Preston Campbell, III, M.D.

Executive Vice President for Medical Affairs

Cystic Fibrosis Foundation

6931 Arlington Road, Suite 200

Bethesda, Maryland 20814

Fax: 301-907-2699

E-mail: pwc@cff.org

Report of Adverse Event/Treatment Failure from Substitution

of Generic Pancreatic Enzyme Product in CF Patients

Date: _________ Reporting Clinician: __________________________________

Institution: __________________________________________________________

Patient initials: ___________ Age: ______ Sex: M F Weight: _________

Prescribed Brand Name Product: ________________________________________

Strength _____________ Dose ______________ Frequency ________________

Name of Dispensing Pharmacy: _________________________________________

Phone: (___) _________ Contact Person:___________________________

Date of Generic Substitution: _________ Manufacturer_______________________

Was Steatorrhea adequately controlled on the generic product? Yes ____No____

Clinical Manifestations/Symptoms? ______________________________________

___________________________________________________________________

___________________________________________________________________

Was Branded Enzyme reinstated? No If “Yes”, when? ___________________

Consequences?______________________________________________________

___________________________________________________________________

Were symptoms controlled on the branded product? Comments: ______________________

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