The U.S. Drug Enforcement Administration (DEA) regulations for communicating controlled substance prescriptions to pharmacies (including electronic prescriptions) outline the rules for submission of these prescriptions from licensed prescribing providers to pharmacies; in addition, the regulations clearly define the roles of practitioners’ secretaries, assistants, and other authorized agents.
To ensure that prescriptions for controlled substances are medically valid and intentional, thereby reducing access to prescription drugs for diversion purposes
The Comprehensive Drug Abuse Prevention and Control Act of 1970 “mandates that [the] DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances” (DEA, 2010b, p. 61613). To support this system and to ensure that it remains closed at the point of sale, the DEA created regulations for the communication of controlled substance prescriptions from licensed prescribing providers to pharmacies. Under these regulations:
- Prescribers are prohibited from delegating the medical determination of need for a controlled substance (DEA, 2010b). Prescriptions must be issued by prescribers “acting in the usual course of their professional practice” (DEA, 2010b, p. 16237).
- Providers are prohibited from delegating their signatory approval, their approval of the elements of a prescription, or their responsibility for ensuring that all required elements of a prescription are included: patient name and address; drug name and strength; quantity prescribed; directions for use; and the name, address, and DEA number of the issuing practitioner (DEA, 2010b).
- Note: Agents who can be delegated prescription-related tasks are individuals who consent to act on behalf of the prescriber, who have the prescriber assent to act on their behalf, and who have a fiduciary relationship with the prescriber. In addition, a prescriber’s secretary, assistant, or other delegated agent can prepare the prescription.
- Delegated agents are permitted to transmit prescriptions for Schedule III, IV, and V controlled substances (DEA, 2010b).
- Pharmacies can only dispense Schedule III, IV, and V controlled substances with a written, oral, or faxed prescription.
- Patients can only transmit written prescriptions
- Prescribers or their delegated agents can transmit oral or faxed prescriptions in addition to written prescriptions.
- Oral and faxed prescriptions must contain all the required elements except the signatory approval.
- Prescriptions are required for Schedule II controlled substances to be dispensed with a written prescription, with the following exceptions (DEA, 2010b):
- Emergency oral prescriptions can be transmitted only by a prescriber and must be followed up by a written prescription within seven days.
- Schedule II prescriptions for individuals in a hospice or a long-term care facility can be transmitted by fax by a delegated agent.
- For controlled drugs, electronic communications are permitted as a substitute for written prescriptions. However, any electronic transmittal system between prescribers and pharmacies must meet four primary DEA requirements to the greatest extent possible (DEA, 2010a):
- Only licensed prescribers can sign electronic prescriptions, and prescriber offices must take steps to protect against theft of prescriber electronic IDs.
- The system must be designed to prevent prescribers from denying that they authorized prescriptions.
- The records of prescriptions must meet judicial system standards for use in legal actions without requiring large numbers of witnesses to verify records.
- The system must be designed to prevent prescriptions from being altered after their creation and to prevent pharmacists from creating prescriptions.
- The regulations acknowledge that the Medicare Modernization Act of 2003 requires Medicare Part D plans to support electronic prescription systems if any covered providers or pharmacies choose to implement them (AHRQ, 2015).
- Pharmacists are encouraged to inquire about a prescription’s legitimacy (DEA, 2010b).
The regulations recognize six levels of sophistication in “e-prescribing” systems, with levels 5 and 6 including the electronic transmittal of prescriptions (Agency for Healthcare Research and Quality [AHRQ], 2015, p. 1):
- Level 1: Electronic reference handbook
- Level 2: Stand-alone prescription writer
- Level 3: Patient-specific prescription creation or refilling
- Level 4: Medication management (access to medication history, warnings, and alerts)
- Level 5: Connectivity to dispensing site
- Level 6: Integration with an electronic medical record
- Note: All six levels have been found to decrease medication errors and improve patient safety to different degrees (AHRQ, 2015). AHRQ-funded evaluation of different e-prescribing systems is ongoing.
Prescribers, prescribers’ staff, pharmacists
No outcome data have been found regarding the role of DEA regulations for communicating controlled substance prescriptions to pharmacies in preventing prescription drug misuse and/or its consequences.
Agency for Healthcare Research and Quality. (2015). Electronic Prescribing. Retrieved from http://healthit.ahrq.gov/key-topics/electronic-prescribing
U.S. Drug Enforcement Administration. (2010a, March 31). Electronic prescriptions for controlled substances. Federal Register, 75 FR 16235 (pp. 16235–16319). Retrieved from https://www.federalregister.gov/articles/2010/03/31/2010-6687/electronic-prescriptions-for-controlled-substances
U.S. Drug Enforcement Administration. (2010b, October 6). Role of authorized agents in communicating controlled substance prescriptions to pharmacies. Federal Register, 75 FR 61613 (pp. 61613–61617). Retrieved from https://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies