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Asking The DEA How To Practice Medicine

By David B. Brushwood, R.Ph., J.D.
University of Florida
April 26, 2006

The official DEA opinion continues to be that multiple Schedule II prescriptions cannot be written for the same drug and same patient on the same day, with "Do Not Fill Until …" (DNF) instructions to the pharmacist written on prescriptions for medications that the patient does not need, or cannot afford, until a time in the future. Health care providers continue to call the DEA asking for permission to issue DNF prescriptions. It is a patient-oriented service that does not contribute one capsule or tablet to drug diversion. Anyone who makes this call will be told that this useful and common practice is now forbidden.

There is no evidence that the DEA is actually enforcing its opinion about DNF prescriptions, and there are good reasons not to enforce it. It is a trivial issue for them because it is unrelated to drug diversion, it is a flip-flop from previous explicit DEA guidance, and it is utterly unsupported in the law. But there is a fear factor that understandably has led some physicians and pharmacists to stop doing what they know to be the right thing to do for their patients, because the DEA tells them to stop it.

The brief history of DNF prescriptions has been told previously on the painandthelaw.org website and it need not be repeated at length. Suffice it to say that the DEA used to instruct physicians and pharmacists to prescribe and dispense Schedule II medications using DNF prescriptions, but a formal endorsement of the practice was withdrawn within weeks of its issuance in 2004, for reasons that likely had nothing to do with the practice itself. The hardline attitude of the DEA likely had everything to do with an aggressive in-your-face DEA posture resulting from Department of Justice prosecutions of physicians and pharmacists, based on the contention that physicians and pharmacists are the primary cause of drug diversion. The DEA attitude has changed since several years ago when the DEA taught that DNF prescriptions were an appropriate way to prescribe, but the law has not changed. Only the DEA opinion of what the law is has changed.

This situation begs two questions. First, "Can the DEA ever be wrong about controlled substance law, or are they always correct in their interpretations even in the absence of clear guidance from statutes and regulations?" Second, "Is it appropriate for health care professionals to ask the DEA to establish standards for the use of controlled substances in patient care, or should health care professionals establish their own standards?"

The first question has recently been addressed by the Supreme Court of the United States in the case of Gonzales v. Oregon. The context of the case was a federal challenge to the Oregon Death with Dignity Act, but the legal principles in the case had nothing to do with physician-assisted dying. The key issue in the case was whether a federal directive interpreting the Controlled Substance Act (CSA) deserves deference when it goes beyond the language of the CSA and its interpretation is inconsistent with specific state law. The Supreme Court ruled that the DEA can be wrong, and in the Gonzales case the Supreme Court ruled that the DEA was wrong. The court specifically held that it is the role of the DEA to prevent drug diversion, but the agency does not have the authority to establish standards of medical practice. The court said:

"The statute and our case law amply support the conclusion that Congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood. Beyond this, however, the statute manifests no intent to regulate the practice of medicine generally."

The Supreme Court has ruled that the DEA, through the Department of Justice, can be wrong in its interpretations of the CSA. The DEA does not deserve uncritical deference when they interpret the law. They are subject to challenge and should be challenged when citizens believe they are wrong.

Is the DEA wrong in its opinion about the illegality of DNF prescriptions? Former Assistant United States Attorney Jennifer Bolen says that they are. Writing in the January/February, 2006 issue of Pain Medicine, Attorney Bolen concludes:

"As a federal agency, the DEA is empowered to interpret and enforce the federal law concerning controlled substances. It may not, however, make law-that is the job of Congress. Even assuming the DEA is genuinely trying to interpret federal law, it lacks legal and logical arguments for its position on DNF prescriptions-a reality it must face."

Speaking truth to power is never easy or comfortable, but it is the right of citizens in a democracy. The Supreme Court has recently invalidated a DEA interpretation of the laws they enforce, and experienced attorneys believe the agency is wrong in their interpretation of the illegality of DNF prescriptions. Citizens have a responsibility not to uncritically accept agency interpretations that lack clear support in the law, have nothing to do with the prevention of drug diversion, and negatively impact the quality of patient care. The DEA may say that DNF prescriptions are illegal, but health care providers simply must ask themselves and each other whether the DEA has gotten it right. Patients deserve no less.

The second question is more fundamental. Asking questions of the DEA about medical practice standards, unrelated to drug diversion, legitimizes the agency as the source of authority on medical standards. There are numerous questions that could be asked of the DEA: How should physical examinations of chronic pain patients be conducted and for how long? What is the maximum dose of morphine to use in a patient who is being treated for pain? What is the drug of choice to treat chronic pain? For what length of time should chronic pain patients be treated with opioids? How many legitimate prescriptions for the same drug may be written on the same day? How can a physician and pharmacist assure a continuing supply of legitimate medication for a patient who is stable and need not be seen for three or six months?

When health care professionals ask the DEA to interpret federal law in areas unrelated to drug diversion, several things can happen. First, there is the risk that the answer will be contrary to the best interests of patients. Health care professionals then are stuck with a restriction on practice that previously did not exist. Alternatively, the answer may be the one that is hoped for, but it may be retracted and replaced with a counterproductive answer years or months later. Asking the agency questions that are not related to drug diversion has the potential to create a monster. It is literally asking too much of the agency, because the promulgation of health care practice standards is outside their authority and beyond their expertise. It should never be done.

There is still room for collaboration between those in health care and those in drug regulation. But the collaboration should focus on the prevention of drug diversion and not on the provision of care to patients. There is no evidence connecting DNF prescriptions with drug diversion. Writing three legitimate prescriptions at the same time is legal. It is not diversion. Writing one illegitimate prescription is illegal. It is diversion. Health care providers and drug regulators should work together to prevent the writing of that one illegitimate prescription, and carefully avoid interfering with the three legitimate prescriptions. Ultimately it is the health care professions who must establish standards for the care of patients. We should be telling the DEA what these standards are, and not asking them to tell us.

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.