FDA approves nasal spray that reverses opioid overdose

first_img Tags drug abuseFDAopioids By David Armstrong Nov. 18, 2015 Reprints Federal health officials have pushed for the development of the spray as the country’s opioid crisis has worsened. In 2013, nearly 25,000 people died from overdoses of heroin and prescription painkillers such as OxyContin, according to the Centers for Disease Control and Prevention. The CDC has cited the expanded use of naloxone as one of the most important ways to respond to the heroin epidemic. Deaths from heroin overdoses increased 286 percent between 2002 and 2013.Health officials hope the nasal spray will make it so easy to administer the drug that friends, family members, and members of the general public will be able to render quick aid to overdose victims. The nasal spray requires only a simple push of a button and there is no assembly of parts involved.advertisement A critical drug used to reverse opioid overdoses will now be sold as a nasal spray, a development that will likely broaden use of the antidote among family members and friends of addicts caught up in a growing national epidemic of drug abuse.The Food and Drug Administration approved the spray form of naloxone Wednesday. Naloxone has been an effective lifesaver when quickly administered to addicts overdosing on heroin or prescription painkillers. Until now, the only approved versions of the drug have been injections that people without medical training were often reluctant to use.“This easy-to-use intranasal formulation will no doubt save many lives,” Nora Volkow, director of the National Institute on Drug Abuse, said in a statement. The FDA expedited its review of the nasal spray, taking less than four months to approve it.advertisement The nasal-spray version of Narcan, which was approved by the FDA. Adapt Pharma, Inc. HealthFDA approves nasal spray that reverses opioid overdose Emergency responders have also pushed for a nasal spray: Not only is it simpler to administer, but it also eliminates the risk of being pricked by a contaminated needle. In some cities, emergency workers have been using adapters placed on the tip of the syringe to convert the injectable into a spray.The new nasal spray product will be sold by a unit of Adapt Pharma, a Dublin-based company that will market the product under the brand name Narcan. The nasal spray should be available in a matter of weeks, said Adapt Chief Executive Seamus Mulligan. The spray will have a “public interest price” of $37.50 for a single unit and $75 for a package of two for entities such as government Medicaid programs that insure low-income people, emergency medical services, and public health organizations, he said. He would not disclose the list price for other purchasers, such as those using private health insurance, but said it would be comparable after taking into account copayments and other discounts.“We are making sure this is priced in a way that is responsible,” Mulligan said. “We have watched as the noise level and price for naloxone has been ramping up.”Last year, public health agencies and emergency responders complained of a sudden and rapid increase in the price of naloxone as the opioid crisis intensified. Massachusetts Attorney General Maura Healey’s office said the wholesale price of naloxone doubled from less than $15 a dose to more than $30 in late 2014. Some first responder agencies reported paying as much as $65 for a single unit of the drug. In August, Healey’s office reached an agreement with naloxone manufacturer Amphastar Pharmaceuticals to pay $325,000 to a state fund used to purchase the drug.A second company, Indivior, is also seeking approval from the FDA for a nasal spray version of naloxone.last_img read more

