Monthly Archives: April 2015

Post Dated Controlled Substance Prescriptions

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.)

Liability With OTCs

Carl Customer comes into your pharmacy and purchases some OTC naproxen sodium.  He is injured from using the product and files a lawsuit.  Does he file it against Pam Pharmacist?  Do pharmacists face liability for the OTC products in their stores?

  1. Carl buys the naproxen without ever speaking to Pam or her even knowing Carl was in the store.
  2. Carl buys the naproxen after receiving counseling from Pam but the harm is a result of a defect in the product unknown to Pam
  3. Carl buys the naproxen after receiving counseling from Pam but the harm is a joint result from a defect unknown to Pam and inadequate counseling
  4. Carl buys the naproxen and the harm is a result of inadequate counseling from Pam.

Pharmacists CAN face liability from the sale of OTC products when the sale results in harm to the buyer/patient.  The probability of liability increases many fold when the pharmacist, who may be just an employee of a chain and has no voice in the purchase of the OTC drugs, has an interaction with the patient that the patient relies on in making the decision to buy.  Bad advice can create the same liability as a prescription dispensing or counseling error.

The two main cornerstones for lawsuits regarding OTC drugs are the same as for prescription medications: errors and failure to counsel.  What kind of errors?  An example would be suggesting aspirin for arthritis for a patient taking blood thinners, ibuprofen for a patient with a history of bleeding ulcers.  Take note: here, the patient has a duty to inform you of health issues or ask you to look over their profile in your computer, though you do need to ask questions.

Let’s look at the examples above.  Liability is least likely to occur in # 1 as there is no pharmacist interaction.  However, lawsuits have been won against pharmacists and pharmacies that a) did not pull recalled products, b) did not pull expired products, or c) did not pull products with recent bad publicity.  The importance of a and b you already know.  With c, these cases can be hard to win for the patient; bad publicity is not often enough reason to pull a product but it has been sufficient in some cases.

In # 2, liability is also not likely to attach to the pharmacist.  Packages are sealed so we cannot look at the tablets inside.  Even if we could, there is no likelihood that we could know naproxen tablets had 3 times the active ingredient as listed on the label just from a visual inspection.  A manufacturing error will be a problem for the manufacturer, not the pharmacist.  Liability attaches when the pharmacist becomes aware of the manufacturing issue and does not immediately act to remove the OTC from where the public can get to it.

With # 3, liability attaches to Pam.  Even if she was unaware of the manufacturing issue, her inadequate counseling caused Carl to buy a product he should not be using.  EG, Pam failed to counsel Carl to avoid other NSAIDs while taking the naproxen.  The extra high dose in the naproxen plus the other NSAIDs causes GI bleeding.  Pam and the manufacturer share fault.

Finally, liability almost attaches for sure.  Bad, wrong, or inadequate counseling that results in harm is a serious matter, as we all know.  Time to call me and/or your malpractice carrier.

In counseling for an OTC product, always refer the patient to the package information.  This may save you, or help somewhat, if your counseling fails to cover every aspect of the patient’s concerns.  Also, point out the lack of FDA approval is there is none.  Your liability falls when the government has such disclaimers on the packaging.  Make the patient verbally acknowledge this.  Finally, like prescription counseling, always end your spiel with “Do you have any more questions?”  You are tossing the ball, and a lot of the responsibility, back onto the patient.

What should be covered in counseling?  The same points that are required by state law in prescription medication counseling.  Follow those points and the liability possibility shrinks substantially.

The majority of the buying public first purchases an OTC product at a location that has a pharmacy, thus showing an implicit reliance on the presence of the pharmacist that the product is good, safe, and effective.  Pharmacists, even if they are employees of a chain and have no say in front end purchasing and stocking, still have the possibility of liability from the public’s purchase of these products, all the more so when the pharmacist is consulted prior to buying.   Approach an OTC consultation with the same professionalism as with a prescription.