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DEA Issues Statement on Prescribers' Agents
By: KATHLEEN WILSON AND HEATHER BOYD
On Oct. 6, the Drug Enforcement Administration published in the Federal Register a five-page “Statement of Policy” intended to clarify the agency's rules on communicating controlled substance prescriptions to pharmacies, especially via nurses and other agents of prescribing physicians.
AMDA President Paul Katz, MD, CMD, called the statement a “first step” toward resolving physicians' problems with DEA's recent enforcement of the Controlled Substances Act in long-term care facilities. But he also said that the statement does not resolve the delays that physicians have had in getting Schedule II pain drugs to some residents.
In “Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies,” the DEA provided an example of a written agreement that would authorize an agent to act on behalf of an individual practitioner in conveying controlled substance prescriptions to pharmacies.
The DEA stated that “where a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V by conveying all the required prescription information to the practitioner's agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist.”
However, the statement added, “An agent may not call in an oral prescription for a Schedule II controlled substance on behalf of a practitioner even in an emergency circumstance.”
The DEA specified that a practitioner or a practitioner's authorized agent may transmit a valid, physician-signed Schedule II prescription to a pharmacy via fax for a patient enrolled in a hospice program or residing in a long-term care facility.
Individual practitioners may designate one or more persons at locations within or outside their practice to act as their agents. Likewise, an individual may act as an authorized agent for multiple individual practitioners. The sample physician-agent agreement is what DEA considers a document “that would properly confer authority to an agent to act on behalf of an individual practitioner with regard to controlled substance prescriptions.”
This agreement must include the name of the registered individual practitioner, the address of the practitioner as it appears on the certificate of registration, the practitioner's DEA registration number, the name of the registrant, and the name of the agent.
AMDA is working with other associations to provide guidance on how members might implement the agreement in facilities. AMDA has concerns about how the agreement would be implemented. Any guidance would have to include considerations of agency nurses and agreements between back-up physicians and nursing staff.
The DEA's actions follow the Aug. 29 submission of a strongly worded AMDA letter asking the agency to make an administrative change in its interpretation of the Controlled Substances Act to better comport with its recognition of long-term care nurses as agents of the prescriber for the purposes of administering controlled medications and to recognize a chart order as a valid prescription. AMDA's letter was in response to the June 29 Federal Register Notice titled, “Dispensing of Controlled Substances to Residents at Long Term Care Facilities.”
According to Dr. Katz, “The DEA's statement of policy is the first step toward recognizing long-term care nurses as agents of the prescriber for purposes of administering controlled medications. However, the statement does not allow the agent to represent the prescriber for Schedule II narcotics when transmitting the prescription orally.”
Fifty percent of AMDA members who responded to a survey on the June DEA notice reported that they prescribe Schedule II narcotics daily. While 71% of respondents said that the delays in obtaining prescriptions for controlled substances apply to all schedules, respondents reported that the problem is worse for Schedule II drugs.
Most respondents cited the need for the physician to fax a prescription or contact the pharmacy directly as the cause for delays. Facilities may have difficulty contacting the physician, when the physician is not in a position to send a fax or call the pharmacy, and when the pharmacy has a backlog of faxes and calls to return. The problem is exacerbated during after-hours, on weekends, holidays, or when the attending physician is on vacation.
Dr. Katz cautioned, “The DEA statement of policy does not address our physician's concerns with delays in getting Schedule II substances to patients in pain. We appreciate the DEA's exception of allowing an agent of the practitioner in a long-term care facility to transmit the prescriber-signed prescription to a pharmacy via facsimile.
“However, without an agent's ability to transmit the prescription orally to a pharmacist, especially in emergency situations, our fear is that physicians may order only combination Schedule III substances – such as hydrocodone 5 mg with acetaminophen 500 mg (Vicodin), 2 tabs every 4 hours – instead of a pure opioid that may be warranted in this situation. In that case, the amount of acetaminophen would exceed the 3-g per day guidelines for elderly patients.
“Prescribers are still going to need to jump through the hoops to get the appropriate pain medication for their patients. The war on pain hasn't been won yet, but we applaud the DEA's statement as a positive first move.”
For the full Federal Register statement, including the DEA's sample agreement, go to edocket.access.gpo.gov/2010/2010-25136.htm
DR. WILSON in the director of government affairs for AMDA. MS. BOYD is a health policy analyst for AMDA.
Excerpts From DEA Statement
Communication by Facsimile or Oral Communication of a Valid Prescription for a Schedule III, IV, or V Controlled Substance May be Delegated to an Authorized AgentThe CSA [Controlled Substance Act] provides that a pharmacy may dispense Schedule III and IV controlled substances pursuant to a “written or oral prescription.” 21 U.S.C. 829(b). DEA regulations further specify that a pharmacist may dispense a Schedule III, IV, or V controlled substance pursuant to “either a paper prescription signed by a practitioner [or] a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, * * *.” 21 CFR 1306.21(a). Accordingly, an authorized agent may transmit such a practitioner-signed paper prescription via facsimile to the pharmacy on behalf of the practitioner.
Controlled substances in Schedules III, IV, and V may also be dispensed by a pharmacy pursuant to “an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required [for a valid prescription], except for the signature of the practitioner.” 21 CFR 1306.21(a). Under DEA regulations, an authorized agent may orally communicate such a prescription to a pharmacist. 21 CFR 1306.03(b). … [T]he practitioner remains responsible for ensuring that the prescription conforms to the law and regulations, and the practitioner cannot delegate to an agent the authority to make a medical determination of need for a controlled substance prescription.
Generally, a Valid Schedule II Controlled Substance Prescription May Not be Communicated by Facsimile
Because Schedule II controlled substances have the highest potential for abuse and the greatest likelihood of dependence among the pharmaceutical controlled substances (those in Schedules II-V), the CSA controls on Schedule II drugs are the most restrictive. The CSA requires that a Schedule II controlled substance be dispensed by a pharmacy only pursuant to a written prescription, except in emergency situations, and prohibits Schedule II prescriptions from being refilled. 21 U.S.C. 829(a). Thus, in most cases, a pharmacist must receive the original, manually signed paper prescription or an electronic prescription prior to dispensing a Schedule II controlled substance. 21 CFR 1306.11(a).
A Valid Schedule II Controlled Substance Prescription For a Person in a Hospice or Long Term Care Facility (LTCF) May be Communicated by Facsimile and That Communication May be Delegated to an Authorized Agent
DEA regulations specify two exceptions whereby a Schedule II controlled substance prescription sent by facsimile may serve as the original written prescription. A practitioner or a practitioner's authorized agent may transmit a valid Schedule II controlled substance prescription to a pharmacy via facsimile for: (1) Patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or hospice programs which are licensed by the State (21 CFR 1306.11(g)); and (2) residents of LTCFs (21 CFR 1306.11(f)). The facsimile serves as the original written prescription and must be maintained by the pharmacy as such. An authorized agent of the prescribing practitioner may transmit the practitioner-signed prescription by facsimile on behalf of the practitioner.
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