Canada May Decide It’s Less
Canada’s top health agency is considering lowering the maximum recommended daily dose of acetaminophen, the active ingredient in Tylenol and other pain relievers.
Citing the risk of liver damage from overdosing on the popular pain medication, Health Canada announced it will review changes to labels, the creation of an educational awareness campaign and possible revisions to dosage recommendations.
Acetaminophen is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. In severe cases, acetaminophen overdose can cause death.
“Our goal is that we will have fewer effects on liver, less hospitalization, less instances of unintentional overdose, and we have more people that are informing themselves about all the products that they use, not just acetaminophen,” Supriya Sharma, senior medical adviser for Health Canada’s Health Product and Food Branch, told the Toronto Star, in an interview.
The announcement comes after the Star published a lengthy investigation last year on the potential dangers of acetaminophen. The Star, which was assisted in its reporting by ProPublica, found that acetaminophen use in Canada had been responsible for hundreds of deaths, tens of thousands of hospitalizations and tens of millions of Canadian dollars in health-care system costs over the last decade.
An earlier ProPublica investigation done in collaboration with This American Life examined the toll of acetaminophen in the United States. The investigation found that 1,500 people in the U.S. had died and tens of thousands more had been hospitalized as a result of overdosing on acetaminophen over the past 10 years.
ProPublica and This American Life also found that the Food and Drug Administration had delayed implementing safety measures for decades. McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol, had worked to repeatedly block tougher safety warnings on its billion-dollar product.
Both investigations found a common problem known as “double dipping.” Acetaminophen is present in hundreds of over-the-counter medicines. Thus, people may take several medicines containing acetaminophen — say Tylenol and Theraflu — and not realize that they have exceeded the maximum recommended daily dose of acetaminophen, which is four grams, or eight 500-mg pills.
Another problem with acetaminophen: While generally recognized as safe and effective, the drug has a narrow safety margin — the dosage that can help is relatively close to the dosage that can begin to affect liver function. Some studies have suggested that liver damage can result from taking a few additional pills over the recommended daily dose for several days.
Canada and the United States are among the few industrialized nations in the world to allow unlimited access to acetaminophen. Countries such as Britain, France and Germany restrict access to the amount of acetaminophen that can be purchased, as well as the amount of medicine in an individual pill.
In response to the ProPublica story, McNeil said the company has always put consumer health first and that Tylenol is safe as long as it is used as directed.
After a 2009 FDA hearing in which experts raised new concerns about acetaminophen safety, McNeil changed the label on its Tylenol product to recommend no more than 3 grams, or six extra-strength tablets, per day.
The company maintains that acetaminophen’s safety compares favorably with other over-the-counter pain medications. (The FDA recently announced additional warnings about the risk of heart attacks of taking non-steroidal anti-inflammatory drugs, or NSAIDs, found in popular brands such as Advil.)
“McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk,” the company wrote in an emailed statement.
“We will continue to work hard to educate and warn consumers of the dangers of acetaminophen overdose, reminding them to read the labels on all medicines before taking them, to take medicines only as directed and to be aware that any medicine they take has risks.”
The FDA did not respond to a request for comment on Friday. The agency has previously acknowledged that its procedure for regulating over-the-counter drugs, known as the monograph process, is cumbersome and slow. More than 38 years have passed since the FDA first began hearings on acetaminophen, and the FDA has yet to issue final guidelines on the safe use of the drug.
Last year, the agency announced that it would begin to review the monograph process in order to improve it.
It has yet to take any action.
Related stories: Read the original investigation and see all of our acetaminophen coverage.
by T. Christian Miller and Jeff Gerth ProPublica
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Header image: Niloo / Shutterstock.com
Popular Blood Thinner Causing Deaths, Injuries at Nursing Homes
When Loren Peters arrived in the emergency room in October 2013, bruises covered his frail body, and blood oozed from his gums.
The 85-year-old had not been in a fight or fallen down. Instead, he had been given too much of a popular, decades-old blood thinner that, unmonitored, can turn from a lifesaver into a killer.
“My goodness, I’ve never seen anything like it,” recalled Lorna Finch, Peters’s daughter, of the ugly purple bruise that sprawled from the middle of her father’s stomach to his hip. “It was just awful.”
Peters took Coumadin at his Marshalltown, Iowa, nursing home because he had an abnormal heart rhythm, which increases the risk of stroke. It’s a common precaution, but the drug must be carefully calibrated: too much, and you can bleed uncontrollably; too little, and you can develop life-threatening clots.
When nursing homes fail to maintain this delicate balance, it puts patients in danger. From 2011 to 2014, at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or its generic version, warfarin, a ProPublica analysis of government inspection reports shows. Studies suggest there are thousands more injuries every year that are never investigated by the government.
“It’s an insidious problem,” said Rod Baird, president of Geriatric Practice Management, a firm that creates electronic health records for physicians working in long-term care facilities. Because it’s so easy to get wrong, “Coumadin is the most dangerous drug in America.”
