMP will go to over 150 countries world-wide be directed towards substitution therapy eventually. For the moment, priority countries are: efforts. It is expected that half of the Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya, budgeted activities will be delivered through Malawi, Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania and Zambia (all AFRO Region); Egypt, Iran, 10 the regional and country offices , while the Morocco, Oman, Pakistan and Sudan (all EMRO Region), remainder of the budget will support ACMP Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech work at WHO headquarters (including 11% Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Romania, Serbia, for staff). Slovenia, Slovakia and Turkey (all EURO Region); Argentina, Colombia and Panama (all AMRO Region), Contributions from governments as Indonesia, Bangladesh and India (all SEARO Region) well as NGOs are urgently needed. Vietnam, China and the Philippines (all WPRO Region).

Further information More information on the Framework of the Access to Controlled Medications Programme, the nature of access barriers for controlled medicines, as well as literature references, is available on the WHO Medicines web site: http://www.who.int/entity/medicines/areas /quality_safety/sub_Int_control/en/index.ht ml

1 The countries with low or no access are defined as countries where the consumption of opioid analgesics is lower than 30% of the adequate per capita consumption. The adequate consumption is defined as the average per capita consumption in the top 20 countries in the Human Development Index.

2 Bradley M, Louisa D et al. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. Lancet 2008; DOI:10.1016/S0140-6736(08)61311-2

3 UNAIDS, AIDS Epidemic Update 07, accessed at http://data.unaids.org/pub/EPISlides/2007/2007_epiu pdate_en.pdf

Medicines Access and Rational Use, Department of Essential Medicines and Pharmaceutical Policies Health Systems and Services, World Health Organization Contact: Dr Willem Scholten Tel.: +41 22 791 5540 Email: [email protected]

National Strategies

National Pain Strategy

35 National Pain Strategy Pain Management for all Australians

Developed by the National Pain Summit initiative www.painsummit.org.au

Led by: Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine Australian Pain Society Chronic Pain Australia

In collaboration with inaugural supporters: MBF Foundation University of Sydney Pain Management Research Institute '

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Chronic pain. negative affect and disability: Preliminary data from the 2005 Statistics Norway Health Survey

Christopher Sivert Nielsen

Background

• The two leading causes of disability are: – Chronic pain – Psychiatric conditions. mainly anxiety and depression (negative affect)

• These conditions are frequently comorbid 56

Research questions

1) Does comorbid anxiety and depression account for the high diability rate among chronic pain patients? 2) Does comorbid chronic pain account for the high diability rate among patients with anxiety and depression? 3) … Or are the two largely independent causes of disability?

Descriptive statistics N: 1689 Age: 26 -65 years Chronic pain a) 29.5 % HSCL > 1.75 b) 8.2 % Disability c) 9.5 %

1) Persistent pain > 6 months 2) Hopkins Symptom Check List. 25-item version 3) Registry data. cutoff = disability > 50% 57

Effect of pain on negative affect

Dependent: HSCL RR P PAP Sex (female) 1.50 (1.09 to 2.15) < 0.05 0.22 ( 0.05 to 0.40) Age (pr. 10–yrs) 1.01 (0.87 to 1.17) n.s. 0.02 (–0.23 to 0.23) Education (< 11 yrs) 1.22 (0.70 to 1.96) n.s. 0.02 (–0.04 to 0.10) Chronic pain 2.82 (2.03 to 3.88) < 0.01 0.36 ( 0.24 to 0.47)

Finding: Chronic pain accounts for 36% of the cases of anxiety and depression (HSCL > 1.75). RR = relative risk; PAP = Population attributable proportion

Effect negative affect on pain

Dependent: Chronic pain RR P PAP Sex (female) 1.42 (1.21 to 1.66) < 0.01 0.18 (0.10 to 0.26) Age (pr. 10–yrs) 1.10 (1.02 to 1.17) < 0.01 0.14 (0.02 to 0.23) Education (< 11 yrs) 1.53 (1.23 to 1.79) < 0.01 0.05 (0.02 to 0.08) HSCL (> 1.75) 1.82 (1.49 to 2.12) < 0.01 0.07 (0.04 to 0.10)

