Editorial: Cephalosporin Extra-Label Use to be Banned

The FDA recently issued an order prohibiting the extra-label use of cephalosporin antibiotics in food-producing animals:
http://www.fda.gov/cvm/CVM updates/2008updates.htm

Obviously, this is a broad ruling by the U.S. Food and Drug Administration (FDA) that poses significant implications for actions they may take in the future. They contend this will "protect the public health by preserving the effectiveness of cephalosporin-class drugs for the treatment of human infections." While we certainly support efforts to prevent the build-up of resistant strains of organisms that would limit the effectiveness of antibiotics in humans, this action appears to be detrimental to public health by denying appropriate treatment for food-producing animals.

The American Veterinary Medicine Association (AVMA) Assistant Executive Vice President testified during a Senate committee hearing in June that "wide-scale bans on approved uses of antimicrobials in food animals would hurt animals, do little to improve public health, and could, in fact, lead to an unsafe food supply." Dr. Vogel of AVMA stated "passing legislation that would ban the use of these antibiotics before science-based studies and risk-based evaluations are done would be detrimental to animal and human health. There is currently the National Antimicrobial Resistance Monitoring System—a multi-agency program monitoring for drug-resistant microbes in people, farm animals, and meats and other animal products since 1996—along with continued compliance with judicious use principles that may be sufficient to protect human health without compromising the health of food animals." Dr. Vogel's statement indicates no "science" exists to support the ruling.

The comment period for this proposed action ends September 2 with the rule to take effect October 1, 2008, unless the FDA revokes the decision, modifies the order, or extends the comment period. I think that the comment period should be extended to allow for more time to respond to this rule prior to it taking effect. Comments are identified by Docket No. FDA-2008-N-0326 and can be submitted electronically to: http://www.regulations.gov/

The ruling, as it now stands, would deny many veterinarians and compounding pharmacies the opportunity to adequately treat animal patients. Remember, this affects ALL CEPHALOSPORINS, not just one or two!

Loyd V. Allen, Jr., PhD, RPh

New Jersey company asking pharmacists and hospitals to return drugs made at one of its facilities
A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities' standards. An FDA inspection at the Actavis Totowa facility in Little Falls, New Jersey revealed operations which did not meet the FDA's or Actavis' standards for GMPs. The recall, only on the pharmacy and retail level, includes about 65 different prescription drugs, such as pain killers, antidepressants, diet medication, and drugs for blood pressure and hypertension.
http://www.chicagotribune.com/business/sns-ap-prescription-drug-recall,0,6799021.story

Prescription Data Used To Assess Consumer's Records Aid Insurers but Prompt Privacy Concerns
Health and life insurance companies have access to a tremendous amount of data that can be used for evaluating whether to cover individual consumers. This can be in the form of a "health credit report" extracted and summarized from databases containing prescription drug records on more than 200 million Americans.

This new industry is involved with collecting and analyzing personal health information in commercial databases and is poised to take off as the nation enters the age of electronic medical records. Lawmakers are debating on how best to oversee the shift to computerized records. Traditionally, insurance companies have judged an applicant's risk by gathering medical records from physicians' offices, but these new tools offer the advantage of being much faster and less expensive, but potentially at a cost of the loss of privacy.
http://www.washingtonpost.com/wp-dyn/content/article/2008/08/03/AR2008080302077.html?nav=rss_health

Study: Psychiatrists Using Less Couch Time, More Pills
The introduction of newer psychotropic medications with fewer adverse effects and insurance policies that favor short office visits are among the reasons given for a decline in psychotherapy practiced by psychiatrists.
http://pharmalive.com/news/index.cfm?articleID=560750&categoryid=9&newsletter=1

FDA Sets Limits to Advisers' Ties to Industry
The FDA has announced policies designed to address concerns about its outside advisers' potential conflicts of interests and ties to the pharmaceutical and medical device industries. The FDA has stated that it is imperative to seek advice from independent experts, and that this be done in a way that is public, open, and transparent. The agency is striving to reduce real and perceived conflicts of interest and to ensure the objectivity of its influential advisory committees.

These panels greatly influence the FDA's decision-making, as the agency typically adopts most of their recommendations. The trustworthiness of the panels' recommendations has been questioned because members sometimes have financial stakes in companies under review.

The new policies would require the following:

1. A scientist or other expert would be barred from participating on an FDA advisory committee if he or she or an immediate family member had a $50,000 or greater financial stake in a company or companies up for review by the panel.

2. A potential committee member with a smaller financial stake would need a waiver from the agency to sit on the panel. Such waivers would be granted only if FDA officials "determine that there is an essential need for the adviser's particular expertise," according to a statement by the agency.

The FDA advisory committees are composed of individuals (researchers and other experts) who offer recommendations to the agency on many matters, including approval of a new treatment, product's label warnings, and the types of patients that can be prescribed a drug or device.

In addition and concurrent with the new financial conflict-of-interest policies, the FDA issued other new rules governing the advisory committee process. From now on, the FDA will make all materials to be used at the meetings available to the public at least 48 hours before a meeting.

Regarding the voting process, in the past, members have voted sequentially; this can result in early-voting members influencing later voting members as votes are cast around the table. Now, voting will occur simultaneously, not sequentially, to avoid members being influenced by the votes cast before their turns. Roll call votes also will be publicly disclosed.
http://thehill.com/leading-the-news/fda-sets-limits-to-advisers-ties-to-industry-2008-08-04.html

The following Standard Operating Procedures will be available on CompoundingToday.com's SOP Library on Monday. The library now contains over 370 SOPs that can be downloaded and customized!

...the activity of tetracycline and nadifloxacin ointments, when mixed together, decreased the antibacterial activity of the mixture?

Kawamoto T, Tayama Y, Sawa A et al. Effect of the admixture of tetracycline and nadifloxacin ointments on their stability and their antibacterial activity. Yakugaku Zasshi 2008; 128(8): 1221-1226.

Abstract

Impetigo contagiosa staphylogenes is commonly treated by administering a combination of nadifloxacin and tetracycline ointments. The purpose of this study was to evaluate the stability of these agents in combination. We also evaluated changes in antibacterial activity after mixing. Mixing the two ointments caused tetracycline to change from yellow to brown in the admixture. Furthermore, the tetracycline content in the ointment decreased in a time-dependent manner, to about 40% at 288 h after mixing. In addition, the nadifloxacin content in the ointment did not change 288 h after mixing. In an alkaline environment (pH 9.0 and 11.0), the tetracycline content decreased and the color of tetracycline changed to brown. These results suggest that sodium hydroxide, which is an additive in nadifloxacin ointment, influences the content of tetracycline. We evaluated the chemical sensitivity of Staphylococcus aureus using disk tests. Nadifloxacin and tetracycline ointment showed the largest radius of inhibition circle, followed by the admixture 0 h after mixing and the admixture 72 h after mixing. These results suggest that the antibacterial activity is inhibited by the admixture. We propose that pharmacists should avoid mixing nadifloxacin with tetracycline ointment in the treatment of impetigo contagiosa staphylogenes and should take care to avoid interactions caused by additives in the ointments.

Hot Lamps!
Lava lamps are coming back! Put a lava lamp in your pharmacy and use it as an opportunity to explain to younger students how they work and increase their interest in science. It gives an opportunity of discussing density, immiscible liquids, affect of heat on density of liquids, and provides an opportunity for them to ask questions. It also may generate interest in a "science fair" project this year.