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Policy Statement
Number 9
August 2002
There are many misperceptions and misunderstanding about the federal regulations and particularly when it comes to issues regarding raising the dose over 100 mgs. Prior to the HIV epidemic in order to raise a patient’s dose it was required for the physician to contact the Food and Drug Administration (FDA) for permission. In the early 1990s this policy was changed and the National Institute on Drug Abuse (NIDA) and the Center for Substance Abuse Treatment (CSAT) issued statements indicating that there should not be a limit on methadone done (NIDA 3/16/99).Permission is no longer required, however many physicians or program staff still believe permission is necessary.
Research has demonstrated that an adequate dose is necessary for patients to respond to treatment (Maxwell and Shinderman, 1999). In order to ensure that an adequate dose is prescribed the monitoring of programs has even been suggested. Usually between 40-60 mgs will block the abstinence syndrome for most patients and prior to our understanding of how methadone works to normalize brain function achieving relief from the abstinence syndrome made sense. The advances in neuroscience have brought a better understanding of addiction as a brain condition and principles of methadone dose. The goal should be to achieve a normal and functional state and the rationale for this is simple — a greater dose is required to block drug craving (Payte and Khuri 1992). By merely prescribing a dose that only blocks abstinence the patient remains in a state of drug craving and from years of data it is now incontrovertible that once drug craving begins it is almost impossible for the addict to resist. Drug craving is initiated by an imbalance in the brain and methadone doses beginning at 60 mgs seem to stabilize this condition. It should be realized that 80 mgs of methadone is a more typical dose to arrest drug craving. At this dose patients are also protected from overdose should they attempt to use illicit narcotics. With the increase in the strength of heroin NIDA has recommended that higher doses are more effective.
Aberrant Metabolizers
It is estimated that about 10-15% of the methadone patient population are what is know as aberrant metabolizers. These patients metabolize their methadone fast and experience the abstinence syndrome before twenty-four hours. Two strategies can be used to effectively treat these patients: (1) split dosing, or (2) increase their dose until they no longer experience the abstinence. Some patients may need a combination of split dosing as well as an increase.
A program that is interested in the welfare of its patients can easily be evaluated by the dose levels prescribed which should reflect a variety of doses that are individualized for the patient. Programs whose patients are not on doses higher than 100 mgs or perhaps only a few patients are receiving slightly over 100 mgs are obviously underdosing their patients and not providing quality treatment.
Guidelines on Prescribing Over 100 mgs
With the new accreditation system there will be more pressure on physicians to prescribe higher doses for patients. Evaluating the range of doses at a clinic will be one of the measures that accrediting bodies will use to ascertain if program may have an unstated policy to not prescribe over 100 mgs or some other amount. Since the emphasis is on individualized treatment a clinic’s range of doses will be an important indicator about the quality of treatment.
There are no longer impediments in the way for a physician to prescribe an adequate dose and the best practices guidelines encourage that dose be individualized for each patient.
Unfortunately some states have already begun to place barriers in the way from requiring the reporting of doses over some designated amount to blood levels being done. It is interesting that none of these methods have yet to use the best indicator that a clinician has which is to ask the patient. Bureaucrats and some clinicians believe that all patients want a higher dose than they are prescribed. While one can be somewhat forgiving about bureaucrats believing this since they have very little patient contact one wonders why they are involved in making medical decisions. And these are not small decisions as proper dose is necessary before a patient can begin to respond to treatment. Clinicians harboring such beliefs is not only troubling but would be considered malpractice for any other medical procedure. Accreditation is helping to improve the understanding of dose amongst clinicians but these will all take time and in the meantime patients continue to suffer.
Unsupervised Medication for Patients Receiving Over 100 mgs
There is the erroneous belief that patients receiving over 100 mgs cannot have take home medication. This myth most probably persists from the rigid regulation of methadone during the 1970s. CSAT has clearly stated that patients that are aberrant metabolizers should not be punished for it and should be eligible for take home medication, as would any other patient. The new accreditation system is clear that take home medication should not be attached to any specific dose. Under the old regulations it was discovered that a significant number of patients were accepting an inadequate dose in order to have take home privileges. It has been wisely decided that no patient should have to make such a decision and that methadone patients should be treated like any other patients.
References
Maxwell, S and, Marc Shinderman, S. Optimizing Response to Methadone Maintenance Treatment: Higher Dose Methadone Journal of Psychoactive Drugs: Vol-31 #2, April – June 1999
Payte, J.T. and Khuri, E. 1992. Principles of methadone dose determination. In: Parrino, M.W. chair/editor. State Methadone Maintenance Treatment Guidelines. Rockville, Maryland: U.S. Department of Health and Human Services. Center for Substance Abuse Treatment.
Higher Doses of Methadone Found to be Safe and Effective NIDA News Release, March 16, 1999.
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