Methadone Treatment and Protection Act 2009

METHADONE TREATMENT AND PROTECTION ACT

Methadone is a synthetic opioid prescription drug that has been extensively tested and federally approved for use in the U.S. for more than thirty years. While it was first prescribed for pain management, methadone is also widely used as part of opioid addiction treatment. Recent reports show methadone prescriptions and methadone-related deaths are on the rise.

According to the Department of Justice’s National Drug Intelligence Center, the number of prescriptions written by physicians for methadone has increased by 715% from 2001 to 2006. Similarly, according to the Centers for Disease Control and Prevention (CDC), in 2005, there were a total of 4,462 methadone-related deaths, representing an increase of 468% since 1999. By contrast, all poisoning deaths by all drugs increased by 66% over the same time period. The age-specific rates of methadone-related deaths are higher for persons age 35 to 44 and 45 to 54 than for other groups and the rate of methadone deaths in younger individuals (age 15-24) has increased 11-fold from 1999-2005. (NOTE: Prior to 1999, methadone did not have separate classification from other opiate-related deaths. Therefore, the study released by the CDC in 2006 was the first opportunity to examine the trends in methadone exclusively. This report was updated in March 2008 with data from 2005.)

Given the alarming increase in methadone-relate deaths, particularly among our nation’s youth, federal legislation is necessary to improve the tools for federal oversight, provide proper practitioner and patient education, and improve data collection – without compromising patient access to methadone treatment

I. Current Federal Oversight of Methadone

The Food and Drug Administration (FDA) is the federal agency responsible for determining if a drug is safe and effective. Originally, federal oversight of methadone distribution and use was also entirely within the jurisdiction of the FDA. However, in 2001, the federal responsibility for oversight of opioid treatment programs, or more specifically in this case Methadone Maintenance Treatment (MMT), shifted to the Substance and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Treatment. Following that transition, SAMHSA replaced FDA’s original method of monitoring methadone distribution with guidelines developed by CSAT. These guidelines require all entities that choose to administer MMT be certified by an accrediting organization and to use the “best clinical practices” as outlined in the accreditation guidelines.

A third federal agency, the Drug Enforcement Agency (DEA), is responsible for monitoring controlled substances and for enforcing the physician registration requirements necessary to prescribe controlled substances, including methadone. Methadone is a Schedule II controlled substance, which means that providers must fulfill specific requirements, including registering with the DEA, if they are to prescribe methadone. All three agencies – FDA, SAMHSA, and the DEA – play key roles in the regulation of methadone. However, their disparate responsibilities and lack of coordination have lead to a fractured system of federal oversight and poor data tracking on methadone treatment and methadone-related deaths. These problems have inhibited the nation’s ability to effectively target problems with methadone use and address these problems in the most efficient manner possible.

II. Legislation to Address the Problem

The FDA and SAMHSA have already launched initial steps to better inform patients and prescribers about proper methadone dosing and the dangers of the drug by way of guidance letters and black box warnings. Additionally, the FDA recently announced plans to place greater restrictions on the distribution of narcotics like methadone. However, to date, no federal legislation has been proposed to comprehensively address the problems associated with methadone, nor improve data collection on the issue. Given the increasing number of methadone-related deaths, the federal government should consider additional options to help reduce the number of methadone-related deaths nationally.

For more than two years, Senator John D. Rockefeller IV (D-WV) has been working on comprehensive legislation – the Methadone Treatment and Protection Act – to reduce methadone-related deaths while preserving access to this effective and proven treatment option. He plans to introduce this legislation in the coming weeks. The Methadone Treatment and Protection Act will significantly improve consumer and provider information about methadone. The bill will mandate the creation of a consumer education campaign and require additional training for practitioners who prescribe methadone and other opioids. The bill will also improve federal oversight of methadone by creating the Controlled Substances Clinical Standards Commission – with membership comprised of the FDA, SAMHSA, and the NIH. The Controlled Substances Clinical Standards Commission will establish safe dosage levels for methadone and other opioids, determine appropriate conversion factors when transferring a patient from one opioid to another, and create specific guidelines for initiating pain management treatment with methadone.

To curtail the problems of doctor shopping and diversion, this legislation would also fund the National All Schedules Prescription Drug Reporting Act (NASPER). NASPER requires providers to submit prescribing information for all schedule II, III, and IV drugs to state run controlled substance monitoring programs and requires states to share this information with one another. Finally, to improve access to comprehensive data on methadone-related deaths, this legislation mandates completion of a standard Model Opioid Treatment Program Mortality Report and its submission to the newly created National Opioid Death Registry.