Board News and Announcements
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.)
MONDAY, JUNE 27, 2016
SAVE THE DATE: CURBING PRESCRIPTION DRUG AND OPIOID ABUSE - AUGUST 11, 2016. Law enforcement, public health, medical, legal, and public policy professionals are encouraged to attend: http://www.ncbop.org/PDF/CurbingRxDrugOpioidAbuseNCDOJ081116.pdf.
Thursday, August 11, 2016
8:30am - 5:00pm
The McKimmon Center at NCSU, 1101 Gorman St, Raleigh, NC 27606
MONDAY, JUNE 27, 2016
BILL MIXON ELECTED TO SECOND TERM ON THE BOARD OF PHARMACY. Voting in the run-off election for the Board’s Western District seat closed on Friday. Pharmacists elected Bill Mixon to a second five-year term on the Board, to begin on May 1, 2017. The voting results are summarized in the table below. The Board expresses its heartfelt gratitude to Cathy Huie for her commitment to service.
As pharmacists know, Keith Vance was elected to the Board’s Northern District last month. Dr. Vance will begin serving a five-year term on May 1, 2017.
The Board will next hold elections in the spring of 2019, for the Northeastern and Central District seats.
WEDNESDAY, JUNE 22, 2016
CDC HOSTS WEBINAR SERIES ON GUIDELINE FOR PRESCRIBING OPIOIDS FOR CHRONIC PAIN.
The Centers for Disease Control and Prevention (CDC) is hosting a series of free continuing education (CE) webinars for health care providers on the CDC Guideline for Prescribing Opioids for Chronic Pain. The first webinar, “Overview of the CDC Guideline for Prescribing Opioids for Chronic Pain,” will be held on Wednesday, June 22, 2016, at 2:00 PM (EDT). The webinar will be available as a live webinar broadcast and will also be archived on the CDC website. CE credit may be earned after participating in the live webinar.
Follow this link for further details and registration information: http://www.nabp.net/news/cdc-hosts-webinar-series-on-guideline-for-prescribing-opioids-for-chronic-pain.
GUIDANCE ON PHARMACY’S USE OF CLIA-WAIVED RAPID DIAGNOSTIC TESTS. Board staff have received numerous questions about pharmacies’ ability to perform “rapid diagnostic” and other “CLIA-waived” tests.
Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called “CLIA-waived” tests. CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories.
When FDA approves an in vitro diagnostic device, it may designate the device as approved “for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” 42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. Id. § 263(a)(d)(2). CLIA-waived tests don’t require, as a condition of FDA approval, any sort of “prescription” or medical order.
Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA. If a facility – including a pharmacy – meets the criteria to perform CLIA-waived tests, and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests. More information about the CLIA waiver process may be found here: https://www2.ncdhhs.gov/DHSR/ahc/clia/cliafaq.html
Staff is of the opinion that there is nothing in the law that would prevent a pharmacy that applies for, and obtains, a CLIA waiver from performing CLIA-waived tests. Of course, a pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient’s provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)
MONDAY, JUNE 20, 2016
STATE LAW ESTABLISHING STATEWIDE STANDING ORDER FOR NALOXONE DISPENSING SIGNED INTO LAW ON MONDAY, JUNE 20, 2016. The North Carolina General Assembly has passed, and Governor McCrory has signed into law, a bill that will allow the State Health Director, Dr. Randall Williams, to issue a statewide standing order for naloxone dispensing – a standing order that any pharmacy in North Carolina may use. This standing order will allow any licensed North Carolina pharmacist who chooses to participate to dispense naloxone to patients who are at risk of an opioid overdose or to their friends or family members or to people in a position to help them.
The North Carolina Department of Health and Human Services (“NC DHHS”) has set up a website to educate pharmacists and the public about the statewide standing order. It may be found at www.naloxonesaves.org. Pharmacists and pharmacies should review the information on the website immediately.
The website includes instructions for pharmacies that wish to dispense under the standing order to notify NC DHHS that they intend to do so. Pharmacies dispensing under a standing order (whether through the State Health Director or through their own standing order) will be listed on the website after contact information is provided to DHHS.
