Editorial: Two Good Questions

Last week I had the opportunity of speaking at the session on "Pharmaceutical Compounding: Opportunities and Challenges" at the American Association of Colleges of Pharmacy meeting in Orlando, Florida. Steven Silverman of the FDA/CDER Office of Compliance was the other speaker in the session.

After we both gave our presentations, the floor was opened for questions for about 30 minutes. Among the many, many questions that were asked, two specifically need to be addressed.

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.

2. Of the seven categories in compounding, in which ones should our pharmacy graduates be proficient upon graduation?

The seven categories in USP Chapter <1075> are:

• Nonsterile-Simple
• Nonsterile-Complex
• Sterile-Low risk
• Sterile-Medium risk
• Sterile-High risk
• Nuclear
• Veterinary

My response was that in my opinion, at minimum, each pharmacy school graduate should be proficient in categories I, II, III, and IV; it would be great if they were also proficient in category V, but that may be asking too much at this point in time. With the increase in the percentage of pharmacists involved in compounding in hospitals, community pharmacies, home health pharmacies, veterinary pharmacies, nuclear pharmacies, etc., pharmacy compounding in categories I through IV should be a requirement for graduation.

There were many other good questions posed, and I appreciate being given the opportunity to share different aspects of contemporary compounding with my colleagues. It also took a few days to complete all the requests for information, etc., which I am very glad to provide.

One last thought�if question #2 was posed to you, how would you respond?


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

USP is conducting a survey regarding compounded medications used in pediatric and geriatric patients to determine the most frequently compounded medications and how often these medications are requested. USP is interested in providing quality standards for compounded medications in order to assist those practitioners who provide this service to patients, and to ensure that the medications compounded are safe for patients and consumers.

The survey deadline has been extended to July 31st. There is only a few more days to help USP gather this valuable data. Every respondent who completes the survey and provides their name, address, and e-mail, will receive a $5.00 gift certificate to Starbucks. For more information see http://www.usp.org/hqi/pharmInfo/compoundingPharmSurvey.html

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