This was the title of a presentation at the Clinical Ligand Assay Society given by Felix W. Frueh, PhD, Associate Director for Genomics of the Office of Clinical Pharmacology of Center for Drug Evaluation and Research (CDER)/US Food and Drug Administration (FDA), on May 22, 2006.

In his presentation, the following was discussed:

• Consideration of several factors important in determining the correct dose for an individual patient
• The patient's genetic profile
• Different weights that may be needed for the different factors, that when used together can significantly reduce uncertainty about a treatment decision
• The need to be able to measure the factors (biomarkers)

A case study was presented at the beginning of the presentation involving warfarin in a patient that was a CYP2C9*3 homozygote. In this case, the patient's genotype, sex, age, body surface area (BSA), and co-medication were considered to adjust the warfarin dose. The calculated dose was 3 mg initially, followed by a maintenance dose of 3.5 mg. Coumadin is commercially available as 1-mg, 2-mg, 2.5-mg, 3-mg, 4-mg, 5-mg, 6-mg, 7.5-mg, and 10-mg tablets. Administering the initial dose of 3 mg is no problem. But, from where is the 3.5 mg maintenance dose coming? One solution is to require the patient to take one 2.5-mg tablet along with one 1-mg tablet. What would have happened, however, if the patient was on a drug requiring a dose that was not commercially available in numerous strengths? Obviously, a compounding pharmacist should be used to provide the patient with the correct dose.

Personalized medicine is about the knowledge—and the use of it—to make smarter decisions to treat patients on an individual basis. Dr. Frueh further stated in his talk, "What we do at the FDA is to promote scientific progress in the field of Personalized Medicine and to ensure its translation into clinical practice."

A Google search of the terms "personalized medicine" results in over 10 million hits. In reading a substantial amount of material on pharmacogenomics from all aspects of healthcare, involving scientific and professional journals, information from the FDA, etc., it is interesting that the emphasis is on the "upfront" parts of personalized medicine, i.e., activities involved in improving and providing the knowledge needed to make better treatment decisions.

In looking at issues that still require a lot of work, one item listed is figuring out the right dose. I would like to add to the lengthy list, "How is the patient going to obtain the right dose once it is determined?" In a sense, this is the same dilemma we have faced for years in pharmacokinetic workups, therapeutic drug monitoring, drug levels, etc. to determine the exact dose required for a patient and the physician then simply using "what is commercially available." Why go to the time and expense of determining the exact dose needed, e.g., 33 mg, when the commercial product is only available as either a 25-mg or 50-mg tablet? In these cases, it is wise to use the expertise of a compounding pharmacist to prepare the exact dose required for the patient.

A statement on a slide during Dr. Frueh's presentation, that was attributed to Robert Temple, in 2004, was the following: "If the 1938 FD&C act started the age of safety for drugs, and 1962 the age of efficacy, we are now in the AGE OF INDIVIDUALIZATION." It seems that we, as compounding pharmacists, have been saying the last part of this statement for years.

To me, individualization requires the professional and scientific expertise of a compounding pharmacist; how can we make this a reality?


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

The ASHP Drug Product Shortages Management Resource Center has updated the drug product shortage bulletins on fosphenytoin injection, lansoprazole for injection, rosiglitazone-metformin tablets, and scopolamine transdermal systems. Drug product shortage bulletins are prepared by the University of Utah Drug Information Center and provided by ASHP through the support of Novation LLC. For more information: www.ashp.org/shortage

Care of the aging skin (whether from age or environmental/sun) and cosmeceuticals bring 44 new citations plus 4 on acne and 1 on radiation dermatitis to our CompoundingToday.com's literature search database this week. Here is a sampling of them:

• Alexiades-Armenakas M. New and emerging treatments for acne and photoaging. J Drugs Dermatol 2006; 5(1): 85.
• Draelos ZD. Concepts in a multiprong approach to photoaging. Skin Therapy Lett 2006; 11(3): 1-3.
• Grossman R. The role of dimethylaminoethanol in cosmetic dermatology. Am J Clin Dermatol 2005; 6(1): 39-47.
• McCullough JL, Kelly KM. Prevention and treatment of skin aging. Ann N Y Acad Sci 2006; 1067: 323-331.
• Rokhsar CK, Lee S, Fitzpatrick RE. Review of photorejuvenation: Devices, cosmeceuticals, or both? Dermatol Surg 2005; 31(9 Pt 2): 1166-1178.

Can't remember the name of that article but remember the author that was published in IJPC? You can now search IJPC's entire archive by author name. Just enter the author's name in the keyword search form at www.ijpc.com/editorial/searchjournal.cfm to get a list of matching articles.

First International Society of Pharmaceutical Compounding (ISPhC) Seminar

Join IJPC at the First International Society of Pharmaceutical Compounding (ISPhC) Seminar held at the 66th International Congress of FIP on August 28, 2006 at Salvador Bahia, Brazil.

The 1st ISPhC Symposium will present an innovative and exciting vision of the role of quality pharmaceutical compounding in contemporary pharmacotherapy by six experienced speakers, coming from very different countries and working in different environments. They will discuss critical topics concerning pharmaceutical compounding, including the reasons and the need for compounding in modern pharmacotherapy, meeting individual patient needs through compounding, quality and regulatory issues, and the right and responsibility of the pharmacist to compound. It is important to understand the strengths and weaknesses of each country so we can learn from each other and incorporate the best practices of quality pharmaceutical compounding to better serve our patients. For details, go to www.isphc.com

"Cleanrooms" editor is misinformed and inaccurate in his editorial. See the following link: http://cr.pennnet.com/Articles/Article_Display.cfm?Section=ARTCL&ARTICLE_ID=259392&VERSION_NUM=3&p=15

Just a reminder for those who are subscribers of IJPC and a news flash to those who are not, each issue of IJPC furnishes our readers with at least 10 formulas that are useful for compounding pharmacists and their patients. For example, our recently released July/August 2006 issue includes the following formulations:

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

Label for Image and Information
Help your image and provide complete, consistent labeling using pharmacy compounding computer software that incorporates the IACP labeling guidelines. RS Software has already launched the new labeling integrated with their software, and other software companies are planning to do the same. The new labeling guidelines explain the unique nature of compounded medications in a very positive manner.