DEA to let doctors write advance prescriptions for schedule II refills

The move would allow "do not fill before ..." prescriptions, but the government won't set out rules to help doctors avoid trouble when treating pain.

By Kevin B. O’Reilly — Posted Oct. 2, 2006

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In an apparent effort to mend its relations with physicians and pain patients, the Drug Enforcement Administration last month proposed a rule that would allow doctors to write multiple prescriptions for schedule II drugs during a single office visit. The total amount prescribed could not exceed a 90-day supply.

The proposed rule, open for comment until Nov. 6, would reverse part of a November 2004 interim policy statement that said preparing "multiple prescriptions on the same day with instructions to fill on different dates is tantamount to writing a prescription authorizing refills of a schedule II" drug, illegal under the Controlled Substances Act.

The DEA clarified last year that the 2004 policy statement doesn't require patients already under a physician's supervision to visit the doctor for a new schedule II prescription. The agency said physicians could mail new prescriptions to the patient or the pharmacy. They also could write a prescription for longer than 30 days, the DEA said. But few doctors used that option, still allowed under the proposed rule, because of worries it might increase the likelihood of diversion or abuse. Also, most insurers won't pay for prescriptions exceeding a month's supply.

"We heard from hundreds of doctors and patients about the burdensome requirement of repeated visits to a doctor's office each month to get a new prescription for an already diagnosed chronic condition such as attention-deficit/hyperactivity disorder or chronic pain," DEA Administrator Karen P. Tandy said in prepared remarks. "We hope to fix that."

The proposed changes -- accompanied by a new DEA policy statement, an updated doctor's guide and a Web page listing the administration's cases against doctors -- received mixed greetings from a pain community hoping for a more balanced approach to controlling the diversion of opioids and other painkillers.

AMA Secretary Rebecca J. Patchin, MD, said in a statement that giving doctors freedom to determine if refills are necessary is a good move. "This proposal will help patients who suffer from chronic pain to safely and efficiently receive the treatment they need," said Dr. Patchin, an anesthesiologist and pain management specialist in Riverside, Calif. At its 2004 Interim Meeting, after the first policy change was announced, the AMA House of Delegates called on the DEA to change its rule.

Frederick Burgess, MD, PhD, president of the American Academy of Pain Medicine, said the proposed rule is a "step in the right direction." Dr. Burgess said the current rule has made life tougher for his chronic pain patients. To comply, he schedules "cursory refill visits" for patients so frail they sometimes require an ambulance just to get to the office.

But June L. Dahl, PhD, co-founder of the American Alliance of Cancer Pain Initiatives and a pharmacology professor at the University of Wisconsin School of Medicine and Public Health, said the proposed rule's 90-day-supply limit was a first of its kind and could open a Pandora's box. "I may just be paranoid, but I'm worried about the long-term implications of this," she said. "By imposing this time limit, could the DEA at some later point issue further regulations about matters that should be left to a practitioner's medical judgment?"

Will Rowe, executive director of the American Pain Foundation, shared Dr. Dahl's concern about the proposed rule. "This could turn out to be a wolf in sheep's clothing," he said.

Physician prescribing concerns persist

The DEA's recent actions won't be enough to stop doctors from worrying about getting in trouble for prescribing painkillers.

Doctors have lingering suspicions given the hundreds of investigations and prosecutions of physicians in recent years, said Kathryn A. Padgett, PhD, executive director of the American Academy of Pain Management. At a group conference days after the administration's September announcement, "There was a palpable concern on the part of prescribing physicians that they'd be targeted for prosecution based on providing adequate pain relief," she said.

Physicians, who comprise 60% of AAPM's approximately 5,400 members, saw the announcement as "business as usual." The "overwhelming response of clinicians I spoke to was that it doesn't change their concerns or create less scrutiny," Padgett said.

In a new policy statement published in the Federal Register, the DEA reaffirmed its right to investigate a physician's practice based on the quantity of pills prescribed, the number of prescriptions issued or suspicion alone. The DEA also said an advisory pain medicine panel was unnecessary and declared that "there are no definitive criteria laying out what is legally permissible" in the prescribing of opioids.

In October 2004, the DEA withdrew from its Web site a comprehensive set of frequently asked questions on pain control and drug diversion, prompting outcries from physicians and pain patients.

