Scheduling medicines as controlled substances: addressing normative and democratic gaps through human rights-based analysis.

Recent years have seen contentious debate about efforts to schedule medicines such as ketamine and tramadol under the international drug control conventions. Proponents argue that misuse poses a significant risk to public health and that scheduling would help address these problems. However, scheduling of medicines can negatively affect their availability, accessibility and affordability for medical purposes, with serious health consequences for patients, especially in low and middle-income countries. The current process for scheduling medicines under the international drug control conventions does not provide sufficient normative standards through which balanced decisions may be reached. It is undemocratic in its structure and opaque in its reasoning. In this article, we argue that such decisions represent de facto limitations on the right to health and may engage the principle of non-retrogression. Using the examples of ketamine and tramadol, we propose that standard legal tests in international human rights law can help to address the normative and democratic deficits in the system and produce more rigorous, fairer and more transparent decisions.

Access to Pain Management as a Human Right.

The concept of access to pain management as a human right has gained increasing currency in recent years. Commencing as individual advocacy, it was later embraced by the disciplines of pain medicine and palliative care and by mainstream human rights organizations.Today, United Nations and regional human rights bodies have accepted the concept and incorporated it into key human rights reports, reviews, and standards. We review the foundations in law of this right and the obligations that flow from it to governments. We analyze the nature and content of the obligation in the context of acute, chronic nonmalignant and cancer pain.Finally, we examine this right in light of the twin crises of inadequate access to pain management and the opioid crisis in the United States and other nations.

Six Key Approaches in Open Society Foundations' Support for Global Palliative Care Development.

CONTEXT: Between 1998 and 2021, the Open Society Foundations (OSF) network invested around US$50 million in supporting the emerging field of palliative care worldwide, funding different approaches and interventions to advance its objective of putting palliative care on the global public health agenda. OBJECTIVE: To describe six approaches that were instrumental to the successes of Open Society Foundations' support in building the global field of palliative care. A robust discussion of lessons learnt is unfortunately not possible because Open Society Foundations did not commission a rigorous evaluation of the impacts of its investments. METHODS: This article describes these six approaches: Investing in versatile palliative care leaders at national and regional level; investing in palliative care champions within the OSF network; proactively engaging the World Health Organization (WHO) in efforts to promote palliative care; developing tools and skills to improve palliative care financing; using a human rights-based approach; and supporting self-advocacy by people with palliative care needs. RESULTS: Deep, long-term investments in national and regional champions from the palliative care community and OSF's own network built palliative care leaders with well-rounded skills, knowledge and opportunities to develop their own networks. The active engagement and involvement of the WHO in efforts to advance palliative care enhanced the credibility of palliative care as a discipline as well its champions, whereas the human rights approach resulted in more diverse strategies to overcome barriers to palliative care. The focus on palliative care financing and self-advocacy showed significant promise for impact. DISCUSSION: The approaches and strategies described helped a nascent palliative care field develop into a health service that is increasingly integrated into public health systems. Other funders and national governments can build on OSF's long term support for the palliative care field and support further integration of palliative care within public health to increase access.

Advancing Global Palliative Care Over Two Decades: Health System Integration, Access to Essential Medicines, and Pediatrics.

CONTEXT: Between 2000 and 2020 Open Society Foundations was one of very few funders that supported global palliative care development and advocacy. OBJECTIVES: To describe progress made in three priority areas-the integration of palliative care into public health systems, access to controlled medicines, and pediatric palliative care-during those 20 years. METHODS: Activities and developments between 2000 and 2020 on global integration of palliative care into health systems, access to and availability of controlled medicines, and pediatric palliative care are described and analyzed. RESULTS: Major progress has been made in each area. Whereas in 2000, integration of palliative care into public healthcare systems was on the agenda in just a few pioneering countries, by 2020 a global consensus had emerged that palliative care should be integral to all health systems including in universal health coverage and countries were increasingly taking steps to integrate it into national health systems. While limited availability of these medicines was barely recognized as a public health or drug control issue in 2000, it had become an important priority in global drug policy debates by 2020 and numerous countries had taken steps to improve access to these medicines. Pediatric palliative care, available mostly in a small number of wealthy countries in the 1990s, has seen rapid growth, especially in low- and middle-income countries, and now has a solid foothold in all world regions. CONCLUSION: Despite this progress, significant challenges remain as funding for palliative care advocacy is limited, the overdose crisis in the US has recently had a chilling effect on efforts to improve availability of opioid analgesics, and economic crises related to the COVID-19 pandemic create uncertainty over the future of universal health coverage.

Progress Update: Development of Palliative Care From 2017 to 2020 in Five Countries in Eurasia.