Finding: Anxiety and depression (HSCL > 1.75) account for only 7% of the cases of chronic pain. RR = relative risk; PAP = Population attributable proportion 58

Pain as a predictor of disability

Dependent: Disability RR P PAP Sex (female) 1.17 (0.89 to 1.53) n.s. 0.09 (–0.07 to 0.23) Age (pr. 10–yrs) 2.21 (1.90 to 2.65) < 0.01 0.81 ( 0.73 to 0.88) Education (< 11 yrs) 1.44 (1.10 to 1.92) < 0.01 0.07 ( 0.02 to 0.14) Chronic pain 4.66 (3.41 to 6.47) < 0.01 0.56 ( 0.45 to 0.66)

Finding: Chronic pain accounts for 56% of the disability cases

RR = relative risk; PAP = Population attributable proportion

Negative affect as a predictor of disability Dependent: Disability RR P PAP Sex (female) 1.40 (1.03 to 1.86) < 0.05 0.17 (0.02 to 0.32) Age (pr. 10–yrs) 2.31 (1.93 to 2.81) < 0.01 0.82 (0.73 to 0.89) Education (< 11 yrs) 1.79 (1.31 to 2.42) < 0.01 0.11 (0.05 to 0.17) HSCL (> 1.75) 2.52 (1.82 to 3.40) < 0.01 0.13 (0.08 to 0.20) Finding: Anxiety and depression account for 13% of the disability cases. RR = relative risk; PAP = Population attributable proportion 59

Controlled for each other:

Dependent: Disability RR P PAP Sex (female) 1.11 (0.96 to 1.52) n.s. 0.06 (–0.03 to 0.22) Age (pr. 10–yrs) 2.20 (1.84 to 2.64) < 0.01 0.81 ( 0.71 to 0.88) Education (< 11 yrs) 1.42 (1.11 to 1.82) < 0.01 0.07 ( 0.02 to 0.13) HSCL (> 1.75) 1.81 (1.43 to 2.31) < 0.01 0.10 ( 0.05 to 0.16) Chronic pain 4.30 (3.16 to 6.21) < 0.01 0.54 ( 0.44 to 0.65) Finding: Almost no change in estimates when controlling for each other RR = relative risk; PAP = Population attributable proportion

Effect of adjustment RRRR – Disability PAP PAP – Disability 5,00 0,60

Ujustert a) Ujustert c) Unadjusted 0,50 Unadjusted 4,00 Justert Justert Adjusted b) Adjusted d) 0,40 3,00 0,30 2,00 0,20

1,00 0,10

0,00 0,00 ChronicSmerte pain HSCL HSCL > 1.75 ChronicSmerte pain HSCL HSCL > 1.75 a) Adjusted for sex + age + educ c) Adjusted for sex + age + educ b) Adjusted for sex + age + educ + HSCL d) Adjusted for sex + age + educ + chronic pain 60

Conclusions 1

• Chronic pain accounts for a large percentage of cases of anxiety and depression (36%) • Anxiety and depression account for few cases of chronic pain (7%) • This difference is due to the difference in prevalence between the two conditions

Conclusions 2

• Chronic pain accounts more than half of the disability cases • Controlling for anxiety and depression has insignificant effect on this estimate • Chronic pain and negative affect are largely independent causes of disability 61

Limitations

• HSCL is not a clinical measure of anxiety and depression • However: the prevalence of clinical anxiety and depression in the population is lower than this measure would indicate.

63

National Program for Pain Management

Directorate-General for Health, Portugal www.dgs.pt 64 National Program for Pain Management

Contents

1. Introduction 3

2. Context 4

3. Guiding Principles 6

4. General Objectives 6

5. Specific Objectives 6

6. Target Population 6

7. Time Line 6

8. Strategy for Intervention 6

9. Strategy for Professional Training 7

10. Strategy for Gathering and Analyzing Information 7

11. Gantt Chart 8

12. Follow-up and Evaluation 9

13. Bibliography 9

Appendix

Organizational Rules and Classification of Chronic Pain Clinics 10

2 National Program for Pain Management 65

Introduction Pain is a physiological mechanism of paramount importance for the physical integrity of individuals. The nociceptive system comprises nervous structures whose main function is to detect harmful or potentially harmful stimuli, so as to set off reflexive and/or cognitive reactions to avoid lesions, or to prevent a lesion from becoming worse and contribute to its healing.

