Ask yourself the following questions. Does anyone other than the dentist ever:
· Prepare prescriptions for controlled substances for the dentist’s signature?
· Call or fax prescriptions to a pharmacy?
· Handle controlled substances for ordering, inventorying, shipping/receiving, and/or preparing for the dentist’s administration to a patient?
· Look up patient/caregiver drug histories in the Prescription Monitoring Program (PMP)?
· Look up the dentist’s prescribing history in the PMP?
· Transport controlled substances to a satellite office?
If you answered ‘yes’ to any of these questions, your office should officially authorize the staff members who perform these functions to be in compliance with federal regulations regarding the use of Designated Agents.
The DEA recognizes healthcare providers’ need for their staff to assist with certain activities involving controlled substances. However, practitioners and their employees must meet certain requirements.
A “designated agent” is “an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser or prescriber. A Designated Agent must be screened and officially authorized to act on behalf of the Registered Agent (dentist who is authorized by the DEA to prescribe controlled substances).
Practitioners utilizing Designated Agents must screen their staff to ensure ‘fitness for duty’ to perform tasks involving controlled substances. If the provider elects not to perform a criminal background check, which I strongly advocate (state and county background checks for each state/county the employee has resided in the last 7 years), then at the very least the employee should be required to answer at least two questions. They are:
1. Within the past five years, have you been convicted of ANY felony; within the past two years, have you been convicted of ANY misdemeanor; are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses, or military convictions, except by general court-martial.)
2. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician?
A ‘yes’ answer to either question does not automatically preclude an employee from acting as a Designated Agent, but the practitioner should carefully weigh their decision to move forward with any employee who cannot answer ‘no’ to both questions.
The past is no guarantee of future behavior. However, it is certainly indicative of past behavior, which you very much need to consider.
Okay, so you have screened your employee and found no reason they cannot or should not be able to perform the duties of a Designated Agent. Next, it is time to establish your authorization of the employee. This should always be established in writing. The DEA does not mandate the use of a specific form. However, the activities they are authorized to perform should be clearly spelled out and communicated in writing. The form (Designated Agent Authorization) should be signed by the practitioner and the employee. The form should be accessible in case of inquiry by a pharmacy or the DEA.
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. As such, pharmacists may request verification when prescriptions are submitted by a Designated Agent.
This very clearly means the practitioner must determine that a prescription for a controlled substance is for a legitimate medical purpose. This determination is the sole responsibility of the practitioner and may not be delegated.
If your practice utilizes designated agents, you must ensure employees are properly screened and officially authorized to ensure compliance with the law. In many states it is unlawful for any person to communicate prescriptions to a pharmacy without authorization. This is a criminal offense known as telephonic prescription forgery.
If your office is not in compliance with these requirements, then take corrective action today.
· DEA Practitioner’s Manual, https://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf, accessed on 03/18/2019
· 21 CFR, part 1306, Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies, https://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr1006.htm, accessed on 03/18/2019
· 21 CFR part 1301.90, Employee Screening Procedures, https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_90.htm, accessed on 03/18/2019
· 22 TAC, part 5, chapter 111, Standards for Prescribing Controlled Substances and Dangerous Drugs, https://texreg.sos.state.tx.us/public/readtac$ext.ViewTAC?tac_view=4&ti=22&pt=5&ch=111&rl=Y, accessed on 03/18/2019
· Texas Health and Safety Code, chapter 481.073 Communication of Prescriptions by Agent. https://law.justia.com/codes/texas/2005/hs/006.00.000481.00.html, accessed on 03/18/2019