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Senate of Pennsylvania
Session of 2017 - 2018 Regular Session


Posted: January 17, 2017 11:29 AM
From: Senator John H. Eichelberger, Jr.
To: All Senate members
Subject: Legislation on Methadone Safety (“Karl’s Law”)
I plan to re-introduce legislation which addresses issues arising from the increased use and diversion of the prescription drug methadone. Currently, state guidelines in Pennsylvania with regard to methadone clinics are only found in regulation (28 Pa.Code 715.1, et. seq.), rather than in statute, as the General Assembly has yet to formally address this issue.

The bill was Senate Bill 532 in the last session, and was co-sponsored by: Greenleaf, Scavello, Brewster, White, Hutchinson, Ward, Alloway, Wozniak, Rafferty and Tartaglione.

The use of methadone as a treatment for both opioid drug addiction and pain management has expanded dramatically. Prescriptions for methadone increased nearly 700 percent over the last decade alone. It should come as no surprise that during this same timeframe of increased prescription and increased diversion, the number of poisoning deaths involving methadone increased 468 percent; and the rate of methadone deaths in younger individuals (age 15 to 24) increased 11-fold, according to the CDC National Center for Health Statistics. Corresponding to this increase in the use of methadone, the National Drug Intelligence Center in the U.S. Department of Justice reported a 109% increase (from 2003 through 2007) in the unlawful diversion of the drug.

Methadone is a drug with its own unique properties. According to the FDA, the short duration of analgesic effect with methadone combined with its significantly longer half-life, increase the risk for methadone toxicity. It is potent and long-acting. Unlike other drugs, therapeutic and lethal concentrations overlap with methadone, particularly when someone is just starting to use the drug, giving uneducated, inexperienced users ample time to make deadly mistakes. A dose of the drug can begin to work slowly in the body and last from 12 hours to several days or more. As noted by the Substance Abuse and Mental Health Services Administration (SAMHSA), one pill or one dose can kill a non or low opiate tolerant person. Even a day or two after the drug is taken, it has lead to deadly consequences for those who mix alcohol or other drugs. Deaths have been reported among children and adults who have accidentally taken methadone, and fatal intoxications have also occurred during the first weeks of treatment or adjustment of the methadone dose.

One tragic example of the serious dangers of diverted methadone occurred in October of 2006 when a young man, Karl Hottenstein, sought treatment for an addiction to painkillers prescribed after an auto accident. He was turned down by a hospital and a standard drug treatment provider, and thereafter died from a liquid dose of methadone diverted from a clinic.

An example of the highway dangers of methadone treatment tragically occurred in my district in 2004. In that year, shortly after an individual left a methadone clinic, she swerved into oncoming traffic causing a horrific accident. She was killed, and the driver of the other vehicle was left with severe and permanent brain damage. According to court records and a press release released by attorneys representing the driver's family, methadone combined with other prescribed antidepressants and sleeping pills, caused her erratic driving. At one previous visit, the clinic recorded in her chart that she was “falling asleep in line waiting for her methadone,” and during another visit “could not even sign her name." Whereas common medical procedures require a chaperone whenever any mild form of sedative is used, it is common practice for methadone patients to be allowed to take their dosage and leave without a driver.
The legislation would amend the “Pennsylvania Drug and Alcohol Abuse Control Act” to require methadone clinic protocols to increase both patient and highway safety. Specifically, it would include the following:
  1. Require all methadone clinics to be open or have coverage 7 days per week, 365 days per year to limit take-home dosages which can be diverted (currently, clinics only stay open 7 days on a voluntary basis).
  2. Require that Narcan (an antidote used to counter the effects of opioid overdose), be offered to patients starting methadone treatment.
  3. Expand testing for substances which, in combination with methadone, increase the incidence of impaired driving
  4. Require testing for Benzodiazepines. Require a patient who is using Benzodiazepines to obtain a signed waiver from a psychiatrist before providing methadone. (Benzodiazepines possess sedative, hypnotic, muscle relaxant and amnesic actions, and are frequently used by methadone users in combination with methadone to get “high.” The combination also increases the risk of driving under the influence.)
  5. Reduce permissions to take methadone home during the first six months of treatment (current regulations allow at 3 months).
  6. Require criminal investigation and reporting in all methadone-related deaths. According to SAMHSA: “Without reporting by [providers] of overdose events and deaths of patients, some key questions about methadone deaths will remain unanswered.”
  7. Require a methadone clinic or other provider who prescribes methadone to immediately revoke any take-home permissions upon notice of arrest or conviction of a patient for driving under the influence.
  8. Develop protocols for determining when methadone is no longer an effective treatment for an individual enrolled in a methadone program.

Introduced as SB301