The importance of pain, especially acute pain, as a symptom of a lesion or an organ dysfunction is well evidenced by the fact that it represents the main reason for the general population to seek health care. Pain is also, countless times, one of the most relevant symptoms for establishing a correct medical diagnosis.

However, except for the vital sounding of the alarm, pain does not represent any other physiological advantage for the organism. In fact, in addition to causing suffering and reducing quality of life, pain is also responsible for physiopathological alterations of the immune, endocrine, and nervous systems, which contribute to physical and psychological comorbidities that may lead to the perpetuation of pain.

Moreover, pain and in particular chronic pain can be present even in the absence of an identifiable lesion, or it may persist after the lesion that originated it has been healed. In this context, pain is not a mere symptom but becomes a disease in itself, as acknowledged in a declaration at the European Parliament in 2001 by the European Federation of IASP Chapters (EFIC)2.

Therefore, and within the scope of high-quality health care services, pain management must be seen as a priority, and also as a decisive factor in the necessary humanization of health care. In fact, according to a proposal presented by the International Association for the Study of Pain (IASP) during the First Global Day Against Pain3, pain relief should be acknowledged as a fundamental human right.

In addition to the enormous impact it has on individuals, pain often constitutes a burden for the patient’s family and/or caregivers and represents a loss that is difficult to quantify for society as a whole. It is worth noting that the socioeconomic repercussions of pain have been compared by EFIC to those caused by cardiovascular diseases or cancer.

Acknowledging the importance of pain management, a working group dedicated to pain was created in 1999 by the Directorate-General for Health, which worked in strict collaboration with the Portuguese Association for the Study of Pain (the Portuguese Chapter of IASP) to develop a National Program for the Fight Against Pain (NPFAP), approved by Ministry Decree on 26 March 2001. This plan, innovative at the national and international level (in Europe, France is the only other country with a governmental plan to fight pain), describes the organizational models for pain management in hospitals, including several general guidelines for pain management. The Portuguese government was also the first to establish a National Day for the Fight Against Pain in 1999.

The time frame of the NPFAP ended in 2007, and although some positive progress toward achieving its objectives is recognized, it is clear that the NPFAP will not meet all of its goals. It should be noted that after the development and publication of the NPFAP, several changes took place in the organizational structure of hospitals with implications for the achievement of its goals. Among these changes, we highlight the reformulation of the Hospital Charter, aggregating some hospitals into hospital centers, the reclassification of hospitals into four categories (multi-purpose hospitals (type A), medical-surgery hospitals (type B), local hospitals (type C), and specialized hospitals (type E), the conversion of some hospitals into public limited corporations, and later, into publicly held corporations, and the approval of the rules for the establishment of university hospitals. It was also noted that the criteria defined in the NPFAP for the classification of chronic pain clinics, based on the classification established by IASP, which follows the American model, are not the most appropriate criteria for the current reality, inasmuch as in some aspects the NPFAP criteria are more demanding than those established by IASP. The recent creation of a Competency in Pain Medicine by the Medical Association, as a way of promoting and recognizing the specialization of doctors dedicated to this field of medicine, also emphasized the need to reformulate those criteria.

The National Program for Pain Management emerged from the need to define new objectives and new operational strategies, as a follow-up to the NPFAP and using the experience gained so far. Hence, in order to obtain epidemiologic knowledge on pain and its distribution in the Portuguese population, to reinforce the organizational capacity of health care service providers, and to improve best practice models regarding pain management, this new National Program for Pain Management should be developed through the implementation, at national, regional, and local levels, of new strategies for intervention, professional development, and data collection and analysis.

2 Available through www.efic.org/declarationonpain.html 3 For more information see www.iasp-pain.org.

3 66 National Program for Pain Management

The National Program for Pain Management is incorporated into the National Health Plan 2004–2010, intersecting with and complementing other national programs in the fields of cancer, rheumatic diseases, and palliative care.

The implementation of the National Program for Pain Management presupposes the participation and collaboration of various health care bodies, namely primary health care, hospitals, the Integrated Network for Continuing Care, institutions of higher education, professional associations, and scientific societies, without precluding the inclusion of other public or private institutions from cooperating as needed, during the course of implementation. The Portuguese Association for the Study of Pain constitutes the permanent scientific interlocutor of the Directorate-General for Health in all aspects of the development, implementation, and evaluation of this program.

