Much faith is put in laboratory results in all different areas of life today ranging from the environment and petroleum industries to medicine and pharmacy. On average, most laboratories in our business environment apparently do a pretty good job. There are, however, occasions when inaccurate results occur: sometimes with serious consequences. These errors that occur may be the result of either determinant or indeterminant errors. Determinant errors are those for which a cause can be identified and usually accounted for or corrected and indeterminant errors are those errors where this is not the case.

One determinant error often overlooked by many occurs when using commercially available drug products for compounding.

First, commercially available drug products contain excipients that may interfere with the analytical procedure: more on this topic later. Second, and the topic of this editorial, is the variability in strength of the dosage forms commercially available today. We are all aware of the tolerances allowed in USP monographs and in New Drug Applications, but many may not be aware of the range of some of these.

Generally, most commercially available products have an allowable range of +/- 5 to 10%. However. Very low dosage drugs may have a range of +/- 20%. Some products, such as some enzymes may have an allowable range of up to 160% of label.

What's the point here? The point is that one potential source of error that may not be addressed by laboratory results is the variability in strength in the starting ingredients (tablets, capsules, injections' etc.) In compounding. Granted, it should be minor in most cases but what happens when a regulatory agency obtains a sample from a pharmacy (community, hospital, etc) and has it analyzed? With the allowable +/- 10% range allowed for the final preparation in compounding due to various manipulations, etc, and the 5 to 10% average strength variation in commercialla available products used in compounding, it may very well be that laboratory results slightly outside the allowable range and reported in the media, etc, may actually occur from compounders that were doing things correctly and the errant results are not their fault. Keep in mind, however, that if bulk chemicals were used, this discussion does not apply.

All this is why one needs to know everything about how a preparation was compounded and all about the analytical methods that were used before making a judgment about the reliability of analytical test results when using commercially available products.

Next week, errors in intravenous admixtures.

Loyd V. Allen, Jr., Ph.D.
Editor-in-Chief

The discussions this week on IJPC�s Compounders Network Listserv include:

1. A physician requested information for compounding botox topical?
2. There was a request for information for Pergolide suspension and capsules for Cushings in a Shetland Pony.
3. Compounders from Australia express appreciation for information and the newly formed long-distance relationships.
4. Listservers share ideas on how to say "Thank You" to physicians for the next holiday season?
5. Frequently prescribed dental compounds were shared?

THIS WEEK more than 30 articles related to transdermal/transmucosal absorption were added to CT.com. Here are few of those articles.

• Abraham MH, Martins F, Mitchell RC. Algorithms for skin permeability using hydrogen bond descriptors: the problem of steroids. J Pharm Pharmacol 1997; 49(9): 858-865.
• Aqil M, Sultana Y, Ali A, Dubey K, Najmi AK, Pillai KK. Transdermal drug delivery systems of a beta blocker: design, in vitro, and in vivo characterization. Drug Deliv 2004; 11(1): 27-31.
• Boinpally RR, Zhou SL, Poondru S, Devraj G, Jasti BR. Lecithin vesicles for topical delivery of diclofenac. Eur J Pharm Biopharm 2003; 56(3): 389-392.
• Cassidy J, Berner B, Chan K, John V, Toon S, Holt B, Rowland M. Human transbuccal absorption of diclofenac sodium from a prototype hydrogel delivery device. Pharm Res 1993; 10(1): 126-129.
• Ghafourian T, Zandasrar P, Hamishekar H, Nokhodchi A. The effect of penetration enhancers on drug delivery through skin: a QSAR study. J Control Release 2004; 99(1): 113-25.
• Johnson ME, Blankschtein D, Langer R. Permeation of steroids through human skin. J Pharm Sci 1995; 84(9): 1144-1146.
• Klausner EA, Lavy E, Barta M, Cserepes E, Friedman M, Hoffman A. Novel gastroretentive dosage forms: evaluation of gastroretentivity and its effect on levodopa absorption in humans. Pharm Res 2003; 20(9): 1466-1473.
• Matsubayashi T, Sakaeda T, Kita T, Nara M, Funasaka Y, Ichihashi M, Fujita T, Kamiyama F, Yamamoto A, Nordlund JJ, Kaneko M, Iida A, Hirai M, Okumura K. Pharmaceutical and clinical assessment of hydroquinone ointment prepared by extemporaneous nonsterile compounding. Biol Pharm Bull 2002; 25(1): 92-96.
• Rawlings AV, Canestrari DA, Dobkowski B. Moisturizer technology versus clinical performance. Dermatol Ther 2004; 17 Suppl 1: 49-56.
• Thomas NS, Panchagnula R. Transdermal delivery of zidovudine: effect of vehicles on permeation across rat skin and their mechanism of action. Eur J Pharm Sci 2003; 18(1): 71-79.

Pharmacy unique in making custom compounds
Gary Grove is a registered pharmacist who operates two pharmacies in Springfield.
For full story, http://springfield.news-leader.com/business/today/0101-SmallBusin-264020.html

The Arizona firm under investigation following the poisonings of four people with a knockoff form of Botox peddled its products aggressively to South Florida doctors, a well-known West Palm Beach cosmetic dermatologist said. Faxes from Tucson, Ariz.-based Toxin Research International and its sister companies have flooded the offices of Dr. Kenneth Beer for at least a year, he said. TRI would always say that the botulinum neurotoxin it was selling was for research purposes only and not meant for use on people.
For full story, http://www.palmbeachpost.com/localnews/content/

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