To become certified to dispense:
Site RequirementsHave immediate access to supplies and personnel competent in the management of acute bronchospasm including: a short-acting bronchodilator (e.g., albuterol), delivered by inhaler (with spacer) or nebulizer, and access to emergency assistance for symptoms that require immediate medical attention.
Designate an Authorized RepresentativeDesignate an authorized representative to carry out the certification process and oversee implementation and compliance with the ADASUVE REMS on behalf of the healthcare setting.
Review the Healthcare Setting GuideHave the authorized representative review the Education Program for Healthcare Settings
Complete the Healthcare Setting Enrollment FormHave the authorized representative enroll in the Adasuve REMS by completing the Healthcare Setting Enrollment Form and submitting it to the Adasuve REMS.
Establish Processes and ProceduresEstablish processes and procedures to:
- assess the patient for respiratory abnormalities before administration by medical history, medication history, and chest auscultation,
- monitor the patient for a minimum of 1 hour after administration for bronchospasm,
- provide that no more than a single dose of ADASUVE is administered within a 24-hour period, and
- provide that ADASUVE is not dispensed outside of the certified healthcare setting.