Four White Papers

After the experience of interviewing for a program produced by ABC-TV, PrimeTime Live, it became very apparent that there is a lack of understanding, education and information about what pharmacy compounding is and its' importance in our society today. Not only that, but there are a lot of misstatements made by a few misguided individuals that appear to have an agenda to minimize the extent of pharmacy compounding today.

Following my return from New York City where the interview occurred, the next day, I put together four White Papers on pharmacy compounding-related topics that we hope will be useful to pharmacists in educating their patients, physicians, nurses, and community about pharmacy compounding. In addition, these White Papers are being sent to the deans of all colleges of pharmacy, all state pharmacy organizations, all pharmacy state boards, all national pharmacy organizations, all national pharmacy publications and to the national media.

The four White Papers are as follows:

1. Pharmacy Compounding? Did you know that without pharmacy compounding:�.?
2. What do you know about pharmacy compounding?
3. Recent advances in quality pharmacy compounding.
4. Reasons the FDA should not be involved in pharmacy compounding.

The first paper listed above is designed for patients and the community. It simply describes what the situation would be if we did not have pharmacy compounding. This paper would make a nice handout or leaflet to provide to all patients coming into your facility. It is also great for handouts when you do presentations to local clubs, etc.

The second paper is designed for distribution to health professionals and will be useful for some patients and even the lay press. It describes the scope of pharmacy compounding and why it is important. It discusses 13 different areas of why we need pharmacy compounding.

The third paper discusses all the recent advances in quality pharmacy compounding that have been in process over the past few years and are now coming to fruition. It is quite remarkable to see the advances that have been made in a relatively short time. It discusses PCAB, USP, Pharmacists Pharmacopeia, ACPE, AACP, educational programs and analytical laboratory support.

The fourth paper simply describes a list of reasons why it is best that the FDA not be involved in pharmacy compounding. Obviously, if the FDA tried to enforce compounding at the level of Good Manufacturing Practices, etc., it would eliminate pharmacy compounding and the good it provides to millions of patients daily. Also, FDA's view that all compounded preparations are "New Drugs" would have a disastrous impact on healthcare today and would even eliminate the intravenous admixture programs in hospitals, etc. With upwards of 10,000 different formulations that are compounded and at a cost of $200 to $500 million dollars per New Drug Application, nobody would be willing to do the work for a New Drug Application and compounding would disappear and we all would be at the mercy of the pharmaceutical industry providing to us only what will make a profit for them.

These White Papers can be framed and displayed in your patient waiting areas for a permanent display and/or can be provided as patient handouts. Please feel free to use them when you are involved in giving presentations to groups about compounding.

These White Papers can be downloaded at www.compoundingtoday.com/whitepapers or professional copies can be obtained by calling the IJPC Customer Service office. Please use them to educate and inform all who will read them about the value of individualized patient care through pharmacy compounding.

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

There are 10 new SOPs being added to www.compoundingtoday.com's Quality Assurance section. Just click "Compliance" from the left-hand tool bar and then SOPs. Quality Assurance is section 9. Here are the titles of the new downloadable, customizable SOPs, at your fingertips:

• SOP No. 9.022.2 - SOP: Sterility Test for Ophthalmic Solutions
• SOP No. 9.023 - SOP: Quality Assessment for Injectable Solutions
• SOP No. 9.024 - SOP: Quality Assessment of Oral and Topical Liquids
• SOP No. 9.025 - SOP: Quality Assessment of Compounded Parenteral Nutrition Preparations
• SOP No. 9.026 - SOP: Quality Assessment of Powder-Filled, Hard-Gelatin Capsules
• SOP No. 9.027 - SOP: Quality Assessment of Special Hard-Gelatin Capsules
• SOP No. 9.028 - SOP: Quality Assessment of Nasal Solutions
• SOP No. 9.029 - SOP: Physical Quality Assessment of Ointments/Creams/Gels
• SOP No. 9.030 - SOP: Particulate Testing for Sterile Preparations
• SOP No. 9.031 - SOP: Performing Physical Quality Assessment of Suppositories, Troches,
• Lollipops, and Sticks

This week www.compoundingtoday.com added article abstracts related to probiotics. The articles are reviews or background reading which will be very beneficial to compounding pharmacists. The basic theory behind probiotics is that allergies, atopic (allergic) skin diseases like eczema, asthma, autoimmune diseases, and other immune-related conditions (which could be just about everything--cancer, diabetes, heart disease, etc) are on the rise because (a) improved hygiene (b) changes in the environment and (c) drugs and stuff we consume, especially antibiotics--are all changing our immune systems through our gastrointestinal tract. The normal microbes that live in our GI tract are getting killed or mutated and thus losing their ability to mount an immune response when we are exposed to something, anything, that might compromise health. The theory is that consuming probiotics, which are beneficial microbes, helps restore the proper microbial balance in our intestines. At first the thinking was that this could help GI conditions like diarrhea and irritable bowel syndrome, but research is starting to find that it is primarily the immune system that benefits.

1. Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr 2005; 146(3): 364-369.
2. D'Souza AL, Rajkumar C, Cooke J et al. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ 2002; 324(7350): 1361.
3. Nowak-Wegrzyn A, Sampson HA. Food allergy therapy. Immunol Allergy Clin North Am 2004; 24(4): 705-725.
4. Ogden NS, Bielory L. Probiotics: A complementary approach in the treatment and prevention of pediatric atopic disease. Curr Opin Allergy Clin Immunol 2005; 5(2): 179-184.
5. Rook GA, Brunet LR. Microbes, immunoregulation, and the gut. Gut 2005; 54(3): 317-320.

There are currently 684 abstracts for articles related to various topics of compounding pharmacy in www.compoundingtoday.com's literature search database

This week on IJPC's Compounder's Network List pharmacists asked:

1. My supplier has discontinued glass rod application bottles. Does anyone know of a supplier?
2. We have a veterinarian requesting we prepare an alpha 2 B interferon ophthalmic for a feline. Does anyone have a formula?
3. I'm looking for a methadone powder supplier.
4. I need to make a mercaptopurine 50 mg/mL oral suspension. Does anyone have a formula they would share?
5. A bleaching cream we dispensed to a patient separated after a few days. Has anyone had this problem? Does anyone have a different formula they would share?

What are you missing on the CNL? Sign up for free at www.compoundingtoday.com or www.ijpc.com.

The International Academy of Compounding Pharmacists provided this regulatory update

DEA Modifies Policy for Controlled Medications Compounded for Office Use
Over the past year, DEA has issued a series of correspondence that clarifies its interpretation of federal law applying to pharmacy compounding and the delivery of controlled substance prescriptions to a physician for administration to a patient. DEA's new policy could require significant change for many pharmacy practices. Click here to find out whether this policy will impact your current practice and options for responding to the policy

IACP Files Amicus Brief in Midland Lawsuit
On March 15th, IACP filed an amicus curiae brief in the Midland lawsuit brought by nine pharmacies against FDA. IACP argues that compounded medications are not new drugs and urges the court to deny FDA's motion to dismiss. Several additional pharmacy groups filed amicus curiae briefs opposing the motion to dismiss, including the American Pharmacists Association (APhA), the Texas Pharmacy Association (TPA), the American Academy of Physicians and Surgeons (AAPS) and a group of veterinary compounding pharmacies. A coalition of respiratory associations filed an amicus curiae brief in support of the government's motion to dismiss. For more information, visit www.iacprx.org/Litigation.html.