FDA approves prescription hand held auto-injector designed for caregivers to treat opioid overdose
SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.
"Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety," stated Margaret Hamburg, FDA commissioner. "Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks."
It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.
Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.
“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” stated Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”
Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose. Family members or caregivers should also become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed.
Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.
Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.
Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. The FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.
Evzio is manufactured for Kaléo of Richmond, Va.
2014 Retail Clinician Education Congress to include Business Leadership Track
MINNEAPOLIS — As retail-based health clinics and the practitioners who work in them become an increasingly important players within the U.S. health care system, the industry is gearing up for the seventh annual Retail Clinician Education Congress in May, which will include the highly anticipated Business Leadership Track.
This year’s RCEC event will be held May 12 to 15 at the Hyatt Regency here in Minneapolis. The Drug Store News Group, in conjunction with the Convenient Care Association and Partners in Healthcare Education, hosts the three-day educational and networking forum.
“The Business Leadership Track on day two of the 2014 Retail Clinician Education Congress is designed to provide great insights on the major growth drivers affecting the retail health care industry and the access to the key leadership responsible for the strategic direction for this important patient care delivery model,” said Wayne Bennett, publisher of the Drug Store News Group.
The Business Leadership track includes the following sessions:
Healthcare Reform: Healthcare Exchanges and You: Health exchanges are organizations set up to facilitate the purchase of health insurance in every state in accordance with Patient Protection and Affordable Care Act. Marketplaces provide a set of government-regulated and standardized healthcare plans from which individuals may purchase health insurance eligible for federal subsidies. This panel will address the role of health exchanges, what they mean to different healthcare provider groups and how you can help your patients and consumers to navigate them.
Telehealth: Many retail clinic operators are utilizing different telehealth capabilities to enhance the quality and services for their patients. From services like health stations or pods to innovative point of care cloud-based testing tools, this session will explore the various ways that retail clinic operators are using telehealth technology to provide comprehensive, high-quality care to consumers.
Consumer Views on Clinic’s Roles: We heard last year from Harris Interactive and Athena health about what research revealed about retail clinics from the view points of the consumer and provider data. In this follow-up session, presenters will address how consumers view and utilize the retail clinics in light of the implementation of the PPACA and how retail clinics are proving to be an important player in healthcare reform thus far from a provider perspective.
Strategic Partnerships and the Building of the Business Model: Retail clinics continue to form strategic partnerships and clinical affiliations to enhance and expand the care provided in the clinics. This panel discussion will address the different types of partnerships that private and nonprofit clinic operators are forming to build upon the existing retail clinic business model. With panelists from hospital systems, private clinic organizations and consulting firms, attendees will get a better understanding of the benefits of these strategic partnerships, how the PPACA has helped shape the partnerships and what they look like from a clinical and business perspective.
CEO Panel: This discussion is designed to offer advanced practice clinicians and executive management an update on healthcare changes, challenges and opportunities that will be reflected in their clinical practice over the next few years. The session will: describe challenges and opportunities the convenient care industry is currently facing; evaluate the future needs of the populations served in retail clinics to achieve improved patient outcomes; define the changing role of providers in retail clinics from inception through the present; identify clinical requirements necessary to evolve the retail clinics; and explain how evolving clinical services and implementation of best practices in the retail clinic can improve access and quality of care available in the United States.
Confirmed participants for the track include —
Heidi Wold, VP operations, Walgreens
- Dave Skibinski, President/CEO, Snap MD
- Noel Obourn, SVP of sales, AmericanWell
- Tobias Barker, VP medical operations, MinuteClinic
- Cynthia Graff, CEO, Lindora
- Debra Richman, SVP, healthcare business development & strategy, Harris Interactive
- Stephen Lazzari, director, FastCare
- Ken Patric, CMO, The Little Clinic
- Web Golinkin, CEO, RediClinic
- Matthew Kollman, VP of quality and service integration; executive director, primary care practices, Memorial Physicians, PLLC
- Nancy Gagliano, CMO, MinuteClinic
- Brian Slusser, CEO, Optimized Care Network
- Joshua Tirado, senior group manager, Clinic, Target Corp.
- Mike Stoll, CEO, The Little Clinic
- Stephen Lazzari, director, FastCare
- Ken Patric, CMO, The Little Clinic
- Web Golinkin, CEO, RediClinic
- Matthew Kollman, VP of quality and service integration; executive director, primary care practices, Memorial Physicians, PLLC.
Click here for more information and to register for the event.
Walgreens divests majority interest in Take Care Employer Solutions
DEERFIELD, Ill. — Walgreens on Thursday announced that it has signed a definitive agreement with Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry, in which Water Street will acquire a majority interest in Take Care Employer Solutions. Take Care Employer Solutions is a Walgreens subsidiary that manages more than 360 worksite health centers nationwide.
Water Street also has signed an agreement to simultaneously invest in CHS Health Services, a provider of more than 130 worksite health centers. Water Street will merge Take Care Employer Solutions and CHS to form a new company dedicated to providing worksite health centers that improve the cost and quality of employee health care. The new company will have more than 85 years of combined experience in employer health solutions, and will serve more than 200 leading corporations through nearly 500 worksite health and wellness centers located across the country.
“Walgreens, CHS and Water Street share a goal of maximizing employers’ return on their healthcare investment,” said Jeffrey Kang, Walgreens SVP health and wellness services and solutions. “This strategic decision to bring together our organizations’ expertise, capabilities and resources to create a leading worksite health and wellness company provides us an opportunity to play an even greater role in improving the cost and quality of workforce health care. Through our continued involvement in the business and as a preferred strategic partner with Water Street, Walgreens expects to accelerate tighter connections with employers — an important stakeholder in the healthcare delivery system.”
“CHS and Take Care Employer Solutions are both deeply committed to finding new ways to drive positive health care outcomes for our clients and their employees," said Stuart Clark, CHS CEO. "This merger will provide us with a significant opportunity to transform onsite health care. Together, we will have the experience and resources to create innovative strategies that will improve patient engagement and positively impact health outcomes.”
Water Street will own a majority interest in the new company, and Walgreens will own a significant minority interest and have representatives on the new company’s board of directors. The new company will be led by Stuart Clark, CEO. Trent Riley, divisional VP Take Care Employer Solutions Group, will serve as COO. The name of the new company will be determined during the integration process.
Walgreens will continue to manage its existing worksite pharmacies in collaboration with the new company.
Healthcare Clinic at select Walgreens, with more than 400 in-store clinic locations that formerly operated under the Take Care Clinic name, is not part of this transaction. Walgreens will continue to manage these clinics.
Similarly, Comprehensive Health Services, an entity related to CHS that specializes in government contracting health services and logistics, is not part of this transaction. It will remain an independent organization with no changes to its ownership structure or leadership team.
Financial terms of the agreement were not disclosed. Walgreens anticipates the transaction will not have a material impact on earnings per share in fiscal year 2014.
The transaction is subject to satisfaction of regulatory requirements and other conditions, and is expected to close by mid-calendar year 2014. Until the close of the transaction, Take Care Employer Solutions and CHS will operate business as usual and as separate companies.