Federal and state regulation of opioids.

Federal and state policy governing opioids is discussed in relation to achieving balance between efforts to control drug abuse and maintain drug availability for legitimate medical purposes. Federal controlled substances law affirms the essential medical value of many drugs that are controlled substances, and states that opioids may be used for extended periods in treatment of patients with intractable pain. Providing opioids to addicts is otherwise unlawful unless the physician is separately registered to treat addiction. State laws, while they permit prescribing of opioids for pain, do not provide affirmative recognition of the medical value of controlled substances. Imprecise legal definition of terms allows patients to be confused with addicts. In addition, some states require physicians to report opioid-dependent patients to the government, regulate prescribing of Schedule II opioids more strictly, and limit the quantity of controlled substances that may be prescribed at one time. Recommendations are offered to revise state laws and to improve communication between health care professionals and regulators.

Are health-care reimbursement policies a barrier to acute and cancer pain management?

US health-care policy and recent literature are reviewed to examine whether there are reimbursement barriers to acute and cancer pain management. The available evidence suggests that lack of coverage and uneven reimbursement policies for health care including prescription drugs, medical equipment, and professional services inhibit access to acute and cancer pain management for millions of citizens, in particular the poor, elderly, and minorities. Medicare, Medicaid, and HMO issues are reviewed. Available evidence suggests that the use of "caps" on prescription drugs limits access to pain medications. Access to the opioid analgesics that are essential to pain management is limited by some state-controlled substances regulations and by some mail-order pharmacy policies. Controlled substances laws appear to create financial disincentives for pharmacies and hospices. Programs to help indigent patients obtain opioid analgesic medications are reviewed. Suggestions are offered for hospices to reduce costly waste of analgesic medications that remain after patients die. Reimbursement for acute and cancer pain management should be reviewed and included in current efforts to reform national health-care policy.

Controlled substances and pain management: changes in knowledge and attitudes of state medical regulators.

Physicians report that concern about regulatory investigation negatively influences their prescribing of opioid analgesics. The views of medical regulators about the legality of prescribing controlled substances for pain management were studied in 1991. However, little is known about whether these views have changed in light of increased emphasis on pain management and educational programs for state medical boards. Two studies that examined this issue are described. In Study 1, a 1997 survey of state medical board members was compared to results obtained in 1991 to evaluate differences in knowledge and perceptions about opioid analgesics. Important changes were observed over time, particularly regarding characteristics of "addiction" and the legality of prolonged prescribing of opioids. For Study 2, a longitudinal survey was conducted of medical board members who participated in five workshops about pain management and regulatory policy. Results revealed significant and sustained changes in attitudes about the incidence of iatrogenic addiction when using opioids to treat pain, the analgesic and side-effect properties of opioids, and the perceived legality of prescribing opioids. Recommendations for reducing concerns about regulatory scrutiny are presented, including the need for a more intensive education program, increasing the rate of adoption of new state medical board policies, and improving communication between regulators and clinicians.

Opioid availability in Latin America: the Santo Domingo report progress since the Declaration of Florianopolis.

The World Health Organization (WHO) has indicated that opioid analgesics are insufficiently available, particularly in developing countries, due to a variety of reasons, including legislative, educational, and policy issues. In its effort to promote the rational use of medical opioids and the adequate treatment of patients with cancer, WHO has sponsored a meeting of Latin American representatives every 2 years, which includes health professionals and government regulators. During March 24-27, 1996, a group of 86 representatives of cancer pain relief and palliative care programs from nine Latin American countries met in Santo Domingo under the auspices of the WHO Palliative Care Program for Latin America. For the first time since the First Latin American Meeting, government regulators were present to help address the issue of opioid availability from their perspective. During the meeting, issues pertaining to cancer pain, opioid availability, and palliative care were discussed. This report summarizes some of the events and presents a summary of the conclusions of an earlier meeting in 1994, as described in the Declaration of Florianopolis, and presents its follow-up, The Santo Domingo Report, generated following the 1996 meeting.

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.

Regulatory issues in pain management.

Undertreatment of pain continues to be a serious public health problem. The use of opioid analgesics is considered essential for chronic pain management and palliative care. Pharmacists are encouraged to become involved in initiatives to improve pain management.

Pharmacists' knowledge of and attitudes toward opioid pain medications in relation to federal and state policies.

