Controlled Prescription Drug Overview

DEA (and state authority)

DEA stands for Drug Enforcement Administration.  The DEA is a federal agency that works with each state to enforce laws concerning Schedule I, Schedule II, Schedule III, Schedule IV, and Schedule V drugs. Dentists that administer, store, and/or write prescriptions for these drugs must be registered with the DEA and state. In certain situations dentists may be required to have multiple registrations from the DEA (and state authority). Dentists and their facilities may be audited if the DEA finds cause to do so or for a routine audit. If violations are found, monetary, imprisonment, and/or lose of DEA certification and physician’s license may follow.

Many states have a state agency (counterpart) of the DEA who enforce rules and regulations that are as restrictive or more restrictive than federal law. Those agencies and your dental board may also audit dentists and their facilities to ensure proper handling of medications, proper record keeping, proper security of prescription pads (software), and that dentists bear current authority to use and write prescriptions for controlled prescription drugs.

Prescription Monitoring Program (PMP)

Most states have PMPs.  These programs are a statewide electronic database that collects information on dispensed scheduled drugs within the state.  The DEA is not involved with PMPs; these programs are run solely by the state.  A PMP provides the following advantages:

  • Identifies and prevents drug abuse and diversion
  • Supports access to legitimate medical (dental) use
  • Aids in identifying and helping persons with addictions to prescription drugs
  • Is available to dentists to view their prescribing history and patients’ consumption history

Record Keeping

The DEA and your state (likely) requires extensive record keeping for controlled substance prescribing, administering, and purchasing and storing.  When prescribing, the record can and must be kept in the patient’s medical record, but must include specific information.  When administering, the record must be kept in the patient’s medical record; however, a separate record log must be kept as well.  For purchasing and storing, a record log must be kept as well.  Federal regulations also require the taking of a physical inventory every two years. Records must be sufficient to account for drugs and minimize the potential for theft or misuse of controlled prescription drugs. Correct record keeping can help during an audit and show good faith in staying compliant.

Audits and Inspections

The DEA (and various state agencies) have the authority and responsibility to monitor and regulate controlled substances.  An inspection can be by consent or with a warrant, but the audit will be the same for either.  The DEA may inspect and copy record keeping verifying correctness.   Most violations are administrative; however, these violations can still impact the practice. If violations are found to be extreme, a full criminal investigation may ensue.  Below are some of the other outcomes of violations:

  • Letter of Admonition:  a warning from the DEA
  • Order to Show Cause:  allows the registrant to explain why his/her license should not be revoked or suspended
  • Memorandum of Agreement (MOA):  an agreement for a specific period of time that the provider is required to take certain measures to establish corrective measures for the violations found
  • Revocation of Registration: a registration may be revoked following a Show Cause hearing.
  • Voluntary Surrender of Registration: is a settlement whereby a registrant voluntarily surrenders their registration to dispense, administer, or prescribe controlled prescription drugs during the course of their practice of dentistry. VSRs typically result in a minimum surrender period of two years.

Consequences:

Violations produce consequences.  Some consequences mentioned above may not seem severe, but they can impact your ability to practice dentistry.   Some of the consequences could be just a warning; however, remember this warning stays with you for future violations and inspections.  Other consequences could be more severe.  In fact, because multiple agencies are tasked with overseeing drug laws in a dental practice dentists can be sanctioned by multiple agencies for one offense and it is not double (or triple) jeopardy because each issues sanction under their own laws or administrative rules. The result could be anything from losing a DEA or dental license to imprisonment.  Following the DEA and State laws are imperative to staying in business.

For more information on how we can help you, contact Dental Compliance Specialists, LLC at (888) 994-4744 or e-mail us.  You may also visit the DEA website http://www.deadiversion.usdoj.gov.