Healthcare Setting Enrollment

Healthcare Setting Information (* Indicates required field)

Healthcare Setting Name

Healthcare Setting NPI #

Healthcare Setting DEA #

Setting Type

Medical Hospital Psychiatric Hospital Other

Setting Address

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Phone

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Healthcare Setting Authorized Representative (* Indicates required field)

First Name

Last Name

Position/Title

Phone

Fax

Preferred communication method

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Authorized Representative Responsibilities

As an authorized representative for the healthcare setting:

I have reviewed the Education Program for Healthcare Settings.
I must establish processes and procedures to:
1. assess the patient for respiratory abnormalities before administration (by medical and medication history, and chest auscultation),
2. monitor the patient for a minimum of 1 hour after administration for bronchospasm,
3. ensure no more than a single dose of ADASUVE is administered within a 24-hour period,
4. ensure ADASUVE is not dispensed outside of the certified healthcare setting.
My healthcare setting has immediate access to supplies and personnel onsite 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.

On behalf of the healthcare setting, we must comply with the following REMS requirements:

Before administering:

Assess the patient's health status for a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD) and other lung diseases associated with bronchospasm, acute respiratory signs and symptoms (e.g. wheezing), and current use of medications to treat airway disease such as asthma or COPD.
Assess the patient's health status for respiratory abnormalities by chest auscultation.

After administering, for a minimum of 1 hour:

During treatment, within a 24-hour period:

At all times:

Not dispense ADASUVE for use outside of the certified healthcare setting.
Report any adverse events of bronchospasm that occur following ADASUVE treatment to the ADASUVE REMS.
Not distribute, transfer, loan, or sell ADASUVE. Maintain appropriate documentation that all processes and procedures are in place and are being followed.
Comply with audits by Alexza Pharmaceuticals, Inc., or a third party acting on behalf of Alexza Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

To maintain certification to dispense:

Have any new Authorized Representative enroll in the ADASUVE REMS by completing the Healthcare Setting Enrollment Form and submitting to the ADASUVE REMS.

, please use your mouse or stylus to sign below:

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