4.1. The right to health, the right to be spared avoidable pain

The WHO Constitution defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, without distinction of race, religion, political belief, or economic or social status. The Constitution also states that the health of all peoples is fundamental to the attainment of peace and security, and is dependent upon the fullest cooperation of individuals and states.

The United Nations Convention on the Rights of the Child (1989) reinforces “the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health”. Signatory countries to the Convention “shall strive to ensure that no child is deprived of his or her right of access to such health care services” (92).

The United Nations Committee on Economic, Social and Cultural Rights recognized as part of this right to health “attention and care for chronically and terminally ill persons, sparing them avoidable pain and enabling them to die with dignity” (93). The United Nations Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, which sets the international control measures for most opioid analgesics, states that opioids are “indispensable for the relief of pain and suffering and adequate provision must be made to ensure the availability of narcotic drugs for such purposes” (94).

The countries signing these international conventions have mandated their governments to respect and act according to these rights. Government policies for the relief of pain should draw on these obligations.

4.2. International regulations on opioid analgesics

Countries operate within an international regulatory framework, which means that essential medicines for opioid analgesia, such as morphine, are subject to international control under the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol. The Convention outlines specific control requirements for narcotic substances and stresses the need to make opioid analgesics available for medical use, as reported above. This concept was reinforced in the United Nations Economic and Social Council's resolution 2005/25, which acknowledges the lack of access to opioids for pain relief for 80% of the world's population, and calls on Member States to remove barriers to the medical use of such analgesics while preventing their diversion for illicit use. This necessity was concurrently affirmed in the 2005 World Health Assembly resolution WHA 58.22 on cancer prevention and control.

Each signatory country to the international drug conventions should abide by the treaties by both ensuring the medical use of controlled substances and preventing their misuse. Countries should have implemented their obligations under the conventions in their national laws and regulations. However, some countries' laws and regulations may include provisions that go beyond the control requirements of the Single Convention on Narcotic Drugs, often hindering access to opioid analgesics. Assessing existing national drug control laws and regulations is a necessary step in improving access to opioid analgesia for moderate to severe pain. Authorities and policy-makers responsible for expanding pain relief treatment in the health system should start by assessing national control regulations for the production, procurement, storage, distribution, prescription, dispensing and administration of opioid analgesics. If a country does not have regulations that allow for the provision of opioids for medical purposes, these should be developed in accordance with the Single Convention on Narcotic Drugs. Those countries that have very strict laws should endeavour to make them less restrictive and more practicable. The World Health Organization has developed guidelines to ensure that a balance is achieved in national opioid control policy, last revised in 2011 (95).

Annex 6. Opioid analgesics and international conventions provides guidance on the main aspects to be considered under the international regulatory framework to make opioid analgesics available for pain relief. Operational and policy officers involved in improving access to pain management and opioid analgesics should be familiar with both the international and national regulations on opioid medicines.

4.3. Dimensions of a national pain treatment policy

The provision of pain management medicines needs to be supported by national policies and regulations. There are several dimensions and players in national policy that are necessary to achieve this goal. Apart from the control aspects of opioid analgesics, countries should consider the policy priorities for pain management. A national policy aiming at ensuring pain treatment within its health system should address several aspects impeding pain relief including attitudinal and educational barriers, and regulatory and supply barriers. Changing the regulatory framework for opioid analgesics, for example, by reducing the burden of dispensing procedures will not automatically result in increased access to pain medication as it will have no effect on unreasonable fear of opioid use (“opiophobia”) among clinicians, pharmacists, nurses, patients and their families. In order to change attitudes, a major effort should be made to educate them on the rational use of opioid medicines. Similarly, overcoming supply barriers and making these medicines affordable within the health system will have little impact on their use if knowledge or regulatory barriers are not addressed.

A policy for improving pain management should be comprehensive in considering how the regulatory, educational and supply aspects will impact on pain management. This implies that governments should consider financial and health workforce resources when formulating policies and implementing pain management plans. Adequate management of pain is also feasible in countries with limited resources.

Pain clinicians, patients and caregivers associations can play an important role in engaging and supporting policy-makers to improve access to pain relief as an integrated component of the national health system. Analysis and research on the different types of barriers to adequate pain management and opioid availability is possible by involving all those associated in the provision of such treatment (from drug control agencies, to ministries of health departments, to health professional associations, to enforcement agencies, etc.).

4.4. Financing pain relief within the national system

As far as possible, governments should ensure that the most cost-effective and appropriate treatment is widely available and accessible. Pain treatment requires a multidisciplinary approach that combines pharmacological and non-pharmacological interventions. Both types of intervention entail costs. These guidelines were developed with the aim of retrieving and assessing the evidence and formulating recommendations on the pharmacological treatment of pain. They provide information on the essential elements to ensure the management of moderate to severe persisting pain in children with medical illnesses. Similarly, the choice of a non-pharmacological intervention needs to be guided by evidence supporting its use and by consideration of its cost-effectiveness and feasibility in relation to other interventions and to national financial and human resources.