CONTEXT: In the early 2000s, palliative care was largely unknown in the Eurasian region. For a period of twenty years starting around 2002, Open Society Foundations (OSF) supported palliative care pioneers in the region to establish palliative care services, train health providers, and advocate for the integration into health services. OBJECTIVES: To report on the development of palliative care in Armenia, Georgia, Moldova, Tajikistan and Ukraine during the period 2017-2021 and explore the impact of OSF's sustained funding for palliative care in these countries. Activities and developments to 2017 were described in country-specific papers in 2018. METHODS: A retrospective case study analysis was used to examine how palliative care developed in each country. We reviewed theories of change, funding and advocacy strategies, implemented activities and interventions, and their outputs and outcomes, and compared them to legal, policy and service developments in practice. RESULTS: By the mid-2010s, each country had laid the foundations for rolling out palliative care-basic policies and guidelines were in place; palliative care medications were available; key health providers were trained; and training capacity and models of care had been created-but service availability remained limited. In subsequent years, advocates increasingly embraced public advocacy to hold governments accountable for meeting their commitments and to include palliative care in universal health insurance. By 2021, Armenia, Moldova, and Ukraine had significantly scaled up service availability and palliative care was firmly embedded in universal health coverage in Moldova and Ukraine whereas progress in Georgia and Tajikistan was more modest. CONCLUSION: Experiences in these countries suggest that a strategy that initially emphasizes training, technical assistance, and engagement to create the building blocks for palliative care combined with or followed by public advocacy and campaigning to demand roll out of services can result in significant advances. Continued progress, however, is not guaranteed, especially considering the COVID-19 pandemic and dwindling donor support.

Progress Update: Palliative Care Development Between 2017 and 2020 in Five African Countries.

CONTEXT: This article provides a progress update on the development of palliative care in five countries in Africa-Kenya, Rwanda, South Africa, Tanzania, and Uganda-between 2017 and 2021, and explores the role of palliative care advocates and the Open Society Foundations in this process. OBJECTIVES: To provide a progress update on the development of palliative care in Kenya, Rwanda, South Africa, Tanzania, and Uganda between 2017 and 2021 and to examine the impact of twenty years of Open Society Foundations support for palliative care in the region on the integration of palliative care into publicly funded health systems. METHODS: In the mid-2000s, palliative care pioneers in these five countries, supported by Open Society Foundations, began to train health care providers and engage policy makers to ensure that people with life-limiting illnesses and their families had access to appropriate services and essential medicines. In the late 2010s, it embraced an approach that mixed strategic communications and advocacy for inclusion of palliative care into universal health coverage with technical assistance. RESULTS: By the mid-2010s, a vibrant palliative care community existed that worked closely with governments to develop palliative care policies, train providers, and ensure access to morphine. By 2021, Kenya and Rwanda had made significant progress scaling up palliative care services as part of the public health care system, and Uganda's government had instructed public hospitals to start providing these services. In South Africa and Tanzania, governments had yet to commit to publicly funded palliative care services. CONCLUSION: The experiences in these countries suggest that mixing advocacy, communications, and technical assistance can lead to substantial progress for patient access although full inclusion in universal health coverage remained uncertain in all but Rwanda.

Access to pain treatment as a human right.

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.

Rejecting the evidence: Russia's drug dependence treatment system.

In at least three regions of Russia, the drug treatment system fails to respond to the needs of injection drug users seeking treatment for their addiction. In this article, based on his presentation at a concurrent session at the conference, Diederik Lohman describes the results of research conducted by Human Rights Watch (HRW). The author explains that the Russian medical establishment ignores overwhelming scientific evidence that treatment substitution programs are both safe and effective.

Palliative Care and Human Rights: A Decade of Evolution in Standards.

CONTEXT: Human rights standards to address palliative care have developed over the last decade. OBJECTIVES: This article aims to examine key milestones in the evolution of human rights standards to address palliative care, relevant advocacy efforts, and areas for further growth. METHODS: The article provides an analysis of human rights standards in the context of palliative care through the lens of the right to health, freedom from torture and ill treatment, and the rights of older persons and children. RESULTS: Significant developments include the following: 1) the first human rights treaty to explicitly recognize the right to palliative care, the Inter-American Convention on the Rights of Older Persons; 2) the first World Health Assembly resolution on palliative care; 3) a report by the UN Special Rapporteur on Torture with a focus on denial of pain treatment; 4) addressing the availability of controlled medicines at the UN General Assembly Special Session on the World Drug Problem. CONCLUSION: Development of human rights standards in relation to palliative care has been most notable in the context of the right to health, freedom from torture and ill treatment, and the rights of older persons. More work is needed in the context of the rights of children, and human rights treaty bodies are still not consistently addressing state obligations with regards to palliative care.

