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Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Ned Milenkovich, PharmD, JD, PTNN. , Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Kelly Davio, welcome to This Week in Managed Care from the Managed Markets News Network

MIT researchers, working with scientists from Brigham and Women’s Hospital, have developed a new way to power and communicate with devices implanted deep within the human body. Such devices could be used to deliver drugs, monitor conditions inside the body, or treat disease by stimulating the brain with electricity or light...The implants are powered by radio frequency waves, which can safely pass through human tissues...in animals, the researchers showed that the waves can power devices located 10 centimeters deep in tissue, from a distance of 1 meter...Even though these tiny implantable devices have no batteries, we can now communicate with them from a distance outside the body. This opens up entirely new types of medical applications...An overarching aspiration is that regulators will provide input to the design and may incorporate framework elements and learnings into regulatory programs. .

Online black-market sales of opioid painkillers more than doubled in the United States during the two years after these drugs were “rescheduled,” putting tighter restrictions on legal prescriptions and sales, according to a recent study...In October 2014, hydrocodone combination products...were reclassified from...schedule III to schedule II, imposing stricter controls on prescriptions written by doctors and on patients’ ability to refill them...Almost immediately, the proportion of all drugs illicitly purchased in the U.S. from sellers on the “dark net” that were in the opioid category began rising, reaching 13.7 percent in 2016. Stronger, more dangerous opioids also gained in popularity in these so-called cryptomarkets...cutting off supply leads to people sourcing their drugs from illegal and uncontrolled sources, and they buy products of higher strength - with all the dangers that this type of supply carries...A better approach would be harm reduction, therapeutic intervention, reliable treatment options, dealing with over-prescription early on, and providing information on the danger of opioid use to reduce stigmas...policy measures like up-scheduling, an introduction of abuse-deterrent formulations, prescribing limits, and prosecuting health care providers created a powerful push that precipitated the changes in the overdose dynamics we are contending with today...

The Food and Drug Administration has published a statement from its commissioner Scott Gottlieb proposing a new reimbursement model for antibiotics and antimicrobials, which it believes will help achieve associated public health goals and overcome investment challenges...The FDA’s idea is that instead of hospitals being reimbursed for antimicrobials on a per-use, which it claims is hindering research and development in the field, they will be reimbursed for licences for certain antimicrobials drugs that target multi-drug resistant infections...The FDA believes this model will help to achieve public health goals because it would ‘create a natural market for drugs that meet certain public health criteria, by providing a predictable return on investment and revenue stream through more foreseeable licensing fees’ and ‘it would put the institutions fully in charge of stewardship of these important medicines. Once they purchase the ability to access a drug, they would be stewards of its use up to a certain number of annual doses’...the proposal would address investment challenges faced by producers of antimicrobials that target multi-drug resistant organisms because it may offer a ‘pull incentive’ that can create a predictable market for antimicrobials with a narrow set of public health applications. In addition, it could disconnect return on investment on these drugs from the volume of the drug that is used...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Dr. Shannon Orsak has been practicing emergency-room medicine in the state of Texas since the late ’90s. In February 2007, he opened the first free-standing emergency room in the state. “My brother and I went to the state and legislated so the politicians would pass a law so we could get a license and with that it opened up a groundwork where other people could go and start their own,” Orsak says...The next goal for Orsak and his partners was to bring his business model to Las Vegas, but make it Vegas-sized...Elite Medical Center is now open within walking distance of the Strip, and will offer emergency medical care with a concierge-type level of service...We’re an acute-care hospital. But most likely our patients are going to be in the emergency and then be discharged. We don’t expect that many admissions. We’re going to be taking care of people on the Strip...We are a full-service hospital so: X-rays, CAT-scans, full-service lab, full-service pharmacy, 20 in-patient beds, 20 ER beds. It’ll look like a hotel and a suite at Caesars. All our staff has the same philosophy—going that extra mile...

Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies...scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs...The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to only one of the ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) and not the other (just excising DNA), he said, “it’s something we need to pay attention to...We need to do the work and make sure edited cells returned to patients don’t become cancerous.”...Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called p53, which either mends the DNA break or makes the cell self-destruct...The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism...The reason why that could be a problem is that p53 dysfunction can cause cancer...P53 mutations are responsible for nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers...