Study: ‘Ubiquitous’ Nature Of Painkillers Lands Kids — Even Toddlers — In The ER


As the nation continues to confront an epidemic of opioid and prescription painkiller addiction and overdoses, its victims seem to flood emergency rooms. But a study out Monday highlights a surprising group of patients suffering from opioid poisoning at rates that have also marked a dramatic increase: adolescents, children and even toddlers.
Because of what the authors call “the now widespread availability of prescription opioids in the United States” — with retail sales of these medications quadrupling from 1999 to 2010 — they sought to examine for the first time the number of pediatric hospitalizations related to these drugs.
The findings, they say, indicate a need for comprehensive strategies that not only continue to tamp down on opioid prescriptions, but also step up efforts to raise awareness about the packaging and safe storage of these painkillers.

“It’s exposure. Opioids are ubiquitous now,” said Julie Gaither, a postdoctoral fellow at Yale School of Public Health and the study’s lead author. “Enough opioids are prescribed every year to put a bottle of painkillers in every household. They’re everywhere, and kids are getting into them.”
Published in JAMA Pediatrics, the study analyzed hospitalization data for children between 1997 and 2012, examining more than 13,000 hospital-discharge records for opioid poisonings and using Census data to extrapolate how common these pediatric opioid overdoses were. They used discharge records collected every three years between 1997 and 2012 by the Agency for Healthcare Research and Quality.
One possible limitation: The data stops in 2012 and, therefore, rates may not reflect a dipping or plateauing because of increased awareness of the opioid epidemic. But the findings track with adult rates of abuse and addiction, which have dropped since 2012 but remain troublingly high, experts say.
Overall, researchers found the number of children hospitalized because of opioid poisoning almost doubled during the 16-year period — from about 1.40 per 100,000 kids to 3.71 per 100,000. Much of that is likely an effect of kids getting into their parents’ medicine chests.
Specifically, the study found the rate of toddlers hospitalized more than doubled, going from 0.86 per 100,00 to 2.62 per 100,000. Many experts speculate these very young patients take the drugs because they think they are candy or a treat.
Teens are also at risk of overdosing on their parents’ meds. Of all children, this age group is most likely to get hospitalized for opioid poisoning, and are more likely to do so deliberately — likely, the researchers wrote, because teenagers are at a particularly high risk of depression. In 2012, 10.17 per 100,000 teenagers were hospitalized for opioid poisoning.
Importantly, the research underscores the need for doctors to talk to patients about ways to keep the drugs safely, especially if children are in the household, Gaither said.
That’s a good idea in theory, said Jonathan Chen, an instructor at Stanford Medical School who has researched the opioid issue. But doctors already face a lengthy list of sensitive subjects they should discuss with patients. And they aren’t always conditioned to consider how a patient’s health patterns may interact with the rest of the family.
“Conceptually, yes, of course that should be part of the conversation,” Chen said. “But there’s a lot of things we should discuss. … When I talk to a patient, I conceptualize them, and I don’t conceptualize who else is in their household as much as I should.” Chen was not involved with the study.
[caption id="attachment_671497" align="alignright" width="370"] Teenagers are the most likely to be hospitalized for opioid poisoning.[/caption]
Pediatricians could also play a role, asking parents at well-child and well-baby visits about whether there’s a risk of children being exposed to opioids. But that sort of screening hasn’t traditionally been drilled into doctors the same way as discussing household risks, such as safe storage of cleaning supplies, whether the family has a swimming pool and even whether there are guns in the home.
Doctors also may not be conditioned to considering toddlers as particularly at risk of opioid poisoning.
“This is largely seen as an adolescent problem or an adult problem,” said Sharon Levy, who directs the adolescent substance abuse program at Boston Children’s Hospital and is an associate professor of pediatrics at Harvard Medical School. “But this paper really highlights that this really knows no age boundaries.” Levy was also not involved with the study.
It’s also unclear, Levy said, what the long-term health effects are for children who ingest opioids that weren’t prescribed to them. Younger people in general are more at risk of addiction. And toddlers who take these drugs at adult doses face the danger of serious respiratory complications.
“Opioids cause respiratory suppression,” she said. “If you are a 30-pound person and getting into the medication that was supposed to be for a 150-pound person, it’s going to be a whopping dose for you.”
The findings also suggest doctors should also be more thoughtful in prescribing to children, and especially teenagers. About 1 in 10 high school students reports having taken opioids for a non-medical reason — and close to 40 percent of them say they got those drugs through their own prior prescription. Meanwhile, the American Academy of Pediatrics notes, the rate of young patients being prescribed opioids almost doubled between the 1990s and 2000s.
The Centers for Disease Control and Prevention has been pushing doctors to prescribe pills in smaller amounts, so that people don’t end up finding and taking leftovers. That could help. Large prescriptions — coupled with the fact that many people don’t know how to dispose of drugs when they finish them — can make it easier for children and teens to get ahold of them, Gaither said.
That’s an important factor to consider, Chen said. “Leftover pills aren’t used, but do they get returned to the pharmacy, or thrown in the trash? Nope. They’re stored in the medicine cabinet.”
Smaller prescriptions will likely help, but they won’t solve everything, Chen noted. After all, there are situations where a larger opioid dosage makes sense. For instance, someone suffering long-term cancer probably needs a larger amount of heavy duty painkillers, even if he or she has children in the house.
But children must be a part of the conversation, Gaither said.
“We’ve got to pay attention to children and the toll the opioid crisis is taking on them,” she said. “Kids make up about a fourth of the U.S. population, and they’re suffering from this crisis, too.”

