Board News and Announcements
FRIDAY, JANUARY 19, 2018
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.
WEDNESDAY, JANUARY 3, 2018
NORTH CAROLINA DIVISION OF MEDICAL ASSISTANCE STATEMENT ON DISPENSING OPIOIDS TO MEDICAID BENEFICIARIES WHEN THE PRESCRIBER HAS NOT OBTAINED A REQUIRED PRIOR AUTHORIZATION. Due to decades of increased prescribing of opioids, North Carolina is experiencing an opioid epidemic. NC Medicaid 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. Modifying clinical coverage criteria to promote safe opioid prescribing was identified as 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 Aug. 27, 2017, NC Medicaid began requiring prior approval (PA) for 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 NC Medicaid Preferred Drug List (PDL). Effective Jan. 2, 2018, the clinical coverage criteria for opioid analgesics was updated to comply with the quantity limits mandated by the Strengthen Opioid Misuse Prevention (STOP) Act, S.L. 2017-74. Prior approval is now required for short-acting opioids for greater than a five-day supply for acute pain and seven-day supply for post-operative acute pain. Prior approval is also required for long-acting opioids for greater than a seven-day supply. Beneficiaries with diagnosis of pain secondary to cancer will continue to be exempt from prior approval requirements.
Soon after implementation of these changes, NC Medicaid began receiving reports from pharmacists that some prescribers were prescribing a 30-day supply of an opioid, but refusing to request prior authorization (PA). This situation has resulted in Medicaid beneficiaries asking the pharmacist to partial fill the opioid prescription with concurrent allowed day supplies or asking to pay cash for the quantity exceeding the quantity paid for by Medicaid.
NC Medicaid is aware that pharmacists may 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 and the partial fill is requested by the patient or the prescriber. However, the intent of our clinical coverage criteria changes were to encourage prescribers to evaluate the medical necessity of an opioid to treat a patient’s chronic pain not related to cancer or end of life care and, when appropriate, request PA for those patients.
NC Medicaid has no authority to prohibit beneficiaries from paying cash for any of their medications and the intent of our clinical coverage criteria changes were not intended to require Medicaid beneficiaries to pay out of pocket for opioids determined to be medically necessary and appropriate to treat their chronic pain. Understanding the intent of our changes to opioid clinical coverage criteria, NC Medicaid encourages pharmacists to use their professional judgement when a Medicaid beneficiary requests to pay cash for their prescribed opioids. Prescribers and pharmacists are also reminded that the Controlled Substance Reporting System (CSRS) collects data on all cash transactions for controlled substances, and this data can be reported to the medical and pharmacy boards for their review and investigation of any suspected inappropriate prescribing or dispensing of controlled substances.
NC Medicaid also encourages pharmacists to contact prescribers who refuse to request PA for an opioid prescription that exceeds criteria to determine the medical necessity for the prescribed opioid and remind the prescriber of the PA requirement. While a pharmacist should not consider failure to follow NC Medicaid PA protocols, by itself, suspicious or inappropriate prescribing, the NC Medical Board continues to encourage pharmacists to report any prescriber they reasonably believe is engaged in suspicious or inappropriate prescribing of any medication.
NC Medicaid appreciates the partnership of all medical and pharmacy providers to combat the opioid crisis in North Carolina and to keep our fellow North Carolinians safe. We realize the impact of these changes to all providers and beneficiaries, but equally realize that these changes were necessary to address this crisis and to promote appropriate opioid prescribing.
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.
WEDNESDAY, JANUARY 3, 2018
BOARD OF PHARMACY ISSUES GUIDANCE TO PHARMACISTS ON IMPLEMENTATION OF THE STRENGTHEN OPIOID MISUSE PREVENTION (“STOP”) ACT. The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act. The STOP Act is an effort to combat the opioid abuse and misuse epidemic. The STOP Act makes changes to the laws governing controlled substance prescribing, controlled substance dispensing, and the North Carolina Controlled Substance Reporting System (“CSRS”). Please refer to this FAQ Guidance for more information.
THURSDAY, DECEMBER 21, 2017
BOARD STAFF CAUTIONS PUBLIC AGAINST BUYING PRESCRIPTION DRUGS THROUGH CHANNELS SUCH AS CRAIGSLIST OR OTHER ONLINE MARKETPLACES. Board staff occasionally receive calls from the public from folks who have found prescription drug products or medical devices offered for sale on online marketplaces – and plainly offered for sale from someone who is not a pharmacist (or any other medical professional). Recently, Board staff was alerted that those offers include insulin and diabetic testing supplies. Board staff cannot emphasize strongly enough that patients should not purchase prescription drugs, medical devices, or medical supplies except from a licensed pharmacy or a device and medical equipment facility. Prescription drugs offered through online marketplaces this way carry a significant risk of being counterfeit, expired, ineffective, and otherwise highly dangerous.
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 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 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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