Board News and Announcements
MONDAY, OCTOBER 7, 2019 - NEW VACCINE ADMINISTRATION AUTHORITY
*UPDATE* GENERAL ASSEMBLY PASSES, AND GOVERNOR COOPER SIGNS INTO LAW, NEW VACCINE ADMINISTRATION AUTHORITY FOR PHARMACISTS. On June 3, Governor Cooper signed into law S.L. 2019-21, which will increase pharmacists’ authority to administer vaccines. Here’s what you need to know:
1. Will pharmacists be able to administer more vaccines to patients 18 and older pursuant to protocol? Yes. This legislation adds Serogroup B meningococcal vaccines, human papillomavirus vaccine, and Hepatitis A vaccine to the list of vaccines that a pharmacist may administer to persons 18 or older pursuant to protocol.
2. Will pharmacists be able to administer flu vaccine by protocol to younger patients? Yes. This legislation authorizes pharmacists to administer flu vaccine to patients at least ten (10) years old pursuant to protocol. Pharmacists are authorized to administer flu vaccine to patients at least six (6) years old pursuant to a prescription order.
3. Is this new authority effective now? Yes. The legislation became effective on October 1, 2019.
4. What resources does the Board recommend for pharmacists?
First, the North Carolina Academy of Family Physicians, the North Carolina Medical Society, the North Carolina Pediatric Society, the North Carolina Association of Community Pharmacists, the North Carolina Association of Pharmacists, and the North Carolina Retail Merchants Association have produced (as required in the statute) a new minimum standard screening questionnaire for immunizing pharmacists. You can download the revised questionnaire here.
Second, Board staff recommends that immunizing pharmacists collaborate with their supervising physicians to revise their vaccination protocols to reflect the new vaccines that may be administered and the new permissible age for flu vaccine administration.
5. I’d like to read the new legislation. Where can I get it? Right here, dear reader.
TUESDAY, SEPTEMBER 24, 2019
PHARMACY AND PHARMACIST-MANAGER RESPONSIBILITIES FOR PHARMACY INTERNS. As pharmacists know, under North Carolina law, a student who is enrolled in a school of pharmacy is not required to register as a pharmacy technician. See NCGS § 90-85.15A(e). A student enrolled in a school of pharmacy is considered a “pharmacy intern” an is authorized to “perform all acts constituting the practice of pharmacy” while “working under a pharmacist preceptor or supervising pharmacist.” 21 NCAC 46.1317(29).
In recent months, Board staff have become aware of two instances in which a person working in a pharmacy as a “pharmacy intern” was not (and never had been) a student enrolled in a school of pharmacy. In both cases, investigations continue.
In the meantime, pharmacist-managers are reminded that, as the person who “accepts responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy” (21 NCAC 46.1317(27), your duties include vetting employees working as pharmacy interns to ensure that they are actually enrolled in a school of pharmacy. The risk to the public of an unqualified person “performing all acts constituting the practice of pharmacy” is obvious. A “pharmacy intern” who is not enrolled in a school of pharmacy is engaged in the unlicensed practice of pharmacy (which is a criminal offense) and the Pharmacy Practice Act specifically authorizes action on a pharmacist’s license or a pharmacy’s permit where either have “aided and abetted an individual to engage in the practice of pharmacy without a license.” NCGS § 90-85.38(a)(9).
MONDAY, SEPTEMBER 23, 2019
IMPORTANT INFORMATION CONCERNING UNITED STATES PHARMACOPEIA’S ANNOUNCEMENT POSTPONING THE EFFECTIVE DATE OF REVISED CHAPTERS <795> AND <797>. The United States Pharmacopeia (“USP”) announced today, September 23, 2019, that – as required by USP by-laws – it is postponing the effective date of USP chapters <795> and <797> while appeals for review of these revised chapters are resolved. These chapters were previously scheduled to go into effect on December 1, 2019. More detail is found here: https://www.uspnf.com/notices/compounding-chapters-postponement
How does USP’s announcement affect North Carolina-permitted pharmacists and pharmacies?
1. Existing USP chapters <795> and <797> will continue to be enforced. Board inspections and investigative staff will continue to use the inspection forms and tools mapped to existing USP chapter requirements (found here: http://www.ncbop.org/phcyinspectionforms.html). As pharmacists know, under both federal law (the Drug Quality and Security Act) and Board rule (21 NCAC 46.2801), compounding activities must conform with the standards in these chapters. The revised chapters will be enforced when they go into effect. USP did not set a new effective date in its announcement today.
