Pharmacy Practice FAQs
PRESCRIPTIONS
Q: Does North Carolina law require that a prescription for a non-controlled substance bear the prescriber’s DEA number? A: No. Though the relevant statutory language is somewhat unclear, all agencies that regulate prescriptions for non-controlled substances agree that North Carolina law does not require a DEA number on such prescriptions.
Epinephrine Auto Injectors / Epinephrine Auto Injectors in Schools Q: I received a prescription for an epinephrine auto-injector for a [camp, college, park, restaurant, etc.]. May I dispense that prescription even though it is not written for a specific patient? A: Yes. GS § 90-21.15A allows a prescriber to prescribe an epinephrine auto-injector to an “authorized entity” (defined as “any entity or organization . . . at which allergens capable of causing anaphylaxis may be present, including, but not limited to, recreation camps, colleges, universities, day care facilities, youth sports leagues, amusement parks, restaurants, places of employment, and sports arenas”). Pharmacists may dispense such prescriptions “issued in the name of an authorized entity.”
Q: How can schools obtain epinephrine auto-injectors as required by state law? A: Board staff has compiled guidance on supplying epinephrine auto-injectors to schools.
Q: How should pharmacists counsel patients on proper use of epinephrine auto injectors? A: As pharmacists are aware, there are several epinephrine auto injector products on the market – e.g., EpiPen, Twinject, Adrenaclick. Because epinephrine auto injectors are used in emergency situations, it is crucial that pharmacists dispensing these devices ensure that the patient or the patient’s caregiver is adequately trained on their proper use at the time of dispensing. Pharmacists must not assume that the patient or patient’s caregiver has been trained by others. Of course, if a prescriber writes for a particular epinephrine auto injector and signs the prescription “dispense as written” (or handwrites “brand medically necessary” where Medicaid patients are concerned), the pharmacist must dispense the indicated product. If substitution is permitted, the pharmacist may do so as allowed by North Carolina law. The pharmacist should be certain that the patient or patient’s caregiver has been trained on proper use of the particular device dispensed. Absent such training, a patient’s life could be placed in danger.
Expedited Partner Therapy (EPT) Q: What is Expedited Partner Therapy (EPT)? A: Expedited Partner Therapy (EPT) is a strategy for treating the sex partner(s) of people diagnosed with chlamydia (Chlamydia trachomatis) and gonorrhea (Neisseria gonorrhoeae). EPT allows health care providers to provide patients with medication or a prescription for their sex partner(s) without a prior medical evaluation or clinical assessment of those partners. EPT also might have a role in partner management for trichomoniasis; however, no partner management intervention has been reported to be more effective than any other in reducing trichomoniasis reinfection rates.
Q: Why is EPT important? A: Studies have found EPT decreases rates of chlamydia and gonorrhea reinfection and increases the number of sex partners reported and therefore treated for chlamydia and/or gonorrhea: CDC Resources for Expedited Partner Therapy.
Q: Who is eligible for EPT? A: EPT is recommended for the sex partners of heterosexual men and women in the 60 days prior to the chlamydia or gonorrhea diagnosis, or the most recent sexual partner if the patient’s last sexual encounter was more than 60 days ago. Considering the limited available data on the efficacy of EPT use among MSM compared to heterosexuals, and the higher potential for co-infections with other bacterial STIs or HIV among MSM partners, shared clinical decision-making regarding EPT is recommended.
Q: What is the recommended treatment for Chlamydia using EPT? A: The recommended treatment for chlamydia is doxycycline 100 mg orally twice daily for 7 days; for partners where doxycycline is contraindicated, azithromycin 1 gram orally in a single dose is an acceptable alternative EPT regimen for chlamydia.
