Brought to you by the International Journal of Pharmaceutical Compounding
December 15, 2006 Volume 3, Issue 50
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editorial: The FDA vs the Federal Government

Well, the FDA has filed an appeal on the Midland Case. It seems odd that one arm of the Federal Government (FDA) disagrees with another arm of the Federal Government (Federal District Courts) and files with the same Federal Government to seek a resolution. Keep in mind that the FDA has already lost the Western States decision, which went all the way to the Supreme Court of the US. So, it seems that the federal court system agrees that the FDA is wrong in their approach to try to "control" pharmaceutical compounding, which is appropriately controlled at the state level.

So, since compounders are under the control of the state boards of pharmacy, why is the FDA continuing to go after pharmacists that compound? Is it because pharmacists are an easy target and the FDA is trying to earn "brownie points" so they can tell Congress that they are protecting the American public? Perspectively, compounding represents less than approximately 5% of the prescriptions in the US and very�very�very few of those result in mishaps. However, the other 97% of prescriptions contain millions of dosage forms that are recalled every single year; some are drugs that are ultimately determined to be too dangerous to be left on the market after the FDA has already approved them!

If a pharmacy is doing something wrong, then they should be investigated and prosecuted according to the authority under which the infraction resides. However, those pharmacies that are unfairly targeted are forced to spend tens of thousands of dollars for legal fees for representation, etc. Possibly the FDA should reimburse these pharmacies, plus provide an allowance for the mental anguish they were forced to endure. Also, the individuals within the FDA should be penalized for poor judgment, etc.

The confidence of the public in the FDA has declined in recent years. Moreover, the confidence of the public in the pharmaceutical industry has been waning for many, many years, as it appears to be an industry interested only in the bottom line and will do almost anything to protect their interests. In fact, both the FDA and the pharmaceutical industry appear to be similar in many ways, including a push to increase their public image. They appear to be more interested in survival and profits than in the interests of patients and patient care in the US. Another interesting aspect of these two entities is that the FDA receives considerable funding from the pharmaceutical companies and appears to be dependent on this income for its survival at its present level of operations.

If one looks at all the difficulties in the pharmaceutical supply chain, the medical device industry, the blood supply in the US, and all the deficiencies written up on a daily/weekly basis, it appears to me that the emphasis should be on attacking the "Goliaths" rather than harassing the "Davids."

It's also interesting that the FDA targets the professionals that rank high in ethics and honesty rather then the pharmaceutical industry that is often charged with wrongdoings, fraud, etc.

I am grateful for the FDA and their function in our society. However, I am concerned about some of the initiatives that appear to be misdirected and misapplied. Until this is corrected, we must continue to be vigilant to protect the rights of physicians to write patient-specific medications for their patients and for pharmacists to be able to compound them. After all, this may very well be a major part of drug therapy in the future, and it must be protected!

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

 
Binders Available for Organizing Copies of the International Journal of Pharmaceutical Compounding (IJPC)

The International Journal of Pharmaceutical Compounding, Inc. (IJPC) has published 10 years of journals. IJPC offers these professional binders that enable you to protect and organize your back issues! Each one has a mortar and pestle graphic with the IJPC logo and a place on the spine to put what years of journals are in the binder. Features include:

  • Each binder holds up to two years of IJPC journals
  • Provides protection for your journals
  • Easy to use, professional style

To see a picture of the binder go to www.ijpc.com/Products/ProductDescription.cfm?PID=2499. To order, complete and mail or fax the IJPC Binder Order Form or call (800)757-4572 today.

 
Regulatory Information

Pharmacy Compounding Accreditation Board� (PCAB) Announces that Five Pharmacies Have Earned the Seal of Accreditation

One hundred of the leading compounding pharmacies in the nation are now undergoing reviews and surveys, comparing them with new national quality standards for compounding. These national compounding standards were written and tested by a Standards Committee of the PCAB, located in Washington, D.C.

