Board News and Announcements
FRIDAY, APRIL 22, 2016
DRUG ENFORCEMENT ADMINISTRATION TO HOLD 11th NATIONAL PRESCRIPTION DRUG TAKE-BACK DAY APRIL 30. The National Prescription Drug Take-Back Day aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the general public about the potential for abuse of medications.
The 11th National Prescriptions Drug Take Back Day is Saturday, April 30, 2016. Follow this link for more information and to search for a collection site near you.
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, APRIL 14, 2016 - VOTING BEGINS TODAY FOR NORTHERN AND WESTERN DISTRICTS
North Carolina Pharmacists –
Voting begins on April 14, 2016 for the Northern and Western District seats. Please follow this link to log in and cast your vote now. It takes less than a minute: https://www.ncbop1.org/online/pharmacistelection/login.asp.
Voting will continue through May 15, 2016. All North Carolina pharmacists residing in the state and actively licensed by the Board as of March 15, 2016 are eligible to vote. Voting is NOT limited to pharmacists who reside in the Northern and Western Districts.
Once you log in you’ll be able to view the candidates’ biographical information before casting your final vote – or you may view them here: http://www.ncbop.org/election2016.html.
**Any pharmacist eligible to vote may instead request a paper ballot by notifying the Board in writing on or before April 20, 2016. Send a fax, letter, or email to the Board and include your name, license number, and home address. Written requests for a paper ballot must actually be received by the Board on or before April 20. Fax your request to 919.246.1056, attention Kristin Moore; mail to NCBOP Election, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517; or email firstname.lastname@example.org.**
Thank you for voting.
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 email@example.com.
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.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 10, 2016.)
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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