Martha A. Maurer

Improving State Pain Policies: Recent Progress and Continuing Opportunities

The National Institutes of Health reports that 100 million Americans suffer from chronic pain, including pain associated with the disease of cancer. Painful conditions can strike anyone, including cancer patients and cancer survivors. Unrelieved severe pain can limit a persons functioning and sometimes even destroy the will to live. When the quality of pain relief provided is inadequate, it is usually the result of failures to apply existing knowledge about pain and its treatment, including the appropriate use of opioids. But pain relief also can be affected by the regulatory environment and fear of being investigated for excessive prescribing. The importance of evaluating and improving policies governing pain management has been recognized by national and international authorities, including the Institute of Medicine and the World Health Organization. A pilot examination of state laws and regulatory policies demonstrated that they contained a number of outdated medical concepts and prescribing restrictions and did not contain key elements of law that can make pain management a priority for licensed medical practitioners. The Pain & Policy Studies Group developed a research program to evaluate US federal and state policy governing the medical use of pain medication. This article describes 3 national policy evaluations and how the results are being used to document improvements in state pain policies. An emerging role for clinicians and their professional organizations to improve their states pain policies is discussed.

An examination of global and regional opioid consumption trends 1980-2011.

ABSTRACT Despite expert recognition that strong opioid analgesics are the cornerstone of treatment for moderate to severe pain, most of the worlds population lacks adequate availability of opioids. Moreover, great disparities in availability of opioids continue to exist between higher- and lower-to-middle-income countries. This study examined more than 30 years of consumption data reported to the International Narcotics Control Board, from 1980 to 2011, for five opioids that are indicated for the treatment of moderate to severe pain: fentanyl, hydromorphone, morphine, oxycodone, and pethidine. As such, this study offers a regional and global perspective on opioid consumption, providing an indication of preparedness for treating moderate to severe pain. Countries are categorized according to the World Health Organizations six geographical regions. Morphine equivalence (ME) statistics were calculated for each study drug, allowing for equianalgesic comparisons between consumption of the study opioids and well as the ability to aggregate all study opioids (Total ME). The ME statistic is adjusted for country population, which allows for uniform global-, regional-, and country-level equianalgesic comparisons of consumption of morphine with other opioids. Although overall trend lines revealed general increases by region, profound inequities in opioid consumption continue to abound globally.

Using a Morphine Equivalence Metric to Quantify Opioid Consumption: Examining the Capacity to Provide Effective Treatment of Debilitating Pain at the Global, Regional, and Country Levels

CONTEXT Morphine has been considered the gold standard for treating moderate-to-severe pain, although many new opioid products and formulations have been marketed in the last two decades and should be considered when examining opioid consumption. Understanding opioid consumption is improved by using an equianalgesic measure that controls for the strengths of all examined opioids. OBJECTIVES The research objective was to use a morphine equivalence (ME) metric to determine the extent that morphine consumption relates to the total consumption of all other study opioids. METHODS An ME metric was created for morphine and the aggregate consumption of each study opioid (Total ME), adjusted for country population to allow for uniform equianalgesic comparisons. Graphical and statistical evaluations of morphine use and Total ME consumption trends (between 1980 and 2009) were made for the global and geographic regional levels and selected developed and developing countries. RESULTS Global morphine consumption rose dramatically in the early 1980s but has been significantly outpaced by Total ME since 1996. As expected, the extent of morphine and Total ME consumption varied notably among regions, with the Americas, Europe, and Oceania regions accounting for the highest morphine use and Total ME in 2009. Developing and least developed countries, compared with developed countries, demonstrated lower overall Total ME consumption. CONCLUSION Generally, worldwide morphine use has not increased at the rate of Total ME, especially in recent years. Examining a countrys ability to effectively manage moderate-to-severe pain should extend beyond morphine to account for all available potent opioids.

Progress to Achieve Balanced State Policy Relevant to Pain Management and Palliative Care: 2000-2003

State laws and regulatory policies govern healthcare practice, including the prescribing, dispensing, and administering of opioid analgesics to treat pain. A number of national healthcare and law enforcement organizations have identified drug regulatory policy as a potential barrier to pain relief and palliative care, and have called for evaluation and removal. This article summarizes and discusses the results of an innovative evaluation methodology that was used to produce three policy analysis tools, including one report that graded and ranked states based on the quality of their policies related to pain management and palliative care (called a Progress Report Card [PRC]). The PRC development and implementation was a first-of-a-kind study that compared pain policies in all states over a three year period according to the same evaluation criteria. Results demonstrate significant progress to improve policy in a number of states during the study period, but also showed that most state policies are characterized by a lack of “balance.” In addition to providing examples of policy change in particular states, the relevance of these findings to current policy issues, including the importance of communicating and implementing new policies is discussed. The need for partnerships between the healthcare and law enforcement communities is emphasized to create a more positive regulatory environment for pain relief and palliative care, which ultimately will benefit patient care.

