As the opioid crisis worsened, the implementation of EPCS as a tool for increased security against diverted controlled substance prescriptions has been recognized (SureScripts, 2022a). E-pre- scribing continued raising the bar for safe, precise prescriptions in 2021 with better data quality and more efficient communication between pharmacists and prescribers. A Centers for Medicare & Medicaid Services (CMS) rule requiring that Part D providers use EPCS took effect January 1, , according to the requirements of the SUPPORT for Patients and Communities Act, and state legisla- Schedule II controlled substance prescribing considerations Schedule II controlled substances require a written, signed pre- scription, except where states have enacted laws allowing EPCS. There is no federal law limiting when a signed prescription ex- pires. A verbal order is permitted only in an emergency for Sched- ule II controlled substances. Written prescriptions for a Schedule II controlled substance 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, 33 states passed legislation limiting it, 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 mil- ligram equivalents (MMEs); most states set exceptions for chronic pain treatment, cancer pain, and palliative care. In addition, some states have also set limits for minors (ORN, 2021). Under federal law, a prescriber may issue multiple prescriptions authorizing the patient to receive up to a 90-day supply of a
tion continued moving forward throughout the year (SureScripts, 2022b). With between 20% and 26% of U.S. adults using tele- medicine every month in 2021, it is no surprise that e-prescribing use grew throughout the year. EPCS brings extra safety and secu- rity to controlled substance prescriptions, which is critical amid an opioid overdose crisis that spiked as the COVID-19 pandemic hit the United States. Already used by virtually all pharmacies, EPCS saw an 18% jump in the number of enabled prescribers in 2021 (SureScripts, 2022b). Schedule II controlled substance based on the following condi- tions: ● Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual pro- fessional practice. ● The prescriber provides written instructions on each prescrip- tion, indicating the earliest date a pharmacy may fill each pre - scription. The first prescription does not need a fill date on it if the prescriber intends for that prescription to be filled im - mediately. ● The practitioner concludes that providing the patient with multiple prescriptions in this manner does not create a 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 sub- stance prescription—by hand delivery, facsimile, phone call, or electronically—DEA regulations make it clear that the legal re- sponsibility 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 intra- spinal infusion may transmit the prescription by facsimile. ● Practitioners prescribing Schedule II controlled substances for residents of long-term care facilities may transmit a prescrip- tion by facsimile to the dispensing pharmacy. The practitio- ner’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 hos - pice 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 sub- stance (or any other controlled substance) will decrease.
Facsimile and oral prescriptions for schedule II controlled substances Generally, a valid Schedule II controlled substance prescription is not allowed to 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, manu- ally signed paper or electronic prescription before dispensing a Schedule II controlled substance (DEA, 2018c). Therefore, a pre- scriber 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 adequate enough to treat the patient only during the emergency period. The prescribing practitioner must provide the pharmacist with a written and signed prescrip- tion within seven days. The pharmacist must notify the DEA if the prescription still needs to be received in that timeframe.
The DEA has granted three exceptions to the facsimile prescrip- tion requirements for Schedule II controlled substances. As a re- sult, 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, written, or by 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 phar- macist 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.” Accord- ingly, an authorized agent may transmit such a practitioner-signed paper prescription via facsimile to the pharmacy on behalf of the practitioner (DEA, 2018c).
Schedules III and IV controlled substances may be refilled if au - thorized on the prescription. However, the prescription may only be refilled up to five times within six months of the date it was is - sued. 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 practitio- ner, 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 ac- cording to an oral prescription made by an individual practitioner. The pharmacist must promptly reduce writing of the oral prescrip- tion containing all information required for a valid prescription, except for the practitioner’s signature.
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Book Code: RPUS3024
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