Monthly Archives: August 2015

Kentucky’s Buprenorphine Regulation–What Pharmacists Need to Know

THE FOLLOWING BLOG ENTRY ADDRESSES A KENTUCKY PHARMACY REGULATION.  READERS FROM OTHER STATES SHOULD STILL BENEFIT FROM READING

201 KAR 9:270 is Kentucky’s new regulation promulgated to oversee and direct prescribing and dispensing practices for the use of buprenorphine and buprenorphine-containing products.

The use of these drugs is increasing almost exponentially.  On the downside, so is the misuse and abuse of buprenorphine.  As much as the opioids buprenorphine is used to treat, the drug has become a means of accomplishing the euphoric state addicts seek, and thus has become a more than suitable substitute for many abusers.  Pharmacists have substantial concern that these drugs be dispensed without creating liability for them, that concern increasing following the decision by the West Virginia Supreme Court that addicts—albeit under specific circumstances—can sue pharmacists who help cause and/or contribute to their addiction.

The regulation looks to help pharmacists with proper and safe dispensing.

Section 1 deals with the requirements of physicians to obtain the necessary education and certification to obtain and maintain the ability to treat opioid addiction and prescribe buprenorphine products.  Pharmacists will know that a prescriber is so certified in that the prescriber will have a DEA number for such prescribing beginning with an “X”.

Two questions that arise frequently.  First, what if the buprenorphine is prescribed for opioid addiction but there is no X DEA number on the prescription?  In the recent past, in response to my question on this, the Board stated that if the X DEA number was not on the prescription blank, it could not be filled.  Can a pharmacist call the prescriber and add the X DEA number? I understood that this could not be done and I still send prescriptions back to the prescriber for him/her to add it.  If this occurring in your practice, unless and until the Board permits otherwise, I would suggest a few prescriptions with the prescriber adding it but then demanding it be pre-printed along with all the other required information.

Section 2 goes on to detail prescribing and dispensing standards:

–transdermal buprenorphine shall be prescribed only for pain

–buprenorphine as a mono-product, with no other ingredient such as naloxone, shall only be prescribed and dispensed to pregnant women, patients with a DEMONSTRATED (not just stated) hypersensitivity to naloxone, and as an injectable in a doctor’s office or health care facility.  This SEEMS to indicate but does not definitively state that injectable buprenorphine may not be dispensed by a retail pharmacy.

–buprenorphine shall not be dispensed with benzos, other hypnotics or opioids.  Under special circumstances, the drug may be dispensed with one of these other drugs but for no longer than 30 days.  Thus, if you do have a patient who receives prescriptions for both, all refills and future prescriptions for these other drugs should be refused.

Section 2 continues to cover what information a prescriber must obtain from the patient, do a KASPER, required blood tests, random and scheduled drug screens, counseling, etc, prior to prescribing buprenorphine.

Pregnant or breastfeeding patients must have the consent of two prescribers before prescribing buprenorphine.  Pharmacists aware of either of these two conditions have no legal duty to obtain the name of the second consenting physician, but might consider doing so as protection against liability.  Injured or malformed babies tend to affect juries in a manner that causes them to write big checks for the child—any and every defending health care professional will need every bit of evidence in their favor.

Prescribing buprenorphine has the additional requirement that the patient enter counseling or engage in a 12 step addiction program.  Pharmacists aware that a patient is not taking part in these should not immediately refuse prescriptions or refills but should inform the prescriber.  Refusal should follow only if the prescriber fails to follow up or the patient refuses to re-enter the counseling and/or program.

After beginning buprenorphine therapy, the patient must be seen by the prescriber at least every ten days for the first month and at least every fourteen days during the second month, then at least monthly thereafter.  Pharmacists aware of a patient’s status (new to therapy, in the first month, in the second month, etc) should not dispense more than enough medication than needed to get the patient to the next appointment, no matter what the prescription indicates.

Patients must be re-evaluated no later than every three months.  As I have long advised, I see no reason for a pharmacist to refuse a prescription three months after the start of therapy, but I do recommend a status report from the physician at least every six months, with emphasis on this if the patient is not seeing any reduction in the dose of the drug.  If the daily dose is 16 milligrams or above, the patient must be evaluated every year by a second physician to justify the continuance of that dose.  Remember, buprenorphine can be prescribed as a maintenance medication (I do have a little problem with this); even so, the pharmacist should be making routine inquiries of the prescriber and writing notes on the prescription.

A pharmacist related to me a few days ago that she contacted the Board about the second physician evaluation requirement and was told that this was beyond the acts necessary of the pharmacist, that this was the responsibility of the prescriber.  As far as any legal requirement goes, I agree.  But, in terms of that devil “liability” and the West VA Supreme Court ruling, I think pharmacists are better advised by doing more.

NOTE: Buprenorphine can be prescribed off-label for pain, and this includes other healthcare prescribers, such as APRNs.  Be wary of this.  I advise getting a diagnosis from the prescriber and writing it on the face of the prescription blank.  If the prescriber refuses to share the diagnosis, refuse the prescription.  And, the pharmacist needs to scrutinize the patient profile as time goes by—if it seems the prescriber is trying to circumvent the requirements of this regulation, report the prescriber immediately upon reaching a reasonable suspicion.

