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Thursday, August 2, 2018

Simple factors that can avoid harmful side effects in type 2 diabetes


Clinicians can match people with type 2 diabetes to the right drug for them to improve control of blood sugar and help avoid damaging side-effects, simply by factoring in simple characteristics such as sex and BMI into prescribing decisions, new research has shown.
The study, by the University of Exeter Medical School, could dramatically improve benefits of drugs and reduce the risk of potentially harmful side-effects such as weight gain and hypoglycaemia, at no additional cost to the NHS.
Metformin is the first line of drug treatment in type 2 , but many  will eventually need additional drugs on top of Metformin to lower their blood sugar levels. Currently, clinicians have to make prescribing decisions on these additional drug options based on limited available guidance. Recent research involving the Exeter team has revealed there is great regional variation across the UK in the prescribing of these additional drugs.
The new study, funded by the Medical Research Council and published in the journal Diabetes Care, provides a starting point for a more evidence-based approach to the prescribing of drugs after Metformin. Based on a patients’ gender and BMI, the authors found important differences in the likely success of the commonly-prescribed drugs sulfonylureas and thiazolidinediones in lowering , and in the risk of common side effects. For example, obese females were far more likely to have good blood glucose control on thiazolidinediones than sulfonylureas, whilst non-obese males had the opposite result—they were far more likely to have good blood glucose control on sulfonylureas than thiazolidinediones.
The Exeter team used anonymous data from more than 29,000 patients who had either taken part in trials or were treated in UK GP practices. By combining these datasets, the researchers were able to show their findings are robust and potentially applicable to many of the 3.5 million-plus people currently diagnosed with type 2 diabetes in the UK.
John Dennis, of the University of Exeter Medical School, was lead author on the study. He said “Our findings are important as they provide the first evidence that personalised or ‘precision’ medicine approaches in diabetes can be based on simple patient characteristics available to any doctor, rather than expensive genetics or other technology. This simple personalised approach could be implemented immediately within the NHS without any additional cost.
The study is also a powerful demonstration of how the sharing of patient data can meaningfully benefit patients—in this case helping to make sure individual patients get the best  for them.”
Professor Andrew Hattersley, a Consultant in Diabetes at the Royal Devon and Exeter Hospital and Research Professor at the University of Exeter Medical School said: “At the moment, clinicians are in the difficult position of making decisions that impact on health in type 2 diabetes based on very little evidence. Now, we can create clear guidelines to enable much more informed conversations about what these treatments will mean for people, in order to get better health outcomes and avoid harmful side effects.”
Dr. Richard Evans, Programme Manager for Stratified Medicine and Molecular Pathology at the MRC, said: “This research used shared clinical trial data from a large number of patients to show that simple patient characteristics can help inform the choice of therapy in diabetes; the results are likely to show real impact, and significant benefits to patients when they are implemented in patient care.
“Diabetes afflicts one in 17 people in the UK—research into precision or stratified approaches to this condition is crucial to getting patients the most appropriate treatment in the most efficient way, underpinned by solid evidence.”
The full paper, ‘Sex and BMI alter the benefits and risks of sulfonylureas and thiazolidinediones in type 2 diabetes: A framework for evaluating stratification using routine clinical and individual trial data’, is published in Diabetes Care.

Rush University to outsource facility management, illustrating a trend


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Rush University Medical Center is working with the real estate firm JLL to manage its facilities, which is expected to net the Chicago-based academic medical center about $40 million in savings.
Part of the cost reduction will stem from more energy-efficient assets, JLL said. JLL will use energy usage and cost data from other healthcare systems in the Chicago area and adapt Rush’s 5 million square feet across 21 buildings accordingly.
Rush’s current facility staff will join JLL, which will provide them with career development opportunities, executives said. There are 110 employees from Rush’s engineering team who are impacted, some of which may retire.
The real estate company will also look to bolster Rush’s local supplier base and educate and train employees at neighboring businesses to try to improve the area economy.
“Healthcare facilities management is becoming increasingly important to the patient, visitor and staff experience with facilities performing as a business enabler,” said Richard Taylor, executive managing director and lead of JLL Healthcare Solutions. “As a result, facilities management is required to be more strategic and more sophisticated in delivering additional value and return on investment.”
More providers are outsourcing property management, including day-to-day maintenance and transactions. Some are selling part of their underutilized space or even their entire property in sale-leaseback deals, freeing them up to spend more time and money on patient care.
Huge swaths of health systems’ revenue are often tied up in brick-and-mortar facilities, which can make it hard to spend on capital-intensive programs related to technology and population health. Adventist Health, based in Altamonte Springs, Fla., for instance, said about $7 billion of its roughly $10 billion in revenue is dedicated to its property.
While it can save providers money and drive efficiency, they are often reluctant to relinquish control.
“It is a lot more difficult for a board of directors to concede that they will relinquish control of their real estate as opposed to their food or technology services,” said Jud Jacobs, a partner at Caddis Healthcare Real Estate. “That can open up questions that rise to the level of CEO or COO.”
Outsourcing facilities management can save providers money and streamline operations, Jacobs said. But they have to be careful and choose the right partner, he added.
“Their real estate is so linked intrinsically to the care they provide,” Jacobs said.
Many times, health systems’ real estate and business models are at odds, said Greg Gerber, senior managing director of healthcare transactions management at JLL.
“Most are trying to do everything themselves,” said Gerber, adding that providers need to stick to their core competencies. “Advanced health systems will deliver healthcare and let someone else manage buildings better than they can.”
Hospitals and health systems are sitting on untapped resources, said Sylvia van Loveren, a senior vice president at JLL. They could free up capital for more staff by outsourcing real estate management or selling part of their property, she said.
“You have to rethink the big box and what you can do with it,” said van Loveren, especially as less care is delivered in hospitals. “Can you reutilize the infrastructure more efficiently so that it’s tailored and customized for your population?”
Commercial real estate firm CBRE said there continues to be strong interest from healthcare providers that look to monetize their real estate portfolios and explore energy-savings programs as well as new development alternatives, said Jim Hayden, CBRE’s executive managing director for healthcare in its global workplace solutions.
“At some point, the economics are going to be such that there is more value in their real estate that would exceed any not-for-profit concessions they would get,” he said. “Hospitals will question whether they need to own their acute-care facility.”

