Methadone Is Regulated as a Controlled Substance and Subject to Additional Requirements When Used for Addiction Treatment

Methadone is regulated as a controlled substance, under federal and state  laws and regulations, when used for pain management and addiction  treatment. For addiction treatment, however, federal and state laws and  regulations impose additional requirements that are specific to the use of  methadone. When Used for Pain Management, Methadone Is Regulated as a Controlled Substance under Federal and State Laws and Regulations

The use of methadone for pain management is regulated under federal and  state laws and regulations that apply to controlled substances generally  and that do not impose requirements unique to methadone. Increased Availability Combined with Lack of Knowledge and Abuse of Diverted Methadone Have Contributed to Increasing Methadone- Associated Overdose Deaths

Although information on methadone-associated overdose deaths is  limited, available data suggest that methadone’s growing use for pain  management has increased availability of the drug, therefore contributing  to the rise in methadone-associated overdose deaths. State data and research support the idea that  lack of knowledge and abuse of diverted methadone contributed to deaths,  but also suggest that the specific circumstances of these deaths are  variable. Similarly, data from IMS  Health, a private company that tracks prescription drug trends, showed  that from 1998 through 2006 the number of annual prescriptions of  methadone for pain increased by about 700 percent, from about 531,000 in  1998 to about 4.1 million in 2006. Lack of Knowledge about Methadone by Practitioners and Patients Has Also Contributed to Methadone-Associated Overdose Deaths

Lack of knowledge about the unique pharmacological properties of  methadone by both practitioners and patients has also been identified as a  factor contributing to methadone-associated overdose deaths. In addition, data and research from the five states we reviewed show that  methadone is often found in combination with other drugs or alcohol,  suggesting a lack of knowledge about the dangers of combining  methadone with other drugs or that people are abusing methadone. Education, Safety, and Monitoring Efforts to Prevent Methadone- Associated Overdose Deaths Have Been Implemented by Government Agencies and Other Organizations

Education, safety, and monitoring efforts have been implemented to  prevent methadone abuse and methadone-associated overdose deaths— either specifically or as part of broader efforts to prevent prescription drug  abuse and deaths—by various federal agencies, states, and other  organizations. Some  officials and experts we spoke with cautioned that methadone is part of a  larger problem of prescription drug abuse, and that prevention efforts  focused on methadone alone might have the unintended consequence of  shifting similar problems to a different drug—much like what occurred  with methadone following reports of abuse and diversion of OxyContin. In November 2006, FDA approved a revised label for methadone 5 mg and  10 mg tablets that included new safety information regarding using  methadone for pain, such as warnings about life-threatening adverse  events and modified dosage instructions. HHS also reiterated that FDA recently sent letters to the  manufacturers of certain opioid drug products, including methadone,  indicating that these drugs will be required to have a Risk Evaluation and  Mitigation Strategy to ensure that the benefits of the drug continue to  outweigh the risks. Both HHS and the Department of Justice provided  technical comments on a draft of this report, which we incorporated as  appropriate. Appendix I: Scope and Methodology

To examine the regulation of methadone for pain management and  addiction treatment, we reviewed relevant codified federal statutes and  regulations pertaining to the prescribing, administering, or dispensing of  methadone for pain management and addiction treatment. Our review was  limited to relevant provisions of the Controlled Substances Act and  implementing regulations, including Department of Justice, Drug  Enforcement Administration (DEA), and Substance Abuse and Mental  Health Services Administration (SAMHSA) regulations. In addition, we interviewed  pain management, addiction treatment, and forensic science experts. In addition, we interviewed officials in  our five selected states’ medical examiners’ offices about the factors  contributing to the increase in methadone-associated overdose deaths in  their states.
Why GAO Did This Study

Prescription drug abuse is a growing public health problem. In particular, methadone-associated overdose deaths--those in which methadone may have caused or contributed to the death--have risen sharply. Before the late 1990s, methadone was used mainly to treat opioid addiction but has since been increasingly prescribed to manage pain. Taken too often, in too high a dose, or with other drugs or alcohol, methadone can cause serious side effects and death. Methadone-associated overdose deaths can occur under several different scenarios, including improper dosing levels by practitioners, misuse by patients who may combine methadone with other drugs, or abuse--using the drug for nontherapeutic purposes. This report examines the regulation of methadone, factors that have contributed to the increase in methadone-associated overdose deaths, and steps taken to prevent methadone-associated overdose deaths. GAO reviewed documents, laws and regulations, data, and research from relevant state and federal agencies, including the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). GAO also interviewed federal officials, officials in five selected states, officials from professional associations and advocacy groups, and experts in pain management, addiction treatment, and forensic sciences.

What GAO Found

Methadone is regulated as a controlled substance, under federal and state laws and regulations, when used for pain management and addiction treatment. When methadone is used for pain management, it is regulated under federal and state laws and regulations that apply to controlled substances generally and that do not impose requirements unique to methadone. For addiction treatment, however, federal and state laws and regulations impose additional requirements that are specific to the use of methadone in opioid treatment programs (OTP), which treat and rehabilitate people addicted to heroin or other opioids. GAO, however, only reviewed relevant state laws and regulations for five selected states. Although information on methadone-associated overdose deaths is limited, available data suggest that methadone's growing use for pain management has made more of the drug available, thus contributing to the rise in methadone-associated overdose deaths. Methadone prescriptions for pain management grew from about 531,000 in 1998 to about 4.1 million in 2006--nearly eightfold. Methadone has unique pharmacological properties that make it different from other opioids, and as a result, a lack of knowledge about methadone among practitioners and patients has been identified as a factor contributing to these deaths. DEA data suggest that abuse of methadone diverted from its intended purpose has also contributed to the rise in overdose deaths as the number of methadone drug items seized by law enforcement and analyzed in forensic laboratories increased 262 percent, from 2,865 in 2001 to 10,361 in 2007. Nonetheless, data and research from five states GAO reviewed suggest that the specific circumstances of these deaths are variable because of drug combinations and unknown sources of methadone. GAO identified selected efforts to prevent methadone abuse and overdose deaths that focused on education, safety, and monitoring. For example, to educate practitioners about using methadone for pain management and addiction treatment, SAMHSA is establishing a physician clinical support system for methadone. To improve safety, in 2006, the Food and Drug Administration (FDA) approved a revised label for methadone tablets that included new safety information regarding the use of methadone for pain and modified dosage instructions for those beginning pain management treatment with methadone. Additionally, to prevent diversion and abuse of controlled substances such as methadone, DEA reports that as of February 2009, 31 states have established prescription monitoring programs. Some officials and experts cautioned that any prevention efforts focused on methadone alone might unintentionally shift similar problems to a different drug. GAO received comments from the Department of Health and Human Services stating that FDA recently notified manufacturers of certain opioid drug products, such as methadone, that they must take certain steps to ensure that the benefits of these drugs continue to outweigh the risks. The Department of Justice provided GAO with technical comments.