Pharmacy News – Tramadol Transitioning to Schedule IV

As many of you may already be aware, Tramadol is being converted into a Schedule IV controlled substance in the State of Florida. This action coincides with the DEA announcement that, effective August 18, 2014, Tramadol will be placed into Schedule 4 of the federal Controlled Substances Act. Several states, including Arkansas, Georgia, Kentucky, Illinois, Mississippi, New York, North Dakota, Oklahoma, Tennessee, West Virginia, Wyoming and the U.S. military had already classified Tramadol as a schedule IV controlled substance under state law.

Known as the brand name Ultram, tramadol has been used for the treatment of moderate to moderately severe pain in the United States for almost twenty years now. A centrally acting opioid analgesic, tramadol has always been a non-controlled legend prescription drug in the State of Florida. Studies have shown that tramadol is approximately equally potent when compared to codeine.

Recently the abuse of tramadol has been on the rise nationwide and has drawn substantial media attention. Recent studies have also shown that long-term usage of high doses of tramadol are associated with physical and psychological dependence. Withdrawal syndrome from tramadol use can be very severe and the possibility of convulsions exists. Other symptoms include anxiety, tremors, headaches, depression, severe mood swings, sweating and aggressiveness. As pharmacists, it is important to recognize these potential withdrawal symptoms if our patients are being taken off of tramadol or receiving lowered doses. Tramadol withdrawal can be dangerous and severe.

The new rule regarding tramadol in Florida was published in the federal register on July 2, 2014 and has an effective date of August 18, 2014. Many pharmacists have been asking how this transition should be handled. Although not a lawyer or providing legal counsel, Michael Jackson, BPharm (the Executive VP of the Florida Pharmacy Association) has provided the following recommendations:

– After August 18, 2014 any prescriptions filled or refilled for Tramadol should be in compliance with the federal (and state) controlled substance laws including but not limited to the 6 month or 5 refill restrictions.

– Pharmacists may want to review the prescribing practitioner to make sure that they have a DEA license and are authorized to prescribe controlled substances.

– Pharmacists should take a few moments to consult with the patient’s prescribing practitioner for those prescriptions written or on file that are outside of the recordkeeping and prescribing rules and regulations for controlled substances with a goal towards continuity of care.

– New written prescriptions will likely need to be on Florida approved tamper resistant prescription blanks.

– Pharmacies will need to add to their controlled substance inventory list Tramadol products and also consider plans to include reporting to e-Forcse sometime in the near future.

Although we here at HCC are not lawyers nor qualified to present legal counsel, we are here to help with any questions that you may have regarding this tramadol scheduling transition. Contact us online or call us at 800-642-1652 today if you have questions or require assistance. As always Healthcare Consultants Pharmacy Staffing is in the business of helping pharmacies and pharmacists!

Bob Miller


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