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