CONTROLLED SUBSTANCE ISSUES Part 2

The last blog reminded pharmacists that these days we need a CS policy in place.  CS issues belong to the pharmacist on duty, as does the liability.  An agreed upon, settled policy between pharmacists in a pharmacy benefits not only the professionals but also the public.   The policy makes it plain to customers/patients, owners, managers, supervisors, etc., how CS Rxs are going to be treated at your location.

Now let’s move on to those issues that are commonly seen and provide some guidelines for dealing with them.

–What can you change, not change, or modify on a C-II prescription?  Since June of 2005, I have suggested that you print out page 4 of that month’s Kentucky Board of Pharmacy newsletter.  It details what you can change or modify and what cannot be changed or added.  June 2005, reprinted Sept 2010 newsletter.  Print out and post it

–A seemingly big issue right now is whether or not the patient’s address on the sticker placed on the back of the CS Rx meets the requirement for the patient’s address being added to the Rx before filling.  Actually, this is the prescriber’s responsibility.  I am seeing  more computer generated Rxs that have addresses on them, but there are plenty of prescribers who do not put them on the Rx.  The address is required, so if the prescriber does not add it, we must.  What the law states about the address or the prescriber’s DEA being on a sticker on the back versus being added to the front of the Rx blank actually does NOT matter at this point.  Everybody has been doing the stickers for upwards of two decades with no one being sanctioned by the Board or any other entity.  Thus, the government has accepted this practice and WAIVED its right to enforce the law, IF it actually requires the address on the front of the blank.  If the Board told you tomorrow that you were being fined for not meeting the law, a first year law student could get you off.  However, keep in mind that the Board or DEA could announce that they were going to start enforcement at some specific time in the future and then start punishing those who failed to conform after such notice.

–No CS Rxs for a practitioner writing for himself.  No CS Rxs for family members only in case of emergency—going to have to exercise your professional judgment to determine if it is an emergency.  Document your reason if you do fill

–On a partial fill for a CS Rx, can you go over the prescribed amount?  No, a partial fill is less than the prescribed quantity

–Days supply limit on a CS Rx.  The Board opined a couple of years ago that a 90 day supply was OK, even on a C-II.  The law does not address this specifically

–This has been described as a “can of worms.”  The DEA came out with provisions stating that a properly “populated” refill request form can serve as a new Rx for a CS.  Since these forms do not conform to the KY CS security prescription blank of 902 KAR 55:105, can we really use them?  Under a strict interpretation of the law, I would have to say “no” but once again, this is something pharmacies have been doing and the Board has not acted against any pharmacist for doing so.  If the Board gives notice that after a certain date, this practice must be stopped, then stop.  Until then, hard to say that following these DEA provisions is truly illegal.

–Phoned in C-IIs are not permitted in KY.  What if you know the prescriber and have a relationship with the patient and the prescriber is in a state that follows the federal law that states phoned in C-IIs are legal?  No.  If the same type of prescriber inside KY cannot do this, then you cannot accept such an Rx from outside KY

–What about methylphenidate from an APRN in a neurology practice for treatment of MS induced fatigue?  Not more than a 72 hour supply in KY.  The APRN was not associated with a psych doctor or facility, which is required for more than a 72 hour supply of psychostimulant drugs in KY.

–E-prescribed CS Rxs.  Not as bad as you think.  They are legal.  The Rx must have a security statement or notice on the Rx when it prints out.  All required information that should be on a written Rx must be here.  No, there is no prescriber signature required.  Like a phoned in Rx, you must sign all e-prescriptions for CS.  And when you put the sticker on the Rx, do not cover the security statement or notice.  A C-II and you don’t have the drug in stock—you don’t give the Rx to the patient to take elsewhere—have the prescriber issue a new Rx to the other pharmacy

–Can we sell pseudoephedrine products based on our professional judgment and skip Methcheck?  No.  Let me put it this way: when the Board catches you doing this, don’t even call a lawyer.  Just say “bye-bye” to your license to practice.

–CS Rxs “For Office Use.”  NO!  Make an invoice (date, buyer name & address, seller name & address, drug name & strength, quantity, price, etc) and use a Form 222 id C-IIs drugs are involved.

— Post dated CS Rxs remain a problem.  The Board considers these to be illegal Rxs.  I was once told that the Board would probably severely punish any pharmacist caught filling a postdated CS Rx AND then turn the evidence over to the Attorney General’s office to have the pharmacist prosecuted by that entity.  Not worth it. Confiscate the Rxs, inform the prescriber a new Rx must be issued, and if there is an ongoing  problem, call the phone number below

–While we are on the subject, you cannot modify, ignore, or change a “Do Not Fill Until” date, even if the prescriber says you can.  New Rx.

–KASPER reports can now be shared or given to prescribers and the patient

–To dispense a CS Rx, you need the patient’s SSN.  If they do not have one, a driver license number.  If neither, all zeroes.  If a child’s first ADD/ADHD Rx and they have no SSN, fill the Rx but tell the parent/caregiver they have a month in which to get the SSN.  For pets, all zeroes, NOT the owner’s SSN.

–BMI.  You are not required to get a BMI to fill a prescription for an anorexiant.  However, if your professional judgment says to, do so.  I recently had two prescribers ignorant of the minimum BMI for writing phentermine Rxs; one of the patients had a BMI of 22!  The law requires a BMI of 27 for anorexiant Rxs, or down to 25 if there are co-morbidities.  (Manufacturer recommendations for the new drugs, Belviq and Qsymia, are a BMI or 30 or 27 if there are co-morbidities)  Keep in mind that while the Board does not require you to get BMIs, they also would have no problem punishing you if you filled a number of Rxs where patients did not meet the BMI requirements

–Doctors and other prescribers who are prescribing inappropriately or over –prescribing.  Contact DEPPB at 502-564-7985.  This is not the KY Board of Medical Licensure.  These people will investigate.

  1. That is It for now. I was submitted more than this to address and if you are interested and let me know, I will do a Part III in the near future.  Keep in mind that laws change—the above is, to the best of my knowledge, current.  And also remember that where I suggested acts of commission or omission, these are guidelines.  Your professional judgment should rule.

Many thanks to those who asked questions or provided ideas for this blog.

As I wrote at the beginning of the first CS Rx blog, the situation is now a fine balance between taking care of the legitimate patient—and there are a lot of them—versus meeting legal requirements versus unscrupulous prescribers and patients.  Err, even innocently, and you endanger your license.  Be overly cautious and the deserving patient suffers.  There is no easy answer.

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