There is likely to be significant media attention to the new law and members of the public may approach your pharmacy to obtain naloxone through the standing order. If you have any questions about the standing order that are not answered by the www.naloxonesaves.org website, you may contact Board of Pharmacy staff or Anna Stein, DHHS Legal Specialist (firstname.lastname@example.org).
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JUNE 27, 2016.)
WEDNESDAY, JUNE 1, 2016
DME SUBCOMMITTEE ELECTION BEGINS TODAY – NORTH CAROLINA DME PERMIT HOLDERS MAY VOTE NOW
The NC Board of Pharmacy DME Subcommittee is holding an election for the Medical Oxygen Supplier seat. This seat is presently held by DME Subcommittee member David Keesee, who is not seeking a second term on the committee.
David Chandler of Wilmington, NC is the candidate for this position. (Follow this link to read more about Mr. Chandler and for voting details, including instructions for requesting a paper ballot.)
NC DME PERMIT HOLDERS, LOG IN HERE TO CAST YOUR VOTE NOW: https://www.ncbop1.org/online/dmeelection/login.asp.
All active North Carolina DME permit holders residing in the state as of March 15, 2016 are eligible to vote. Voting runs from June 1 through June 30.
TUESDAY, MAY 24, 2016
TUESDAY, MAY 24, 2016
Telecommunications technology presents both opportunities and challenges for health care providers. As part of a continuing assessment of how technology can improve pharmacy practice, Board staff is interested in receiving comments from pharmacists on the question below. Comments will be used by Board staff solely for informational and staff-educational purposes. The Board has not proposed any new rules concerning telepharmacy practice, and this request is not a component of any investigation.
How might you be able to employ “telepharmacy” technology -- defined for purposes of this question as a pharmacist remotely supervising by live video and audio telecommunication dispensing or compounding functions by a pharmacy technician -- in a way that would improve the delivery of pharmacy services (in general or in specialized situations) while also ensuring an appropriate level of protection for your patients? Do you think you could employ technology to do so under existing laws and rules governing the practice of pharmacy in North Carolina? If not, what changes to laws and rules would be necessary?
Please send your comments to email@example.com by Friday, June 17, 2016.
TUESDAY, MAY 24, 2016
CHANGES TO THE RULES GOVERNING CLINICAL PHARMACIST PRACTITIONERS: WHAT DO THEY ENTAIL?
The Medical and Pharmacy Boards recently collaborated on a series of changes to the rules governing Clinical Pharmacist Practitioners (21 N.C.A.C. 46.3101). The chief aims of the amendments are: (1) transfer primary administrative responsibility for CPP application, renewal, and monitoring to the Board of Pharmacy; (2) bring supervising physician consulting and oversight responsibilities in line with those for nurse practitioners and physician assistants; and (3) allow CPPs to designate “primary” and “back-up” supervising physicians, something particularly helpful for CPPs who service patients in a group practice.
This document answers some questions that are likely to arise immediately among presently-approved CPPs and CPP candidates currently seeking approval: http://www.ncbop.org/faqs/Pharmacist/AmendedCPPrules3101FAQ.pdf.
TUESDAY, MAY 10, 2016
BOARD OF PHARMACY IMPLEMENTS PERIODIC CRIMINAL BACKGROUND CHECKS FOR LICENSEES AND REGISTRANTS. Consistent with its obligation to protect the public health and safety, the Board of Pharmacy has implemented a system to conduct periodic sweeps of the North Carolina court system for public records concerning criminal charges filed, pending, or resolved against Board licensees or registrants. The Board’s procedure for reviewing and, potentially, taking action based upon such public information is found here: http://www.ncbop.org/PDF/BackgroundCheckPolicy.pdf. Board licensees and registrants are, of course, still obligated to report information concerning criminal charges or dispositions each year as part of the license and registration renewal process.
