Grifols’ Gamastan formulation gets FDA approval for HAV, measles
Grifols, a leading global producer of plasma-derived medicines, has received the green light from the Food and Drug Administration for a new formulation of its Gamastan immune globulin (human) for hepatitis A virus (HAV) and measles postexposure prophylaxis.
Gamastan, which is available in 10 mL and 2 mL vials, is manufactured using a sophisticated caprylate chromatography process, according to the highest quality and safety standards, and includes labeling for capacity to remove prions, the company said.
Gamastan is the only immune globulin product on the U.S. market approved for immediate protection against HAV and measles. The FDA approval is an important research and development milestone for Grifols as a global leader in postexposure prophylaxis — the treatment of a person after exposure to a virus — and immune globulin products for patients, according to the company.
“Vaccination, while a valuable option for hepatitis A and measles postexposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses,” MidState Medical Center infectious disease specialist Stephen Scholand said. “Immune globulins such as Gamastan have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection.”
The Centers for Disease Control and Prevention states that for persons age 40 years old and older, an immune globulin is preferred for HAV postexposure prophylaxis. The CDC also recommends that immune globulin should be used for children aged less than 12 months, immunocompromised persons, persons with chronic liver disease and persons who are allergic to the vaccine or a vaccine component. When administered within two weeks after exposure to HAV, immune globulin is 80% to 90% effective in preventing hepatitis A infection, according to the CDC.
Gamastan also is approved for rubella and varicella postexposure prophylaxis.
“As a company driven by innovation, we strive to provide the highest-quality products possible to our patients” Grifols North America sales and commercial operations president Bill Zabel said in a statement. “This advancement in the Gamastan formulation marks an important milestone in Grifols’ ongoing R&D efforts, and we are confident that it will continue to be an important treatment option for healthcare providers.”
NACDS celebrates successful 2018 TSE by announcing 2019 plans
After closing out 2018 Total Store Expo in Denver at the end of August, the National Association of Chain Drug Stores is celebrating the success of the meeting, while gearing up for 2019.
Numerous educational sessions, influential speakers and unlimited networking opportunities were just a few of this year’s TSE’s highlights. Among the strategic business meetings that took place, and one of TSE’s biggest attractions was “Meet the Market,” a special program designed to introduce the latest innovative products, technology and services to the retail audience. Participating exhibitors presented their company and products to retailers through a series of 10-minute appointments.
Attendees also discovered the latest products and services from innovative suppliers of consumer goods, pharmacy, supply chain and logistics technology during a full one-day floor exhibition.
NACDS is already going full steam ahead with its plans for 2019 TSE, slated to be held in Boston from Aug. 24 to 26, 2019.
AAP, FDS partner to boost pharmacy members’ profitability
The American Associated Pharmacies and FDS, a pharmacy-centric healthcare technology company, are partnering to bring AAP members ProfitAmp, a groundbreaking business analytics tool to improve their pharmacies’ performance and profitability.
ProfitAmp provides powerful business intelligence and a unique level of detail that cannot be obtained with other BI tools on the market, according to the company.
“FDS is committed to helping pharmacies improve efficiency while positively impacting their bottom line, a mission that aligns well with AAP’s goal of providing member pharmacies with tools to enhance profitability, streamline operations and improve care quality,” AAP’s vice president of preferred partners Tracie Heyrman said. “Partnering with FDS to bring our members impactful BI solutions from an industry-leading technology company was a natural pairing, one we expect will deliver significant value and rapid ROI, while improving patient outcomes and strengthening the pharmacy-patient relationship.”
Available exclusively to AAP members, ProfitAmp delivers a deeper look into pharmacy operations, including an analysis of dispensing data through the Pharmacy Management System to identify key dispensing trends, lost patients and income opportunities. It also enables AAP to design organizational strategies around the health of its community to improve member pharmacies’ revenues and profits based on aggregate membership performance.
“The goal of this partnership is to continue providing AAP members with the solutions they needed to excel in today’s pharmacy marketplace. Our business intelligence and analytics tools leverage data from their existing pharmacy systems to drive financial, clinical and operational growth, and improve patient outcomes,” FDS executive vice president of business development Rich Bukovinsky said. “We take pride in the continued confidence and trust that AAP has placed in FDS’ products and services, and look forward to delivering true value to its member pharmacies.”