Are You Practicing Legally?

My law practice takes me inside a lot of pharmacies. Also, pharmacists have been e-mailing or calling me for years with legal questions. This has increased substantially in volume in the last few years. I put this down to increased pressures at work from larger workloads as well as government and third party oversight. From what I observed, these pharmacists were performing his/her duties to the best of their knowledge, but not quite in compliance with the law. Many times when I spoke up, the reply was, “I didn’t know that” or “I thought my way was correct.” These pharmacists were trying to do the right and legal thing; most often, they were simply unaware of a new or change in the law.
The following is a list of the top ten issues I encountered in that time period. Please remember that this is a general overview and should not be relied upon as specific legal advice for a specific set of circumstances. Also keep in mind that the law changes. Everything mentioned below is subject to change, possibly even before publication.

1. Faxes for controlled substances. These are legal; I just have never seen it done right. The correct way to receive a faxed CS Rx is that the prescriber must fax the Rx using a KY controlled substance blank. The blank must have the word “Faxed” written on it as well as the name of the person sending. The pharmacist must sign.
But I saw numerous faxes on regular paper or prescription forms that did not meet the KY requirements. When these come through, the pharmacist must get a verbal Rx from the prescriber, writing “Confirmed by Sandy, John Smith, RPh” or simply rewriting the Rx onto another blank. But I saw numerous Rxs being filled without any notation that the prescriber had been contacted and I rarely saw a pharmacist signature.
Someone is going to argue that faxing a KY CS blank will bring out the latent “VOID” pattern and most Rxs will be difficult, if not impossible, to read. True. Still, this is the law, until the Board makes changes.
2.At the time of this writing, receiving CS Rxs by e-prescribing is allowed in KY.  Look for a safety verification stamp as part of the Rx.  if it is not there, confirm by telephone with the prescriber and take as a verbal. Watch out! Most e-prescribing programs do not recognize tramadol as a CS, because it is not a CS by any federal standard (yet).  What most pharmacists fail to do here, even if it is legitimately sent, is to sign the e-Rx for a CS.

3.APRNs can only write for a 30 day supply of ADD/ADHD drugs if they are associated with a psychiatrist, psych clinic or mental health facility. Otherwise, if the APRN is not so associated, you may fill the prescription but just for a 72 hour supply.

4.Physician Assistants may only practice when in the same facility as their supervising physician. A prescription called in after hours from the PA’s home (I even had one stop by my pharmacy) is of questionable legitimacy. Keep in mind that your liability will go through the roof if the Rx causes harm and it is discovered the PA wrote it when not in proximity to the supervising physician.

5.Going in early and staying late to handle the prescription load? While this is laudable…. Stop. Most malpractice insurance policies will not cover you for errors made when the pharmacy is not open or you are not on the clock. Check your policy before engaging in professional duties outside posted hours. If you call and ask your insurer about this and someone tells you that you are covered, do not take their word for it—get it in writing.

But what if closing time comes and you are in the middle of filling a prescription?  Your malpractice remains in place for “carryover,” work that is begun before closing time and extends a short time after.
6.The minimum BMI for an anorexiant prescription is 27 (25 with associated co-morbidities). Few prescribers seem to know this—I argued with one doc who prescribed for a patient whose BMI was 23.6 (she wanted to lose 5 pounds to fit into her wedding dress, the story from the doctor went!). If you see the patient, you can make a judgment call. But I suggest requiring the prescriber to supply you with the BMI before filling.

7.What can you change, add or modify on a controlled substance prescription, especially a C-II? A very complicated issue over the years. In September 2008, the Board newsletter included an excellent article spelling out just what can be added, modified, etc. I suggested then and continue to suggest that every pharmacy print out that article and keep it on a bulletin board for easy reference. It Is available on the Board website under “Newsletters.”

8.C-II prescriptions where the third party will not pay for the entire quantity prescribed. Can you make a second fill for the remainder and let the patient pay cash? Yes, IF your computer system assigns the same Rx number to the prescription. If the computer will not do this and instead assigns a different Rx number, you may not do the cash partial fill. A C-II prescription cannot have two numbers assigned to it. (This is not a discussion of the 72 hour partial fill in cases where the patient cannot afford the entire prescription or the pharmacy does not have the entire amount in stock, but these situations do also require a single prescription number.)

