B. Consideration Shall Include, but Not Limited to the Following

Policy Number / AHC.PHARM.022
Date of Issue / February 2013
Review Dates
Revision Dates / May 2013
Policy Owner(s) / Pharmacy
Outsourcing Sterile Compounding Services

I.  Purpose

The purpose of this policy is to provide decision making standards for out-sourcing compounded sterile products (CSPs) for the pharmacy department.

II.  Scope

The policy applies to all Anywhere Health Care (AHC) pharmacy departments servicing hospital inpatient and hospital outpatient areas. This policy includes the ambulatory clinics or retail pharmacies if those entities purchase sterile compounds from sources external to Anywhere Health Care.

Applies to / Approved by
AHC Hospital A
AHC Hospital B
AHC Hospital C
AHC Hospital D
AHC Hospital E
AHC Hospital F
AHC Hospital G

III.  Policy Statements

A.  Prior to outsourcing, the director of pharmacy shall perform an assessment to determine the reason and need for out-sourcing of CSPs.

B.  Consideration shall include, but not limited to the following:

1.  Internal needs assessment

2.  Cost analysis

3.  Careful review of prospective compounding pharmacies

Policy Number / AHC.PHARM.022
Date of Issue / February 2013
Review Dates
Revision Dates / March 2013
Policy Owner(s) / Pharmacy
Outsourcing Sterile Compounding Services

C.  The contractor assessment tool, “Outsourcing Sterile Products Preparation”, developed by American Society of Health System Pharmacists (ASHP) Foundation shall be utilized during the evaluation of each compounding pharmacy. http://www.ashpfoundation.org/sterileproductstool For the outsourcing company to be considered by Anywhere Health Care, a minimum score of 80% is required.

D.  The completed initial assessment will be sent to Performance Improvement lead for the facility for review prior to entering into an agreement.

E.  Ongoing evaluation of the compounding pharmacy’s performance will be done to ensure all standards established in the contract continue to be met.

IV.  Procedures/Standards and Roles & Responsibilities

A.  Outsourcing Assessment

1.  Outsourcing the production of sterile compounds should be considered as an alternative to in-house production when:

a.  The volume of CSPs is very low.

b.  The volume of certain CSPs is high and staff resources are limited or unavailable to prepare sufficient quantities for the facility’s demand.

c.  The facility does not possess the technology required to produce the CSP needed.

d.  Commercially prepared, pre-mixed products are not available.

2.  The ASHP Foundation Contractor Assessment Tool is completed with information obtained from the vendor representative. The assessment tool analysis includes regulatory, quality & patient safety, medication administration safety features, and service excellence.

3.  A cost analysis is performed in conjunction with the appropriate Finance personnel for the facility to ascertain the financial feasibility of utilization of the compounding pharmacy’s services.

4.  A site visit to the compounding pharmacy operation is required prior to implementing an agreement and purchasing products from the compounding service.

5.  The needs of the facility shall guide the identification of potential compounding pharmacies with appropriate expertise and capabilities.

B.  Outsourcing Contract

1.  The facility Pharmacist-in-Charge must be involved in the selection of, and agreement with the compounding pharmacy.

Policy Number / AHC.PHARM.022
Date of Issue / February 2013
Review Dates
Revision Dates / March 2013
Policy Owner(s) / Pharmacy
Outsourcing Sterile Compounding Services

2.  An agreement between the hospital and compounding pharmacy will be written and approved by the legal departments of both Anywhere Health Care and the compounding pharmacy. Authorized signatures for both entities will be obtained to execute the agreement. The approval must be obtained at a system and local level.

C.  Evaluation of Compounding Pharmacy’s Performance

1.  The compounding pharmacy will regularly submit quality reports to the facility director of pharmacy for review, i.e. quarterly quality assurance/PI data.

2.  Ongoing evaluation of the compounding pharmacy’s performance may include improved hospital staff productivity & performance, improved pharmacy processes, improved pharmacy costs, and working relationship between hospital staff and compounding pharmacy.

D.  Documentation

1.  The Director of Pharmacy shall maintain a copy of the contractor assessment tool, site visit inspection, and quality assurance data.

V.  Enforcement and Exceptions

A.  All parties will operate within the terms of the executed contract

VI.  Definitions

A.  CSPs: Compounded Sterile Products.

B.  ASHP: American Society of Health-System Pharmacists

C.  PI: Performance Improvement

VII.  Internal References

[This section intentionally left blank.]

VIII.  External References

ASHP Foundation. Outsourcing Sterile Products Preparation: Contractor Assessment Tool http://www.ashpfoundation.org/sterileproductstool

ASHP Guidelines on Outsourcing Sterile Compounding Services http://www.ashp.org/DocLibrary/Bestpractices/MgmtGdlOutsourcingSterileComp.aspx

Policy Number / AHC.PHARM.022
Date of Issue / February 2013
Review Dates
Revision Dates / March 2013
Policy Owner(s) / Pharmacy
Outsourcing Sterile Compounding Services

IX.  Approved

Chief Executive Officer
President and Chief Operating Officer
[ENTER Policy Owner Name, Title]

X.  Policy History

Former Policy Policy Title #