Biennial Review of Pain

Palliative care and pain treatment in the global health agenda Liliana De Lima

Abstract The Global Atlas of Palliative Care at the End of Life, published by the Worldwide Palliative Care Alliance (WPCA) jointly with the World Health Organization (WHO) estimated that every year .20 million patients need palliative care (PC) at the end of life. Six percent of these are children. According to the Atlas, in 2011, approximately 3 million patients received PC and only 1 in 10 people in need is currently receiving it. Although most PC is provided in high-income countries (HIC), almost 80% of the global need is in low- and middle-income countries (LMIC). Only 20 countries have PC well integrated into their health-care systems. In regards to opioids, .5 billion people (83% of the world’s population) live in countries with low to nonexistent access, 250 million (4%) have moderate access, and only 460 million (7%) have adequate access. In order for PC and pain treatment strategies to be effective, they must be incorporated by governments into all levels of their health care systems. In 1990, the WHO pioneered a public health strategy to integrate PC into existing health care systems which includes four components: (1) appropriate policies, (2) adequate availability of medications, (3) education of health care workers and the public, and (4) implementation of PC services at all levels throughout the society. This topical review describes the current status of the field, and presents several initiatives by United Nations (UN) organizations and the civil society to improve access to PC and to pain treatment for patients in need. Keywords: Palliative care, Pain treatment, Global health, Access to medicines

1. Access to pain treatment The International Narcotics Control Board (INCB) collects the consumption data of controlled medications and, along with other UN organizations, has called on governments to improve availability and access to opioids for medical treatment.9 More than 5 billion people (83% of the world’s population) live in countries with low to nonexistent access, 250 million (4%) have moderate access, and only 460 million (7%) have adequate access.31 A recent report by the European School of Medical Oncology (ESMO) in alliance with the European Association for Palliative Care (EAPC) assessed the availability of the 7 opioid medications in Africa, Asia, Latin America and the Caribbean, and the Middle East reached similar conclusions.2 In 2006, the world used 231 tons of morphine equivalents, but the amount needed to meet the needs of all patients in pain would be more than 1000 tons.18

3. Palliative care in public health policy

2. Access to palliative care According to the Global Atlas, in 2011, approximately 3 million patients received PC and only 1 in 10 people in need is currently receiving it. Although most PC is provided in high-income

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. International Association for Hospice and Palliative Care, Houston, TX, USA *Corresponding author. Address: International Association for Hospice and Palliative Care, 5535 Memorial Dr. Suite F-PMB 509, Houston, TX 77007, USA. Tel.: (713) 880-2940; fax: (713) 589 3657. E-mail address: [email protected] (L. De Lima). PAIN 156 (2015) S115–S118 © 2015 International Association for the Study of Pain http://dx.doi.org/10.1097/01.j.pain.0000460349.23083.0b

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countries (HIC), almost 80% of the global need is in low- and middle-income countries (LMIC). Only 20 countries worldwide have PC well integrated into their health care systems.29 Two PC Regional Associations, the EAPC and the Latin American Association for Palliative Care (ALCP for its Spanish acronym), have also published detailed regional Atlases. According to the ALCP Atlas, Latin America has 922 PC services in 19 countries or 1.6 services per million.16 The EAPC Atlas suggests that in Europe, there is a relationship between the establishment of PC programs and the Human Development Index and between indicators related to national expenditure on health.1 In both regions, there are also countries that do not report having any services, reflecting the fact that the majority of patients with PC needs do not have access to treatment. There are no other regional atlases of PC published.

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In the majority of cases, the development of pain treatment and PC has been a “bottom-up” approach in which individuals and groups started programs or initiatives that eventually are incorporated into institutional programs. This approach lacks official recognition and therefore reimbursement, budget, and resource allocation are mostly unavailable, making these very fragile programs with limited viability. For PC and pain treatment strategies to be effective, they must be incorporated by governments into all levels of their health care systems. In 1990, the WHO pioneered a public health strategy to integrate PC into existing health care systems.19 Based on this, a Public Health Model for PC was developed, which includes 4 components: (1) appropriate policies, (2) adequate availability of medications, (3) education of health care workers and the public, and (4) implementation of PC services at all levels throughout the society (Fig. 1). www.painjournalonline.com

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Table 1

Essential medicines for pain and palliative care included in the WHO model list of essential medicines. 2. Medicines for pain and palliative care 2.1 Nonopioids and nonsteroidal anti-inflammatory medicines Acetylsalicylic acid Ibuprofen*

Paracetamol Figure 1. WHO Public Health Model for Palliative Care.

