Editorial: Melamine is Back!

You probably recall the reports on melamine-contaminated pet food, infant formulas, and milk products. The FDA issued a Guidance to Industry: Pharmaceutical Components at Risk for Melamine Contamination (August 2009). Although the FDA is unaware of any contamination involving pharmaceuticals with melamine, they have developed a list of "at-risk components" that may be used in manufacturing and compounding and asked that pharmacy manufacturers and compounders obtain certification by the manufacturer/distributor that the ingredients are tested for the absence of melamine contamination. The list of at-risk ingredients is as follows:

Adenine
Albumin
Amino acids derived from casein protein hydrolysates
Ammonium salts
Calcium pantothenate
Caseinate or sodium caseinate
Chlorophyllin copper complex sodium
Colloidal oatmeal
Copovidone
Crospovidone
Dihydroxyaluminum aminoacetate
Gelatin
Glucagon
Guar gum
Hyaluronidase
Imidurea
Lactose
Melphalan
Povidone
Povidone-Iodine
Protamine sulfate
Protein hydrolysate (powder) for injection
Taurine
Thioguanine
Urea
Wheat bran
Zein

Regular USP testing for meeting USP standards is not specific for melamine. The FDA website has testing methods for melamine contamination.

http://www.fda.gov/downloads/Drugs/Gui.../Guidances/UCM175984.pdf

http://www.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources/ucm135002.htm


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

Tagatose NF

Tagatose (C₆H₁₂0₆, MW 180.16) is a sweetening agent in beverages, foods, and pharmaceutical applications. A 10% aqueous solution is about 92% as sweet as a 10% sucrose solution. It is a low-calorie sugar containing about 38% of the calories of sucrose per gram. It occurs naturally in low levels in milk products. It occurs as a white, anhydrous crystalline solid, is stable above pH 3 and caramelizes at elevated temperatures. It is soluble 1 in 0.7 parts water and 1 in 5,000 parts ethanol.

Drug-Donation Program in Wyoming Helps Needy Residents
Created through a 2005 state law, the Drug Donation Program Act began operating the following year, said Donna Artery, pharmacist consultant for the office of Pharmacy Services at the Wyoming State Department of Health.

The purpose of the program is to provide donated medications at no cost to low-income state residents who lack prescription drug insurance coverage. Artery said the typical patient served by the pharmacy is someone 50 to 64 years old, retired or out of work, and poor as a result of the ongoing recession.

Innovative efforts have resulted in obtaining space for the pharmacy, used computers to connect to the state network, and lots of donations of drugs. Drug quantities on hand for each medication varied from a single tablet to many thousands of units.

The pharmacy has funding support for one half-time pharmacist plus one full-time and one part-time pharmacy technician. The pharmacy is open 4 hours a day, 4 days a week.

"We've got lots of really nice letters from some of our mental health patients saying this is the first time in several years that they've been able to have a normal life, and they feel so much better and are so thankful that they can actually get their drugs," Gallizzi said.

Until recently, disposing of expired medications was a nearly overwhelming problem for the pharmacy, as exemplified by photos on the program's website where boxes of expired medications are shown stacked in the pharmacy's lavatory and encroaching on the waiting area. They now have a contract with a disposal company to take the unusable medications away monthly.

"When people come in, they don't feel like it's just a giveaway to the poor people. It's an actual pharmacy," Artery said. "It is very professional."

http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3174

Stockley's Herbal Medicines Interactions
Williamson E, Driver S, Baxter K, eds.
London, UK: Pharmaceutical Press
2009; Hardback; 400 pages; $89.95

A great reference text that is easy to use and very informative. It is an invaluable resource for pharmacists that desire evidence-based information on the interactions of conventional medicines with herbal medicines, dietary supplements, and nutraceuticals.

This book contains data on over 150 of the most commonly used herbal medicines, dietary supplements, and nutraceuticals in monographs that are highly structured, rigorously researched, and fully referenced. A great resource!

The July 2009 "Supplement to the Female Patient"-Waiting Room Edition, contained articles on "The Buzz on Bioidenticals: The Facts About Hormone Therapy." Notwithstanding all the misrepresentations, half-truths, and untruths, (and some truths) the supplement is nothing more than a "PAID ADVERTISEMENT" for Ascend Therapeutics' "EstroGel" product! However, it is not marked as a "PAID ADVERTISEMENT," leading readers to believe it is all factual content.

Motivation
Be careful of what you read or to what you listen. The author's or the speaker's motives must be considered. Oftentimes it is not untruthful but filled with misrepresentations and partial truths that may lead the reader/listener to a different conclusion than if the whole story was presented.