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NIH ANNOUNCES AVAILABLE END-OF-LIFE AND PALLIATIVE CARE GRANTS
The National Institutes of Health (NIH) will be awarding grants toward research on the perspectives, needs, wishes, and decision-making processes of adolescents and young adults aged 12–24 with serious, advanced illnesses. The grants will also be supporting research on end-of-life/palliative care models that support the physical, psychological, spiritual, and social needs of 12–24-year-olds with serious illness, their families, and caregivers. NIH will begin accepting submissions January 6, 2016, for exploratory/development grants to fund projects of up to 5 years whose budgets “reflect the actual needs of the proposed project.” On January 16, 2016, NIH will begin accepting submissions for two-year research project grants totaling $275,000. For the announcement of this funding opportunity, visit the following URL: http://grants.nih.gov/grants/guide/pa-files/PA-15-325.html.
FDA APPROVES ROLAPITANT FOR CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
On September 2, 2015, Tesaro, Inc., announced that the US Food and Drug Administration (FDA) approved rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Varubi is a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, with a plasma half-life of approximately 7 days. Results from three Phase 3 trials of VARUBI demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. A 180 mg dose of Varubi is to be administered approximately 1 to 2 hours prior to chemotherapy administration in combination with a serotonin type 3 (5-HT3) receptor antagonist and dexamethasone. No dosage adjustment is required for dexamethasone, a cytochrome P450 (CYP) 3A4 substrate, when administering Varubi.
“The approval of Varubi, our first product, represents a significant milestone in Tesaro's evolution into an integrated biopharmaceutical company with strong development and commercialization capabilities,” said Lonnie Moulder, CEO of Tesaro. “Results from the Phase three trials of Varubi demonstrated that patients receiving emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, benefitted from the addition of Varubi to their antiemetic regimen. Data from multiple well-controlled trials demonstrate that patients who receive only a 5-HT3 receptor antagonist and dexamethasone often continue to suffer from nausea and vomiting for several days following chemotherapy administration. Patient surveys and our primary market research also point to the high rate of CINV and its potentially debilitating effects. We look forward to expanding the awareness of CINV and working with healthcare providers to make this important medicine available to patients during the fourth quarter.”
“While important strides in preventing nausea and vomiting associated with chemotherapy have been made, still up to half of patients receiving emetogenic cancer chemotherapy can experience delayed CINV,” said Richard J. Gralla, MD, professor of medicine at Albert Einstein College of Medicine in New York. “Because NK-1 receptors are key drivers of CINV, especially in the delayed Phase, NK-1 receptor antagonists such as VARUBI, when combined with a 5-HT3 receptor antagonist and a corticosteroid, provide enhanced protection from CINV, and do so in the delayed timeframe where the most help is needed.”
Full prescribing information for VARUBI is available at: www.VarubiRx.com.
CAMBIA HEALTH FOUNDATION GRANTS $1.8 MILLION TO INCREASE PALLIATIVE CARE ACCESS
On September 2, 2015, the Cambia Health Foundation today named the 10 recipients of a 2-year, $180,000 grant through its annual, national Sojourns Scholar Leadership Program. The innovative program promotes palliative care workforce development by funding research, clinical, educational, or policy projects. In addition, national leaders will mentor the Sojourns Scholars, further broadening their learning and leadership development opportunities.
In palliative care, a team of doctors, nurses, and others provide an extra layer of support for people with serious illness. The goal is to improve quality of life for the patient, family, and/or caregiver. By advancing palliative care quality, awareness, and workforce development, Cambia Health Foundation furthers the Cambia Cause: serving as a catalyst to transform health care to be more person-focused.
The 2015 class of Sojourns Scholars spans the nation, representing Massachusetts, Missouri, New York, North Carolina, Oregon, Pennsylvania, Washington, and Washington, DC. Their projects will build on the groundbreaking work of the 2014 inaugural class to improve care for patients of all ages facing a variety of serious illnesses.
