PHARMACY

NABP report highlights need for .Pharmacy domain health initiative

BY Antoinette Alexander

 

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy has issued a report underscoring the need for the .Pharmacy Top-Level Domain Program as a public health initiative to help consumers distinguish legitimate online pharmacies from rogue online drug sellers.

As detailed in the "Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2015," the two most common characteristics of sites NABP has identified as rogue drug sellers are dispensing prescription drugs without a valid prescription and offering foreign and unapproved drugs. Such factors place public health at risk and undermine regulations put in place to safeguard the drug supply chain, highlighting the need for the .pharmacy domain.

To explore trends related to this issue, NABP conducted a review of data collected on web sites selling medicine illegally online to United States patients since the Association began reviewing web sites in 2008. Over the last seven years, NABP has reviewed nearly 11,000 Internet drug outlets, finding that 96.3% (10,521) of the sites reviewed operate out of compliance with U.S. pharmacy laws and practice standards. During that time period, the average percentage of "Not Recommended" sites selling drugs without a prescription was 93.4%. Current data shows that over 62% of “Not Recommended” sites do not post a physical address. These sites tend to be the ones most likely to dispense counterfeit drugs. Further, of the 10,521 “Not Recommended” sites, 91% appear to have affiliations with rogue networks of Internet drug outlets, and 12% dispense controlled substances, according to NABP.

To protect consumers buying medications online, NABP launched the .Pharmacy TLD Program. Only legitimate Internet pharmacies and related entities will qualify for .pharmacy domains, giving consumers a way to distinguish safe and legal online pharmacies and resources from rogue sites. NABP began accepting applications for .pharmacy domain names in late 2014, and several boards of pharmacy have now registered and activated their .pharmacy domain names.

Following a series of special registration periods that will continue through the first half of 2015, general availability will open for eligible pharmacy community members on June 3.

For the full report with detailed findings on the characteristics of rogue websites and the list of “Not Recommended sites,” visit AWARErx.org/get-informed/safe-acquisition/not-recommended-sites.
 

 

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FDA adds approved use for Shire’s Vyvanse

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration announced that it has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults, making it the first FDA-approved medicine to treat this condition.
 
Patients with binge-eating disorder experience bouts of compulsive overeating, consuming larger amounts of food than what is normal. Patients also experience the sense that they lack control, the agency stated. Patients with the disorder will eat when they're not hungry — often to the point of being uncomfortably full. 
 
“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, M.D., director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
 
Vyvanse — marketed by Shire U.S. — received FDA approval in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 years and older. Because of the drug's high potential for abuse, it is categorized as a schedule II controlled substance. 
 
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Mylan expands women’s healthcare portfolio with Famy Care acquisition

BY Ryan Chavis

PITTSBURGH and MUMBAI, India — Mylan announced that it will acquire certain businesses from specialty women's healthcare company Famy Care Limited for $750 million, with additional contingent payments of up to $50 million. 
 
Famy Care is a global leader in generic oral contaceptive products and its acquisition by Mylan makes it a leader in the hormonal contraceptives market, Mylan said. The transaction is expected to close in the second half of 2015. 
 
"In 2008, Mylan established a partnership with Famy Care, significantly enhancing its presence in the women's health care segment in the United States and other developed country markets. With today's acquisition, we are building on this successful partnership and further accelerating our global growth in this important therapeutic area," said Mylan CEO Heather Bresch.
 
The transaction will complement the company's pending acquisition of Abbot's non-U.S. developed markets specialty and branded generics business, which also contains a women's healthcare portfolio. 
 
"By adding this vertically integrated business and globalizing our women's healthcare platform, we are creating the right foundation to become a leader in this growing, attractive sector. Famy Care brings us a broad portfolio, strong technical capabilities and dedicated hormone manufacturing, which complement Mylan's powerful global commercial footprint and supply chain infrastructure," said Mylan president Rajiv Malik. 
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