MONDAY, MAY 2, 2016
INFORMATION FOR PHARMACISTS DISPENSING ANTIBIOTICS PURSUANT TO EXPEDITED PARTNER THERAPY PRESCRIPTIONS. The Pharmacy Practice Act and rules have always authorized pharmacists to dispense prescription medications prescribed pursuant to Expedited Partner Therapy. From time to time, Board staff receive questions about the specifics of EPT therapy and dispensing. Our colleague, Amanda Fuller Moore, at North Carolina Public Health Preparedness and Response, has assembled an FAQ document to guide pharmacists: http://www.ncbop.org/faqs/Pharmacist/ExpeditedPartnerTherapyFAQsMay2016.pdf
WEDNESDAY, APRIL 20, 2016
NORTH CAROLINA MEDICAL BOARD TO INVESTIGATE HIGH VOLUME, HIGH DOSE OPIOID PRESCRIBERS
The North Carolina Medical Board is launching a new effort to address potentially unsafe opioid prescribing in an attempt to reduce patient harm from misuse and abuse of these medications. The Board emailed licensed physicians and physician assistants (PAs) about the new program this week.
Using data provided in accordance with state law by the NC Department of Health and Human Services (NCDHHS), the Board will investigate prescribers who meet one or more of the following criteria:
- The prescriber falls within the top one percent of those prescribing 100 milligrams of morphine equivalents (MME) per patient per day.
- The prescriber falls within the top one percent of those prescribing 100 MMEs per patient per day in combination with any benzodiazepine and is within the top one percent of all controlled substance prescribers by volume.
- The prescriber has had two or more patient deaths in the preceding twelve months due to opioid poisoning.
The Medical Board will determine the appropriateness of prescribing through standard methods, including review of patient records, independent expert medical reviews and written responses from the prescriber. In its email to physicians and PAs, the Board acknowledged that prescribers identified through the stated criteria may be practicing and prescribing in accordance with accepted standards of care. Given the known risks of opioids and the rising incidence of unintentional overdose deaths, the Board wrote that it has an obligation to verify that care and prescribing is clinically appropriate.
Physicians and others who treat chronic pain are encouraged to review current standards of care by reading NCMB’s position statement on use of opiates for the treatment of pain. According to the Board, cases that result in public action against the prescriber universally involve one or more significant departures from accepted standards of care.
url to NCMB position statement:
FRIDAY, APRIL 15, 2016
FDA ISSUES THREE DRAFT GUIDANCE DOCUMENTS CONCERNING HUMAN DRUG COMPOUNDING. On April 15, 2016, the Food and Drug Administration (“FDA”) issued three draft guidance documents concerning human drug compounding. Each of the draft guidance documents may be found here: http://www.fda.gov/Drugs/DrugSafety/ucm493463.htm
The first, entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act” does not appear to differ in any way from the plain language of the Drug Quality and Security Act or from the DQSA guidance document prepared by Board staff and available here: http://www.ncbop.org/faqs/FAQsDQSA030615.pdf
The second, entitled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act,” contains FDA’s first concrete guidance on issues specific to hospitals and health systems. All directors of pharmacy of hospital or health-system pharmacies should closely review this draft guidance.
The third, “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act” contains further FDA guidance on how cGMP standards apply in “dual-use” facilities – i.e., facilities that are registered as Section 503B Outsourcing Facilities but also compound prescription drugs pursuant to individual patient prescriptions. For a refresher on the state licensing requirements for Outsourcing Facilities, please see the a guidance document prepared by Board staff here: http://www.ncbop.org/faqs/Pharmacist/faq_OutsourcingFacilities.html
The cover page of each draft guidance document provides instructions on how and when to provide commentary to the FDA.
THURSDAY, MARCH 17, 2016
CHRONOLOGICAL SEARCH OF BOARD DISCIPLINARY ACTIONS NOW AVAILABLE. Board staff has added a chronological listing of actions taken against pharmacist licenses, technician registrations, and pharmacy and DME permits, beginning with orders from February 2016. Orders of discipline will still be searchable alphabetically by last name/facility name.
Any person or organization wishing to be placed on an email listserv to receive monthly disciplinary order updates should send an email to Kristin Moore or call (919) 246-1050 ext. 209.
