10/04/2012 – Front Range Laboratories Response: Meningitis Outbreak

As you are most likely aware, a recent outbreak of a rare type of meningitis has been linked to spinal injections for back pain and has killed four people and sickened at least 30 others in five states including Tennessee, Florida, North Carolina, Virginia and Maryland.

Recent reports cite that this outbreak has been linked to a Methylprednisolone Acetate PF injectable product dispensed from a compounding pharmacy. The compounding pharmacy implicated in news reports is NOT a client of Front Range Laboratories.

Over the coming weeks, it is likely that our entire industry will face intense scrutiny in regards to how we conduct testing to ensure patient safety and prevent outbreaks like this one. In fact, we have already received many calls from you, our clients, inquiring if the testing we perform on your products would detect this type of contamination. The answer is YES.

Front Range Laboratories is diligent in our strict adherence to USP testing standards. As you may know, USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are developed and relied upon in more than 140 countries (www.usp.org).

The sterility testing we carry out on a daily basis is according to USP71. This method requires validation of the drug substance against four different types of control organisms that represent a broad spectrum of microbiological species. They are Gram Positive, Gram Negative, yeast and mold samples. To evaluate your product we must be able to show the recovery of each control against the drug product.

The mold control recommended by USP is Aspergillus. Regarding the current situation, this is reportedly the genus of microbe that is at fault in the suspected contaminated drug. Many have asked if a separate fungal test is required to detect this type of microbe. The answer is NO; you do not have to run a specific fungal test on your product.

Your products are tested within a class 6 cleanroom environment by a microbiologist and a certified aseptic compounding pharmacy technician. Samples are processed the same day they arrive into our facility.

When talking to your clients, you can inform them that the sterility testing carried out by your laboratory:
* Is in accordance with USP71
* Utilizes two incubational temperatures
* Uses two different incubational temperatures for the evaluation
* Screens for Gram Negative Bacteria, Gram Positive Bacteria, Yeast and Mold

For more detail, you can find the USP71 recommended sampling plan atwww.FrontRangeLabs.com

Additionally, USP currently provides the option for laboratories to employ newer technologies for sterility testing that are referred to as Rapid Microbial Methods (RMM). We have invested in two of these technologies: Flow-Cytometry and Bioluminescence. These methods provide a benefit to our clients that are two-fold. First, by using an automated system for the detection we no longer rely solely on human visual observation to judge the pass/fail basis of the end-product. Second, with the increased sensitivity of our detection with both systems, we are able to move incubational times down from 14 days to 3-5 days, depending on the product. This gives us the ability to notify clients in an expedited manor if contamination is detected in their products.Validation of your individual products can be performed so you have documentation to show your clients that your testing method does cover your product. If you have not yet switched your products over to our Rapid Microbial Methods and are interested, please give us a call today so we can assist you with this advanced testing technology.

Our goal is to provide you with end-product testing that is in compliance with USP guidelines within a cGMP compliant environment. We view ourselves as your partner in delivering end-products of the highest quality possible to your clients and the individual patients who receive these medications. We continue to provide advanced training to our employees, as well as re-investing in our laboratory to provide the best possible technology available to evaluate your end-products.

I hope that this information will address any concerns you may have at this time about the testing services we provide. Should you require additional documentation to reassure your clients that your products have been tested properly or have any questions, please do not hesitate to contact me at 1.888.pHarmQC (1.888.742.7672).

Sincerely,
Michael Travis
President, Front Range Laboratories