Here's a breakdown of electronic prescriptions for controlled substances (EPCS) in the United States.
Basic Requirements for Controlled Substance Prescriptions
- Issuance by Qualified Practitioners: The prescription must be issued by a qualified practitioner who is authorized to prescribe controlled substances and is registered with the DEA (or exempted from registration).
- Legitimate Medical Purpose: The prescription should be for a legitimate medical reason and issued in the ordinary course of professional practice.
- Pharmacist’s Responsibility: The pharmacist filling the prescription also has a responsibility to ensure the prescription is legitimate.
- Information Required: The prescription must include the patient's full name and address, drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills authorized.
- Schedule II Substances: Prescriptions may be written or electronic. Oral prescriptions are only allowed in emergencies.
- Schedule III-V Substances: Prescriptions can be written, electronic, or oral.
Electronic Prescriptions (EPCS)
- Optional but Regulated: EPCS is optional but if used, must comply with DEA regulations.
- Software Requirements: The software used for EPCS must be DEA-approved.
- Two-Factor Authentication: Practitioners must use a two-factor authentication process to sign electronic prescriptions.
- Identity Proofing: This can be conducted either by the institution employing the practitioner or through a credential service provider (CSP) or certification authority (CA).
- State Regulations: Practitioners must also comply with any state laws and regulations governing EPCS.
Schedule II Specifics
- No Refills: Federal law prohibits refilling prescriptions for Schedule II controlled substances.
- Quantity Limits: While there are no federal limits on the quantity that can be prescribed, it must be for a legitimate medical purpose.
It's essential for both the prescribing practitioner and the pharmacist to understand these regulations to ensure they are operating within the bounds of federal and potentially state law.
CLICK HERE to read the DEA Practitioners Manual - Part 2: Disposal of Controlled Substances.