The capacity of a country to provide pain relief as a part of the right to health relies on how its health financing system is designed. Patients' out-of-pocket spending will hardly allow them to access pain relief medicines, as well as other essential medicines. Studies have shown that prices of opioid analgesics in an out-of-pocket spending system are higher in developing countries than in developed countries, making these essential medicines even more inaccessible to patients in need (96, 97). Out-of-pocket payments for health care foster inequalities among the population in accessing care and essential medicines and are barriers for the poorest (98–100). Reimbursing and increasing access to pain relief treatment within the context of either health insurance schemes, such as tax-funded health schemes, or social health insurance schemes can be a sustainable way of ensuring that pain relief is part of the right to health. Alternative financing mechanisms, such as community health insurance schemes, may be a suitable substitute in settings where the institutional framework for traditional health insurance schemes is weak.

The development and maintenance of pain treatment services take place within the broader context of national health-care financing. An understanding of the way health funds are underwritten and allocated is, therefore, important in planning the introduction and maintenance of pain treatment services. The use of risk-pooling schemes is a viable approach to paying for health services, as well as a more suitable way of developing and sustaining pain relief services at primary, secondary and tertiary health-care levels, and in the community.

4.5. Estimating needs for pain relief

Determining the total resources and associated costs needed to initiate and maintain pain relief services at all levels of the health system is a key element of strategic planning. A needs assessment is a formal systematic attempt to determine important gaps between what services are needed and those that are currently provided. The assessment involves documenting important gaps between current and desired outcomes, and then deciding in which order those gaps should be closed. Cost estimates should include different scenarios for scaling up services for both pharmacological and non-pharmacological interventions.

Needs assessments and cost estimates to improve pharmacological treatment of pain should comprise the following areas:

Educational needs

• Training costs for health professionals in pain management. Training gaps must be assessed and training plans on pharmacological interventions adopted at country level. This may include training of nurses and pharmacists, upgrading medical school curricula, and on-the-job training for health professionals. Once the national treatment guidelines for pain management have been prepared, they should be disseminated and countrywide training plans prepared.
• Training costs for all officers and professionals involved in the procurement, supply and dispensing of opioid medicines. Different types of training should be costed according to the targeted professionals and their needs for training on national drug control requirements and regulation of opioid analgesics. This should include health professionals, drug control regulators and enforcement officers. This type of training is needed when changes are made to national control policies, to ensure that the regulations are properly understood and applied. It may also be needed when inaccurate knowledge about national drug control regulations results in a problem of availability of these substances for medical use.
• Advocacy costs for promoting and disseminating information on the medical use of opioid medicines for pain relief and palliative care to the general public. Supplementary costs may need to be factored into the cost of training health-care providers and all officers and professionals playing a role in the procurement, supply, prescription and dispensing of medicines. In certain countries, the education of the general public on the medical use of opioid analgesics for pain relief may be crucial in overcoming misconceptions and biases towards these medicines.

Supply chain requirements and quantification of needs

• Equipment costs to ensure no diversion of controlled opioid medicines. Measures to avoid trade diversion during storage and distribution are generally in place in the private and public sectors. Drug control regulations require measures to safeguard opioid medicines (such as locked cupboards) in order to avoid the diversion of controlled medicines for illicit use. While these safeguards, which are defined at country level and not set by international drug conventions, should ensure that no diversion takes place, they should not impair the availability of drugs for medical use, both in terms of feasibility and costs.
• Medicine costs, storage and distribution costs. These should be factored into the budgets of national health systems for the supply of medicines. Parallel supply systems are usually not cost-effective (101, 102).
• Quantification of needs. The quantification of treatment needs is important in planning treatment services and in reviewing the accessibility of services to different population groups. It is the basis for forecasting the amount of medicines, in particular of opioid analgesics, that will be needed by the pain-relief services.

Policy and regulatory needs

• Assessment and modification of policies, laws and regulations costs. These costs are both direct and indirect. The direct costs are linked to the assessment and modification of policies and regulations; the indirect costs are linked to information dissemination to ensure that the new policies and regulations are known and applied in the country and to scale up the different levels of services. These indirect costs may partly overlap with training needs, but it is important that governments also factor these costs into their planning to improve pain management.

Similarly, cost estimates for the introduction and implementation of non-pharmacological interventions should be factored and integrated wherever possible into the health system's comprehensive planning for pain management.

4.6. Saving resources by treating pain

The burden of pain on the individual, family, community and society is often underestimated. Traditional methods for estimating the economic burden of disease, such as prevalence and incidence, are difficult to employ when determining the burden of acute and persisting pain. Moreover, these methods fail to take into account the consequences of the distressing nature of pain and its impact on daily life. Chronic pain has a major impact on labour market participation and productivity, and is often the reason why people leave the labour market prematurely. Similarly, persisting pain in children is the cause of missed days at school and parents' and caregivers' absenteeism.

Untreated pain not only affects the individual in pain, but also his or her family, the community and society as a whole. This is because pain is accompanied by other symptoms, such as depression, anxiety and physical limitations, and social isolation for patients and their siblings. The adequate management of pain through a comprehensive approach, which considers the pharmacological, physical, behavioural and spiritual dimensions, offers a solution that not only relieves pain, but also removes these hidden costs.

