Board News and Announcements
WEDNESDAY, DECEMBER 6, 2017
MISLEADING PROMOTIONAL LETTER CONCERNING HEMP PRODUCTS BEING SENT TO NORTH CAROLINA PHARMACIES. It has come to Board staff’s attention that Nature’s Vitamins and Herbs in Asheville has begun circulating a sales letter claiming that the “North Carolina Board of Pharmacy has recently approved sales of hemp based products.” This statement is false and misleading. The Board of Pharmacy has not “approved” sales of hemp based products. The Board has provided a guidance document (found here: http://www.ncbop.org/faqs/Pharmacist/Sale_of_Hemp_Products_FAQ_Oct2017.DOCX) to pharmacists and pharmacies that discusses the various state and federal laws that govern the sale of hemp-derived products. It contains no statement of “approval,” nor has the Board ever issued any such statement. Pharmacists and pharmacies are advised to use that document to guide their decisionmaking in this area and are also specifically advised in the document to direct certain questions to the North Carolina Industrial Hemp Commission. Finally, Board staff notes that Nature’s Vitamins and Herbs is not a pharmacy. And though the owners, Bill Cheek and Mike Rogers, conspicuously state that they hold pharmacy degrees and have “decades of pharmacy and dietary supplement experience,” neither holds a North Carolina license to practice pharmacy: http://www.ncbop.org/Disciplinary%20Actions%20-%20PHARMACISTS/RogersMichael06864March2015volsurrender.pdf ; http://www.ncbop.org/Disciplinary%20Actions%20-%20PHARMACISTS/CheekWilliam07868volsurrenderMarch2015.pdf.
2018 RENEWAL PERIOD NOVEMBER 1, 2017 - MARCH 1, 2018
The 2018 renewal period began on November 1, 2017 and runs through the end of December. If you have not already created a new user name and password through the Board's new Gateway, you must do so prior to renewing your pharmacist license or PA/NP, dispensing physician, technician registration for 2018. Gateway and detailed renewal instructions may be found here.
Pharmacy and DME facilities - Click on the Facility Management tab in the Gateway to log in and renew your permit.
WEDNESDAY, OCTOBER 18, 2017
INSTITUTE FOR SAFE MEDICATION PRACTICES (“ISMP”) ISSUES BULLETIN REGARDING INCORRECT USE OF INSULIN PENS IN THE HOME. ISMP has issued an alert regarding incorrect insulin pen usage at home. ISMP reports several insulin-dependent patients failed to remove the inner cover from a standard insulin pen needle prior to administering insulin. More information is found here -- http://www.ismp.org/NAN/files/NAN-20171012.pdf.
MONDAY, OCTOBER 9, 2017
BOARD UPDATES GUIDANCE ON THE SALE OF HEMP-DERIVED PRODUCTS. Based on developments in the law, Board staff has updated its guidance to pharmacists on hemp products. This document replaces the prior guidance document issued on May 16, 2017.
THURSDAY, OCTOBER 5, 2017
BOARD OF PHARMACY STATEMENT ON UNITED STATES PHARMACOPEIA CHAPTER <800> IMPLEMENTATION. In light of questions to Board members and staff concerning the implementation of USP chapter <800>, which sets standards for hazardous drug handling by health-care personnel, as well as USP’s announcement on Friday, September 29, 2017 concerning the chapter’s effective date, the Board has issued the following statement concerning USP <800>: http://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf. *UPDATE 11/16/17* The United States Pharmacopeia has some additional guidance and information about USP chapter <800> implementation: http://www.ncbop.org/PDF/USP%20800%20FAQ%20Nov2017.pdf.
