Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be FilledAugust 10, 2023
If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. That is until August 28th when DEA’s final rule becomes effective. DEA explained its chief reasons for amending its regulations to allow the transfer of EPCS for initial filling are to provide patients with the option of transferring to prevent treatment delays, reducing patient burden and stress, as well as minimizing opportunities for diversion. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. Reg. 48365, 48369 (July 27, 2023). DEA also recognized the potential diversion if the prescriber transmits a new prescription to a different pharmacy and fails to cancel or void the original prescription. Id. at 48366.
DEA has amended its regulations to allow, upon request from a patient, the transfer of an EPCS between retail pharmacies for initial filling on a one-time basis only. Id. at 48379 (to be codified at 21 C.F.R. § 1306.08(e)). Any authorized refills included on schedule III-V prescriptions transfer with the original prescription. The pharmacy must transfer the EPCS in its electronic form and cannot convert it to another form (such as paper or facsimile) for transmission. Id. (to be codified at 21 C.F.R. § 1306.08(f)(1)). The content and prescription information elements required by 21 C.F.R. § 1306.06 cannot be altered during the transmission. Id. (to be codified at 21 C.F.R. § 1306.08(f)(2)). Two licensed pharmacists must directly communicate the transfer. Id. (to be codified at 21 C.F.R. § 1306.08(f)(3)). The transfer of EPCS for initial dispensing is permissible only if allowable under existing State or other applicable law. Id. (to be codified at 21 C.F.R. § 1306.08(g)).
Patients wishing to transfer EPCS to another pharmacy should confirm that the receiving pharmacy has the ability to fill the prescriptions before requesting the transfer.
The transferring pharmacist must update the EPCS prescription record to note the transfer. That pharmacist must also update the prescription record with:
- Name, address, and DEA registration number of the pharmacy to which the prescription was transferred;
- Name of the pharmacist receiving the transfer;
- Name of the transferring pharmacist; and
- Date of the transfer. Id. (to be codified at 21 C.F.R. § 1306.08(f)(4)).
The receiving pharmacist must document:
- The word “transfer” to the electronic prescription record;
- Transferring pharmacy’s name, address, and DEA registration number;
- Name of the transferring pharmacist;
- Date of the transfer; and
- Name of the pharmacist receiving the transfer. Id. (to be codified at 21 C.F.R. § 1306.08(f)(5)).
The transferring or receiving pharmacy’s prescription processing software may, if capable, capture the required information from the EPCS and automatically populate the corresponding data fields documenting the transfer. Id. (to be codified at 21 C.F.R. § 1306.08(f)(6)). The transferring or receiving pharmacist must ensure that the populated information is complete and accurate. Id.
As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. Id. at 48379-80 (to be codified at 21 C.F.R. § 1306.08(h)). DEA’s final rule does not alter or revise any other prescription or electronic prescription requirements.
DEA’s allowing patients to request a pharmacy to transfer an EPCS for initial filling to another pharmacy not only provides flexibility when medication may be needed most, but it actually reduces the potential for diversion by a prescriber duplicating the prescription without canceling or voiding the original prescription.