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Shortages of life-saving medicine because of political protests in Nepal that have blocked key roads could lead to a crisis, as hospitals have started to cut services…Hospitals are rescheduling surgeries by weeks, and patients are finding it difficult to get to medical facilities due to fuel shortages…Truckloads of medicine have been blocked at the main border crossing with India for the last few months by Nepal's Madhesi ethnic protesters…adding that Indian authorities were also not allowing the shipments across even at points where there are no protests…The...Madhesis have been protesting Nepal's new constitution, demanding to be given greater autonomy over local matters…Nepal imports about 60 percent of its medicine from India. The remaining locally made drugs also get most of the raw material and packaging from India.

Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.

In the wake of an inspection that found "multi-systemwide failures" that created a major risk of patient harm, Seattle's Western State Hospital may lose millions in Medicare and Medicaid funding…Department of Health and Human Services will end its relationship with Washington's largest psychiatric hospital on November 28, costing the 842-bed facility a total of more than $15 million a year in federal funds. State officials said the hospital is working to correct the problems that inspectors discovered before the deadline…"Patient and staff safety remain priorities and to that end we are working to recruit more staff, which is key to improving safety and providing quality services to the patients at all of our state psychiatric hospitals," said Kathy Spears, a spokesperson for the state Department of Social and Health Services. "We have not lost federal funding..."

Avoiding pre-market verification is downright easy…Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many…Pathway Genomics, Admera Health, and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies have published data about their tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what's known as the "laboratory developed test" loophole — which makes avoiding pre-market verification downright easy...Under the LDT loophole, any company that develops and conducts a diagnostic test in their own lab…can avoid submitting that test to the FDA before using it on patients. This get-out-of-regulation-free card exists because research hospitals often modify commercial tests. In the case of these hospitals, the academic researchers tend to publish their results anyway…The FDA knows this — even they’ve been calling LDTs a loophole — and the agency wants to change the way these tests are regulated…until that loophole closes, we’ll keep seeing companies using the LDTs as a dodge, because it’s a simpler and cheaper way to get to market. The real expense, of course, is patients’ health.

All health care facilities would be banned from flushing drugs among other changes in a proposed rule…Stop flushing pills down the toilet…That’s the message behind a proposed rule from the Environmental Protection Agency that would ban health care facilities from disposing of hazardous pharmaceuticals by flushing them…significant changes may be required if the rule is enacted…The EPA estimates that the proposal is projected to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually…The rule would fall under the Resource Conservation and Recovery Act, and is open for comment from the public until Dec. 24.

Most members of a Senate committee had few reservations yesterday about Robert Califf's qualifications to be the next commissioner of the US Food and Most members of a Senate committee had few reservations yesterday about Robert Califf's qualifications to be the next commissioner of the Food and Drug Administration.. Questions about Dr Califf's ties to the pharmaceutical industry, however, have dogged him since President Obama nominated him…to lead the FDA…Trying to head off those concerns, Chairman Alexander noted at the outset of the hearing that Dr Califf had gone through an extensive vetting process that involved the White House, the FBI, the Office of Government Ethics, and dozens of pages of questions from the HELP committee…Sen. Elizabeth Warren confronted Dr Califf directly about his past relationships with drug companies. "It's no secret that during your time at Duke University you received significant financial support from the pharmaceutical industry both personally and through your research,"...She asked him whether he believed that the FDA should lower its standards for approval…"I've never been a proponent of lowering standards," said Dr Califf. "If anything, I've argued for raising standards."

For municipal-bond buyers, the boost from Obamacare is waning…municipal bonds have rallied, delivering 16 percent returns in the past two years as the providers were stuck with fewer unpaid bills…“The effect of the Affordable Care Act is fading,”… “We don’t really have any new states adopting Medicaid so you don’t have that expansion.”…The federal law has provided health-care coverage to 17.6 million Americans as a majority of states expanded access to the Medicaid program for the poor and others bought subsidized insurance. The factors that have driven that growth are now weakening…while rising premiums may cause some consumers to go without or lose their policies for not paying their bills…About 9.9 million people were paying for coverage purchased on the exchanges created by the law as of June 30, a decline of 300,000 from March 31…Department of Health & Human Services estimates that about 9.1 million people will be enrolled by the end of the year…“It’s very safe to bet that a lot of hospitals across the country are not going to see as many people getting insurance as they had expected,” The law…has been a boon to investors who hold tax-exempt bonds sold by hospitals: The securities have delivered outsized returns since then, beating a dozen other revenue-bond sectors, including toll roads, airports and utilities…The bonds’ prices have slipped 0.4 percent over the past month amid speculation that the Federal Reserve will raise interest rates as soon as December.

French hospitals' mass casualty response can be a guide for United States..The horrifying attacks on restaurants, clubs and cafés in Paris last week have resulted in a call by U.S. federal agencies for healthcare providers and hospitals to review their disaster plans and to exercise "enhanced vigilance"…Department of Homeland Security and Health and Human Services urged healthcare providers this week to "review and exercise their security plans" in the wake of the attacks…The notice urged healthcare organizations to:

• Review security plans and conduct drills that incorporate scenarios based on tactics recently used
• Review active shooter, suspicious activity reporting, and counter-IED preparedness in training and awareness initiatives and in organizational safety briefings
• Ensure proper functioning of emergency communications equipment and conduct regular tests

New this year is quality reporting data…The Office of Inspector General in the Department of Health and Human Services is charged with overseeing the agency's programs to make sure they function efficiently and safely…OIG recently released its work plan for 2016…Here, among the vast responsibilities assigned to the office are five items OIG will check to ensure hospitals provide quality care and maintain safety:

1. CMS validation of hospital-submitted quality reporting data
2. Hospitals' contingency plans for protecting data in the EHR
3. Hospital preparedness and response to high-risk infectious diseases
4. Long-term-care hospitals – adverse events in post-acute care for Medicare beneficiaries
5. Inpatient rehabilitation facilities – adverse events for Medicare beneficiaries

The reputation of India's massive $15 billion drug industry is being threatened at the federal and state level by a lack of properly trained personnel and a shortage of funding that points out possible changes may be needed in how the country finances inspections and quality control work…almost half of all regulatory positions in the country's central and state drug offices remain unfilled and that "existing staff (are) not trained to meet the regulatory requirements of the growing sector."…Officials…said the government's recommendations of having one inspector for 50 manufacturing plants and retail outlets means the country should have 3,200 inspectors, but in reality the country only has 846 currently working…This means key regulatory functions such as inspections are undertaken in an ad-hoc manner…There is a risk of large-scale corruption because inspectors perform sensitive functions, including launching of prosecution...