According to Washington State Pharmacy Law, which of the following information about Electronic Prescriptions for Controlled Substances (EPCS) is/are TRUE?
I. Electronic signatures are required on all electronically communicated prescriptions.
II. The prescription that is generated electronically and transmitted via fax shall follow the ECPS rules.
III. An ECPS cannot be used to prescribe Schedule II controlled substance.
a. I only
b. I and II only
c. II and III only
Answer: I only is true, [Washington State Pharmacy Law July 2016 News Letter].
All 50 states, including Washington State, have rules in place allowing electronic prescriptions for controlled substances (EPCS), including Schedule II medications.
Pharmacies and practitioners wishing to use EPCS must first select software that meets the requirements of Title 21 Code of Federal Regulations (CFR) §1311. The software application provider must be approved by the federal Drug Enforcement Administration (DEA), and in Washington State it must also be approved by the Commission. Practitioners may not transmit, and pharmacies may not receive, EPCS until their software provider obtains a third-party audit or certification review that determines that their software application complies with DEA’s requirements and provides the audit/certification report to the practitioner/pharmacy.
Under Title 21 CFR §1300.03, electronic prescription is defined as a prescription that is generated on an electronic application and transmitted as an electronic data file. Therefore, an electronic prescription does not include prescriptions transmitted by facsimile, even if generated electronically and transmitted via fax, or printed on a computer printer.
An electronic signature is defined as a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person’s approval of the information contained in the message.
According to DEA, electronic signatures are required on all electronically communicated prescriptions and are not allowed on CS prescriptions delivered by fax or hard copy to the pharmacy. CS prescriptions sent from fax to fax, computer to fax, printed on a computer printer, or manually written must all contain a manual signature. A manual, or wet, signature means the practitioner directly signs the prescription by hand using ink or indelible pencil.
Signing a signature pad on a computer so the prescription is printed or faxed with the signature image, or stamping the prescription with a signature stamp, does not meet DEA requirements for manual signatures. This also applies to EPCS where the electronic transmission fails and the prescription is returned to the practitioner by the intermediary.
These prescriptions must be manually signed by the prescriber before being faxed to the pharmacy, even if they include an electronic signature. Pharmacists should recognize they are responsible for ensuring CS prescriptions meet DEA signature requirements and contacting the prescriber whenever necessary.