FDA approves Northera
SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.
NOH is a rare, chronic drop in blood pressure upon standing that’s associated with Parkinson’s disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH, and we are committed to helping make safe and effective treatments available.”
Northera received orphan-product designation from the FDA; it is made by Charlotte-based Chelsea Therapeutics.
Diplomat Pharmacy contributes to expansion of N.E.W. Life Center facility
FLINT, Mich. — The N.E.W. Life Center, a Flint-based ministry supported by Diplomat Pharmacy, on Tuesday expanded its facility, the specialty retailer announced.
The community program is based out of the former St. Luke’s Catholic Church on Lawndale Avenue. N.E.W. Life Center founded N.E.W. Life Enterprises, a business that produces scrubs and hospital gowns for use in medical facilities along with other sewn items. The renovation and expansion will house work stations for the seamstresses.
St. Luke’s is located in Flint’s Civic Park neighborhood, which is protected by state and federal restrictions as a historic area. Plans to build a new facility have been put on hold as Diplomat works with the city and state to determine if new construction can be permitted. With current demand for products from N.E.W. Life Enterprises resulting in a two-month backlog of orders, additional delays would have been problematic. Diplomat stepped in to fund the $10,000 project to renovate the facility’s 4,000 square foot gymnasium into useable workspace. Sixty work stations have been built along with new light fixtures, electrical wiring and ceiling fans.
The final stages of the renovation and moving process were completed Saturday, Feb. 15, by teams of volunteers from Diplomat and Siwek Construction.
Currently N.E.W. Life Enterprises employs 26 women in full-time positions. The additional space will allow the business to add 20 new jobs and increase work capacity. “Diplomat’s goal is to support the Sisters and NEW Life Enterprises,” stated Phil Hagerman, Diplomat CEO.
Number of BPS board certified pharmacists up 21%
WASHINGTON — The results of the 2013 BPS specialty certification and recertification exams were announced Tuesday by the Board of Pharmacy Specialties, the post-licensure certification organization serving the pharmacy profession.
A total of 3,247 pharmacists passed the exams in the six specialties currently offered by BPS: ambulatory care pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, psychiatric pharmacy and pharmacotherapy. There are now 19,109 BPS board certified pharmacists, which represents an increase of almost 21% from 2012.
"BPS is very pleased with the number of pharmacists who pursued BPS board certification or recertification in 2013,” stated BPS executive director William Ellis. “With intensifying challenges in the delivery of healthcare, coupled with the complexity of medication regimens, the demand for pharmacists who are BPS board certified continues to grow exponentially.”
To meet that demand, starting in 2014 pharmacists will have the opportunity to take the BPS certification and recertification exams in the spring and fall, rather than only once a year. Ellis said that BPS also plans to double the number of specialties over the next four years, including critical care pharmacy and pediatric pharmacy which were recently approved; pharmacists will be able to sit for the certification exams for these two new specialties in the fall of 2015.
“Depending on their specialty, BPS board certified pharmacists assist in designing or modifying existing medication regimens; monitor for and prevent adverse medication reactions; customize medication regimens for patients taking multiple medications; and recommend the most effective treatments,” Ellis said.