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Clarification on Electronically Generated Prescriptions & Validity of Electronic Signatures

At several fall pharmacy night events, members have been requesting clarification regarding electronically generated prescriptions for controlled substances, raising the question as to whether a prescription for a controlled substance is valid if electronically signed by a prescriber and transmitted via e-mail or fax. MPhA has sought clarification on this matter from both the DEA and the Minnesota State Board of Pharmacy. Both agencies have indicated that electronically generated controlled substance prescriptions must be printed out and manually signed by the provider. The rules sited by the agencies specifically pertaining to this issue are as follows:

Except under limited circumstances, a pharmacist may dispense a Schedule II controlled substance only upon receipt of the original written prescription manually signed by the practitioner (21 U.S.C. 829, 21 CFR 1306.11). A pharmacist may dispense a Schedule III or IV controlled substance only pursuant to a written and manually signed prescription from an individual practitioner, which is presented directly or transmitted via facsimile to the pharmacist, or an oral prescription, which the pharmacist promptly reduces to writing containing all of the information required to be in a prescription, except the signature of the practitioner (21 U.S.C. 829, 21 CFR 1306.21).

The Board of Pharmacy clarification specifically states, “that the current rules are such that electronically generated controlled substance orders (for all schedules) that are electronically signed and sent to a pharmacy's facsimile machine are not legally valid prescriptions. Nor are they legally valid if they are printed out and handed to the patient - unless the prescriber manually signs them.”

Samples of letters sent to providers from both the DEA and the Minnesota Board of Pharmacy providing further clarification on this issue are here for your review.

CMS has provided the Medicare’s Practical Guide to the E-Prescribing Incentive Program that explains the e-prescribing incentive program, how eligible professionals can participate, and how to choose a qualified e-prescribing system.

By adopting e-prescribing through Medicare’s program, eligible professionals can save time, enhance office and pharmacy productivity, and improve patient safety and quality of care while earning incentives from Medicare.

For additional information about e-prescribing, visit:
www.cms.hhs.gov/PQRI. Select “E-prescribing Incentive Program”.
www.cms.hhs.gov/eprescribing (information on Part D e-prescribing standards effective April 1, 2009).
www.ehealthinitiative.org to download “A Clinician’s Guide to Electronic Prescribing.”

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