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Prescribers, Is the Relationship with Your "Authorized Agent" Explicit, Transparent and Proper?
Sept. 8, 2011
By: Alix C. Michel
This article, written by health law litigation attorney Alix Michel, was originally published in Tennessee Medicine, the online journal of the Tennessee Medical Association (September 2011).
Violation of the Controlled Substances Act (CSA) exposes practitioners and pharmacists to criminal, civil, and administrative sanctions. Late last year, the U.S. Drug Enforcement Administration (DEA) issued a policy statement on the "Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies". The statement contains the DEA’s recommendations for the proper use of agents in prescribing controlled substances. Two areas were specifically covered: 1) establishing a valid agency relationship between an individual practitioner and an identified individual; and, 2) explaining the appropriate role an authorized agent may play when communicating controlled substance prescriptions to pharmacies, regardless of the setting.
A Valid Agency: To be consistent with the purpose of the CSA, the DEA recommends that an agency relationship between a registered individual practitioner and an identified agent for the purposes of communicating controlled substance prescriptions must be explicit and transparent. The DEA suggests it is in the best interests of the practitioner, the agent, and the dispensing pharmacist that the designation of any persons authorized to act on behalf of the practitioner, and the scope of any such authorization, be reduced to writing.
The DEA also recommends that the practitioner keep the original signed agency agreement during the term of the agency relationship and for a reasonable period after termination or revocation (a two-year suggestion appears in the policy statement). A signed copy should also be provided to the practitioner's designated agent, the agent's employer (if other than the practitioner), and any pharmacies that regularly receive communications from the agent pursuant to the agreement. The DEA notes that providing a copy to pharmacies likely to receive prescriptions from the agent on the practitioner's behalf may assist those pharmacies with their corresponding responsibility regarding the dispensing of controlled substances.
Because the agency agreement may be revoked at any time by the practitioner or by the agent, the DEA recommends that the party terminating the agreement should notify the other party immediately upon termination. The practitioner should notify those pharmacies that were originally made aware of the agency agreement of the termination of that agreement. In most circumstances where an agent changes employment, the agreement should be revoked.
To further assist practitioners, the DEA policy statement contains a draft agency agreement for use by practitioners. (See Table A.)¹
Proper Acts An Agent May Take: A valid prescription issued by a DEA-registered practitioner is required for dispensing a controlled substance. The DEA emphasizes that, to be valid, a prescription for a controlled substance must be issued for 1) a legitimate medical purpose by 2) a practitioner acting in the usual course of professional practice.
While the core responsibilities pertaining to prescribing controlled substances may not be delegated to anyone else, an individual practitioner may authorize an agent to perform a limited role in communicating such prescriptions to a pharmacy in order to make the prescription process more efficient. DEA regulations specifically permit a practitioner to use an authorized agent to perform certain ministerial acts in connection with communicating prescription information to a pharmacy. Accordingly, the DEA has summarized the acts that an agent may take as follows:
- An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription.
- An authorized agent may telephone the pharmacy and convey prescription information to the pharmacist, if a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V and conveyed all the required prescription information to the practitioner's authorized agent.
- An authorized agent may transmit the practitioner-signed prescription to the pharmacy by facsimile, if an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy.
While the DEA anticipates the utilization of electronic prescribing by practitioners for controlled substance prescriptions will ultimately reduce the role of agents over time, the policy statement serves as a useful resource for prescribers in the interim. The entire policy statement can be found at http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr1006.htm
¹ From a practical standpoint, can an agency relationship exist in situations where physician assistants and nurse practitioners jointly prepare written protocols with their supervising physicians? In the author’s opinion, the creation of protocols would not suffice. However, if the physician assistants and nurse practitioners were to sign an acknowledgement of the protocols, then a valid agency would likely exist.