Killer snails and assassin bugs: secrets of the world’s deadliest creatures

first_imgThe list sparked controversy because, technically, it’s not the mosquito — or the freshwater snail, or the tsetse fly, or the dog — that kills. It’s the viruses and parasites these critters transmit. Judge the human species by the same standard and we would be far and away the most lethal creature on the planet, because we transmit deadly diseases such as HIV and tuberculosis to one another, as Jonathan Eisen, a biologist at the University of California, Davis, noted in a blog post.Point well taken.advertisement @ericboodman By Eric Boodman April 4, 2016 Reprints Another important point: Most of these killers disproportionately affect poor people in the developing world. Not only do they often live in close contact with flies, mosquitoes, and water-dwelling worm larvae; it’s also harder for them to get proper medical care.All that said, we at STAT were curious about how, exactly, the creatures on Gates’s list do us in. So, taking Gates’s numbers at face value, here’s the science behind the scary statistics.MosquitoesDeath toll: 725,000 people a yearWhen a mosquito sticks its proboscis into your skin, the tip wiggles around, looking for a blood vessel. Once it hits a jackpot, the bug injects its saliva to prevent the blood from clotting. But the saliva can contain stowaways — and they’re the ones actually doing the killing. Most often, deaths occur because of Plasmodium, the genus of parasites that cause malaria, which reproduces first in your liver and then on your red blood cells. Deadly viruses like dengue, chikungunya, and yellow fever are also masters at hitching rides with mosquitoes.HumansDeath toll: 475,000 people a yearTurns out we’re perfectly good at doing other humans in, even without help from lions. Or mosquitoes. Most evolutionary psychologists see our murderous leanings as a natural outgrowth of the aggression that helped our ancestors stay alive and protect their offspring, even if killing wasn’t the ultimate goal. But a few researchers argue that natural selection perpetuated or even honed our capacity to kill, since it may have been evolutionarily beneficial to murder in specific situations.SnakesDeath toll: 50,000 people a yearDoctors Without Borders calls the fallout from snakebites “one of the world’s most neglected public health emergencies.” The incidents often take place in rural areas, making it hard to reach medical care before the venom causes irrevocable damage by attacking your central nervous system, shriveling your tissues, or causing you to bleed profusely. The wide variety of snakes, and symptoms, makes it hard to develop an effective treatment. Still, one enzyme called sPLA2 may be prove an effective drug target — and there’s already a biotech company trying it out.DogsDeath toll: 25,000 people a yearMan’s best friend is also one of our worst enemies. Your pooch’s saliva can contain the virus responsible for rabies; if it does, the virus will travel up the dog’s nerves and into its brain, making it unusually aggressive and more likely to bite. Oh, and it will also become terrified of water and unable to swallow properly. Undiluted saliva means more virus present in every last drop. Just when you thought it was safe to pet your poodle …Tsetse fliesDeath toll: 10,000 people a yearThis large brown fly often has an unseen passenger in its gut and its saliva: an immature single-cell parasite called Trypanosoma brucei. A bite from the fly will inject this parasite into your body. As soon as it’s in, the single cell lengthens out — picture a leech becoming long and graceful to swim — and can burrow into your tissues and your central nervous system, causing sleeping sickness.Assassin bugsDeath toll: 10,000 people a yearThis is a particularly nasty one. The assassin bug sits on your face, drinking your blood —and it has no qualms about defecating at the dinner table. The bite itches, so you scratch it — and in doing so, you brush those tiny feces into your mouth, eyes, or the broken skin from the bug bite. That’s bad news because the feces contains parasite called Trypanosoma cruzi, which can wreak havoc by causing Chagas disease, sometimes causing your heart or intestines to swell up. Assassin bugs are widespread in Central and South America, and are present in the southern United States, but tend to afflict mostly those who can’t afford screens and secure roofing to keep out unwanted pests.Freshwater snailsDeath toll: 10,000 people a yearSnails might seem pretty harmless. But they harbor a particular type of worms that are released into bodies of water as larvae. Step into the water to bathe or wash your clothes, and those larvae can penetrate your skin by degrading its proteins. They won’t leave a wound. But they will leave you with a terrible illness called bilharzia or schistosomiasis.Correction: An earlier version of this story misstated the dates for the Gates and Eisen blog posts. HealthKiller snails and assassin bugs: secrets of the world’s deadliest creatures About the Author Reprints Hyacinth Empinado/STATcenter_img Eric Boodman General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. The world’s deadliest animal doesn’t have fangs or bone-crushing coils. It doesn’t even have teeth. But it can inject parasites and viruses straight into your bloodstream.What is this killing machine? None other than the humble mosquito.That, at least, is what Bill Gates wrote when he put out a list of the world’s most deadly creatures.advertisement [email protected] Tags mosquitoesparasitessnakebitelast_img read more

Hospitals could bear the financial brunt of the American Health Care Act

first_img Hospitals could bear the financial brunt of the American Health Care Act The stakes couldn’t be higher for America’s hospitals in the debate over the GOP replacement for Obamacare. Here’s a quick breakdown of the top issues to watch and how they could impact providers across the country.Medicaid, Medicaid, MedicaidHospitals could face a huge financial hit from the Medicaid overhaul as they grapple with lost payments and reduced volume. Republicans would freeze the expansion in 2020 (11 million people have gained Medicaid coverage under Obamacare) and impose block grants, or per capita limits in state funding, by 2020. By Casey Ross March 7, 2017 Reprints David Goldman/AP Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More Tags hospitalspolicypolitics STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. @caseymross Casey Rosscenter_img [email protected] What is it? GET STARTED About the Author Reprints Politics What’s included? National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTEDlast_img read more

Pharmalittle: Doctor gets four years for taking Insys kickbacks; Valeant kills CEO stock award

