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DEA proposes easing restrictions on Schedule II drugs

In a recently issued policy statement, the Drug Enforcement Administration proposed a new rule that would ease current restrictions on prescribing Schedule II controlled substances. Under the new rule, doctors will be able to prescribe 90-day supplies of Schedule II medications such as OxyContin (oxycodone, Purdue Pharma), methylphenidate HCl, and codeine. The public can submit comments about the new rules through Nov. 6.

"We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment and studied their concerns carefully," explained DEA administrator Karen P. Tandy in a written statement. "The policy statement reiterates DEA's commitment to striking the proper balance to ensure that people who need pain relief get it, and those who abuse it, don't."

The proposed change is designed to make it easier for patients with chronic pain to avoid multiple doctor visits. Physicians will be permitted to prescribe up to a 90-day supply of Schedule II drugs during a single office visit, when medically appropriate. Doctors can write a single prescription or multiple Rxs, as long as the total does not exceed a 90-day supply. The Controlled Substances Act (CSA) does not permit refills.

The changes came about as a result of a concerted effort by pharmacists and doctors to clarify the DEA position. "We are extremely pleased with the turn of events," said Kevin Nicholson, R.Ph., J.D., VP of pharmacy regulatory affairs at the National Association of Chain Drug Stores. "We're glad DEA recognizes that the earlier rules were an unnecessary inconvenience. In some ways, these rule changes will provide more oversight over patients."

The American Medical Association was also pleased with the new rule. "Relieving suffering while doing everything we can to prevent the abuse of controlled substances reflects appropriate patient care, a standard that's easier to achieve when a strong patient-physician relationship exists," explained Rebecca J. Patchin, M.D., an AMA board member, in a written response to the new rule.

The new rule is the result of a long, slow process to update the existing rules governing Schedule II drugs. In September 2001, the agency committed itself to a "balanced policy," which aimed to give equal measure to both the enforcement of abuses and the legal use of controlled substances. In February 2004, DEA issued an interim statement and invited feedback.

The challenge has been to control nonmedical uses of controlled substances without adversely impacting patients with true medical need. Abuse of Rx drugs appears to be a growing trend. According to the recent National Survey on Drug Use and Health by the Department of Health & Human Services, prescription drugs are now the second-most commonly abused drugs, behind only marijuana. In 2004, the survey noted, 2.4 million people used Rx drugs for nonmedical reasons. In another study, by the University of Michigan, in 2005 9.5% of 12th graders reported using Vicodin (acetaminophen; hydrocodone bitartrate, Abbott) during the previous year and 5.5% reported using oxycodone during the same period.

One of the side effects of the increased misuse of Rx drugs has been a tendency to underprescribe controlled substances. In 2004, the Federation of State Medical Boards of the United States noted that a significant body of evidence suggests that "both acute and chronic pain continue to be undertreated." The group attributed the problem to a lack of knowledge of medical standards, current research, and clinical guidelines for appropriate pain treatment; fear of undue scrutiny by regulatory authorities; misunderstanding of addiction and dependence; and a lack of understanding of regulatory policies and processes.

In its statement, DEA noted that it would not indicate when prescribing controlled substances was and was not medically appropriate. The agency noted that its authority under the CSA is "equivalent to that of a state medical board" and that the agency "does regulate the general practice of medicine."

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More than 8,000 prescriptions electronically filed in the eRx Collaborative system were changed this June as a result of drug-drug or drug-allergy alerts. The eRx Collaborative initiative is a consortium created by Blue Cross Blue Shield of Massachusetts, Tufts Health Plan, and Neighborhood Health Plan to spur e-prescribing in the state. It includes 3,400 prescribers. The 8,000 prescriptions represented 2% of the approximately 400,000 total electronic Rxs filed in June. In fact, as a recent study from the Medical Records Institute noted, avoiding drug allergy was the prime use for e-prescribing, followed closely by access to drug reference information.

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