A Tragic Reminder of the Importance of USP <797>


November 2012 - Vol. 9 No. 11 - Page #3

“While the current outbreak cannot be considered an outlier event, it should certainly be the very last event before enacting state and federal legislation to protect the public from preventable compounding errors and contamination.”
~ ISMP Medication Safety Alert! 10.18.12;
Vol 17, Issue 21 [emphasis ours.]

Truthfully, there is no positive outcome that can be taken from the tragedy of the recent meningitis outbreak and related illnesses and deaths associated with contaminated, outsourced compounded products. So far, more than 20 people have lost their lives and many others have been sickened or remain in fear for their lives. The domino effects caused by this disaster will have enormous ramifications on the ability of health care facilities to provide the level of care their patients deserve. This places hospital pharmacy in quite a predicament, as recent events will surely amplify shortages, while simultaneously limiting the number of available sources for quality outsourced CSPs. 

In PP&P’s 2012 State of Pharmacy Compounding supplement, we reported the trend toward increased dependence on outsourced compounders. There is now renewed vigor in calling for more stringent oversight of outsourcers. The tenets of USP <797> must apply to all sterile compounding practices and non-sterile compounding also should be held to the same scrutiny of USP <795>. We support ISMP in calling upon TJC to establish a standard requiring pharmacy evaluation and monitoring of the quality of any supplier of compounded products and to consistently survey compliance with the USP <797> standard. In addition, we call for State Boards of Pharmacy to be required to inspect and enforce USP <797> and <795>. Likewise, BOP inspectors must be compelled to achieve demonstrable expertise in USP <797> and <795>.

The belief that this maleficent series of events will spurn legislation designed to prevent them from happening again is likely of little comfort to those so profoundly affected. The fact remains that these events were not the result of a simple series of mistakes. Nonetheless, when outsourced compounded preparations are purchased without a corresponding prescription, accountability does not rest solely with the vendor violating these regulations. Anyone making such a purchase is in violation of their professional responsibilities. Pharmacy must have the power (and support from their administration) to make decisions on drug procurement that ensure patients’ needs are met to the best of our ability in the safest manner. Procuring product by whatever means necessary should never supersede patient safety or professional accountability. The rules governing patient safety carry much larger implications than the simple acknowledgement of what is lawful and what is not; when lives are at stake, there is no acceptable level of failure. 

We join the ISMP and all pharmacy practitioners in mourning this avoidable tragedy.

All the best,

R. Mitchell Halvorsen
Publisher

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