Q: What is the recommended treatment for Gonorrhea using EPT? A: For gonorrhea, every effort should be made to ensure that a patient’s sex partners from the past 60 days are evaluated clinically and treated with the recommended regimen of a single dose of ceftriaxone 500 mg IM. However, because that is not always possible, providers should still consider EPT for partners of patients diagnosed with gonorrhea who are unlikely to access timely evaluation and treatment. In those cases, if a chlamydia infection in the patient has been excluded, a single 800 mg oral dose of cefixime, could be used. If a chlamydia negative test result has not been documented for the patient, the partner may be treated with a single 800 mg dose of oral cefixime plus oral doxycycline 100 mg twice daily for 7 days. If adherence to a multiday dosing regimen is a considerable concern or doxycycline is contraindicated, a single oral dose of azithromycin 1 gram can be substituted for chlamydia coverage instead of doxycycline. *Note* azithromycin has lower treatment efficacy among persons with rectal chlamydia. Alternative regimens should be considered if the partner is known to have an allergy to one of the recommended therapies. More guidance available at CDC Resources for Expedited Partner Therapy.
Q: What is the recommended treatment for Trichomonas using EPT? A: The recommended treatment for trichomonas is metronidazole 500 mg twice daily for 7 days for women or metronidazole 2 grams orally in a single dose for men.
Q: How will sex partner(s) know if it’s safe to take EPT without seeing a health care provider? A: Providers using EPT are required to give patients educational materials to give to their sex partner(s). These materials address allergic reactions, potential side effects, and contraindications to taking EPT regimen prescribed. Other states have been using EPT for over ten years and no adverse events and/or life-threatening allergic reactions have been reported to date.
Q: How should the EPT prescription be labeled for dispensing if the partner(s) name is unknown? A: The pharmacist should label the drug for the named partner in accordance with normal procedures as specified by the Pharmacy Practice Act. If the partner is unnamed, the pharmacy may create a unique identifier and use that instead of a name for both labeling and record keeping purposes. An example of this if John Doe was the patient and his partner’s name was not known, could be “John Doe Partner ABC.” Sites should use a log to connect partners back to patients and can use any nomenclature that suits their needs as long as it can be tracked to a single partner and single patient.
Q: How is patient counseling handled for an unknown partner? A: The pharmacist is not required to obtain an EPT partner’s name, address, or demographics; however, the pharmacist should ask the patient about any known allergies or other drugs being taken by their partner(s). The pharmacist should also provide the patient with written information on each EPT prescription and instruct the patient to give it to each partner with the medication(s). The pharmacist should advise the patient to encourage each partner to call the pharmacist before taking the drug if they have any questions or concerns regarding the EPT prescription provided.
Q: Must a prescription label state the drug's generic name? A: Board Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is on the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone". Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke’s Mouthwash" or "Compounded Cafergot".
Q: What information is required to be on the prescription label? A: The following information must be on every prescription label: These requirements do not prohibit pharmacists from including additional information on the label. For example, no federal or North Carolina statute requires that the label indicate the number of refills remaining. But such information is, for obvious reasons, typically included on the prescription label.
Narrow Therapeutic Index (NTI) drugs Q: What is a narrow therapeutic index (NTI) drug? A: GS 90-85.27(4a) defines narrow therapeutic index drugs as those “having a narrowly defined range between risk and benefit. Such drugs have less than a twofold difference in the minimum toxic concentration and minimum effective concentration in the blood or are those drug product formulations that exhibit limited or erratic absorption, formulation-dependent bioavailability, and wide intrapatient pharmacokinetic variability that requires blood-level monitoring.”
Q: Which drugs are on the Narrow Therapeutic Index (NTI) List? A: The North Carolina NTI list includes:
Q: What restrictions apply to dispensing an NTI drug? A: A first-time prescription for an NTI drug must be dispensed as written (if the prescriber so designates) or may be substituted by an equivalent drug product (if the prescriber so designates). The pharmacist must refill the NTI prescription (or new prescriptions continuing NTI drug therapy) with the same manufacturer’s product initially dispensed to the patient. The pharmacist may not dispense a different manufacturer’s product on a refill (or new prescription continuing NTI drug therapy) until the pharmacist obtains the documented consent of the prescriber and the patient for the change.
Q: Does an AB Rating from FDA change how a prescription for a Narrow Therapeutic Index drug is handled? A: No. An AB Rating from the Food and Drug Administration in its Orange Book publication does not change the application of the NTI law as noted above.
