Current Considerations for Outsourcing Pharmacy Sterile Preparations Compounding Services: Quality, Safety, and Selection

Program Overview

Please read the following program information before accessing the presentations using links located at the bottom of this page.

Release Date:  March 1, 2009              Expiration Date:  February 28, 2010

Accreditation for Pharmacists

ACPE LogoThe American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The program provides 2 hours (0.2 CEUs) of continuing education credit (program number 204-000-08-466-H01P).

Methods and Format

This is an online activity consisting of audio and slides for three presentations, a post-test, and an activity evaluation tool. Participants must view all presentations, take the activity post-test, and complete the course evaluation to receive continuing education credit. A minimum score of 70% is required on the test for credit to be awarded, and participants may print their official statements of continuing education credit immediately. The estimated time to complete this activity is 2 hours. This activity is provided free of charge.

Target Audience

This continuing education program is beneficial for pharmacists who are interested in understanding the outsourcing of compounding sterile preparations, and various factors involved in the decision to outsource, including safety, regulatory requirements, and quality considerations.

Activity Content

The decision to pursue the outsourcing of pharmacy compounding services involves a comprehensive analysis of many factors and processes. Environmental influences, reasons organizations choose to outsource, and operational considerations such as beyond use dating, volume requirements, and product selection will be discussed. Regulatory, liability, and accreditation concerns related to the compounding of sterile preparations will be addressed. Joint Commission and USP Chapter 797 requirements and safety considerations such as labeling, bar coding and regulations by which outsourcing providers are governed will be reviewed. Guidance on assuring high quality outsourcing services will be presented, including information such as request for proposal (RFP) development and content, vendor references, and delivery, as well as what items should be included in a contract. Implementation issues will be discussed, such as how to integrate the outsourced preparations into pharmacy operations, including quality issues of data, reporting, and quality assurance requirements. In addition, the faculty will discuss measures to evaluate and document an outsourcer’s performance.

Learning Objectives

At the conclusion of this knowledge-based educational activity, participants should be able to

Faculty

Michael D. Sanborn, M.S., R.Ph., FASHP
Program Chair
Corporate Vice President, Cardiovascular Services
Baylor Health Care System
Dallas, Texas

William W. Churchill, M.S., R.Ph.
Executive Director of Pharmacy Services
Brigham and Women’s Hospital
Boston, Massachusetts

James R. Rinehart, M.S., R.Ph., FASHP
Director of Pharmacy
BryanLGH Medical Center
Lincoln, Nebraska

Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education's and the Accreditation Council for Pharmacy Education's Standards for Commercial Support, ASHP Advantage requires that all individuals involved in the development of program content disclose their relevant financial relationships and that conflicts of interest be identified and resolved prior to delivery of the activity.

The faculty and planners report the following relationships:

Michael D. Sanborn, M.S., R.Ph., FASHP, reports no relationships pertinent to this activity.

James R. Rinehart, M.S., R.Ph., FASHP, reports no relationships pertinent to this activity.

William W. Churchill, M.S., R.Ph., reports no relationships pertinent to this activity.

Ron DeChant, M.S., R.Ph., reports no relationships pertinent to this activity.

This activity is supported by an educational grant from PharMEDium Services, LLC.

Launch Presentation

Launch PresentationFactors and Processes: Should Our Health Care Organization Outsource Pharmacy Compounding Services? (30 minutes)
Michael D. Sanborn, M.S., R.Ph., FASHP

Launch PresentationOff-site Pharmacy Compounding Sterile Preparations: Safety, Regulatory, and Accreditation Considerations (30 minutes)
James R. Rinehart, M.S., R.Ph., FASHP

Launch PresentationAssuring High-Quality Outsourcing Services (45 minutes)
William W. Churchill, M.S., R.Ph.

*Allow additional time to complete the post-test and evaluation.

Download Post-Test

Click here to print the post-test for your reference.  Please note that to be eligible for continuing education credit, you must go to the ASHP Learning Center and complete the test online.