Octapharma USA to reintroduce immune disorder drug
HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.
Octapharma USA said Octagam (immune globulin intravenous [human]) 5% would be available for distribution in a few weeks. The company voluntarily withdrew selected lots of the drug in August 2010 when a number of patients using it experienced thromboembolic events, or TEEs, in which blood clots form in arteries and veins, break loose and are then carried by the bloodstream to block another blood vessel. Octapharma USA said the FDA has observed that a number of similar drugs can cause similar problems due to a blood-clotting factor called activated factor XI.
The company said it worked with the FDA’s Center for Biologics Evaluation and Research to develop and validate a scientific means of measuring and minimizing the amount of activated factor XI during the manufacturing process and in the finished product in order to prevent TEEs in the future.
"We are extremely pleased that the FDA has authorized the market return of Octacam 5%," Octapharma USA president Flemming Nielsen said. "Our collaboration with the FDA over the last year has enhanced awareness of the industrywide concerns regarding procoagulant activity and TEEs."
Marsh offers Diabetes Care program
INDIANAPOLIS — Marsh Supermarkets is offering a new program for patients with diabetes, according to the Indianapolis-based chain’s website.
Under Marsh’s Diabetes Care program, patients who bring a new prescription to a Marsh supermarket pharmacy or transfer an existing one will receive up to a 30-day supply of qualifying generic diabetes medications for free, as well as free universal lancets.
The medications include glipizide, metformin, glimepiride and glyburide. The program is available through the end of May 2012.
Report: Walgreens places pharmacists in the aisles armed with iPads
CHICAGO — Walgreens may be on the verge of revolutionizing the role of the pharmacist — the pharmacy operator is placing iPads in the hands of "health guides" across 20 pilot stores in Chicago, the Chicago Sun-Times reported Thursday.
The Internet-armed pharmacist is one of the healthcare innovations Walgreens showcased at the TEDMED conference in San Diego last month. Features of those stores include a pharmacist desk area in front of the pharmacy counter to provide greater customer access to the pharmacist; private and semi-private consultation rooms; an open and redesigned layout with expanded fresh food and beauty products, with more accessible shelving and checkout lines; and such technology as Walgreens Web Pickup, which allows customers to order online and pick up at the store and touchscreen kiosks that allow patients to quickly refill prescriptions.
“The concept is meant to create a pharmacy and health care ‘help desk’ where customers get solutions or referrals for their personal health questions,” Colin Watts, Walgreens chief innovation officer, told the Chicago daily.
The report identifies the bigger picture behind the implementation of the health guides. Beyond offering a greater level of personalized service, these guides help crystallize the role of the pharmacist beyond adjudicating prescriptions by increasing potential patient-pharmacist consultations.
A Chicago-based company, M-Healthcoach, won a competition against 24 other companies nationwide to develop the apps for Walgreen’s health guide initiative.
For the full report, click here.