2. Context Pain is defined by the International Association for the Study of Pain (IASP) as “an unpleasant multidimensional, sensory and emotional experience associated with actual or potential tissue damage, or described in relation to such damage”4. This definition implies that pain has the capacity to affect the individual as a whole, and therefore its management must often be approached on multidimensional levels, taking into consideration not only the sensory aspects of pain, but also the psychological, social, and cultural factors associated with the painful condition.

The prevalence of pain in Portugal was studied by the National Health Observatory in 2002, by means of telephone interviews with Portuguese families that were part of the ECOS sample group5. The study concluded that approximately 74% of those interviewed had felt some kind of pain in the two weeks preceding the telephone interview. The study also revealed that low back pain, osteoarticular pain, and headaches were the types of pain most frequently referred to.

The reduced number of the sample group that participated in the study, as well as the difficulty in determining the severity of pain and its clinical relevance, precluded the establishment of the prevalence of pain in Portugal regarding acute postsurgical pain and chronic pain, the two most clinically relevant types of pain.

Several studies carried out in European countries, with greater sophistication than the ones observed in Portugal in the context of acute postsurgical pain, have demonstrated insufficiencies in the management of this type of pain. This fact is hard to understand and accept because this is a type of pain inflicted by a physician in the course of a therapeutic intervention, and therefore its causes are well known. The management of this type of pain essentially depends on the adequate application of procedural protocols in the perioperative period. The same principle applies to other types of pain inflicted by therapeutic processes or complementary diagnostic tests. On the other hand, it has also been established that as well as preventing unnecessary pain, adequate analgesia in the perioperative period contributes to the reduction of morbidity and decreases the period of hospitalization, thus representing an advantage in economic terms as well.

Chronic pain is usually defined as persistent or recurrent pain that lasts for 3 months or longer and/or persists after the lesion that caused it has been healed. In a recent European study6, which did not include Portugal, the average prevalence of chronic pain in Europe was cited at approximately 20%. Given that this study found significant differences between each country (the prevalence of chronic pain in Norway was 30%, while in Spain it was 11%), it is not possible to make a reliable estimate for Portugal. In any case, the increase in average life expectancy and the consequent aging of the population, as well as the increased longevity of patients suffering from diseases accompanied by pain, allow us to project an increase in the prevalence of chronic pain for the future.

The main causes of chronic pain in Portugal are also unknown, but several international studies corroborate in choosing low back pain as the primary cause of pain. Osteoarticular and musculoskeletal conditions, in addition to low back pain, are other causes of high prevalence of chronic pain, as well as headaches, and on a lesser scale, neuropathic pain. Pain deriving from oncological conditions, often seen as one of the main causes of chronic pain, only represents a small percentage of the chronic pain suffered by patients. However, it has a special importance because cancer is the second largest cause of death in Portugal, and moderate to severe pain is present in 90% of patients with terminal cancer.

______4 H. Merskey and N. Bogduk, 1994 5 S. Rabiais et al., 2004

4 National Program for Pain Management 67

Similarly, the socioeconomic impact of pain has not been studied in Portugal. However, a study conducted in the United Kingdom7 estimated that health care expenses relating to low back pain, which is, as previously stated, the most prevalent chronic pain condition, amounted to €2.5 billion in 1998 alone. However, when the consequent indirect costs are added, namely loss of productivity, absenteeism, and early retirement pensions, the total cost reaches almost €20 billion.

With the exception of specific cases, such as acute postsurgical pain, or pain resulting from labor, pain management should be initiated by, and in most cases restricted to, primary care services. These services must necessarily be the foundation for any strategy that aims to enhance pain management for the general population, especially considering that pain constitutes one of the main motivations for family doctor consultations. In addition to the appropriate technical know-how, the family doctor should have the necessary qualifications to evaluate the social and cultural components of the patient’s environment that may be relevant to the management of pain.

However, the complexity of diagnosis, the need to perform complementary examinations or different therapeutic techniques, and the difficulty of pain management are factors that may lead to the necessity of referring the patient to specialized health facilities that have health professionals competent in pain diagnosis and management.

