Special Event – Increasing Access to Controlled Medicines: Addressing the Global Disparity in Pain Relief

H.E. Ghislain D’hoop, Belgian Ambassador (Moderating): The global disparity in pain relief is unacceptable to my country, and we provide resources to UNODC and INCB to address this challenge.

Yury Fedotov, UNODC Executive Director: The number on this issue speak for themselves. Pain management is a human rights concern, and palliative care is essential. Controlled substances are necessary to relieve pain in many different settings – they are a mainstay of treatment for cancer, childbirth, surgery, injuries and other medical conditions. The conventions recognise this and call on parties to ensure their availability. They specifically call on countries to improve access while protecting against diversion and abuse. This is also essential for SDG 3.8. Yet more than 80% of those in need of such medicines lack access. INCB estimates that 92% of morphine is produced in countries with 17% of the world’s population – while those in low- and middle-income countries are left with limited or no access. Working with WHO, the Union of International Cancer Control and INCB, UNODC promotes the availability of controlled drugs while preventing their diversion. There are several barriers to their availability – including legislation and policy-based barriers. We need a balance between ensuring availability of psychotropic drugs for medical purposes, while also preventing abuse. Both sides of this balance are concerned with public health and safety, and the conventions are clear. Working together, we can contribute to the right to health and the SDG 3.

Credit: VNGOC

Dr Viroj Sumyai, INCB President: Scheduled substances should be adequately provided and should not be unduly restricted for medical and scientific purposes. But these requirements are far from being universally met. This was highlighted in the UNGASS outcome document. Last year, INCB made progress in implementing the recommendations in the outcome document, and carried out a survey of 130 member states. We also asked civil society organisations to provide their views, in time for the 2018 INCB Annual Report. In most countries, medical specialists can prescribe controlled substances – but only a few countries allow nurses to do this. In many countries, the lack of doctors and centralised health systems makes it difficult to access these medicines. This translates into an obstacle to obtain the required treatments. Many countries are changing their health insurance systems and setting affordable prices for the medicines that people need. In many settings, action is still needed – such as: training of healthcare professionals; including palliative care in national medical curricula; bolster the production of generic medicines to improve affordability; ensuring that the pharmaceutical industry produces affordable products; prevent false advertisements; ensure that health concerns are prioritised when issuing licences; review national instruments to ensure they are adequate; expand coverage of health services and ensure WHO Essential Medicines are included in national lists of essential medicines; and establish tools for import and expert authorisation – linked to the international systems which are available for member states to use for free. There is clear indication of progress being made since 2016. Governments remain committed to the goal of ensuring access to essential medicines, and this is key to achieving SDG 3. This should also be at the heart of national drug control and practice.

David Laffan, Australian Department of Health: Australia is pleased to be a part of this event, and to see this issue being discussed. The UNGASS outcome document contains key operational recommendations on this issue. This special event today is a welcome addition to our work on this issue, and we thank Belgium for making contributions alongside Australia for the Global Programme. The Programme allows governments to review their existing frameworks, to engage policy makers and facilitators at the local level, and to deliver pilot programmes – such as those funded in Ghana and Timor. It shows the effectiveness of collective efforts. The multi-sector panel here today is a reminder of the multi-sector response to this problem. This is fourth such special event at the CND on this topic. In terms of practical improvements, we still have a lot of work to do to. Opioid overdose deaths are increasing in Australia, and are at crisis levels around the world. This is an issue of significant international importance. We need to do more to address the global disparity, to reduce unnecessary pain and suffering while also preventing diversion. This has consequences on many people around the world.

Anastasia Nazarova, Russian Ministry of Industry and Trade: In Russia, there are 25 registered medicines containing internationally controlled psychotropic substances, but only a few imported from other countries. We welcome the efforts to expand production of generics to improve affordability and access. We have made serious efforts to reduce dependency on imports – including for the gold standard of pain relief, morphine (quick release). With reference to the WHO Essential Medicines for Children, we have made important pain relief medicines available in formats for children. Medicines on the list are subject to the state controls on prices. Over recent years, we have made the following changes to policy and law. Prescription procedures for opioid receptor antagonists have been simplified. The dispensing of narcotic drugs by medical services in rural areas in the absence of pharmacies was also permitted. This has improved access to controlled substances. Our requirement for these drugs has increased more than five times. In 2019, the Russian Ministry of Health allowed for electronic prescriptions to save time, increase effectiveness of accounting systems and controls, and allow patients to receive medicines without delay.

