Configure NCPDP SCRIPT 2017071 REMS (Risk Evaluation and Mitigation Strategy) request and response transactions for a REMS-restricted drug

Steps

1. Identify the REMS program requirements for the target drug via the FDA REMS database (accessdata.fda.gov/scripts/rems); confirm which transaction model applies—some REMS programs require prescriber enrollment, patient enrollment, or pharmacy certification
2. Implement the NCPDP SCRIPT 2017071 REMSInitiationRequest transaction: populate with prescriber NPI, patient demographics, drug NDC, and REMS program identifier; transmit to the REMS data hub or registry endpoint designated by the drug manufacturer
3. Receive the REMSInitiationResponse: parse REMSStatus (Compliant, NonCompliant, PendingCertification) and required compliance actions; if NonCompliant, surface the specific REMS requirement gap to the prescriber (e.g., prescriber not enrolled, required lab not on file)
4. For programs requiring patient enrollment (e.g., iPLEDGE for isotretinoin), integrate with the REMS program's own patient registry API or portal; NCPDP SCRIPT REMS transactions may complement but not fully replace program-specific registry interactions
5. Transmit the NewRx only after REMSInitiationResponse confirms Compliant status; do not transmit prescriptions for REMS-restricted drugs without confirmed REMS compliance status
6. At the pharmacy, verify REMS compliance again before dispensing: some REMS programs require a pharmacy-level dispense authorization check with the REMS registry on the day of dispensing