Insurers, Hospitals Clash Over Help Paying Obamacare Premiums


MADISON, Wis. — Having health insurance is vital for 21-year-old Mercedes Nimmer, who takes several expensive prescription drugs to manage multiple sclerosis. So Nimmer was thrilled to get health insurance last year through the Affordable Care Act’s marketplace and qualify for a federal subsidy to substantially lower her cost.
Yet, the government assistance still left her with a $33 monthly premium, a hefty amount for Nimmer, who makes $11,000 a year as a part-time supply clerk.
Nimmer, though, doesn’t have to worry about even that expense thanks to a United Way of Dane County program that has provided premium assistance to about 2,000 low-income people since 2014. The program, called HealthConnect, is funded by a 2013 gift of $2 million from UW Health, a large academic hospital system connected to the University of Wisconsin that also runs its own marketplace health plan.
“Oh my gosh, this is a big deal for me to get this help,” Nimmer said, noting the insurance is vital to cover her medications. The money she saves from the assistance program goes to help pay for gas to get to work, she said.
HealthConnect is one of several community-based programs across the United States helping thousands of lower-income Americans with their Obamacare marketplace premiums. Similar efforts operate in Texas, Oregon, Washington, North Carolina and South Carolina.

But premium assistance programs have come under fire from insurers. They argue that it is not fair for hospitals, other health providers and disease advocacy groups financed by providers to try to steer people who could be covered by Medicare or Medicaid into marketplace plans with higher reimbursement rates.
The federal government has banned hospitals from directly subsidizing patients’ health insurance premiums. But America’s Health Insurance Plans, the industry’s lobbying group, wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers with a financial interest in the patient’s care.
“In many cases these practices are harming patients and undermining the individual market by skewing the risk pool and driving up overall health care costs and premiums,” AHIP said in Sept. 22 letter to Andy Slavitt, the acting administrator of the Centers for Medicare & Medicaid Services. The letter notes specific concerns about plans assisting patients requiring kidney dialysis. It says one insurer saw its spending on those patients rise from $1.7 million in 2013 to $36.8 million in 2015 when the number of patients with serious kidney disease rose from 28 to 186.
AHIP officials also said patients could face consequences if the third-party groups stop paying premiums or the government determines patients are receiving a federal subsidy for which they are not eligible.
[caption id="attachment_671140" align="alignright" width="270"] America’s Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.[/caption]
In response, CMS says it is considering new rules for third-party payment programs.
Nonetheless, insurers are taking action. Aetna, which announced this summer that it was scaling back its marketplace offerings, said that third-party groups steering patients to the individual market had contributed to an unhealthy mix of customers in its marketplace plans.
Blue Shield of California in July filed suit in a state court against CenCal Health, which manages the Medicaid program in Santa Barbara and San Louis Obispo counties. Blue Shield alleges that CenCal was avoiding millions of dollars in medical care claims by enrolling around 40 of its very ill members in Blue Shield’s individual health plans and paying the premiums on their behalf. CenCal denied the allegations in lawsuit, saying it paid the patients’ monthly Blue Shield insurance premiums so they could afford private insurance. It has since discontinued the practice.
UnitedHealthcare filed a lawsuit in federal court in July against kidney dialysis provider American Renal Associates, accusing it of encouraging patients in Florida and Ohio who were eligible for Medicaid or Medicare to move to the insurer’s commercial plans to extract up to 20 times more than the $300 or so that the federal programs pay in reimbursements. American Renal Associates has said the suit is without merit.
