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FDA Approves First Pill with Digital Ingestion Tracking System

November 14, 2017
by Heather Landi
| Reprints

The U.S. Food and Drug Administration (FDA) has approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal, according to the FDA.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

About 1 percent of Americans have schizophrenia, a chronic, severe and disabling brain disorder. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

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Geisinger, Merck Co-Develop Patient Communication and Care Delivery Applications

August 17, 2018
by Rajiv Leventhal
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Geisinger Health System and global biopharmaceutical company Merck have collaborated on two new mobile applications that will aim to help patient-provider communication and medication adherence.

According to officials in an announcement this week, the first of the two solutions, the Family Caregiver Application, helps two-way communications and coordination of care for patients and their caregivers. The other workflow solution, the MedTrue application, integrates different medication data sources to assist with medication reconciliation and adherence, resulting in a patient- and healthcare team-verified medication list. 

The applications, which were developed through an ongoing collaboration between Geisinger and Merck, are embedded directly within the electronic medical record (EMR) and in the healthcare provider's workflow. The applications are also accessible to patients and the Family Caregiver Application is accessible to family caregivers. Both workflow solutions can be used remotely.

What’s more, the applications will use SMART on FHIR (Substitutable Medical Applications, Reusable Technologies/Fast Healthcare Interoperability Resources) technology, an open, standards-based platform for utilizing data from disparate EMRs, so both products can be used in healthcare systems anywhere, officials said.

The Family Caregiver application was developed and piloted in oncology, and is designed to be translated to other therapeutic areas to enhance coordination of family caregiving activities among medical and caregiving teams. Meanwhile, officials noted, the driver behind the MedTrue application was the health system’s research which found that about 70 percent of its medication lists were inaccurate.

"Providing these tools for patients and family caregivers — tested within our own system — enables patients to be more active in healthcare decisions and could increase the likelihood that patients will adhere to their treatment plans and lead healthier lives,” said David H. Ledbetter, Ph.D., Geisinger executive vice president and chief scientific officer.

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Fitbit, Blue Cross Blue Shield Launch Mobile Health Partnership

August 13, 2018
by Heather Landi
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San Francisco-based fitness wearable maker Fitbit continues its push into the health plan market with a new digital health deal to incorporate its fitness tracker into health and wellness programs.

Blue Cross Blue Shield Association announced a partnership with Fitbit to include the company’s wearables and fitness trackers in its Blue365 health and wellness program for Blue Cross and Blue Shield (BCBS) members.

Through this program, more than 60 million BCBS members in 23 affiliated health plans to have access to a special offer on Fitbit activity trackers and smartwatches. The deal with BCBSA follows similar partnerships with Humana and UnitedHealthcare.

As part of a commitment to providing consumers with affordable health and wellness products, the Blue365 program also partners with employers to help build a culture of health in the workplace. Employers can either buy in bulk or subsidize a purchase of Fitbit devices for their employees.

“There is no question that increasing activity and moving more is a tremendous benefit that can improve health, and I'm excited Blue365 members will have even more incentives to get and remain healthy by exercising at a pace that's right for them,” Mark Talluto, vice president of strategy and analytics for Blue Cross Blue Shield Association (BCBSA), said in a statement. “This strategic partnership will bring personalized health and wellbeing to the next level, allowing members to put their health first.”

"Fitbit provides a powerful platform to engage consumers by offering data, insights and guidance to help them meet their health goals," Adam Pellegrini, general manager of Fitbit Health Solutions, said. "This partnership is an example of how Fitbit is expanding access to our devices and software so that we can help more people focus on their health and wellness and achieve better health outcomes."

Blue365 is available to members of the 23 participating BCBS companies, as well as the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program® (FEP®).

 

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