This roundup includes the following news briefs:
The FDA issued a drug safety communication(www.fda.gov) on March 9 cautioning that Chantix (varenicline), a prescription smoking cessation medication, can change how people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported.
The FDA recommends that health care professionals weigh the potential risk of seizures against the potential benefits of Chantix before prescribing it to patients with a history of seizures or other factors that can lower the seizure threshold. The agency also recommends that physicians advise patients to immediately stop taking Chantix if they develop agitation, hostility, aggressive behavior, depressed mood or changes in behavior, especially if they develop suicidal ideation or behavior.
The FDA has approved changes to the Chantix label to warn about these risks.
On March 9, the Department of Veterans Affairs (VA) announced in a news release(www.va.gov) that it is accelerating the deployment of a tool intended to help protect patients who use high doses of opioids or who have medical risk factors that confer an increased likelihood of developing complications from opioid medication use.
The tool, called the "Opioid Therapy Risk Report," is being made available now to all staff in the Veterans Health Administration. It includes information about appropriate dosages of narcotics and other sedative medications, significant medical problems that could contribute to an adverse reaction, and monitoring data to aid in management of complex patients.
"All of American medicine is aiming to better understand how to treat severe pain, and veterans receiving care in the VA health care system typically suffer from higher rates of chronic pain than the general public," said Carolyn Clancy, M.D., the VA's interim under secretary for health. "While opioid medications may be appropriate in some cases of chronic pain, we are dedicated to using them safely and providing effective pain care to our veterans. It is critical that we ensure systemwide implementation of the Opioid Therapy Risk Report in the weeks ahead."
Late last month, the World Health Organization (WHO) finalized its recommendations(www.who.int) regarding which influenza strains should be included in the vaccine for countries in the Northern Hemisphere during the 2015-16 flu season. WHO officials based their recommendations on observations of strains already circulating throughout the Southern Hemisphere.
On March 4, the FDA's Vaccines and Related Biological Products Advisory Committee voted to endorse the WHO's recommendations.
Specifically, the strains recommended for inclusion in trivalent vaccines to be used in the Northern Hemisphere during the 2015-16 season are
- an A/California/7/2009 (H1N1)pdm09-like virus
- an A/Switzerland/9715293/2013 (H3N2)-like virus
- a B/Phuket/3073/2013-like virus
In quadrivalent vaccines that contain two B viruses, the committee recommended that a B/Brisbane/60/2008-like virus be added to the three above.
It's worth noting that the H3N2 vaccine component for the 2015-16 flu season differs from that used in 2014-15, which proved far less effective than anticipated. Whereas the H3N2 vaccine component for the flu season now winding down was a A/Texas/50/2012-like virus, the A/Switzerland/9715293/2013 (H3N2)-like virus component chosen for the coming season's vaccine has already been shown to protect against viruses circulating and predominant in China, other parts of Asia and Africa.
In January, HHS set goals of moving 30 percent of Medicare fee-for-service payments to alternative payment models such as patient-centered medical homes or accountable care organizations by 2016 and 50 percent by 2018. Overall, the agency hopes to tie 85 percent of all Medicare payments to quality or value by 2016 and 90 percent by 2018.
To help achieve these goals, HHS recently launched the Health Care Payment Learning and Action Network.(www.cms.gov) The agency is looking for partners from across the private, public and nonprofit sectors, including physicians and physician organizations, payers, states, consumer groups, individuals, and all other interested entities, to join the effort to increase adoption(innovation.cms.gov) of value-based payments and alternative payment models.
Most meetings will be held by teleconference or as webinars; in-person meetings will be scheduled in the Washington, D.C., area. Register today(innovationgov.force.com) to join the network. The launch is set for March 25 and will be covered via live streaming video.
The Harvard Medical School Center for Primary Care(primarycare.hms.harvard.edu) in Boston recently announced the first class of fellows to participate in a new initiative dubbed InciteHealth.
According to a press release,(primarycare.hms.harvard.edu) participants will "invent the future of health care" by working in multidisciplinary teams with patients, industry experts and mentors to generate new approaches to improving primary care and patient health. Teams will develop and test novel solutions and vie for as much as $25,000 in funding from the center to put their concepts into action.
The 21 fellows(primarycare.hms.harvard.edu) come to the project from varied backgrounds and will serve one-year fellowship terms on a part-time basis.