4. Resources and strategies Some of the most relevant and recent resources and strategies include the following:

2.2 Opioid analgesics Codeine Morphine

4.1. World Health Organization guidelines—Access to Opioid Medication in Europe project In 2010, the EAPC in alliance with WHO and other organizations, developed the Access to Opioid Medication in Europe (ATOME) project, which aims to improve access to opioids. Key Milestones of the ATOME project were successfully completed, including the publication of the revised WHO policy guidelines ensuring balance in national policies on controlled substances.27 The guidelines provide guidance on policies and legislation regarding availability, accessibility, affordability, and internationally controlled medicines to improve access to legitimate use while preventing diversion. They have been successfully implemented in Latin America in opioid availability workshops, which have resulted in changes in regulations and elimination of barriers that interfere with legitimate access to pain treatment.7 The guidelines are available in several languages. 4.2. International Narcotics Control Board/World Health Organization guidelines

Tablet: 30 mg (phosphate) Granules (slow‐release; to mix with water): 20 mg to 200 mg (morphine sulfate) Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1‐ml ampoule Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 mL Tablet (immediate release): 10 mg (morphine sulfate) Tablet (slow release): 10 mg to 200 mg (morphine hydrochloride or morphine sulfate) Note: Alternatives limited to hydromorphone and oxycodone

2.3 Medicines for other common symptoms in palliative care Amitriptyline Cyclizine† Dexamethasone

Diazepam

Docusate sodium

Identification of a country’s actual requirements for internationally controlled substances is a critical step in ensuring availability of opioids. In 2012, INCB and WHO published a set of guidelines to help governments establish the adequate estimate of controlled substances to meet the demand for medical and scientific needs.10 These are available in several languages.

Fluoxetine*

4.3. Essential medicines in palliative care

Lactulose† Loperamide Metoclopramide

The “essential medicines” concept developed by the WHO states that there is a list of minimum medicines for a basic health care system, including the most efficacious, safe, and cost-effective ones for priority conditions.28 They satisfy the primary health care needs of the population and should therefore always be available, affordable, and used adequately. In May 2014, the WHA adopted a resolution aimed at improving access to essential medicines. The resolution includes a number of actions for governments to take on access to medicines, such as providing adequate resources for comprehensive national medicine policies, governance of pharmaceutical systems, and coordination of activities.25 In April 2013, the WHO Expert Committee on the Selection and Use of Essential Medicines updated the editions of the WHO Model Lists of essential medicines for adults (EML) and children (EMLc). The

Suppository: 50 mg to 150 mg Tablet: 100 mg to 500 mg Oral liquid: 200 mg/5 mL Tablet: 200 mg; 400 mg; 600 mg Not in children less than 3 mo* Oral liquid: 125 mg/5 mL Suppository: 100 mg Tablet: 100 mg to 500 mg Note: Not recommended for anti‐inflammatory use due to lack of proven benefit to that effect

Haloperidol

Hyoscine butylbromide Hyoscine hydrobromide†

Midazolam

Ondansetron*†

Senna

Tablet: 10 mg; 25 mg; 75 mg Injection: 50 mg/mL Tablet: 50 mg Injection: 4 mg/mL in 1 mL ampoule (as disodium phosphate salt) Oral liquid: 2 mg/5 mL Tablet: 2 mg†; 4 mg Injection: 5 mg/mL Oral liquid: 2 mg/5 mL Rectal solution: 2.5 mg; 5 mg; 10 mg Tablet: 5 mg; 10 mg Capsule: 100 mg Oral liquid: 50 mg/5 mL Solid oral dosage form: 20 mg (as hydrochloride) .8 y* Injection: 5 mg in 1‐mL ampoule Oral liquid: 2 mg/mL Solid oral dosage form: 0.5 mg; 2 mg; 5 mg Injection: 20 mg/mL Injection: 400 micrograms/mL; 600 micrograms/mL Transdermal patches: 1 mg/72 h Oral liquid: 3.1‐3.7 g/5 mL Solid oral dosage form: 2 mg Injection: 5 mg (hydrochloride)/mL in 2‐mL ampoule Oral liquid: 5 mg/5 mL Solid oral dosage form: 10 mg (hydrochloride) Injection: 1 mg/mL; 5 mg/mL Oral liquid: 2 mg/mL† Solid oral dosage form: 7.5 mg; 15 mg Injection: 2‐mg base/mL in 2‐mL ampoule (as hydrochloride) Oral liquid: 4 mg base/5 mL Solid oral dosage form: Eq 4 mg base; Eq 8 mg base .1 mo* Oral liquid: 7.5 mg/5 mL

* Age or weight restriction on use of the medicine. † Use is restricted to children.

