AAFP Joins Medical Organizations in Addressing Flaws in DEA Policy

Agency's Position on Schedule II Drugs Harmful to Patients in Long-Term Care

November 10, 2010 04:45 pm David Mitchell

The DEA's policies for prescribing Schedule II controlled substances in long-term care practice settings create unnecessary delays in managing patients' pain and conflict with CMS guidance, according to a letter to the DEA(www.amda.com) signed by the AAFP, six other national health care organizations and more than 30 state medical associations.

The Nov. 5 letter, which was spearheaded by the American Medical Directors Association, or AMDA, responds to a DEA policy statement(www.federalregister.gov) that was published Oct. 6 in the Federal Register.

Federal regulations require prescriptions for Schedule II controlled substances to be made in writing and signed by a clinician registered with the DEA. If the prescribing health professional determines that the situation is an emergency, a pharmacist may dispense a Schedule II drug after receiving verbal authorization directly from the prescriber. The prescribing clinician is required to follow up with a written prescription within seven days of a verbal order.

According to the AMDA, the DEA has been aggressively enforcing regulations for Schedule II controlled substances, forcing health care professionals in long-term care settings to modify long-standing procedures and delaying dispensing of controlled substances to patients who urgently need them.

In August, the AAFP signed on to a tip sheet(www.amda.com) developed by the AMDA to help physicians in their efforts to ensure proper prescribing of controlled substances.

The tip sheet -- which also is supported by the American Academy of Hospice and Palliative Medicine, the American Geriatrics Society, and the AMA -- offers the following recommendations for prescribers to expedite the filling of controlled substance prescriptions:

  • Always carry a prescription pad that meets state requirements.
  • Know what information is legally required for a controlled substance prescription -- date of issue; patient's name and address; practitioner's name, address and DEA registration number; drug name, strength, dose, and quantity prescribed; directions for use; number of refills authorized; and manual signature of prescriber.
  • Write prescriptions at a facility with a fax machine, and fax the prescription to the provider pharmacy rather than calling it in.
  • Purchase a home fax for after-hours and weekend use.
  • In emergency situations when a physician is unable to fax a prescription or does not have a prescription pad available, the physician should call the pharmacist directly and provide the order while also providing it to the nurse.
  • Reach out to local hospitals to educate staff so that patients who require controlled substances are discharged with a hard copy prescription for several days' worth of their needed medication. The prescription should specify the drug but also say "or formulary equivalent."

The DEA clarified in its new policy statement that the agent of a practitioner in a long-term care facility may fax a prescriber-signed prescription to a pharmacy. The DEA also said that agents may telephone pharmacies and convey prescription information from the prescriber for controlled substances in Schedules III-V.

However, agency officials held firm on the position that agents cannot call in an oral prescription for a Schedule II controlled substance on behalf of a practitioner "even in an emergency circumstance."

The aforementioned medical organizations, including the AAFP, are advocating that Congress and the DEA change the rules to allow the long-standing practice of having nurses act as the physician's agent in such circumstances.

Family physician Dale Moquist, M.D., of Sugar Land, Texas, told AAFP News Now that the current regulation works against patient safety.

"Patients in the nursing home setting have multiple chronic problems, which can lead to chronic and acute pain," said Moquist, who holds a certificate of added qualifications in geriatric medicine and is geriatric coordinator at the Memorial Family Medicine Residency in Sugar Land. "This regulation can interrupt and delay the care a patient deserves."

The letter to the DEA says that the agency's policy on Schedule II drugs conflicts with CMS guidance for long-term care, which calls for residents to be given rapid relief of "excruciating pain."

According to the letter, the conflicting regulations could cause nursing facility staff to inadequately treat pain by not prescribing needed medication or risk failing to comply with DEA policy.

"Pain that is not promptly treated, due to avoidable delays in receiving Schedule II analgesic medications, can lead to difficulty with self-care, behavioral difficulties, anxiety, depression, difficulty sleeping, and poor appetite, in addition to the signs and symptoms of drug withdrawal, including diarrhea and abdominal cramping, bone pain, and severe malaise and myalgias, as well as extreme dysphoria," the letter says.