Board News & Announcements

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MONDAY, MAY 5, 2008

Digitek Recall. The Board is aware that Actavis Totowa LLC (formerly Amide Pharmaceuticals) has recalled various strengths of its Digitek digoxin tablets. A copy of the recall notice may be found here. Pharmacists are also aware that digoxin is a Narrow Therapeutic Index drug. Under North Carolina law:

A prescription for a narrow therapeutic index drug shall be refilled using only the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless the prescriber is notified by the pharmacist prior to the dispensing of another manufacturer's product, and the prescriber and the patient give documented consent to the dispensing of the other manufacturer's product. For purposes of this subsection, the term "refilled" shall include a new prescription written at the expiration of a prescription which continues the patient's therapy on a narrow therapeutic index drug.

N.C.G.S. Section 90-85.28(b1).

Board staff understands that the Digitek recall will require switching some patients to a different manufacturer’s digoxin product. Compliance with the letter of N.C.G.S. Section 90-85.28(b1) may prove difficult in certain circumstances. In the unusual circumstances of this recall, it is critical to ensure that patients continue to receive their medication. Accordingly, where switching a patient to a different manufacturer’s digoxin product is necessary because of the recall, pharmacists must counsel affected patients on the switch, the reason for it, and possible side effects/therapeutic changes that could be associated with the change. Moreover, pharmacists must contact the patient’s prescriber to alert of the change so that monitoring of digoxin levels and therapeutic effect can, if necessary, begin.

MONDAY, MAY 5, 2008

Forgery Reporting Form - The Board posts suspected forgeries as they are reported. Pharmacists should visit our website regularly: https://www.ncbop1.org/online/pharmacist-login.asp to check for the latest forgery reports. While we do accept forgery reports by phone, we prefer that you complete this form which can be submitted by email or printed and faxed to the Board office.

THURSDAY, APRIL 24, 2008

DEA Numbers Not Required on Prescriptions for Non-Controlled Substances. As pharmacists in the state are aware, it appeared that N.C.G.S. Section 106-134.1 required a DEA number on all prescriptions, whether for a controlled substance or a non-controlled substance. This was, of course, an extremely odd result. And the Board of Pharmacy, in its guidance on the matter, consistently advised pharmacists not to refuse to fill a prescription for a non-controlled substance on the basis that a DEA number was lacking. After consultation with David Henderson, Executive Director of the Medical Board, and David McLeod, Assistant Commissioner for the Department of Agriculture, our agencies are all in agreement that the statute’s reference to DEA numbers is properly read as referring only to controlled drugs mentioned in paragraph (a)(1) of the statute, and not to all legend drugs. Accordingly, the Pharmacy and Medical Boards agree that the proper interpretation of NCGS Section 106-134.1 does NOT require that prescriptions for a non-controlled substance contain the prescriber’s DEA number. Board staff thanks Messrs. Henderson and McLeod for showing us a way out of what had been a troubling legal issue.

THURSDAY, APRIL 24, 2008

Approval of Non-ACPE, Non-NCAP Continuing Education Credits. To streamline approval and tracking of non-ACPE, non-NCAP continuing education opportunities that a pharmacist may use to satisfy their annual license renewal requirements, Board staff now require a short form to be filled out and submitted for approval. Pharmacists seeking such approval may access the application here.

Health Advisories (last updated May 5, 2008) - Check here regularly for the latest alerts and recall notices.

Medicare/Medicaid (last updated February 25, 2008) - Check here regularly for the latest updates regarding Medicare/Medicaid.

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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.