Electronic Prescriptions for Controlled Substances

Electronic Prescriptions for Controlled Substances (EPCS) was originally a proposal for the DEA to revise its regulations to provide practitioners with the option of writing electronic prescriptions for controlled substances. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rule.

In 2010, DEA regulations were modified which lifted previous restrictions against the use of electronic prescribing for controlled substances that have presented a major obstacle to e-prescribing proliferation. As healthcare providers move to implement these new regulations, e-prescribing can be expected to reduce paperwork for pharmacies and practitioners, reduce prescription forgery and help integrate prescription records in electronic medical records.

The rule “Electronic Prescriptions for Controlled Substances” (75 FR 16236, March 31, 2010) [Docket No. DEA-218, RIN 1117-AA61] provides practitioners with the option of writing and transmitting prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule became effective on June 1, 2010.

In 1970, the DEA implemented the Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act (CSA) (21 U.S.C. 801–971). At this time, most transactions, and particularly prescriptions were done on paper.

These regulations ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes. The regulations also deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Part of CSA mandate included that some records must be created and kept on forms that DEA provides and that many controlled substance prescriptions must be manually signed.

In 1999, in response to requests from the regulated community, the Drug Enforcement Administration (DEA) began to examine how to revise its regulations to allow the use of electronic systems within the limits imposed by the existing statutes, while being mindful that the records had to be usable in legal actions. On April 1, 2005, after extensive consultation with the regulated community, DEA published a final rule that allowed the electronic creation, signature, transmission, and retention of records of orders for Schedule I and Schedule II controlled substances, orders that prior to that time had to be created on preprinted forms that DEA issued.

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