A Step in the right direction!

Jim

---------------------------

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


Story

DEA Revises Rule on Prescribing Painkillers
Doctors Freed to Write Multiple Prescriptions

By Marc Kaufman
Washington Post Staff Writer
Thursday, September 7, 2006; A04


The Drug Enforcement Administration yesterday overturned a two-year-old policy that many pain specialists said was limiting their ability to properly treat chronically ill patients in need of powerful, morphine-based painkillers.

While defending its efforts to aggressively investigate doctors who officials conclude are writing painkiller prescriptions for no "legitimate medical purpose," the agency agreed with the protesting experts that it had gone too far in limiting how doctors prescribe the widely used medications.

The unusual turnaround was welcomed by relieved doctors, who said it will help restore "balance" in government policy between the needs of pain patients and the effort to control prescription drug abuse and diversion.

Specifically, the DEA proposed a formal rule that would allow doctors with patients who need a constant supply of morphine-based painkillers to write multiple prescriptions in a single office visit. Under the new rule, a doctor can write three 30-day prescriptions at a time -- two of them future-dated -- to be filled a month apart.

Two years ago, the agency clamped down on the common practice of writing such multi-month prescriptions, which it said were probably illegal and were contributing to the growing abuse of prescription painkillers.

As a result of the DEA's position, many doctors began requiring patients to come in each month for a new prescription -- office visits many doctors considered medically unnecessary but essential to keep them out of trouble with the DEA.

Yesterday, DEA Administrator Karen Tandy said the agency had been wrong in limiting the multiple prescriptions and had made the tough decision to reverse course. She said the DEA received more than 600 comments from doctors, patients and others about its policies on narcotic painkillers, many of them strongly opposed to the agency's position on limiting refills.

"Think about how hard it is for anybody to go out publicly and say, 'We think this is probably prohibited by law,' " she said, referring to the earlier decision to prohibit multiple refills. "And then you listen to people and then you say, 'You know what? You're right,' and we're going to propose a rule that interprets this correctly. And that's what we've done."

When the DEA issued its restrictive 2004 drug refill guidelines, many pain specialists saw it as a sign that relations between their profession and the agency had deteriorated badly. They also complained that DEA arrests and prosecutions of doctors treating pain were creating a "chill" on medical practice and denying patients drugs they needed.

Agency officials had earlier worked for two years with pain and hospice experts on a "frequently asked questions" guideline to advise doctors on how to prescribe controlled drugs in a way that would not get them into trouble with law enforcement. The agency briefly posted the guidelines on its Web site in 2004 but then pulled them down and disavowed them.

One of the doctors involved with writing the guidelines -- who became a critic of the DEA when they were abruptly discarded -- called Tandy's actions yesterday "a very positive step forward in restoring that necessary cooperation between practicing physicians and the DEA."

Howard Heit, a Fairfax County pain and addiction specialist, also said the new policy will help patients get better care by allowing doctors more flexibility in prescribing controlled drugs.

But Siobhan Reynolds, who created the Pain Relief Network several years ago to help defend pain doctors who she said were being unfairly arrested and prosecuted, disagreed and said the new DEA policy has changed little.

"Ms. Tandy states here, as she has on many occasions, that doctors need not fear criminal prosecution as long as they practice medicine in conformity with what these drug cops think is 'appropriate,' " Reynolds said. "If that isn't a threat, it will certainly pass for one within the thoroughly intimidated medical community."

The use of prescription narcotics rose sharply over the past decade as knowledge grew on how to control intractable pain and specialists found what they considered better ways to help patients. That growing use, however, has led to abuse as well, and to scores of deaths and injuries associated with prescription narcotics.

In addition to publishing its new policy statement and rulemaking yesterday, the DEA began posting extensive information on its Web site about doctors who have been arrested and prosecuted for their prescribing practices. Tandy said that she hopes doctors will review the cases so they will see that only "egregious" offenders are being prosecuted.

© 2006 The Washington Post Company


Another story on same subject

Jim

Karen Tandy needs to spend more time chasing illegal drug runners at the Mexican border, and to crack down on heroin and meth. users... Once a new administration takes over in 2008, she's gone!! As Felix the Cat said as he left Baghdad on a flying carpet waving to the people below, " goodby and good riddance."

crity

I know this is an old article and I am aware of the 90 day rule posted on the diversion site. My regular pain doctor used to give me 3 scripts, but because I live in Florida and Gov. Scott launched his new witch hunt on July 1, 2011 I could see the writing on the wall after being treated by regular Doc after 7 years. Two months ago I had an issue where an assitant had filled out my scripts badly and they were unacceptable to the pharmacy under the new rules. The Doc was out of town and at the office I asked if another Doctor could take care of the issue. As it ended up the boss of the 10 Doctor practice had to fix the issue after I told the front end that it was not my fault and this needed handled now! I was already a day past my due date and had 3 pills left.---- Long story short, my Doctor gave me a letter that said the practice will no longer accept or treat chronic pain patients. She had done this once before about 3 years ago and posted a notice on her waiting room wall. When I asked her about the notice she said it would not apply to me as I am a stable patient. I had to register with a Pain Management Specialist and go through thier bookig process and they want to see me every month at $40 copays as oppossed to $10every 90 days. I mentioned the DEA rule and they payed it no heed.

What are the FDLE and DOH rules regarding 90 day schedule ll fills? Does the new Doctor disregard the DEA rule because another agency overules the DEA? I have to think that my new Doctor consulted legal council before thinking about giving three scripts to patients. Are all the Florida agencies in sync? I cannot find any info in Florida Statutes or Department of Health, and the state trumps DEA rules. I am disabled and my income is very limited.