Room for Better Safety at Surgery Centers

Ambulatory surgery centers (ASCs) and hospital outpatient departments (HOPDs) aren’t doing all they could to ensure patient safety, according to a report released Tuesday from the Leapfrog Group.
“Despite the fact that so much surgery is done in outpatient and ambulatory settings, there is very little publicly available data about quality and safety,” Leapfrog Group president and CEO Leah Binder said Friday on a phone call with reporters. “We believe families and loved ones deserve to have this information to make informed decisions.”
The Leapfrog Group, a 19-year-old nonprofit focused on patient safety and quality issues, surveyed 321 ambulatory surgery centers and 1,141 hospital outpatient departments about some of their patient safety practices. Current survey data only include aggregate numbers, although data on specific centers will be available in the next round of surveys starting in 2020.
In terms of ownership, 38% of participating ASCs represented a joint venture among physicians and a management company, while 29% were owned by either a single physician or multiple physicians, and 18% were owned by a combination of physicians and/or a hospital joint venture. The remaining 15% had other ownership structures.
Board certification was one issue of concern identified by the researchers. The survey found that in both ASCs and HOPDs, 65% of all individuals performing procedures were board-certified, as were 83% and 71%, respectively, of those administering anesthesia in HOPDs and ASCs.
“The problem in ambulatory surgery is many events that are truly catastrophic — or even that cause minor to moderate complications — are rare, although certainly with increasingly complex patients and procedures, they will be increasing in the future,” said Lee Fleisher, MD, an anesthesiologist at the University of Pennsylvania in Philadelphia, and chair of Leapfrog’s Ambulatory Surgery Center/Hospital Outpatient Department Expert Panel.
“Patients should be informed that they should ask if their anesthesiologists and surgeons are either board-certified or board-eligible … [Otherwise], experts who are available to treat true complications may not be present in the facility, so we did feel this is an important structural measure to assess,” Fleisher noted.
Hand hygiene was another area of concern. The survey showed that while nearly all ASCs and HOPDs used direct observation to see whether hospital staff was following good hand hygiene practices, no ASCs and only 6% of HOPDs were using electronic monitoring.
“One shortcoming with direct observations is that you are limited in the number of observations you can do,” said Missy Danforth, vice president for health care ratings at the Leapfrog Group. In addition, “we’re seeing that there are some gaps in HOPDs and ASCs having a system in place for initial and recurrent training and validation. You can imagine as new staff are brought on, it’s incredibly important they’re trained appropriately in hand cleaning to prevent different kinds of healthcare-associated infections.”
The Leapfrog Group also found a low result for electronic monitoring when it surveyed inpatient hospitals, “which was surprising and, disappointing, frankly, because it’s a way of monitoring 100% of interactions with patients and that’s important, given the importance of hand hygiene to every single patient every minute of the day,” Binder said.
In addition, only 53% of ASCs and 69% of HOPDs said they held their leadership accountable for their facility’s maintenance of good hand hygiene. “For those most important aspects of patient safety like hand hygiene, it helps if the leadership is held accountable in some way, either through annual performance reviews or compensation,” said Danforth.
As far as patient experience was concerned, ambulatory surgery centers performed slightly better on measures of patient satisfaction; for instance, 87% of ASC patients gave the facility the highest possible overall rating, versus 83% of HOPD patients. However, fewer ASCs were distributing patient satisfaction surveys, Danforth said. “We’d encourage more ASCs to administer the survey to their patients.” In addition, 86% of ASC patients surveyed said they would recommend the facility to others, versus 82% of HOPD patients. ASCs and HOPDs scored virtually the same on other measures such as quality of facilities and staff, and what patients should do if they notice signs of infection following their procedure.
Information about what to expect during recovery is a critical component for patients, Fleisher noted. “Many facilities do not call patients 24 hours [after the procedure],” he said. “Discharge instructions are frequently lost within 10 to 12 hours … We found a very high incidence that patients had a phone number, but the ability to re-set expectations if they have questions, or potentially learning of complications and how to get the centers to perform even better would be better achieved by contacting patients at that 24-hour mark.”
One thing the group found most surprising was the answer to the question in the survey about whether or not ASCs and HOPDs were using a “safe surgery checklist,” Danforth said; the survey found that 3% of ASCs and 4% of HOPDs do not use such a checklist.
“Safe surgery checklists have been a buzzword for a long time,” and although the Centers for Medicare & Medicaid Services has stopped asking about the checklist in its quality reporting programs because the measure was “topped out” and everyone was doing it, “we found that not everyone’s doing it,” said Danforth. “We’re going to look to making those questions a little more robust next year. We think it’s the patient’s expectation that when they go in for a procedure in any of these settings, the surgical team is doing everything they can to make sure they’re going to be kept safe, and there is a lot of evidence that the safe surgery checklist can do that.”
https://www.medpagetoday.com/surgery/generalsurgery/82854

EU to ban Bayer’s pesticide linked to harming bees

European Union governments on Tuesday widened the EU ban on pesticides linked to harming bees after deciding not to renew their approval for Bayer’s insecticide known as thiacloprid.

