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 world's 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.

Is the DEA's new "prescription series" regulation balanced?

To address the dual public health imperatives of enhanced pain management and decreased abuse and diversion of prescription medications, the U.S. Drug Enforcement Administration (DEA) recently adopted regulations to allow practitioners to issue multiple prescriptions for a Schedule II controlled substance on the same day, to be dispensed sequentially. Public feedback suggested there was concern that practitioners could interpret the initially proposed language as limiting the quantity of prescribed medication and establishing an ambiguous practice standard. The DEA later explicitly confirmed that they did not intend to impose undue limits on practice. Rather, if implemented appropriately, the new regulation can be considered an important mechanism to control medication diversion while maintaining access for legitimate medical purposes and patient care.

The federal Drug Enforcement Administration "prescription series" proposal: continuing concerns.

Two leading health and pain policy analysts discuss the implications of the federal Drug Enforcement Administration proposed position on the legality of practitioners writing series of controlled substance prescriptions for the purpose of providing ongoing pain management without the necessity for unneeded patient visits to their prescribers. This issue led to a series of regulatory proposals that engendered great concern in the pain management community. The proposed positive outcome from the DEA is described.

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 person's 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 state's pain policies is discussed.

State medical board members' beliefs about pain, addiction, and diversion and abuse: a changing regulatory environment.

UNLABELLED: Three national surveys were conducted in 1991, 1997, and 2004 to evaluate state medical board members' knowledge and attitudes about prescribing opioid analgesics for pain management. Topics addressed include perceived legality of prolonged opioid prescribing, characteristics of addiction, prevalence of medication abuse and diversion, and perceived importance and influence of medical board policy. Questions were added in 2004 to determine board members' views about law enforcement involvement in physician investigations and prosecutions. This study assesses medical regulators' current beliefs and compares the 2004 responses with previous responses to determine how knowledge and attitudes about prescribing opioids have changed in recent years. Survey results show that board members have a greater understanding of pain management issues, particularly regarding characteristics of addiction and the legality of prolonged opioid prescribing for chronic noncancer pain. During the last 15 years, there has been substantial regulatory policy development, with medical boards adopting regulations, guidelines, or policy statements to provide guidance to licensees about using opioids to treat pain. However, many board members believe that federal and state law enforcement agencies have increased criminal investigations and prosecutions of physicians. We discuss appropriate regulatory and law enforcement responses to opioid prescribing violations, and suggest crucial next steps. PERSPECTIVE: The authors examine the evolution of state medical board members' knowledge and attitudes about prescribing opioid analgesics to treat chronic pain, demonstrate that medical regulators believe that there have been increased criminal investigations and prosecutions of physicians for their prescribing practices, and suggest ways to avoid unwarranted criminal prosecutions.

Ensuring opioid availability: methods and resources.

The pain and palliative care fields are encouraged to learn about government drug control policy and to engage with their governments to examine these policies and their implementation in order to address impediments to patient access to pain management. Although pain management is a necessary part of palliative care, it is often impossible because strict national and state regulations block access to opioid analgesics. It is important for us to know that in adhering to international drug treaties, governments often concentrate on drug control to the exclusion of their obligation to ensure opioid availability for medical and scientific purposes. Indeed, international health and regulatory authorities are increasingly concerned about wide disparities in national consumption of opioid analgesics and have called on governments to address barriers in their national laws and regulations that govern the prescribing of opioid analgesics. The Pain & Policy Studies Group (PPSG) has developed methods and resources to assist governments and pain and palliative care groups to examine national policies and make regulatory changes. Romania, India, and Italy are examples. The PPSG is developing several new resources, including a training program for Fellows from low- and middle-income countries, enhanced support of collaborators working on opioid availability, an internet course in international pain policy, an improved website with policy resources and country profiles, and new approaches to the study of opioid consumption indicators.

India: opioid availability. An update.

In India, a million people with cancer and an unknown number of people with other incurable and disabling diseases, need opioids for pain relief. Only about 0.4% of the population in need have access to them. Major barriers to access to opioids are complicated regulations and problems related to attitude and knowledge regarding pain relief and opioids among professionals and the public. The Pain and Policy Studies Group at Madison Wisconsin has been collaborating with many Indian palliative care workers and government officials to improve availability of opioids to those who need them for pain relief. As a result of this collaborative effort, the Government of India asked all state governments to modify the narcotic regulations following a model given to them. To facilitate the process, the collaboration has conducted workshops in 13 states in association with local champions. Currently, 13 states in India and one union territory have simplified regulations, but opioid availability has improved only in a minority of these states. Establishment of simple standard operating procedures to implement the simplified regulations, advocacy, and improved education of professionals are essential for further improvement of the situation. The past decade has demonstrated that government policy can be changed if palliative care enthusiasts work in tandem with the government. The progress has been slow, but real and encouraging.

