Methadone-Associated Mortality:
Report of a National Assessment

Part 6. Conclusions

From the data examined during this National Assessment, it appears that the recent upsurge in public concern over methadone abuse and fatalities is linked to several factors, some of which may be an appropriate impetus to new health policy.

• First, recent years have seen documented increases in abuse of heroin and all opioid analgesics. When their preferred drugs are not available, some individuals turn to abuse of methadone.
  

• Second, over the same period, methadone (primarily in tablet form) has become more accessible as physicians increasingly have prescribed it for pain relief.
  

• Third, press reports in some States have suggested that methadone has become more available to unauthorized users following the adoption of new Federal regulations that enabled OTPs to relax their policies regarding take-home doses of methadone. However, these allegations are not supported by the data reviewed during the National Assessment. In fact, the perception that OTPs are contributing to the problem of overdose deaths appears to be highly exaggerated. An argument can be made that Federal requirements for dosing during the start-up (induction) phase of methadone maintenance treatment actually may have helped to minimize methadone-associated fatalities. It also should be noted that OTPs provide demonstrably effective treatment for opioid addiction.

Three primary scenarios characterize current reports of methadone-associated mortality:

In the context of legitimate patient care, methadone accumulates to harmful serum levels during the first few days of treatment for addiction or pain (that is, the induction period before methadone steady state is achieved or tolerance develops).

Illicitly obtained methadone is used by some individuals who have diminished or no tolerance to opioids and who may use excessive and/or repetitive doses in an attempt to achieve euphoric effects.

Methadone - either licitly administered or illicitly obtained - is used in combination with other CNS depressant agents (such as benzodiazepines, alcohol, or other opioids).

The data reviewed for this National Assessment show that the greatest incremental growth in methadone distribution in recent years is associated with use of the drug as an analgesic and its distribution through pharmacies. In fact, the rate of increase in distribution of solid methadone formulations (tablets and diskettes), primarily through pharmacies, has surpassed the rate of increase in distribution of the liquid formulations that are the mainstay of dispensing in OTPs (Figure 5).

Figure 5. Number of Units of Methadone Distributed Through Retail and Other Channels, by Dosage Form

Data from IMS Health, Retail and Provider Perspective,
courtesy of Laura A. Governale, PharmD.

Taken together, the data confirm a correlation between increased methadone distribution through pharmacy channels and the rise in methadone-associated mortality. The data, thus, support the hypothesis that the growing use of oral methadone, prescribed and dispensed for the outpatient management of pain, explains the dramatic increases in methadone consumption and the growing availability of the drug for diversion to illicit use. Although the data remain incomplete, National Assessment meeting participants concurred that methadone tablets and/or diskettes distributed through channels other than OTPs most likely are the central factor in methadone-associated mortality.

With the release of this National Assessment Report, it is hoped that action will be initiated at the Federal and State levels, and in the public and private sectors, to implement the recommendations offered here. Additionally, SAMHSA must continue its current vigilance and ongoing efforts to improve the quality, safety, efficacy, and reliability of addiction treatment, as well as enhancing patient satisfaction and community understanding and acceptance of methadone treatment. This will ensure that OTPs continue to make an important contribution to solving the problem of methadone-associated mortality.