The suit alleges that the patients’ premiums were paid by the American Kidney Fund, an advocacy group for patients.
AHIP officials note that the fund is supported by dialysis providers who stand to benefit financially from patients gaining marketplace coverage over payments from Medicaid or Medicare.
The nonprofit American Kidney Fund has helped more than 6,400 people with their marketplace premiums. The fund’s officials said it’s not trying to steer people away from government coverage but trying to help those who otherwise couldn’t afford coverage.
“It is critically important to emphasize that people with disabilities in general — and with end-stage renal disease in particular — should not be broadly excluded as a class from the insurance marketplace if they are unable to afford their health insurance premiums,” LaVarne Burton, the fund’s CEO, said in a statement.
Some patient advocates, like those at HealthConnect in Wisconsin, say third-party payers have an important role in helping low-income customers afford their coverage. UW Health said in a statement that HealthConnect helps all providers, including UW Health, by reducing the number of uninsured patients and potentially helping people seek care earlier in their illness.
The program pays an average of $109 monthly per person in premium assistance. For every dollar spent, HealthConnect generates $2.26 in federal subsidies, said Krystal Webb, a spokeswoman for United Way of Dane County.
United Way said it structured HealthConnect to avoid a conflict of interest. Eligible people first buy their policy, which can be any of several silver-level plans on the federal marketplace. After that, they can apply for a HealthConnect subsidy. The program is administered by United Way, and UW Health plays no role in patients’ choice of health plan, although its marketplace plan, Unity Health, refers people who may be eligible there.
Despite AHIP’s concerns, some health insurers in Dane County say HealthConnect is filling a need, according to interviews with several plans. “We support United Way’s HealthConnect efforts as a way to provide affordable insurance options to the residents of Dane County,” said a spokesman for Dean Health Plan, one of the larger marketplace plans in the county.
In Texarkana, Texas, Christus St. Michaels Health System donated $200,000 last year to an assistance program serving 138 people with marketplace coverage. The program is run by a local government agency called the Ark-Tex Council of Governments, and Christus has no control over who enrolls or what plan they choose.
“Our mission is to help the poor and this is certainly one of the ways to do that, and it gives people the opportunity to have health coverage when they normally wouldn’t,” said Mike Hargrave, the hospital’s manager of employee assistance and community outreach services. People with incomes between 100 and 150 percent of the federal poverty level (about $11,880 to $17,820 for an individual) are eligible.
Hargrave doesn’t deny the hospital could benefit when more people gain insurance, but he notes other hospitals in the region benefit, too.
The insurance industry is also troubled by premium assistance programs funded by anonymous donors since they could be hospitals looking to protect their identity, said AHIP spokeswoman Clare Krusing.
For example,, run by United Way of the Greater Triangle in North Carolina helps more than 850 people with incomes between 100 percent to 175 percent of the federal poverty level in Durham, Orange and Wake Counties.
An anonymous donor provided $1.2 million in funding for the program, said Melanie David-Jones, a senior vice president for United Way. She would not say why the donor wished to remain anonymous.
Noel Pitsenbarger, 48, of Durham, said the program made it possible for him to have health insurance this year by covering the $200-a-month premium for his Blue Cross Blue Shield of North Carolina policy. With insurance, he said, he got a colonoscopy, physical exam and help paying for several medications. And it saved him from having to pay a $1,000 bill after he cut his finger and had to go to the emergency room.
“It’s been extremely beneficial,” he said.

