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The ISMA explains DEA policy for prescribing controlled substances
e-Reports, December 6, 2010
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DEA issues new policy statement to help you comply with the law
The U. S. Drug Enforcement Administration (DEA) has clarified its rules to help you prescribe needed medicines to patients in a timely manner, while helping you comply with existing regulations.

Get tips on prescribing controlled substances

A new tip sheet from the AMA provides advice on how you can comply with federal law on prescribing controlled substances to patients in nursing homes or long-term care facilities.

The guidelines suggest you fax controlled-substance orders to pharmacies and purchase a home fax machine for after-hours or weekend calls.

The document is available on the AMA's website here.

In the Oct. 6 Federal Register, the DEA explained the role of authorized agents in communicating controlled substance prescriptions to pharmacies, which has caused confusion for physicians nationwide.

“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,” explained Julie Reed, ISMA legal counsel. “Physicians can authorize one or more persons at one or more locations within or outside their practice to act as their agent.”

Here are the basic requirements of the law:

  • All prescriptions must be issued in the usual course of professional practice and for a legitimate medical purpose.
  • An authorized agent may prepare a prescription based on the instructions of the prescribing physician, then must present the prescription to the practitioner for review.
  • The authorized agent may not make medical determinations; therefore, a physician cannot delegate to an agent the authority to make a medical determination of need for a prescription.
  • Prescriptions must be dated as of, and signed on, the day when issued.
  • The physician must personally sign the prescription, manually or electronically.
  • The prescribing physician cannot delegate signature authority.

The DEA also clarified the delegated communication of prescriptions for these drugs:

Schedule III, IV & V controlled substances 

  • Fax – An authorized agent may transmit via fax a prescription that is physician-signed to the pharmacy on behalf of the physician.
  • Oral – A physician may convey all required prescription information to the authorized agent, who may orally communicate that prescription to a pharmacy. The pharmacy must reduce it to writing.

Schedule II controlled substances

  • Fax – Not permitted, except an authorized agent may transmit via fax for:
    1. Patients enrolled in a hospice care program certified and/or paid for by Medicare or hospice programs that are licensed by the state.
    2. Residents of long-term care facilities.

  • Oral – Authorized agents may not issue oral prescriptions for Schedule II drugs, even in an emergency circumstance.
    • Physicians may issue oral prescriptions for Schedule II drugs in an emergency. It must be limited to the quantity necessary to treat the patient during the emergency period and followed up within seven days by a physician-signed written prescription. Also, prescriptions must be immediately reduced to writing by the pharmacist.
    • No refills are permitted.

“An emergency includes those situations in which no alternative treatment is available, and it is not possible for a physician to provide a written prescription to the pharmacy,” noted Reed.

Background on the issue
In 2009, the DEA began taking action against long-term care pharmacies for dispensing controlled substances without written physician orders. Traditionally, physicians have given these orders orally with nurses acting as their agents.

However, in complying with the rules, physicians nationwide reported that patients suffered because of delayed dispensing of controlled substances to those patients.

“The DEA statement of policy is helpful, but it does not fully address the AMA’s concerns about dispensing delays for urgently needed Schedule II drugs that may occur when physicians are neither available to sign a written prescription nor able to get in touch quickly with the pharmacist by phone,” notes the AMA.

A coalition of health care groups, including the AMA, is lobbying Congress and the DEA to change the rules.

The new DEA policy statement includes a sample written agreement between a DEA-registered physician and an agent, such as a nurse at a long-term care facility. The ISMA has formatted this agreement, which can be found on the ISMA website.

“The agreement may be tailored to fit physician needs,” said Reed. “But, as a reminder, some authority vests only in the practitioner and cannot be delegated, and an agent may not re-delegate responsibilities.”

Find the five-page DEA policy statement at the Federal Register.

Copyright: Information written and displayed on www.ismanet.org is the property of ISMA and may not be reproduced without expressed written permission of the Indiana State Medical Association.

For a more detailed sitemap click here.