In this, the second part of our series on demystifying sedation dentistry record keeping, we discuss best practices and federal guidelines for the storing and dispensing of controlled substances from your dental practice.

By Genni Burkhart Print & Go Guidance!

The addition of sedation dentistry to your dental practice offers a wide variety of benefits to both the patient and clinician. With that, there’s also the additional responsibility of following DEA regulations for controlled substances. If you’re new to sedation dentistry, thinking of becoming certified in sedation, or your practice could use a clinical record keeping tune-up, the guidance offered here highlights the key elements as set by the Drug Enforcement Agency (DEA). For complete guidance and additional resources visit the U.S. Department of Justice website.

In the previous issue of the Incisor, we discussed the key elements of DEA compliance in regard to record-keeping of controlled substances for sedation dentistry. In this follow-up article, we’ll review best practices for the storing and dispensing of controlled substances in sedation dentistry, and the rules and regulations of the DEA.

Records for the dispensing of controlled substances in your dental practice should include:

  • Name, address, and DEA number of each doctor.

  • The date and time inventory is taken.

  • Name and signature of trusted staff person taking the inventory.

  • TIP: DOCS MEMBERS can use their DOCS DEA compliant drug logbook suggested for use by Dispensers of Schedule 2, 2N, 3, 3N, and 4 controlled substances. Some states require your logbook in a binder so check on your state regulations or consult DOCS Regulatory Counsel.

  • Pull meds from the container originally started before opening a new container.

  • Once a bottle is open, each tablet needs to be recorded under the DEA number.

  • Whoever is trained and authorized to remove the drug from the double-locked drug cabinet needs to have their name listed as authorized to get into the locked (double) drug cabinet in the drug logbook/binder.

  • Pick one day of the month, preferably the end of the month, to reconcile. This helps to find mistakes and correct them faster, making for more accurate records.

  • Dental offices that are extremely busy and have multiple doctors will need more time to account for all medications to avoid the risk of potential misuse and abuse.

 

It’s required that controlled substance drug logs are kept onsite for two years. These sedation records must include:

  • Categories on stocking page (in any order): date medication received, lot number, expiration, and starting amount.

  • If expired, draw a line through the drug entry on the drug log and initial and put the expired drug in (locked) “expired” cabinet.

  • DOCS Members can use inventory and dispensing sheets provided.

  • Each controlled substance needs to be tallied and accounted for at the end of every month.

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What are the Guidelines for Storing Controlled Substances?

DEA-controlled substances must be kept in a double-locked cabinet that's also anchored to the wall. When a drug is removed that drug must remain in the possession of trusted personnel, and the cabinet keys should be kept in a secret location known ONLY to designated staff (keeping the number of designated staff as small as feasible). Keep all logbooks and destruction forms locked as well.

For a complete list of guidelines on storing controlled substances in your dental practice visit the DEA PART 1301 — REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES.

Handling of Expired Drugs Via the Secure and Responsible Drug Disposal Act of 2010

Expired controlled substances must be kept in a separate double-locked cabinet from unexpired drugs. Steps in the disposal of these expired substances include:

  • Controlled substances can be legally destroyed by a Registrant authorized to collect controlled substances and authorized drug collection activities.

  • To become a Registrant you can apply via DEA Form 41.

  • Complete Form 41 and return in triple.

  • The DEA will contact you on how to destroy and return drugs along with a copy of form 41.

  • Registrants authorized to collect and authorized collection activities are typically pharmacies, law enforcement, and reverse distributors.

  • The use of reverse distribution (an outside company) to destroy medications is allowed. There is a fee (within the DEA restraints), and the company must be registered with the DEA. Usually, these companies charge by weight.

Benefits of Dispensing Medications from Your Office

There are benefits to dispensing medications directly from your dental office. Some of those benefits include maintaining control of dosage (before/after appointments), prevention of cancellations, decreasing “no show” rates, and allowing additional convenience to the patient. However, in order to dispense from the office, you’ll need:

  • Medication containers for dispensing to patients.

  • Containers MUST be labeled properly, DOCS Members can download a template from docseducation.com.

  • Check with your state, or as a DOCS Member consult DOCS Regulatory Counsel, for additional requirements for labeling controlled substances.

  • Check with your state, or as a DOCS Member consult DOCS Regulatory Counsel, for additional state regulations concerning dispensing controlled substances, such as provider registration with and mandatory searches on databases that screen for substance abusers.

While detailed and thorough record-keeping in sedation dentistry is a sound clinical practice, it’s also essential for patient safety and provides additional protection for the clinician against disciplinary actions by dental boards. Through proper training, organization, and adherence to federal and state guidelines for controlled substances, sedation dentistry record-keeping is easily demystified.

 

Author: With over 10 years as a published journalist, editor, and writer Genni Burkhart’s career has spanned politics, healthcare, law, business finance, and news. She resides on the western shores of the Puget Sound where she works as the Editor in Chief at DOCS Education out of Seattle, WA.

The information contained in this, or any case study post in Incisor, should never be considered a proper replacement for necessary training and/or education regarding adult oral conscious sedation. Regulations regarding sedation vary by state. This is an educational and informational piece. DOCS Education accepts no liability whatsoever for any damages resulting from any direct or indirect recipient's use of or failure to use any of the information contained herein. DOCS Education would be happy to answer any questions or concerns mailed to us at 3250 Airport Way S, Suite 701 | Seattle, WA 98134. Please print a copy of this posting and include it with your question or request.
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