Editorial: Adverse Event Reporting in Compounding

After last week's newsletter was published, Steven Silverman with the FDA sent me an update and clarification on his presentation made at the "Pharmaceutical Compounding Opportunity and Challenges" section of the American Association of Colleges of Pharmacy meeting in Orlando, Florida. We are pleased to reprint part of the editorial which includes his clarification.

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1. How many deaths are attributed to pharmacy compounding each year?
   
   Despite all the hype in the media, it was shown by a slide during Steven's talk that there were 38 deaths between 1990 and 2005. Using Steven's figures for calculating, 38 deaths divided by 15 years is 2.53 deaths per year. This actually pales in comparison to the 98,000 deaths due to errors occurring annually in hospitals according to the Institute of Medicine report."

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I'm troubled by your use of the information that I provided. In presenting the slide containing adverse-event data about pharmacy compounding, I made clear that the figures were based on information in FDA's possession, which had been received anecdotally. I stated that, because pharmacies are not required to report adverse events to FDA, there may be many additional adverse events, including deaths, of which we are unaware. Following is an excerpt of my speech making these points:

"This slide provides an overview of the deaths and injuries related to drug compounding, from about 1990 through 2005. It's worth noting that this slide only reflects adverse events that we know of. Unlike commercial drug manufacturers, compounding pharmacies aren't required to report adverse events to FDA. So there may be more deaths and injuries than the ones shown on this slide."

Thus, it is not the case that FDA's data demonstrates that there have only been 2.53 deaths/year associated with compounding. At best, this data shows that anecdotal adverse events reported to FDA over a 15-year period demonstrate a rate of 2.53 deaths/year.

I am confident that your misuse of this information was unintentional. But as it paints a stark and incorrect picture, I would ask you to correct this mistake in the next edition of your newsletter.

We appreciate Steven adding his clarification to last week's Editorial. I think it is time that we document the adverse events related to deaths that have occurred in pharmacy compounding as well as the causative factors. There are too many inaccurate statements made by all parties that certain deaths were due to compounding, when in fact, they were not; they were due to improper administration, usage, etc. and the compounded preparations were made properly. In this Editor's opinion, this is an important area if we wish to document the actual situation. Once the information is gathered and published, we hope it can be used by all interested parties to present an accurate picture on the safety of pharmaceutical compounding.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

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Don't throw that away!
Sometimes we discard used equipment, etc. that still has a lot of use left in it. With the increase in home schooling in the U.S., some parents may be able to use some of the laboratory supplies and basic chemicals called for in their curriculum. True, a lot of this is available for purchase through laboratory supply companies and those that sell direct to parents for home schooling, etc. However, it may be that some beakers, forceps, microscope slides, spatulas, etc. would be greatly appreciated by some of your patient-parent home schoolers.