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT What’s included? What is it? Good morning, everyone, and how are you today? We are just fine, thank you, despite another round of heavy snowflakes descending on the wintry Pharmalot campus. After all, our shortest person successfully departed for the local schoolhouse and the official mascots are resting comfortably and quietly. All of which is to say our task is made easier. Of course, a few cups of stimulation can help. So feel free to join us. Meanwhile, here are some tidbits to aid you on your own journey. Hope today is a good one and do keep in touch …A Rhode Island doctor was sentenced to more than four years in prison after admitting he took kickbacks from Insys Therapeutics (INSY) to prescribe its fentanyl-based cancer pain drug Subsys to people who did not suffer from the condition, Reuters tells us. Jerrold Rosenberg, 63, was sentenced by U.S. District Judge John McConnell in Providence, R.I., who said the doctor effectively sold his medical license to a pharmaceutical company seeking to boost its profits. Rosenberg admitted Insys paid him $188,000 in the form of speaker fees. Pharmalot About the Author Reprints Pharmalittle: Doctor gets four years for taking Insys kickbacks; Valeant kills CEO stock award GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Ed Silverman March 13, 2018 Reprints Log In | Learn More [email protected] Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Tags drug pricingopioidspharmaceuticalspolicySTAT+ @Pharmalot Ed Silvermanlast_img read more

New approach to breast cancer screening — tailoring guidelines for each patient — may save lives and money, study says

first_img Too much screening has misled us about real cancer risk factors, experts say Please enter a valid email address. HealthNew approach to breast cancer screening — tailoring guidelines for each patient — may save lives and money, study says Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. While the harms are real, so are the benefits: Early detection can save lives. The two guidelines — both from trusted sources — reflect a difference in how the two organizations weigh the benefits and harms associated with screening. But the new study proposes a screening strategy that considers each woman’s individual risk.The researchers ran computer simulations on a hypothetical cohort of over 360,000 women to test the efficacy and costs of risk-stratified screening. They took data from the National Health Services Breast Screening Program in the U.K. to model outcomes.The team, led by Dr. Nora Pashayan, a physician and public health researcher at the University College London, compared three interventions: no screening, age-based screening, and risk-stratified screening based on each woman’s genetic profile and her estimated susceptibility to developing breast cancer. They tested 100 definitions for low risk that determined when they decided not to screen their hypothetical patients. The theoretical patients below that threshold weren’t screened, and patients at or above it were screened according to U.K. guidelines.As fewer women were screened, both the number of overdiagnosed breast cancer decreased, as did the number of breast cancer deaths prevented by screening. Pashayan and her colleagues determined that to maximize the benefit-to-harm ratio, the 30 percent of women at the lowest risk do not need mammograms.The researchers also looked at cost-effectiveness on a population level to determine the financial impact of screening and overdiagnosing patients. They found a plateau where costs continued to rise, but the benefits leveled off.“If you go purely by cost-effectiveness, you would only screen the very high risk group,” or the top 30 percent, Pashayan said. Tags cancerdiagnosticspatients By Orly Nadell Farber July 5, 2018 Reprintscenter_img Leave this field empty if you’re human: Organizations like the U.S. Preventive Services Task Force and the American Cancer Society choose their ideal benefit-to-harm ratio when issuing guidelines. Since 2009, the U.S. Preventive Services Task Force — an independent panel of experts in disease prevention — has recommended that women get mammograms every two years beginning at age 50. The American Cancer Society recommends that women have annual mammograms from the age of 45 to 54, and then switch over to an every-two-year schedule.advertisement Preventive care experts have been divided for years on how to best counsel women on when to get breast cancer screenings. But a new study suggests that women might benefit from individualized approaches to mammograms rather than from universal guidelines.The study, published Thursday in JAMA Oncology, looks at personalized screening protocols tailored to each woman’s risk of developing breast cancer. The study showed that not offering mammograms to women at low risk for breast cancer might reduce the harms associated with screening, while still maintaining the benefits. And it might even be more cost-effective.Mammograms, the gold standard for breast cancer detection, come with the risk of false-positive results — that is, incorrectly identifying a cancer that isn’t really there. Or they might overdiagnose — lighting up for lumps and bumps that may never have become cancerous. That means some women undergo biopsies, surgery, chemotherapy, or radiation they may never have needed in the first place.advertisement A new study suggests women might benefit from individualized approaches to breast cancer screening. Rich Pedroncelli/AP Privacy Policy Related: Dr. Lydia Pace, the director of the Women’s Health Policy and Advocacy Program at Brigham and Women’s Hospital, said she approaches screening by examining the potential benefits and harms for each patient, like the study suggests.“I think that’s how most clinicians and most patients want to be making the decision,” Pace said.Part of that process is considering a patient’s preferences. Pace weighs a patient’s genetic profile, but also her personal fears and willingness to accept risk, when making a screening decision.Because the study is based on a hypothetical model of data in the U.K., the findings might not translate directly to the U.S. population. But that doesn’t mean its findings aren’t relevant to the U.S., Pace said. And it could reflect where screening protocols are headed: toward personalized care.last_img read more

