Editorial: Have We Learned Our Lesson Yet?

This year on July 4 we may need to consider celebrating "dependence day," when we should be celebrating "independence day"! In the past 20 years, we have become dependent upon foreign countries for our drugs, oil, electronics, toys, clothing, automobiles, much of our food, and who knows what else; the list could go on and on.

Through our own efforts and enjoyment of the "good life," we have developed into a society that has become a "consumer society," not a "producer society." If we look back in history, it is consumer societies that ultimately fail, as they can too easily be held "hostage." That's not a very promising statement, but we should think about it.

We are no longer in control of our daily lives. Think about all the changes in the past 20 years in airline travel (security lines), cost of fuel (almost $4 a gallon), identification theft (credit cards being changed all the time to foil thieves), failing school systems (can't spell, do math, or speak or write using proper grammar), lowering of standards in universities (degrees given for life-experiences and not programmed studies: e.g., "Get a B.A. degree in one year going only one night a week!"), and environmental laws that have made it so expensive to produce anything in the U.S. that most companies are outsourcing production to foreign countries.

I thought this was America, "Land of the Free and Home of the Brave"; not land of the freeloaders and home of the dependents. We need to consider changing some laws so that we can manufacture and produce our goods here in the U.S. so we can control the quality and costs again, decrease welfare, and increase decent-paying jobs.

Let's face it; it is not a perfect world and decisions have to be made that will not be popular with everybody. Politicians should realize this fact and make decisions for the good of the people and not for election/re-election purposes or financial gain. We can't afford to give everybody a free ride�the cost is too high! Corporations need to bring their production back into the U.S. where we can better control quality and quantity. I'm not sure that the idea that has been promoted for so many years of "globalization of the economy" is going to work, as the different governments have different values, quality standards, and political structures that are "immiscible" (using a pharmaceutical term). One thing you learn in business when you expand is that you start losing some control over parts of your operation�it is happening today in the world.


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

Question: We have an ISO Class 7 cleanroom with a horizontal laminar airflow hood. Is it necessary to discard all the garments if I leave for a time and then re-gown with all new garments?

Answer: All items but the gown should be discarded (gloves, shoe covers, face mask, body hair covers, etc.). The gown can be removed and re-used during that same work shift only. It should be folded in on itself and hung on a hook and re-used during that shift of operation only. A new gown should be used each shift but a gown can be re-used during the same shift.

Editors Note: There is a great article on the healthcare insurance industry in the latest edition of The Pharmacist Activist. It can be accessed at:

To VIEW the current issue online, click below:
http://www.pharmacistactivist.com/2008/april_2008.shtml

To DOWNLOAD a printable version of the current issue of The Pharmacist Activist (PDF format), click below:
http://www.pharmacistactivist.com/2008/pdfs/april_2008.pdf

Heparin Deliberately Contaminated?
The New York Times (4/30, A11, Harris) reported that members of the U.S. House Energy and Commerce Committee's Oversight and Investigations Subcommittee heard testimony this past Tuesday from federal drug regulators who "believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration (FDA) has only hinted at previously."

This has been not been proven, but the FDA is looking into it. The FDA is requesting additional funds to better regulate foreign suppliers of U.S. drugs. Baxter International, Inc. had approved the facility for producing its heparin product.

http://www.nytimes.com/2008/04/30/health/policy/30heparin.html

Editors Note: It is obvious that the FDA is sorely lacking in personnel to do global policing of our food and drug supplies. Why, then, do they spend so much time on compounding pharmacy?

Rethinking Therapeutic Blood Levels Again
In addition to the diclofenac patch, the FDA has approved a 1% diclofenac topical gel, which is discussed in the Medical Letter (April 21, 2008). The article states that the systemic exposure with diclofenac gel is limited. After topical application, the area under the time-concentration (AUC) curve is only 6% of that with the same dose of the oral drug. Also, side effects that occur with oral administration, including gastrointestinal bleeding or nephrotoxicity, have not been reported with the gel.

Editors Note: In compounding, we have known this for 10 years! Another example of compounded preparations becoming commercially manufactured products.

Taxpayers subsidizing the Pharmaceutical Industry�again
The Government Accountability Office said this week that it would cost the FDA about $70 million a year to keep tabs on overseas drug manufacturers. Now, 80% of drugs sold in the U.S. use active ingredients manufactured overseas, up from 70% just a couple of years ago; and, it seems to be climbing. Interesting that the drug companies are saving money, but this is "cost-shifting" at the expense of taxpayers to the tune of $70 million a year (or more). If these drugs were manufactured in the U.S., we would not see our taxes being spent on overseas oversight! Maybe the PDUFA model should be used and the pharmaceutical industry required to pay for these inspections, not the taxpayers.

IJPC strongly urges you to support our current advertisers and supporters. In next week's newsletter, the resource directory will feature laminar airflow work benches.

Thus far, our newsletters have featured the following products:

Get 10% discount and FREE SHIPPING by using the Promotional Voucher Code IJPC2008 at: www.pharmpress.com

Researchers are saying that graphics and symbols may help to reduce prescription errors. The article, published online in BMC Medical Informatics and Decision Making, "essentially reduced a package insert and patient records to 103 central pictograms, 20 external shapes and shape modifiers, five colors and eight top-right pictograms." The researcher, of the University of Paris, presents this language as a "visualization of medical knowledge" and stated that the new system should translate to use in other languages.

Parenting Tips: 5 ideas for Traveling with your Grandkids this Summer
Go to www.IJPC.com and download a free page that can be reprinted for your patients. It is from the book The Joyous Gift of Grandparenting by Doug and Robin Hewitt. Download, print, and provide as a bagstuffer and order a few copies for sale in your pharmacy.