Board News and Announcements
NCBOP APRIL MEETING CHANGE -
The NC Board of Pharmacy's April meeting has been moved back one week and will be held on Tuesday, April 24, 2018.
THURSDAY, APRIL 19, 2018
*REMINDER* DEA POSITION ON TRANSFER OF “ON FILE” CONTROLLED SUBSTANCE PRESCRIPTIONS. Pharmacists continue to call Board staff with understandable confusion on whether and how “on file” controlled substance prescriptions that were never filled may be transferred. To recap:
In April 2017, word began swirling that DEA viewed transfers of “on file” controlled substances as not allowed. On July 7, 2017, Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration sent an email to Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy, setting forth DEA’s view on the matter.
In that email (found here -- http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf), Mr. Miller states the view that 21 CFR 1306.25 allows a pharmacy, “once it has filled an original prescription for a controlled substance in Schedule III-V,” to “transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . .” Mr. Miller further stated that “an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.”
Mr. Miller then stated that, based on “the preamble” of an “interim final rule,” it is DEA’s “policy” that an electronic prescription for a controlled substance of any schedule may be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy” even if that prescription had not been filled.
To say that DEA’s positions in this matter create a mess is a gross understatement. First, while Mr. Miller’s reading of 21 CFR 1306.25 is textually plausible, it represents a departure from decades of standard pharmacy practice and there has been no suggestion from DEA or anyone else that the standard practice of transferring “on file” but unfilled (as opposed to once-filled) controlled substance prescriptions has caused or materially contributed to controlled substance abuse or misuse. Second, neither Mr. Miller’s email nor any language in the preamble he references contains so much as a hint as to what an appropriate mechanism for “forwarding” (and documenting the forwarding of) an unfilled electronic controlled substance prescription would be. Third, Mr. Miller’s email does not explain why “forwarding” an unfilled electronic controlled substance prescription is substantively different than transferring an unfilled controlled substance prescription, whether electronic, verbal, or written. Fourth, DEA’s position creates not only an incentive, but a practical necessity, for patients seeking to change their pharmacy of choice to obtain duplicate controlled substance prescriptions from their caregiver. Interpretations and policies that guarantee duplicate prescriptions for controlled substances in multiple pharmacies hardly seems consistent with the Controlled Substance Act’s purpose to create a controlled, closed distribution system and minimize controlled substance abuse and misuse.
All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us?
(1) Though “forwarding” of unfilled electronic controlled substance prescriptions is available by “policy,” the lack of any guidance from DEA on how a “forwarding” should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them?
(2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA’s position means that there is no mechanism for moving them from one pharmacy to another.
(3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach.
Some pharmacists have inquired why Board staff, the Board, or the North Carolina legislature have taken this position. As the above makes clear, none of the three are to blame. The present state of affairs is attributable solely, and entirely, to the DEA. Board staff will, of course, update pharmacists if the DEA sees reason and backs away from these positions. Until then, send your cards, letters, and calls to the DEA.
MONDAY, APRIL 9, 2018
DEA WARNS PUBLIC OF EXTORTION SCAM BY DEA SPECIAL AGENT IMPERSONATORS
DEA is aware that registrants are receiving telephone calls and emails by criminals identifying themselves as DEA employees or other law enforcement personnel. The criminals have masked their telephone number on caller id by showing the DEA Registration Support 800 number. Please be aware that a DEA employee would not contact a registrant and demand money or threaten to suspend a registrant’s DEA registration.
THURSDAY, MARCH 15, 2018
FDA REQUIRES STRENGTHENED WARNINGS ON LABELING FOR CODEINE-CONTAINING PRODUCTS AND TRAMADOL PRODUCTS
In fall 2017, the U.S. Food and Drug Administration required manufacturers of codeine-containing and tramadol containing products to strengthen warnings on those products’ labeling. Specifically, FDA has advised that children younger than 12 should not take codeine-containing products to treat pain or cough, and children younger than 12 should not take tramadol products to treat pain. FDA also warns that children younger than 18 should not take tramadol products to treat pain after surgery to remove the tonsils (tonsillectomy) or adenoids (adenoidectomy). Finally, FDA warns that youths ages 12 through 18 who are obese, have obstructive sleep apnea (blocked airflow during sleep), or have a weakened respiratory system should not take codeine-containing products or tramadol products.
More information is located here: https://www.fda.gov/forconsumers/consumerupdates/ucm315497.htm
THURSDAY, FEBRUARY 22, 2018
OPIOID PUBLIC SERVICE ANNOUNCEMENT CAMPAIGN - ADS AVAILABLE FOR DOWNLOAD
Beginning February 8, 2018, the Board of Pharmacy opened an opioid public service announcement campaign on Wilmington and Greenville-area television stations and on social media platforms. The advertisements feature Joe Adams, a pharmacist and past president of the National Association of Boards of Pharmacy, sharing his deeply personal story of losing his son to an opioid overdose in 2014. These ads emphasize the important of obtaining help and the critical role pharmacists can play.
The ads come in 30-second, 60-second, and 6-minute versions, and are available for download here. Board members and staff welcome and encourage pharmacists using these ads to educate their patients and communities about proper medication use and the dangers of opioid abuse.
The Board thanks Third Wheel Media of Chapel Hill and the National Association of Boards of Pharmacy (NABP) for their tremendous efforts on this issue. Pharmacists will note that texting “abuse” to 555888, as instructed in the ads, will result in a reply text providing a link to an NABP-created and hosted page containing resources for pharmacists to share with patients and their communities. That page may be accessed directly here: https://nabp.pharmacy/homepage/prescription-drug-safety/.