Thus, policy-makers should embrace a whole-system approach for the treatment of pain and make it an integral part of the national health and social system. Indeed, adequate management of pain in adults and children reduces costs for society, positively impacts on the rational utilization of health-system services, and generates both an economic and social return for the country (103–108).

4.7. Pain management coverage

The coverage of pain management in the health system should comprise all three levels of care: tertiary, secondary and primary. These treatment guidelines have been conceived to provide a tool to be used and adapted for these three levels of services. Pain management coverage can also be successfully extended to the community level.

Community health approaches have been adopted for palliative care, especially in contexts where the burden of palliative care could not be sustained in the primary health-care level. This approach has been adopted in countries with serious shortages of health-care providers and a high burden of disease. Given the very limited health infrastructure and resources, and the high demand for palliative-care service coverage, community and home-based care is viewed as key in responding to palliative-care needs.

Some countries have developed strong home-based care networks in coordination with the primary health-care system to respond to the HIV/AIDS epidemic, and as part of the continuum of care for cancer and other chronic conditions. Important palliative-care initiatives involve both governmental as well as nongovernmental initiatives, supported in many cases by international organizations. These initiatives have produced a solid knowledge base of how non-costly, good-quality palliative care can be provided in low resource settings. They rely mainly on networks of community members, educated and supervised by a palliative-care team (109, 110).

4.8. Human resources for pain management

Pain management should be provided within the available health workforce of a country's health system. Some countries are experiencing health workforce shortages and overburdened health services. Countries should consider how to use the available health workforce in a cost-effective way while introducing or expanding pain management to the community level. Each country designs and regulates its health system taking into account the composition of its health manpower (type and numbers of health professionals, level of training on analgesia, geographical distribution within the country, e.g. rural versus urban areas).

In the context of pain management, the delegation of tasks means that a number of activities for pain assessment and pain management are transferred from specialized doctors to other health professionals. This may include the prescription of opioid analgesics. The delegation of tasks must be implemented within systems that contain adequate checks and balances to protect both health-care providers and the people receiving treatment and care. A few countries have been changing policies and regulations to allow nurses and clinical officers to prescribe opioid medicines in order to provide service coverage for pain relief. The above recommendation was formulated by the Guidelines Development Group taking into account the published and unpublished experience in pain management in national health systems as well as the implementation and quality of care provided for other medical conditions (Annex 3. Background to the health system recommendations). Additional documented evidence is needed to inform policy-makers on the possible strategies to increase coverage of services while maintaining quality of care. The World Health Organization has developed a series of global recommendations for task shifting of HIV services, whose general principles can be adopted for other delegation of tasks in the health system (111).

These global recommendations and guidelines on task shifting have looked at the following aspects:

• the adoption of a task shifting approach as a health initiative after consideration of the human resources analysis and gaps;
• the creation of an enabling regulatory environment for its implementation (e.g. legally empowering health professionals to perform the delegated tasks);
• the assurance of quality of care and sustainability of this approach in the health system.

4.9. What treatment should be available

Evidence of effectiveness and safety in children is a prerequisite for making programmatic choices on the types of medicines and formulations to be made available for pain treatment in children. Considerations of costs, availability and feasibility of medicines also influence the choice between medicines with comparable effectiveness and safety profiles.

These guidelines cover the minimum pharmacological interventions to relieve persisting pain in children with medical illnesses. Evidence on the use of non-opioid analgesics, opioid analgesics and possible adjuvant medicines to relief pain in this specific population was retrieved and appraised. As part of this transparent and rigorous process, a research agenda for missing evidence on these pharmacological interventions was produced to guide the international scientific community in its research in this field (Annex 5. Research agenda).

The adoption of evidence-based guidelines provides the basis for selecting essential medicines for countries' health systems. Each country should have its own list of essential medicines. This central policy tool, inspired by the concept set out in the WHO model lists of essential medicines for adults and children, is used to plan the availability and affordability of medicines in the national pharmaceutical sector. The goal of the national essential medicines list is to provide a minimum list of the most efficacious, safe and cost-effective medicines needed for a basic health-care system in order to treat priority diseases and conditions. Priority diseases are selected on the basis of current and estimated future public health relevance for the country.

In conjunction with the development of national evidence-based guidelines for the treatment of pain, which is supported by WHO guidance, countries should ensure that medicines for pain management in children (adequate strengths and formulations) are included in their national essential medicines list and in their national essential medicines procurement processes, and health insurance schemes.

While opioids are potent medicines for the relief of moderate and severe pain, there is a risk of misuse and diversion, which can be low or high, depending on the country. Measures to reduce the risk of misuse of opioid medicines include alertness for this possibility and appropriate prescribing, including careful patient selection. To prevent accidental overdose by family members, the caregivers and the patient should be warned to store the medicines in a safe place in child-proof containers. The possibility that one of the parents may have opioid dependence and may be taking the opioids themselves should also be considered.