Myalept gets FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, which is a condition associated with a lack of fat tissue.
Patients with cogenital generalized lipodystrophy are born with little or no fat tissue, and those patients with acquired generalized lipodystrophy will generally lose fat tissue over time. Patients with both types are prone to develop severe insulin resistance at a young age, which may lead to diabetes that is difficult to manage or very high levels of triglycerides in the blood (hypertriglyceridemia) that may lead to inflammation of the pancreas.
“Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalized lipodystrophy and provides a needed treatment option for patients with this orphan disease,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy program due to the risks associated with the development of neutralizing antibodies and lymphoma. Under the REMS program, prescribers must be certified with the program by enrolling in and completing training. Pharmacies must also be certified with REMS and only dispense the drug after receipt of the Myalept REMS Prescription Authorization Form for each new prescription.
SpartanNash to launch pharmacy app this summer
GRAND RAPIDS, Mich. — SpartanNash on Tuesday announced the formation of a partnership to offer a comprehensive mobile and web pharmacy solution to SpartanNash customers. The mobile solution, powered by mscripts, will enable SpartanNash customers to refill prescriptions, receive pickup and dosage reminders, and manage accounts for their family members.
SpartanNash operates 88 pharmacies in six states throughout the upper Midwest.
“We are thrilled to provide a solution to help our customers manage their medications conveniently,” stated Larry Pierce, VP of center store merchandising at SpartanNash. “This helps our customers, particularly those who have complex medication regimes, stay on top of their health. They can refill through text or in the app, no matter where they are. They can set reminders to take their medications without having to enter all the prescription information first. They can see a list of all their scripts any time.”
“SpartanNash really understands the role mobile can play in forging close ties to their local community,” added Mark Cullen, CEO of mscripts. “This allows SpartanNash pharmacy customers to see and manage their prescriptions, either on the phone or through the website, making it easy to fill and take their medications on schedule and as prescribed.”
The new app will be available to SpartanNash customers in early summer 2014 as a free download through Apple iTunes and the Android Market. The application will operate on a secure network and integrated with McKesson’s EnterpriseRx pharmacy management system, enabling SpartanNash to offer a variety of digital communication pathways to its customers.
DEA’s Atlanta division establishes prescription drug texting tip line
ATLANTA — The Drug Enforcement Administration’s Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public.
The TIP411 web-based initiative is the first-ever federally administered prescription drug abuse tip line of its kind in the state, the DEA noted. The TIP411 service allows for the public to quickly, easily and anonymously report prescription drug abuse by texting TIP411 or 847-411 then using the keyword PILLTIP. The tips will be forwarded directly to a DEA agent, who will then act upon the information.
"This method of communication is a great opportunity for the public to anonymously engage in the fight against state-wide prescription drug abuse while keeping up with today’s technology," said Harry Sommers, Special Agent in Charge of the DEA AFD. "The illegal prescription drug market and relative ease of which pharmaceutical substances can be obtained has resulted in a sharp increase in prescription drug abuse throughout Georgia. DEA and its federal, state and local partners are fully committed to combating this growing issue."
When the TIP411 program becomes active, the DEA AFD will simultaneously send prescription drug abuse educational packets to 1,200 pharmacies located throughout the Atlanta metropolitan area. The packets will contain a refrigerator magnet which displays, "Report RX Fraud Anonymously," a Pharmacist’s Guide to Prescription Fraud, a Prescription Drug Intelligence Alert from SAC Sommers and a TIP411 advertisement brochure.