I’m sure you’ve heard about the recent meningitis outbreak tied to a contaminated batch of preservative-free methylprednisolone acetate. 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and as many as eight have died as a result of receiving an injection of the contaminated steroid (this data is already out of date since I started composing this post yesterday).
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 a lot of reasons for wanting to outsource sterile product compounding. One only has to take a quick peak at the literature to see why1-4. But it’s important to remember that outsourcing sterile compounding isn’t without risks, which may include loss over quality control for your sterile product preparation. You really don’t know how someone else handles their QA, and in this case whether or not it may lead to the death of a patient or patients.
When considering whether or not to purchase sterile preparations from a third party consider the following: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, you really should go beyond that 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. Saving a little money isn’t worth the risk of getting a product that isn’t safe.
There’s no positive to take away from this devastating incident. People died and lives have been forever changed. While no one can fix that, it’s clear that the incident has put a spotlight on the danger associated with medications made during the sterile compounding process. It’s also given compounding pharmacies a black eye, which is unfortunate because they serve a purpose. Please don’t condemn the entire discipline because of this incident. As cliché as it sounds mistakes do happen. Until this is all sorted out and a thorough investigation performed we won’t know where the system broke down or whether negligence was involved.
One thing is for sure, 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. There are no short cuts boys and girls. Remember that.
- ASHP Guidelines on Outsourcing Pharmaceutical Services. Am J Health-Syst Pharm. 1998;55:1611-17.
- Donnelly, A. Outsourcing Your Sterile Product Preparation. Pharmacy Purchasing and Products. Vol. 2, No. 2. pages 6-7.
- If You Outsource It, What Benefits Will Come? Pharmacy Practice News. 2006;May; 1, 40.
- Belden, H. What To Watch For When Choosing a Compounder. Drug Topics Health- System Edition. 2005;Sept 26:10.
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