9.Interns may give or take transfers of prescriptions, but the prescriptions may not be for controlled substances. Those, per the DEA, must still be done by pharmacists.

10.Professional judgment trumps the policy of an owner, corporation or even the PIC. If a decision is made on the basis of professional judgment, that decision belongs to the pharmacist on duty and no one else. The example I am most asked about is displaying and/or selling pseudoephedrine products. If in a pharmacist’s professional judgment, these should be hidden rather than displayed, that pharmacist’s decision overrules an owner’s policy to display.  I plan to cover PIC/professional judgment vs. employer/owner in more detail in the near future.

5 thoughts on “Are You Practicing Legally?

  1. Another great post, Dr. Cohron. Thanks!

    In regards to #1, it dawned on me a few months back that the typical pharmacy chain “Refill Requests” (you know, the ones that get sent over to a doctor’s office on regular printer paper, written and signed by MD…if you are lucky…approving refills, then faxed back to the pharmacy to be filled) these are in NO WAY legally compliant with KY controlled substance prescription requirements (902 KAR 55:105 Section 4). If it’s faxed, it has to be on a security blank, period. I admit I probably signed (without calling to verify) and filled thousands of these refill approvals when practicing retail; it was/is the standard of practice. Seriously, who has time to call back on every faxed CS refill approval? Pharmacists should probably stand up and say “these are not legally compliant and we will no longer bear the burden.” And hey, I now work in Drug Enforcement, so if I am aware…

    In regards to #2, I strongly urge all pharmacists to review the DEA website for FAQ’s on Electronic Prescriptions for Controlled Substances (EPCS).

    http://www.deadiversion.usdoj.gov/ecomm/e_rx/

    For example, a pharmacy is not allowed to process EPCSs unless BOTH the MD prescribing application (software) AND and the pharmacy dispensing application (software) have been audited OR certified as meeting the DEA requirements. If you are not sure if the software systems meet the requirements, ask the prescriber/pharmacy for the audit report or certificate. Further, there are details on how to handle failed electronic transmissions or transfers of electronic prescriptions. Pharmacists need to know this stuff!

    Finally, in regards to #3, many pharmacists don’t know how to verify if an APRN is “certified in psychiatric-mental health nursing” in order to write 30 day supplies for psychostimulants. You can find this information on the KY Board of Nursing website (www.KBN.ky.gov) by looking up/validating the nurse’s license. When you pull up the license, look for “Population Focus:” If it says “PSY/MENTAL HEALTH” then they are certified. If it says anything else, they are not…most say “FAMILY”. The direct link for license validation is listed below:

    https://secure.kentucky.gov/kbn/bulkvalidation/basic.aspx

  2. Additional info on #4 please:

    Does a PA have to physically be in the same building as a supervising DO or MD? What if it is just a PA and APRN working in a building together, if that building is owned/operated by a hospital group with physicians? Where I am at there was an office that only had an APRN, and now has a PA too. As far as I know there is not a physician present in the building with them.

    1. PAs can only work when their supervising physician is “under the same roof” or “on the premises.” APRNs and PAs cannot work together without a PA-supervising physician also there. APRNs can work in locations by themselves and the Legislature is looking at doing away with Collaborative Care Agreements after an APRN has worked so many years, but that has not been OK’d yet. If there is no physician there, what the PA is doing is illegal. Watch yourself. You can be held liable for filling the PA’s rxs.

      1. Update. It seems at the last meeting of the KY Board of Medical Licensure that PAs practicing without their supervising physician “on the premises” is now OK so long as the SP can be reached immediately. However, this does not make up for the past. My concern over this situation is lessened but only slightly

  3. I don’t know the full details, but it concerned me as well when the PA started about a week ago. The building has 4-5 suites, and I don’t know if the official supervising physician is in one of those other suites or not.

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