Farmers will not be allowed to use the insecticide, sold under brands Calypso and Biscaya, after April 30, 2020, when its current approval expires.
A majority of EU countries approved the proposal of the European Commission, the bloc’s executive arm, not to extend approval.
The Commission based its assessment on findings of the European Food Safety Agency published in January 2019. It highlighted concerns about the active substance being toxic for humans and present in too great a concentration in ground water, an EFSA spokesman said in an email.
The EU prohibited the use of three so-called neonicotinoids everywhere except greenhouses in April 2018. France has already outlawed all four insecticides and one other, including in greenhouses.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-EU-to-ban-Bayer-s-pesticide-linked-to-harming-bees-29435192/

Euro panel backs Lilly’s Baqsimi as non-injectable for severe low blood sugar

The EMA’s human medicines advisory committee has recommended approval of Eli Lilly’s Baqsimi as the first needle-free treatment for severe low blood sugar levels (hypoglycaemia) in diabetics in the EU.
Baqsimi is a nasal spray formulation of glucagon, already widely used as an injectable treatment for hypoglycaemia, which can occur when people with diabetes inadvertently take too much insulin.
Lilly’s new product was approved by the US FDA in July and is indicated for use in people aged four and over.
Severe hypoglycaemia occurs when the level of sugar in the blood drops to a level where the patient becomes confused or unconscious and requires assistance from another person to administer a rescue medicine, and if untreated can lead to coma and death.
Injectable glucagon has been the primary treatment for severe hypoglycaemic episodes for many years, as the drug mobilises glucose stored in the liver and releases it into the blood stream.
Giving the drug by subcutaneous or intramuscular injection requires training however as it needs to be mixed in a several-step process, whereas Lilly’s nasal spray sidesteps that requirement and so should be easier and quicker to administer in an emergency.
“The medicine comes in a single-use dispenser which is ready to use and can be administered through the nose by caregivers,” says the EMA. “Patients do not need to inhale or breathe deeply after dosing, enabling drug delivery even in unconscious patients.”
Baqsimi was tested in two clinical trials in diabetics with insulin-induced hypoglycaemia, and was found to increase blood sugar levels within 30 minutes of administration working as safely and effectively as injected glucagon, according to the EMA’s Committee for Medicinal Products for Human Use (CHMP).
In the US, Baqsimi is now competing head-to-head with Xeris’ Gvoke, pre-filled syringe and pen injector formulations of glucagon that don’t require the mixing steps and can be used in patients aged two and above.
Both products are priced at a similar level to the glucagon injection kits available on the market, with a list price of $280 per dose, and in the US Xeris has partnered with Amazon’s PillPack division to enable home delivery of Gvoke without a visit to the pharmacy.
Gvoke hasn’t yet been submitted for approval in Europe but that is expected to happen before the end of the year.
The jury is out on which product will find most favour in the marketplace, with some analysts backing Gvoke as the more familiar approach to this type of rescue therapy for healthcare practitioners, likening it to Mylan’s $1 billion EpiPen product for severe allergic reactions.
Gvoke is being launched in the pre-filled syringe format first however with the pen-injector not due to hit the market until next year, so Lilly has first-mover advantage. The total market for glucagon products for hypoglycaemia has been estimated to be worth around $2 billion worldwide.
Lilly acquired rights to Baqsimi from Canadian biotech Locemia Solutions in 2015, but didn’t disclose how much it paid for the rights. Unconfirmed estimates suggest the deal was valued at around $150 million.
A pen-injector formulation of a glucagon analogue from Zealand Pharma – dasiglucagon – is also in development and could be ready for filing early next year, potentially adding a third product to the marketing fray.
Zealand claims its water-soluble analogue works rapidly, with a single dose restoring normal glucose levels in the blood within 10-15 minutes.

CHMP backs Lilly’s Baqsimi as non-injectable for severe low blood sugar

Veracyte up 3% on positive nasal swab test data

Veracyte (VCYT +3.1%) is up on average volume in reaction to its announcement of preliminary clinical data supporting the value proposition of its noninvasive nasal swab test for lung cancer. The results are being presented at the CHEST Meeting in New Orleans.

Based on a group of 261 patients with lung nodules found on CT scans, the company’s test classified over 40% as low risk for cancer, implying sensitivity (correctly identifying true positives) of over 95%. The test’s sensitivity in patients with malignant nodules was 94%.

The company says that researchers in the study believe that the nasal swab test would identify over 70% more low-risk patients and 18% more high-risk compared to clinical risk calculators.

