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Editorial: More on the United States Pharmacopeia General Notices, Part IX

This week we will continue our discussions on the USP General Notices by covering Part 9 and a portion of Part 10.

This section states that prescriptions for compendial articles are to be written stating the quantity and/or strength in metric units. Also, apothecary unit designations on labels and labeling shall not be used. It also states that slight changes in volume resulting from variations in room temperatures may be disregarded.

The remainder of this section will be covered next week.

Containers are what holds an article (substance, product, or preparation) and is or may be in direct contact with the material enclosed. Light-resistant containers must meet the standards described in USP Chapter <671> Containers-Performance Testing. Well-closed containers differ from the most commonly used tight containers because the latter has tighter restrictions, which include not only protection from extraneous solids and loss but protection from contamination by extraneous liquids, solids, vapors, and from efflorescence, deliquescence, or evaporation under ordinary or customary conditions.

The application of single-unit, single-dose, unit-dose, unit-of-use, multiple-unit, and multiple-dose containers can be reviewed in the notices. Also discussed in this section are the requirements under the Poison Prevention Packaging Act; where it is required and where it is exempt.

Next week we will conclude our review of the USP General Notices.


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

China Cracks Fake Drug Ring, Seizing 114 People
China's Henan province police have arrested 114 people in a crackdown on a counterfeit drugs ring, seizing $30 million worth of fake medications and more than 65 million medicine bottles. China's increasing role producing pharmaceuticals for the world market has ratcheted up concern over the scandals involving fake, adulterated, and otherwise unsafe drugs; this is especially troubling with the mail-order and Internet-order situation. We now have more than 80 percent of the active pharmaceutical ingredients used in the U.S. coming from overseas, as well as 40 percent of all finished medicines
http://www.washingtonpost.com/world/asia-pacific/china-cracks-fake-drug-ring-seizing-114-as-us-fda-official-urges-vigilance/2011/11/01/gIQAdWePbM_story.html

Pressure Points in Emerging Markets Noted by Pharma Companies
GlaxoSmithKline and others are finding that selling medicines into countries such as China, Russia, Brazil, and Turkey is not easy sailing. Recent results from leading pharmaceutical companies highlight some unexpected bumps-in-the-road in the emerging market growth story, as governments flex their muscles to limit the cash bonanza for international companies. Along with this, law enforcement is looking hard at sales practices, raising issues for some over bribery allegations.

AstraZeneca's emerging market sales growth slipped to 7 percent in the third quarter from 10 percent in the second and 13 percent in the first, hit by an upset in Brazil where generics have arrived early for key drugs Crestor and Seroquel. Sales to China by Denmark's Novo Nordisk, the world's biggest supplier of insulin, fell 3 percent in the quarter, due to healthcare reforms there designed to curb costs. GSK has seen price squeezes in both Turkey and Russia.
http://www.reuters.com/article/2011/10/28/us-pharmaceuticals-emerging-idUSTRE79R3SV20111028

Chinese Pharmaceuticals Now Testing Sales in the U.S. Drug Market
Chinese pharmaceutical companies are working at getting their products approved for overseas markets, including the U.S. About 30 businesspeople from the Chinese pharmaceutical industry, including CEOs of pharmaceutical companies, editors from industry magazines, and directors from investment institutions, visited New York and Boston for six days at the end of last month. Their visit was to learn from the major international pharmaceutical entrepreneurs and to look for cooperation possibilities. Their visit included Amgen, Pfizer, and others.
http://usa.chinadaily.com.cn/weekly/2011-10/28/content_13993395.htm

$10 Million Lawsuit Against Wyeth Filed Over Hormone Replacement Drug
An Orleans Parish woman diagnosed with breast cancer has filed a lawsuit against the manufacturer of her hormone replacement therapy drugs. The suit was filed against Wyeth, Wyeth Pharmaceuticals Inc., Pfizer Inc., Pharmacia Corp., and Pharmacia & Upjohn Company on October 21 in federal court in New Orleans.

The defendants have been accused of manufacturing and selling hormone therapy drugs that dramatically increase the risk of breast cancer, ovarian cancer, strokes, blood clots, and cardiovascular disease; the drugs involved include Prempro, Premarin, and Provera.
http://www.louisianarecord.com/news/239338-wyeth-suit-seeks-10-million-over-hormone-replacement-drug

Cancer Drug Studies Face Delays From J&J's Doxil Shortage
The ongoing shortage of Doxil has not only cut off a treatment for many cancer patients, but it is also crimping cancer research. Several of the more than 30 clinical trials testing Doxil with or against other cancer drugs are now either on hold or face potential delays as a result of the shortage. A reported 2,500 cancer patients are on the waiting list for Doxil
http://online.wsj.com/article/BT-CO-20111031-712178.html

Lipitor "Deals" and "OTC" Plans
Pfizer is striking deals with drug-benefit plans and providing discounts to patients to encourage continued use of branded Lipitor, and to preserve a big chunk of its nearly $11 billion in annual sales as soon as it loses U.S. market exclusivity on November 30. Over the long term, Pfizer will seek to sell an over-the-counter version of Lipitor, which, if successful, would counter the generic market.
http://online.wsj.com/article/SB10001424052970204528204577011492595048250.html

Facilitating Learning in Healthcare
Carter S, ed.
Paperback; $55.00; 160 Pages

As Colleges of Pharmacy seem to be shifting more and more pharmacy education activities to practicing pharmacists, this book will be of some value to those that have limited experience in teaching. It contains tips, personal accounts, and exercises in the following areas: (1) teaching and learning theories and concepts, (2) developing course material, (3) teaching strategies and approaches to learning, (4) assessing learning, (5) evaluating teaching, and (6) reflecting on teaching and learning. This book can be of great value to practitioners as well as college faculty and is written by experienced authors.

�it has been said that "The government is like a baby's alimentary canal, with a happy appetite at one end and no responsibility at the other"?

Saving Time
Don't forget, "Daylight Saving Time" ends Sunday, November 6, 2011, at 2 am; don't forget to get up and change your clocks!