It is within this context that pain clinics appear within hospitals. They hold distinct levels of specialization according to the respective team and hospital structure in which they are based. The most specialized pain clinics should be at the higher level of the referral system, based on the increasing complexity of the clinical situation or therapeutic strategy.

According to a survey carried out by the Monitoring Committee of NPFAP in 2003, 53 hospitals within the National Health Service had incorporated entities dedicated specifically to chronic pain. This number represents an increase of 40% compared to a similar survey carried out in 1999, before the implementation of NPFAP. However, and similarly to the situation in 1999, the majority of the facilities did not have the recommended levels of differentiation and specialization, particularly as they were monodisciplinary units, lacking psychiatrists or clinical psychologists and doctors with other specialties, with reduced weekly activities and no clinical investigations. It should be noted that the data obtained may be overrated because no independent evaluation was performed.

The same survey stated that only 22 postsurgical acute pain clinics existed, which represents a decrease of 4 clinics in relation to 1999. The reasons for this decrease are hard to understand because such clinics are merely operational units that promote organized action plans and protocols for postsurgical analgesia, which should include all health professionals involved in the perioperative period, namely anesthesiologists, surgeons, and nurses.

Regarding analgesia during labor, it was noted that there was organized activity in 31 of the 53 hospitals that participated in the survey. The maternity centers of Júlio Diniz (Oporto), Bissaya Barreto (Coimbra), and Alfredo da Costa (Lisbon) have obstetric analgesia 24 hours a day, seven days a week. There are more than 15 hospitals offering 24-hour obstetric analgesia and 9 offering it 12 hours a day. Of these hospitals, 16 offer obstetric analgesia 7 days a week. It was also observed that pain intensity was recorded in only 24% of hospitals offering obstetric analgesia.

The Directorate-General for Health published a regulation on June 14, 2003 (no. 09/DGCG), which declares pain to be the Fifth Vital Sign. As such, it has since become considered good clinical practice and mandatory to evaluate and record the intensity of pain regularly, in all health care services, as has long been done for the four “classic” vital signs (respiratory frequency, heart rate, blood pressure, and body temperature). This regulation also indicates the scales that may be used in evaluating the intensity of pain, providing basic instructions for their use. However, it has been observed that this regulation has not yet been implemented in many health care services, perhaps due to a lack of knowledge and awareness of the duties of health care professionals and the public’s right to pain management. The standardization of the evaluation and recording of the intensity of pain could have a significant impact on the treatment of pain in health care units, providing a huge qualitative leap in the humanization of the care provided.

______6 Breivik et al,. 2006 7 N. Maniadakis e A. Gray, 2000

5 68 National Program for Pain Management

3. Guiding Principles The National Program for Pain Management is based on the following guiding principles: 3.1. Subjectivity of Pain – As it is currently understood, pain does not constitute any biologically measurable indicator, and as such, pain intensity must necessarily be considered to be the way it is described by each patient. Particular attention should be given to individuals who have difficulty in communicating, or who find it impossible to communicate verbally. 3.2. Pain as the Fifth Vital Sign – Pain represents a vital alarm signal for the integrity of the individual and is fundamental for the diagnosis and monitoring of a number of diseases, but it should not be the cause of unnecessary suffering. As referenced in the aforementioned regulation distributed by the Directorate-General for Health, regular evaluation and recording of the intensity of pain constitutes a measure of good clinical practice and should be carried out in all health care institutions. 3.3. The Right to Pain Management – All individuals have the right to adequate pain management, whatever the cause of the pain, so as to avoid unnecessary suffering and reduce the morbidities associated with pain. 3.4. Duty to Manage Pain – All heath professionals should adopt pain prevention and pain management strategies for individuals under their care, contributing to their well-being and decreased morbidity, as well as to the humanization of health care. Particular attention should be given to the prevention and management of pain caused by diagnostic methods or therapy. 3.5. Special Treatment for Pain – Pain management should be provided at all levels of the health care network, generally starting with primary health care, and, whenever necessary, continuing through to further levels of specialization.

