Board News and Announcements
MONDAY, DECEMBER 3, 2018
LIVE STUDENT AND HEALTH CARE PROFESSIONAL CONTINUING EDUCATION WEBINAR HOSTED BY FDA's DIVISION OF DRUG INFORMATION
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Division of Drug Information is presenting a series of continuing education webinars designed to aid health care professionals and future clinicians to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety:
Biosimilar and Interchangeable Products in the US: Scientific Concepts, Clinical Use, and Practical Considerations
Date: Monday, December 10, 2018
Time: 1 PM EDT | 10 AM PDT
Duration: 60 minutes
Webinar registration link and further details at https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm626386.htm
THURSDAY, NOVEMBER 29, 2018
Some licensees, registrants, and permittees attempting to renew through the Licensure Gateway on November 29, 2018 between 12:00am and 9:00am may have been unable to log-in. Thank you to callers who alerted Board staff to the problem. The problem is fixed, and the Licensure Gateway is operating as it should. As always, feel free to contact staff with questions and concerns.
FRIDAY, NOVEMBER 2, 2018
The NC Board of Pharmacy has an opening for an Inspector/Investigator.
The available position is in Northwestern NC (District 2) covering the counties of: Alexander Alleghany, Ashe, Avery, Buncombe, Burke, Caldwell, Cherokee, Clay, Davidson, Davie, Forsyth, Graham, Haywood, Iredell, Jackson, Macon, Madison, McDowell, Mitchell, Rowan, Stokes, Surry, Swain, Watauga, Wilkes, Yadkin, Yancey. It is recommended that applicants live within the area in which they will be working.
The primary duties of the position:
- Conduct investigations and inspections of permitted facilities, licensees, and registrants to ensure compliance with all state and federal pharmacy laws and regulations.
- Review pharmacy records for proper documentation
- Conduct interviews with pharmacists, pharmacy technicians, complainants, and other health care personnel.
- Compile findings into investigative reports and inspection reports
- Testify in administrative hearings and judicial proceedings
Requirements for application for the inspector/investigator position:
- 4-year degree and one year of pharmacy experience and/or investigations experience strongly preferred, or
- 2-year degree and two years of pharmacy or investigative experience minimum.
- Valid, unrestricted NC Driver’s License
- Excellent time management skills
- Proficient in MS Word, Excel, and PowerPoint software programs
- Excellent verbal and written communication skills
- Strong problem-solving skills
- Experience with testifying preferred
All applicants should submit a cover letter of interest along with a resume no later than Friday, November 30, 2018.
If you are selected for an interview, you must bring a certified copy of a criminal background check from your local county Superior Court Clerk.
FRIDAY, NOVEMBER 2, 2018
The 2019 renewal period began on November 1, 2018 and runs through December 31, 2018 (with a grace period from January 1, 2019 through March 1, 2019.)
All licensees/registrants/permittees should follow the link below to log in and begin the online renewal process:
You will need a Visa, MasterCard, American Express, or Discover Card to pay for your renewal. You are required to print your own 2019 certificate.
PHARMACISTS: All pharmacists are required to have, at minimum, a total of 15 hours to renew. Five (5) of those hours must be LIVE hours and the remainder hours can be either live or correspondence.
Entry of your continuing education credits in your NC Board of Pharmacy CE profile is no longer required. You will simply attest that you have met the CE requirements when you renew.
DME PERMIT HOLDERS: The NC Board of Pharmacy DME Subcommittee is holding an election for the Medical Equipment representative seat. This seat is presently held by Doug Tonucci, who is seeking a second term on the committee and is the only candidate on the ballot. Once you log in to your account through the FACILITY MANAGEMENT tab, you will see a ballot link to cast your vote.
Answers to renewal-related Frequently Asked Questions may be found here:
TUESDAY, OCTOBER 23, 2018
NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (JANUARY 15, 2019) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .2403 AND .2502 – DRUGS AND DEVICES TO BE DISPENSED AND RESPONSIBILITES OF PHARMACIST-MANAGER. Follow this link for details, including the proposed rule language and instructions for submitting comments.
*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.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED DECEMBER 3, 2018.)
THURSDAY, OCTOBER 18, 2018
21 NCAC 46 .1815 EMERGENCY PRESCRIPTION REFILL DUE TO INTERRUPTION OF MEDICAL SERVICES
The North Carolina Board of Pharmacy reminds pharmacy owners, pharmacy managers, and persons-in-charge of DME businesses to ready their disaster plans for the preservation of records, medications and other inventory. Additionally, pharmacies may follow Rule .1815 to provide emergency prescription refills, as outlined below:
21 NCAC 46 .1815 EMERGENCY PRESCRIPTION REFILL DUE TO INTERRUPTION OF MEDICAL SERVICES
In the event a pharmacist or device and medical equipment permit holder receives a request for a prescription refill and the pharmacist or permit holder is unable to readily obtain refill authorization from the prescriber because of the prescriber's inability to provide medical services to the patient, the pharmacist or permit holder may dispense a one-time emergency supply of up to 90 days of the prescribed medication, provided that:
(1) The prescription is not for a Schedule II controlled substance;
(2) The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition;
(3) In the pharmacist's or permit holder's professional judgment, the interruption of therapy might reasonably produce undesirable health consequences;
(4) The dispensing pharmacist or permit holder creates a written order entered in the pharmacy's automated data processing system containing all of the prescription information required by Section .2300 of these Rules and signs that order;
(5) The dispensing pharmacist or permit holder notifies, or makes a good faith attempt to notify, the prescriber or the prescriber's office of the emergency dispensing within 72 hours after such dispensing.
