Editorial: Things are Changing!

It's very difficult at this point to "guess" what the next few years will bring. They may bring prosperity, freedom, and good times (good), or, they may bring financial and personal bondage (bad).

There are some outstanding senators and house members in Congress that are tremendously dedicated to their task. However, that is not uniformly the case, as we have observed over the years with some of them. It has been interesting to watch Congress over the decades as some of them seem to follow a pattern:

Initially upon arriving in Washington Congressmen�

1. Look at the needs of the people.
2. Look out for the welfare of the people.
3. Look out for the safety of the people.
4. Maintain our freedoms.

5. Try to please special interest groups.
6. Push pork barrel spending through.
7. Take care of their own individual financial condition.
8. Get as much positive press coverage as possible.
9. Minimize any negative press coverage as much as possible.
10. Try to keep the folks back home pacified for re-election purposes.
11. Manipulate their standing within the House or Senate to get good positions if possible.
12. Try to stay out of controversy if it makes them look bad.
13. Look at the changing demographics of their state and try to please the group that will help them be re-elected. (Note: Changing demographics is a topic for discussion later.)

You cannot legislate the poor into freedom by legislating the wealthy out of freedom. What one person receives without working for, another person must work for without receiving. The government cannot give to anybody anything that the government does not first take from somebody else. When half of the people get the idea that they do not have to work because the other half is going to take care of them, and when the other half gets the idea that it does no good to work because somebody else is going to get what they work for, that my dear friend, is about the end of any nation. You cannot multiply wealth by dividing it."

Pharmacists, regardless of their practice site, must be a part of the legislative process or be willing to accept the changes that may come. Our role must be to "educate" our elected officials with facts so they can make wise decisions. Too many decisions are made on misrepresentations and even false information in order to get a bill through. The purpose of elected officials is not to just get a bill through so they can chalk it up on their resumes and get their name on it, but to enact legislation for the good of the people. Let's get their focus back where it belongs.


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

Concern spreads over outsourced drug substances:
As reported in this column several times in the past, reliance on other countries for our drug substances is placing the U.S. in a precarious position. Finally, on the front page of its Science Times section of the New York Times, it is reported that "experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad and they are calling for a law that would require that certain drugs be made or stockpiled in the United States." The article goes further to state that if China stopped supplying pharmaceutical ingredients tomorrow, the pharmaceutical industry worldwide would collapse.
http://www.nytimes.com/2009/01/20/health/policy/20drug.html?_r=1&scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt

Reported Prescription Drug Product ADRs and Deaths on the Rise
The Institute for Safe Medication Practices report for the first quarter of 2008 states a record number of deaths and serious injuries associated with drug therapy were reported. Serious injuries related to drug therapy reached a total of 20,745 and a total of 4,824 reported deaths, which is a 2.6 fold increase from the previous quarter. Chantix, Champix, the smoking cessation aid, accounted for more serious injuries than any other prescription drug with a total of 1,001 new cases and 50 additional deaths. Since its FDA approval in 2006, it has accounted for 112 deaths and 3,325 reported serious injuries in the U.S.

This total of 20,745 new cases was 38% higher than the average for the previous four quarters and the highest for any quarter. Some of the specifics follow:

• The top five drugs associated with serious injury reports included varenicline, heparin, fentanyl, interferon beta, and infliximab.
• The top five drugs associated with reported deaths included oxycodone, alprazolam, acetaminophen, and acetaminophen/butalbital/caffeine.
• The top five reported serious adverse events for the most frequently prescribed brand name drugs included Lipitor, Lexapro, Singulair, Nexium, and Plavix.

Quarter Watch: 2008 Quarter 1. Hospital Pharmacy 2009; 44(1): 47-56.

Trissel's Stability of Compounded Formulations. 4th ed.
Trissel LA
Washington, DC: American Pharmacists Association; 2009.

This fourth edition of the book we have come to depend upon so much in compounding is now available. It has been updated with 78 new monographs, and 433 monographs have been updated since publication of the 3rd edition.

The book is arranged alphabetically by nonproprietary name and is intended to assist readers in determining beyond-use dates for compounded preparations, to properly store and repackage compounded preparations, formulate to meet documented standards, and to counsel patients on the use and storage of compounded medications.

With 1,233 references covering the past 50 years and two new appendices on beyond-use dating for nonsterile and sterile compounded preparations summarized from the USP, this is a "must have" for any compounding pharmacy.

The USP offers training sessions on USP Chapter <797> over the Internet and as hands-on workshops. Information can be found at: http://www.usp.org/education/pe/courses.html?course_id=6

News Releases
Read every news release carefully, even those from government agencies. Some that have come out this past week on topical anesthetics (FDA) still present to the public and healthcare providers the information as if it was current. In fact, the occurrences of death in this report are a few years old, and the warning letters mentioned were issued back in 2006.