TIANEPTINE SODIUM: ADD AS SCHEDULE 2 DRUG
Senate Bill 801 as reported from House committee
Sponsor: Sen. Rick Jones
House Committee: Law and Justice
Senate Committee: Judiciary
Complete to 3-15-18
SUMMARY:
Senate Bill 801 would amend Article 7 (Controlled Substances) of the Public Health Code to designate tianeptine sodium as a Schedule 2 controlled substance. The bill would take effect 90 days after enactment.
MCL 333.7214
BACKGROUND INFORMATION AND BRIEF DISCUSSION OF THE ISSUES:
Tianeptine sodium is a substance similar to tricyclic antidepressants and is used in the treatment of major depressive disorders. It is available for sale in the United States on the internet as Stablon and Coaxil, among other names. As it is not currently regulated by the federal Food and Drug Administration (FDA), a prescription is not needed and it is not illegal to buy or use. Therefore, many self-treat with dosages found on online blogs and limited medical literature. The substance is widely available in Europe and countries around the world, though some countries have already made it a listed substance requiring a prescription.
Arguments in Support of the Bill
Though tianeptine sodium appears to be an effective treatment for some sufferers of anxiety, depression, and mood swings when taken orally and in small doses, it is not currently approved or regulated by the FDA for use in the U.S. However, it is not illegal to purchase or to use at this time. Unfortunately, since it binds to opioid receptors in the brain, some have discovered that at high doses, tianeptine sodium can trigger similar, albeit short-lived, opiate-like euphoria and satisfy opiate or cocaine cravings. Because the substance does not show up on drug screens, many have found that employment or parole drug tests can be passed even with recent use. Recently, reports of the negative effects of tianeptine sodium use at higher amounts and reports of some people injecting the drug intravenously have begun to surface. According to the Michigan State Police, the city of Midland is in the grip of this drug, with reports of violent, painful withdrawals. No deaths caused by ingestion or IV use of tianeptine sodium have been confirmed, but since there are no definitive lab tests to detect the substance in the body at autopsy, there is no way to rule out its involvement. In an attempt to protect the public and deter its use, it has been suggested that the substance be designated as a Schedule 2 drug. As a Schedule 2 drug, it could be used by medical researchers and, if approved by the FDA in the future for medical uses, Michigan health care practitioners could prescribe it for their patients. Until such time, the bill would make it illegal to possess, use, sell, manufacture, or deliver tianeptine sodium within the state.
Arguments in Opposition to the Bill
Some people say that tianeptine sodium is more effective and safer at low doses to treat their depression and anxiety than many currently prescribed antidepressants, antianxiety medicines, and SSRIs such as Prozac and Xanax. Further, as it is not toxic to the liver, tianeptine sodium may be an option for alcoholics, which in turn could aid in their recovery. Doctors cannot currently prescribe tianeptine sodium, but information on dosage is available online. Though some report violent withdrawal symptoms, a brief search of the medical literature available online does not appear to support that contention (at least not at lower, therapeutic doses). To take away an option for relief of debilitating depression or anxiety because some are abusing tianeptine sodium could be devastating for those who are carefully self-dosing. Further, it is not clear why the bill would not apply to all forms of tianeptine, such as tianeptine free acid, which is more dangerous when not used properly, but would only restrict use of the more helpful form.
Drug Schedules
Section 7204 of the Public Health Code requires a substance to be scheduled similarly to how it is scheduled under federal law. However, as the Code authorizes the “administrator,” defined as the Michigan Board of Pharmacy, to add, delete, or reschedule drugs and substances listed as scheduled substances, a substance may be listed, rescheduled, or deleted differently than under federal law. Designation as a Schedule 1 to 5 controlled substance is generally based on whether the substance has a currently accepted medical use in treatment in the U.S. and also on the substance’s relative potential for abuse and likelihood of causing dependence. Under the Code, substances are placed on the list of Michigan controlled substances as follows:
Schedule 1
Substances in Schedule 1 have a high potential for abuse, have no accepted medical use in treatment in the U.S., or lack accepted safety for use in treatment under medical supervision. Heroin, LSD, marijuana, and “ecstasy” are examples of Schedule 1 drugs.
Schedule 2
Schedule 2 substances have a high potential for abuse, have currently accepted medical use in treatment in the U.S. (or accepted medical use with severe restrictions), and may lead to severe psychic or physical dependence. Examples include morphine, cocaine, fentanyl, and drugs such as OxyContin®, Demerol®, Adderall®, and Ritalin®.
Schedule 3
A substance is placed as a Schedule 3 drug if it has a potential for abuse that is less than substances listed as a Schedule 1 or 2 substance, if it has currently accepted medical use in treatment in the U.S., and if abuse may lead to moderate or low physical dependence or high psychological dependence. Schedule 3 substances include certain products containing hydrocodone (e.g., Vicodin®) or codeine (e.g., Tylenol® with codeine) and products used to treat opioid addictions.
Schedule 4
These substances have a low potential for abuse relative to substances in Schedule 3, they have a currently accepted medical use in treatment in the U.S., and their abuse may lead to limited physical dependence or psychological dependence relative to substances in Schedule 3. Darvocet® is a Schedule 4 controlled substance.
Schedule 5
Schedule 5 controlled substances generally have a low potential for abuse relative to the other schedules and include substances containing lower amounts of codeine and other narcotics than substances listed on other schedules or higher amounts of ephedrine than over-the-counter allergy and cold medications.
HOUSE COMMITTEE ACTION:
The House Committee on Law and Justice reported the Senate-passed version of the bill without amendment.
FISCAL IMPACT:
Senate Bill 801 would have an indeterminate fiscal impact on the state and on local units of government. Information is not available on the number of persons that might be convicted under provisions of the bill. New felony convictions would result in increased costs related to state prisons and state probation/parole supervision. In fiscal year 2017, the average cost of prison incarceration in a state facility was roughly $37,000 per prisoner per year, a figure that includes various fixed administrative and operational costs. State costs for parole and felony probation supervision averaged about $3,600 per supervised offender in the same year. New misdemeanor convictions would increase costs related to county jails and/or local misdemeanor probation supervision. The costs of local incarceration in a county jail and local misdemeanor probation supervision vary by jurisdiction. The fiscal impact on local court systems would depend on how provisions of the bill affected caseloads and related administrative costs. Any increase in penal fine revenues would increase funding for local libraries, which are the constitutionally designated recipients of those revenues.
POSITIONS:
A representative of the Michigan Department of State Police testified in support of the bill. (2-27-18)
Legislative Analyst: Susan Stutzky
Fiscal Analyst: Robin Risko
■ This analysis was prepared by nonpartisan House Fiscal Agency staff for use by House members in their deliberations, and does not constitute an official statement of legislative intent.