Sandoz launches generic contraceptives
PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.
Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson’s Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.
"We are pleased to add two more products to our portfolio of oral contraceptives," Sandoz president Don DeGolyer said. "Sandoz is committed to helping meet the needs of women in the U.S. by providing cost-saving, high-quality options for women’s healthcare."
Ortho Cyclen and Ortho Tri-Cyclen had sales of $116 million and $240 million, respectively, during the 12-month period that ended in January 2013.
Pharmacy interoperability and emerging care models: Conversations from HIMSS13
In early March, more than 30,000 healthcare industry participants swarmed upon New Orleans for the annual HIMSS conference. In the words of keynote speaker James Carville, this is the Super Bowl of conventions. Most attendees arrived on Sunday to discover a water outage warning. Even when the water pressure returned to normal, the message was clear — do not drink it! On Monday morning, there was not a latte to be found in the entire city. We were roughing it…
It was hard to believe the HIMSS13 crowd was under-caffeinated as endless educational sessions and top notch exhibit presentations proved to be very high energy. One major theme resonating across the show floor was the importance of interoperability within healthcare ecosystems. And in the pharmacy space, interoperability has been centered on advances in e-prescribing and clinical messaging.
Statistics substantiate that federal regulations surrounding the HITECH Act and Meaningful Use have been market drivers with an aggressive impact on both pharmacy and physician implementation of ePrescribing over the past five years. And logically so. Not only does e-prescribing save time while offering incentive dollars for meeting federal requirements for Meaningful Use, but it also can have a positive impact on patient safety and satisfaction. With a myriad of options for integrating an e-prescribing system into the workflow, that adoption will likely continue to rapidly increase. Regardless of whether that workflow comes from a standalone system, fully implemented electronic health record or a practice management system, submitters can benefit from more direct connectivity with the pharmacy when it comes to clinical information exchange that can now be expanded to include not only e-prescriptions but other valuable data that can help impact better health outcomes for patients.
Along these lines of clinical messaging and interoperability, many conversations at HIMSS focused on emerging healthcare models such as accountable care organizations (ACOs) and their promise to elevate quality and lower costs by harnessing the power of provider, payer and patient collaboration. Pharmacists can play an essential role in delivering efficient and effective coordinated care as well. Highly trained pharmacists can likewise coordinate patient care with providers by playing a role in reconciling medications, one of the most important activities healthcare professionals can undertake to help prevent hospital readmissions. Pharmacists today are teaming with healthcare information service providers to reconcile medications using claims-based continuity of care documents (CCDs), which include information about an individual’s medication profile, laboratory and radiology results, as well as discharge summaries.
But pharmacies still must overcome operational and technical challenges before they can ubiquitously share patient information with the broader clinical community. For one, they will need to forge new risk- and savings-sharing partnerships with insurers, physician practices, hospitals and integrated delivery networks (IDNs). And they require an interoperability platform and the related HIE connectivity that will enable them to exchange patient data within and across diverse information systems. But with this capability, pharmacies will be well-positioned to increase care quality while potentially lowering healthcare costs in the ACO environment.
Healthcare is changing. We all know that. Now is the time for pharmacies to actively participate in this evolution, to discover new ways to contribute to patient care. Some have already begun with immunizations and in-store clinics. Additionally, some pharmacies are offering lab services as well as disease management counseling. This is just the beginning of what pharmacies can offer. I, for one, am grateful to be a part of this evolution and certainly look forward to HIMSS14 and the even larger part the pharmacy community will continue to play in health care.
Emdeon senior director of clinical services
Lathe Bigler serves as Emdeon’s senior director of clinical services for the pharmacy services division. His focus on developing layers of competitive advantage and increasing market growth are instrumental in Emdeon’s advancement in the exchange of electronic prescriptions and other clinical information. Lathe has more than 15 years experience in healthcare and information technology fields and has held roles in marketing, product management, business development and industry relations with corporations such as NDC Health, Midmark Diagnostics, DrFirst and AltaPoint Data Systems. Lathe has a bachelor’s degree in marketing and business administration.
FDA picks acting director for Office of Generic Drugs
SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.
In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.
"Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position," Woodcock wrote. "In her fifteen years with [the] FDA, Dr. Uhl has become widely-regarded both inside and outside of the agency as a compassionate, committed, and dedicated leader. Because of her strong management skills and extensive expertise in clinical pharmacology, I am confident in her abilities to lead OGD during a time of transition as we work to evolve quality throughout the Center and implement the Generic Drug User Fee Amendments of 2012."
The agency has started a nationwide search to find a new director to replace Geba, Woodcock wrote.