The DEA's actions last month are merely a "PR device in response to criticism of the agency," said Ronald T. Libby, PhD, a political scientist at the University of North Florida in Jacksonville and author of a Cato Institute monograph, "Treating Doctors as Drug Dealers: The DEA's War on Prescription Painkillers." The new policy statement is "deliberately vague," he added, saying anything more specific "presupposes that they're practicing medicine."

DEA avoids a do's and don'ts list

Aaron Gilson, PhD, policy research associate director at the University of Wisconsin Pain & Policy Studies Group, said the DEA is right to be circumspect about setting out do's and don'ts for prescribing painkillers. "The responsibility of the DEA is to make sure that controlled substances are not prescribed for other than legitimate medical purposes," he said. "That's a completely separate responsibility from defining medical purpose or medical practice. ... That's not their bailiwick."

It's up to states to determine what constitutes accepted medical practice, he added. And the states have made great strides in adopting balanced pain policies, according to a newly released Pain & Policy Studies Group report card grading state laws, regulations, and medical and pharmacy board policies. In 2000, less than half of states received a "C" grade or better, but by this year 82% of states were at that grade or higher, Dr. Gilson said.

Back at the federal level, concerns may persist regarding the DEA's approach to pain matters, but Dr. Dahl sees cause for hope.

"Things got broken for a couple of years," she said. "There wasn't any ability for the pain community to communicate with the DEA. Now it may be possible to do so. ... We shouldn't be adversaries. We should be talking to each other and negotiating issues of concern."

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What not to do

The DEA has refused to issue comprehensive guidelines to help physicians avoid investigation under the Controlled Substances Act, saying "each case must be evaluated based on its own merits." However, the agency says, these practices "may be indicative of inappropriate prescribing:"

  • Prescribing an inordinately large quantity of controlled substances or writing large numbers of prescriptions, compared with other physicians in an area.
  • Failing to perform a physical examination.
  • Warning the patient to fill prescriptions at different drug stores.
  • Issuing prescriptions knowing the patient is delivering the drugs to others.
  • Issuing prescriptions in exchange for sexual favors or for money.
  • Prescribing controlled drugs at intervals inconsistent with legitimate medical treatment.
  • Using street slang rather than medical terminology for the drugs prescribed.
  • Failing to show a logical relationship between the drugs prescribed and treatment of the condition allegedly existing.

Source: DEA Office of Diversion Control, "Practitioner's Manual: An Informational Outline of the Controlled Substances Act," 2006 Edition, Appendix B, "Questions and Answers"

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DEA shares info on federal cases over pain medications

In an effort to allay physicians' fears about being unjustly investigated for using opioids to treat their patients' persistent pain, the Drug Enforcement Administration in September launched a Web page (link) listing criminal cases and administrative actions the agency has brought against doctors since 2003.

A physician invited by the DEA to speak at a news conference unveiling the "Cases Against Doctors" Web page said it should relieve doctors' worries.

"Physicians who know the rules and follow them have nothing to fear from the DEA," said William S. Jacobs, MD, co-founder of NexStep Integrated Pain Care in Jacksonville, Fla.

The Web page lists 25 criminal cases against doctors since 2003. It includes examples of physicians who wrote prescriptions in exchange for sex and cash, and to patients who had admitted to reselling the drugs. The page also notes only 595 of the 720,290 physicians registered with the DEA were investigated in 2005.

Critics said the DEA's list doesn't reflect the scope of threat against doctors because it excludes the scores of investigations that occur at the local and state levels. John P. Flannery II, a former federal prosecutor in New York who is now defending patients and doctors in five separate pain cases, said the Web page is not helpful.

"This doesn't tell me anything I can use in the sense of putting me on notice about what I, as a doctor, may safely do," Flannery said. "All this tells me is that they're prosecuting a bunch of doctors out there and not telling me if I could fall into that category or not."

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External links

Drug Enforcement Administration manual, "An Informational Outline of the Controlled Substances Act, 2006 Edition" (link)

"Proposed Rule: Issuance of Multiple Prescriptions for Schedule II Controlled Substances," Federal Register, Sept. 6 (link)

"Policy Statement: Dispensing Controlled Substances for the Treatment of Pain," Federal Register, Sept. 6 (link)

AMA position on pain management with opioid analgesics (link)

"Model Policy for the Use of Controlled Substances for the Treatment of Pain," Federation of State Medical Boards, May 2004, in pdf (link)

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