DEA's flip-flop on prescribing fuels concern

An abrupt change in the Drug Enforcement Administration's stance on serial prescribing of Schedule II controlled substances has stirred fear among pharmacists and compromised patient care, according to pharmacy leaders.

Within a few weeks of releasing August 2004 document that answered frequently asked questions (FAQ) from healthcare and law enforcement folks about highly addictive prescription drugs that are both medically useful but subject to abuse, DEA without warning removed the FAQ document from its Web site. The document addressed pain medications such as Percocet (acetaminophen and oxycodone, Endo) and OxyContin (oxycodone, Purdue Pharma) but also applied to attention deficit hyperactivity disorder (ADHD) drugs like Ritalin (methylphenidate HCl, Novartis).

Developed in partnership with the Last Acts Partnership and the Pain and Policy Studies Group at the University of Wisconsin-Madison Medical School, the FAQ was hailed upon release as an important resource for providing effective pain relief without contributing to abuse and criminal diversion.

After yanking the FAQ from its Web site, DEA issued in the Nov. 16, 2004, Federal Register an interim policy statement reversing its position on serial prescribing and two other key points. The notice said the FAQ wasn't an official statement of the agency and had been withdrawn because "it contained misstatements."

"For a physician to prepare multiple prescriptions on the same day with instructions to fill on different dates is tantamount to writinga prescription authorizing refills of a Schedule II controlled substance," the interim guidance said.

DEA said it would issue a more complete statement on serial prescribing and other issues. But calls to DEA officials did not yield any estimate of when that will be, or further comment on the interim policy statement.

Many health professionals believe DEA's flip-flop came in response to the drug trafficking trial of a Virginia physician, William Hurwitz, whose attorneys tried to introduce the FAQ into evidence.

But the upshot of DEA's change of heart on the issue is that most pharmacists "won't touch serial prescriptions, even if a patient is going on vacation," said Jennifer M. Strickland, Pharm.D., BCPS. The member of ASHP's pain management and palliative care task force added, "Most people don't want to open themselves to a DEA investigation," so they don't do what's most appropriate for patients.

Susan Bishop, the American Pharmacists Association's associate director of regulatory affairs, said DEA has thrust pharmacists into an uncomfortable position. "It puts pharmacists in the role of looking at patients as potential drug abusers and takes them out of their role as healthcare providers," she said.

Bishop, Strickland, and William Winsley, M.S., R.Ph., executive director of the Ohio State Board of Pharmacy, noted that no federal law prohibits serial prescribing. "DEA should enforce the laws, not make them. That's Congress' job," Winsley said. His board is unusual in that it's still advising pharmacists to continue serial prescribing, when appropriate.

There are instances when "serial prescribing is nothing short of drug trafficking," Winsley acknowledged. But the portion of the DEA interim guidance that equates serial prescribing to authorizing refills of Schedule II substances is "one of the most ridiculous things to come out of a law enforcement agency in a long time," he observed. "A serial prescription is not a refill just because it involves multiple pieces of paper."

Under the interim guidance, Winsley, Strickland, and Bishop pointed out, a prescriber could write a six-month Rx that's easier to divert than a 30-day one because there are more pills for potential illegal sale.

In the early 1990s, the Ohio board first suggested serial prescribing in part to prevent trafficking and to minimize doctor visits by children stabilized on methylphenidates for ADHD.

With the interim guidance, said Bishop, "it seems like DEA is changing medical practice, which is regulated by states. It makes you wonder if it may do the same thing for standards of pharmacy practice, which are also regulated by states."