Access to Opioid Analgesics

In most of the world, people dying of cancer and other painful illnesses do not have access to basic pain relief medication and palliative care services. Low- and middle-income countries, which account for 83% of the global population, consume only 8% of the medical morphine consumed globally. High-income countries, accounting for only 17% of the global population, account for 92% of global medical morphine consumption. [1]   It is estimated that 78% of adults in need of palliative care at the end of life live in low and middle-income countries. [2]    The World Health Organisation estimates that each year 5.5 million terminal cancer patients suffer from moderate to severe pain that is not managed at all. [3]  

While the scale of the problem is large, we know what needs to be done to address it. The common barriers to access are well-known and can be lifted. They include inadequate training of healthcare workers, misconceptions about pain and its treatment with morphine and other opioids, and overly restrictive laws and regulations that are designed to prevent the diversion and misuse of opioids but in practice operate as obstacles to medical use.

International control of opioid analgesics

Opioid analgesics are regulated internationally under the United Nations Single Convention on Narcotic Drugs 1961, as amended by its 1972 Protocol. The Single Convention recognizes that ‘the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes'. It is concerned not only with ensuring their availability, but also with preventing their diversion and abuse. It seeks to strike a balance between the two aims.

The Single Convention establishes a regulatory system for narcotic drugs. Under this system, government authorization is required for participation in the trade and distribution of narcotics. Each state must provide to the International Narcotics Control Board an estimate of its need for narcotic drugs for medical and scientific purposes, annually, as well as other data about stocks, production, manufacture, consumption, import and export. Export and import licences are required for each international transaction. Those who trade or distribute narcotic drugs must hold licences and keep detailed records. Medical prescriptions are required for dispensation to patients.

The key international agencies with mandates to work towards ensuring the availability of opioid analgesics and other controlled medicines are the UN Commission on Narcotic Drugs (CND), the UN Office on Drugs and Crime (UNODC) the International Narcotics Control Board (INCB) and the World Health Organization (WHO). CND is a functional commission of the United Nations Economic and Social Council (ECOSOC). It is the UN's lead drug policy-making body, and one of the governing bodies of UNODC (along with the Commission on Crime Prevention and Criminal Justice). UNODC is the intergovernmental agency with lead responsibility for coordinating global action in relation to drugs, crime and terrorism. INCB is an independent and quasi-judicial body responsible for monitoring implementation of the international drug control conventions. WHO is the UN's specialized agency for health, with a mandate to act as the directing and co-ordinating authority on international health work.

Legal and regulatory barriers to access

The regulatory requirements established by the drug control treaties are designed to prevent the diversion and abuse of controlled drugs. However, in their domestic laws and policies, many states have adopted measures that exceed those required by the Convention which in practice impede the availability of opioids for medical use. Examples of overly restrictive practices include:

  • limiting of prescription authority to medical professionals who qualify for specific licences;
  • special prescription procedures for opioids;
  • a requirement that prescriptions be approved by a healthcare worker's colleagues or superiors, and/or that dispensing be witnessed by multiple healthcare workers;
  • a requirement that patients receive special permission or registration to render them eligible to receive opioid prescriptions;
  • unreasonable limitations on the number of days' supply that may be provided in a single prescription;
  • unreasonable limitations on maximum daily doses that may be prescribed;
  • arbitrary restrictions on the number of pharmacies permitted to dispense opioid medications;
  • unreasonable requirements relating to the storage of opioid medications; and
  • overly burdensome bureaucratic procedures that dissuade healthcare institutions from using opioids.

In addition, a range of factors can combine to create fear among healthcare workers that prescribing opioids may make them liable to legal sanction, including: ambiguity in regulations; poor communication by drug regulators to healthcare workers about the rules for handling opioids; the availability of harsh sanctions; and in some countries, prosecutions of healthcare workers for unintentional mishandling of opioids.

Recent global attempts to improve availability

The last few years have seen significant activity towards increasing global attention on the need for pain relief and palliative care, and the importance of striking a more appropriate balance in drug policy and practice.