Prescriptions Issued by Physician Assistants or Nurse Practitioners Q: What prescribing authority does a physician assistant or nurse practitioner have? A: PA and NP prescribing authority is regulated by the North Carolina Medical Board:
Q: Must a prescription issued by a physician assistant or nurse practitioner contain the supervising physician’s information? A: No. A supervising physician’s information is not required on NP- or PA-issued prescriptions. On February 1, 2021, the NC Medical Board amended the prescribing authority rule for physicians’ assistants by removing the supervising physician information requirement for prescriptions written by physicians’ assistants. 21 NCAC 32S .0212 On August 1, 2021, the NC Medical Board amended the prescribing authority rule for nurse practitioners by removing the supervising physician information requirement for prescriptions written by nurse practitioners. 21 NCAC 32M .0109. Even before the Medical Board’s 2021 rule amendments (as detailed in long-standing Board guidance, see Item 2403 in the April 2020 Board of Pharmacy Newsletter), the absence of a supervising physician’s name and telephone number did not render a PA- or NP-issued prescription "invalid," “illegal,” or otherwise ineligible for dispensing under the North Carolina Food Drug and Cosmetic Act or the North Carolina Pharmacy Practice Act.
Prescriber Retirement, Death, or Loss of License A: Yes. A physician’s (or other prescriber’s) death, retirement, or loss of license does not void prescriptions written prior to the date the physician ceased practicing. As long as, in your professional judgment, the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship, you may fill the prescription and any authorized refills.
Prescribers Treating Family Members Q: May physicians or other prescribers prescribe drugs for themselves or their families? A: The North Carolina Medical Board has the following position statement with respect to self- or family member-prescribing: Self-Treatment and Treatment of Family Members
Public Health Registered Nurses Transmitting Standing Orders Q: May a registered nurse at a public health department transcribe a standing order for a prescription medication to a written prescription blank for dispensing by an in-house or contracted pharmacy? A: Yes. A registered nurse at a public health department may act as the agent of the prescriber for the purpose of transcribing a standing order for a prescription medication to a written prescription blank for dispensing by an in-house or contracted pharmacy. The public health registered nurse should include on the prescription the standing order prescriber’s name and credentials, as well as the registered nurse’s name and an indication “per standing order” (or similar). Ex. Jane Smith, MD/by Mary Jones, RN/per standing order. Each transcribed prescription does not have to include a copy of the standing order, but public health departments are encouraged to provide their contracted pharmacies with reference copies of standing orders to facilitate the prescribing and dispensing process.
Q: If a prescription authorizes several refills, may I combine refills if the patient asks? A: Board Rule .1802(b) allows a pharmacist to combine refills and dispense up to the total amount authorized if “deemed appropriate in the pharmacist’s professional judgment.” Pharmacists may not combine refills for dispensing for controlled substances or psychotherapeutic drugs unless the prescriber authorizes the pharmacist to do so.
Q: What authority does a pharmacist have to dispense an emergency refill if there are no refills remaining on the current prescription and the prescriber is not available to authorize refills? A: If the prescription has no refills remaining Board Rule .1809 authorizes a pharmacist to provide a one-time emergency refill for up to a 30-day supply when the prescriber is not available to authorize refills. If the pharmacist determines, in her professional judgment, that the medication is “essential to the maintenance of life or to the continuation or therapy in a chronic condition” and that “interruption of therapy might reasonably produce undesirable health consequences,” then the pharmacist may dispense the emergency refill. The pharmacist must create an order containing all prescription information required by law, sign the order, and notify the prescriber or prescriber’s office of the emergency dispensing within 72 hours. Schedule II controlled substances may not be dispensed as an emergency refill.
Q: What authority does a pharmacist have to dispense an emergency refill if there are no refills remaining on the current prescription and the prescriber is no longer able to provide medical services? A: If the prescription has no refills remaining, Board Rule .1815 authorizes a pharmacist to provide a one-time emergency refill for up to a 90-day supply when the prescriber is “unable to provide medical services” (e.g., a natural disaster prevents the prescriber from providing medical services; the prescriber passes away). A Schedule II controlled substance may not be dispensed as an emergency refill.
Q: Does a prescription with a specific number of refills “expire” after one year? A: No. GS § 90-85.32 states that “prescriptions marked PRN shall not be refilled more than one year after the date issued by the prescriber unless otherwise specified.” If a prescription indicates a specific number of refills or a specific duration of refills that extend beyond one year, it may be refilled as refills come due. Different, specific rules govern refill limits on controlled substance prescriptions. And pharmacists must exercise professional judgment in filling or refilling all prescriptions, as specified in Board Rule .1801.
