Dentists, There’s A New Drug On The Schedule IV Horizon!

Let's talk drugs! Honestly, it can be hard to keep up with all the innovations in the pharmaceutical industry and frequently it's just easier to rely on either your Dental supply rep or pharmaceutical sales folks to keep you abreast of the "latest and greatest" in your prescribing options.

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But, let's face it…it's NOT in their best interests to always keep you informed of the regulations governing those prescriptions you write, either for your practice use or your patients! And this past week, amid all the holiday hoopla, the U.S. Drug Enforcement Administration (DEA) published the Final Rule updating the classification of tramadol.

Prior to this point, only a few states — including Arkansas, Kentucky, Mississippi and New York — had tramadol placed on the list of scheduled controlled substances. However, effective August 18, 2014, the DEA has now moved this pain-reliever into the Schedule IV category on a federal level. With the exception of your opiates, few states had specific pharmaceuticals named as scheduled substances. In fact, our research shows carisoprodol as one of the only frequently-recurring drugs on state-by-state listings.

The good news is, the DEA understands it can take time for suppliers and medical personnel to get up-to-speed, so to speak, for the requirements imposed on Schedule IV substances. Normally, you would have 30 days to deal with the new sets of restrictions, but they have extended this to a 45-day period — hence, the August. 18th effective date.

Every state has a different set of regulations governing the prescription of controlled-substances, so it would be wise to check out the rules for your specific state. And, if you're not even sure of the applications and pharmacology of tramadol, this would be a good time to take a closer look at this newly-designated Schedule IV drug.

Regardless of whether or not you currently use or plan to prescribe tramadol, know that you must now place all tramadol products into a secured environment (which Dentists should already be doing with ALL drugs in your practice!) and Prescription Monitoring Systems must be updated to include all tramadol orders. Additionally, all manufacturers must print the C-IV designation on every bottle and it will be a crime to distribute containers that fail to carry that labeling. And, per your DEA registration, you must now take and keep inventory control of all tramadol you stock in compliance with 21 C.F.R. §1304.11 (d).


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Bottom line, it's always a good idea to know what you're prescribing and/or using within your office…Schedule IV or otherwise. If you don't currently have or maintain a Drug Log of some sort, now would be a good time to start! And remember, if you have any questions about whether or not these rules may — or may not — apply to you, our Dental Compliance Specialists team is always here to help. Be sure to check out more on the subject of writing prescriptions next week, when we visit an interesting "hypothetical question" and dissect the ethics of some hypoth"ethical" situations!