Drug Enforcement Administration

Free Resource: Tip Sheet on Controlled Substance Prescribing in LTC

Kohl Bill Would Allow Nurse to be Prescriber’s Agent

According to Senator Kohl's office, the bill would modify the Controlled Substance Act to permit pain medication to be dispensed in emergency situations by nursing home professionals without a direct written order by a physician prior to its dispensing. A physician would be able to authorize the administrator of a long-term care facility to designate one or more licensed health care professionals employed by the facility to act as a “facility designee.” In emergency situations only, and upon receiving an oral prescription from the physician, a facility designee would be permitted to contact a pharmacy to have the prescription filled and then dispense Schedule II medications to long-term care facility residents. The facility designee would document the physician’s prescription in writing and transmit the written document to a pharmacy so that the prescription can be filled. After the pharmacy fills the prescription, it must send a copy of the written document memorializing the prescription to the physician for his or her endorsement within 72 hours. The physician must then send the endorsed document, confirming the oral prescription, to the pharmacy within five business days.

To protect against drug diversion, the bill requires careful recordkeeping by facilities and pharmacies, which can then be reviewed by the DEA as necessary. It requires each actor – the physician, facility designee, and pharmacist – to make a record of his or her role in the process. Long-term care facilities are asked to maintain a written or electronic logbook that memorializes prescriptions and their administration. The bill also enhances criminal and civil penalties for long-term care facility administrators and facility designees who divert drugs, or who violate recordkeeping requirements.

Over the past two years, AMDA has led multiple physician and provider organizations to address DEA enforcement policies.  The legislation is being reviewed by AMDA's national and state leaders.

DEA Denies Petition to Initiate Proceedings to Reschedule Marijuana

On October 9, 2002 the Coalition for Rescheduling Cannabis petitioned the DEA to remove marijuana from the list of Schedule I controlled substances based on the assertion that: cannabis has an accepted medical use in the United States; cannabis is safe for use under medical supervision; cannabis has an abuse potential lower than Schedule I or II controlled substances; and cannabis has a dependence liability that is lower than Schedule I or II controlled substances.

In response to this petition, DEA requested scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services. Their research found that “marijuana continues to meet the criteria for Schedule I control under the Controlled Substances Act because [it] has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”

AMDA’s House of Delegates reviewed a policy resolution last year asking AMDA to help its state affiliates address the issue of medical marijuana use in nursing facilities. In addition, AMDA recently requested the Centers for Medicare and Medicaid Services (CMS) Skilled Nursing Facility/Long Term Care Open Door Forum to address the status of CMS’ opinion on how facilities should handle the use of marijuana for medical purposes. We are currently awaiting a response on that request.

For more information and materials on the DEA’s decision, click here.

AMDA and Medical Societies Follow-Up with DEA on Statement of Policy

AMDA, the American Academy of Family Physicians, the American Medical Association, and the American Osteopathic Association, sent a follow-up letter to the Drug Enforcement Administration’s (DEA) November 5, 2010 letter urging them to allow an agent to represent the prescriber for Schedule II controlled substances when transmitting the prescription orally. The letter states, “Nearly five months have elapsed since we last wrote to you and we have seen no action taken by the DEA to allow an agent to represent the prescriber for Schedule II controlled substances.”

The letter reiterates previous statements on the issue, noting that “diversion of controlled substances via nurse-falsified verbal orders is a vanishingly rare phenomenon.  The current standard of care, state regulations, and pharmacy regulations require all verbal orders to be reduced to writing by a nurse and then be transmitted to the pharmacist – that is a verbal order must be recorded in the residents chart, which ultimately is reviewed by the attending physician and other nursing facility staff – thus making the possibility of diversion negligible.”

NMDA Joins Medical Organizations in Urging DEA to Revise Schedule II Policy

The Nebraska Medical Directors Association (NMDA) has joined AMDA in urging the Drug Enforcement Administration (DEA) to allow an agent to represent the prescriber for Schedule II controlled substances when transmitting the prescription orally.  “For most health care providers in Nebraska, it is absolutely essential, to have nurses be able to transmit prescriptions orally, to improve the response time for nursing home patients and hospice patients to receive critical pain and symptom relieving medicine in a timely fashion,” said Edward Vandenberg, MD, CMD, NMDA President.  

The NMDA letter supports the November 5th letter signed by AMDA, the American Academy of Family Physicians, American Academy of Hospice and Palliative Medicine, American College of Osteopathic Family Physicians, American Geriatrics Society, American Medical Association, American Osteopathic Association, and 33 state chapters.

Vandenberg said, “A revised policy is critical to resolve the delays that physicians have experienced in providing schedule II pain medications to residents whom urgently need them.”  

DEA’s Written Agreement: What You Need to Know

On October 6, the Drug Enforcement Administration (DEA) issued a five-page Statement of Policy on the “Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies.” The DEA Statement provides an example of a written agreement that would confer authority to an agent to act on behalf of an individual practitioner with regard to controlled substance prescriptions. AMDA has received numerous calls about the written agreement. Therefore, this article outlines the written agreement and AMDA’s proposed response.

Question: Is the DEA mandating the use of a written agreement?
Answer: No. However, in the Statement of Policy, the DEA states “DEA believes it is in the best interests of the practitioner, the agent, and the dispensing pharmacist that the designation of those persons authorized to act on behalf of the practitioner and the scope of any such authorization be reduced to writing.”

Question: What should be in the written agreement?
Answer: In the Statement of Policy section “Written Authorization of an Agent Recommended—Sample Agency Agreement,” 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.

There is a sample physician-agent agreement that is offered by the DEA in their Statement of Policy. The document is one “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.

