David E. Joranson

Pain Management and Prescription Monitoring

Preventing diversion and abuse of prescription controlled substances while ensuring their availability for legitimate medical use is an important public health goal in the United States. In one approach to preventing and identifying drug diversion, 17 states have implemented prescription monitoring programs (PMPs) to monitor the prescribing of certain controlled substances. While PMPs are not intended to interfere with legitimate prescribing, some in the pain management community feel that they negatively affect prescribing for pain management. This article describes a collaborative project initiated by the Pain & Policy Studies Group that brought together regulatory and pain management representatives twice in 1998 to share perspectives and reconcile differing views on the effects of PMPs. The ultimate goals of this project are to provide accurate information to healthcare clinicians about PMPs, better define the balance between preventing drug diversion and providing pain management, and promote continued dialog and cooperation among the groups.

Improving access to opioid analgesics for palliative care in India.

Approximately one million people in India experience cancer pain every year. 1 As in many developing countries, it is typical that cancer is diagnosed in the late stages, when pain is prevalent and often severe. 2 Severe pain destroys a person’s quality of life and dignity. Severe pain also affects families, neighbors, and the community: a painful death leaves an indelible mark, especially in India, where the person with cancer is often cared for in the community and at home. 1,3

Regulatory barriers to pain management.

OBJECTIVES To provide an overview of relevant federal and state policies, as well as recommendations for identifying and addressing barriers to the treatment of cancer and non-cancer pain. DATA SOURCES Review of federal and state statutes and medical board guidelines. CONCLUSIONS There has been an increase in pain-related policies since the mid 1980s, with recent years showing a significant amount of policy development and adoption. However, a variety of laws and policies contain provisions that have the potential to discourage the use of opioid analgesics for the relief of pain. IMPLICATIONS FOR NURSING PRACTICE The evaluation and treatment of patients with cancer and non-cancer pain can be enhanced by a knowledge of the specific restrictions of controlled substances statutes and practice guidelines. In this way, there will be less chance for nurses to practice outside established legal parameters.

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.

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. Romanias 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 Romanias 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.

Policy issues and imperatives in the use of opioids to treat pain in substance abusers.

great deal has been learned in the past fifteen years from the study of pain mechanisms.’ More A ecently, the relief of pain has begun to receive much needed attention as we1L2 Although most, if not all, acute and cancer pain can be relieved: recerG evidence shows that inadequate treatment of pain is still common among the general population-even for pain due to cancer: Inadequate treatment of cancer pain is even more likely if the patient is a member of an ethnic minority, female, elderly, or a child.5 Evidence also suggests that substance abusers are at risk for poor pain treatment! A number of barriers which involve problems of knowledge, attitudes, and laws and regulations affect health care professionals, patients, and the health care system; collectively, they contribute to the inadequate treatment of pain. For example, practitioners prescribe opioids that are insufficient in strength, amount, or frequency due to lack of knowledge, lack of concern about pain management, or fear of addiction.’ However, reluctance to prescribe or dispense opioids for intractable pain conditions can also be attributed to physicians’ perceptions that they will be investigated for violation of the laws or regulations that govern medical practice and controlled substances.* Unfortunately, various federal and state laws, regulations, and other policies inappropriately or excessively regulate the medical use of controlled substances, in particular, the opioids that are essential in pain management? These laws and regulations amount to legal barriers to pain management.’O With accurate education and appropriate regulation, the medical use of controlled substances can provide great improvements in the quality of life for millions of people with debilitating medical conditions.” However, severe discomfort and distress are likely consequences if the appropriate use of opioids for pain management is obstructed,12 as are unnecessary hospitalizations and increased health care ~0sts.I’ Does the regulation of controlled substances and medical practice increase the risk that substance abusers with pain will receive less than adequate pain management fot painful conditions where opioids are indicated? The purpose of this paper is to identify laws, regulations, and other policies that have the potential to interfere with the appropriate prescribing of controlled substances to treat patients with pain, including substance abusers.