“Our first class of Sojourns Scholars in 2014 gave us confidence that the future of palliative care is in good hands,” said Peggy Maguire, president and board chair of Cambia Health Foundation. “Our excitement continues with this second cohort, given the remarkably talented group of individuals receiving the grant this year. Palliative care has gained traction as a vitally important practice area that could touch the lives of every one of us, either as patients or as caregivers.
Nearly two thirds of Americans have had a personal or family experience with palliative care, end-of-life care, or hospice care; however, only half of those respondents say that they were prepared for the experience. Cambia Health Foundation's work to develop palliative care leaders and workforce helps create the awareness and access to this specialty care.
“These grants are career-changing opportunities for exceptional physicians and nurses who are future leaders in palliative care,” said Dr. Anthony Back, co-director of the Cambia Palliative Care Center of Excellence at the University of Washington. “The Sojourns Scholar Leadership Program is creating the next generation of leaders who will shape innovations, policies, and systems to improve the quality of care for individuals living with serious illness and their families.”
For more information, see: http://www.cambia- healthfoundation.org.
FDA ADVISORS RECOMMEND AGAINST NEW TAMPER-RESISTANT OXYCODONE DOSAGE FORM
An advisory panel to the US Food and Drug Administration (FDA) voted on September 10, 2015, against approving Purdue Pharma's new oxycodone immediate-release, tamper-resistant dosage form over concerns of overdosing. The recommendation follows comments from the agency staff 2 days earlier on likely errors in administering the drug. The new drug, to be called Avridi on approval, was designed as an abuse-deterrent, fast-acting form of opioid painkiller oxycodone. The FDA panel voted 23 to 1 against the approval. Avridi is among the first few drugs to be evaluated by the FDA for the efficacy of such formulations’ abuse-deterrent properties. Avridi is designed to be taken every 4 to 6 hours on an empty stomach and the presence of food could cause inadequate pain control. Inadequate pain control could lead to patients taking more of the drug, the FDA staff had said.
HHS TO ADDRESS OPIOID-DRUG-RELATED OVERDOSE, DEATH, AND DEPENDENCE
US Health and Human Services (HSS) Secretary Sylvia M. Burwell has announced a targeted initiative aimed at reducing prescription opioid–and heroin-related overdose, death, and dependence. Deaths from drug overdose have risen steadily over the past two decades and currently outnumber deaths from car accidents in the United States. The President's FY (fiscal year) 2016 budget includes critical investments to intensify efforts to reduce opioid misuse and abuse, including $133 million in new funding to address this critical issue.
The Secretary's efforts focus on three priority areas that tackle the opioid crisis, significantly impacting those struggling with substance use disorders and helping save lives.
Providing training and educational resources, including updated prescriber guidelines, to assist health professionals in making informed prescribing decisions and address the overprescribing of opioids.
Increasing use of naloxone, as well as continuing to support the development and distribution of the life-saving drug, to help reduce the number of deaths associated with prescription opioid and heroin overdose.
Expanding the use of medication-assisted treatment (MAT), a comprehensive way to address the needs of individuals that combines the use of medication with counseling and behavioral therapies to treat substance use disorders.
Addressing the opioid crisis is a top priority for the department and the Secretary is committed to bipartisan solutions and evidence-informed interventions to turn the tide against opioid drug-related overdose and misuse.
“Opioid drug abuse is a devastating epidemic facing our nation. I have seen firsthand, in my home state of West Virginia, a state struggling with this very real crisis, the impact of opioid addiction. That's why I'm taking a targeted approach to tackling this issue focused on prevention, treatment and intervention,” said Secretary Burwell. “I also know we can't do this alone. We need all stakeholders to come together to fight the opioid epidemic.”
Prescription drugs, especially opioid analgesics—a class of prescription drugs used to treat both acute and chronic pain, such as hydrocodone, oxycodone, codeine, morphine, and methadone, have increasingly been implicated in drug overdose deaths over the last decade. Deaths related to heroin have also sharply increased since 2010, with a 39% increase between 2012 and 2013. Among drug overdose deaths in 2013, approximately 37% involved prescription opioids. Given these alarming trends, it is time for a sustainable response to prevent and treat opioid use disorders.
