- Stop the Bleed program provides emergency training (businesspress.vegas)
Trauma surgeons at University Medical Center are spearheading an awareness campaign to train the public on how they can stop someone from bleeding to death if they get shot or stabbed...Called “Stop the Bleed,” it’s part of a national campaign launched by the White House in October 2015. The goal is for people to get trained to help in a bleeding emergency before EMTs arrive at the scene...Doctors credit concertgoers for saving many lives during the Oct. 1 mass shooting by applying pressure on wounds before the victims could get treatment...UMC is offering the program for businesses who want hospital staff to train their employees at their site, along with schools, athletic teams and other groups. There are also sessions where the public can come to UMC for training, he said...“This is for every single person to obtain this training, to the average soccer mom to any construction zone and anybody we already teach CPR,” Fraser (Dr. Douglas Fraser, UMC trauma surgeon) said. “This is a movement, so we’re not relying on 911 in mass incidents. Time is of the essence, and they may not have time to get there. Innocent bystanders can become health care providers in order to stop the bleed right in front of you.”...Kuhls (Dr. Deborah Kuhls, UMC trauma surgeon) said she and others will lobby the Nevada Legislature in the 2019 session to require companies, governments and others to place wall-mounted Stop the Bleed compression kits with special gauze and tourniquets wherever heart defibrillators are placed. Several states have proposed the kits in public facilities, she said.
- FDA Begins Adding Suffixes to Newly Approved Biologics’ Names (raps.org)
The US Food and Drug Administration this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015...The first additions of the meaningless suffixes came for...approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, and...approval of Ultragenyx Pharmaceutical's Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with a rare inherited condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome...The newly added suffixes were not preceded by an announcement from FDA, though the shift was not entirely unexpected...Back in January, FDA finalized guidance on how biosimilars and their biologic reference products' names should include this four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name...But until this week, only new biosimilars had the suffixes attached to their names. The agency did not respond to a request for comment on why new biologics' nonproprietary names included the suffixes this week.
- Fentanyl Billionaire John Kapoor To Plead Not Guilty In Opioid Kickback Case (forbes.com)
Fentanyl billionaire John Kapoor is set to plead not guilty this morning on charges of racketeering, mail fraud, wire fraud and conspiracy to violate the anti-kickback law...The founder and former CEO and chairman of ...Insys Therapeutics, Kapoor became a billionaire in 2013 because of the skyrocketing sales of that company’s Subsys, a form of the powerful opioid fentanyl that is sprayed under the tongue. He was arrested and charged on October 26 for allegedly leading a conspiracy to use fraud and bribes to market the drug and is set to appear in federal court in Boston...for his arraignment...Prosecutors...allege that Kapoor and six other executives...were arrested and charged...as part of a superseding indictment, offered bribes and kickbacks to doctors and nurses to get them to write large numbers of Subsys subscriptions to patients, most of whom did not have cancer.
- Pharmacy Week in Review: November 17, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- CVS may have a secret weapon against Amazon’s move into healthcare (CVS, AMZN) (markets.businessinsider.com)
CVS is reportedly in talks to buy Aetna in a deal that could help protect its business from the entry of the tech giant in to the healthcare space...CVS should focus on its vertical integration strategy, according to Morgan Stanley, and steer clear of gong head to head with Amazon in next day or same day delivery...Don't go head-to-head with Amazon...Goldwasser said that CVS' strength is its vertical integration. CVS has made a number of acquisitions over the past decade, such as Caremark RX, a pharmacy benefits manager, Omnicare, a leading pharmacy services provider and Target's pharmacy and retail clinic businesses. That push puts the company on a better footing to engage consumers, improve access to care, and deliver cost savings, he said.Goldwasser said however that any plans to go head-to-head with Amazon in next-day or same-day delivery service of prescriptions may impact the company's front-store sales. CVS already offers this service and plans to expand it to all of its locations in 2018.