Sounds Like A Good Idea? High-Risk Pools

This is the third in a series of videos about campaign health proposals that “sound like a good idea.” This one explores why a Republican suggestion to establish a new federal high-risk insurance pool may not be such a good idea after all.
The first video in KHN’s “Sounds Like A Good Idea” series examined selling insurance across state lines. The second dealt with regulating drug prices. Scroll down for the full transcript.
For more information on the high-risk pools, see earlier KHN coverage: House Republicans Unveil Long-Awaited Plan To Replace Health Law.
And from other sources:
The Kaiser Family Foundation: High-Risk Pools For Uninsurable Individuals Health Insurance And High-Risk Pools
Video Transcript:
One of the main goals of the Affordable Care Act was to help people get insurance who couldn’t get it before. Particularly people with pre-existing health issues who buy their own coverage.
Before the health law passed in 2010, insurers could just say no and not sell policies to sick people at any price. Even minor problems could get you turned down.
Now, that’s illegal. And insurers can’t charge sick people more either. The health law also says everybody has to buy insurance – that mandate is supposed to help bring more healthy customers to insurers.
But that piece of the law isn’t working very well right now. Insurers say too many sick people have been buying insurance, and not enough healthy people have been joining them.
That can help cause premiums to rise, and insurers to lose money. Some companies say they are losing too much and have stopped offering coverage in the health exchanges.
One way Republicans say the system could be fixed is by returning to something called a high-risk pool.
The idea is to let all the sick people buy their policies in a separate insurance pool, and then have insurance companies and states and the federal government all chip in to pay for their care and keep their premiums low.
Before the Affordable Care Act, 35 states had high-risk pools.
The federal government had one, too, as a transition to the health law. But none of them worked very well.
The biggest problem? Both premiums and other costs remained too high for many people with health conditions to afford. The federal program ran out of money almost a year before it was scheduled to end.
Sometimes the pools got so expensive for states that they had to impose waiting lists for coverage.
And often, to keep costs down, risk pools set up waiting periods before they started paying bills for the very illness that made people high risk.
Republicans say their new risk pools plan would be better than the old ones. Their plan says it would keep premiums low, and no wait lists would be allowed.
But it’s not clear that the $25 billion in federal funding they propose would be enough, or that states would step in to help fund the pools.
So high risk pools are another idea that sounds good, but that’s very hard to make work in the real world of health care.

Presidential ‘Parity’ Panel Offers Steps To Treat Mental Illness Like Other Disease

Acknowledging that “there is more work to be done” to ensure that patients with mental illness and addiction do not face discrimination in their health care, a presidential task force made a series of recommendations Friday including $9.3 million in funding to improve enforcement of the federal parity law.
The long-awaited report is the product of a task force President Barack Obama announced in March during a speech about the opioid epidemic.
“These disorders affect society in ways that go beyond the direct cost of care,” the report authors write. “Without effective treatment, people with these health conditions may find it difficult to find or maintain a job, may be less able to pursue education and training opportunities, may require more social support services, and are more likely to have their housing stability threatened.”
Since the passage of the Mental Health Parity and Addiction Equity Act in 2008, health insurers and employers have made progress toward improving coverage for mental health and substance abuse issues. Most insurance plans, for example, no longer charge higher copays or separate deductibles for mental health care.

