On April 7, 2011, the much abused medications Ultram (tramadol) and Soma (carisoprodol) will become Class Four (C-IV) controlled substances in a revision to Tennessee state law 940-06-01-.04. Those readers (and you know who you are) who want to skip the details should scroll to the “What this means for patients/prescribers” section at the end of the column.
Tramadol is a non-opioid compound that has action affecting the opioid receptors in the body as well as the uptake of serotonin and norepinephrine. According to the Drug Enforcement Agency’s (DEA) drug diversion website, this medication is abused primarily “by narcotics addicts, chronic pain patients and health care professionals.” Your Intrepid Pharmacist is still digesting the last three words of that quote. A study on the effects of making tramamdol a controlled substance appeared in the Annals of Pharmacotherapy in June 2010. The study compared Poison Control reports over seven years of tramadol exposure between the states of Ohio and West Virginia, where the drug is not scheduled as a controlled substance, and the states of Arkansas and Kentucky where it had been moved to controlled substance status. The study found a decrease in tramadol exposures in the states where the drug was now controlled (4% in Kentucky and a whopping 31% in Arkansas, while the comparator states saw a continued annual increase of 14% in the number of tramadol related poison control cases.
According to a lengthy Tennessee government document examining the issue (starting on page 33 for those who want to read along), major branches of health care (including the Board of Medical Examiners and Tennessee Pharmacists Association) and law enforcement supports the new law. The detractors consisted of one veterinary prescriber and two spokesmen for the drug manufacturers. The most laughable part for your Intrepid Pharmacist comes on page 38 where Edgar Adams, a consultant to the tramadol manufacturer, states in section 11b that tramadol was scheduled in Arkansas and Kentucky in spite of low evidence of abuse. Apparently he did not read the aforementioned comparative study on poison control reports.
The muscle relaxant Soma (carisoprodol), on the other hand, is an older drug and has a longer history of abuse. The drug is already a controlled substance in Alabama, Arizona, Arkansas, Florida, Georgia, Hawaii, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, Nevada, New Mexico, Oklahoma, Oregon, Texas, and West Virginia. Washington state joins this list as of February 2011 and Tennessee joins it in April. The scheduling of this drug, which is under consideration at the national level, should come as no surprise to anyone since its active metabolite meprobamate is already a controlled substance.
What this means for patients/prescribers: Both Ultram (tramadol) and Soma (carisoprodol) will now be class four controlled substances. Physicians in Tennessee will only be able to write for a maximum of six total fills of the drug (2 if it’s done in 90 day supplies instead of the usual 30 days) as opposed to an entire year’s worth when a drug is not controlled. The prescription will be good for six months from the date of writing (not the date you first fill it!) and is limited to a one time transfer between two pharmacies. Prescriptions for both drugs also will now be reported to the state’s Controlled Substance Monitoring Database, to which all prescribers and pharmacists are legally required to have access, as part of patient’s drug utilization review.