Are You Compliant in the Recording, Storing, Dispensing and Disposal of Controlled Substances?

Print & Go GuidanceBy Genni Burkhart, Incisor Editor

The addition of sedation dentistry to your dental practice offers a wide variety of benefits to both the patient and the clinician. With that, there's also the additional responsibility of following DEA regulations for controlled substances. Suppose you're new to sedation dentistry, thinking of becoming certified in sedation, or your practice could use a clinical recordkeeping tune-up. In that case, the guidance offered here highlights the key elements 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 regarding the recordkeeping of controlled substances for sedation dentistry. In this follow-up article, we'll review best practices for storing and dispensing controlled substances in sedation dentistry and the DEA rules and regulations.

Controlled Substance Recordkeeping

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.
• DOCS Education members can use their DOCS DEA-compliant drug logbook, which is suggested for use by Dispensers of Schedule 2, 2N, 3, 3N, 4, and 5 controlled substances. Logbooks are required to be bound and have pages fixed in an unchangeable order.

Further requirements include:

• Pull meds from the container originally started before opening a new container.
• Once a bottle is opened, 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.

It's required that controlled substance drug logs be kept onsite for two years. These sedation records must include the following:

• The categories on the inventory page (in any order) are the date the medication was received, the lot number, the expiration date, and the starting amount.
• If expired, draw a line through the drug entry on the drug log and initial and put the expired drug in the (locked) “expired” cabinet.
• DOCS members can use the inventory and dispensing sheets provided.
• At the end of each day, controlled substance dispensing pages must be tallied, accounted for, and reconciled with the appropriate inventory page for that substance.
• A complete inventory must be taken at least every two years. It is highly recommended that one be conducted at least once a year, if not every six months, to catch inconsistencies.
• Pick one day of the month, preferably the end of the month, to reconcile. This method helps you find and correct mistakes faster, resulting in 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.

Storage of Controlled Substances

What are the DEA 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, it must remain in the possession of trusted personnel. The cabinet keys should be kept in a secret location known ONLY to designated staff and by keeping the number of designated staff as small as feasible.

All logbooks and destruction forms should also be locked.

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, only an entity registered as a reverse distributor can destroy the substances. This authorized reverse distributor will then provide Form 41 to the practitioner as a receipt of the damaged (expired) substances. "Your average practitioner has to use a reverse distributor these days to dispose of expired or unused controlled substances," explains DOCS legal counsel David Palmer, Esq.

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.
• Registrants authorized to collect and authorized collection activities are typically pharmacies, law enforcement, and reverse distributors.
• Using reverse distribution (an outside company) to destroy controlled substances comes with a fee (within the DEA restraints), and the company must be registered with the DEA. Usually, these companies charge by weight.

Dispensing Medications From Your Dental Practice

For clarity, this section refers to dispensing medication for a patient to take at home, NOT for drugs administered in the office during the appointment.

Practitioners are not allowed to prescribe drugs for their patients, and the patient then fills the prescription and brings it to their dental appointment, where the practitioner uses it to sedate the patient. This scenario is not permitted.

When administering medications during the appointment, providers are only allowed to use drugs from their practice, not those provided by the patient.

Given this, there are benefits to dispensing prescription medications directly from your dental practice. Some of those benefits include maintaining control of dosage (before/after appointments), preventing cancellations, decreasing “no-show” rates, and allowing additional convenience to the patient. To dispense medications to patients from your dental practice (for them to take home), you'll need:

• Medication containers for dispensing to patients.
• Containers MUST be appropriately labeled. (DOCS members can download a template)
• 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 and mandatory searches on databases that screen for substance abusers.

In Conclusion

Thorough recordkeeping in sedation dentistry is crucial for patient safety and clinician protection against disciplinary actions. Proper training, organization, and a complete understanding of federal and state guidelines can quickly demystify the recording, storage, dispensing, and disposal of controlled substances.

For more information on dental sedation regulations, visit the DOCS Education regulations page here. DOCS Education members can contact David Palmer, Esq. at [email protected] with regulatory questions.

Author: With over 13 years as a published journalist, editor, and writer, Genni Burkhart's career has spanned politics, healthcare, law, business finance, and news. She resides in Northern Colorado and is the Editor in Chief of the Incisor for DOCS Education.