Foundations of opioid risk management.

Increased abuse and diversion of prescription opioids has been a consequence of the increased availability of opioids to address the widespread problem of undertreated pain. Opioid risk management refers to the effort to minimize harms associated with opioid therapy while maintaining appropriate access to therapy. Management of these linked public health issues requires a coordinated and balanced effort among a disparate group of stakeholders at the federal, state, industry, practitioner, and patient levels. This paper reviews the principles of opioid risk management by examining the epidemiology of prescription opioid abuse in the United States; identifying key stakeholders involved in opioid risk management and their responsibilities for managing or monitoring opioid abuse and diversion; and summarizing the mechanisms currently used to monitor and address prescription opioid abuse. Limitations of current approaches, and emerging directions in opioid risk management, are also presented.

Reform of drug control policy for palliative care in Romania.

Unrelieved pain from cancer and HIV/AIDS is a substantial worldwide public-health problem. Inadequate pain relief is partly due to excessively strict national drug-control policies that constrain medical use of essential medicines such as morphine. Romania's drug-control policies are more than 35 years old and impose an antiquated regulatory system that is based on inpatient post-surgical management of acute pain that restricts prescription authority and makes access to opioid treatment difficult for outpatients with severe chronic pain due to cancer or HIV/AIDS. A Ministry of Health palliative-care commission used WHO guidelines to assess and recommend changes to Romania's national drug control law and regulations. The Romanian parliament has adopted a new law that will simplify prescribing requirements and allow modern pain management. Achievement of adequate pain relief is a vital part of worldwide health and will be dependent on reform of antidrug regulations in many countries.

State policy affecting pain management: recent improvements and the positive impact of regulatory health policies.

Criteria-driven policy analysis resources from the University of Wisconsin Pain and Policy Studies Group (PPSG) evaluated drug control and professional practice policies that can influence use of controlled substances for pain management, and documented changes over a 3-year period. Additional research was needed to determine the extent of change, the types of messages contained in the policies, and what has contributed to changing policy content. Four research aims guided this study: (1) evaluate change between 2000 and 2003 of state policy that can affect pain relief, (2) describe content differences for statutes, regulations, guidelines, and policy statements, (3) evaluate differences between policies specific to pain management and policies governing general healthcare practice, and (4) compare content of policies specific to pain management created by healthcare regulatory boards to those created by state legislatures. Results showed that more current policies, especially policies regulating health professionals, tend to encourage pain management and avoid language that restricts professional decision-making and patient treatment. In addition, pain policies from healthcare regulatory boards were generally less restrictive than statutes or policies that govern general healthcare practice. These findings suggest that the positive policy change results primarily from state medical, pharmacy, and nursing boards adopting policies promoting pain management and the use of opioids, while containing few if any restrictions. Despite this improvement, further progress can be made when states continue to abrogate additional restrictions or clinically obsolete provisions from policies. PPSG policy evaluations provide guidance to lawmakers, healthcare regulators, and clinicians who are striving to achieve balanced policy, an attainable but redoubtable goal, to benefit patient care.

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 "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.

A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002.

This study updates a previous analysis of trends in medical use and abuse of opioid analgesics, and provides data from 1997 through 2002. Two research questions were evaluated: 1) What are the trends in the medical use and abuse of frequently prescribed opioid analgesics used to treat severe pain, including fentanyl, hydromorphone, meperidine, morphine, and oxycodone? 2) What is the abuse trend for opioid analgesics as a class compared to trends in the abuse of other drug classes? Results demonstrated marked increases in medical use and abuse of four of the five studied opioid analgesics. In 2002, opioid analgesics accounted for 9.85% of all drug abuse, up from 5.75% in 1997. Increase in medical use of opioids is a general indicator of progress in providing pain relief. Increases in abuse of opioids is a growing public health problem and should be addressed by identifying the causes and sources of diversion, without interfering with legitimate medical practice and patient care.

Definitions related to the medical use of opioids: evolution towards universal agreement.

Misunderstandings regarding the nature and occurrence of addiction have historically been barriers to the appropriate treatment of pain and have stigmatized the medical use of opioids. This article reviews the evolution of nomenclature related to addiction, presents current scientific understanding of addiction that may help shape universally acceptable terminology, and discusses an integrated effort of pain and addiction professionals to reach consensus on addiction-related terms. The article suggests key principles that may clarify terminology including: clear differentiation of the concepts of addiction and physical dependence, conceptualization of addiction as a multidimensional disease, and use of a label for the phenomenon of addiction that does not include the ambiguous term "dependence." More universal agreement on terminology related to addiction is expected to improve the treatment of both pain and addictive disorders; improve communication between health care providers, regulators, and enforcement agencies; and reduce health care and other societal costs.