4. General Objectives The National Program for Pain Management encompasses three main objectives: 4.1. Reducing the prevalence of non-managed pain in the Portuguese population; 4.2. Improving the quality of life of patients living with pain; 4.3. Rationalizing resources and controlling the costs necessary for the management of pain.

5. Specific Objectives To achieve the above-referenced general objectives, it will be necessary to achieve the following specific objectives: 5.1. Identify the prevalence of chronic pain among the Portuguese population; 5.2. Identify the prevalence of acute postsurgical pain among the Portuguese population. 5.3. Identify the prevalence of deliveries carried out without recourse to epidural analgesia; 5.4. Improve the current knowledge of health care professionals regarding the diagnosis and management of pain; 5.5. Establish a network of specialized hospital structures for the diagnosis and management of all types of pain; 5.6. Reduce the prevalence of non-managed chronic pain; 5.7. Reduce the prevalence of non-managed acute postsurgical pain; 5.8. Increase analgesia offered during labor; 5.9. Improve access to and rationalize the prescription and use of analgesic drugs.

6. Target Population The target population of this program must include the entire Portuguese population. Particular attention should be given to patients attending health care centers.

7. Time Line This program has an extended period of 10 years and will receive a strategic interim evaluation at the end of 2010. This evaluation may result in the need to introduce corrective measures.

8. Intervention Strategies The following intervention strategies aim to reinforce the organizational capacity and the development of good practice models for pain management approach: 8.1. Reinforcement of the information referring to Regulation No. 09/DGCG of 14 June 2003, issued by the Directorate-General for Health, establishing pain as the Fifth Vital Sign; 8.2. Revision of the organizational regulations regarding chronic pain clinics as stated in the above- referenced National Program for the Fight Against Pain (see Appendix); 8.3. Revision of the organizational regulations regarding acute postsurgical pain clinics, as stated in the above-referenced National Program for the Fight against Pain; 8.4 Revision of the organizational regulations for obstetric analgesia, as stated in the above- referenced National Program for the Fight against Pain;

6 National Program for Pain Management 69

8.5. Establishment or development of special hospital structures for the specialized treatment of pain; 8.6. Evaluation of specialized hospital structures for the specific treatment of pain; 8.7. Establishment and distribution to health professionals of a hospital referral circuit for patients with chronic pain; 8.8. Establishment and distribution of technical guidelines for health care professionals regarding the referral of patients with chronic pain; 8.9. Establishment and distribution of technical guidelines for health care professionals on how to deal with pain in children; 8.10. Establishment and distribution of technical guidelines for health care professionals on how to deal with pain in the elderly; 8.11. Establishment and distribution of technical guidelines for health care professionals on how to deal with pain in those who suffer from substance abuse; 8.12. Establishment and distribution of technical guidelines for health care professionals regarding the use of opioids in the treatment of noncancer pain; 8.13. Preparation of a list of Homogenous Groups for Diagnosis (GDH) for activities undertaken in pain clinics; 8.14. Preparation of a proposal for a technical regulation regarding opioid therapy and driving; 8.15. Revision of the prescription rules for opioids, specifically referring to medicines subject to special medical prescriptions; 8.16. Preparation of a proposal for the revision of the reimbursement system for opioids.

9. Professional Training Strategies The following strategies are aimed at health care professionals, and within the scope of communication, to the general population: 9.1. To raise awareness in medical colleges of the need for improvement in dealing with pain in pre- and postgraduate training; 9.2. To raise awareness in nursing colleges of the need to improve pre- and postgraduate training in dealing with pain; 9.3. To raise awareness in psychology colleges of the need to improve pre- and postgraduate training in dealing with pain; 9.4. Preparing a proposal for mandatory professional training in dealing with pain as part of the medical residency program and general and family medicine competence; 9.5. Preparing a proposal for mandatory Professional training in dealing with pain as part of the complementary residency programs in surgery, vascular surgery, endocrinology, physical and rehabilitative medicine, internal medicine, neurology, obstetrics and gynecology, oncology, rheumatology, orthopedics, trauma, and psychiatry; 9.6. Preparing a proposal for the creation of a special cycle of studies dedicated to pain; 9.7. Development of multidisciplinary partnerships for the creation of teaching instruments for basic training on pain; 9.8. Development of multidisciplinary partnerships for clinical training sessions regarding pain, with special emphasis on family doctors; 9.9. Development of multidisciplinary partnerships for training sessions on pain for nurses; 9.10. Development of multidisciplinary partnerships for distributing information to the general population regarding pain, especially on the National Day for the Fight Against Pain.

