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August 26, 2016  |  Volume 13  |  Issue 34
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
U.S. Food and Drug Administration "Import Alerts", Part 2
 

As mentioned in last week's editorial, there are many drug companies in other countries that are sometimes prohibited from exporting pharmaceuticals to the U.S. due to quality issues; these may impact the safety of the products and cause patient harm.

There are four different types of import alerts, including:

  • Country or Area-Wide: Relates to certain products offered for entry from a specified country or area
  • Manufacturer/Product Specific: Relates to certain products from specific manufacturers
  • Shipper: Relates to certain products from shippers
  • Country/World Wide Alert: Relates to certain products from all countries outside of the U.S.

Import Alerts are issued under certain conditions including, but not limited to, the following:

  • Product has been sampled and tested violative for a pathogen
  • Product has been sampled and contains illegal colors or food additives
  • Firm has not provided sufficient evidence to support adding them to the "green list"
  • Product is an unapproved new drug
  • Foreign firm had a violative inspection by the FDA
  • Foreign firm has refused inspection by the FDA

Next week, we will look at interpreting import alerts and what is a red, green, and yellow list.

Note: Correction to last week's listing of Import Alerts websites. The following is the corrected website for a "Country" listing: http://www.accessdata.fda.gov/cms_ia/countrylist.html


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

 

CompoundingToday.com

In addition to formulas, etc., two new SOPs have been added this week:

1.20    Impaired licensed employee responses
1.21Theft or diversion or self-use of stolen prescription drugs by a licensed employee
 

News

New Menopause Guidelines Update Hormone Therapy Safety Evidence (2016)
Hormone therapy (HT) continues to be the most effective treatment for menopause symptoms according to updated guidelines on managing women's overall midlife health from the International Menopause Society (IMS).

Since the risk-benefit ratio differs for perimenopausal women compared with older, postmenopausal women, "[Menopausal HT (MHT)] must be individualized and tailored according to symptoms and the need for prevention, as well as personal and family history, results of relevant investigations, the woman's preferences and expectations," write Rodney J. Baber, MD, from the University of Sydney in Australia, and colleagues from the IMS Writing Group.

The recommendations update the previous ones issued in 2013 but with several new features: grades for the recommendations, levels of evidence, and "good practice points." "New data and re-analyses of older studies by women's age show that, for most women, the potential benefits of MHT given for a clear indication are many and the risks are few when initiated within a few years of menopause."

"These recommendations give enough evidence to almost give providers 'permission' to recommend [HT] to help women who are suffering because many practitioners have been hesitant," Dr Makai, director of minimally invasive gynecologic surgery for the Department of Obstetrics and Gynecology, Christiana Care Health System, Wilmington, Delaware, explained. "The evidence for HT is so broad, and the way it affects women is so vast, that it's really difficult for a provider who is evidence-based, but not at a major academic center, to keep up with the guidelines."

Climacteric. 2016; 19: 109-150. Published online June 20, 2016.
http://www.medscape.com/viewarticle/867600

"Fraudulent Scheme" Used by Valeant, T Rowe Price Accuses
Charges of using a secret pharmacy network, deceptive pricing and reimbursements, and fictitious accounting to shield the company's brand-name drugs from generic competitors and artificially inflate revenues and profits have been charged by T. Rowe Price against Valeant.

Valeant has "hid from investors the company's clandestine network of controlled pharmacies and other deceptive practices that were true drivers of Valeant's purported growth and which exposed the company to massive risks," it is alleged.

Philidor Rx Services are at the center of the action: Philidor is a Pennsylvania mail-order pharmacy that was Valeant's partner in a since-canceled prescription distribution deal. Valeant "built a network of secret pharmacies around Philidor," and then created shell companies owned through the partner to acquire interests in retail pharmacies across the U.S, the lawsuit charged. Funneled prescriptions for its high-priced, branded drugs through Philidor involved Valeant staffers who worked at Philidor under aliases, "were instructed to employ a host of deceptive practices to prevent the substitution of cheaper generic equivalents for Valeant-branded drugs," the lawsuit charged.
http://www.usatoday.com/story/money/2016/08/18/valeant-pharmaceuticals/88939416/

 

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Did You Know ...

�that here is a great opportunity for compounding?

The American Pharmacists Association (APhA) is looking for volunteers for a taskforce to:

  • write a brief synopsis of compounding pharmacy
  • collate useful resources for those interested in compounding pharmacy
  • identify additional resources to be created in 2017 by APhA member volunteers

 

Tip of the Week

Those who volunteer for the APhA taskforce will participate in teleconference calls as needed throughout a 4 to 6 week period and participate in email exchanges regarding the content developed and collated for APhA's website.

Go to: www.pharmacist.com/volunteer and complete the application form.

 

Looking Back

Headline news,
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