WEDNESDAY, MARCH 9, 2016
BOARD OF PHARMACY AND UNC ESHELMAN SCHOOL OF PHARMACY PARTNER TO PROVIDE PHARMACISTS WITH A NO-COST CONTINUING EDUCATION COURSE ON USE OF THE NORTH CAROLINA CONTROLLED SUBSTANCES REPORTING SYSTEM. The Board of Pharmacy and The Academy at the UNC Eshelman School of Pharmacy have partnered to build a continuing education program for pharmacists on the North Carolina Controlled Substances Reporting System (“CSRS”). The on-line CE module educates pharmacists on the process for activating CSRS access, the menu system for acquiring data in the CSRS, and, perhaps most importantly, provides a series of interactive case scenarios designed to guide pharmacists in the appropriate use of CSRS data in various practice settings. To access the program, which is available without cost to pharmacists, please click the link below and complete each section of the website. At the end of the program, you will have an opportunity to take a post-assessment test and claim one (1) hour of distance based CE credit. Link: https://learn.pharmacy.unc.edu/csrs/#/csrs_home.
WEDNESDAY, MARCH 9, 2016
The NC Medical Board has provided the following link in order for pharmacists to check for disciplinary action(s) against a physician or physician’s assistant. Should you have further questions, please contact the Medical Board at: (919) 326-1100. http://www.ncmedboard.org/about-the-board/latest-board-activity/recent-board-actions.
THURSDAY, MARCH 3, 2016
In June 2016, the NC Board of Pharmacy DME Subcommittee will hold an election for the Medical Oxygen Supplier representative seat. This seat is presently held by David Keesee, who does not plan to seek a second term on the committee. The Board is requesting nominations for this position between now and April 1, 2016.
The Medical Oxygen Supplier representative must practice in the particular area for which he or she is nominated, but need not practice exclusively in that area. If interested in becoming a candidate for this position, a person-in-charge (“PIC”) of a DME facility (who is the permit holder for purposes of North Carolina law) who also meets the practice area qualification stated above may submit a petition to appear on the June ballot.
The petitioner must be a registered North Carolina DME permit holder (PIC) as of March 15, 2016. The petition must be accompanied by signatures of ten (10) actively registered North Carolina DME PICs. The petition, along with the required 10 original signatures, must be filed in the Board office or postmarked by April 1, 2016. Anyone wishing to learn more about the duties of a DME subcommittee member may contact Cindy Parham, NCBOP Investigations and Inspections Coordinator, at firstname.lastname@example.org.
All North Carolina DME permit holders residing in the state as of March 15, 2016 are eligible to vote. Voting will be electronic again this year; a DME PIC will log in to his/her individual Board account to cast an electronic ballot. More details, including instructions for requesting a paper ballot if preferred, will follow in the coming weeks and will be posted here.
WEDNESDAY, FEBRUARY 17, 2016
New FAQs for Pharmacists on Prescriptions Generated by Telemedicine Encounters: http://www.ncbop.org/faqs/Pharmacist/faq_PrescriptionsTelemedicine.htm.
MONDAY, DECEMBER 14, 2015
BOARD OF PHARMACY ENTERS INTO AN AGREEMENT WITH THE NORTH CAROLINA PHYSICIANS HEALTH PROGRAM TO SERVE AS AN EVALUATION AND MONITORING PROGRAM FOR PHARMACISTS AND PHARMACY PERSONNEL WITH SUBSTANCE ABUSE ISSUES. Earlier this fall, the Board of Pharmacy entered into an agreement with the North Carolina Physicians Health Program (“NCPHP”) to serve as an evaluation and monitoring program for pharmacists and pharmacy personnel. NCPHP is well positioned to serve as a resource for professionals and to facilitate early intervention before impairment or other professional consequences occur. Over the coming weeks, current clients of North Carolina Pharmacy Recovery Network (“NCPRN”) will be transitioned to NCPHP, and more information will be distributed about NCPHP, its team, and its services.
With this transition, the Board of Pharmacy is ending its agreement with NCPRN, and the Board does so with extreme gratitude for NCPRN’s tremendous work for its clients, the profession of pharmacy, and the public health and safety. The transition to NCPHP ensures that these same services – and more – will continue to be available for pharmacists and pharmacy personnel in North Carolina.
More information about NCPHP may be found here: http://www.ncphp.org/.
Health Advisories (last updated March 7, 2016) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated May 12, 2015) - 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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