2. Board staff will not begin inspecting for compliance with USP chapter <800> standards in compounding activities on December 1, 2019. USP’s announcement notes that chapter <800> is not subject to an appeal and will go into effect on December 1, 2019. Nonetheless, both the DQSA and Board rule .2801 require compliance with chapters <795> and <797> and other chapters incorporated into them. Existing chapters <795> and <797> do not incorporate chapter <800>. Revised chapters <795> and <797> do. Accordingly, Board staff will begin inspecting for compliance with chapter <800> standards at such time as the revised chapters go into effect. Again, USP did not set a new effective date in its announcement today. Pharmacies that have already implemented changes to comply with chapter <800> are commended for doing so. And pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations. For a review of prior Board statements concerning USP <800>, see http://www.ncbop.org/PDF/BoardPositionStatementforUSP800UPDATEDMarch2019.pdf and http://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED OCTOBER 7, 2019.)
THURSDAY, SEPTEMBER 19, 2019
A FEW WORDS ABOUT PRESCRIPTION TRANSFERS. On a semi-regular basis, Board staff receive calls from pharmacists raising concerns or complaints about prescription transfer practices. Typically, the concern or complaint takes one of the following forms: (a) the pharmacist complains that another pharmacy (or, more frequently, a particular pharmacist) refuses to transfer prescriptions upon request; (b) the pharmacist complains that another pharmacy (or pharmacist) agrees to transfer prescriptions, but takes a long time to do so; (c) the pharmacist complains that another pharmacy (or pharmacist) is “tricking” or “coercing” patients into transferring prescriptions.
Let’s set the table. Board of Pharmacy Rule .1806 (21 NCAC 46.1806; http://www.ncbop.org/LawsRules/rules.1800.pdf) authorizes the transfer of prescriptions among pharmacies, and it sets forth procedural and recordkeeping requirements for doing so. Pharmacists seldom have questions about these procedural or recordkeeping requirements. Instead, most of the focus in these situations is one word in the rule – “permissible.” The introductory language of Rule .1806 says that the “transfer of original prescription information for the purpose of refill dispensing is permissible between pharmacies . . . .” Pharmacies or pharmacists who have refused to transfer a prescription typically respond to a complaint by saying that the rule makes transfers “permissible,” and not “mandatory.” What tends to get lost in this blinkered argument is the most important factor – the patient.
Patients have the right to select their pharmacy provider. Patients have many reasons for choosing a particular pharmacy in the first instance, or deciding that they wish to change to a different pharmacy. Whatever those reasons, the patient is the decision maker. A patient’s wishes must be respected not only because it’s the right thing to do, but also to avoid interruption of care that could well prove harmful to the patient.
With this background in mind, this is how Board staff approach transfer complaints:
- Pharmacists are expected to consult with one another professionally and politely to resolve transfer issues. Staff often find that the root of a transfer dispute is a personal or business conflict among pharmacists or pharmacies. These sorts of disputes are not a reason to involve the Board, nor are they a reason to delay (or deny) a patient’s care.
- In some cases, a pharmacist alleged to have wrongly refused a transfer will state that he/she simply wants to confirm the request with the patient. That, in and of itself, doesn’t necessarily raise an issue. But “I’m checking with the patient” must not become a pretext for denying a transfer or delaying one to such a degree that the patient’s continuity of care is jeopardized. And pharmacy policies and procedures that incentivize staff pharmacists to delay or deny transfers place those pharmacists, the pharmacist-manager, and the pharmacy permit in potential jeopardy.
- Board staff treats a transfer complaint from a patient as a higher priority matter than a transfer complaint from a pharmacist. This is because, as noted above, transfer complaints relayed by pharmacists are often rooted in personal or business conflicts. Direct patient complaints are more typically rooted in potential harm resulting from interrupted drug therapy. A patient who alerts the Board that his/her transfer request is not being honored, or is not being honored in a timely fashion, will find a ready ear and a helping hand from Board staff.
- If, after a patient complaint, neither professional consultation among the pharmacists nor informal intervention of Board staff (usually by way of a phone call to both pharmacists with a suggestion that the patient’s request be met without further delay), Board staff will open a case and pursue it as a disciplinary matter focusing on potential negligence in a pharmacist’s/pharmacy’s outright refusal to transfer or a dilatory transfer.
