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The Institute for Safe Medication Practices has been awarded a contract from the FDA to assess medication safety practices in the perioperative setting from the time patients are prepared for a procedure until they are discharged home...Due to the complexity and fast-paced setting of perioperative care procedures, ISMP’s Medication Safety Self-Assessment for Perioperative Settings will provide facilities with a way to examine their medication safety practices, identify opportunities for improvement, and compare their experiences over time with the aggregate experience of demographically similar organizations...READ MORE

A little more than a week ago, a who’s-who of Nevada leaders — the governor, attorney general, state superintendent and health officials from across the state — packed a government building lobby in downtown Las Vegas...They came to display a unified front as Nevada braced for what seemed inevitable: a coronavirus case within the Silver State’s borders. Gov. Steve Sisolak even demonstrated the proper technique for coughing or sneezing into an elbow...“We’re going to prepare, not panic,” he said...Five days later, on Wednesday, Nevada’s first patient tested presumptively positive for COVID-19. Then came a second case in Reno the following day, and the third and fourth cases in Southern and Northern Nevada on Sunday...READ MORE

A suppository maker that has been a problem for the FDA in the past is at it again. An inspection of its New Jersey manufacturing facility found its equipment was “filthy” and some of it held together with tape and plastic wrap...On top of that, the warning letter for Acino Products, an over-the-counter maker of suppositories and topical solutions, said it could not come up with documents for microbiological testing...While the company pledged to make fixes and improvements, the FDA said it was not nearly enough...READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network

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.

When an inspection of Cipla’s sterile injectable plant in Goa, India, went badly last fall, it appeared pretty certain a warning letter would follow. The inspection report, after all, went on for 38 pages, detailing equipment layered in residue and bacterial contamination. The bad news has now arrived...The Indian drugmaker confirmed in a filing...that it had received a warning letter for the September inspection of the sterile products plant in Vasco Da Gama in Goa state. It said it “will work closely with the agency to comprehensively address all the observations” but didn't mention there were a dozen of them, many targeting shoddy cleaning methods and microbial contamination...READ MORE

Chain pharmacies and US government agencies are doing everything they can to mitigate shortages of facemasks, hand sanitizers, and other products as consumers rush to purchase supplies due to coronavirus...fears..."The extreme demand in some areas certainly is affecting supplies," Chris Krese, spokesperson for NACDS, told Drug Topics®...Meanwhile, the FDA announced the first drug shortage due to COVID-19, but declined to list the drug in shortage...This information is considered proprietary...hand sanitizers and facemasks have been virtually stripped from store shelves, and that Amazon, Walmart, and other retailers’ web sites are running out of affordable hand sanitizers..."Due to high demand and to support all customers, we will be limiting the number of sanitization, cold and flu-related products to 5 each per order," Kroger said on its website...READ MORE

Trump ordered travel from Europe to the United States restricted for 30 days, responding to mounting pressure to take action against a rapidly spreading coronavirus outbreak disrupting nearly all corners of U.S. daily life...“We are marshaling the full power of the federal government and the private sector to protect the American people,” Trump said in a prime-time televised address from the Oval Office on Wednesday...READ MORE

Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend a Roche arthritis drug to tackle that rampage...Roche’s blockbuster Actemra, first approved by the U.S. FDA in 2010 for rheumatoid arthritis, can now be used to treat serious coronavirus patients with lung damage, China’s National Health Commission said in its updated treatment guidelines for COVID-19...READ MORE

FDA Commissioner Stephen Hahn offered more details of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak...While FDA inspections are suspended in China, the agency may ask firms for facility records ahead of or instead of inspections, allowing the agency to review records ahead of time and identify plants that most warrant an inspection...“These records will help the agency when we resume drug inspections in China,” allowing it to focus early inspections and help prevent an inspection backlog, he said...READ MORE