A new venture fund will invest in reproductive medicine. Here’s what’s worth watching in the field

first_img The field of fertility medicine is booming right now. Women are waiting longer and longer to have children. Same-sex couples looking to start families are increasingly turning to in vitro fertilization. And investors are pouring money into startups pitching egg freezing and genetic testing and other services to young women.There are few observers more qualified to weigh in on this business than Dr. David Sable. Sable previously spent years as an IVF doctor and now he invests in biotech on Wall Street, as a portfolio manager for the firm Special Situations. [email protected] [email protected] By Rebecca Robbins, Adam Feuerstein , and Damian Garde Oct. 12, 2018 Reprints @damiangarde What is it? Business Damian Garde STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. @adamfeuerstein About the Authors Reprintscenter_img Log In | Learn More A new venture fund will invest in reproductive medicine. Here’s what’s worth watching in the field Tags fertilityfinanceSTAT+ Adam Feuerstein National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. GET STARTED What’s included? Wong Maye-E/AP Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDlast_img read more

Value extends beyond the cost of drugs and health care

first_img By Jennifer Bright and Mark Linthicum March 14, 2019 Reprints First OpinionValue extends beyond the cost of drugs and health care Related: The U.S. shouldn’t use the ‘QALY’ in drug cost-effectiveness reviews Jennifer Bright Adobe In the ongoing debate about value in health care, the narrative in the media, political campaigns, and congressional hearings has consistently focused on the relatively narrow issue of drug pricing.We are squandering time and resources trying to find a neat answer to “what is value?” by focusing on the cost of drugs without tackling other hard questions at the heart of measuring value across health care interventions.Determining the value of health care requires understanding both its benefits and its costs — a complex undertaking that is sadly oversimplified in the public debate. Tellingly, Novartis CEO Vas Narasimhan said recently that one of the biggest things he has learned in the past year was how little understanding there is among the public about the concept of value versus the upfront price of drugs.advertisement [email protected] As consumers are being asked to bear more responsibility for choosing and paying for health care services, it’s logical to assume they should be asked what they value. But they usually aren’t. As Centers for Medicare and Medicaid Services Administrator Seema Verma recently wrote in STAT, “Today, patients are essentially shut out of the process of defining value, when they should be at the center of it.”Patient perspectives must be sought when assessing the value of a drug, a therapy sequence, a diagnostic test, or even a hospital service. Doing so unlocks a vital understanding regarding what is important to patients — including productivity, out-of-pocket spending, convenience, and the promise of hope, among many other concerns — that can and should be considered in calculating value.There is growing consensus that incorporating sources of real-world data beyond effectiveness in clinical trials is important to understanding a treatment’s worth. Such data include health-related factors like real-world effectiveness, side effects, and impact on quality of life, as well as effects on caregivers, economic productivity, work restrictions, and broader medical costs. All of these must be considered when evaluating value. Tags drug pricinghospitalscenter_img She’s calling for a health care revolution. The radical first step: listen to patients Advanced methods to tailor value assessments to subgroups are also essential for illuminating our understanding of value. Relying only on population-wide estimates of clinical- and cost-effectiveness essentially assumes that everyone responds in similar ways to therapies, and we know that isn’t the case.Advanced value assessment platforms, including those our organization is building, strive to account for relevant value factors — especially patient diversity — that go beyond population averages. Such innovations are needed to enhance decision makers’ abilities to deliver optimized treatments most likely to benefit patients.Developing methods and building platforms that provide deeper insights into value is no simple matter, but that can’t be an excuse to throw up our hands and embrace the status quo as “good enough.”We challenge all stakeholders to commit to bringing forward new concepts and methods for measuring the value of health care. As former Congresswoman Shirley Chisholm often said: “You don’t make progress by standing on the sidelines, whimpering and complaining. You make progress by implementing ideas.”Jennifer Bright is the executive director of the nonprofit Innovation and Value Initiative. Mark Linthicum is its director of scientific communications. About the Authors Reprints While the Institute for Clinical and Economic Review’s assessments that use cost per quality-adjusted life year have dramatically moved the ball forward on assessing the concept of value, a narrow focus on “right price” overlooks other essential elements of value, like worth, utility, and importance. The challenge arises in the complexity. Monetary value is an easy calculation, while worth, utility, and importance are more difficult to define, let alone quantify. So how should health care decisions account for the more intrinsic attributes of value? By using fully transparent scientific approaches and a range of methodological tools that meet the diverse needs of all end users — patients, clinicians, employers, and others — to measure the worth of medicines and health care technologies.advertisement @IVI_health Mark Linthicum Related:last_img read more