- Pharmacies are expected to have adequate staff on hand to fulfill a patient’s transfer request in a timely fashion. As noted in Item 2389 of the July 2019 Newsletter (http://www.ncbop.org/Newsletters/July2019.pdf), in recent months some pharmacies have abruptly closed without adequate (and legally required) notice to patients. Predictably, this results in the pharmacy receiving the prescription files getting bombarded with transfer requests. The pharmacist-manager of the receiving pharmacy must staff it sufficiently to accomplish timely transfers. Failure to do so will lead to a Board staff investigation and potential discipline.
- If a pharmacy or pharmacist complains to the Board that it believes a patient was “tricked” or “coerced” into transferring prescriptions, Board staff needs, at a minimum, the patient’s name and contact information and strongly prefers to receive the complaint from the patient directly. In Board staff’s experience, most often the patient explains that he/she did authorize a transfer but was uncomfortable admitting this to his/her now-former pharmacy. But if a patient directly alleges that he/she experienced a transfer that he/she did not authorize, that is a serious matter that could involve not only the Board of Pharmacy, but also law enforcement agencies or the North Carolina Attorney General’s office.
TUESDAY, JULY 30, 2019
More Powerful NC and the North Carolina Board of Pharmacy Announce Partnership to Confront Prescription Opioid Misuse. More Powerful NC, a public private partnership formed to fight the opioid epidemic, and the North Carolina Board of Pharmacy today announced a partnership to confront prescription opioid misuse. The Board of Pharmacy will provide pharmacies with new prescription drug labels (see photo of labels here) that encourage patients to safely dispose of unneeded medication. The Board of Pharmacy will also provide bag stuffer handouts in several sizes that pharmacists, pharmacies, and North Carolinians can download for more information about how to prevent opioid misuse.
“Too many people use their friends’ and families’ medicine cabinets to create or fuel addiction,” said Attorney General Josh Stein. “The Board of Pharmacy educational resources will help patients safely dispose of unneeded medication so that it doesn’t get into the wrong hands. I encourage anyone who is interested in learning more about what they can do to confront this crisis to visit www.MorePowerfulNC.org to learn more. Together, we are more powerful than this epidemic.”
Board of Pharmacy member Ashley Duggins agreed. “Pharmacists are doing their part to educate, protect, and empower their patients when it comes to proper medication use and disposal. The Board is pleased to join with More Powerful NC and provide resources that advance this crucial mission.”
* * *
The Board is pleased to provide two more resources for pharmacists and pharmacies in support of the More Powerful NC campaign:
First, the Board has printed prescription vial auxiliary labels that pharmacists are encouraged to place on pain medication prescriptions. These labels -- pictured here -- encourage patients to protect our children by disposing of meds safely and provide the morepowerfulnc.org link. Board inspectors have sheets of the labels for distribution to pharmacies, and any pharmacy that would like to obtain them should email or call Kristin Moore at the Board office (http://www.ncbop.org/v-cards/Kristin%20Moore.vcf). These auxiliary labels are available to pharmacies at no cost, as long as supplies last!
Second, Board member Ashley Duggins worked closely with NCDOJ staff to produce one-sheet “bag stuffer” handouts in several sizes and formats. These bag stuffers provide information to pharmacists and patients on the resources available at MorePowerfulNC.org. Board field investigators will soon have copies of these bag stuffers to hand out at pharmacies. And the file is available for any pharmacist, pharmacy, or member of the public to download: http://www.ncbop.org/PDF/MorePowerfulNCOpioidBagStufferJuly2019.pdf.
The Board encourages pharmacists and pharmacies to make these new resources a part of their opioid dispensing process. And the Board thanks pharmacists and pharmacies for their unceasing efforts to encourage and ensure proper opioid use, storage, and disposal!
TUESDAY, JULY 23, 2019
HOPE ACT AUTHORIZES CERTIFIED DIVERSION INVESTIGATORS TO OBTAIN PRESCRIPTION RECORDS. The 2018 HOPE Act authorizes certain law enforcement officers to obtain pharmacy records directly. This FAQ document explains those provisions of the Act, which went into effect on July 1, 2019.
TUESDAY, JULY 9, 2019
GENERAL ASSEMBLY PASSES AND GOVERNOR COOPER SIGNS INTO LAW LEGISLATION ALLOWING DONATION OF MORE DRUGS TO FREE AND CHARITABLE PHARMACIES. Late last month, the General Assembly passed an amendment to NCGS 90-85.44, which governs the donation of drugs and devices in North Carolina. Prior to this amendment, North Carolina law required that a donated drug or device have at least six months remaining on its expiration date at the time of donation. As amended, the statute makes a drug eligible for donation if, among other things, the drug has not reached its expiration date at the time of donation. Board staff has updated the FAQ on drug donation to reflect this change. Pharmacists are encouraged to review that FAQ -- http://www.ncbop.org/faqs/Pharmacist/faq_DonatingRXs.htm -- for a refresher on drug donation regulation.
