opioid overdose crisis that spiked as the COVID-19 pandemic hit the U.S. Already used by virtually all pharmacies, EPCS saw Schedule II controlled substance prescribing considerations Schedule II controlled substances require a written, signed prescription, except where states have enacted laws allowing EPCS. There is no federal law specifying when a signed prescription expires. A verbal order for Schedule II controlled substances is permitted only in an emergency. Written prescriptions for Schedule II controlled substances may not be refilled. While there is no federal quantity limit for Schedule II controlled substance prescriptions, many states have enacted legislation limiting quantities for opioid prescriptions. As of 2018, there were 33 states that had passed legislation limiting and/or providing guidance or other requirements related to prescribing opioids (NCSL, 2019). In general, this legislation limits first- time opioid prescriptions for acute pain to a supply for a certain number of days (i.e., 3, 5, 7, or 14 days) or dosage limits (i.e., morphine milligram equivalents (MMEs). Most states set exceptions for chronic pain treatment, cancer pain, and palliative care. In addition, some states have set specific limits for minors (Opioid Response Network [ORN], 2021). manually signed paper or electronic prescription before dispensing a Schedule II controlled substance (DEA, 2018c). Therefore, a prescriber may transmit a Schedule II prescription to the pharmacy via facsimile to expedite the filing. However, the original Schedule II prescription must be presented to the pharmacist for review before the controlled substance is dispensed. In an emergency, a practitioner may call in a prescription for a Schedule II controlled substance to the pharmacy. The pharmacist may dispense the medication, provided the quantity prescribed and dispensed is limited to what is adequate to treat the patient only during the emergency period. The prescribing practitioner must provide the pharmacist with a written and signed prescription within seven days. The pharmacist must notify the DEA if the prescription is not received in that timeframe. The DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. As a result, the facsimile of a Schedule II prescription may serve as the original prescription as follows. Schedules III–V controlled substance prescribing considerations A prescription for controlled substances in Schedules III, IV, and V may be communicated verbally, in writing, or via facsimile to the pharmacist. It may be refilled if authorized on the prescription or by call-in. The CSA provides that a pharmacy may dispense Schedules III and IV controlled substances according to a “written or oral prescription.” DEA regulations further specify that a pharmacist may dispense a Schedule III, IV, or V controlled substance according to “either a paper prescription signed by a practitioner [or] a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy.” Accordingly, an authorized agent may transmit such a practitioner-signed paper prescription via facsimile to the pharmacy on behalf of the practitioner (DEA, 2018c).
an 18% jump in the number of enabled prescribers in 2021 (SureScripts, 2022b).
Under federal law, a prescriber may issue multiple prescriptions authorizing their patient to receive up to a 90-day supply of a Schedule II controlled substance based on the following conditions: ● Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual professional practice. ● The prescriber provides written instructions on each prescription, indicating the earliest date a pharmacy may fill each prescription. The first prescription does not need a fill date on it if the prescriber intends for that prescription to be filled immediately. ● The practitioner concludes that providing the patient with multiple prescriptions in this manner decreases the risk of diversion or abuse. ● Issuing multiple prescriptions is permissible under applicable state laws. ● The practitioner complies with all other requirements of the CSA and any other provisions of state law. Regardless of the method of transmission of a controlled substance prescription—by hand delivery, facsimile, phone call, or electronically—DEA regulations make it clear that the legal responsibility for issuing a valid prescription that “conform[s] in all essential respects to the law and regulations” rests upon the prescribing practitioner. However, a pharmacist is responsible for properly prescribing and dispensing controlled substances: ● A practitioner prescribing Schedule II controlled substances to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may transmit the prescription by facsimile. ● Practitioners prescribing Schedule II controlled substances for residents of long-term care facilities may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. ● A practitioner prescribing a Schedule II narcotic-controlled substance for a patient enrolled in a hospice care program certified and paid for by Medicare under Title XVIII or a hospice program licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or agent may transmit the prescription to the pharmacy and will note on the prescription that it is for a hospice patient. As electronic prescribing of controlled substances becomes more widespread, the need to fax or call in a Schedule II controlled substance (or any other controlled substance) will decrease. Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may be refilled only up to five times within six months of the date it was issued. After five refills or six months, whichever occurs first, a new prescription is required. Prescriptions for Schedules III through V controlled substances may be transmitted by facsimile from the practitioner, or an employee or agent of the individual practitioner, to the dispensing pharmacy. The facsimile is equivalent to the original prescription (DEA, 2020a). In addition, a pharmacist may dispense a controlled substance listed in Schedules III, IV, or V according to an oral prescription made by an individual practitioner. The pharmacist must promptly reduce to writing the oral prescription, and it must contain all information required for a valid prescription, except for the practitioner’s signature.
Facsimile and oral prescriptions for Schedule II controlled substances Generally, a valid Schedule II controlled substance prescription cannot be transmitted via facsimile. The CSA requires that a Schedule II controlled substance be dispensed by a pharmacy only according to a written prescription, except in emergencies, and prohibits Schedule II prescriptions from being refilled. Thus, in most cases, a pharmacist must receive the original,
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