Editorial: FDA and HHS National Leaders Support Individualized Medications!

Yes, it's true! The Department of Health and Human Services (HHS) Secretary Michael O. Leavitt stated at the recent FDA Science Forum that the development of personalized drug therapies through pharmacogenomics will redefine: (1) the pharmaceutical industry, (2) the practice of medicine, and (3) the FDA, in much the same way that the Internet expanded but disrupted the telecommunications trade.

Felix Frueh, Associate Director of Genomics in FDA's Office of Clinical Pharmacology and Biopharmaceutics went further to state that the paradigm of a "one-size-fits-all" approach to prescribing a medication is "clearly outdated."

These comments were made at an FDA Science Forum of more than 2,100 scientists in April of this year in Washington, DC. Dr. Freuh went on to say that, "What we had before, yesterday's medicine, is a trial-and-error approach where everybody's treated at the same dose; whereas today, with a pharmacogenomic-driven approach, we can look at individualizing or personalizing the dose that's needed for effective treatment".

Pharmacogenomic testing should identify patients that need higher-than-normal or lower-than-normal dosage and those that might be at risk for adverse events due to the active medication or an excipient in the drug product.

Just a note to our national leaders: Concerned physicians and compounding pharmacists have been individualizing medications for many years. This is nothing new to us. We have, however, been doing it without the luxury of pharmacogenomics and have had to rely on clinical responses, etc. With the new era of pharmacogenomics, compounding pharmacy may flourish far beyond anyone's dreams. Why? Basically because I seriously doubt if the pharmaceutical industry is interested in individualizing doses and formulations of medications for individual patients; it is not economically feasible to do this on a large scale without a major restructuring of the industry. Pharmacists, however, do this every day and with new pharmacogenomic tools and interested physicians, pharmacy compounding can serve to provide specific medications for each individual patient. It may be that the pharmaceutical industry may still be able to serve a significant percentage of patients if appropriate changes are made; however, the remaining patients may require the services of compounding pharmacists.

Dr. Leavitt stated that the FDA "will have to learn to deal with this new environment" and will be forced to "devise new approaches to regulation." Dr. Freuh stated that "What we need to do now is to make sure the transition is happening successfully, appropriately, and with the right education for physicians, but also, and most importantly, for consumers and patients."

It is comforting to know that compounding pharmacists are positioned to aid in ushering in the new era of pharmacogenomics and individualized patient medications. We have made tremendous strides in supporting and enhancing quality compounding in recent years. This trend must continue for us to appropriately and deservedly take our place in the new era of pharmacogenomics.

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

A Pharmacist's Guide to Providing Veterinary Prescription Services
by Deborah Chan

This is an excellent resource for pharmacists and pharmacy students who are interested in providing veterinary prescription services. Written like a textbook, this reference explains the "who, what, where, when, and why" of providing veterinary prescription services. It contains information about a wide variety of agencies as well as services that are available to help pharmacists. Topics include pertinent laws and regulations, labeling requirements for veterinary prescriptions, extralabel drug use, over-the-counter drugs and human medications that have veterinary applications, generic substitution for and compounding of drugs for animals, marketing, and advertising directly to pet owners. This reference contains everything that the experienced provider should know and the beginner or prospective provider needs to know.

Learn more about this book: http://www.ijpc.com/products/ProductDescription.cfm?PID=2297

See more book reviews related to compounding pharmacy: http://www.compoundingtoday.com/Books/ReviewList.cfm

In the past seven days the following information has been accessed and downloaded from CompoundingToday.com:

• 612 Formula Downloads
• 191 Standard Operating Procedures
• 128 Abstracts and Citations
• 77 Oral Vehicle Tool
• 72 Veterinary Transdermal Tool
• 46 Filter Tool - Membrane Types
• 43 Preservative and Antioxidant Tool
• 26 Chemotherapy Vial Reconstitution and Stability Tool
• 21 Compliance Articles (DEA, FDA, NIOSH, and USP)
• 16 Patient Advisory Leaflets

What do you need to compound today? Click here to get it: www.compoundingtoday.com

Did you know that in the UK there are a number of specialist pharmacies? The role of these pharmacies is to actually compound, on a very large scale, select compounded medications for distribution to pharmacies and patients. These specialist pharmacies are not manufacturers and do not have to do the equivalent of our NDAs, ANDAs, etc. However, they are required to meet the equivalent of current Good Manufacturing Practices (cGMPs). The advantage to this system is consistent quality of selected standardized formulations.

This week compounding pharmacists discussed a multitude of topics on the Compounders Network List, a free email forum devoted to compounding topics. Here are some of the topics discussed this week:

• Levoxyl 37 mcg/mL formula needed
• pH of Nasal Sprays
• NCPDP # discussion
• Phenylbutazone powder for horses formulation discussion

Compounding pharmacists need literature - abstracts, citations and references - on a regular basis to serve as a proof source for their compounding practice. And while there are many ways to obtain literature, searching PubMed, going the local medical or pharmacy school library, these sources are so inclusive searching for exactly what you need is tedious and time consuming.

CompoundingToday.com has refined the searching process and adds only those articles relevant to compounding to its database. At CompoundingToday.com Literature Search Database you can:

1. Keyword search a topic
2. Review citations and abstracts on the particular topic
3. Print the citation and abstract
4. Link to the original publisher of the article to obtain a copy of the full-text article.

Each week CompoundingToday.com adds articles related to compounding and a specific topic. This week 32 article citations and abstracts were added to the database. Here are some samples of the articles included:

• Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised, controlled, 6-week trial. BMC Musculoskelet Disord 2005; 6: 44.
• Fajardo M, De Cesare PE. Disease-modifying therapies for osteoarthritis: current status. Drugs Aging 2005; 22(2): 141-161.
• Niethard FU, Gold MS, Solomon GS et al. Efficacy of topical diclofenac diethylamine gel in osteoarthritis of the knee. J Rheumatol 2005; 32(12): 2384-2392.
• Rosenthal NR, Silverfield JC, Wu SC et al. Tramadol/acetaminophen combination tablets for the treatment of pain associated with osteoarthritis flare in an elderly patient population. J Am Geriatr Soc 2004. 52(3): 374-380.
• Towheed TE, Maxwell L, Anastassiades TP et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev 2005; (2): CD002946.

Bedford Labs Initiates Nation Wide Recall of Injectable Methotrexate

Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot# 859142, exp 09/07. Bedford Laboratories was informed by the manufacturer of the Methotrexate USP active drug substance ("ADS") that the ADS used to manufacture Lot # 859142, contained low levels of ethylene glycol. Human use of preservative free Methotrexate formulations for intrathecal administration containing ethylene glycol is not permissible. Consumers that have received this product and have questions should contact their physicians.

See the complete announcement from PR Newswire.

Cooling While Stirring
Need to cool down an emulsion or other liquid while continuing to stir it? Place a glass or plastic, low-wall container on the magnetic stirrer that contains about � inch of water and some ice cubes. Position the beaker containing the heated emulsion or other heated liquid and a stir bar into the cool water and turn on the stirrer. If the ice melts too quickly, add additional ice cubes. Another alternative is to add a small quantity of water into a plastic bag and set it flat in the freezer with a weighted beaker setting in the middle of it. Upon freezing, a "doughnut-shaped" hole is formed. When the need arises, place this frozen bag on the magnetic stirrer, place the container of emulsion or hot liquid to be cooled in the doughnut hole, and turn on the stirrer. The bag can be refrozen and re-used. This minimizes any mess and can save time.