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editions include creation of a new, separate section “Medicines for Pain and Palliative care” with a list of medications proposed by the International Association for Hospice and Palliative Care (IAHPC) to treat the most common symptoms in PC. The EML includes 17 medications, and the EMLc includes 14 medications.30 Table 1 includes the essential medicines included in both lists. 4.4. Opioid price watch A UN report found that in the public sector, generic medicines are only available in 38% of facilities, and cost on average 250% more than the international reference price. In the private sector, those same medicines are available in 63% of facilities, but cost on average about 610% more than the international reference price.23 High prices limit access to medicines costing a significant portion of the salary of workers in developing countries. The cost of treatment for chronic diseases is particularly unaffordable because of the need for long-term treatment protocols. In 2014, the IAHPC released the Opioid Price Watch (OPW) as a component of the agreement of work as a nongovernmental organization in formal relations with the WHO. Results from this study indicate that the availability of opioids at the pharmacy level is directly correlated to the country’s Gross National Income, which is consistent with opioid consumption reports published by the INCB and Pain and Policy Studies Group (PPSG). Findings of OPW also indicate that in regards to its international reference price (USD 0.47), the median price of morphine oral solid immediate release (10 mg) is 5.8 times higher in LMIC than in HIC. Monthly treatment costs of morphine oral solid immediate release (IR) measured in the number of days’ wages of the lowest-paid worker varies greatly (Philippines 29, India 21, and Guatemala 8 days). Many people in LMIC live below the international poverty line of USD 1.25/d,3 indicating that the number of working days needed to pay the cost of treatment may be higher than the results in this study and that pain treatment is accessible to only a few who can afford it. A campaign called the Morphine Manifesto21 to raise awareness about this problem was released by Pallium India, the IAHPC, and the PPSG previous to OPW, calling for an end to the unethical practice of promoting access to expensive opioid analgesics without also making available low-cost immediate-release oral morphine.

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Cultural Rights.11 The General Comment 1422 further applies the principles of accessibility, availability, appropriateness, and assured quality to essential medicines. The UN Special Rapporteur on Torture, Cruel, Inhuman, or Degrading Treatment or Punishment has stated that “the de facto denial of access to pain relief, if it causes severe pain and suffering, constitutes cruel, inhuman, or degrading treatment or punishment” and brought attention to critical obstacles that “unnecessarily impede access to morphine and adversely affect its availability.”4 4.7. Civil society initiatives Several organizations have developed and implemented public campaigns for recognition of access to pain treatment and PC as human rights. Some of these include the following: Joint Declaration for the Recognition of Access to Pain Treatment and Palliative Care as Human Rights: A joint campaign by IAHPC and WPCA became the first one to be developed and signed by international organizations in the field of PC, hospice, pain, cancer, HIV/AIDS, and others.14 4.8. Montreal Declaration The Montreal Declaration was launched by the International Association for the Study of Pain (IASP) to address the tragedy of unrelieved pain in the world.8 The Prague Charter, a public campaign developed by the EAPC in alliance with other NGOs and civil society calling on governments to take the steps to ensure access to PC and its recognition as a human right.17 Based on the above and other declarations, reports, and recommendations from international civil society organizations13,15,20,21,32 and Human Rights organizations,5,6,12 the PC obligations that member states have can be summarized as follows: (1) The creation and implementation of PC policies. (2) Equity of access to services, without discrimination. (3) Availability and affordability of essential medications, especially opioids. (4) Provision of PC at all levels of care. (5) Integration of PC education at all levels of the learning continuum from informal caregivers to health professionals.

4.5. Palliative care resolution In May 2014, the World Health Assembly (WHA)—the supreme decision-making body of WHO—unanimously adopted a groundbreaking resolution urging countries to ensure access to pain medicines and PC for people with life-threatening illnesses.24 The resolution outlines clear recommendations such as including PC in all national health policies and budgets, in the curricula for health professionals, and highlights the critical need for countries to ensure that there is an adequate supply of essential PC medicines including those needed to alleviate pain. 4.6. Access to pain treatment and palliative care as human rights The right to health and freedom from suffering is a fundamental part of human rights and of a life in dignity.4 It was first articulated in the 1946 Constitution of the WHO, whose preamble defines health as “a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity.”26 The statement on the right to the highest attainable standard of physical and mental health can be found under article 12 in the 1966 International Covenant on Economic, Social, and

5. Conclusions Access to pain treatment and to PC has been an increasing trend in the last few decades. The situation in developed countries has improved over time, but services in developing countries are scarce and very fragile and more is needed to guarantee their permanence and survival. Education needs to be incorporated in the undergraduate medical and nursing curricula to guarantee the provision of services by a large body of health care providers. Services and medications need to be subsidized for those who are unable to pay and should be incorporated in the public health care systems and reimbursement plans for providers. These developments have the potential to benefit millions of patients, as long as governments, the civil society, and the academia act on them, to ensure adequacy of services, availability of medications, and education of health professionals.

Conflict of interest statement The author has no conflicts of interest to declare.

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The author received support from the International Association for the Study of Pain to attend the 15th World Congress on Pain in Buenos Aires, Argentina. Article history: Received 1 October 2014 Received in revised form 12 December 2014 Accepted 16 December 2014

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Copyright Ó 2015 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.

Palliative care and pain treatment in the global health agenda.

The Global Atlas of Palliative Care at the End of Life, published by the Worldwide Palliative Care Alliance (WPCA) jointly with the World Health Organ...
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