As part of these priority areas, the Secretary's efforts build on current HHS strategies to address the opioid epidemic and expand many of the most promising initiatives with the greatest potential for impact, including
Helping health professionals to make the most informed prescribing decisions:
Teaching medical professionals how and when to prescribe opioids by working with lawmakers on bipartisan legislation requiring specific training for safe opioid prescribing and establishing new opioid prescribing guidelines for chronic pain
Supporting data sharing for safe prescribing by facilitating prescription drug monitoring programs (PDMPs) and health information technology integration and further adoption of electronic prescribing practices
Increasing investments in state-level prevention interventions, including PDMPs, to track opioid prescribing and support appropriate pain management
Increasing use of naloxone:
Supporting the development, review, and approval of new naloxone products and delivery options
Promoting state use of Substance Abuse Block Grant funds to purchase naloxone
Implementing the Prescription Drug Overdose grant program for states to purchase naloxone and train first responders on its use
Expanding use of medication-assisted treatment (MAT):
Launching a grant program in FY 2015 to improve access to MAT services through education, training, and purchase of MAT medications for treatment of prescription opioid and heroin addiction
Exploring bipartisan policy changes to increase use of buprenorphine and develop the training to assist prescribing
Through bipartisan work across the federal government and with Capitol Hill, as well as strategic partnerships with states and private industry, Secretary Burwell will work to address the current opioid epidemic and reduce prescription opioid and heroin overdoses and deaths.
On March 6, the Centers for Disease Control and Prevention launched the Prescription Drug Overdose Prevention for States program (program description accessible at: http://www.grants.gov/view-opportunity.html?oppId = 274995) to provide state health departments with resources to enhance their PDMPs and advance innovative prevention efforts. This funding will support approximately 16 states in implementing robust prevention programs to improve safe prescribing practices and turn the tide on the prescription drug overdose epidemic. The application period is currently open to states. As part of her efforts to combat the opioid crisis as outlined above, Secretary Burwell included in the HHS 2016 budget a major expansion of this program so that this critical investment can reach all 50 states and Washington, DC.
The Food and Drug Administration also plays an integral role in combating opioid-drug-related abuse and misuse from its review of products to monitoring use after distribution. FDA will continue to use its expedited review authorities to encourage the development of nonopioid pain medications intended to treat chronic pain. FDA also supports the wider use of naloxone and is working to support the development of abuse-deterrent opioid products.
For more information on the Secretary's efforts and this initiative, see: http://aspe.hhs.gov/basic-report/opioid-abuse-us-and-hhs-actions-address-opioid-drug-related-overdoses-and-deaths.
UNITED KINGDOM NATIONAL FRAMEWORK FOR PALLIATIVE CARE ACTION
On September 8, 2015, the National Palliative and End of Life Care Partnership, made up of statutory bodies including National Health Service England, the Association of Adult Social Services, and charities including National Council for Palliative Care (NCPC) and groups representing patients and professionals announced the development of a framework for action in making palliative and end-of-life care a priority at local level. Ambitions for Palliative and End of Life Care: A national framework for local action 2015–2020, is aimed at local health and social care and community leaders. It builds on the Department of Health's 2008 Strategy for End of Life Care and responds to an increased emphasis on local decision-making in the delivery of palliative and end-of-life care services since the introduction of the Health and Social Care Act 2012. Since the publication of the strategy, good progress has been made in end-of-life care, but there is still much more that needs to be done. Research by Hospice UK and the National Council for Palliative Care, carried out last year, show that only around 4 in 10 (43%) Health and Wellbeing Boards in England include the needs of dying people in their key strategies that shape health and social care services
Yet over the next 25 years, the number of deaths will increase by around 100,000 more deaths each year. The UK is considered a world leader in end-of-life care, but a recent Ipsos MORI survey commissioned by Marie Curie found that carers say that 7 out of 10 people with a terminal illness in the UK do not get all the care and support they need. This national framework for action sets out six “ambitions”—principles for how care for those nearing death should be delivered at local level. These are (1) Each person is seen as an individual, (2) Each person gets fair access to care, (3) Maximizing comfort and well-being, (4) Care is coordinated, (5) All staff are prepared to care, and (6) Each community is prepared to help.