What do I advise beyond what I have stated above? 1) If you have a buprenorphine patient for over a period of time (six months, nine months, a year—whatever your professional judgment calls for), keep a file on the patient beyond their prescription profile.  Get a copy of the agreement between patient and presciber, and request a copy of patient evaluations regularly.  2) Watch dispensing.  Many patients purchase doses daily, every few days, every week.  Set a weekly or monthly limit and make sure that what is dispensed over that time period does not exceed the daily dose   Many of those who abuse or misuse the drug can be and are caught through their purchasing habits.  Keep in mind that failing to do this would be a substantial piece—if not THE substantial piece–of evidence against you in a lawsuit.

The Board has promulgated an extensive regulation that should significantly aid physicians and pharmacists in seeing that buprenorphine is prescribed and dispensed correctly and wisely.  Still, pharmacists must consider not only following the law but avoiding liability, and the latter calls for pharmacists to be pro-active

Zero Tolerance and the Fifth Amendment

Question.  My son started pharmacy school recently.  In the materials sent by the college, there was a mention of the school’s zero tolerance program, that if the applicant had been convicted of any crime there was no use sending in the application. On the application, there was a space for a “yes” or “no” to be checked after the question: “Has the applicant ever been convicted of any crime, except for a traffic violation?”

I (the parent) told him to answer “no.”  The incident—a DUI (alcohol) arrest–took place more than two years before he filled out the application.  He was punished by me and the court; after this wake-up call, he turned his life around.  And—here is my legal question—wasn’t it a violation of his Fifth Amendment right against self-incrimination to have to reveal this?

As you can guess, the school of pharmacy did a background check that was not completed until after classes started (delayed due to computer glitches).  Now, the college has informed my son that it has begun the process to expel him.

 

The first thing I did upon receiving the question above was to get more facts from both the college and the parent.  The college was seeking to expel the young man on the basis of having lied on his admissions application, not for the DUI.  This made the case harder.

But not impossible.  I told the parent to engage counsel as quickly as possible.

Was this a Fifth Amendment violation?  The 5th Amendment requires the government to prove a criminal case against the defendant without the aid of the defendant as a witness against himself.

First, the college will claim that it is not the government.  True.  However, in cases regarding funding and other criminal matters, entities such as state run universities and colleges have been found to be so closely tied to the government as to be an agent of the same.  I think the college will lose here.

But is this association so great that it provides the college with police powers?  Actually, yes.  The power to punish or sanction—suspend or expel—has been found to be analogous enough to be comparable with police powers.

Second, the college will claim that this is not a criminal matter.  This argument should also fail.  The college will say that it is not a court of law.  Courts have extended the venue from custody by any entity with police powers to “giving testimony in a trial or other legal proceeding….”  The application process is most certainly quasi-judicial in that it promises action for acts that are false and/or misleading.  Expulsion surely ranks among the varied definitions of “punishment” or “sanction” as defined by the courts.

Third, the college will claim its application is analogous to a job application in the private sector.  In the work environment, especially where there is little to no government funding involved, it is almost always legal to ask these questions on an employment application.  Especially in a pharmacy, asking questions about prior criminal acts and terminating those who lie about such acts has been upheld more often than thrown out, the thought being that we want to strongly prevent access to controlled substances by those likely to divert, steal, etc.  If the young man’s crime had been linked to drugs, his case would likely fail.

But since his crime was alcohol, we return to the question: is the college’s expulsion policy a violation of the young man’s Fifth Amendment right against self-incrimination?  The answer is “I do not know.”  In the three areas mentioned above, it is easy to find cases where courts have gone both ways.  But it seems that it can be argued strongly that it is a violation.  The application requires information to be provided that subjects the applicant to “criminal prosecution” in the form of expulsion or denial of admission (though denial is much harder to fit the description of punishment).  Forcing the applicant to reveal this information has the appearance of ignoring that person’s right to not incriminate himself.

This argument is strengthened by the fact that the college has—and employs—other means to ascertain this information: the detailed background check.  If this were not available, the case would be harder.  That the check was delayed until after classes had begun is an issue for the college, not the applicant.  If the expulsion holds up, the young man should be able with little problem to get the return of all tuition and fees paid.

 

A short editorial moment.

I do not agree with the growing trend of colleges (not just pharmacy) to adopt this “zero tolerance” attitude toward applicants and those who engage in any “youthful indiscretion” while in a professional program.  We as a people are as much the result of our mistakes and foibles as we are our good grades and community service.

Should we stop listening to Elvis Presley because he misused and abused controlled substances?  Should we eliminate George Washington from the history books because he was a prolific philanderer?  While I do not condone these activities, I merely suggest that only opening up the professional path to the unsullied will deny us many excellent professionals, persons who have as much, if not more, to offer because of their mistakes.

I have represented pharmacy students with four state boards of pharmacy and one college of pharmacy. In all the cases, I managed to persuade the boards and college to keep the person licensed or in school.  One is now a department head in a university hospital, two are PICs, and the others are licensed and working.

I am lucky that I was rarely caught and never caused harm when I engaged in “youthful indiscretions.”  I am grateful also that most of them occurred as they helped me who I am.  A zero tolerance policy in my day and this attorney/pharmacist/(retired) college professor would not be writing this blog.

How should these youthful indiscretions be handled?  By looking at the rest of the application and seeing what else the applicant has to say about him or herself.  And then by an in-person interview to judge that the indiscretion has indeed been used by the applicant to better him or herself.