WEDNESDAY, OCTOBER 10, 2018
RXQ COMPOUNDING LLC ISSUES VOLUNTARY RECALL - RXQ Compounding, LLC has issued a voluntary recall of 1 lot of RXQ's Lidocaine 1% and Epinephrine 1:100,000 50mL vial (MDV) product shipped between 6/22/18 and 9/5/18. The product may produce sub therapeutic levels of numbing when used subcutaneously or topically. More information may be found here.
TUESDAY, OCTOBER 2, 2018
2019 RENEWAL PERIOD FOR ALL LICENSEES, PERMITTEES, REGISTRANTS DOES NOT BEGIN UNTIL NOVEMBER 1. Board staff would like to remind everyone that you cannot renew your license, permit, or registration until November 1, 2018. The Board only communicates with pharmacists and other registrants concerning renewals by email and through this website. Any mailers received are not from the Board, no matter what kind of official looking "seal" is affixed to the mailer.
WEDNESDAY, SEPTEMBER 19, 2018
DHHS INFORMATION FOR PHARMACIES CONCERNING NEW PLATFORM FOR THE NORTH CAROLINA CONTROLLED SUBSTANCE REPORTING SYSTEM. The North Carolina Department of Health and Human Services, which administers the Controlled Substance Reporting System (“CSRS”), is migrating the CSRS to a new software platform. The below information has been emailed to CSRS users. Please take note:
Dear CSRS User,
We are pleased to announce that thenew North Carolina Controlled Substance Reporting System (CSRS) is now available.
How It Affects Me:
Your existing CSRS account has automatically been transferred into the new software system.
IMPORTANT: Your username for the new system will be the e-mail address where you received this notice.
Follow the steps below to access the new CSRS website:
- Go to: https://northcarolina.pmpaware.net
- Click the ‘Reset Password’ button on the homepage. Instructions will be emailed to you for resetting your password. If the email does not appear in your inbox, please check the junk/spam folder.
- Once you have reset your password, you will be logged into the system.
- If prompted, update your demographic information.
- To request patient reports, please review the Quick Reference Guide: Making a Patient Request. (The full CSRS User Guide can be found under the “Help” section of the website.)
Note that the old website, https://nccsrsph.hidinc.com, is no longer available.
Please note that there will be a delay of some prescription drug monitoring data as a result of this transition. Data collected between September 6, 2018 and September 19, 2018 will be loaded within two weeks of the transition date. We appreciate your understanding and patience during this time of transition.
If you have any questions or concerns, please contact support directly at 855-962-4767. Technical assistance is available 24 hours a day, 7 days a week. Should you have any policy questions in the meantime, you may contact CSRS at by email at NCCSRS@dhhs.nc.gov.
MONDAY, SEPTEMBER 10, 2018
DME SUBCOMMITTEE - UPCOMING ELECTION FOR MEDICAL EQUIPMENT REPRESENTATIVE SEAT
During the 2019 renewal period, the NC Board of Pharmacy DME Subcommittee will hold an election for the Medical Equipment representative seat. This seat is presently held by Doug Tonucci, who plans to seek a second term on the committee.
The Board is requesting nominations for this position between now and October 15, 2018. More about the election and nomination process may be found here.
MONDAY, JULY 30, 2018
EDUCATION FOR PHARMACISTS ON MITIGATING THE EFFECTS OF THE OPIOID MISUSE AND ABUSE CRISIS A FOCUS OF 2018 NCAP ANNUAL CONVENTION AND REGIONAL WORKSHOPS
In November of 2017, the NC Board of Pharmacy agreed to provide financial support to the North Carolina Association of Pharmacists (NCAP) to subsidize a series of educational programs to address opioid misuse and addiction. The first of several planned regional workshops will take place at NCAP’s Annual Convention, September 21-22, 2018 in Winston-Salem. Participants will hear a keynote address and participate in workshops and sessions all devoted to the opioid epidemic and the importance of dismantling stigma.
Details and registration information may be found here: https://ncapatwork.wixsite.com/ncap2018convention.
Following the convention, NCAP will host a series of Regional Advanced Opioid Workshops for pharmacists. These workshops will educate pharmacists on Pain Management Topics and Best Practices, Harm Reduction Topics and Service Concepts, Use of SBIRT (Screening, Brief Intervention, and Referral to Treatment), and fundamentals of Medication Assisted Treatment. More information on the regional workshops may be found here.
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.
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.
Health Advisories (last updated October 10, 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.
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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