DOSE REGULATIONS LOWERED, DEATH RATES RISE
March 3, 2013/ By Fay Rose
In 1980, Methadone regulations were held to a more stringent set of standards than those of today.
Prior to 2001, initial Methadone dosage was limited to 30 mg per day, with an additional 10 mg allowable in the 4 to 8 hours after initial administration, if needed to suppress withdrawal symptoms. The usual range of maintenance doses in 1980 was between 40 and 100 mg. Doses over 100 mg required that the state authority and the FDA be notified in writing or by telephone within 72 hours of the dose, eliminating the requirement of prior approval.
Also back then, fewer take-home doses were allowed – medication was allowed after daily observation (or at least observation on 6 days a week) in the first 3 months of treatment; then the patient could receive 2-day take-homes for the next 2 years in treatment; finally, conditional on good behavior, 3-day take-homes were authorized. If good behavior was observed for 3 treatment years, a weekly take-home of 6-days was allowed. Restriction or probationary withdrawal of take-home privileges was required if scheduled clinic appointments were missed, or if a urine test was positive for morphine-like drugs or negative for methadone. Take-homes were NOT permitted for patients with a daily dose greater than 100 mg.
The regulations governing Methadone treatment were changed in 2001 by SAMHSA, which is the Federal agency governing opioid treatment programs. In 2001, SAMHSA eased regulations on take- home doses, and although states and even individual clinics can enact more stringent regulations, each methadone clinic must apply for SAMHSA certification, and if SAMHSA thinks that any clinic’s procedures vary too far from Federal Guidelines, it will not endorse certification renewal. Basically, although there is a little leeway – clinics must stay close to federal suggestions if they want to keep their license to prescribe methadone (unless state regulations preclude them from following federal guidelines*). Local regulations may call for slightly more stringent protocols, but local regulations should be basically in-line with federal regulations.
The following are the post-2001 mandatory minimum standards for the allowance of take home doses:
- Days 1-90 – A maximum of 1 scheduled take home dose per week, as well as a take home dose for 1 day if the clinic closes on Sunday.
- Days 90-180 – A maximum of 2 scheduled take home doses per week as wells as a take home dose for the 1 day a week the clinic will close.
- Days 180-270 – A maximum of 3 scheduled take home doses per week + 1 for days the clinic is closed.
- Days 270-365 – Up to 6 take home doses per week.
- After 1 year – A maximum of two weeks take home doses allowed.
- After 2 years – A maximum of one month supply allowed and monthly visits required.
An SMA-168 exception request must be submitted (and approved) whenever a physician wishes to vary from the opioid treatment standards set forth in Federal Regulation 42 CFR 8.12 in the treatment of an individual patient.
The most common reasons for submitting exception requests are to request: (1) A temporary increase in the number of take-home doses permitted for unsupervised use or (2) An exception to the detoxification standards outlined in the regulation. However, a common misperception is that a program must obtain approval from SAMHSA when treating a patient with methadone at doses greater than 100mg. SAMHSA does NOT endorse dose caps. Research has found that clinics that operate with maximum capped doses are operating outside of best practices guidelines. In addition, SAMHSA does not cap take home doses. There is no federal regulation against take home doses in excess of 100 mg per day, thus no SMA-168 exception request is required by SAMHSA in this case.
With the new lowered regulations on take-home doses, the number of methadone-related deaths increased significantly. From 1999 through 2006, methadone poisoning deaths increased 390 percent. The percentage increase in methadone deaths exceeds the percentage increase in “other opioid” (including oxycodone, morphine, hydromorphone, and hydrocodone) deaths during the same period. Most deaths are attributed to the abuse of methadone diverted from hospitals, pharmacies, practitioners, and pain management physicians. Some deaths result from misuse of legitimately prescribed methadone or methadone obtained from narcotic treatment programs, including use in combination with other drugs and/or alcohol.
Various methods are used to divert Methadone. Wholesale-level quantities of methadone are stolen from delivery trucks and reverse distributors, and midlevel quantities are stolen from businesses such as hospitals and pharmacies. Retail-level quantities frequently are obtained through traditional prescription drug diversion methods such as doctor-shopping, prescription fraud and, to a much lesser extent, rogue Internet pharmacies. Methadone can be misused by patients being treated for chronic or cancer pain who obtain the drug using legitimate prescriptions. Following increases in OxyContin (oxycodone) addiction and death rates, many practitioners began using methadone to manage chronic pain and pain associated with cancer. However, patients who are prescribed methadone need to be monitored by a physician well trained in the pharmacodynamic and pharmacokinetic properties of the drug, particularly if the patients have no prior history of opioid use for pain management or have a history of over-using opioids.
A 2004 SAMHSA national assessment of methadone poisoning deaths determined that most deaths involved one of three scenarios:
- The accumulation of methadone to toxic levels during the start of opioid treatment or pain management caused by an overestimation of tolerance and methadone’s long, often variable, half-life.
- The misuse of diverted methadone by individuals with little or no opioid tolerance who may have taken excessive doses in an attempt to achieve euphoric effects.
- The synergistic effects of methadone in combination with other central nervous system depressants (alcohol, benzodiazepines, or other prescription opioids) among individuals with little or no tolerance.
Fay Rose is a freelance writer, editor and creative artist based in Los Angeles. Her articles have appeared in publications, both print and online, including Campus Circle, Blue Pacific News and Entertainment Today. Fay Rose has recently launched her small business, Soul Inspired Designs, featuring original jewelry creations. She also supports charitable causes including Susan G. Komen Race for the Cure, Run For Hope, Kiss For A Cause and Lynne Cohen’s Kickin’ Cancer.
Tags: Fay Rose, Methadone, methadone regulations, methadone take home doses, Methdone Deaths