These ads are the first phase of a multi-media campaign. Board staff will continue to keep pharmacists updated as the campaign progresses.
Please contact Board staff at 919.246.1050 with questions.
MONDAY, FEBRUARY 12, 2018
BOARD OF PHARMACY GUIDANCE TO CONSUMERS ON SAFE DISPOSAL OF UNWANTED OR UNNEEDED MEDICATIONS. Board staff often receive questions concerning safe medication disposal. This guide provides guidance on safe disposal methods, as well as links to helpful resources. Staff thanks Vera Reinstein of Alliance Behavioral Healthcare and Nidhi Gandhi of the Wingate University School of Pharmacy for leading the effort to create this guidance leaflet.
FRIDAY, FEBRUARY 2, 2018
UPDATE TO NORTH CAROLINA PHARMACISTS ON TAMIFLU (OSELTAMIVIR)
AVAILABILITY. During this season’s flu outbreak, several pharmacists have contacted Board staff inquiring about potential shortages of Tamiflu (oseltamivir).
The Food and Drug Administration maintains a list of shortage drugs, found here: https://www.accessdata.fda.gov/scripts/drugshortages/.
As of this writing, brand name Tamiflu is not on that list. While some pharmacies may have experienced short-term supply crunches from a particular wholesaler, those are due to local demand issues, and not due to an overall shortage of the drug.
The Centers for Disease Control and Prevention (CDC), however, report shortages of generic oseltamivir: https://www.cdc.gov/flu/professionals/antivirals/supply.htm
The FDA has provided contact information for manufacturers of brand and generic osemtamivir manufacturers here: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM593462.pdf
If Tamiflu or oseltamivir is in shortage, FDA permits pharmacies to compound an oral suspension from capsules. UNC Healthcare has assembled an extremely helpful guide to oseltamivir oral suspension compounding, which is found here: http://www.ncbop.org/PDF/TamifluCompoundingInstructionsMar2018.pdf.
According to the Walgreens Flu Index, North Carolina is now the ninth heaviest hit state for flu activity in the United States. Pharmacists are reminded to encourage their patients to obtain a flu shot, which provides important protections even this late in the flu season.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 28, 2018.)
WEDNESDAY, JANUARY 24, 2018
NORTH CAROLINA CONTROLLED SUBSTANCE REPORTING SYSTEM IS NOW CONNECTED TO PMP INTERCONNECT. The North Carolina CSRS is now connected to PMP Interconnect (http://www.ncnn.com/edit-news/10195-more-money-going-to-fight-opioids-), which is a program developed by the National Association of Boards of Pharmacy that allows data sharing among states’ prescription monitoring programs. This enhancement provides a significant new resource for pharmacists exercising their professional judgment when dispensing controlled substances. NC DHHS staff advise that pharmacists may access data from other states by selecting the “Multiple State Query” link on the left side of the CSRS query page. A menu of available states will appear in a “Disclosing States” field. Some states (including Virginia) are already accessible. Other states will be added in the near future. Pharmacists with questions about the data sharing features are encouraged to contact Alex Asbun of DHHS’ Drug Control Unit, who directly administers the CSRS: firstname.lastname@example.org; (919) 733-1765
WEDNESDAY, JANUARY 17, 2018
PHARMACIST-MANAGERS REMINDED OF THEIR OBLIGATIONS WITH RESPECT TO PHARMACY TECHNICIAN HIRES AND REGISTRATION APPLICATIONS. In recent months, Board staff have seen an uptick in the number of pharmacy technician applications in which the applicant’s significant criminal history is not disclosed. Certainly, not every criminal conviction disqualifies a pharmacy technician applicant. But a failure to fully disclose a criminal history can – and often does – result in denial of the registration for the applicant’s having “made false representations or withheld material information in connection with registering as a pharmacy technician.” NCGS 90-85.15A(d)(1). Not infrequently, a withheld (or, for that matter, a disclosed) criminal history includes matters that are disqualifying of themselves or strongly suggest other grounds for disqualification. See NCGS 90-85.15A(d)(2)(“Been found guilty of or plead guilty or nolo contendere to a felony involving the use or distribution of drugs.”); 90-85.15A(d)(3)(“Indulged in the use of drugs to an extent that renders the pharmacy technician unfit to assist a pharmacist in preparing and dispensing prescription medications.”)
Pharmacist-managers “accept responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy and distribution of drugs . . . .” 21 NCAC 46.1317(27). Accordingly, pharmacist-managers must take reasonable steps to ensure that pharmacy technician applicants are qualified for registration. That includes taking reasonable steps to ensure that applicants make truthful and complete disclosures on their registration applications, and that applicants do not have disqualifying criminal histories. Such steps are, of course, also part of a prudent hiring process generally.
THURSDAY, JANUARY 11, 2018
INFORMATION AND RESOURCES FOR PHARMACIES CONCERNING IV FLUID SHORTAGES. As many pharmacists know, Hurricane Maria’s devastation of Puerto Rico has interrupted supplies of IV fluids. This document provides additional resources and information on the shortage, FDA’s responses, and suggested means of mitigating the shortage’s effects on patient care.
TUESDAY, JULY 11, 2017
DEA ISSUES GUIDANCE STATEMENT ON TRANSFER OF “ON FILE” CONTROLLED SUBSTANCE PRESCRIPTIONS. On April 12, Board staff posted an item concerning apparent confusion over the ability to transfer “on file” controlled substance prescriptions that have not been filled. That notice stated that “if personnel at the DEA issue formal policy guidance” regarding such transfers, Board staff would advise pharmacists accordingly. This email from Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration to Carmen Catizone, Executive Director, National Association of Boards of Pharmacy spells out DEA’s policy on this issue: http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf.
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