Counseling Patients on the Use of Pancreatic Exocrine Insufficiency (PEI) Drug Products: An Update

Counseling Patients on the Use of Pancreatic Exocrine Insufficiency (PEI) Drug Products: An Update
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ACPE Universal Program Number: 207-000-06-165-H01
Release Date: December 15, 2006
Expiration Date: December 15, 2009


Description

Pancreatic extract drug products are indicated in the treatment of exocrine pancreatic insufficiency, which is a potential complicating factor in cystic fibrosis, chronic pancreatitis, pancreatic tumors, or pancreatectomy. Pancreatic extract drug products, long marketed in the United States, have a broad range of dosages and delivery mechanisms. The FDA evaluated the safety and effectiveness of these drug products and based on a review of all available data, including the studies and adverse event reports the FDA concluded that the safe and effective use of pancreatic enzyme drug products requires that the products be marketed by prescription only and that the products be approved through the new drug approval process to standardize enzyme activity. The FDA determined that bioactivity must be shown to correlate with the stated potency of each product, particularly for newer formulations that include microspheres and high-potency levels of pancreatic enzymes, which underlines the importance of consistent drug therapy in the class of pancreatic enzymes and the difficulties the pharmacist must be aware of in generic substitution and therapeutic interchange.

Learning Objectives
Upon successful completion of this activity, the pharmacist should be better able to:

  1. Describe conditions/disease states that require pancreatic enzyme replacement.
  2. Discuss the history of the safety and effectiveness of pancreatic enzyme replacements over the years.
  3. Discuss the current approval process for pancreatic enzyme treatments.
  4. List and describe currently approved replacement therapies including indication, dosing, side effects.
  5. Identify key opportunities for pharmacist intervention with pancreatic enzyme replacement treatment.

Target Audience
The target market for this program is pharmacists and pharmacy technicians.

Instructions for Participation
To receive a certificate of completion that indicates your eligibility for continuing education credit, you must:

  • Review the content of the activity.
  • Successfully complete the post-test (70% or higher).
  • You will have two (2) opportunities to successfully complete the activity.

Your statement of credit will be issued immediately upon successful completion of the post-test and submission of the evaluation.

Fee
There is no fee for this activity.

Accreditation

Pharmacists
ACPE logoNCPA is approved by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program will provide 2.0 contact hours (.2 CEUs) of continuing pharmacy education credit under the number 207-000-06-165-H01.

 

Faculty
Gary Milavetz, B.S., Pharm.D.
Associate Professor of Pharmacy
Division of Clinical and Administrative Pharmacy
College of Pharmacy
University of Iowa

Mary E. Teresi, B.S., Pharm.D.
Director of Clinical Trials
Pediatric Allergy and Pulmonary Division
Department of Pediatrics
University of Iowa Hospitals and Clinics

Maria Osterhaus

Doctor of Pharmacy Candidate
College of Pharmacy
University of Iowa



Disclosure Declaration
It is the policy of the National Community Pharmacists Association (NCPA) to ensure independence, balance, objectivity, scientific rigor, and integrity in all of their continuing education activities.

The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that information contained herein is accurate in accordance with the latest available scientific knowledge at the time of accreditation of this continuing education program. Information regarding drugs (e.g., their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions) and drug delivery systems are subject to change, however, and the reader is advised to check the manufacturer's package insert for information concerning recommended dosage and potential problems or cautions prior to dispensing or administering the drug or using the drug delivery systems.

Approval of credit for this continuing education activity does not imply endorsement by NCPA of any product or manufacturer identified.

Any medications or treatment methods suggested in this CE activity should not be used by the practitioner without evaluation of their patient's condition(s) and possible contraindication(s) or danger(s) of use of any specific medication.


Commercial Support
Commercial Support Provided by Solvay Pharmaceuticals, Inc.

Software Requirements
PC
Windows 2000
Internet Explorer 5.5 or Firefox
*Adobe Acrobat Reader

MAC
Mac OS 10.2.8
Safari

*Adobe Acrobat Reader

*REQUIRED TO VIEW PRINTABLE VERSION OF CE LESSON

 

 

 

 

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