But there have been significant problems with the parity law, too, including lax enforcement and little guidance for the public about the law itself or how to file a complaint.
Over the past seven months, the task force received 1,161 public comments from patients, families, insurers, advocates, state regulators and others. Based on the findings, the group has taken several actions.
The Centers for Medicare & Medicaid Services is awarding $9.3 million to states to help enforce parity protections. California, New York, Massachusetts, Oregon and Rhode Island were cited as models of promising enforcement efforts.

A new government website will help consumers identify the right agency to assist with their parity complaints and appeals.

A newly released consumer guide will help patients, families and providers understand their rights and look into whether they have experienced a parity violation.

The Department of Labor will report each year on its investigations into parity violations.
In addition, the task force recommended that the government increase its capacity to audit health plans for parity compliance and allow the DOL to assess civil monetary penalties for violations.
Former congressman Patrick Kennedy, one of the authors of the parity law, said the report and actions were a step in the right direction. “However, much of what was released today still places the burden of real action squarely on the shoulders of the patients living with these conditions,” he said in a written statement. “[We] are asking these individuals to take up their own cases when they experience a parity violation, which usually occurs at the height of their crisis.”
The next administration, Kennedy added, will need to be vigilant in enforcing the parity law.
America’s Health Insurance Plans, the insurance industry’s main trade group, gave its support to the task force’s finding. “Health plans are committed to parity. We will continue to work hard to implement these changes,” AHIP said in a statement. “The report also recognizes the need for clearer, more consistent guidance on parity compliance for everyone.”
The American Psychiatric Association was also on board. “Adoption of the Task Force recommendations is essential to achievement of parity for patients with mental illness,” said Dr. Saul Levin, the CEO and medical director of the association. “APA trusts that Congress and the Administration will work together to ensure that the recommendations become reality.”
But even if the recommendations of the task force are successfully implemented, Benjamin Miller, director of the health policy center at the University of Colorado School of Medicine, said true parity will only come from erasing the lines between “mental” and “physical” health care.
“Separate is not equal — mental health is core to health,” said Miller. “People do not see themselves as a disease or a select health benefit, but rather a person who has needs. Benefits and payments should follow the person, address their needs, and address the whole of their health.”

The 10 Most Unanswered Questions about Health

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FDA Faults 12 Hospitals For Failing To Disclose Injuries, Deaths Linked To Medical Devices


Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston and New York, failed to promptly report patient deaths or injuries linked to medical devices.
The Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.
Some of the reporting lapses were found at Massachusetts General Hospital in Boston, NewYork-Presbyterian Hospital and two hospitals in Los Angeles — the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center.
Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the violations pointed to a larger problem among hospitals nationwide in reporting patient harm tied to medical devices.
“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote in an agency blog post his week. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA’s medical device reporting requirements.”
Under federal rules, hospitals must within 10 days report serious injuries potentially caused by devices to the manufacturer and notify both the manufacturer and the FDA about any deaths that may have resulted. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device.
Among the 17 hospitals reviewed, the FDA said six didn’t properly report both patient deaths and injuries linked to devices within 10 days as required. Five other hospitals didn’t report serious injuries in a timely manner, according to the FDA. The inspection at one hospital, NewYork-Presbyterian, focused only on a death.

