Outsourcing sterile product preparation and the importance of quality assurance

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It is unlikely that the recent meningitis outbreak tied to a contaminated batch of preservative-free methylprednisolone acetate has escaped your attention. The story has received significant attention as more that 100 people have been sickened and as many as eight have died as a result of receiving an injection of the contaminated steroid.

The tragedy of this incident has brought to light one of the unforeseen consequences of purchasing sterile compounded products from a third party. Outsourcing sterile preparations is not uncommon. In fact, many hospitals have turned to outsourcing sterile preparations as a way to not only meet the demand caused by drug shortages, but also as a way to achieve compliance with USP Chapter <797> for high-risk compounding.

There are valid reasons for wanting to outsource sterile product compounding1-4, but it is important to remember that outsourcing sterile compounding is not without risk which has been clearly demonstrated by recent events. Those risks may include loss over quality control for your sterile product preparation, and in this case, may have resulted in the death of several patients. This is an important caveat when considering whether or not to purchase sterile preparations from a third party. If a facility does decide to use sterile preparations from a third party, it is important to consider the following factors:2

  • Product match
  • Extended beyond-use dating
  • Risk of product shortages
  • Company reputation
  • Scope of product line
  • Vendor proximity
  • Product cost

Company reputation and scope of product line will help one determine if the company is a good candidate for sterile product preparations. However, it is important that further steps are taken to ensure quality and product safety. Quality assurance procedures should be readily available and easily accessible. Don’t be afraid to ask questions. Above all else, be diligent in your selection process as these products will ultimately be used in your patients.

There is no “positive” to take away from the devastation caused by this most recent incident. Lives have been forever changed and that cannot be undone. However, the incident has certainly put a spotlight on the danger associated with medications made during the sterile compounding process. Pharmacists everywhere should use this as an opportunity to refocus on ensuring that our patients receive medications in the safest, most cost effective and efficient manner possible.

  1. ASHP Guidelines on Outsourcing Pharmaceutical Services. Am J Health-Syst Pharm. 1998;55:1611-17.
  2. Donnelly, A. Outsourcing Your Sterile Product Preparation. Pharmacy Purchasing and Products. Vol. 2, No. 2. pages 6-7.
  3. If You Outsource It, What Benefits Will Come? Pharmacy Practice News. 2006;May; 1, 40.
  4. Belden, H. What To Watch For When Choosing a Compounder. Drug Topics Health- System Edition. 2005;Sept 26:10.
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