Q: I have received a prescription generated by a telemedicine encounter. May I dispense it? A: Yes, upon appropriate exercise of professional judgment. The pharmacist must exercise professional judgment, as noted in Board Rule .1801. A pharmacists shall not fill or refill a prescription “if, in the exercise of professional judgment, there is or reasonably may be a question regarding the order’s accuracy validity, authenticity, or safety for the patient.”
Q: I thought the Board’s rules prohibited pharmacists from dispensing a prescription generated by a telemedicine encounter? A: At one time, Board rule .1801 provided that a pharmacist could not fill or refill a prescription if the pharmacist knew or reasonably should have known that a prescription was issued in the absence of a prior prescriber-patient relationship or a physical examination. That rule reflected the Medical Board’s then-position on telemedicine-based prescribing. In late 2014, however, the Medical Board amended its position on telemedicine, which is found here: Medical Board Telemedicine Position Statement That position notes that telemedicine-based encounters may be appropriate for evaluating patients “if the licensee employs technology sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care.” In response to the revised Medical Board position, the Board of Pharmacy amended Board Rule .1801 to state that a prescription order is valid if “issued by a health care provider for a legitimate medical purpose, in the context of a patient-prescriber relationship, and in the course of legitimate professional practice as recognized by the [Medical Board].”
Q: May I dispense a prescription for a controlled substance generated by a telemedicine encounter? A: The Medical Board’s statement states: “It is the position of the Board that prescribing controlled substances for the treatment of pain by means of telemedicine is not consistent with the standard of care.” Medical Board Telemedicine Position Statement Furthermore, the federal Controlled Substances Act and regulations state that a pharmacist may only dispense a prescription for a controlled substance issued for legitimate medical purpose in the usual course of professional practice. The Ryan Haight Online Pharmacy Consumer Protection Act governs the issuance of controlled substance prescriptions. Please consult DEA's Guidance on Telemedicine Encounters.
Q: What are a pharmacy's responsibilities when a patient requests a transfer? A: 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. Board Rule .1806 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:
Q: Can prescriptions be transferred more than once under North Carolina law? A: Yes, provided that refills remain on the prescription. Prescriptions for non-controlled drugs may be transferred from one pharmacy to another providing that refill authorizations remain. Federal law limits the transfer of prescriptions for controlled substances. DEA rule 21 CFR 1306.25(a) permits a one-time transfer of a prescription for a Schedule III, IV, or V prescription. Pharmacies that electronically share a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
Q: May a technician, certified technician, or pharmacy student transfer or receive transfers of prescriptions for controlled substances? A: Under federal law, an original prescription for a C-III, C-IV, or C-V substance may be transferred for refill on a one-time basis. If pharmacies electronically share a “real-time, on-line database,” then those sharing pharmacies “may transfer up to the maximum refills permitted by law and the prescriber’s authorization.” 21 CFR 1306.25(a) Federal law, however, requires that any transfer of a C-III, C-IV, or C-V prescription be “communicated directly between two licensed pharmacists . . . .” 21 CFR 1306.25(a)(1)
Q: Must a veterinary prescription contain a DEA number for non-controlled drugs or an NPI number? A: No. A veterinarian (or, for that matter, any other health care provider) who writes a prescription for a drug that is not a controlled substance does not need a DEA number to do so. Nor does North Carolina law require a DEA number to appear on a prescription for a non-controlled substance. Moreover, veterinarians are not eligible to obtain an NPI number. In 2013, the Centers for Medicare and Medicaid Services clarified that veterinarians do not meet the regulatory definition of “health care provider” for purposes of obtaining an NPI. More information can be found here. The Board appreciates, as always, pharmacists’ efforts to ensure that prescriptions comply with all applicable laws and rules. But demanding a DEA number for a non-controlled substance prescription and/or an NPI number from a veterinarian who is not eligible to obtain one is not required by law. And doing so can pose a barrier to timely, effective treatment of veterinary patients.
Q: What are the best references supporting the practice of veterinary pharmacy? A: The following references are critical: Saunders Comprehensive Veterinary Dictionary
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