10. Gathering and Analyzing Information Strategies The following strategies for gathering and analyzing information focus on the epidemiological understanding of pain and its distribution amongst the Portuguese population, as well as measuring the health benefits arising from pain treatment: 10.1. Development of multidisciplinary partnerships to carry out an epidemiological study on the prevalence of chronic pain and its personal, social, and economic impact; 10.2. Development of multidisciplinary partnerships to carry out an epidemiological study on the prevalence of acute postsurgical pain; 10.3. Quantitative and qualitative assessment of implementing, at the National Health System level, Regulation no. 09/DGCG of 14 June 2003 of the Directorate-General for Health, which promotes pain as the Fifth Vital Sign; 10.4. Performance of an evaluation survey of existing hospital structures dedicated to the treatment of chronic pain; 10.5. Performance of an evaluation survey of existing hospital structures dedicated to the treatment of acute postsurgical pain; 10.6. Performance of an evaluation survey on the conditions for administering analgesia in labor; 10.7. Evaluation of the health benefits obtained by the implementation of the program.

7 70 National Program for Pain Management

11. Gantt Chart

1st Year 2nd Year 3rd Year 4th Year 5th Year Quarters Quarters Quarters Quarters Quarters

12. Follow-up and Evaluation The Directorate-General for Health is responsible for coordinating, monitoring, and evaluating the National Program for Pain Management, carried out by a National Committee for the Management of Pain, to be officially appointed by the Minister of Health.

In order to collect data and perform a systematic analysis regarding the information on pain, to be provided to the above-mentioned Committee, there will be an effort to promote the creation of a Center for Observation of Pain, in accordance to the informative memorandum no. 46/DSPCS, of 13 October 2006, by the Directorate-General for Health.

8 National Program for Pain Management 71

The National Program for the Fight Against Pain is evaluated by means of the following indicators:

12.1 Evaluation of Impact 1. Prevalence of moderate or severe chronic pain; 2. Prevalence of moderate or severe acute postsurgical pain; 3. Percentage of deliveries carried out with epidural analgesia; 4. Number of first consultations in chronic pain clinics per million inhabitants; 5. Consumption of opioid drugs per capita.

12.2 Implementation Monitoring 1. Number of chronic pain clinics, of various types, per million inhabitants; 2. Number of acute postsurgical pain clinics, per million inhabitants; 3. Number of doctors with competency in pain medicine, per million inhabitants; 4. “Prevalence” of regular assessment and recording of pain intensity in national health centers (pain as the Fifth Vital Sign); 5. Average delay for scheduling a first consultation in a chronic pain clinics.

13. References Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. European Journal of Pain, 10 (2006) 287-333.

H. Merskey, N. Bogduk. Classification of chronic pain. 2nd edition. IASP Press, Seattle, 1994, pp 209-214.

Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 84 (2000) 95-103.

Rabiais S, Jorge Nogueira PJ, Marinho Falcão J. A dor na população portuguesa. Alguns aspectos epidemiológicos (2002). [Pain in the Portuguese population. Some epidemiological aspects (2002)]. Dor, 12 (2004) 6-39.

Appendix Organizational Rules and Classification of Chronic Pain Clinics

1. Chronic Pain Consultation This refers to all organized forms of diagnosis and treatment of chronic pain that do not necessarily have the characteristics of pain clinics. In this sense, chronic pain consultations may operate with a limited number of doctors (in the extreme, only one), without other health care professionals specifically assigned to pain consultations, or having specific facilities. However, regular activities (at least once a week) should be undertaken, and patients should be registered. The doctor(s) incorporated into the chronic pain consultation clinics should have adequate training for pain management, and there should be at least one doctor with competency in pain medicine, attributed by the Medical Association. A protocol for collaboration should be established with a pain clinic, for referral of patients.

