Allows a Prescriber to Send a Prescription to a Pharmacy for a Controlled Substance

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Federally required	Cost	Test Tool Availability
Implementation Specification	NCPDP SCRIPT Standard, Implementation Guide, Version 10.6	Final	Production	Yes	$	No
Implementation Specification	NCPDP SCRIPT Standard, Implementation Guide, Version 2017071	Final	Production	No	$	No
Standard	HL7, Version 2	Final	Production	No	Free

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
The following transactions need to be implemented for interoperability purposes: 21 CFR §1311 implements US Drug Enforcement Administration's Electronic Prescription for Controlled Substance regulation. DEA's EPCS requires additional information satisfied by the following SCRIPT 10.6 elements: Digital Signature Indicator - Use Drug Coverage Status Code - "SI - Signed Prescription" Controlled Substance Indicator - Use DEA Schedule field is indicate the controlled substance schedule class Earliest Fill Date - Use Date/Time/Period Qualifier- value= "07 - Effective Date (Begin)" Drug Abuse Treatment Identifier - Use DRU Segment Ø9Ø Free Text - value= “NADEAN:xxxxxxxxx” (Narcotics Addiction DEA Number)" Medication Indication for GHB (Gamma-Hydroxybutyric acid) - Use DRU Segment Ø9Ø Free Text - value="medical need for GHB" The SUPPORT for Patients and Communities Act, once implemented, will require a prescription for a Medicare part D drug be transmitted electronically using NCPDP SCRIPT 10.6, or the latest implemented version. Please note that the NCPDP electronic prescribing test tool currently tests the capabilities of any health IT to conform to the ONC Health IT Certification Program criterion 170.315 (b)(3), but does not test system capabilities to conform to DEA EPCS certification requirements. Both the prescriber and the pharmacy must have their systems configured for the transaction in order to facilitate successful exchange, including the ability to send or receive verify, status, or error transactions. See NCPDP projects in the Interoperability Proving Ground.	The DEA's EPCS regulation, 21 CFR §1311, requires additional security considerations that: An individual practitioner must obtain an authentication credential from a credential service provider or certification authority using two of the following three factors: Something only the practitioner knows, such as a password or response to a challenge question. Something the practitioner is, biometric data such as a fingerprint or iris scan Something the practitioner has, a device (hard token) separate from the computer to which the practitioner is gaining access. The practitioner must submit identity proofing information to the credential service provider or certification authority The electronic prescription application must be capable of the setting of logical access controls to limit permissions for certain functions

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

The following transactions need to be implemented for interoperability purposes:
21 CFR §1311 implements US Drug Enforcement Administration's Electronic Prescription for Controlled Substance regulation.
DEA's EPCS requires additional information satisfied by the following SCRIPT 10.6 elements:
- Digital Signature Indicator - Use Drug Coverage Status Code - "SI - Signed Prescription"
- Controlled Substance Indicator - Use DEA Schedule field is indicate the controlled substance schedule class
- Earliest Fill Date - Use Date/Time/Period Qualifier- value= "07 - Effective Date (Begin)"
- Drug Abuse Treatment Identifier - Use DRU Segment Ø9Ø Free Text - value= “NADEAN:xxxxxxxxx” (Narcotics Addiction DEA Number)"
- Medication Indication for GHB (Gamma-Hydroxybutyric acid) - Use DRU Segment Ø9Ø Free Text - value="medical need for GHB"
The SUPPORT for Patients and Communities Act, once implemented, will require a prescription for a Medicare part D drug be transmitted electronically using NCPDP SCRIPT 10.6, or the latest implemented version.
Please note that the NCPDP electronic prescribing test tool currently tests the capabilities of any health IT to conform to the ONC Health IT Certification Program criterion 170.315 (b)(3), but does not test system capabilities to conform to DEA EPCS certification requirements.
Both the prescriber and the pharmacy must have their systems configured for the transaction in order to facilitate successful exchange, including the ability to send or receive verify, status, or error transactions.
See NCPDP projects in the Interoperability Proving Ground.

The DEA's EPCS regulation, 21 CFR §1311, requires additional security considerations that:

An individual practitioner must obtain an authentication credential from a credential service provider or certification authority using two of the following three factors:
- Something only the practitioner knows, such as a password or response to a challenge question.
- Something the practitioner is, biometric data such as a fingerprint or iris scan
- Something the practitioner has, a device (hard token) separate from the computer to which the practitioner is gaining access.

The practitioner must submit identity proofing information to the credential service provider or certification authority
The electronic prescription application must be capable of the setting of logical access controls to limit permissions for certain functions

Comment

Submitted by danwoodard on 2021-06-29

eprescribing with NADEAN

Electronic prescriptions for controlled drugs require the prescriber's DEA number. This is included automatically with every prescription with most EHRs as the DEA number is not confidential, is assigned to the user, and the user must perform two-factor authentication. Most electronic prescriptions for buprenorphine also require an NADEAN number. The NADEAN likewise is not confidential, in fact it appears on every prescription for buprenorphine, and is only a slight modification of the DEA number. Nevertheless, some EHRs require the user to manually enter the NADEAN on every prescription for buprenorphine, not the best use of our time. Is this a regulatory requirement? Why can't the NADEAN be filled in automatically for the authenticated provider? Any information is appreciated.

Submitted by [email protected] on 2021-09-29

NCPDP Comments

NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 update Adoption Level to 5.

Submitted by [email protected] on 2021-09-29

NCPDP Comments

Sunset NCPDP SCRIPT Standard, Implementation Guide, Version 10.6

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Allows a Prescriber to Send a Prescription to a Pharmacy for a Controlled Substance

Comment

eprescribing with NADEAN

NCPDP Comments

NCPDP Comments