WEDNESDAY, OCTOBER 4, 2017
MAILER FROM A CONTINUING EDUCATION SERVICE PROVIDER SUGGESTING BOARD OF PHARMACY “RECOGNITION” Board of Pharmacy staff have become aware of a mailer sent to North Carolina pharmacists by an organization that provides certain continuing education services. That mailer says, in part, that the organization “is recognized by the North Carolina Board of Pharmacy to provide CE activities that satisfy the aforementioned renewal requirements.” To the extent that this statement implies some sort of formal (or even informal) recognition or endorsement of the company by the Board, pharmacists should be aware that the Board does not “recognize” or otherwise endorse this CE company – or any other. Pharmacists should be aware of North Carolina continuing education requirements for renewal – which are changing January 1, 2018 (more info here: http://www.ncbop.org/faqs/Pharmacist/CEFAQChangesEff010118.pdf). Continuing education credits must meet those requirements, but, again, the Board does not “recognize” or otherwise endorse any particular provider of CE services. The company has been made aware of this concern, and has advised that it will no longer use this, or similar, language, in any future solicitations to North Carolina pharmacists.
TUESDAY, SEPTEMBER 26, 2017
REMINDER TO PHARMACISTS, TECHNICIANS AND PERMIT HOLDERS CONCERNING NABP E-PROFILE NUMBERS; NOTICE TO PHARMACISTS CONCERNING CSRS ACCESS REGISTRATION
Pharmacists and Technicians Need to Act **NOW** to Obtain an NABP e-Profile Number, or to Recover One Previously Obtained
New Board Rule .1516 (21 NCAC 46.1615) requires all pharmacists, technicians, pharmacies, and DME facilities to obtain and report to the Board a National Association of Boards of Pharmacy e-Profile Number. Combined with the changes to the CE rules going into effect on January 1, 2018 (more info here: http://www.ncbop.org/faqs/Pharmacist/CEFAQChangesEff010118.pdf), this rule will further simplify the CE tracking process for pharmacists. This requirement will also make it easier for Board staff to access and track information on continuing education fulfillment, pharmacy and DME facility inspections, and out-of-state disciplinary actions. Note that there is no cost to obtain an e-Profile number.
All pharmacists are required to report an NABP e-Profile Number in order to renew their licenses for 2018. The vast majority of pharmacists already have an e-Profile number, as one is required to obtain credit for ACPE-accredited continuing education coursework. Any pharmacist who does not have an e-Profile number or who does not remember his/her e-Profile number can obtain one (or recover one) through NABP at no cost. Detailed instructions are found here: http://www.ncbop.org/PDF/NABPeProfileInstructionsRPhandTechJune2017.pdf.
All pharmacy technicians are required to report an NABP e-Profile Number in order to renew their registrations for 2018. All PTCB-certified technicians already have an e-Profile number, which was assigned at the time of certification. Registered technicians may obtain one through NABP. Any technician who does not have an NABP e-Profile Number or who does not remember his/her NABP e-Profile Number can obtain one (or recover one) through NABP at no cost. Detailed instructions are found here: http://www.ncbop.org/PDF/NABPeProfileInstructionsRPhandTechJune2017.pdf.
Pharmacies and DME Facilities
Pharmacies and DME facilities will not be required to obtain and report an NABP e-Profile Number to renew permits for 2018. Board staff is working with NABP staff to determine the most efficient method for pharmacies and DME facilities to obtain an e-Profile number. At such time as that process is developed, information will follow from Board staff. For now, pharmacies and DME facilities do not need to contact NABP about obtaining an e-Profile number. Again, when a process is in place for assignment of e-Profile numbers to pharmacies and DME facilities, Board of Pharmacy staff will communicate that to pharmacies and DME facilities.
Pharmacists Should Act **NOW** To Register for Access to the North Carolina Controlled Substance Reporting System
The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act.
Among other things, the STOP Act requires all pharmacists to register for access to the North Carolina Controlled Substance Reporting System (“CSRS”), with a narrow exemption.
As a condition of renewing a pharmacist license for 2018, a pharmacist must attest either: (a) he/she has registered, or applied, for CSRS access; or (b) he/she is not employed in a pharmacy practice setting where Schedule II, III, or IV controlled substances are dispensed from a North Carolina-based facility or to North Carolina patients.
Any pharmacist who does not already have a CSRS access registration should immediately apply for one. Pharmacists can access a simple, on-line application here: https://www.ncdhhs.gov/divisions/mhddsas/ncdcu/csrs#csrs4
Note: Pharmacists should register for a “master” account (not a “delegate” account); The STOP Act requires an individual registration – your pharmacy’s registration for purposes of uploading data to CSRS is not sufficient.