Multivariate analysis of countries’ government and health-care system influences on opioid availability for cancer pain relief and palliative care: More than a function of human development

Background: Many international governmental and nongovernmental organizations regard unrelieved cancer pain as a significant global public health problem. Although opioids such as morphine are considered essential medicines in the provision of palliative care and for treating cancer pain, especially when the pain is severe, low- and middle-income countries often lack such medications. Aim: The primary aim of this study was to examine countries’ government and health-care system influences on opioid availability for cancer pain and palliative care, as a means to identify implications for improving appropriate access to prescription opioids. Design: A multivariate regression of 177 countries’ consumption of opioids (in milligrams/death from cancer and AIDS) contained country-level predictor variables related to public health, including Human Development Index, palliative care infrastructure, and health system resources and expenditures. Results: Results were highly explanatory (adjusted R2 = 82%) and Human Development Index was the most predictive variable when controlling for all other factors in the statistical model (B = 11.875, confidence interval = 10.216, 13.534, p < 0.0001). Conclusions: Study findings demonstrate that a limited number of predictor variables characterizing a country’s government and health-care system infrastructure can explain its opioid consumption level, with the greatest influence being very high Human Development Index. However, Human Development Index is not the most policy-relevant factor, and this finding should be reconciled against the reality that many countries with low or medium Human Development Index have succeeded in creating and sustaining a health-care system to strengthen cancer pain care and palliative care, including through the appropriate use of essential prescription opioids.

Improving State Medical Board Policies: Influence of a Model

D espite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account for the gap between what is known about pain management and what is practiced.’ Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing2 State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. Since 1989, forty-one state medical boards have adopted such policies, including regulations, guidelines, and policy statements (see Figure 1). “Regulations” are official rules issued by the medical board pursuant to legislative authority; regulations have the force of law and establish the boundaries of acceptable conduct for licensed physicians. “Guidelines” are official statements that define the parameters of medical practice as viewed by the board. “Policy statements’’ are position statements that address matters of concern to the board and may clarify the board’s expectations. While guidelines and policy statements

An Ethnographic Study of Barriers to Cancer Pain Management and Opioid Availability in India

The worlds global cancer burden disproportionally affects lower income countries, where 80% of patients present with late-stage disease and have limited access to palliative care and effective pain-relieving medications, such as morphine. Consequently, millions die each year with unrelieved pain. Objective. The objective of this study was to examine barriers to opioid availability and cancer pain management in India, with an emphasis on the experiences of nurses, who are often the front-line providers of palliative care. Methods. Fifty-nine participants were recruited using a purposive, snowball sampling strategy. Ethnographic data collection included in-depth, semistructured interviews (n = 54), 400+ hours of participant observation, and review of documents over 9 months at a government cancer hospital in South India. Systematic qualitative analysis led to identification of key barriers that are exemplified by representative quotes. Results. Morphine is more available at this study site than in most of India, but access is limited to patients seen by the palliative care service, and significant gaps in supply still occur. Systems to measure and improve pain outcomes are largely absent. Key barriers related to pain management include the role of nursing, opioid misperceptions, bureaucratic hurdles, and sociocultural/infrastructure challenges. Implications. Interventions must streamline process details of morphine procurement, work within the existing sociocultural infrastructure to ensure opioids reach patients most in need, target unexpected audiences for symptom management education, and account for role expectations of health care providers. Conclusion. Macro- and micro-level policy and practice changes are needed to improve opioid availability and cancer pain management in India.

Toward Safe Accessibility of Opioid Pain Medicines in Vietnam and Other Developing Countries: A Balanced Policy Method

Moderate or severe pain is common among people with advanced cancer and other life-threatening illnesses. Yet despite agreement that pain relief is a human right, the poorest 80% of the worlds population rarely have access to strong opioid analgesics. Excessively restrictive opioid policies, especially in developing countries, both stem from and propagate misguided fears about opioids, so-called opiophobia. Because opiophobia, like any norm, is historically, socially, and culturally situated, efforts to change opiophobic policies will be most effective if guided by awareness of their historical, social, and cultural determinants. We describe some of these determinants in Vietnam and report on results of an ongoing project there to allay opiophobia and improve safe access to opioids for medical uses. We used a method that entails working with committed local partners, including a high-level official from the Ministry of Health, to review all Vietnamese policies governing opioid accessibility to identify the barriers; devising an action plan to safely reduce or circumnavigate the barriers; obtaining buy-in for the plan from all stakeholders, including drug regulators and the police; and assisting the Ministry of Health to implement the plan. Since the start of the project, morphine consumption has increased each year and as of 2010 was ninefold greater than in 2003, and the number of hospitals offering palliative care has increased from three to 15. We conclude that this balanced policy method appears to be helping to reduce barriers to opioid access in Vietnam and should be used in other developing countries.

Ensuring Patient Access to Essential Medicines While Minimizing Harmful Use: A Revised World Health Organization Tool to Improve National Drug Control Policy

ABSTRACT In 2011, the World Health Organization (WHO) published a series of 21 guidelines to assist governments in improving their national drug control laws, regulations, and administrative procedures to promote the availability of controlled medicines for pain relief and for a variety of acute and chronic diseases and conditions. These guidelines ultimately are designed to encourage the development of policies designed to fulfill a countrys dual obligation concerning these medicines: to prevent their abuse, diversion and trafficking while ensuring access for medical and scientific purposes. This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them. It is hoped that representatives of governments and medical institutions, as well as health care professionals, will commonly and effectively use the revised WHO guidelines as a policy change tool.

Examining Influences on the Availability of and Access to Opioids for Pain Management and Palliative Care

ABSTRACT 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.