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NABP advises pharmacies not to dispense combination drugs with more than 325 mg of APAP per dose

BY Michael Johnsen

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.  

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

The Food and Drug Administration is withdrawing approval of 108 abbreviated new drug applications for prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit. For the 108 ANDAs, the manufacturers asked to withdraw their applications, as announced in the March 27, 2014 Federal Register notice. A second Federal Register notice addresses the applications of six manufacturers who have discontinued marketing their products, but who have not withdrawn their applications. 

The notice also announces FDA’s intention to begin the process of withdrawing approval of those applications.

FDA asked manufacturers to voluntarily withdraw these products from the market to reduce the risk of severe liver injury from inadvertent acetaminophen overdose. In January 2014, FDA recommended that providers consider prescribing acetaminophen products containing 325 mg or less per dose.

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A.Bauer says:
May-02-2014 10:59 am

Quoting an FDA report, acetaminophen's narrow safety margin places a large fraction of users close to a toxic dose in the ordinary course of use. Taken over several days, as little as 25 percent above the maximum daily dose – or just two additional extra strength pills a day – has been reported to cause liver damage, according to the agency. http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed

A.Bauer says:
May-02-2014 10:57 am

The list of risks for acetaminophen is long and growing. The most serious concerns are two new studies which show adverse neurodevelopment in children whose mothers used acetaminophen while they were pregnant. The study in 3 year olds (Brandlistuen et al. 2013) found a 70% increased risk of motor and behavioral problems and double the risk of communication problems (autism phenotypes). The study in 7 year olds (Liew et al. 2014) found increased risk of ADHD behaviors and Hyperkinetic Disorders. This is in addition to close to 30 studies finding an association to asthma and allergic disorders, 4 studies finding an association to male congenital malformations (cryptorchidism) and additional studies finding associations to skin disorders and mind numbing (relief of existential dread).

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FDA approves prescription hand held auto-injector designed for caregivers to treat opioid overdose

BY Michael Johnsen

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.

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2014 Retail Clinician Education Congress to include Business Leadership Track

BY Antoinette Alexander

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 —

Healthcare Reform:


Heidi Wold, VP operations, Walgreens 


Telehealth:

  • Dave Skibinski, President/CEO, Snap MD
  • 
Noel Obourn, SVP of sales, AmericanWell

  • Tobias Barker, VP medical operations, MinuteClinic

  • Cynthia Graff, CEO, Lindora
 


Research:


  • Debra Richman, SVP, healthcare business development & strategy, Harris Interactive
  • athenahealth


Strategic Partnerships:

  • 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
 


CEO Panel:

  • 
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.

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