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Pedigree Legislation and the Effect on the Pharmaceutical Supply Chain
Program Overview
This presentation is an introduction to the Food and Drug Administration’s Drug Pedigree regulations and how they could effect the distribution of medication in the United States. These regulations are intended to reduce counterfeit medication from entering the US drug distribution system. Although the concept of a drug pedigree has existed since the Prescription Drug Marketing Act of 1987, only recently has the FDA decided to enforce a federal pedigree requirement.
Presentation
The program can be completed by viewing the PowerPoint® slide show (using Microsoft® PowerPoint® 97 or later), answering the post-test questions and completing the program evaluation on line. Statements of credit can be printed after successful completion of the program.
Program Information
- Target Audience
All Registered Pharmacists.
This program is not accredited for Pharmacy Technicians.
- Learning Objectives
After participating in this program, the pharmacist should be able to:
- Explain the history of the Prescription Drug Marketing Act (PDMA)
- Summarize the stages of development of pedigree regulations on both state and federal levels
- Identify the consequences of a breakdown in the integrity of the pharmaceutical supply chain
- Recognize how drug pedigree relates to patient safety
Program Faculty
- Faculty Disclosure Statement
In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, Northeastern University Bouvé College of Health Sciences School of Pharmacy requires that faculty members disclose any relationship (e.g., shareholder, recipient of research grant, consultant, or member of an advisory committee) that the faculty may have with commercial companies whose products or services may be mentioned in their presentations. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on faculty presentations.
- Faculty and Disclosure Information
Patrick Carpenter, MS, RPh
Graduate Lecturer
Northeastern University
School of Professional and Continuing Studies
Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices
Boston, Massachusetts
- Patrick Carpenter has no actual or potential conflict of interest in relation to this program.
- Patrick Carpenter does not plan on discussing unlabeled/investigational uses of a commercial product.
Program Support
This program is supported by an educational grant from ASD Healthcare and CSL Behring.
The fee for this program is $25.00.
Continuing Education Accreditation Information
Northeastern University Bouvé College of Health Sciences School of Pharmacy is approved by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. Pharmacists successfully participating in this program will receive a statement of credit for two contact hours (0.2 CEUs). Statements of Credit may be printed on-line after successful completion of the learning assessment (70%).
ACPE # 027-000-06-067-H03. Initial release date: June 27, 2006, expires June 27, 2009.
Further Disclosure of Unlabeled Use and Disclaimer
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