Management will host a conference call today at 5:00 pm ET to discuss Q3 results and provide a general business update.

https://seekingalpha.com/news/3507854-veracyte-3-percent-positive-nasal-swab-test-data

FDA OKs eight Swedish Match modified risk smokeless tobacco products

In a first for the agency under its modified risk tobacco product (MRTP) pathway, the FDA has approved eight snus smokeless tobacco products sold under the “General” brand name by Swedish Match AB’s (OTCPK:SWMAF) U.S. unit.

The approval allows the company to market the products with the following statement: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The products have been available in the U.S. since 2015 without modified risk claims.

https://seekingalpha.com/news/3507830-fda-oks-eight-swedish-match-modified-risk-smokeless-tobacco-products

This device could cut older people’s risk of dementia, depression and falls

One small device can make a big difference in the lives of older people, but few of them get the helpful gadget, a new study suggests.
People age 66 and older who got a hearing aid shortly after being diagnosed with hearing loss were less likely to receive a first-time diagnosis of dementia or depression, or be injured by a fall, in the following three years, a study published recently by the Journal of the American Geriatrics Society found.

Researchers from the University of Michigan examined insurance data from nearly 115,000 Michigan residents whose insurance covered part of the cost of hearing aids. People who got hearing aids had an 18% lower risk of being diagnosed with dementia, including Alzheimer’s disease, within three years of their hearing loss diagnosis, the study found. The risk of a depression diagnosis was 11% lower and the risk of being injured in a fall was 13% lower.

“Though hearing aids can’t be said to prevent these conditions, a delay in the onset of dementia, depression and anxiety, and the risk of serious falls, could be significant both for the patient and for the costs to the Medicare system,” said Elham Mahmoudi, a University of Michigan health economist who led the study.

People with hearing loss may have higher rates of dementia, depression and fall injuries for a variety of reasons, the researchers said, including diminished social interaction, loss of balance and less brain stimulation.
Though their insurance covered part of the cost, only 12% of the people in the Michigan study got hearing aids after they were diagnosed with hearing loss. People wait an average of 10 years to address their hearing loss, sometimes because they don’t like the way hearing aids look or don’t want to feel “old,” according to Johns Hopkins Medicine.
Cost is another barrier, but could become less of an obstacle next year when over-the-counter hearing aids will become available under a law passed in 2017. The OTC hearing aids are expected to be cheaper, but they’re only designed to help mild or moderate hearing loss, according to the AARP.
Medicare, the government insurance program for people 65 and older, doesn’t pay for hearing aids, which run between $1,000 and $4,000 for one, according to the Hearing Industry Association, the trade group for hearing aid manufacturers.

The Michigan study found disparities in who was more likely to get a hearing aid: 13.3% of men with hearing loss received them, compared to 11.3% of women. Only 6.5% of people of Latino heritage got a hearing aid, versus 9.8% of African-Americans and 13.6% of whites.
The study builds on previous research that has identified a link, though not necessarily a causal one, between hearing loss and dementia.
Hearing loss affects people’s relationships, their overall physical health, and even their earning power: People with “unaided” hearing loss earned on average $20,000 less annually than those who used hearing aids or cochlear implants, according to the Hearing Loss Association of America.
https://www.marketwatch.com/story/this-one-device-could-cut-your-risk-of-dementia-depression-and-falls-2019-09-06?siteid=rss&rss=1

Novartis: data suggest payers getting breaks on gene therapy Zolgensma

Novartis sales data on Tuesday suggested the Swiss drugmaker is reaping less than the $2.1 million U.S. list price for its gene therapy Zolgensma, as insurers may be getting breaks on the world’s most-expensive one-time treatment.

The spinal muscular atrophy (SMA) treatment, approved by the U.S. Food and Drug Administration in May, has reaped $175 million in revenue this year, including $160 million in the third quarter.
On a call following third-quarter results, Chief Executive Vas Narasimhan said roughly 100 patients have been treated under the paid programme.
The figures would suggest it is receiving around $1.75 million per patient on average, a 17% discount to the U.S. list price. Novartis has said previously it was offering discounts to U.S. insurers on the condition they add Zolgensma to their policies to ensure quick authorisation.
“With respect to Zolgensma, you have to divide the total sales by the net pricing that we’ve achieved and also look at our U.S.-EU mix,” Narasimhan told analysts on the call. “We’re in the range of 100 patients treated currently under the paid programme.”
Narasimhan also told reporters on Tuesday that insurers are seeking to tie payments to Zolgensma’s long-term efficacy, but said he has seen no “material uptake” of five-year instalment plans that Novartis has suggested to help soften the financial burden.
Novartis declined to confirm the average per-patient cost figure based on revenue and patients treated.

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-data-suggest-payers-getting-breaks-on-gene-therapy-Zolgensma-29435215/