NewYork-Presbyterian said it filed medical device reports “in accordance with FDA regulations” and none of the agency’s findings related to the quality or safety of patient care.
It’s hard to discern what devices were involved or other details in many of these cases because the inspection reports are brief and partly redacted by the FDA. The inspection reports indicate that in some cases hospitals reported events late and in others not at all.
At Massachusetts General, an FDA investigator found reporting delays of 10 months and 18 months in two separate patient deaths related to devices.
In a statement, hospital spokeswoman Terri Ogan said the FDA’s findings all have been addressed. “Massachusetts General Hospital takes its reporting obligations very seriously and strives to comply with all requirements in a comprehensive and timely manner,” she said.
At Huntington Memorial Hospital in Pasadena, Calif., an FDA investigator found that a patient died from complications related to a multi-drug resistant infection and cardiac arrest following a procedure involving a duodenoscope, a long and flexible instrument put down a patient’s throat.
According to FDA records, the hospital learned through test results that the patient’s infection was likely related to 14 other confirmed infections caused by contaminated duodenoscopes. “However, this death was not reported to the FDA and the manufacturer by your facility,” the FDA inspector wrote in a December 2015 report.
A spokeswoman for Huntington Memorial, Eileen Neuwirth, said “we have taken steps to ensure rigorous compliance going forward.”
The FDA findings underscore concerns raised by a U.S. Senate report in January, which exposed reporting failures by hospitals as well as mistakes by device makers that contributed to multiple superbug outbreaks across the U.S. from contaminated duodenoscopes. The FDA’s oversight of medical devices was also faulted in the report.
As many as 350 patients at 41 medical centers worldwide have been infected or exposed to contaminated duodenoscopes from 2010 to 2015, according to the FDA.
The agency initiated its investigation of hospitals’ reporting in December 2015, a month before the Senate report was released. But the agency was already under fire by then for spotty oversight of duodenoscope manufacturers and other devices.

Shuren said in his blog post that the agency focused on hospitals where safety issues had occurred involving either duodenoscopes or power morcellators, a surgical tool used in hysterectomies. Morcellators are used to cut up benign growths called fibroids, but the FDA has warned about the device spreading cancerous tissue in the abdomen and pelvis. The investigators examined incidents involving other devices as well.
Other than publicly announcing the violations, Shuren said the agency didn’t plan on taking further action against the hospitals. Instead, he said he wants to work with the hospital industry to improve monitoring of devices.
“We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path,” Shuren wrote.
Lawmakers, health policy experts and the FDA have proposed various reforms aimed at strengthening device surveillance, including tracking insurance claims data to supplement the injury reports and automating “adverse event” reports through electronic health records.
The issue may take on more urgency after federal authorities this month highlighted the infection risk from yet another commonly used device — heater-cooler units used in open-heart surgeries. The FDA is holding a public meeting Dec. 5 on improving hospital-based surveillance of devices.
According to the FDA, the hospitals that didn’t report deaths as required were Advocate Lutheran General in Park Ridge, Ill.; Huntington Memorial Hospital; Reading Hospital and Medical Center in West Reading, Pa.; Allegheny General Hospital in Pittsburgh; NewYork-Presbyterian; and two in Boston — Brigham and Women’s Hospital and Massachusetts General.
The agency said those that failed to report serious injuries in time were UCLA; Cedars-Sinai; Virginia Mason Medical Center in Seattle; UMass Memorial Medical Center in Worcester, Mass.; and Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
The FDA inspection for Advocate Lutheran General Hospital refers to 10 deaths related to a scope-related outbreak of carbapenem-resistant enterobacteriaceae, a superbug known as CRE. But a spokeswoman for the hospital said a “review of medical records in all 10 cases confirmed the cause of death was not linked to CRE.”
Dr. Leo Kelly, vice president of medical management at Advocate Lutheran, said in a statement the hospital will continue to work with the FDA and manufacturers “to ensure the safety and well-being of our patients.”
Many of the hospitals involved said they welcomed the agency’s feedback and supported efforts to improve device oversight.
Cedars-Sinai said the FDA’s findings related to its use of a surgical stapler in June 2015.
UCLA said it promptly reported scope-related cases to the FDA but the agency asked for duplicate reports through a separate system.
Suzanne Anderson, president of Virginia Mason Medical Center, said the FDA’s recommendations on device reporting “will ultimately enhance patient safety across the country.”
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.