- Government BANS companies from exporting 80 crucial drugs including intensive care medications adrenaline and morphine amid fears coronavirus crisis will overload hospitals (dailymail.co.uk)
The British Government has banned companies from buying up drugs used on intensive care wards and selling them to hospitals in other countries...The Department of Health has announced that the exporting of certain drugs including painkillers, antibiotics and anaesthetics will no longer be allowed...This ban on international sale of the drugs is intended to shore up Britain's supplies of drugs which are crucial for treating intensive care patients...Increasing numbers of people will need to be admitted to critical care units in the coming weeks and the Government must move to make sure they can be looked after. Although bed capacity is an issue, banning the drugs is one way hospitals can make sure their supplies don't run dry...READ MORE
- Drug Shortage Concerns Are Top of Mind Amid COVID-19 Outbreak (pharmacytimes.com)
As the novel coronavirus crisis continues, one key issue for pharmacists, other health care professionals, and patients is the potential for drug shortages in the United States...There is growing concern because although reserves exist, China experienced a drop-off in drug production during the height of its COVID-19 outbreak, though that is leveling off. And India, another big supplier, has also said that it will keep some of the medications it makes on reserve...“We are now starting to see spot shortages for a few different products, in part due to disease progression around the world, especially across Europe, which is a large producer of drugs,”... the FDA has announced a drug shortage caused by the COVID-19 outbreak but has not identified the drug or the country where it is made, in an effort to prevent hoarding and panic...READ MORE
- U.S. Approves Abbott Labs Coronavirus Test For Hospital Use (forbes.com)New Coronavirus Test 10 Times Faster Is FDA Approved (bloomberg.com)
Abbott Laboratories won U.S. approval for its molecular test for the Coronavirus strain COVID-19, which will be used by hospitals and academic medical centers to speed diagnostic capabilities...The “emergency use authorization” from the U.S. Food and Drug Administration allows Abbott to begin shipping 150,000 laboratory tests immediately, the company said Wednesday. The tests are run on Abbott’s “m2000TM RealTime System,” which is already located in more than 175 U.S hospitals and academic medical centers...Abbott said the company will begin scaling up production at its U.S. manufacturing plant “to reach capacity for 1 million tests per week by end of March.” Abbott said its systems have “the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing.”...READ MORE
- Clinical Trial Launched for Investigational COVID-19 Vaccine (drugtopics.com)NIH begins clinical COVID-19 investigational vaccine trials (drugstorenews.com)Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals (statnews.com)
A clinical trial evaluating an investigational vaccine for the 2019 novel coronavirus, SARS-CoV-2, has been launched, with volunteers receiving the first injection on Monday, March 16, Kaiser Permanente Washington Health Research Institute...This is the first trial to be launched in humans for a vaccine for this virus, which caused COVID-19, according to Kaiser Permanente...The phase 1 federally sponsored study involves 45 volunteer participants and is evaluating the investigational vaccine called mRNA-1273, developed by Moderna, over a 6-week period. In this phase of the study, Kaiser Permanente researchers are testing the safety of various doses and whether these doses produce an immune response...READ MORE
- Shredded documents and trick cameras: FDA knocks Indian drugmaker Windlas for brazen errors (fiercepharma.com)
When the FDA comes down on drug manufacturers, it can be for a range of wrongdoings, including poor testing policies and unsanitary conditions. But shredding key documents and leading investigators to incorrect rooms during an inspection? That's bold, and Indian drugmaker Windlas could pay the price...The FDA said Windlas Healthcare failed to adequately address a slew of issues at its Dehradun, India, plant including employees shredding and disposing of key documents and clandestinely signing paperwork while investigators were on-site, according to a warning letter...READ MORE
- OCR will ease restrictions on telehealth tech during COVID-19 (healthcareitnews.com)Trump administration expands Medicare telehealth benefits for COVID-19 fight (healthcareitnews.com)
The HHS Office for Civil Rights announced... that during the coronavirus pandemic it will use discretion when enforcing HIPAA-compliance for telehealth communications tools...Even though some of those technologies may not fully comply with HIPAA requirements, OCR says it "will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency."...Covered entities seeking to use audio or video communication tech to reach patients where they live "can use any non-public facing remote communication product that is available to communicate with patients," said the agency. "This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19."...READ MORE
- Google’s coronavirus screening website is live, but it’s not the resource you want (bgr.com)California COVID-19 risk screening and testing (projectbaseline.com)
One of the measures that President Trump announced on Friday when he declared the coronavirus national emergency was a website that Google was supposedly developing to facilitate the access to coronavirus testing. Google had 1,700 engineers working on the project, he said. But it turned out that Google didn’t really know it was making such a website. Instead, Google-sister company confirmed that a more limited site was in the works and that it wasn’t the nationwide project Trump referred to. Since Friday Google confirmed it’s working with the US government on a nationwide site, stopping short from revealing any specific details about it. Verily, meanwhile, launched its coronavirus screening site, proving this isn’t the COVID-19 website you expect...READ MORE
- This Week in Managed Care: March 20, 2020 (ajmc.com)
Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network
- Two generic drugs being tested in U.S. in race to find coronavirus treatments (reuters.com)
U.S. researchers, following the lead of scientists in other countries, have launched studies to see whether widely-available, low-cost generic drugs can be used to help treat the illness caused by the new coronavirus...But a 1,500-person trial, led by the University of Minnesota, began this week to see whether malaria treatment hydroxychloroquine can prevent or reduce the severity of COVID-19. Two other trials are studying the blood pressure drug losartan as a possible treatment for the disease...READ MORE
- How are pharma supply chains reacting to COVID-19? Without info, it’s hard to tell: analyst (fiercepharma.com)
The novel coronavirus is putting pharma's complicated global supply chain under strain, no question. What's up in the air is just how supplies could be affected––and unfortunately, analysts just can't be sure...Why? Lack of transparency, for one thing. A dearth of information is making it hard on pharma watchers who'd like to diagnose the growing impact COVID-19 has had on individual companies' struggles...READ MORE