*REMINDER* DEA POSITION ON TRANSFER OF "ON FILE" CONTROLLED SUBSTANCE PRESCRIPTIONS
Pharmacists continue to call Board staff with understandable confusion on whether and how “on file” controlled substance prescriptions that were never filled may be transferred. To recap:
In April 2017, word began swirling that DEA viewed transfers of “on file” controlled substances as not allowed. On July 7, 2017, Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration sent an email to Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy, setting forth DEA’s view on the matter.
In that email (found here -- http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf), Mr. Miller states the view that 21 CFR 1306.25 allows a pharmacy, “once it has filled an original prescription for a controlled substance in Schedule III-V,” to “transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . .” Mr. Miller further stated that “an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.”
Mr. Miller then stated that, based on “the preamble” of an “interim final rule,” it is DEA’s “policy” that an electronic prescription for a controlled substance of any schedule may be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy” even if that prescription had not been filled.
To say that DEA’s positions in this matter create a mess is a gross understatement. First, while Mr. Miller’s reading of 21 CFR 1306.25 is textually plausible, it represents a departure from decades of standard pharmacy practice and there has been no suggestion from DEA or anyone else that the standard practice of transferring “on file” but unfilled (as opposed to once-filled) controlled substance prescriptions has caused or materially contributed to controlled substance abuse or misuse. Second, neither Mr. Miller’s email nor any language in the preamble he references contains so much as a hint as to what an appropriate mechanism for “forwarding” (and documenting the forwarding of) an unfilled electronic controlled substance prescription would be. Third, Mr. Miller’s email does not explain why “forwarding” an unfilled electronic controlled substance prescription is substantively different than transferring an unfilled controlled substance prescription, whether electronic, verbal, or written. Fourth, DEA’s position creates not only an incentive, but a practical necessity, for patients seeking to change their pharmacy of choice to obtain duplicate controlled substance prescriptions from their caregiver. Interpretations and policies that guarantee duplicate prescriptions for controlled substances in multiple pharmacies hardly seems consistent with the Controlled Substance Act’s purpose to create a controlled, closed distribution system and minimize controlled substance abuse and misuse.
All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us?
(1) Though “forwarding” of unfilled electronic controlled substance prescriptions is available by “policy,” the lack of any guidance from DEA on how a “forwarding” should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them?
(2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA’s position means that there is no mechanism for moving them from one pharmacy to another.
(3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach.
Some pharmacists have inquired why Board staff, the Board, or the North Carolina legislature have taken this position. As the above makes clear, none of the three are to blame. The present state of affairs is attributable solely, and entirely, to the DEA. Board staff will, of course, update pharmacists if the DEA sees reason and backs away from these positions. Until then, send your cards, letters, and calls to the DEA.
OPIOID PUBLIC SERVICE ANNOUNCEMENT CAMPAIGN - ADS AVAILABLE FOR DOWNLOAD
Beginning February 8, 2018, the Board of Pharmacy opened an opioid public service announcement campaign on Wilmington and Greenville-area television stations and on social media platforms. The advertisements feature Joe Adams, a pharmacist and past president of the National Association of Boards of Pharmacy, sharing his deeply personal story of losing his son to an opioid overdose in 2014. These ads emphasize the important of obtaining help and the critical role pharmacists can play.
The ads come in 30-second, 60-second, and 6-minute versions, and are available for download here. Board members and staff welcome and encourage pharmacists using these ads to educate their patients and communities about proper medication use and the dangers of opioid abuse.
The Board thanks Third Wheel Media of Chapel Hill and the National Association of Boards of Pharmacy (NABP) for their tremendous efforts on this issue. Pharmacists will note that texting “abuse” to 555888, as instructed in the ads, will result in a reply text providing a link to an NABP-created and hosted page containing resources for pharmacists to share with patients and their communities. That page may be accessed directly here: https://nabp.pharmacy/homepage/prescription-drug-safety/.
These ads are the first phase of a multi-media campaign. Board staff will continue to keep pharmacists updated as the campaign progresses.
Please contact Board staff at 919.246.1050 with questions.
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