Minnesota tries an unusual approach to make drug makers, wholesalers pay for the opioid crisis

first_imgPharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Ed Silverman Seeking to recover costs attributed to the opioid crisis, Minnesota has adopted a first-of-its kind law that requires drug makers and wholesalers that market the addictive painkillers to pay various fees.The move, which is expected to raise an estimated $20 million annually over the next five years, was designed to ensure the state has the financial means to pay for various services, such as addiction prevention and treatment, as a hedge against the outcome of lawsuits that Minnesota officials filed against various opioid makers. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What is it? [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. @Pharmalot center_img Patrick Sison/AP Minnesota tries an unusual approach to make drug makers, wholesalers pay for the opioid crisis About the Author Reprints GET STARTED Tags opioidspharmaceuticalsSTAT+ What’s included? By Ed Silverman May 30, 2019 Reprints Log In | Learn More last_img read more

What money? The CDC is urged to acknowledge industry funding

first_img Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED [email protected] Several advocacy groups petitioned the Centers for Disease Control and Prevention to stop making claims that it does not accept commercial support or have financial relationships with drug makers and other companies that may benefit from agency research.In arguing their case, the groups contend that disclaimers appear in various CDC publications, even though the agency has actually accepted tens of millions of dollars of commercial support through the National Foundation for the Centers for Disease Control and Prevention. The nonprofit, which was created by Congress to generate private sector support for the agency’s work, was launched in 1995. Log In | Learn More By Ed Silverman Nov. 5, 2019 Reprints What is it? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What money? The CDC is urged to acknowledge industry funding center_img Ed Silverman GET STARTED David Goldman/AP Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints @Pharmalot Tags government agenciesSTAT+last_img read more

Government rules led electronic health records astray. It’s time to reimagine them

