Editorial: States of Matter; States of States!

Recall back in your high school science classes about the three states of matter�and again in college and in the pharmaceutics classes? We are aware of the different states of matter, their definitions, conversions between states, characteristics, and uses. We can see water when it is in the form of a solid with defined borders (ice), when it is transformed into a mobile liquid with ill-defined boundaries (liquid water), and, finally, when it becomes less visible as it transforms into a gas (diffuse with no limitations other than its container).

When the U.S. was founded in 1776, it was formed from a "collection of states." Each individual state had its own identity, legal documents, law-forming bodies, laws, regulations, standards, boundaries limiting expansion and intrusion, etc. The Federal Government was formed to assist the states by forming a "bond" between them to increase their strength by working together. The states were well separated from the federal government but were associated by a common bond for protection and working for the people.

"States Rights" and associated responsibilities are unique, depending upon the state, its geographical location, and its composition of people. Even though we are similar, each state has its own unique characteristics and character. State government is "close to the people" and more responsive to the people than the distant federal government. However, over the years, the federal government has been usurping the powers from states, often in a disguised or not-so-disguised manner. States like to get money from the federal government. The federal government attaches "strings" to this money, forcing the state to do what the federal government wants done if the states accept the money; the federal government then controls the states.

One problem with this scenario is that the states become dependent upon and subservient to the federal government. As the federal government provides more money to the states and more strings are attached, the "states" tend to change from being independent, well-defined entities (solids) into less well-defined masses (liquids) as we are now and soon will be indistinguishable (gaseous or vapor state). At that point, we will change from the "United States of America" to the "State of America"! Not a pretty picture is it?


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

Tainted syringes killed five people: North Carolina plant shipped dirty saline, heparin; two plead guilty, one is sought
Authorities are hunting the mastermind behind a "horrific case" in which bacteria-laden syringes shipped from an Angier, North Carolina plant sickened at least a hundred people and killed five.

Two men have already pled guilty in U.S. District Court in Raleigh for their roles in ignoring sterility standards at the former AM2PAT Inc. plant. Conditions there appeared more consistent with a textile factory than a pharmaceutical facility.

The men-plant manager Aniruddha Patel and quality-control director Ravindra Kumar Sharma- were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace. The relatively light sentence was in exchange for information about chief executive officer Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-2007 that did not undergo proper sterility testing.

The plant was subject to U.S. Food and Drug Administration requirements for its production process. A photograph entered into evidence shows a "cleanroom" refreshed with a common window fan that was held together with duct tape. In another photo, women work on an assembly line under lamps, surrounded by what looks like green plastic recycling bins. One bin is resting on its side on the floor between two workers. Floor paint has peeled.

Once the syringes were loaded with drugs, each batch was required to be held for two weeks while employees tested for bacteria and other contaminants in solution. Batches of syringes went straight from the production line into the marketplace. When tests were done, the results were ignored. If a sample came up positive for bacteria, employees simply grabbed another until they found one that tested clean.
http://www.newsobserver.com/news/health_science/story/1416688.html

FDA Ignored North Carolina Syringe-Plant Complaints
A report says regulators ignored complaints for months about tainted syringes produced at a factory in Angier. The News & Observer of Raleigh reported that the U.S. FDA had complaints as early as 2005 about contamination in syringes filled with blood thinner by AM2PAT at its plant in Angier. The FDA pulled the product from the market in December 2007. Authorities say tainted syringes from the plant sickened hundreds of people and are linked to five deaths.
http://www.wral.com/news/state/story/4607551/

Firm Apparently Faked Generic-Drug Tests
India's largest drugmaker has falsified laboratory tests for generic drugs that had been approved for sale in the U.S., according to officials at the FDA.

The FDA cited the fraudulent laboratory tests yesterday as it took the unusual step of stopping its review of all pending applications from Ranbaxy Laboratories. The problems involve the company's plant in Paonta Sahib, which has produced 25 drugs that have been approved by the FDA. Most of those medications are not thought to be on U.S. pharmacy shelves. Since September, Ranbaxy has been prevented from exporting those drugs to the U.S. The FDA is not seeking a recall because regulators do not believe the drugs pose a health risk. The affected drugs include medications for high cholesterol and an antihistamine, but the FDA would not provide specifics.
http://www.washingtonpost.com/wp-dyn/content/article/2009/02/25/AR2009022503715.html?hpid=topnewsist

FDA Slaps Warning on Heartburn Drug Tied to Spasms
The FDA is adding their sternest warning to Reglan, which they state has been shown to cause spasms and tics when used for long periods of time or at high doses. The problems include uncontrollable movement of the limbs, face, and tongue, and are usually irreversible, even after patients stop taking the drug, according to the FDA's warning. The agency is requiring drugmakers to add a black-box warning, the most serious type available, to their products.
http://hosted.ap.org/dynamic/stories/H/HEARTBURN_DRUGS_FDA_WARNING

Pharmaceutical Calculations 13th ed
Ansel HC
Wolters Kluwer/Lippincott Williams & Wilkins; 2009

The standard textbook for teaching Pharmaceutical Calculations is now in its 13th edition. Published for both teaching and self-assessment purposes, this edition has many examples and practice problems, including those related to biotechnology. This latest edition is very practice-oriented with many examples that compounding pharmacists can use daily. Consisting of 23 chapters and 3 appendices, this book is highly recommended and should be a part of every compounding pharmacy for reference and teaching purposes; as a review for pharmacists; and a teaching tool for technicians.

�that on February 19, 2009, the U.S. federal debt was $10.8 trillion dollars�or about $37,851 per person in the U.S. That was before the stimulus package and the currently debated bail-out package. Your share for a family of four is $151,404 and does not include your usual annual federal taxes paid to the IRS! Better get a second job! Ooops, can't do that because then I may make too much and the government will take even more of it!
http://en.wikipedia.org/wiki/United_States_public_debt

Be News Savvy
Keep up with the national and international news every day! Never have things moved more quickly to affect your life and the lives of your family. We must not only be aware of what goes on in our profession, but in the political arena as well!