Dr Gilles Forte, WHO: Access to controlled medicines of an assured quality is essential to achieve the SDGs, and are these drugs are necessary for a range of conditions. We remain very concerned about the global lack of these medicines that are often life-saving, in particular in emergency situations. At the same time, we see increased overdoses and abuse in some parts of the world. It presents us with a paradox. As part of our commitment, we work to ensure that such medicines are available to those who need them, while also preventing their diversion. Several World Health Assembly resolutions have outlined commitments to ensure the appropriate use of opioids for medical use and emergency situations. WHA 69.25 addresses the global shortage of medicines, and includes several recommendations for member states – and mandates WHO to create an emergency medicines shortage system. As part of its mandate, WHO has developed and promoted a series of guidelines, including of pain in children and the management of cancer pain for adults. WHO also collaborates with governments to ensure balanced legislation on access, the quantification of needs for these medicines, etc. WHO are currently engaged with UNODC and INCB on the Global Programme, and thank Belgium and Australia for their support for this work. WHO works in over 150 countries, the vast majority of which have little or no access to these medicines. The new WHO programme of work includes a commitment to support countries to improve access to medicines. WHO continues to foster collaborations to ensure that safe, effective and quality ensured medicines are available and affordable for people who need them.

Kirstin Hopkins, International Atomic Energy Agency: I was an oncologist from the UK for 25 years, but realise how fortunate I was to be able to offer opiates in a safe, controlled and free environment. My role now is to support the safe expansion of radiotherapy, mainly in relation to cancer. In many low- and middle-income countries, most patients present at a late stage of disease. I want to use this forum to promote the need for radiotherapy as well as pain medicines – it is not one or the other. Radiotherapy has a curative role, but can also alleviate pain and bleeding. But we need opiates too, we work together on this. Especially at the end of life, we can turn a horrendous outcome and change it into a more modern, dignified end to life.

Dr Sonali Johnson, Union for International Cancer Control: 18.1 million cancer cases per year, and this is expected to increase. Globally, 1 in 6 deaths are due to cancer, and most occur in countries where adequate pain medicine is not available. UICC has issued new guidance to address this issue in adults and children. More than 2.5 million children around the world die every year in need of pain relief. This is included in the Single Convention, and member states should start by reviewing their national legislations around opioids. Care givers and patient associations can play an important role. We must develop drug policies that work for patients, and adopt an approach that is aligned with our health commitments and the SDGs.

Heloisa Broggiato-Matter, Civil Society Task Force: The alleviation of pain and suffering related to life threatening health conditions is a global health and equity imperative. Countries cannot meet target 3.8 of the SDGs Agenda without addressing this issue. Target 3.8 of SDG 3 is to achieve Universal Health Coverage, access to essential health care and essential medicines. International collective action is necessary to ensure that all people, including poor people have access to palliative care and pain relief. Therefore, it is crucial to work for the achievement of an international drug control system not only focused on the illicit use and prevention of abuse of controlled medicines, but rather on a balanced approach. I would like to highlight the work of the Lancet Commission on Palliative Care, which has useful recommendations for improving the access to pain medication and palliative care, particularly in low and middle income countries. The Lancet Commission is formed by a group of specialists on this topic and published a report in 2017 recommending the Essential Package of Palliative Care and Pain to remedy the situation of countries lacking access to pain medication and palliative care, particularly low and middle income countries. These countries also need to be aware that there are opportunities to improve this situation at modest cost. The essential package includes a list of medicines from the WHO’s Essential Medicines’ List, essential equipment and human resources necessary to guarantee a minimum standard of quality palliative care that any health system can achieve. The most emphatic recommendation of the essential package is the availability of oral and injectable morphine. This medication is inexpensive and off-patent. The Lancet Commission on Palliative care recommends the integration of the essential package into national health systems as part of the Universal Health Coverage. The cost of this essential package in LMICs is about US$3 per capita. Just more than $1 million is enough to address the unmet medical need for opioid analgesics for children in Low Income Countries. And $145 million would close the global gap in the need for morphine in palliative care and provide relief to millions of people with preventable pain worldwide.

