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.

A Multifaceted Approach to Improve the Availability and Accessibility of Opioids for the Treatment of Cancer Pain in Serbia: Results From the International Pain Policy Fellowship (2006-2012) and Recommendations for Action.

Cancer is the second leading cause of death in Serbia, and at least 14,000-16,000 patients experience moderate-to-severe cancer pain every year. Cancer pain relief has been impeded by inadequate availability of opioid analgesics and barriers to their accessibility. In 2006, a Serbian oncologist was selected as an International Pain Policy Fellow. The fellow identified barriers to opioid availability in Serbia and implemented an action plan to address the unavailability of oral morphine, attitudinal and knowledge barriers about opioids, and barriers in the national opioid control policy, in collaboration with the government, local partners, and international experts, including those from the World Health Organization. Collaborative efforts resulted in availability of immediate-release oral morphine, registration of controlled-release hydromorphone, and reimbursement of oral methadone for cancer pain; numerous educational activities aimed at changing inadequate knowledge and negative attitudes toward opioids; recognition of opioids as essential medicines for palliative care in a new National Palliative Care Strategy; and recognition of the medical use of opioids as psychoactive-controlled substances for the relief of pain included in a new national law on psychoactive-controlled substances, and the development of recommendations for updating regulations on prescribing and dispensing opioids. An increase in opioid consumption at the institutional and national levels also was observed. This article outlines a multifaceted approach to improving access to strong opioids for cancer pain management and palliative care in a middle-income country and offers a potential road map to success.

Do national drug control laws ensure the availability of opioids for medical and scientific purposes?

OBJECTIVE: To determine whether national drug control laws ensure that opioid drugs are available for medical and scientific purposes, as intended by the 1972 Protocol amendment to the 1961 Single Convention on Narcotic Drugs. METHODS: The authors examined whether the text of a convenience sample of drug laws from 15 countries: (i) acknowledged that opioid drugs are indispensable for the relief of pain and suffering; (ii) recognized that government was responsible for ensuring the adequate provision of such drugs for medical and scientific purposes; (iii) designated an administrative body for implementing international drug control conventions; and (iv) acknowledged a government's intention to implement international conventions, including the Single Convention. FINDINGS: Most national laws were found not to contain measures that ensured adequate provision of opioid drugs for medical and scientific purposes. Moreover, the model legislation provided by the United Nations Office on Drugs and Crime did not establish an obligation on national governments to ensure the availability of these drugs for medical use. CONCLUSION: To achieve consistency with the Single Convention, as well as with associated resolutions and recommendations of international bodies, national drug control laws and model policies should be updated to include measures that ensure drug availability to balance the restrictions imposed by the existing drug control measures needed to prevent the diversion and nonmedical use of such drugs.

Examining influences on the availability of and access to opioids for pain management and palliative care.

This commentary relates to the recently published essay in PLOS Medicine, entitled "Untreated Pain, Narcotics Regulation, and Global Health Ideologies." That essay describes regulatory and other systemic barriers preventing the accessibility of opioid analgesics and contributing to patients not receiving adequate pain relief. Four main points highlighted in the essay are discussed in this commentary: (1) the role of international treaties in medication availability; (2) the role of the International Narcotics Control Board in medication availability; (3) the role of regulatory policy in treating pain; and (4) the role of opioid analgesics in treating pain. Recent authoritative statements and activities suggest a strengthened infrastructure within which governments currently can work to improve the availability of controlled medicines to enhance patient pain and palliative care services.