Medicare officially kills 25% rule for long-term care hospitals


The CMS on Thursday finalized its plan to eliminate the so-called 25% rule that would ding long-term care hospitals’ Medicare reimbursement rates.
Under the long-postponed policy, if more than a quarter of a long-term care hospital’s patients came from a single acute-care hospital, the long-term care hospital would receive a reduced Medicare reimbursement rate for patients exceeding that threshold.
The reduced rate would be 50% to 60% less than what they would have received otherwise, according to the National Association of Long Term Hospitals.
The 25% rule was first introduced in the CMS’ 2004 inpatient pay rule and has been delayed regularly since by both the CMS and Congress due to industry concerns. It was scheduled to finally kick in on Oct. 1.
Overall, under the changes included in this final rule, the CMS projects that long-term care hospital payments will increase by approximately 0.9%, or $39 million, in fiscal 2019. That’s down from the $110 million increase they received last year.
The latest inpatient pay rule also finalized the CMS’ overhaul of the meaningful use program to better emphasize measures that require the exchange of health information between providers and patients and give providers incentives to make it easier for patients to obtain their medical records electronically.
To reflect these priorities, it renamed the meaningful use program to “promoting interoperability” earlier this year.
The rule encourages providers to use application programming interfaces that would allow patients to collect their health information from multiple providers and incorporate all of their health information into a single application. That would allow patients to share their records with other clinicians easily, which could reduce duplication and improve continuity of care.
The rule will also eliminate some quality measures that acute-care hospitals report. All in all, the CMS will nix 18 measures, saving hospitals $72 million in reporting costs. The CMS said the measures were redundant and process-driven.
The changes outlined in the final annual inpatient hospital rule will give hospitals $4.8 billion more in Medicare inpatient funding next year. That amount is more than last fiscal year’s $2.4 billion bump in inpatient funding.

PET Imaging Can Measure Synaptic Loss From Alzheimer’s


Positron emission tomographic (PET) imaging can directly measure synaptic loss with Alzheimer’s disease, according to a small study published online July 16 in JAMA Neurology.
Ming-Kai Chen, M.D., Ph.D., from the Yale University School of Medicine in New Haven, Conn., and colleagues used PET imaging to compare hippocampal synaptic vesicle glycoprotein 2A (SV2A) binding in 10 participants with AD and 11 cognitively normal participants.
The researchers found that participants with Alzheimer’s disease had significant reduction in hippocampal SV2A-specific binding compared with cognitively normal participants (P = 0.005). After correction for atrophy, these reductions remained significant (P = 0.02). There was a correlation between hippocampal SV2A-specific binding potential and a composite episodic memory score in the overall sample (P = 0.01).
“This approach may provide a direct measure of synaptic density, and it therefore holds promise as an in vivo biomarker for AD and as an outcome measure for trials of disease-modifying therapies, particularly those targeted at the preservation and restoration of synapses,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.