PCAB was formed by six pharmacist organizations, the United States Pharmacopeia (USP), and the National Association of Boards of Pharmacy (NABP) to promote high-quality compounding practices. "While compounding is regulated by each state, PCAB accreditation is an even more comprehensive way to present to the public and prescribers those compounding pharmacies proven to meet the highest quality safety standards," says Ken Baker, JD, RPh, Executive Director of PCAB. Those that meet these standards are listed on the national website at www.pcab.org.

PCAB recently announced that five pharmacies have received the PCAB's Seal of Accreditation. These pharmacies are the first to earn the right to use the designation "PCAB AccreditedTM Compounding Pharmacy." This designation and seal indicates that each of these pharmacies have met tough national standards, including an on-site survey by trained compounding experts. Those accredited pharmacies are:

  • The Compounding Shoppe of Homewood; Birmingham, Alabama
  • The Apothecary Shop; Scottsdale, Arizona
  • Pharmacy Innovations; Erie, Pennsylvania
  • Pharmacy Innovations; Jamestown, New York
  • North Pointe Pharmacy; Oklahoma City, Oklahoma

To learn more about PCAB and the accreditation process, visit www.pcab.org or www.pcab.info.

 
Drug Information Articles and Abstracts

It's that time of year again, when dry skin prevails. Even those who haven't had dry, itchy skin due to weather or as an allergic reaction to a food or something in the environment can develop it. Depending upon the age and body make-up (obese, malnourished, etc.) and the climate where the patient lives, not everyone responds to the same therapy.

CompoundingToday.com's literature search database this week looks at 63 citations with numerous therapies to treat atopic dermatitis and other inflammatory skin conditions. Here is a sampling:

Topical sodium cromoglycate in the treatment of moderate-to-severe atopic dermatitis.
Moore C, Ehlayel MS, Junprasert J et al. Ann Allergy Asthma Immunol 1998; 81(5 Pt 1): 452-458.

A cross-sectional survey of complementary and alternative medicine use in patients with atopic dermatitis.
Simpson EL, Basco M, Hanifin J. Am J Contact Dermat 2003; 14(3): 144-147.

Moisturizing effects of topical nicotinamide on atopic dry skin.
Soma Y, Kashima M, Imaizumi A et al. Int J Dermatol 2005; 44(3): 197-202.

Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial.
Stucker M, Pieck C, Stoerb C et al. Br J Dermatol 2004; 150(5): 977-983.

Effects of probiotics on atopic dermatitis: A randomized controlled trial.
Weston S, Halbert A, Richmond P et al. Arch Dis Child 2005; 90(9): 892-897.

 
Current Issue of International Journal of Pharmaceutical Compounding (IJPC)

Veterinarians who treat large animals understand the difficult task of medicating such animals. Thanks to innovative veterinarians and pharmacists, pharmaceutical technology has entered a new phase in delivery systems for medications and vaccines to large animals. IJPC's November/December 2006 issue on veterinary compounding includes an article titled Biobullet: Innovative Pharmaceutical Compounding for Treating Cattle. The article furnishes information on an advanced method of administering prescription drugs with the Biobullet, a ballistic bullet with a core of antibiotic. Read this article on pages 428 through 433. Readers will also find articles related to topics other than veterinary medicine in the issue. If you are not a subscriber you can purchase and download a specific article at http://www.ijpc.com/editorial/SearchByIssue.cfm?PID=2469

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.

 
Compounding Tip of the Week

Put Some Lights Up!
Need to "lighten" up some display shelving? Try attaching a Christmas "rope light" on the inside of the front decorative frame of the shelf so that the light is directed back toward the shelf and is not really seen from the front. Cover any lights you don't want seen with plastic tape and wrap around that section of the rope light. These lights last a long time and are relatively inexpensive. Properly done, this can provide an attractive display in a part of the store that may need to be brightened up.

RxTriad
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