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Minnesota News: E-Prescribing and Controlled Substances
Reprinted from the January 2009 Minnesota Board of Pharmacy Newsletter.
The Board frequently receives questions from pharmacists concerning the legal validity of controlled substance prescriptions that have been electronically “signed.” Such prescriptions may have the electronically captured signature of the prescriber printed on them. Or a phrase such as “electronically signed by the prescriber” may be printed on the prescription. They are sometimes directly faxed to the pharmacy, sometimes sent via true e-prescribing to the pharmacy’s computer, and sometimes are printed out and given to the patient. Regardless of how an electronically “signed” controlled substance prescription arrives at the pharmacy, it is not legally valid. Current federal laws and rules do not permit electronic signatures for controlled substance prescriptions.
This may change because the United States Drug Enforcement Administration (DEA) recently published proposed rules for the electronic prescribing of controlled substances. There are indications that those rules may be adopted by April 2009. However, here is an excerpt of DEA’s description of the rules that are currently in place. This description clearly indicates that DEA interprets current federal laws and rules to prohibit electronic signatures for controlled substances:
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). (Emphasis added).
Schedule II controlled substance prescriptions must also be manually signed by the prescriber but can only be phoned or faxed to a pharmacy in the limited circumstances allowed under federal law and rules. Further information is available on the Board’s Web site at www.phcybrd.state.mn.us/faq.htm#9.
Note that a manually signed Schedule III or IV controlled substance prescription can be presented directly to the pharmacist. A manually signed Schedule III or IV prescription can also be faxed to the pharmacist. However, there is nothing that allows an electronically signed controlled substance prescription to be “directly” faxed from an electronic medical record to a pharmacy. Instead, the Board advises pharmacists that an electronically generated prescription for a controlled substance drug is not valid unless it has been printed out and manually signed by the prescriber. A pharmacist that receives an electronically signed Schedule III or IV controlled substance prescription is allowed to contact the prescriber and take the prescription as an oral order. The Board understands that it can be inconvenient and time-consuming to do this. However, until DEA adopts the proposed rules mentioned above, the Board has no choice but to advise pharmacists to obey the current federal laws and rules. Board staff has provided information about this issue to the boards that license prescribers, to the Minnesota Medical Association, and to some of the health care systems that are using electronic prescribing systems – in hopes that the prescribers would be notified of the requirement for controlled substance prescriptions to be manually signed.