2. Therapeutic Pain Clinic This is a specific clinic for diagnosis and treatment of chronic pain that carries out some treatments and, whenever necessary, refers patients to complementary services, when possible, through a protocol established with other hospital services. The clinic should have at least two doctors with competency in pain treatment and a psychiatrist or clinical psychologist. Alternatively, a protocol for regular collaboration with these doctors may be established. One of the doctors, with competency in pain medicine, should be the coordinator of this clinic. The assisting team should also comprise at least one nurse. It should operate in specific facilities, even if the facilities are shared, it should have regular activity (at least three times a week), and all patients should be registered. The clinic should be incorporated into an outpatient hospital, when there is one, but it is to be managed through a separate cost center.

3. Multidisciplinary Pain Clinic This unit focuses on the diagnosis and treatment of chronic pain and comprises a multidisciplinary team. It should include at least one doctor with competency in pain management who coordinates the clinic and its doctors, who must encompass at least three different competencies, including psychiatry, or alternatively two competencies and one clinical psychologist. The team should also have a nurse, a physiotherapist, a social service technician, and an administrative technician. The clinic should be integrated into an outpatient hospital when there is one, should be managed through a separate cost center, operate in its own facilities, and have daily activities, including telephone answering services. It should be equipped to treat patients on an outpatient basis, on an inpatient basis (in collaboration with other hospital services), or in emergency situations. The activities undertaken in the clinic should be subject to therapeutic protocol, be subject to regular evaluations, and may also establish additional protocols for collaboration with complementary medical

9 72 National Program for Pain Management

specialties. The clinic may be involved in the treatment of acute pain by working with an acute postsurgical pain clinic. Additionally, it should take part in clinical investigation projects and postgraduate training for health care professionals.

4. Multidisciplinary Pain Center This has the same characteristics as a multidisciplinary pain clinic but should have at least two doctors with competency in pain medicine and should be integrated into a university hospital or university teaching hospital, in accordance to Decree Law no. 206/2004 of August 19. In addition, a multidisciplinary pain center should conduct clinical or basic investigation through independently funded investigation programs, the results of which should be regularly published. It should also promote regular postgraduate training to health care professionals and when solicited, take part in pre-graduate teaching.

Notes on the classification of pain clinics I. The above-referenced requisites should be understood as minimum requirements. For example, it is stated that any pain clinic may develop or participate in clinical investigation programs, irrespective of the unit’s level of specialization. Similarly, the teams comprising pain clinics may employ more specialized professionals than those mentioned here, and may comprise different specialists, such as an occupational therapist.

II. Given that the criteria for attributing competencies in pain medicine by the Medical Association are very recent, during an interim period, pain clinics will be allowed to operate without a doctor with competency in pain medicine, but all clinic coordinators are advised to obtain this specialization.

III. The organization and degree of specialization for the specific treatment of pain should be adjusted to the hospital into which they are integrated, and should possess at least the following characteristics: (i) Pain consultation in local hospitals (type C) (ii) Pain treatment clinics in surgical hospitals (type B) (iii) Multidisciplinary pain clinics in multipurpose hospitals (type A) (iv) Multidisciplinary pain centers in university hospitals (v) Multidisciplinary pain clinics in specialized oncology hospitals (unit E)

The current document was drafted by the Directorate-General for Health, within the scope of action of the Monitoring Committee for the National Program for the Fight Against Pain.

Scientific Coordination: José M. Castro Lopes

Executive Coordination: Alexandre Diniz

10 73

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Information and Public and Services and Monitor and Data Analysis Patient Needs Support Evaluate

QUALITY Service examples … ASSESS

CASE MANAGED SERVICES Multi-professional pain centre High Risk Modality oriented clinics Level 4 Pychological care for complex cases Patient Data Case Management Respite & carer support

PERFORMANCE NETWORK BASED SERVICES Secondary/Social MANAGEMENT Level 3 Pain clinic Care Information/ Pain management services High Risk Management Trends Interface with GP clusters

PRACTICE BASED SERVICES Pathways of Care Primary/Social Level 2 Community based therapies eg Care Data, QOF physiotherapy, chiropractic, Population Management EVALUATION Patient Data osteopathy, occupational therapy, Community pharmacists

HEALTH IMPROVEMENT Level 1 Population Prevention eg Welsh backs Data Primary Prevention Acute pain services & Health Promotion NHS direct Self-management PUBLIC/PATIENT Expert patient programme CONSULTATION

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