Opioid Addicts Turning to Unapproved Antidepressant for High


In a trend that suggests opioid addicts are turning to new fixes, a government report shows that use of an unapproved antidepressant is becoming more widespread in the United States.
Tianeptine is used in some European, Asian and Latin American countries for treatment of depression and anxiety. But the U.S. Food and Drug Administration has not approved use of the drug in the United States, according to the U.S. Centers for Disease Control and Prevention.
Despite this, U.S. poison control centers have been receiving a growing number of reports related to tianeptine, which is sold abroad under the names Coaxil or Stablon.
There have been 207 calls to poison control centers regarding tianeptine within the last four years, compared with just 11 calls in the 14 years prior, according to a report in the Aug. 3 issue of the CDC’s Morbidity and Mortality Weekly Report.
“There’s essentially been an exponential increase in cases being reported to poison control, which likely underestimates the prevalence of tianeptine use or exposure by many orders of magnitude,” said Dr. Harshal Kirane, director of addiction services for Staten Island University Hospital in New York City.
Tianeptine produces effects similar to opioids, and officials suspect that people are taking the drug as an alternative to those narcotics, the new report noted.
There were 83 reports of tianeptine being used with other substances, most commonly benzodiazepines, opioids, ethanol and phenibut, an anti-anxiety medication also sold abroad, Dr. Tharwat El Zahran, of the CDC’s National Center for Environmental Health, and colleagues reported.
Kirane said, “I don’t think it’s a coincidence that the uptick in these tianeptine reports coincides with some of the broader changes in [tightening] prescribing policies” for opioid painkillers.
Tianeptine acts upon opioid receptors in the brain, the authors of the report explained. People taking it can become addicted and suffer from withdrawal when they stop. Poison control received 29 calls associated with tianeptine withdrawal, the researchers found.
Dr. Robert Glatter, an emergency physician with Lenox Hill Hospital in New York City, said, “Tianeptine is a dual threat. It not only leads to euphoria and a high, but also leads to opiate withdrawal in casual users who abuse this antidepressant.”
The opioid-overdose drug naloxone is effective in reversing a tianeptine overdose, the report stated.
Although tianeptine is not sold in the United States, it is readily available for purchase online as a dietary supplement or research chemical, according to the report.
Experts like Glatter and Kirane are particularly concerned that standard drug screens don’t look for tianeptine.
“Tianeptine is not something that is generally screened for,” Kirane said, “so detecting if someone is using this is from the outset quite challenging.”
Reports like these reaffirm the need for better addiction treatment in the United States, said Linda Richter, director of policy research and analysis for the National Center on Addiction and Substance Abuse.
“Unless we fix our broken addiction treatment system and get people with opioid use disorder the treatment they need, they will continue to turn to dangerous, non-prescribed drugs to stave off withdrawal and cravings,” Richter said.
“While awareness about tianeptine among the public and health professionals is critical, the growing misuse of this drug is just the latest sign that our efforts to end the opioid epidemic have mostly amounted to putting Band-Aids on a hemorrhage,” Richter concluded.
More information
The U.S. National Institutes of Health has more about tianeptine.
SOURCES: Harshal Kirane, M.D., director, addiction services, Staten Island University Hospital, New York City; Robert Glatter, M.D., emergency physician, Lenox Hill Hospital, New York City; Linda Richter, Ph.D., director, policy research and analysis, National Center on Addiction and Substance Abuse, New York City; Aug. 3, 2018, Morbidity and Mortality Weekly Report

U.S. subpoenas AmerisourceBergen over opioid products


Drug wholesale distributor AmerisourceBergen Corp said on Thursday it had received a grand jury subpoena from federal prosecutors in Florida seeking documents related to opioid products and its communications with a drugmaker.
AmerisourceBergen said in a filing with the U.S. Securities and Exchange Commission that it received the subpoena in May. The company is among several drug manufacturers and distributors facing lawsuits over their roles in the U.S. opioid epidemic.
The Chesterbrook, Pennsylvania-based company did not immediately respond to a request for comment.
Opioids were involved in more than 42,000 overdose deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.
Hundreds of lawsuits by states, counties and cities have accused drugmakers of pushing addictive painkillers through deceptive marketing and allege that wholesale distributors failed to report suspicious drug orders.
AmerisourceBergen, which is among the defendants, is one of the largest drug distributors in the country. AmerisourceBergen and rivals Cardinal Health Inc and McKesson Corp control 85 percent of the U.S. prescription drug market.
The subpoena came from the U.S. Attorney’s Office for the Southern District of Florida.
That office previously in January sent grand jury subpoenas to pharmaceutical manufacturers Endo International Plc and Mallinckrodt Plc regarding products they produce that contain the opioid painkiller oxymorphone, both companies have said.
Endo and Mallinckrodt did not immediately respond to a request for comment.
AmerisourceBergen has previously disclosed receiving subpoenas dating back to 2012 from federal prosecutors in other states regarding its program for controlling and monitoring the diversion of controlled substances into improper channels.

683 report illnesses after eating at Ohio Chipotle, Dayton Daily News says


At least 683 people have reported illnesses after dining at a Chipotle location in Powell, Ohio, Dayton Daily News reports. The cause of the illnesses that are allegedly linked to the restaurant remains unknown, the report says, citing Delaware County Health District spokeswoman Traci Whittaker.