first_imgFirst OpinionGovernment rules led electronic health records astray. It’s time to reimagine them Adobe [email protected] Andrew Muchmore Please enter a valid email address. About the Author Reprints Newsletters Sign up for STAT Health Tech Your weekly guide to how tech is transforming health care and life sciences. With the passage of the HITECH Act in 2009, the Department of Health and Human Services successfully pushed the medical community to adopt electronic health records. Leading that effort was the Office of the National Coordinator for Health Information Technology (ONC).After 10 years of use and billions of dollars of investment, electronic health records (EHRs) have not only failed to live up to their potential but have helped create a crisis in medicine.To be sure, developing computer software to cover modern medical care is a daunting task. But what has been virtually ignored in the blame game is how designs mandated by ONC have virtually assured that electronic health records will be poorly designed and excessively complex.advertisement For example, the protocols required electronic health record companies to create test users who were then instructed by the testing proctor to place an order for two different medications and then go back and change the order without leaving any trace that the order had been modified — something that goes against best practices. An order should never be erased once they are entered. The clinical portion was rife with other errors: test protocols that included drugs that had been withdrawn from the U.S. market, incorrect laboratory values, and the like.Another major cause of user frustration is ONC’s mandate that electronic health records force users to document to certain coding schemes. For example, providers are required to document a patient’s smoking history using the Systematized Nomenclature of Medicine — what everyone calls SNOMED — codes. There are nine different ways to “smoke” (or not), and these overlap in confusing ways.A “never smoker” is an individual who has smoked fewer than 100 cigarettes in his or her lifetime. After making that determination, however, providers have to pick from eight different ways to smoke: every day smoker, some day smoker, heavy tobacco smoker, light tobacco smoker, and the like.This kind of complexity and reliance on rigid coding systems permeated the ONC requirements. It affects how clinicians document a patient’s spoken language, allergies, ethnicity, diagnosis assigned, drugs administered, and so on. The list covers virtually every aspect of EHR documentation.To add to the complexity, there was no uniformity in the design of the back-end data. For example, one set of diagnosis codes (ICD-10) was required for reimbursement, while another more complex set of diagnosis codes (SNOMED) was required to document patient care. The net effect is that a patient’s clinical issues are stored in two incompatible formats. This duplication and inconsistency affects all aspects of documentation, from medications dispensed to procedures performed. Through a series of expert committees, ONC developed certification and testing criteria that electronic health records had to meet to become certified in 2011. By that time, my company, Codonix, had been providing clinical EHR systems for 15 years, first to hospital emergency departments and later to physician-owned clinics. It was clear to me from the beginning of the new ONC testing protocols that almost no clinical oversight had gone into their development.advertisement Related: Current electronic health records have a number of usability issues. A 2018 survey of physicians across the U.S. by Stanford Medicine and the Harris Poll found that 59% of physicians users felt that their EHR needed a “complete overhaul.” Users estimated that 62% of their time was spent entering data into the EHR, leaving only 38% of their time to be spent directly with patients. That is just one of many studies linking the use of electronic health records to physician burnout. Critics complain of complex rigid user interfaces, interminable cascading check boxes, lack of clinical content, and a focus on business and regulatory issues instead of patient care. Covid-19 will be the ultimate stress test for electronic health record systems By Andrew Muchmore March 27, 2020 Reprints Leave this field empty if you’re human: These design criteria forced EHR developers to require clinical users to follow complex coding rules, virtually guaranteeing user dissatisfaction.ONC also required electronic health record developers to support several complex and incompatible protocols used to communicate with different EHRs, with the patient, with state immunization records, and with the Department of Health and Human Services itself to report quality measures. A total of five different incompatible communication protocols are required. Because each of these require different data elements, EHR designers must force users to document encounters to meet the requirements of these various protocols. Submitting an influenza immunization message to a state registry, for example, requires users to enter the patient’s next of kin and mother’s maiden name. This level of complexity and inconsistency is not user friendly.The mission of ONC has transformed over time from one of encouraging the adoption of electronic health records to one that purports to improve health care quality through the use of ONC-mandated systems.Under the Merit-based Incentive Payment System (MIPS), users must report quality measures using a system that is so burdensome and confusing that a mini industry has sprouted up to coach and guide users on how to aggregate and submit data — if not game the system. These reporting requirements are mandated despite the overwhelming clinical consensus that this type of data submission is time consuming, probably counterproductive, and is becoming cost prohibitive.Although studies have shown that electronic health records can lead to better reporting (by which I mean box-checking), there is almost no evidence that they lead to better outcomes for patients. In Stanford’s poll, 92% of respondents felt that their EHR had little to no value for clinical decision support. In a survey conducted by the Medical Group Management Association, 76% of respondents felt that MIPS reporting played no role in improving patients’ clinical outcomes.The Department of Health and Human Services has a poor track record designing software — just think Healthcare.gov — and EHR software is several orders of magnitude more complex. As currently implemented and designed by committee, the existing ONC requirements are best described as spaghetti code.Instead of simplifying and standardizing back-end data collection — which would be transparent to the doctor, nurse, or other user and would allow EHR designers to focus on clinical usability — ONC has instead opted to use electronic health records as a reporting tool instead of as clinical a clinical documentation tool, putting the design paradigm backwards.Electronic health records should not be expected to support 28 different coding schemes and multiple communication protocols, each with their own limitations, which subtly or blatantly force users to follow certain rules. Instead, these potentially transformative systems should be designed with the provider and the patient at the center.Rather than designing clinical software, ONC should focus on analyzing, simplifying, and standardizing the huge amount of information stored in the background. Rigid, outdated, and incompatible coding and communication protocols need to be simplified and rationalized.Physicians have long been trained to document patient encounters in organized and structured ways. A medical chart should be designed so clinicians can quickly scan and abstract all of the necessary information about a patient in a short period of time. At the same time, EHRs can transparently generate a huge amount of discrete data ranging from drug codes to diagnosis codes to procedure codes. In short, normal clinical records generated by a typical electronic health record system are a treasure trove of organized and coded information; there is no need to force them into cumbersome reporting structures.Google can abstract an enormous amount of information from unstructured text. Imagine the power of similar algorithms when used to analyze health data that is not only already organized but also has a huge amount of attached discrete data. In this regard, the ONC and electronic health record makers can learn a lot from Google.Andrew Muchmore, M.D., is the founder, chairman, and chief technology officer of Codonix.last_img read more