NATPARA REMS Program Pharmacy Certification
To become certified, pharmacies must designate an authorized Pharmacy Representative to coordinate the setting’s activities and assure compliance. The designated Pharmacy Representative must complete the following steps for certification:
Review the NATPARA REMS Program: Training Module for Pharmacy Representatives and successfully complete the Knowledge Assessment.
Complete and sign the NATPARA REMS Program: Pharmacy Enrollment Form.
Submit the Knowledge Assessment and the NATPARA REMS Program: Pharmacy Enrollment Form.
- Fax to 1-844-NAT-REMS (628-7367) or
- Scan and e-mail to NATPARAREMS@shire.com
A confirmation of your certification in the NATPARA REMS Program will be sent to the pharmacy so you can begin to distribute NATPARA.
Ensure all relevant staff involved in dispensing NATPARA are trained on the NATPARA REMS Program requirements as described in the NATPARA REMS Program: Training Module for Pharmacy Representatives.
Put processes and procedures in place to ensure the following verifications and safe use conditions are met prior to dispensing NATPARA:
- Verifying that the prescriber is certified in the NATPARA REMS Program by reviewing the prescriber’s information against a list of REMS-certified prescribers sent from the NATPARA REMS Program Coordinating Center
- Verifying that a NATPARA REMS Program: Patient-Prescriber Acknowledgment Form has been completed and submitted for the corresponding patient and prescriber by reviewing the patient and prescriber against a list of REMS-approved patients and prescribers available through the NATPARA REMS Program Coordinating Center
Make available to Shire and/or a designated third-party of the FDA, documentation to verify understanding of, and adherence to, the requirements of the NATPARA REMS Program.
Recertify in the NATPARA REMS Program if the pharmacy designates someone else as the authorized Pharmacy Representative.
If you have any questions, contact the NATPARA REMS Program Coordinating Center at 1-855-NATPARA.