In late 2007 the US Drug Enforcement Administration promulgated 21 CFR 1306.05 which stated that controlled substance prescriptions (CS Rx) must be dated the day they were written. Postdated prescriptions were no longer permitted. From that point on, if a prescriber desired the CS Rx not be filled for a specific period of time, the CS Rx would have to be dated the day it was written and the caption “Do Not Fill Until ____” added to the prescription. The federal regulation continues “A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.” In short, pharmacists filling these CS Rx are in violation of the law.
In Kentucky, postdated CS Rxs, the Kentucky Board of Pharmacy told me, are considered to be illegal prescriptions. Upon receipt of them, pharmacists should destroy them.
Despite this regulation, more than seven years later a substantial number of prescribers still postdate CS Rx. For various reasons—not offending the prescriber, not wanting the patient to have to make a second trip to the doctor for a new Rx—many pharmacists still receive these and fill them when due, on the date on the Rx. These are placed in a drawer or otherwise hidden and kept until due. The attitude of many pharmacists is “I’m not likely to get caught.”
Maybe not. But the practice of taking and keeping these Rxs must be stopped. The danger of getting caught may be increasing and the probability of an end to a career is now very very real.
What has changed? Mainly, the federal and state oversight agencies are more than a little upset that prescribers and pharmacists continue to ignore the law. The DEA told me that it is looking into sending out a message later this year to state boards of pharmacy asking that pharmacy inspectors make “heightened efforts” to find postdated CS Rx during routine inspections. In addition, the federal administrative agency is considering prosecuting pharmacists (and prescribers) that are caught, even if state agencies do so too.
(For you armchair attorneys, different sections or branches of government may prosecute individuals for the same crimes or violations without violating the doctrine of double jeopardy.)
On the state level, two state boards of pharmacy are looking into more aggressive inspections. The “open drawer” policy is just that: pharmacy inspectors would open drawers during their routine inspections to look for hidden postdated CS Rx.
In Kentucky, pharmacists need to note two things: first, the Board told me that a pharmacist caught with these prescriptions would face prosecution by the state attorney general as well as the Board. The theory propounded to me was that the pharmacist would be prosecuted for practicing medicine without a license. This carries the likelihood of a jail sentence as well as a substantial fine. Second, after that, the Board would also prosecute the pharmacist.. What that punishment would be the Board did not say. However, I was reminded that the recent passage of House Bills 1 and 217 called upon the Board to have the ability to invoke a lifetime license revocation for violations regarding controlled substances.
Checking with other states, the same situation exists. The atmosphere is charged over CS Rx and controlled substances in general, as it has been for a while. Taking strong action against pharmacists in violation of the federal postdating regulation seems to be the direction of all. A pharmacy board member from a Midwestern state told me that that state board would not be considering anything less than a five year suspension and it would also be referring violators to the state attorney general, who would then prosecute pharmacist and prescriber for distribution of controlled substances without a prescription. A southern state attorney general has stated that his office would add conspiracy to the distribution charge and prosecute for both.
Again, what has changed? State and federal government recognize the many and ongoing issues related to CS Rx. Seven years of failing to meet and abide by federal postdated CS Rx law has raised more than a few eyebrows. Maybe the chances of getting caught is not that high, but now pharmacists must face the probability that if they are caught, their careers will more than likely be over. In addition, state or federal prosecution could lead to jail time and a huge fine. It is (past) time for the profession to conform its performance regarding CS Rx to the law. Filling these is no longer worth the risk.
What do I suggest? When I get a postdated Rx these days, I circle the date, write on the face of the Rx “Received on (actual earlier date),” and add a comment about being postdated and being illegal to fill. I have a one page note on the CFR referred to above that I staple to the Rx and then I send the patient back to their prescriber. This is not destroying the prescription as directed by the Kentucky Board, but I want to ensure the prescriber the patient has not filled the CS Rx elsewhere. (If you want a copy of the message, e-mail me and I will provide it.)