Editorial: 2010 USP Convention

Every five years the U. S. Pharmacopeial Convention, Inc. (established in 1820) holds its convention, which is occurring this week (April 21-24) in Washington, DC. Delegates representing Colleges of Pharmacy, Colleges of Medicine, State Pharmacy Associations, State Medical Associations, and numerous national organizations that are health-related as well as international delegates attend this meeting.

During the meeting, resolutions are considered, officer and Board of Trustee elections are held as well as the election of the Council of Experts. The Council of Experts consists of the chairs of 20 different expert committees that conduct a lot of the work of the Convention over the next five years. The 20 expert committees include those related to Small Molecules; Biologics and Biotechnology; Excipients; Dietary Supplements; Food Ingredients; Chemical Analysis; Physical Analysis; Biological Analysis; Dosage Forms; Microbiology; Packaging, Storage and Distribution; Nomenclature, Safety and Labeling; Compounding; Reference Standards; Statistics; and Toxicology.

This next five year cycle (2010-2015) will only involve one pharmacy compounding expert committee. In the past, there was only one compounding committee, but for the recent two cycles (2000-2010) there were two committees because of the large amount of work to be done. These were the "nonsterile" and the "sterile" compounding committees. The new expert committee will address both nonsterile and sterile compounding, in addition to veterinary compounding, etc.

Once the Pharmacy Compounding Expert Committee chair has been elected this week, the additional members of the committee will be selected in the near future from those individuals that have submitted their applications for consideration. A chair can only serve for two 5-year cycles.

There is only one resolution to be considered regarding compounding at this point, stating that the "USP should continue its commitment to standards for compounding, working with the compounding community and other stakeholders to develop and maintain optimal process and preparation standards and promote adoption of such standards by compounding professionals and regulatory authorities."

There are numerous pharmacists and others at the meeting who are involved in representing compounding. The USP offers many opportunities for pharmacists to be involved in working in the standards-setting process for pharmacy.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

FDA Acts on Advertisements
The FDA has said an advertisement for a GlaxoSmithKline PLC cancer drug and a Website for a bladder treatment the company co-promotes were "false or misleading." It has also taken issue with a consumer email from Novartis AG about Voltaren gel.

An advertisement for Arzerra (Glaxo) specifically omitted "important information about the drug's safety and effectiveness," the FDA said in a letter to the company that was posted on the agency's Website. The FDA said the ad failed to reveal any risks associated with the product, including a serious brain infection, pneumonia, fevers, and blood disorders. A Glaxo spokeswoman said the Arzerra ad referenced by the FDA won't be used again, and they are working to resolve any remaining questions and ensure that their materials reflect the direction provided by the FDA.

In another letter, the FDA said a Website for Vesicare, which is co-promoted in the U.S. by GlaxoSmithKline and Astellas Pharma Inc., presented unsubstantiated superiority claims and overstated the effectiveness of the product. Vesicare is approved to treat overactive bladder. The Website suggested Vesicare was better than Tolterodine at improving incontinence, by citing a study comparing the products. However, the agency said the information used to make a superiority claim involved a secondary study endpoint, rather than a main study goal, and doesn't provide sufficient evidence to make the claim. The companies said the website has been changed to remove the concerned content.

The FDA said an email sent by Novartis involving Voltaren "minimizes risks associated with the use of Voltaren Gel, overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel." Novartis responded that the Swiss company was reviewing the letter it received and they plan to work with the FDA to address concerns.
http://online.wsj.com/article/SB10001424052702303491304575188501070131496.html?mod=dist_smartbrief

MedImmune Shortens Expiration Dates on 47 H1N1 Vaccine Lots
The FDA has announced a "field correction" affecting the expiration dates for 47 lots of MedImmune Inc.'s monovalent influenza H1N1 vaccine. This correction resulted in expiration dates that are shorter by up to 21 days from the dates printed on the intranasal syringes that contain the live, attenuated vaccine. The FDA's notice requested that the affected lots be administered before passing the corrected expiration dates.

This is the second field correction for MedImmune's monovalent H1N1 vaccine and, in addition, in December, the company recalled and requested the return of 13 lots of vaccine that fell below potency specifications before reaching the labeled expiration date.

MedImmune has stated that the expired syringes should be disposed of as medical waste and not returned to the company.
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3319

Agency Cites Concerns with Niacin Added to Pain Drug
The FDA has questioned if an experimental pain drug from King Pharmaceuticals and Acura Pharmaceuticals would deter abuse. Acurox combines an immediate-release form of oxycodone with niacin, a B vitamin. The addition of niacin was meant to discourage people from taking multiple pills at once as high niacin doses can cause uncomfortable flushing.

An advisory panel will be used to provide input on the drug. A key question will be if flushing is an acceptable risk for legitimate patients with pain taking oxycodone. The agency also will ask the panel about the ability of food and over-the-counter pain medicines to reduce flushing.

Acura, in a summary report for the panel, states the drug would limit misuse without causing an incremental safety penalty. Also, in addition to niacin, the drug includes ingredients designed to cause burning in the nose if an abuser crushes and snorts it, and the drug turns to a gel if added to water or another solvent to discourage injection.
http://www.reuters.com/article/idUSN2011743020100420

��as a reminder, that sterility testing on a compounded preparation is only applicable to the specific pharmacy where the compounding occurred? The results of sterility testing are "nontransferable" as they relate only to the procedures, activities, personnel, and facilities that are involved in the preparation of the specific batch of a compounded preparation.

Spring Cleaning

Now is the time to clean up and fix up! All those small jobs that you have been putting off can be done in the warmer weather of springtime. High school and college students can be great part-time employees to do a lot of these activities.