A Step in the right direction!

Jim

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DEA Proposes 90-Day Prescriptions for Schedule II Controlled Substances

BETHESDA, MD, 08 September 2006 — The Drug Enforcement Administration (DEA) this week proposed a rule to allow physicians, when medically appropriate, to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit.

The law prohibits Schedule II controlled substance prescriptions to be refilled. If a prescriber wants a patient to continue on the same Schedule II controlled substance beyond the amount specified on the first prescription, the prescriber must provide a separate prescription.

To get around the law, prescribers often provide patients with at least three 30-day prescriptions for Schedule II substances at once, writing "do not fill" until a specified date on the additional prescriptions so that patients do not have to return to their health care provider's office each month for a new prescription, according to DEA.

During a media briefing Wednesday, DEA chief Karen Tandy said the agency's regulations that implement the law did not address the issuance of multiple prescriptions.

According to the agency, some prescribers mistakenly interpreted a 2004 DEA interim policy statement as requiring patients to visit their providers each month to obtain a prescription for a Schedule II substance.

DEA issued a clarification document in 2005, which asserted that the 2004 document "did not state that such patients must visit their physician's office every month to pick up a new prescription."

The 2005 clarification document "explained some of the possible ways in which, under appropriate circumstances, patients can continue to receive Schedule II prescriptions without visiting their physicians' offices every month," officials said.

Tandy said that her agency heard from hundreds of health professionals and the public about the burden placed on patients to visit a physician's office each month to get a new prescription for an already diagnosed chronic condition, such as attention-deficit/hyperactivity disorder (ADHD) or chronic pain.

Officials said that the newly proposed rule, which was published in Wednesday's Federal Register, will make it easier for patients to obtain their needed medications for conditions such as chronic pain or ADHD, and will ensure that physicians "have the latitude to prescribe in a manner consistent with their sound medical judgment, while enabling DEA to fulfill its legal obligation to prevent drug abuse and diversion."

According to the agency, Schedule II controlled substances have the highest potential for abuse and are the most likely to cause dependence of all the controlled substances with FDA-approved labeling.

"Physicians must, therefore, employ the utmost care in determining whether their patients for whom they are prescribing Schedule II controlled substances should be seen in person each time a prescription is issued or whether seeing the patient in person at somewhat less frequent intervals is consistent with sound medical practice and appropriate safeguards against diversion and misuse," DEA stated in Wednesday's Federal Register notice.

The proposed rule is open for public comment until November 6.

DEA also issued a new policy statement on Wednesday which outlines the longstanding legal requirements on dispensing controlled substances for the treatment of pain.

The document specifies DEA's policy for taking appropriate legal action "against those very few physicians who illegally prescribe controlled substances."

"The DEA has an obligation under the law and to the public to ensure that controlled substances are prescribed and dispensed only for legitimate medical purposes in accordance with the Controlled Substances Act," said William Jacobs, cofounder and president of NexStep Integrated Pain Care, a Florida-based group of pain treatment experts.

"The release of the DEA's policy statement today reemphasizes the administration's commitment to fulfill those obligations while leaving medical decision making in the hands of medical practitioners," he told reporters.

In addition, the agency launched a new Web site at http://www.deadiversion.usdoj.gov/cr...ons/index.html that lists facts about criminal cases against physicians involved in diversion of controlled substances.

The Web site is intended to help dispel rumors that DEA targets physicians who prescribe pain medication, officials said.

"I urge all physicians to learn the facts about how and why the DEA investigates a doctor on the newly added webpage," Jacobs said. "There is no giant computer counting the number of prescriptions or pills a physician writes and then signaling a SWAT team attack on a physician's office. There has been a significant amount of misinformation propagated about some of the more public cases. In most cases the DEA becomes aware of a doctor selling prescriptions from local pharmacists or physicians."

"Physicians who know the rules and follow them have nothing to fear from the DEA," he declared.

—Donna Young


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