Credit: VNGOC

Dr Robertas Badaras, Head of the Toxicology Centre, Vilnius, Lithuania: Looking at history, the love story between humans and opioids starts more than 5,000 years ago, including the widespread use of laudanum in the 16th Century. With the introduction of the hypodermic syringe, heroin was synthesised at the end of the 19th Century alongside other medicines like oxycodone – designed to relieve pain with less dependence risk. Research has indicated that between 21-29 percent of patients prescribed opioids for chronic pain misuses them. It is mandatory to use opioids for the higher levels of pain, we cannot escape this need. So how can we respond to this situation, with increased deaths associated with prescribed medicines. Some patients are also cautious about opioids – they “do not want to become drug users”. Yet opioids are the most effective response. So how to get the balance? Is this ‘Mission Impossible’? In Lithuania, we have a good supply of opiates to patients, yet the levels have remained stable over the past few years. Opioid detox is effective, but not for most patients – many of whom leave units prematurely, after the last dose but before the withdrawal symptoms are finished. We therefore need effective, shorter-term detox responses. One study in Lithuania showed that this is possible, so we started to provide prescription opioid detoxification. Patients stopped or decreased their opioid use, with statistically significant improvements in quality of life. The mission is not impossible. Are prescription opioids ‘beauty’ or ‘the beast’?

Professor Rosa Buitrago del Rosal, University of Panama: I want to ask – what would happen to you if you suffered a fracture in your home country and you were in extreme pain? Of course, it depends on what country you live in. And this is just for accidents, not mentioning diseases and end of life pain. The research by the Lancet Commission outlines an essential package of palliative care and pain relief health services – including human resources and medical professionals who are prepared to address pain; and training and capacity building. The UNGASS outcome document was clear on the need to improve education and training. In Panama, research on access to controlled medicines asked if access was enough to alleviate pain alone. Many Panamanians are dying in pain, and access across the country and not just in the capital is far below those in, for example, Canada and the USA. This inequality is even worse for morphine, and even in 2015 our morphine use per capita was virtually nothing. We explored the key components for opioid access in Panama, to identify the training needs. Issues includes opioid awareness, the knowledge of opioid rotation, common shortages in supply, and calculations of needs based on historical records (last year’s amount plus a certain percentage). This is why we have a shortage. Respondents agreed on the need for continued education on this topic. We went to all of the key cities across the country, and also reached out to international summer schools and others with different courses and trainings in 2018-2019. We work with a wide number of partners to support this work.

Dr Nahla Gafer, Head of Palliative Care, Sudan (and Board Member for IAHPC): 80% of those with palliative care needs live in low- and middle-income countries with little or no access to these medicines. Unless clinicians are trained how to treat pain, it does not matter how much morphine is on the shelves. It is essential to know how to identify and diagnose pain. Yet pain management are not an integral part of medical studies, apart from in a few countries worldwide. This phobia leads medical practitioners to prescribe tramadol when they should be given morphine. My own son was in a traffic accident, and had to cry for hours before he was given morphine. And then they would only provide additional doses when he showed extreme pain again. This was in a high-income country, and the nurses say they have to follow the protocol. We have seen patients in extreme pain, and we asked to see the drugs that she had been given. She had been given one tramadol every eight hours, and she was being given it only when she cried. Why? “Because it is a dangerous drug”. The situation is strange. Although the regulations say any physician should be able to prescribe opioids, in reality only some are. The process is convoluted, with the patient needing to go back and forth several times. We have a lot of fears and taboos to destroy before pain can be properly addressed. This will require collaboration. My units have seen 20,000 patients with no cases of misuse or diversion. These medicines are important to those who receive them. As clinicians, we have witnessed the benefits of good pain management – comfortable deaths, prolonged lives. Morphine consumption tripled within months of starting palliative care services, but this is in the capital. For those in the rural places and for non-cancer patients? Even in our units, we have several problems. There is not one single pharmacy in the whole country that prescribes opioids outside of office hours. There have been pushes for higher-price medicines to be purchased, leading to stock-outs. For one eight-year old patient in Mauritania, the mother did not know about the break-through pain that can occur. He said: “Mother, when I die, to whom will you give the morphine”. We have to provide the best medicines to these voiceless communities.

Statement from Kenya (from the floor): The efforts that must be made to address these gaps must be anchored in the three conventions which we have all signed on to. Let us be guided by the spirit of those conventions and the UNGASS outcome document. There are a number of people who access pain and cannot access these substances. Yet there are other challenges that go with this – including the lack of qualified physicians. We need to ensure we do not open the door to diversion, which is a more serious issue. We have a dedicated agency in Kenya to tackle this issue, and have in place mechanisms to monitor.

Statement from Switzerland (from the floor):As one of the co-sponsors of this event, we want to thank the panellists and reflect on how universal this issue of pain relief and palliative care really is. In line with the 2016 UNGASS and the 2030 Agenda, Switzerland will continue to follow this issue closely.

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