Palliative Care Need and Availability in Four Referral Hospitals in Senegal: Results from a Multicomponent Assessment.

CONTEXT: With prevalence of noncommunicable diseases and life expectancy rising in Senegal, the need for palliative care is likely growing. No national palliative care needs assessments have been carried out. OBJECTIVES: To assess the capacity and need for palliative care in Senegal. METHODS: A multicomponent assessment of availability and demand for palliative care was conducted in two tertiary and two regional hospitals in Senegal in 2015 with approval from Senegal's National Ethics Committee for Health Research. The assessment consisted of (1) an inpatient hospital census; (2, 3) surveys of inpatients and outpatients with life-limiting illness; (4) a knowledge, attitudes, and practices survey among health care workers; and (5) a facility survey to assess availability of palliative care medications. RESULTS: Nearly half (44.4%) of all inpatients (n = 167) had an active life-limiting illness. Among them, 56.6% reported moderate-to-severe pain in the past three days, 2.3% of whom received morphine, and 76.7% received weak or no pain medication. Inpatients also experienced moderate-to-severe dyspnea (42.1%), fatigue (66.5%), nausea (16.5%), and drowsiness (42.1%). About 39.2% of all outpatients (n = 395) reported moderate-to-severe pain, and 52.8% reported that the treatment they had received relieved their pain only partially or not at all. Two-thirds of all doctors reported feeling comfortable prescribing pain medicines; however, 83.0% rarely or never prescribed morphine. Two of four hospitals reported no use of morphine in 2014. CONCLUSION: There is significant need for palliative care in Senegal. Training of health care workers and ensuring availability of relevant medications should be prioritized.

Predictors and Prevalence of Pain and Its Management in Four Regional Cancer Hospitals in India.

PURPOSE: More than 1 million new occurrences of cancer are diagnosed in India annually. Among patients with cancer, pain is a common and persistent symptom of the disease and its treatment. However, few studies to date have evaluated the prevalence of pain and the adequacy of pain management in Indian hospitals. This cross-sectional study aimed to assess the prevalence and sociodemographic patterns of cancer pain and pain management among a sample of inpatients and newly registered outpatients at four large regional cancer centers in India. METHODS: A sample of 1,600 patients with cancer who were current inpatients or newly registered outpatients were recruited and administered a questionnaire that was based on the Brief Pain Inventory. The survey tool included questions on demographics, medical history, and extent of clinical pain experienced. In addition, a pain management index score was created to link the severity of cancer pain with medication prescribed to treat it. RESULTS: A total of 88% of patients reported pain in the past 7 days, and approximately 60% reported that their worst pain was severe. Several demographic and medical characteristics of the study population predicted severe pain, including the following: lower educational level, outpatient status, and debt incurred as a result of illness. A total of 67% of patients were inadequately treated with analgesics. Inadequate pain management was associated with both treatment hospital and patient type, and patients who reported debt as a result of their illness were more likely to have inadequate pain management. CONCLUSION: A majority of Indian patients with cancer experience significant pain and receive inadequate pain management. Improvement of pain management for Indian patients with cancer is needed urgently.

Civil Society-Driven Drug Policy Reform for Health and Human Welfare-India.

The lack of adequate access to opioids in India as analgesics and for agonist therapies, forces millions to live with severe unalleviated pain, or languish with suffering associated with drug dependence. Although India is a major opium exporter, the excessively prohibitive 1985 narcotics law formulated to control harmful use of drugs, impeded the availability and access to opioids for medical and scientific purposes. Amendment of this law in 2014 established a new national regulatory framework for improved access to essential opioid analgesics. This article reflects on key elements and processes that led to this landmark achievement. Unlike quick timelines associated with effecting policy reforms for law enforcement, realizing the 2014 drug policy change primarily to mitigate human suffering, was a 22-year-long process. The most exacting challenges included recognizing the multilayered complexities of the prior policy framework and understanding their adverse impact on field practices to chart an appropriate and viable path for reform. The evolution of an informal civil society movement involving health care professionals, lawyers, media, policy analysts, government officials, and the public was pivotal in addressing these challenges and garnering momentum for reform. The success of the effort for improving access to opioid medications was underpinned by a three-pronged strategy of 1) persuading the executive arm of the government to take interim enabling measures; 2) leveraging judicial intervention through public interest litigation; and 3) crafting a viable policy document for legislative approval and implementation. We hope our findings are useful for realizing drug policy reforms, given the current transformed global policy mandates emphasizing humanitarian, healthcare, and quality-of-life considerations.