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Continued Fallout From DEA Pain Management FAQ Withdrawal

By David B. Brushwood, R.Ph., J.D.
University of Florida
September 01, 2005

The DEA has issued a bewildering "clarification" of their foolishly issued Interim Policy Statement of November 16, 2004. Recall that the agency proudly adopted an extensive Pain Management FAQ in August of 2004, only to withdraw that same document in early October, 2004. The agency justified this abrupt removal of a document laboriously developed over several years, and through many painstaking drafts, by claiming it contained "misstatements," one of which endorsed the prescribing of multiple prescriptions on the same day for patients who did not need to see their doctor every month.

DEA's interpretation that this common, patient-oriented and cost-saving practice is illegal was greeted with sharp criticism from patients, pharmacists, physicians, state regulators, and state attorneys general. These groups all spoke truth to power. The DEA was wrong. This practice is not illegal. It never has been.

In the aftermath of this arrogant move, many of those who prescribe and dispense controlled substances for pain patients were told by DEA representatives that a physician must conduct a physical exam of a patient each time a C-II prescription is issued. I was told this personally by individuals at two DEA field offices, after having been told by health care providers that this incorrect advice was being given out, with accompanying threats of enforcement. Prescribers across the country began to insist that their stabilized chronic pain patients unnecessarily visit the clinic each month for a physical exam to obtain a new authorization for analgesic medication.

Now the DEA has backtracked. In a Federal Register notice issued on August 26, 2005, they tell us we were under the "mistaken impression" that monthly visits for a physical exam is necessary. We were not mistaken. They were. We knew all along this was not required. They are the ones who thought otherwise. Apparently they are now eager to make amends, because this flip-flop has been issued quickly and with a sense of panic. They are apparently afraid to wait for a promised "complete recitation of the pertinent legal principles relating to the dispensing of controlled substances for the treatment of pain." Too many people in high places have taken a close look at them and have not liked what they have seen.

The recent corrective notice is welcome over the short term. It will relieve the burden of monthly travel to a clinic for patients in chronic pain. Prescribers can now feel free to mail monthly C-II prescriptions to their patients or to the pharmacy, as long as the prescriptions are dated when issued. Pharmacists can confidently fill monthly prescriptions mailed to them, or brought to them by patients, even though they know there has been no physical exam correlated with the specific prescription.

Yet, this arbitrary back-and-forth approach to rules interpretation has a distinctly unsettling aspect to it. Do they really understand what they have said? They apparently didn't when they issued the FAQ in August, 2004, or they wouldn't have withdrawn it so abruptly. Could this be more of the same? The agency seems to be in complete disarray. Do they appreciate the full implications of what they have done?

The most recent notice actually says that a C-II prescription for a pain patient can be legally issued without a physician seeing the patient in person. This will be a huge disappointment to prosecutors who have latched onto the absence of a physical exam as the litmus test of an unlawfully issued prescription. Rumor has it that prosecutorial angst brought about the withdrawal of the original FAQ document because it specifically authorized as legal certain activities the prosecutors were using as evidence of illegal prescribing. Perhaps there will be another outcry from prosecutors trying to put doctors in prison for decades as a public show of success in the failed War on Drugs. Will their influence lead to another lame explanation that a "misstatement" has been made?

Of continuing concern is the still effective DEA interpretation that multiple same-day prescriptions (with "do not dispense until ____" instructions) are unlawful. This compassionate practice does not contribute one tablet or capsule of narcotics to the problem of drug diversion. Maybe the agency will recognize their larger error when they eventually issue the more extensive document.

Equally of concern in the recent notice is the incomplete explanation of faxed C-II prescriptions. The notice states that "faxing may be used to facilitate the filling of a schedule II prescription, but only if the pharmacy receives the original written, signed prescription prior to dispensing the drug to the patient." While this statement of a general rule is true enough, the notice fails to include three significant exceptions to the general rule. Within these exceptions, a faxed C-II prescription can serve as the original. When a C-II narcotic is prescribed for a patient undergoing home infusion pain therapy, or when a C-II is prescribed for a patient residing in a nursing home, or when a C-II narcotic is prescribed for a patient in hospice care, the faxed C-II prescription is the original.

Because the DEA did not include this information in the notice, people who take their explanation literally will once again be under what DEA calls a "mistaken impression" about what they said. Patients will be denied medication they deserve and need because all faxes will be considered illegal unless a written, signed prescription is brought to the pharmacy prior to dispensing. In plain language, the DEA has said this is the law and they are wrong.

The DEA seems very awkward when they step outside their traditional realm of illicit drug abuse. They are either not able to evaluate medical and pharmacy practice standards or they don't have the resources necessary to do it well. The time has come for patients, professionals and state regulators to take back the responsibility for developing rules on appropriate prescribing and dispensing of opioids. This has nothing to do with drug diversion. It has everything to do with compassionate care for people who are dying and living in pain. The DEA's relentless intervention in patient care hurts people and it does not prevent drug diversion.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME). For information about ASLME pain policy projects, go to ASLME.