Methadone-Associated Mortality:
Report of a National Assessment

Part 5. Recommendations

Available databases and other evidence support many valid and important observations. However, participants in the National Assessment also recognized that certain information deficits will require further consideration as efforts to assess and address methadone-associated mortality move forward.

Uniform Case Definitions Should Be Established

Comparisons of data from various epidemiologic databases or studies of methadone-associated mortality are difficult, because they often do not employ common terminology or definitions (Kung, et al., 2001). It would be helpful to develop uniform medical examiner/coroner case definitions and reporting methods, as well as a data-collection system sufficiently comprehensive and flexible to handle new problems as they arise.

Scientifically concise and universally accepted case definitions can address the critical distinction between deaths caused by methadone and deaths in which methadone is a contributing factor or merely present.

Professional organizations need to agree on a uniform nomenclature that clearly distinguishes between the expected consequences of physiologic dependence and drug tolerance (which occur with many commonly used opioid medications) and the phenomenon of addiction (which is a chronic, relapsing, neurobiological disorder with behavioral manifestations).

Development of a central repository for opioid-related medical examiner/coroner cases - that is, a National Opioid Death Registry - would facilitate the necessary data compilations and analyses. National Assessment participants concluded that Federal support and involvement would be needed to ensure that comprehensive toxicologic analyses are conducted in all local jurisdictions and reported to such a national registry.

Standards for Toxicologic Testing Are Needed

Standards should be developed to guide toxicologic testing in cases of suspected drug-induced deaths (Milroy and Forrest, 2000; Merrill, 1996; Prouty and Anderson, 1990). National Assessment participants suggested that the Food and Drug Administration might provide reference standards for such toxicologic tests, with relevant professional organizations providing input and assistance. Once standard case definitions are determined, investigative techniques for medical examiners and coroners should be enhanced and standardized.

More Useful Data Are Needed

Overall, more flexibility is needed in the design of data sets and the performance of data analyses, as are better methods of integrating data from different collection systems. Procedures for accessing new and existing data also should be simplified.

Better information is needed to describe how methadone-associated deaths occur. For example, data could inform whether the drug's potential for lethality may be the result of a slow onset of action, leading to repeated dosing - and, ultimately, overdose - as an individual attempts to achieve the desired drug effect. Today, such a conclusion requires additional information.

More information is needed about the particular formulations of methadone - tablets, diskettes, liquids, or injectables - involved in specific cases of mortality (natural, accidental, suicide, homicide, or undetermined).

Accurate information is needed to determine the sources of methadone associated with fatalities (e.g., thefts, robberies or diversion from medical practices, pharmacies, or OTP clinics). For example, current data indicate that most methadone-associated deaths, where dosage form information is available, involve 5 and 10 mg tablets. However, it is not clear whether those tablets are obtained through legal prescriptions, prescription forgeries, other diversion tactics, or pharmacy thefts or robberies. Future reviews will benefit from improvements to DEA's Drug Theft System over the past year. These changes will permit the extraction and review of data for specific drugs in a more reliable manner. While more timely information will be available, some limitations will remain, since the accuracy of the system is totally dependent on pharmacies and other registrants submitting acceptable reports. In addition, unlike other DEA systems, the Drug Theft System is not completely automated and relies instead on the manual inputting of data.

More information is needed about the population being legitimately prescribed methadone - their health history, concomitant use of other medications, and current or past involvement with alcohol or other drugs. This information would be useful in assessing factors that may be contributing to mortality and why so many fatalities involve individuals using multiple drugs.

It would be helpful to know what information individuals are receiving from their physicians when methadone is prescribed, and whether patients and prescribers fully understand the potential dangers of methadone misuse and abuse.

It also would be useful to compare data from IMS Health, ARCOS, or State prescription monitoring programs (PMPs) with medical examiner data to estimate how much methadone is being prescribed in regions that report increased cases of methadone-associated deaths. The group endorsed the expansion of PMPs, including creation of a uniform system for reporting and compiling data, leading to a national database. However, participants also recognized that PMPs have limitations and need to be improved, and that further assessment of possible adverse effects on patient confidentiality and access to care is needed (Droz, meeting presentation, 2003).