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.

Improving Availability of Opioid Pain Medications: Testing the Principle of Balance in Latin America

FOR A NUMBER OF YEARS, my colleagues and I have been working through a process to formulate an idea into a model that can be used to evaluate and then improve anti-drug abuse policies so they do not interfere with the use of opioid analgesics for pain relief. We refined this idea into the principle of “balance.” Our work started in Wisconsin and led ultimately to the development of policy evaluation guidelines that were endorsed by key agencies associated with the United Nations. Real world testing of the model with regulators and clinicians took place in several countries, including in Latin America.

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

Access to therapeutic opioid medications in Europe by 2011? Fifty years on from the Single Convention on Narcotic Drugs

Nearly 50 years after the Single Convention on Narcotic Drugs, the importance of this statement continues to hold true and is reinforced by recent UN policy declarations (ECOSOC, 2006). However there continues to be ongoing problems with access to opioid analgesics for relief of pain globally. Cherny and his colleagues from the European Association for Palliative Care (EAPC) and the European Society of Medical Oncology (ESMO) Drug Policy Initiative have documented the current status in Europe of access to opioids for pain relief in an article published in the current issue of Annals of Oncology. The authors reference the extensive work of the University of Wisconsin–Madison Pain and Policy Studies Group (PPSG), aWHOCollaborating Center for Policy and Communication in Cancer Care. PPSG has described the opioid consumption trends around the world, using consumption data reported by governments to the International Narcotics Control Board (INCB).Most of the countries of the world, including those in Eastern Europe, fall well below the European and global means for opioid consumption. While there has been a significant increase in opioid consumption in Western Europe, there has been little change in the last 20 years in Eastern Europe. There is evidence that in many European countries, particularly those in Eastern Europe, patient access to the opioid medicines recommended by the WHO to relieve cancer pain is profoundly restricted by inadequate formularies, excessive regulation and the attitudes and misconceptions of both clinicians and patients. While there are clear disparities between Eastern and Western Europe, there is also variation within the two regions. Morphine (sustained or immediate release [IR]) is available to the patient for less than 25% of the total cost in every Western European country except Iceland where patients pay 100% of the cost, perhaps a norm of their health care system. Turkey is the only Western European country without IR morphine, but does have available controlled release (CR) morphine and transdermal fentanyl, two preparations that are included in the International Association of Hospice and Palliative Care (IAHPC) list of essential drugs for palliative care. However, in that list, the IAHPC panel of experts recommended to the WHO that governments should not approve controlled release formulations of morphine, fentanyl or oxycodone, without first guaranteeing the wide availability of IR oral morphine. The lack of IR morphine in Turkey is evident in many countries in Eastern Europe. No IR morphine is available in Albania although CR morphine is available. Belarus has no IR morphine but has CR morphine and TD fentanyl, as do Lithuania, Georgia, and the Ukraine (patients bear 100% of the cost of fentanyl in Georgia). While these are available in many Eastern European countries because of the marketing practice of pharmaceutical companies, the PPSG opioid consumption data for morphine (as shown in the paper) demonstrates a low level of consumption of CR morphine in these countries and the low level of fentanyl consumption is shown on the PPSG web site (http:// www.painpolicy.wisc.edu). These data suggest that the national approval of a controlled-release opioid pharmaceutical does not necessarily lead to the appropriate use for analgesia, and may inadvertently minimize the importance of IR formulations. Cherny and colleagues warn us that some aspects of their data, provided by practicing clinicians in 41 countries, may have deficits due to the selective nature of the survey process. On the other hand, the results are valuable perceptions of practice by these clinicians in their respective countries. The ESMO and EAPC survey is an important step; it is a window that can be used to continue the study, discussion and reform of regulatory barriers in Europe. It should be recalled that these laws were not enacted to prevent pain relief but rather to address drug abuse and diversion, an understandable concern about public health and safety of many governments.