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

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	HL7®, Version 2	Final	Production		No	Free
Implementation Specification	NCPDP® SCRIPT Standard, Implementation Guide, Version 2017071	Final	Production		No	$	No
Implementation Specification	NCPDP SCRIPT Standard, Implementation Guide, Version 2023011	Final	Feedback requested	Feedback Requested	Yes

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 to 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.	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 to 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.

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 pwilson@ncpdp.org on 2024-08-13

NCPDP Comment

NCPDP recommends removing NCPDP SCRIPT Standard, Implementation Guide, Version 2022011, as this version was never implemented. NCPDP SCRIPT Standard Implementation Guide, Version 2023011 is the next version named by ASTP/ONC and Medicare. Federally required should be changed to a Yes for the NCPDP SCRIPT Standard Implementation Guide, Version 2023011.

Submitted by pwilson@ncpdp.org on 2023-10-06

NCPDP Comment

NCPDP recommends that ONC update NCPDP SCRIPT Standard, Implementation Guide, Version 2022011 to Implementation Maturity = Pilot, Adoption Level = 1, Federally Required = Yes.

Submitted by shellyspiro on 2023-10-02

Pharmacy HIT Collaborative (PHIT) comment

PHIT supports NCPDP’s recommendation to add NCPDP SCRIPT Standard, Implementation Guide, Version 2022011 to Federally Required.

Submitted by pwilson@ncpdp.org on 2022-09-30

NCPDP Comments

NCPDP recommends to sunset NCPDP SCRIPT Standard Implementation Guide Version 10.6

Submitted by pwilson@ncpdp.org on 2021-09-29

NCPDP Comments

Sunset NCPDP SCRIPT Standard, Implementation Guide, Version 10.6

Submitted by pwilson@ncpdp.org on 2021-09-29

NCPDP Comments

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

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 pwilson@ncpdp.org on 2020-11-07