e-Profile Login and ID Quick Search
Delaware News: Electronic Transmission of Controlled Substance Prescriptions
Published in the March 2008 Delaware State Board of Pharmacy Newsletter
There have been a number of recent inquiries and some confusion regarding the validity of electronically transmitted controlled substance prescriptions from a practitioner’s office to a pharmacy. E-prescribed controlled substance prescriptions, using an electronic signature, are not permitted under either federal or state law. This includes all controlled substance prescriptions Schedule II through V. At a recent National Association of State Controlled Substances Authorities meeting, Drug Enforcement Administration (DEA) indicated that it is currently reviewing this issue but such signatures are not allowed at this time.
Faxing controlled substance prescriptions is permitted under the following federal and state laws:
Controlled Substance Regulation 4.2.3 states that written prescriptions for controlled substances may be transmitted via facsimile by a practitioner or by the practitioner’s authorized agent to a pharmacy only when the transmission complies with 21 CFR 1306.11, 1306.21, and 1306.31.
1306.11 A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec. 1304.04(h) of this chapter. The facsimile serves as the original written prescription for purposes of:
Exception (e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
Exception (f) A prescription prepared in accordance with Sec. 1306.05 written for Schedule II substance for a resi¬dent of a long-term care facility may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile; and
Exception (g) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmit¬ted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner’s agent will note on the prescription that the patient is a hospice patient.
Pursuant to 1306.21 (a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescrip¬tion signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner.
Additionally, according to the requirements of Delaware Pharmacy Regulation 5 all electronically transmitted prescrip¬tions shall be transmitted directly to a pharmacist in a licensed pharmacy of the patient’s choice with no intervening person having access to the prescription drug order; identify the trans¬mitter’s phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law; be transmitted by an authorized practitioner or his designated agent; and be deemed the origi¬nal prescription drug order provided it meets the requirements of this subsection. The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order communicated by way of electronic transmission consistent with existing federal or state laws and rules. All electronic equipment for receipt of prescription drug orders communicated by way of electronic transmission shall be maintained so as to ensure against unauthorized access. Persons other than those bound by a confidentiality agreement pursuant to Section 2.A. (2)(k) shall not have access to pharmacy records containing confidential information or personally identifiable information concerning the pharmacy’s patients.
Controlled substance prescriptions may only be electroni¬cally transmitted via a facsimile. Facsimile prescriptions must meet the following requirements in addition to the above listed electronic transmission requirements. The prescription order shall include the fax number of the transmitter, the number of transmitted pages, the name, phone number, and electronic number of the pharmacy intended to receive the transmission, and a confidentiality statement in bold type stating the electronic transmission should not be seen by unauthorized persons; unless the prescription is written for a Schedule II controlled substance, the prescriber should not issue the written prescription to the pa¬tient; a facsimile transmitted prescription order must be reduced to writing, unless received as a non-fading document, with a notation that the order was received by facsimile; the receiving facsimile machine must be in the prescription department to protect patient-pharmacist-authorized prescriber confidential¬ity and security; both non-controlled and controlled substance prescriptions may be transmitted via facsimile following state and federal requirements. All prescription orders for controlled substances shall be hand-signed by the practitioner.
For further specific federal and state code information please see 21 CFR 1300 to the end and 24 Del. C. 2500 to the end, respectively.