Outcome Document of the UN General Assembly Special Session on the World Drug Problem, New York April 2016

In April 2016, the UN General Assembly held a Special Session (UNGASS) on drugs. The UNGASS covered a wide range of drug policy issues including the availability of controlled medicines, drug prevention, treatment, HIV prevention, alternative development, and judicial cooperation.

The UNGASS led to the adoption of an Outcome Document by the General Assembly. In the Outcome Document, states made significant commitments to address the lack of availability of opioid analgesics and other controlled medicines. In particular, the preamble “note[s] with concern that the availability of internationally controlled drugs for medical and scientific purposes, including for the relief of pain and suffering, remains low to non-existent in many countries of the world, and [highlights] the need to enhance national efforts and international cooperation at all levels to address that situation”. It includes detailed standalone operational recommendations on availability of and access to controlled medicines, including a ‘strong commitment to improving access to controlled substances for medical and scientific purposes ... while concurrently preventing their diversion, abuse and trafficking', and to address existing barriers related to legislation, regulatory systems, the training of health-care professionals, education, and awareness. It makes specific recommendations on removing legislative and regulatory barriers, strengthening national control and assessment systems, expediting import and export authorisations, affordability, capacity-building, supply management, and coordination between the WHO Model List of Essential Medicines and scheduling decisions under the drug control treaties.

For more on the Outcome Document, see our blog post

INCB Availability Report 2016
The International Narcotics Control Board released its report on Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes in February 2016. The report updates its 2010 report on the same topic. It highlights the disparities in access to controlled drugs for medical purposes, including the relief of pain from cancer, and contains a number of recommendations to address barriers to access, including in relation to legislation and regulatory systems, health systems, affordability, training of health care professionals, and education and awareness.

For more on this report, see our  blog post 

World Health Assembly Resolution on Palliative Care
Adoption by the World Health Assembly in May 2014 of a ground-breaking resolution Strengthening of palliative care as a component of comprehensive care throughout the life course. The resolution affirmed the importance of palliative care, recognized the limited availability of palliative care services in much of the world and the great avoidable suffering for millions of patients and their families, and urged Member States, and requested the WHO Director-General, to take a number of steps to improve the availability of palliative care.

For more on this resolution, see our page May 2014 WHA Resolution on palliative care.

CND Joint Ministerial Statement
Adoption of a Joint Ministerial Statement of the 2014 high-level review by the CND of the implementation by Member States of the 2009 Political Declaration five years after its adoption. The Joint Ministerial Statement notes with concern that ‘the availability of internationally controlled drugs for medical and scientific purposes, particularly for the relief of pain and for palliative care, remains low to non-existent in many countries of the world'. The Statement calls for continued cooperation between Member States, INCB and WHO to ensure adequate availability of narcotic drugs, including opiates for medical and scientific purposes, while preventing their diversion into illicit channels.

Global Monitoring Framework for NCDs
Inclusion of a specific target on access to essential medicines in the Global Monitoring Framework for Non-Communicable Diseases, with a specific indicator for access to palliative care, namely 'morphine- equivalent consumption of strong opioid analgesics (excluding methadone) per death from cancer.

Other developments include:

Global access to pain relief initiative

UICC has a major focus on enhancing access to opioid analgesics for the treatment of cancer pain. UICC's World Cancer Declaration includes the target that by 2020 effective pain control measures will be available universally to all cancer patients suffering pain.

To realise this commitment, in 2009, UICC initiated the Global Access to Pain Relief Initiative (GAPRI) which aims to:

  • empower governments to take the lead in expanding access to pain relief and palliative care;
  • integrate pain management and palliative care into national cancer control plans; and
  • mainstream pain treatment and palliative care in the global health and drug regulation agenda.

References

[1] United Nations Office on Drugs and Crime, World Drug Report 2014, p 30.   
[2] World Palliative Care Alliance, World Health Organization, ‘Global Atlas of Palliative Care at the End of Life' , 2014, p 25
[3] World Health Organisation, Ensuring balance in national policies on controlled substances, Guidance for availability and accessibility of controlled medicines, (2011) , p3

Links