TUESDAY, SEPTEMBER 12, 2017
NORTH CAROLINA MEDICAID AND NORTH CAROLINA HEALTH CHOICE STATEMENT CONCERNING PRIOR APPROVAL REQUIREMENTS FOR OPIOID PRESCRIPTIONS. North Carolina is facing an opioid epidemic. Three North Carolinians die from an opioid-related overdose every day. Modifying clinical coverage policies to promote safe opioid prescribing is an essential and significant step to realize the vision of the North Carolina Opioid Action Plan to reduce opioid deaths by 20 percent by 2021. On August 27, 2017, prior approval became effective for Medicaid and NC Health Choice opioid prescribed analgesic doses that exceed 120 mg of morphine equivalents per day; are greater than a 14-day supply of any opioid; or are non-preferred opioid products on the North Carolina Medicaid Preferred Drug List. The Department of Health and Human Services (DHHS) worked closely with prescribing physicians and pharmacists to develop the best approach to reduce the oversupply of prescription opioids available for diversion and misuse, promote safe opioid prescribing for patients, and encourage alternative pain management, while minimizing administrative requirements as much as possible.
Pharmacists with questions about North Carolina Medicaid’s prior authorization program should contact John Stancil at NC DMA: (919) 855-4305; email@example.com.
Opioid Prescriptions: Emergency Supply and Partial Fill
As a reminder, pharmacy providers may use the 72-hour emergency supply allowed for drugs requiring prior approval. Federal law requires that this emergency supply be available to Medicaid beneficiaries for drugs requiring prior approval (Social Security Act, Section 1927, 42 U.S.C. 1396r-8(d)(5)(B)). Use of this emergency supply will allow access to medically necessary medications until prior approval is obtained or a revised opioid prescription not requiring prior approval is received.
As an additional reminder, the Comprehensive Addiction and Recovery Act of 2016 (CARA), and the rules and regulations of the NC Board of Pharmacy, allow a North Carolina licensed pharmacy to provide a partial fill of a Schedule II controlled substance prescription when the prescription is written and filled in compliance with federal and state law, the partial fill is requested by the patient or the prescriber and the total quantity dispensed in all partial fills does not exceed the total quantity prescribed. The total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date of the prescription.
If a pharmacist receives a verbal Schedule II controlled substance prescription pursuant to an emergency, the pharmacist may provide a partial fill, but must provide the remainder of the prescription amount within 72 hours. After 72 hours, no further dispensing on the emergency prescription is allowed. All other requirements regarding the need to receive a hard copy (or valid electronic) prescription within seven days remain. More information is found here: http://www.ncbop.org/faqs/Pharmacist/faq_SchIIControlledSub.htm
DHHS appreciates the partnership of prescribing physicians and pharmacists to combat the opioid crisis in North Carolina and to keep our fellow North Carolinians safe. Opioid safety and alternative pain management provider resources are available on the Medicaid Outpatient Pharmacy website and the Community Care of North Carolina Medicaid Opioid Safety Resources website.
Pharmacists with questions about North Carolina Medicaid’s prior authorization program should contact John Stancil at NC DMA: (919) 855-4305; firstname.lastname@example.org
TUESDAY, SEPTEMBER 5, 2017
**IMPORTANT** UPDATE FOR PHARMACISTS ON 2018 LICENSE RENEWAL PROCESS. As pharmacists are aware, the Board of Pharmacy is changing over to a new information technology system, which will be used for 2018 license renewals. To complete online license renewal for 2018, pharmacists will not have to enter their CE course titles or numbers. Rather, pharmacists will attest that they have completed the requisite CE requirements for renewal. It is, of course, imperative that pharmacists truthfully attest to having completed the requisite CE requirements for renewal. For more information about CE requirement changes that go into effect January 1, 2018, pharmacists are directed to this FAQ: http://www.ncbop.org/faqs/Pharmacist/CEFAQChangesEff010118.pdf.
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.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED NOVEMBER 7, 2017.)
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 July 2017) - 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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