OBJECTIVE: To assess Wisconsin pharmacists' knowledge of and attitudes toward the use of opioid analgesics in the management of chronic cancer and noncancer pain, and to explore the potential for these beliefs to interfere with pharmacist dispensing, the last link of the distribution chain of controlled substances to patients. DESIGN: Mail survey. SETTING: Urban and rural pharmacies, long-term care facilities, hospitals, and outpatient clinics in Wisconsin in 1998. PATIENTS OR OTHER PARTICIPANTS: Representative sample of Wisconsin pharmacists. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Responses to self-administered questionnaires. RESULTS: Although most respondents were knowledgeable about the issues addressed in this study, there were important exceptions. Not all pharmacists knew what constitutes legitimate dispensing practices for controlled substances under federal or state policy in emergencies or for patients with terminal illnesses, and many were unaware of the important distinctions among addiction, physical dependence, and tolerance. Many respondents did not view the chronic prescribing/dispensing of opioids for more than several months to patients with chronic pain of malignant or nonmalignant origin as a lawful and acceptable medical practice; this was especially true when the patient had a history of opioid abuse. CONCLUSION: Pharmacists play a pivotal role in ensuring patient access to medications. Viewed in the context of federal and state controlled substances policies, our findings suggest that the incorrect knowledge and inappropriate attitudes of some pharmacists could contribute to a failure to dispense valid prescriptions for opioid analgesics to patients in pain.

delta 9-Tetrahydrocannabinol and therapeutic research legislation for cancer patients.

The Controlled Substances Board evaluated the implementation of the National Cancer Institute (NCI) program in Wisconsin that distributes delta 9-tetrahydrocannabinol (delta 9-THC) to cancer chemotherapy patients with nausea and vomiting refractory to conventional antiemetic drugs. The board concluded that the distribution mechanism for delta 9-THC is appropriate and adequate in Wisconsin. The drug does relieve nausea and vomiting in some cancer chemotherapy patients, but adverse side effects are prevalent. Important questions about its safety and effectiveness remain and should be resolved through scientific research and within the existing framework for testing investigational drugs that are controlled substances. "Marijuana therapeutic research" legislation, similar to that passed in 32 states, was introduced in Wisconsin after implementation and evaluation of the NCI program, but failed to recognize the existing legal framework for approving new drugs and threatened to disrupt the NCI program. With assistance from the American Cancer Society, the State Medical Society, and volunteers and professionals in cancer research, the legislation was adapted to the existing legal and administrative framework.

Wisconsin physicians' knowledge and attitudes about opioid analgesic regulations.

This pilot study was designed to evaluate physician knowledge of the controlled substance regulations that govern the prescribing of opioids and whether concerns about regulatory scrutiny affect reported prescribing practices. Two hundred Wisconsin physicians were surveyed, and 90 (45%) of the questionnaires were evaluable. Approximately 50% of the responses to questions about controlled substance regulations were incorrect. Concern about regulatory scrutiny ranked low compared to concerns about addiction and other opioid side effects. However, 54% of the respondents indicated that, due to concern of regulatory scrutiny, they will do one of the following: reduce drug dose or quantity, reduce the number of refills, or choose a drug in a lower schedule. These results indicate that many physicians have poor knowledge of controlled substances regulations and that the perceived risk of regulatory scrutiny can alter physician prescribing practice. Implications for patient care, policy and further research are discussed.

Medical use, misuse, and diversion of opioids in India.

In less-developed countries, opioids such as morphine are often not available for pain relief because of excessive regulations imposed to prevent their misuse and diversion. We describe the effect that these draconian measures have had on the availability of drugs for medical use in Kerala, India, and present results of a study, which we did to ascertain whether or not the misuse and diversion of opioids is as prevalent as the government reaction would suggest. We followed 1723 patients in Calicut, India, who were being treated for pain with oral morphine on an outpatient home-care basis. Over 2 years, we did not identify any instances of misuse or diversion. These results suggest that, in the context of India as a less-developed country, oral morphine can be dispensed safely to patients for use at home. We recommend that palliative care programmes talk to concerned governmental authorities, to make them aware of the medical need for opioids, and communicate with local news media to increase awareness of palliative care and the use of these analgesics. Our project has overcome regulatory barriers that had interrupted availability of morphine and its use in pain relief in India.