PHARMACY

FDA approves Shire’s Xiidra

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Shire’s Xiidra (lifitegrast ophthalmic solution, 5%), the company announced Tuesday. Xiidra is twice-daily eyedrop solution indicated to treat signs and symptoms of dry eye, which affects an estimated 16 million adults in the U.S. The drug is the first approval from Shire’s ophthalmics pipeline
 
“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition,” Shire CEO Dr. Flemming Ornskov said. "As Shire's first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs.”
 
Shire said it expects Xiidra to be available in the third quarter of 2016. 
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APhA warns new language and anti-discriminatory rules may impact pharmacy

BY Michael Johnsen

WASHINGTON – Beginning July 18, pharmacies will be required to abide by rules that regulate discriminatory behavior and practices, such as refusing to provide adequate language assistance services to customers with limited English proficiency or refusing to dispense medications for gender transitions.

Infractions under the regulation, issued by the U.S. Department of Health and Human Services and its Office of Civil Rights, could result in civil lawsuits against pharmacies.  To help pharmacists adhere to the Nondiscrimination Regulation, the American Pharmacists Association has developed an overview of requirements and a more detailed summary that highlights key aspects of the rule and requirements relevant to pharmacists.

The rule, which implements Section 1557 of the Affordable Care Act’s prohibition on sex discrimination, requires health care entities receiving federal financial assistance, such as those that accept Medicaid and Medicare, to engage in practices designed to prevent discrimination on the basis of age, race, color, nationality or gender, including gender identity.

At the heart of the rule are requirements that pharmacies take reasonable steps to provide meaningful access to individuals with limited English proficiency or a disability, particularly the blind and deaf. Measures to address this include requiring pharmacies to display posters and notices informing patients that it will make available language assistance to patients who need it. HHS will make the notices available online, which will already be translated into several languages to ease costs and help health care entities comply.

In addition to providing free services and materials for people with limited English proficiency or disabilities, other steps that a health care entity has to comply with as part of its financial assistance application include proof that it is informing the public on how to obtain aids and services, contact methods for the employee responsible for compliance, the availability of a grievance procedure, and OCR’s contact information for discrimination complaints.
 

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Iroko names Louis Vollmer president, CEO

BY David Salazar
PHILADELPHIA — Iroko Pharmaceuticals on Monday announced that it had named Louis Vollmer to the positions of president and CEO at the company, effective July 6. He has been president of the company since March 2015 and succeeds Iroko founder Osagie Imasogie as CEO. 
 
Vollmer will oversee day-to-day operations and long-term planning for Iroko, with a focus on its SoluMatrix franchise brands. Osagie will stay on as chairman of Iroko’s board. 
 
"Lou is a seasoned and well-respected leader whose perspective and business acumen will be invaluable to Iroko as it evolves into a true leader in providing responsible pain management options to healthcare professionals and patients," Imasogie said. 
 
Vollmer began his more than 25-year career in the pharmaceutical industry at DuPont Merck, eventually becoming SVP sales and marketing for DuPont Multi Source Products. He was also one of three founding partners and management team leaders of Endo Pharmaceuticals. 
 
“I am honored to lead Iroko at this stage of the company's evolution," Vollmer said. “Iroko is in a strong position for growth within the United States and worldwide. I look forward to helping the company deliver significant value to patients and healthcare professionals and achieving strong and sustainable growth.”
 
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