PRESCRIPTION DRUG ABUSE PREVENTION AND TREATMENT ACT OF 2011

(S. 507)

BILL SUMMARY

PROBLEM: LACK OF EDUCATION

Solution: Provider Education

• Background: Currently, there are no specific education or certification requirements for practitioners to fulfill before prescribing methadone or other opioid pain relievers. Linking education to the existing Drug Enforcement Administration registration system would help ensure that physicians get the education and support they need to safely prescribe these powerful drugs.

• Proposed Change: Require the Department of Health and Human Services (HHS) to establish a mandatory and comprehensive practitioner education program for methadone and other opioids, in collaboration with relevant professional societies. Completion of this education program will be required as part of the Drug Enforcement Administration’s (DEA) current registration process used to authorize practitioners to prescribe, dispense and administer controlled substances.

• Reason for Change: Under the Controlled Substances Act, the DEA must register practitioners who prescribe controlled substances like methadone or other opioid pain relievers. However, there is no federal education requirement for those who prescribe these drugs. For example, methadone stays in the body after its pain relieving effect has worn off – resulting in a greater risk of overdose. It is necessary for practitioners to be properly educated about the complicated nature of methadone and other opioid pain relievers so that they can properly and safely prescribe these powerful drugs.

Solution: Consumer Education

• Background: There is a knowledge gap about the dangers of prescription pain relievers and how to avoid diversion and misuse. Forty percent of teens believe that prescription drugs, even if they are not prescribed by a doctor, are “much safer” to use than illegal drugs. Sixty-four percent of teens (12-17) who have abused pain relievers say they got them from friends or relatives, often without their knowledge.

• Proposed Change: Provide competitive grants to states and community organizations to educate consumers and communities about safe and appropriate use of prescription pain relievers, including methadone.

• Reason for Change: Consumers need to know how to understand the dangers of prescription drug misuse as well as how to safely use controlled substances when prescribed for them. For example, methadone has a long half-life of between 8 - 59 hours, however, the analgesic effect is usually only felt for between 6 - 12 hours. This long half-life coupled with a significantly shorter analgesic effect means that is possible for dangerous levels of methadone to accumulate in the body as consumers take additional methadone seeking pain relief. High levels of methadone can lead to respiratory distress, cardiac arrhythmia and even death.

PROBLEM: LACK OF WIDESPREAD CLINICAL GUIDELINES

Solution: Controlled Substances Clinical Standards Commission

• Background: There is widespread agreement that prescribers need better information and guidelines for safe prescribing of controlled substances including methadone and other opioids, and that health care professionals face significant challenges when trying to balance the need for legitimate pain relief with the need to prevent misuse of opioid pain relievers -- yet widely agreed-upon clinical guidelines are not in use.

• Proposed Change: Create the Controlled Substances Clinical Standards Commission to establish patient education guidelines, appropriate and safe dosing guidelines for all forms of methadone, benchmark guidelines for the reduction of methadone abuse, appropriate conversion factors for transition patients from one opioid to another, guidelines for the initiation of methadone for pain management, and consensus guidelines for the treatment of pain management with prescription opioids. In creating such guidelines, the Clinical Standards Commission would be required to collaborate with outside experts, health care professional societies, patient representatives, and others.

• Reason for Change: As the number of methadone prescriptions has significantly increased in recent years, so has the number of methadone related deaths. A standards commission will compliment the current oversight structure by providing evidence-based information to improve guidance for the safe and effective use of opioid pain relievers as well as methadone for both pain management and opioid addiction treatment.

Solution: National All Schedules Prescription Electronic Reporting Act (NASPER)

• Background: Currently 38 states have enacted legislation requiring prescription drug monitoring programs (PMPs), and many states were able to fund these initiatives in part from grants available through the Harold Rogers Prescription Drug Monitoring Program. A second program created in 2005 through the National All Schedules Prescription Electronic Reporting Act (NASPER), would provide even more assistance, but has only recently been funded with $2 million in each of FY2009 and FY2010.

• Proposed Change: This legislation would appropriate $25 million a year for NASPER to establish interoperable prescription drug monitoring programs within each state.

• Reasons for Change: The Harold Rogers Prescription Drug Monitoring Program allows states to establish their own requirements with regard to controlled substances monitored and information shared between states. NASPER goes a step further in mandating that all state prescription drug monitoring programs submit data for Schedule II, III, and IV drugs and requires interoperability between states to reduce diversion and doctor shopping across state lines.


PROBLEM: NO UNIFORM REPORTING SYSTEM FOR OPIOID-RELATED DEATHS

Solution: National Opioid Death Registry

• Background: There is no comprehensive national database of drug-related deaths in the United States, nor is there a standard form for medical examiners to fill out with regard to opioid-related deaths.

• Proposed Change: Create a National Opioid Death Registry to track all opioid-related deaths and related information. Also, establish a standard form for medical examiners to fill out which would include information for the National Opioid Death Registry.

• Reasons for Change: Since there is no comprehensive database of methadone-related deaths, the number of deaths may actually be underreported. In order to truly reduce the number of methadone-related deaths, quality data must be collected and made available.

MISCELLANEOUS PROVISIONS

• Improving Patient Safety: Opioid treatment programs will be required by law to make acceptable alternative arrangements for the safe distribution of methadone for patients who are not permitted take home doses on days where the clinic is closed.

• Moratorium on 40-mg Methadone Diskettes: For two years, no provider may prescribe and no pharmacy or opioid treatment clinic may distribute 40-mg methadone diskettes unless the prescription or dispensation is consistent with DEA policy.

• Annual Report on Effectiveness: No later than September 30, 2012 the Secretary will report to Congress the effectiveness and evaluate the success of efforts to reduce opioid addiction and methadone-related deaths including the impact of health care provider and patient education.

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