FDA approves Jardiance tabs
SILVER SPRING, Md. — The Food and Drug Administration announced approval for Jardiance (empagliflozin) tablets, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
The drug is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels, the agency stated.
"Jardiance provides an additional treatment option for the care of patients with type 2 diabetes," said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals.
QS/1 leads the way with EPCS security
SPARTANBURG, S.C. — QS/1 is implementing additional security measures to better validate electronic prescriptions for controlled substances, the company announced. QS/1 pharmacies already have access to the new Signature Indicator feature through the company's partnership with Surescripts.
“The Signature Indicator flag has been the most common signing approach by early adopters to EPCS,” said John Frady, QS/1’s market analyst for pharmacy products. “As more doctors and pharmacies use electronic means to prescribe controlled substances, there will be an increase in the use of the even more secure FBCA PKI standard.”
The new security standard is the Federal Bridge Certificate Authority Public Key Infrastructure digital signatures for EPCS transmissions. Surescripts uses this to transmit signatures to verify that they are valid. The network also allows bi-directional exchange of information between hospitals, physicians, payers, pharmacies, labs and more, the company said.
“While other pharmacy management system software providers may have taken an easier route for EPCS security,” Frady added. “QS/1 took the extra steps to use the FBCA PKI standard. When this becomes the preferred method of validation, QS/1 will not have to go through the process of recertification.”