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August 26, 2011 Volume 8, Issue 34
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.


Editorial: What is "about" all about?

The United States Pharmacopeia-National Formulary (USP-NF) uses the phrase "weigh out about xx mg" in several places when tests, etc. are being conducted. Patents use the phrase "about" in a lot of their terminology in the specifications and claims. In cooking, we see the word "about" used in referring to quantities of ingredients to be used. But, what does the word "about" mean?

In dictionaries, the word "about" means approximately, almost, near, nearly, around, in the immediate neighborhood, in the area or vicinity, close to, not many more or less, etc.

As the standards-setting compendia in pharmacy, what does the USP say about the word "about"? At the beginning of the USP-NF are the General Notices and Requirements. This section presents the basic assumptions, definitions, and default conditions for the interpretation and application of the USP and NF. Requirements in this section apply to all articles recognized in the USP-NF and to all general chapters, unless specifically stated otherwise. The exceptions would be if different information is specifically explained and stated in the General Chapter or the Monographs.

The word "about" is defined in Section 8.20 of the General Notices where it states: "'About' indicates a quantity within 10%." However, if the measurement is stated to be "accurately measured" or "accurately weighed," follow the statements in the General Chapters Volumetric Apparatus <31> and Weights and Balances <41>, respectively.

So, here we have it. When reading the quantities of ingredients and the word "about" is used, it means within 10% of the target amount stated.

Well, I'm "about" finished with the editorial this week! Next week, we will look at more of the USP General Notices and their impact on compounding pharmacy practice standards.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

 
Other News

Illegal Pharmacy Ads Cost Google $500 Million
Google Inc. has agreed to pay $500 million to settle a U.S. government investigation into the Internet search leader's distribution of online ads from Canadian pharmacies illegally selling prescription drugs to Americans. As a result of this settlement, Google will not face criminal prosecution for accusations that it improperly profited from ads promoting Canadian pharmacies that illegally imported drugs into the U.S. This is the first time an Internet search engine is being held responsible for the illegal distribution of drugs.
http://www.washingtonpost.com/national/google-settles-probe-into-ads-from-illegal-pharmacies-for-500-million/2011/08/24/gIQAe60KbJ_story.html

Physicians in Spain Required to Prescribe Cheaper Generic Drugs
Spain's pharmacies now must provide the cheapest available versions of drugs to patients. This move is designed to save �2.4 billion a year. This results from Spain's socialist government passing a law forcing doctors and pharmacies to prescribe/dispense generic drugs rather than the more expensive brand-name products.

Doctors now only write prescriptions giving the details of the active ingredients of the medicine that their patients must take, as well as the dose and format.

The prime minister explained to parliament that the measures would help Spain continue to lower the cost of drugs to the state; a move that began last year and has led to the first-ever fall in the national pharmaceutical bill of 10%, in part because of measures that had increased the generic drugs used.
http://www.guardian.co.uk/world/2011/aug/23/spanish-doctors-cheaper-generic-drugs

Dinners Enjoyed by Physicians
PHARMA-sponsored dinner meetings have recently covered multiple sclerosis; updates on new anti-clotting drugs; pain management; bipolar disorder; and reimbursement issues and physicians like them. However, the meetings must be kept brief and plenty of time left for questions.

In a recent survey, almost three-fourths of physicians responding attend dinner meetings at medical conferences, while 62% participate in traditional programs. Still, 27% actually avoid speaker programs because of the industry's transparency push; several drugmakers are now reporting all payments to doctors, including free meals.

Physicians responding said they enjoy Q&A sessions and "spirited discussions" that can follow speakers' formal presentations. One pediatrician said "I like to challenge the claims of the drug companies and force the speaker to send me more information when I don't think we are getting the whole story." Time is critical. A good speaker gets right to the subject at hand and can say it in no more than 45 to 60 minutes. They should leave with at least one new fact" after every meeting.
http://clients.sermo.com/Article?art=0007

Acid Reflux Drugs: Public Citizen Petitions FDA for Stricter Warnings
The watchdog group Public Citizen has filed a petition to require a black box warning on proton pump inhibitors. The director of Public Citizen's Health Research Group said he hopes stricter warnings will curb unnecessary use of the drugs. "These drugs have a use, but they're grossly overused," Wolfe said. "We hope use will go down when doctors and patients know the risks."

Proton pump inhibitors are the third highest-selling class of drugs in the U.S. The Public Citizen petition calls for black box warnings on both prescription and over-the-counter proton pump inhibitors.
http://abcnews.go.com/Health/Drugs/acid-reflux-drugs-public-citizen-petitions-fda-stricter/story?id=14365447

U.S. Scrambling to Ease Shortage of Vital Medicine
Federal officials, lawmakers, the drug industry, and doctors' groups are rushing to find remedies for critical shortages of drugs to treat a number of life-threatening illnesses, including bacterial infection and several forms of cancer. Proposed solutions, which include a national stockpile of cancer medicines and a nonprofit company that will import drugs and eventually make them, are still in the early or planning stages.

So far this year, at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections, and other diseases have been declared in short supply—a record number. Prices for some have risen as much as twenty-fold, and clinical trials for some experimental cures have been delayed because the studies must also offer older medicines that cannot be reliably provided.

Of interest to compounders, in one proposed plan, the government would store the dry ingredients for cancer drugs and, in the face of a shortage, distribute them to hospitals, where pharmacists could mix them into injectable compounds.
http://www.nytimes.com/2011/08/20/health/policy/20drug.html?_r=1

 
Did You Know...

...that it seems like government regulations (EPA, OSHA, Unions, taxes, etc.) have pushed jobs out of the U.S. to other countries in recent years; overall resulting in the worst shortage of drugs ever experienced in the U.S.? Now, the same government is going to try to figure out what happened, how it happened, and what to do about it! This should be interesting!

 
Compounding Tip of the Week

Market, market, market!
How many times over the past 10 years have you seen new businesses go in locally and then close up after a time because no one knew they were there?

The next RxTriad newsletter will be on the topic of "Bioidentical, Natural, Semisynthetic and Synthetic HRT and BHRT." Order this great marketing tool today!

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