Editorial: USP Chapter <797> Workshop #1

The first of three workshops on USP Chapter <797> was held at the USP headquarters in Rockville, MD on Monday and Tuesday of this week. Comments heard from the participants included:

"Excellent program: the details for implementing 797 were great."

"Hundreds of questions were answered with specific details over the two days, Great Program!"

"The "hands-on" sessions really helped me to understand how to do things that I was not familiar with."

"797 is not as complicated as I thought it was going to be. The instructors really broke it down into easy-to-understand language."

"Being able to get direct and detailed answers from those involved with writing the chapter and other experts from the companies with the equipment and supplies and doing exercises was excellent."

Having the opportunity of moderating the two-day session, I was impressed with the details presented as compared to the seminars conducted in 2005. This is a "workshop," not a "seminar," and involves small group interaction and "hands-on" exercises. I also learned a lot from the exhibitors and instructors and thank them for their time and effort in putting on a first-class program.

Two more workshops are scheduled; one on April 18 and 19, and one on May 22 and 23. See http://www.usp.org/hottopics/generalChapter797.html?hlc, or contact Dr. Claudia Okeke at 301-816-8243 to register.



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

Headlines and news this week!
Federal Agencies say their rules pre-empt injury suits! [www.PharmaLive.com - Monday, March 31, 2008]. If a prescription drug causes injury, the FDA now says you can't sue the maker for injury if it met the agency standards! Not only is the FDA saying this but also the Consumer Product Safety Commission, National Highway Traffic Safety Administration, etc. We already know the standards developed by different agencies of the government are not perfect, but this is a big blow to consumers; especially those that receive prescription drugs that have little choice in their selection. Consequently, these adverse events, including death, are going to occur and now the consumer has no recourse. Think about this as you read the following headlines from this week and refer back to last week's newsletter to the list of top 10 drugs causing deaths in recent years. It seems our agencies are not protecting consumers�they are prohibiting them from seeking damages in the event a flawed product is approved by "them" and causes harm! (Editors Note: This doesn't seem right. Think about this as you read the following.)

*Glaxo defends safety record of HIV Drug abacavir after publication of a report suggesting its use could increase the risk of heart attacks in the Lancet. [www.PharmaLive.com - Wednesday, April 2, 2008]

*FDA MedWatch-Singular (montelukast)-Possible association between use of Singular and Behavior/Mood changes, suicidality and suicide. [Pharmacist e-link - Monday, March 31, 2008]

*FDA MedWatch-Regranex (becaplermin) Gel study data suggest possible increased risk of death from cancer in diabetic patients using the product. [Pharmacist e-link - Monday, March 31, 2008]

*FDA MedWatch-Ziagen and Videx study data indicates a higher risk of heart attack in patients infected with HIV-1 and taking the drug. [Pharmacist e-link - Monday, March 31, 2008]

*A two-year-trial has shown that Vytorin and Zetia that block the intestine from absorbing cholesterol may do little to prevent heart attacks. Requests have been made to withdraw them from the market. The manufacturers, Merck and Schering-Plough, are accused of withholding negative results to boost sales. [www.PharmaLive.com - Tuesday, April 1, 2008]

Editors Note: The patients involved do not really have much of a choice in the treatments they receive. The "choice" is up to the physician, the managed care provider, the insurance company, etc. They are prescribed the treatment and:

This is a bad trend because it appears no one wants to be held responsible for their actions. They strive for authority, but don't want responsibility! In pharmacy practice, it doesn't work that way. We ARE responsible for our actions over which we have authority.

Other News:
On another note, the pay for the Amgen CEO dropped 29% in 2007 following FDA warnings on 2 of its drugs; The CEO's compensation fell from $18.6 million to $13.2 million dollars! [www.PharmaLive.com] (Editors Note: How is the CEO going to afford to heat the swimming pool this winter? Maybe we should take up a collection?)

IJPC supplies this list of providers of USP Chapter <797> products as a service to our readers. We strongly urge you to support the current advertisers and supporters (listed in bold) of IJPC. In next week's newsletter, the resource directory will feature Microbial Air Samplers.

At any time the opportunity arises, IJPC attempts to remove the complications from Chapter <797> implementation. This ongoing effort is echoed in our May/June 2008 issue, which features part 1 of an article on microbial air sampling equipment as it relates to USP Chapter <797> standards and contains a comparison table listing many different devices, their specifications, and some of the manufacturers and distributors. Our July/August 2008 issue features part 2 of this informative article.

Don't miss this valuable information! Subscribe today online at www.IJPC.com/Subscriptions or call 800-757-4572.

You shouldn't take everything you read, see, and hear as the truth. Many do, and they continue to propagate information that is not factual. Check it out first! When scientists, professionals, politicians, media personnel, and others have opposite opinions, it is sometimes difficult to get to the truth. We tend to take what we are exposed to the most as the truth. What we are reading, seeing and hearing is often nothing more than "opinion" not necessarily the "truth." Maybe disclaimers should be required in the media when "opinions" are given that are not backed up by facts. Think about all the statements you've made [to patients] that have been found to not be factual about the safety and effectiveness of many drugs that were later withdrawn from the market. Our patients believe us. It seems we may all be guilty.

Ask them to ask!
Train your employees and students to be responsible for their actions. If they are unsure about how to do something, this is a great educational opportunity. Make sure you encourage your employees and students to ask questions so they can "just do it right!".