Italy reforms national policy for cancer pain relief and opioids.

Treatment of pain caused by cancer in Italy has been reported to be inadequate for more than a decade. The problem has been documented in the literature by International Narcotics Control Board (INCB) reports that show Italy's low consumption of morphine, and by INCB statements reflecting concern that pain medications are not adequately available to suffering cancer patients. The reasons for undertreatment include lack of physician education, low public awareness about pain management and overly restrictive regulations that inhibit the prescribing of opioid analgesics. In 1999, a workgroup appointed by the Ministry of Health began to address inadequate cancer pain management. In 2000, the workgroup issued a proposal to reform national policy, including simplification of opioid prescribing requirements. The proposal was adopted by Parliament in January 2001 and was effective from March 6th. Distribution of a new opioids prescription form to selected regions in Italy began in December 2001. The change, when fully implemented, will be an important step toward relieving cancer pain.

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.

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.

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.

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.

Trends in medical use and abuse of opioid analgesics.

CONTEXT: Pain often is inadequately treated due in part to reluctance about using opioid analgesics and fear that they will be abused. Although international and national expert groups have determined that opioid analgesics are essential for the relief of pain, little information has been available about the health consequences of the abuse of these drugs. OBJECTIVE: To evaluate the proportion of drug abuse related to opioid analgesics and the trends in medical use and abuse of 5 opioid analgesics used to treat severe pain: fentanyl, hydromorphone, meperidine, morphine, and oxycodone. DESIGN AND SETTING: Retrospective survey of medical records from 1990 to 1996 stored in the databases of the Drug Abuse Warning Network (source of abuse data) and the Automation of Reports and Consolidated Orders System (source of medical use data). PATIENTS: Nationally representative sample of hospital emergency department admissions resulting from drug abuse. MAIN OUTCOME MEASURES: Medical use in grams and grams per 100,000 population and mentions of drug abuse by number and percentage of the population. RESULTS: From 1990 to 1996, there were increases in medical use of morphine (59%; 2.2 to 3.5 million g), fentanyl (1168%; 3263 to 41,371 g), oxycodone (23%; 1.6 to 2.0 million g), and hydromorphone (19%; 118,455 to 141,325 g), and a decrease in the medical use of meperidine (35%; 5.2 to 3.4 million g). During the same period, the total number of drug abuse mentions per year due to opioid analgesics increased from 32,430 to 34,563 (6.6%), although the proportion of mentions for opioid abuse relative to total drug abuse mentions decreased from 5.1% to 3.8%. Reports of abuse decreased for meperidine (39%; 1335 to 806), oxycodone (29%; 4526 to 3190), fentanyl (59%; 59 to 24), and hydromorphone (15%; 718 to 609), and increased for morphine (3%; 838 to 865). CONCLUSIONS: The trend of increasing medical use of opioid analgesics to treat pain does not appear to contribute to increases in the health consequences of opioid analgesic abuse.

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.

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.

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.

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.