- This Week in Managed Care: August 3, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Mount Sinai’s medical school opens blockchain research center (medcitynews.com)
...blockchain technology has moved from cryptocurrency to other fields…The Icahn School of Medicine at Mount Sinai and the Institute for Next Generation Healthcare opened the Center for Biomedical Blockchain Research...with the aim of developing partnerships with companies looking to apply the technology to clinical medicine and biomedical research…Researchers have also been seeking to apply the technology to clinical trials...the British Medical Journal concluded that blockchain provides a significant opportunity for clinical research because it can help structure more transparent, checkable methodology and, under certain conditions, check clinical trial integrity...Imperial College London played host to a hackathon specifically to explore the use of blockchain in clinical trials...to replace the operations of contract research organizations...The two finalists proposed using distributed ledger technologies to operate all the necessary transactions between drug companies running trials and the clinical trial sites where they take place...
- Cooking Pots and Household Power Tools: FDA Warns California Drugmaker (raps.org)
Food and Drug Administration’s...warning letter for BioDiagnostic International featured an odd note about halfway down the CGMP violations: “You use kitchen cooking pots and household power tools to manufacture your drug product used for biopsy procedures.”...The surprising detail – part of one of four CGMP violations cited – comes as an FDA investigator further found an employee food prep station within its Brea, CA-based drug manufacturing area “with no separation between open manufacturing equipment, cooking utensils, and personal-use items.”...Parts of the facility to manufacture product...were also “open to the outdoors,” which FDA said increases “the likelihood of your drug products becoming contaminated.”...
- Nebraska lawmaker urges Pfizer to sue over use of its drugs in lethal injection procedure (fiercepharma.com)
Pfizer protested the use of its drugs in lethal injection procedures last year, asking states to return the drugs for a refund. But not all of them have, and with an execution planned for Aug. 14 in Nebraska, a state senator is urging Pfizer to sue to halt use of its drugs..."Time is of the essence," Nebraska state Sen. Ernie Chambers said in a letter...to Robert Jones, J.D., Pfizer vice president of U.S. government relations...A Pfizer representative said the company's "records do not show any sales of any restricted products to the Nebraska Department of Corrections. We are again asking the Nebraska DOC to return any Pfizer restricted product.”...Pfizer's position is that its drugs are to "enhance and save the lives of the patients we serve." The company "strongly objects" to the use of its drugs as lethal injections...As Chambers noted in his correspondence, Alvogen recently blocked the use of its drugs in a Nevada execution through the courts.
- August 3 Pharmacy Week in Review: FDA Approves Drug to Treat Schizophrenia, HIV Therapy Study Yields Positive Results (pharmacytimes.com)
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.
- Ugandan hospitals hit by shortages of drugs, other supplies (reuters.com)
Public hospitals in Uganda have been hit by shortages of essential medicines and supplies needed for emergency care…The shortages are affecting the East African country’s main Mulago Hospital, which handles serious cases referred to it from other facilities, Uganda Medical Association said...UMA President Ekwaro Obuku...said government hospitals were experiencing serious shortages of basic medicines for emergency care such as vaccines and other drugs, syringes, gloves, catheters, gauze and others...Vivian Nakaliika Serwanjja, health ministry spokeswoman, said shortages had been caused by financial disruption at the government agency responsible for procurement of medical supplies...the scarcities are not widespread,” she said, adding only a few hospitals were affected and supplies had started being delivered...
- More drugmakers build Brexit stockpiles as EU agency faces exodus (reuters.com)
Sanofi and Novartis said...they planned to increase stockpiles of medicines in Britain in preparation for potential disruption if the UK crashes out of the European Union without a deal...the European Medicines Agency...warned of bigger than expected staff losses and cuts in some activities as a result of having to move from London to Amsterdam due to Brexit...Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market...The European Medicines Agency...expressed “serious concerns” over the availability of some 108 medicines that are manufactured exclusively in the UK.
- FDA seals loophole that allowed some drugmakers to avoid pediatric clinical trials (medcitynews.com)
PREA loophole had allowed companies to receive orphan drug designations for diseases common in adults...The Food and Drug Administration moved...to close a loophole that had inadvertently excused some drugmakers from having to conduct clinical trials in children for drugs to treat diseases that commonly affect adults...the FDA announced that it had finalized a draft guidance...intended to close a loophole in the Pediatric Research Equity Act that allowed drug companies making medicines for non-orphan diseases in adults – meaning those affecting more than 200,000 patients – to get pediatric subpopulation designation. Consequently, companies were exempt from conducting the clinical trials in children that PREA would normally have required...“Addressing the inadequate testing of drugs in pediatric populations has been a priority for the FDA, the medical community and Congress and has led to important laws to ensure this important, vulnerable population is not overlooked,” FDA Commissioner Scott Gottlieb said...
- Superbugs now also becoming resistant to alcohol disinfectants (reuters.com)
Multidrug-resistant “superbugs” that can cause dangerous infections in hospitals are becoming increasingly resistant to alcohol-based hand sanitizers and disinfectants designed to hold them at bay...In a study of what the researchers described as a “new wave of superbugs”, the team also found specific genetic changes over 20 years in vancomycin-resistant Enterococcus, or VRE - and were able to track and show its growing resistance...efforts to tackle the rise of hospital superbugs such as VRE and MRSA, or methicillin-resistant Staphylococcus aureus, institutions worldwide have adopted stringent hygiene steps - often involving hand rubs and washes that contain alcohol...health authorities should try higher-alcohol concentrate products and renew efforts to ensure hospitals are deep cleaned and patients found to be carrying VRE infections are isolated...
- Mental health providers concerned about proposed limits on therapy sessions for Medicaid patients without prior approval (thenevadaindependent.com)Nevada Medicaid shift could impact continuity of mental health care (reviewjournal.com)
Nevada Medicaid will decide next month whether to impose additional requirements for patients to undergo therapy on an ongoing basis, a move the state says will increase accountability and ensure people are getting the care they actually need...mental health providers across the state are decrying as yet another barrier to access to mental health care for a vulnerable population...The Division of Health Care Financing and Policy...to decide whether to require psychologists, therapists and other mental health professionals to provide written documentation demonstrating medical necessity and receive prior approval to continue providing talk therapy or neurotherapy…State officials describe the policy as an effort to be both fiscally and socially responsible, ensuring that providers are only getting paid for services that are actually necessary and that patients are receiving the right treatment for their condition...opponents...argue that it will damage an already-thin safety net for patients by imposing additional administrative burdens on providers…