Compounding This Week Newsletter from www.CompoundingToday.com
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November 12, 2010 Volume 7, Issue 46
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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: Changes and Opportunities

We would like to announce a change in the operation of the Compounders' Network List (CNL) and a new opportunity for participation in this weekly CompoundingToday.com newsletter.

COMPOUNDERS' NETWORK LIST

Effective January 1, 2011, participation in the CNL will be a benefit of subscribing to the International Journal of Pharmaceutical Compounding (IJPC), the CompoundingToday.com subscription website (individual subscription or site license), and to those that support IJPC, including advertisers (advertising at least three times in the previous year or a current similar contract).

The CNL is the most active pharmacy list serve in pharmacy compounding with participants from throughout the world. Students enrolled in a college of pharmacy that subscribes can continue to "read" but not "post" on the CNL. All other aspects of the CNL will remain unchanged.

If you are not a subscriber, please go to www.ijpc.com or CompoundingToday.com to subscribe and continue participating in the CNL. Subscribers may join the list by following the CNL link on the site's home page.

CLASSIFIED ADS IN THIS WEEKLY NEWSLETTER

Effective immediately, classified ads can be posted in this free, weekly Newsletter. Rates are as follows:

$25 for items being sold up to $500
$125 for items being sold over $500
$25 for items of any value desiring to buy

Ads are limited to 25 words and are for practitioners only; no commercial vendors. The contacts between buyer and seller will be offline by e-mail, telephone, etc. Examples of items that can be listed include used equipment, excess supplies, etc. To place an ad, please contact Lauren Bernick at lbernick@ijpc.com or at 405-513-4236. Emergency requests for items can still be posted on the CNL.

We hope this will benefit compounding pharmacists.


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

 
Other News

Drugmakers May Receive Less Under Medicare
The U.S. deficit-reduction commission has urged limits to the popular Medicare health insurance program, smaller payments to drugmakers, and more power for a health cost-control board.

This is a draft proposal and calls for increasing rebates that drugmakers provide to the government and lowering payments to doctors; also, seniors could pay a higher proportion of Medicare costs.

These proposals will likely be unpopular across the board. The draft proposals, which received a mixed reception from other commission members, are portrayed as achieving $4 trillion in deficit reduction through 2020. A final report from the panel is due December 1, 2010.
http://www.reuters.com/article/idUSN1020096120101111

Germany: Drugmakers Face Pricing Pressures
In Germany, drugmakers face more than 2 billion Euros ($2.76 billion) in price cuts after lawmakers in Berlin approved the first controls on the cost of innovative medicines.

Under the new law, companies have a one-year window to negotiate prices with insurers after introducing new drugs. This potentially affects Novartis AG's multiple sclerosis treatment Gilenya and AstraZeneca Plc's blood thinner Brilinta among other medicines that haven't been approved yet in Europe. If no agreement is reached, the Health Ministry would set a maximum price, and the drugs would undergo a cost-benefit analysis by a semi-state agency.

"We are breaking the price monopoly of the pharma industry," says Jens Spahn, a lawmaker with Chancellor Angela Merkel's Christian Democratic Union party who sits on parliament's Health Committee.
http://www.bloomberg.com/news/2010-11-11/drugmakers-face-pressure-on-prices-after-germany-votes-to-break-monopoly-.html

Drugs, Supplements Come to U.S. from China Largely Unregulated
Prescription drugs and dietary supplements are pouring in from China, but U.S. regulators are not ensuring their quality, safety, or proper labeling. U.S. federal regulators inspect only a fraction of the hundreds of Chinese factories making prescription drugs for the U.S. market, says a new report from the Government Accountability Office.

Country-of-origin labeling laws are not being enforced, so consumers can't tell where imported drugs and dietary supplements originate. Chinese officials and businesses defend the quality of their products. They say their defect rates have been decreasing. However, problems with Chinese products keep cropping up-such as a recent case of Viagra contaminated with a drywall ingredient.

These overseas plants produce nearly 80 percent of the pharmaceutical ingredients and nearly 40 percent of the finished prescription drugs consumed in the U.S. About half of those imports, the FDA says, come from China and India.
http://www.kansascity.com/2010/11/06/2401823/drugs-supplements-come-to-us-from.html#ixzz155OoEvg7

Healthcare Costs Being Shifted in Companies to Better-paid Employees
As healthcare costs climb even higher during this enrollment season, more employers are adopting a tiered system to pass on the bulk of those costs to their employees by assigning bigger contributions to workers in top salary brackets and offering some relief to workers who make less money.

Employees have seen their contribution to their healthcare insurance costs go up as companies ask them to contribute more to premiums and deductibles. Now, as people enroll in health plans for the coming year, the sticker shock is more jolting than ever; this is because so many companies are passing on to their workers most, if not all, of the higher costs.
http://www.nytimes.com/2010/11/10/business/10insure.html?_r=1&ref=health

Medicare Fraud Scrutiny Eyes Drug-firm Executives
Drug-company executives will be prevented from doing business with the U.S. government if their companies are convicted of Medicare fraud if the government gets its way. Under guidelines from the DHHS's Office of Inspector General, executives can be barred from contracting with federal health programs when they knew, or if the inspector general concludes they should have known, about fraud at their firms.

In recent time, GlaxoSmithKline was ordered to pay $750 million for the sale of defective drugs; Pfizer agreed to pay $2.3 billion for fraudulent marketing of medicine. A company that employs someone barred from doing business with the government cannot receive federal payments.

Certain crimes, such as patient abuse or a felony conviction of healthcare fraud, require automatic exclusion by law, according to the inspector general's Website.
http://www.washingtonpost.com/wp-dyn/content/article/2010/11/08/AR2010110805757.html

FDA Criticized Over Generic Drug Approval
Momenta Pharmaceuticals won the first right to sell the generic version of Sanofi-Aventis' blood thinner Lovenox but had performed months of free work for the FDA in 2008, according to a report by the Government Accountability Office.

As Momenta was providing consulting work for the FDA, FDA officials were reviewing its application to sell its generic blood thinner. This report will say that the FDA risked giving the appearance it compromised its integrity. The generic blood thinner is marketed by Momenta in partnership with Novartis AG's Sandoz unit.
http://www.reuters.com/article/idUSTRE6A80DN20101109

 
Did You Know...

�that the particle size of an active pharmaceutical ingredient is the most critical material quality attribute affecting the uniformity of solid dosage forms, especially for low-dose drugs? (J Pharm Sci 2010; 99(10): 4351-4362)

 
Compounding Tip of the Week

Homogeneity is Good!
To achieve a homogeneous distribution, oversized particles can be removed by sieving and re-worked to achieve the desired particle size distribution.

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