- Ohio’s PDMP Gives Pharmacists Better Patient View (drugtopics.modernmedicine.com)
After a successful pilot program with Kroger’s pharmacies, Ohio’s prescription drug monitoring program is the first in the United States to offer advanced analytics for pharmacists and health care providers...The State of Ohio Board of Pharmacy is working with Appriss Health, provider of a comprehensive platform for substance use disorder, to enhance the state’s PDMP, known as Ohio Automated Rx Reporting System...The PDMP now provides NarxCare, an advanced analytics and patient support solution, to Ohio prescribers and pharmacists, in clinical workflow and via OARRS, to assist in clinical decision-making and promote patient safety. The analytics are available for free to Ohio healthcare providers and pharmacists accessing OARRS via electronic health records and pharmacy management systems...NarxCare...aggregates and analyzes prescription information from providers and pharmacies...then presents visual, interactive information — as well as advanced analytic insights, complex risk scores...The system also provides tools and resources that support patients’ needs and connects them to treatment, if necessary.
- Lab-Grown Mini Organs Could Speed Up Drug Discovery (forbes.com)
The thought of lab-grown organs conjures up Frankenstein-like imagery. The reality however, is somewhat less visually dramatic, with the term ‘organoids’ used to describe tiny 3D structures of human tissue, a millimeter or so in diameter...these tiny lumps of cells are creating a lot of excitement in the world of medical research...Cells in dishes and animal models have been used for preclinical testing of drugs for decades. Success in these experiments is a key hurdle for any new medicine to overcome before being given the green light for all-important human clinical trials...Organoids are most commonly made either from a small sample of tissue needled out of a person or from stem cells cultured in a cocktail of nutrients intent on pushing them towards becoming a particular tissue type. So far, organoids have been made resembling several tissues including lung, liver, brain, kidney and intestine...as a relatively new innovation they are being used to investigate dozens of conditions from infectious diseases to cancer.... A study published last year in Science Translational Medicine by scientists at the University Medical Centre, Utrecht generated organoids formed from the rectal tissue of 71 people with cystic fibrosis and exposed them to experimental drugs. By observing changes in the organoids, the scientists accurately predicted which patients would respond to the therapies in just one week at a cost of around $1200 per patient. The results were so convincing that a positive organoid test is now considered sufficient evidence for insurance companies to fund the new therapies in the Netherlands...
- Drug Companies Are Warming Up to the Idea of an Amazon Pharmacy (bloomberg.com)
The market is buzzing with speculation that Amazon.com Inc. will enter the pharmacy business. Some drugmakers are just fine with changes the tech retail giant might bring to the complex market...Drug companies say getting medicine into patients’ hands is too complicated and costly. Some have pointed to the multiple layers of middlemen -- including insurers, pharmacy benefit managers, distributors and pharmacies -- as one reason for distorted prices and high costs in the U.S...Amazon’s entry could bring more efficiency, Takeda Pharmaceutical Co. Chief Executive Officer Christophe Weber said during an interview in London. That could impact business in the U.S. or in other markets...“I am all in favor of a more effective distribution system,” Weber said, adding that in some countries the markup can be higher than the manufacturer’s own price. “For us it doesn’t matter so much where the point of sale is, as long as we reach the patient.”
- Europe’s drug industry waits for white smoke in Brussels (reuters.com)
It may be a cross between the Eurovision Song Contest, a papal conclave and a social club raffle but a ballot among EU ministers...could hurt Europe’s pharmaceutical industry and the health of millions...It will fix the new home of the European Medicines Agency, which must leave London by 2019 when Britain leaves the European Union; most of its 900 staff may refuse to move to many of the 19 cities in the running, the EMA warns. Replacing them would delay drug approvals and patient safety checks...Yet the result, diplomats agree, is utterly unpredictable; months of horse-trading on issues unrelated to healthcare will end up in hours of haggling between secret ballots in Brussels...It could even come down to drawing lots...Senior officials liken the process to Europe’s annual TV music schlock-fest, when the winner of the Eurovision Song Contest is often determined by viewers phoning in votes for acts from like-minded neighbouring states and historic allies...British bookmaker Ladbrokes has Milan the 2-1 favorite to secure the EMA...seasoned diplomats hesitate to quote odds: “The most likely result is one that will be perverse,” said one, recalling previous upsets behind closed doors...Another referred to closeted cardinals electing popes at the Vatican: “In the end,” he said, “We will get the white smoke.”
- This Week in Managed Care: November 17, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network