DEA Classification Change for Carisoprodol

What is Carisoprodol?
Carisoprodol (brand name Soma) is a skeletal muscle relaxant approved by the FDA for use in painful musculoskeletal conditions on an acute basis.  When the 350mg strength dosage was approved 53 years ago, the medication was classified as a non-controlled, non-scheduled drug.  However, on December 12, 2011 the DEA ruled under the CSA that all Carisoprodol products are to be reclassified as schedule IV, controlled substances as of January 12, 2012 due to the high potential for abuse and addictive qualities.

Carisoprodol’s increase in popularity as a frequently prescribed muscle relaxant has led to a rise in its potential for abuse.  The addictive properties of this medication are due to the body metabolizing it into Meprobamate (a schedule IV, controlled substance).  Carisoprodol was also found to accelerate the affects of other drugs, such as Hydrocodone and Codeine, resulting in greater abuse potential among users. 

What are Controlled Substances and how are they classified by the DEA?
Controlled Substances are categorized into “schedules”.  Schedule I drugs are considered highly addictive with no medicinal purpose, whereas a schedule V drug has a relatively low potential for abuse and is recognized for its accepted medicinal use.  Prior to the DEA ruling, several states had already taken it upon themselves to classify Carisoprodol as a schedule IV, controlled substance at the state level due to its addictive properties.  Consequently, the reclassification of this drug to a controlled substance on the federal level is not surprising. 

How will the reclassification of Carisoprodol impact the workers’ compensation industry? 
As a controlled substance, prescriptions for Carisoprodol will now have restrictions on the length of time the prescription remains valid and on the number of refills allowed during this time frame.  Previously, a prescription was valid for one year from the date it was written with no limitation on the number of refills.  As a controlled substance, prescriptions will be valid for only 6 months from the date they are written with 6 total refills allowed (original & 5 refills).  If only 4 refills are used in 6 months the prescription is no longer valid and the patient would not be allowed to obtain the remaining two refills. This could result in double the number of office visits required for the patient to maintain use of this medication which in turn produces increased costs to insurance carriers.  Only those prescribers with a valid DEA license (authorizing them to write for controlled substances) will be allowed to write prescriptions for Carisoprodol. 

As a result of this change, the industry may see a decrease in the number of prescriptions written for Carisoprodol and an increase in those written for its alternatives such as Tizanidine, Cyclobenzaprine, Metaxalone, Methocarbamol, and Baclofen, which are not controlled substances.  If this occurs, insurance carriers could see an increase in prescription costs depending on which alternative medication is prescribed.  The most commonly prescribed strength of Carisoprodol is 350mg costing approximately $.09/tab.  Tizanidine 4mg costs $1.39/tab and Metaxalone 800mg is $8.09/tab.  If an injured individual is switched to either of these medications, prescription costs could increase significantly.

PMSI will continue to follow any further changes to Carisoprodol’s use and classifications as well as other common drugs in workers’ compensation claims.  As a leader in providing solutions for cost containment, we understand that these changes could greatly impact prescription drug costs in claims.

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