The DEA provides an example of a written agreement that would properly confer authority to an agent to act on behalf of an individual practitioner with regard to controlled substance prescriptions. The relevant section is below:

Individual practitioners may choose to designate and authorize one or more persons at one or more locations within or outside their practice to act as their agent. Likewise, an individual may act as an authorized agent for multiple individual practitioners depending upon the circumstances. A practitioner may or may not wish to delegate all of these types of authorized communications to a particular agent and may tailor the agreement accordingly. The agreement should be clear that the agent may not further delegate the outlined responsibilities.

Designating Agent of Practitioner For Communicating Controlled Substance
Prescriptions to Pharmacies
_________________
(Name of registered individual practitioner)
_________________
 (Address as it appears on certificate of registration)
_________________
 (DEA registration number)
I _________________ (name of registrant), the undersigned, who is authorized to dispense (including prescribe) controlled substances in Schedules II, III, IV, and V under the Controlled Substances Act, hereby
authorize _________________ (name of agent), to act as my agent only for the following limited purposes:
1. To prepare, for my signature, written prescriptions for controlled substances in those instances where I have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR 1306.05).
2. To convey to a pharmacist by telephone oral prescriptions for controlled substances in Schedules III, IV, and V in those instances where I have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR1306.05).
3. To transmit by facsimile to a pharmacy prescriptions for controlled have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR1306.05) and I have signed the prescription.

This authorization is not subject to further delegation to other persons. Both the undersigned DEA-registered individual practitioner and the undersigned agent understand and agree that the practitioner is solely responsible for making all medical determinations relating to prescriptions for controlled substances communicated by the agent pursuant to this agreement, and for ensuring that all such prescriptions conform in all other essential respects to the law and regulations.

The undersigned agent understands he or she does not have authority to make any medical determinations. The undersigned DEA-registered prescribing practitioner further understands that the prescribing practitioner must personally communicate all Schedule II emergency oral prescriptions to the pharmacist.

Both the undersigned practitioner and agent understand that the agent may not call in an emergency oral prescription for a Schedule II controlled substance on behalf of the practitioner.

This agency agreement shall be terminated immediately if and when any of the following occur:
1. The undersigned practitioner no longer possesses the active DEA registration specified in this agreement.
2. The undersigned agent is no longer employed in the manner described in this agreement.
3. The practitioner or the agent revokes this agency agreement by completing the revocation section at the end of this document or by executing a written document that is substantially similar to the revocation section at the end of this document.

_________________
(Signature of practitioner)
 I _________________ (name of agent), hereby affirm that I am the person named herein as agent and that the signature affixed hereto is my signature.

I further affirm that I am a  _________________ (title), licensed in the State of  _________________, (where applicable) and (if applicable) am employed by/under contract with _________________ (name of employer or contracting entity). I agree to abide by all the terms of this agreement and to comply with all applicable laws and regulations relating to controlled
substances.
 _________________
(Signature of agent)
_________________
 (State license number of agent where applicable)
 _________________
 (Name of employer/contracting entity where applicable)
_________________
 (Address of employer/contracting entity where applicable)

Witnesses:
1. _________________
2. _________________

 Signed and dated on the _________________day of _________________
  (month), _________________ (year), at _________________ .

Revocation
The foregoing agency agreement is hereby revoked by the undersigned. The agent is no longer authorized to communicate Schedule II, III, IV and V controlled substance prescriptions to a pharmacy on my behalf. A copy of this revocation has been given to the agent this same day.
_________________
(Signature of registered practitioner revoking power)

Witnesses:
1. _________________

2. _________________

Signed and dated on the _________________ day of _________________
 (month), _________________ (year), at _________________.

DEA recommends that the original signed agency agreement be kept by the practitioner during the term of the agency relationship and for a reasonable period after termination or revocation. DEA requires that inventory and other records be kept for at least two years (21 U.S.C. 827(b), 21 U.S.C. 828(c), 21 CFR 1304.04). This is simply a suggested time period for retention of agency agreements and is not required by DEA.

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. 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. It is important to reiterate that a pharmacist always has a corresponding responsibility to ensure that a controlled substance prescription conforms with the law and regulations, including the requirement that the prescription be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, and a corresponding liability if a prescription is not prepared or dispensed in a manner consistent with the CSA or DEA regulations. Even where the pharmacist has a copy of an agency agreement, the pharmacist may also have a duty to inquire further depending upon the particular circumstances. Because the agency agreement may be revoked at any time by the practitioner or by the agent, 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.”

Question: Does the DEA allow me to have an agreement that is not individually signed? I would have one agreement between me and all the nurses employed by the nursing home.
Answer: We do not have a specific answer from the DEA. AMDA analysts do not believe that these “blanket agreements” meet the DEA’s intent to have an agreement between a practitioner and a specific agent. Don’t rely on this information alone when developing your written agreement. Instead, AMDA recommends that practitioners consult with the nursing facility you serve and legal advisors.

Question: How is AMDA addressing the written agreement?
Answer: AMDA has conducted qualitative interviews with several state chapters to discuss concerns with the written agreement and suggestions for addressing any problems identified with the agreement. Most members interviewed felt that the written agreement would be a significant burden in the long-term care setting. As medical directors for more than one nursing home, they are concerned that it would be difficult to have individual agreements with each nurse in every nursing home where they serve as attending physician or medical director. The consensus was that one solution to the written agreement would be to have one agreement between a physician and all of the nurses within a specific facility.

AMDA is communicating with the American Health Care Association and the American Association of Homes and Services for the Aging to strategize on how to best address the issue. AMDA will be drafting a response to the written agreement to send to the DEA and Senator Herb Kohl (D-WI), who has been active on this long-term care issue.

As we gather more information, AMDA will share it with its membership through Health Policy Advisor.

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