Board News and Announcements

 

 

 

JULY 2018 NEWSLETTER

 

 

FRIDAY, JULY 20, 2018

FDA ISSUES WARNING ABOUT SYNTHETIC CANNABINOID PRODUCTS CONTAMINATED BY RAT POISON. The FDA has issued a warning that synthetic cannabinoid products marketed under names like “K2” and “Spice” -- and often sold at convenience stores -- may contain brodifacoum, a long-acting anticoagulant used in rat poison.  The FDA notes that these products are not legal, yet continue to be distributed – often with “not for human consumption” labeling intended (though utterly ineffectively) to allow manufacturers and distributors to dodge accountability for their products.  Consumption of products contaminated by brodifacoum can trigger severe bleeding and can be life threatening.  Consumers should not obtain or consume these products.  Pharmacies must not stock them.  More information here:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614027.htm  

 


 

WEDNESDAY, JULY 18, 2018

BOARD OF PHARMACY SELECTS ASHLEY DUGGINS TO FILL OPEN CENTRAL DISTRICT SEAT.  At The Board of Pharmacy members have selected Ashley Duggins to fill the Central District seat for a term to conclude on April 30, 2020.  Dr. Duggins is a 2002 graduate of the UNC Eshelman School of Pharmacy.  She owns and operates Prevo Drug in Asheboro.  Dr. Duggins’ many professional and community memberships activities show a deep commitment to public service.  The Board Members and staff welcome Dr. Duggins.

The Board Members and staff also thank all of the candidates who applied to fill the Central District seat.  Coming from a broad spectrum of practice backgrounds and experience, all were impressive.  They are:  Ismail Badjie, Jay Brown, Duke Calfas, Wes Cowell, Nicole Eastman, Jeff Eudy, Sam Forrester, Jennifer Funkhouser, Catherine Huemmer, Abdul Kader, Max Reece, Scott Romesburg, Angela Smith, Richard Sterling, Greg Vassie, Tim Weber, and Doug Yoch.

 


 

MONDAY, JULY 16, 2018

FDA ANNOUNCES RECALL OF SEVERAL MEDICATIONS CONTAINING VALSARTAN.  FDA has announced a voluntary recall of several medications that contain valsartan.  The recall stems for detection of an impurity, N-nitrosodimethlamine (NDMA), in the recalled products.  NDMA is a probable human carcinogen.  Not all valsartan-containing products have been recalled.  More information for health-care professionals and patients is found here:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

 


 

FRIDAY, JUNE 29, 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. 

 


 

WEDNESDAY, JUNE 20, 2018

CENTERS FOR DISEASE CONTROL (“CDC”) ISSUES GUIDANCE DOCUMENT ON THE PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT (“PPAEMA”) AND ITS PROVISIONS RELATING TO MAINTENANCE AND USE OF CONTROLLED SUBSTANCES BY EMERGENCY MEDICAL SERVICES (“EMS”). From time to time, Board staff receive questions from pharmacies (typically health-system based) concerning providing controlled substances to EMS crews.  The PPAEMA, signed into federal law on November 17, 2017, substantially clarified the means by which EMS crews can obtain, store, and administer controlled substances.  The CDC has issued a guidance document that pharmacies and EMS crews may find useful.

 


 

FRIDAY, JUNE 8, 2018

HOSPIRA ISSUES VOLUNTARY NATIONWIDE RECALL FOR TWO LOTS OF NALOXONE HYDROCHLORIDE INJECTION, USP, IN THE CARPUJECT™ SYRINGE SYSTEM DUE TO THE POTENTIAL PRESENCE OF PARTICULATE MATTER

The Food and Drug Administration (FDA) is urging Naloxone carriers to check their product against a national recall list. The maker of the drug, Hospira, has issued a voluntary recall of the opioid overdose reversal drug Naloxone due to the presence of loose particulate matter in the syringe plunger. More information here: https://www.fda.gov/Safety/Recalls/ucm609668.htm.



 

MONDAY, JUNE 4, 2018

PHARMACISTS CAUTIONED ON PROPER FILING OF PRACTICAL PHARMACY EXPERIENCE AFFIDAVITS  Each spring sees an influx of Practical Pharmacy Experience Affidavits submitted by graduating pharmacy students.  Under North Carolina law, a pharmacist must obtain 1,500 hours of practical pharmacy experience as a condition of licensure.  21 NCAC 46.1503(a).  For North Carolina licensure, the Board deems the 1,500 hour requirement to be satisfied by completion of an accredited Doctor of Pharmacy program as certified by the school. 21 NCAC 46.1503(a).

Some states, however, require licensure applicants to demonstrate practical pharmacy experience obtained outside of the Doctor of Pharmacy curriculum.  Where the applicant obtained some or all of that practical experience in North Carolina, the Board of Pharmacy must certify the experience.  To certify that experience, the applicant must provide one or more Practical Pharmacy Experience Affidavits, found here:  http://www.ncbop.org/Forms%20and%20Applications%20-%20Pharmacists/PracticalPhcyExperienceAffidavit.pdf

It is critical to note that the pharmacist submitting the affidavit is stating, under oath, that he/she is a North Carolina licensed pharmacist in good standing and that the “applicant will have my immediate and personal supervision and can render no pharmaceutical services except when under my immediate and personal supervision . . . .”  In other words, the pharmacist submitting the affidavit is not simply confirming that an applicant worked a number of hours in a pharmacy with various pharmacists, but, rather, that the applicant obtained a number of hours of practical experience under the “immediate and personal supervision” of the pharmacist.  This may, of course, require the applicant to get affidavits from several pharmacists who provided “immediate and personal supervision.”  

Any pharmacist or license applicant with questions about the Practical Pharmacy Experience Affidavit should contact Stacie Mason, smason@ncbop.org, (919) 246-1050.  

 


 

TUESDAY, MAY 29, 2018

WWW.SAFE.PHARMACYTOOLS AND INFORMATION TO ASSIST THE PUBLIC IN AVOIDING UNSAFE ONLINE PHARMACY SITES AND SERVICES 
The National Association of Boards of Pharmacy has long been at the forefront of helping educate consumers and the public on the dangers of unsafe and illegitimate on-line “pharmacy” sites and services.  www.safe.pharmacy gives the public quick and easy access to verified and legitimate pharmacy (human and veterinarian) websites and resources. The ”Find a Safe Site” section is updated on a regular basis with newly verified pharmacies and pharmacy-related resource websites.

 


 

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.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MAY 29, 2018.)


 

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.

 


 

The North Carolina Board of Pharmacy's monthly meetings are live-streamed via YouTube. Follow the link below to subscribe to the Board's YouTube channel. (Meeting dates found here.)

https://www.youtube.com/channel/UC8Kgn3mOzRT8s0FJwsu8U0g

 


 

Health Advisories (last updated June 2018) - Check here regularly for the latest alerts and recall notices.

 


 

Medicare/Medicaid (last updated January 3, 2018) - Check here regularly for the latest updates regarding Medicare/Medicaid.


 

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The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.

For more information, please see About the NCBOP.



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