CHECK THIS OUT CII you can get multiple refiles

Discussion in 'Chit Chat' started by suzetal, Dec 26, 2007.

  1. suzetal

    suzetal New Member

    Same Day Multiple Prescriptions: Clarifying the Bungled DEA Message

    By David B. Brushwood, R.Ph., J.D.
    Professor of Pharmacy Health Care Administration
    The University of Florida

    Doctors and pharmacists across America are bickering about a trivial matter while drugs continue to be diverted and patients in pain continue to be marginalized. What a shame that remedial columns like this one have to be written when there is so much important work to be done treating the disease of addiction and the disease of pain. Because the DEA has carelessly issued an ambiguous and threatening message to doctors and pharmacists, and because the DEA message interferes with the practice of medicine and pharmacy, a clarification (with brief history) is necessary.

    Most opioid analgesics are classified as Schedule II (C-II) under federal law, and prescriptions for C-II drugs cannot be refilled. A new prescription must be presented to a pharmacist each time a supply of a C-II drug is needed by a patient. Many patients travel long distances to see a pain management specialist or other doctor brave enough to prescribe opioid in the current regulatory climate. Because many of these patients simply do not need time-consuming and expensive medical followup each month (because their illness is stable) some physicians choose to provide a three month supply of a C-II drug to some of their patients by issuing three one-month prescriptions at a time and noting to the pharmacist that two of the prescriptions are to be filled later. Insurance will usually not pay for more than a 30 day supply at one time, and it is expensive to purchase three months of medication at once. Furthermore, it reduces the possibility of diversion through theft from patients when a limited supply is dispensed at one time. In some states this practice cannot be done, because C-II prescriptions expire after a period of time, but in most states it is not restricted.

    Prior to the fall of 2004, this practice was specifically authorized by the DEA. On its website, the DEA posted the following (now deleted) message:

    “Question: What date should be placed on a written prescription when multiple prescriptions are written for the same drug for the same patient at one time?

    Answer: The date that should be placed on a written prescription is the date that the prescribing practitioner actually writes and signs the prescription. A practitioner can write multiple prescriptions for a controlled substance on the same day if permitted by state law. These prescriptions must be signed and dated on the day they are written. The prescriber should then indicate on each prescription the directions for dispensing (i.e., “do not dispense before mm/dd/yy).”

    In late August, 2004, the DEA proudly published on its website a document called “Prescription Pain Medication: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel.” This document stated, among many other things:

    “Schedule II prescriptions may not be refilled; however, a physician may prepare multiple prescriptions on the same day with instructions to fill on different days.”

    On October 6, the DEA decided to rescind the entire document. It was a stunning move. Agencies with a recognized mission and effective leadership do not rescind in a matter of weeks documents that took years to produce. No reasons were given. The reasons must have related to some major principle discussed in the document. The real reason could not have had anything to do with something as inconsequential as same-day multiple prescriptions. No diversion is prevented by forbidding this patient-oriented and cost-saving practice. Single prescriptions are just as likely to be invalid as are multiple prescriptions.

    Nevertheless, when the official explanation came out in the Federal Register as an “Interim Policy Statement” on November 16, 2004, the DEA claimed that one of the main reasons it pulled the Pain Management FAQ document was what it called the “misstatement” authorizing multiple same-day C-II prescriptions. This was, of course, a statement that the agency had made for years prior to the fall of 2004. In the Federal Register, the agency claimed that it had now decided that 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.” This is obviously a preposterous position. Writing successive C-II prescriptions for the same patient every month for years is also tantamount to authorizing monthly refills. But it is not illegal. Neither is writing multiple prescriptions on the same day illegal. How could it be illegal if the DEA specifically authorized that it be done only two months earlier, and the law had not changed at all in the interim?

    The DEA has now solicited comments on the withdrawal of the Pain Management FAQ document, including the multiple same-day C-II prescriptions “misstatement.” They are hearing an earful from the public. They are hearing an earful from the Congress. Fortunately, we continue to live in a country where the people have influence, and head-in-the-sand bureaucrats cannot change their mind arbitrarily in a way that results in restricted access to necessary medications, terrible inconvenience for disabled patients for whom travel to their doctor is a huge challenge, vastly increased medical expenses at a time when this is the last thing we need, and no progress whatsoever toward the goal of reducing substance abuse.

    If you comment to the DEA, you will receive a welcome message. It is agency speak for “don’t worry, it is ok.” They can’t come right out and admit a mistake, but they can infer it. And we appreciate it. As we suspected all along, there are some good hearted and good headed people in the DEA who are trying to do the right thing despite an outdated and misguided system that makes their efforts virtually pointless. The letter you will receive in response to your comment says that the solicitation of comments “does not represent any change in the agency’s investigative emphasis or approach.” This means that whether or not the language authorizing multiple same-day C-II prescriptions is ultimately determined to be a “misstatement,” for now the agency will not change its investigation of doctors and pharmacists to reflect the interim policy statement. This only makes sense, because any document labeled “interim” should not cause an immediate change in enforcement.

    The bottom line is that doctors can continue issuing multiple legitimate prescriptions for C-II drugs on the same day and pharmacists can continue filling them. This has never been illegal. Hopefully it never will be. It is a practice that has no effect on the diversion of controlled substances and it greatly relieves the burden on patients in pain.

    Perhaps this silly episode will serve as a lesson to the DEA. They do interfere with medical practice and pharmacy practice. They need to knock it off. Stick to diversion prevention. Leave doctors, pharmacists, and patients alone!


  2. suzetal

    suzetal New Member