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Editorial: Two Inter-related Stories

Just this week, the FDA announced another shortage of Tamiflu Oral Suspension. Last year, pharmacists filled in the gap by compounding the suspension using the formula listed in the package insert or using other formulas from published studies. It looks like we are in the same situation again. Suppliers are announcing that they are ready to provide the necessary vehicles again this year. See the following two websites for further information:

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

http://www.tamiflu.com/hcp/resources/hcp_resources_pharmacists.jsp

In a related story, just yesterday the FDA announced that they and the CDC are investigating an increase in fever-related seizures in young children receiving the flu shot. There have been 36 confirmed reports of seizures recently in children ages 6 months to 2 years. The FDA announcement resembles a previous one issued by the agency in July 2010 about increased rates of febrile seizures among Australian and New Zealand children who were vaccinated with another trivalent inactivated vaccine, Afluria (CSL Limited). The children involved in that announcement were mostly younger than 5 years. They were immunized during the 2010 influenza season of the Southern Hemisphere with the same trivalent formula now in use in the Northern Hemisphere.

Bottom line is that if patients shy away from the flu vaccine, there is a possibility that the number of flu cases may increase. If they do increase, then the demand for Tamiflu may also increase with an associated increase in the need for the Tamiflu (Oseltamivir phosphate) oral suspension, which will need to be compounded.


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

A newly proposed USP General Chapter <17> on Prescription Container Labeling is available for review and comment. This may directly have an impact on your practice in the future on the dispensing labels of all prescriptions. For further information, a copy of the proposed chapter and instructions to submit comments, go to:
http://us.vocuspr.com/ViewAttachment.aspx?EID=bK0ke822q8svy24Psob15hb/gmKMwnuDvYOUnHhwyiw%3d

FDA Requests More Trials for Mannkind Inhaled Insulin
Mannkind Corp. has announced that the FDA has asked for two additional clinical trials of its inhaled insulin Afrezza using next-generation inhalers. The FDA wants trials of the new inhalers in patients with type 1 and type 2 diabetes; they want at least one trial to measure the performance of the inhalers against the MedTone inhaler the company used in late-stage clinical testing. Additional information on performance characteristics, usage, handling, and storage of the next-generation device is also being sought.

MannKind Chairman and CEO stated they were disappointed by the FDA response but encouraged that the agency was asking for studies only to confirm bridging and handling of the next-generation inhaler.
http://pharmalive.com/news/index.cfm?articleID=756248&categoryid=9&newsletter=1

J&J Faults Cleaning Procedures in Massive Recalls
In the last year, Johnson and Johnson's reputation has been tarnished by repeated recalls totaling nearly 200 million bottles of various drugs. They may also face criminal charges from the U.S. Department of Justice.

While the company said it had identified a number of areas for improvement, it disclosed only the cleaning problem and a minor labeling irregularity. They found insufficient equipment cleaning procedures and instances where employees failed to adequately document cleaning at McNeil's Fort Washington, Pennsylvania plant where J&J suspended production last April. McNeil also found one product with a label that did not include all the information required by regulators, J&J said.

The recalls involved nearly 43 million bottles of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Upper Respiratory, Benadryl, Sudafed PE, and Sinutab, and nearly 4 million bottles, rolls, and packages of Rolaids. Also involved were all batches of Softchews Rolaids produced by an outside manufacturer after people found wood and metal bits in the product.
http://www.reuters.com/article/idUSTRE70D6RC20110115

Honest Medicine
Schopick J.
Oak Park, IL: Innovative Health Publishing; 2011: 308 pages
Paperback

The frustrations of the author with the way her husband was medically treated and the resistance to effective, time-tested, inexpensive treatments for life-threatening diseases that were not FDA approved or supported by Big PHARMA, is presented in a very informative, easy-to-read and interesting book. This book is well documented with case histories written by physicians. The treatments described have been used for many years, but many patients are sent home with no hope by physicians trained in the traditional methods that seem to be "closed-minded" or uninformed of other options available to them. Some say they are just "too busy" to look at other options! Drugs described in this book include Silverlon, alpha lipoic acid, and low dose naltrexone; the ketogenic diet is also described. A "very good read" that will support a lot of the recommendations by pharmacists and physicians who are open to other treatment when traditional methods fail. Available at Amazon.com.

�that the innovative edge that brought the U.S. medical technology industry to global dominance may be slipping? In the next decade, China, India, and Brazil will experience the strongest gains in developing next-generation lifesaving products, as capital, jobs, and research gravitate toward these growing markets.
http://www.startribune.com/business/113992004.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aUac8HEaDiaMDCinchO7DU

Pricing Reason
Be reasonable in pricing all compounded preparations, especially the Tamiflu oral suspension. Last year there were news reports of price gouging. A fair profit is needed and is expected for one to stay in business. Excessive profiteering hurts the entire profession!

For Sale
Exakt 50 Ointment Mill, $3750.00.
Purchased four months ago for $4,500. Excellent condition, year and a half warranty left, owner's manual and all accessories Selling it because it's not the right technology for my cosmeceutical cream.

Priscilla 225-993-9887