Better information is needed about the nature of education and prevention messages currently being communicated to and by the public, patients, practitioners, and the media. Given inaccurate or incomplete information, patients may be deterred from seeking treatment using methadone or other opioid drugs for legitimate medical problems, including addiction. Anecdotal information contributed by meeting participants suggests an urgent need to clarify popular misperceptions and to correct misinformation at all levels.

In identifying data needs, participants concluded that it would be helpful to know of any specific national and local concerns. Whatever research occurs should be interdisciplinary, involving stakeholders from various fields. It would be helpful if the Federal government developed a special work group to focus on this issue.

Health Professionals Need Better Training in Addressing Pain and Addiction

Today, pain and addiction are recognized as pervasive medical disorders for which health professionals have an ethical obligation to provide the best available treatment. All FDA-approved opioid medications, including methadone, are powerful and useful drugs in this treatment. On the other hand, inappropriate prescribing, misuse, and abuse of prescription opioids (including methadone) are serious public health problems attended by substantial morbidity and mortality. The medical community and government agencies are responsible both for ensuring that such medications continue to be available for therapeutic use and for preventing their misuse or abuse.

Thus, physicians and other health professionals must become well-grounded in their knowledge of how to treat both pain and addiction. Accordingly, the diagnosis and treatment of addiction, and appropriate pharmacotherapies for pain and addiction, should be part of core educational curricula for all health care professionals. In particular, physicians need to understand methadone's pharmacology and appropriate use, as well as specific indications and cautions to consider when deciding whether to use this medication in the treatment of pain or addiction. While this recommendation is relevant to the educational needs of the medical community as a whole, it has particular resonance for staff of OTPs and physicians who provide pain treatment.

Public Misperceptions About Methadone Must Be Addressed

There is an immediate need for professional organizations and regulatory agencies to present scientific evidence and credible data to counter misinformation about methadone and "methadone clinics" (OTPs) presented in the mass media. The public needs to know that methadone-associated mortality is being addressed, and that when methadone is prescribed, dispensed, and used appropriately, related mortality is virtually eliminated. To this end, National Assessment participants agreed that professional associations, provider organizations, and advocacy groups need to be engaged in these educational activities.

Participants also agreed that a special evidence-based "White Paper" on methadone should be developed to communicate vital information to policymakers, health professionals, and the public. Such a White Paper would incorporate information from the meeting deliberations and Background Briefing Report prepared for the National Assessment, in addition to other information that may be required to address a range of issues.

The contents of the White Paper could be made available in relevant form to various stakeholder groups, including: addiction treatment providers (physicians, nurses, counselors) and administrators, pain management specialists, psychiatrists, pharmacists, and others. Patient advocacy groups also could play a significant role in disseminating this vital information.

National Assessment participants viewed the White Paper as an organizing tool and as a way to initiate a process that could become more far-reaching in its objectives.

Public Policies Must Respond to Multiple Needs

More than 50 years of clinical experience have shown that methadone is a fundamentally safe and effective medication. Accordingly, neither policy nor regulatory concerns should impede patients' access to medically indicated use of methadone and other medications vital to the treatment of pain and addiction.

Any comprehensive framework affecting health care policy and medical practice regarding opioid medications should address the needs of law enforcement and regulatory agencies, professional education, pain management, and addiction treatment providers. For example, National Assessment participants agreed that broad regulatory actions directed toward all OTPs, such as State-imposed restrictions on prescribing methadone, are unlikely to be effective. The exception would be actions focusing on particular programs or geographic areas where problems are identified. In the absence of such specific problems, generalized actions against OTPs would have no effect on the overall mortality problem at best and, at worst, could have damaging effects on the availability of a vital treatment modality.