Nursing homes around the country are routinely cited for lapses that imperil residents, from letting those with dementia wander off to not stopping elders from choking on their food. For years, advocates, researchers and government officials have worried about the overuse of antipsychotic medications that can put elderly patients into a stupor and increase their risk of life-threatening falls. A national initiative helped reduce the use of such drugs among long-term nursing home residents by 20 percent between the end of 2011 and the end of 2014.
But the dangers of the widely used Coumadin have drawn relatively little scrutiny, perhaps because the drug has clear benefits. Still, improper use has caused some patients incalculable suffering and, in some cases, greatly hastened deaths.
Dolores Huss, an 89-year-old grandmother of eight, died from internal bleeding after a San Diego facility gave her an antibiotic that multiplies the effects of Coumadin then didn’t alert her physician that she needed additional blood tests to measure how long it was taking her blood to clot.
Shirley Reim, recovering from hip surgery, was hospitalized with blood clots in her legs after a Minnesota nursing home failed to give her Coumadin for 50 days in a row and also didn’t perform the blood test ordered by her doctor. She suffered permanent damage. Details of the cases come from government inspection reports and lawsuits filed by the patients’ families, which were settled confidentially.
Periodic inspections document hundreds of additional errors that were caught early enough to prevent serious harm, but the real toll is likely much higher, experts say.
A 2007 peer-reviewed study in The American Journal of Medicine estimated that nursing home residents suffer 34,000 fatal, life-threatening or serious events related to the drug each year. North Carolina data shows more medication errors in nursing homes involving Coumadin than any other drug.
Despite such evidence, Coumadin deaths and hospitalizations have drawn only limited attention from the Centers for Medicare and Medicaid Services, the federal agency that regulates nursing homes. Federal officials haven’t tallied Coumadin cases to see the full extent of the damage or identify common problems involving the use of the drug. Neither has the American HealthCare Association, the trade group for nursing homes.
The government investigates incidents like the one involving Peters that trigger complaints or surface in routine inspections. Sometimes, CMS slaps homes with “immediate jeopardy” citations, fining them and threatening to cut off federal funding if quick action isn’t taken. Villa del Sol, where Peters lived, received such a citation related to his care and was fined $33,345.
More commonly, though, homes are not fined and are simply asked to correct the problems and put policies in place to keep them from happening again, ProPublica’s analysis shows.
Last year, the Department of Health and Human Services identified Coumadin and other anticoagulants as one of the drug categories most frequently implicated in “adverse drug events,” calling on government agencies to work on solutions. In a statement, CMS, which is part of HHS, said it is raising awareness of such events, training its inspectors to do a better job at identifying them and working with nursing homes to prevent them.
In Peters’s case, no one at the nursing home conducted the blood test needed to see the effect Coumadin was having, even as bruises spread across his body over a two-week period, government inspectors later found. Peters never recovered, dying a few days after he was brought to the hospital.
Villa del Sol recently changed its name to Hawkeye Care Center Marshalltown. Doug Johnson, president of the home’s parent company, Hawkeye Care Centers, declined to comment by e-mail. “We adhere to privacy rules and practices and do not comment on litigated matters.”
A Breakthrough Drug, With Risks
Coumadin’s roots go back to the 1940s, when scientists at a nonprofit affiliated with the University of Wisconsin at Madison 2014 the Wisconsin Alumni Research Foundation 2014 came up with a rat-and-mouse killer called warfarin, a play off the nonprofit’s initials.
It was derived from a chemical in spoiled sweet clover that had caused cattle to bleed to death after dehorning, castration and other procedures. The substance disrupted the clotting process, so that animals hemorrhaged internally and died.
In the 1950s, drugmaker Endo Laboratories began selling warfarin for human use under the brand name Coumadin. It is in a category of drugs known as anticoagulants. An early user was then-President Dwight D. Eisenhower, who was prescribed the medication after having a heart attack.
Coumadin was a breakthrough for patients with an array of heart troubles associated with blood clots. These include abnormal heart rhythms, along with pulmonary embolisms and deep vein thrombosis.
But the drug interacts badly with certain foods and medications, particularly antibiotics, and it requires regular blood tests to ensure it’s working as intended. The test measures the time it takes for blood plasma to clot.
In Medicare’s prescription drug program, known as Part D, 2.4 million seniors and disabled people filled at least one prescription for warfarin, the generic of Coumadin, in 2013, making it one of the most-used drugs. About 280,000 were prescribed brand-name versions, Coumadin and Jantoven. Many people, including health inspectors, continue to call the generic versions Coumadin because it is so well known.
About 1 in 6 of the nation’s 1.3 million nursing home residents take an anticoagulant, according to federal data from earlier this year; the majority are believed to be on Coumadin or its generic.
Newer anticoagulants, including Eliquis, Pradaxa and Xarelto, have entered the market in recent years and, in some ways, are easier to use than Coumadin. Patients taking these drugs don’t need regular blood tests and don’t have to avoid certain foods.
But unlike Coumadin, the effects of which can be reversed with vitamin K, there currently is no antidote if patients taking the newer drugs begin bleeding uncontrollably.
Some doctors also are reluctant to use the new drugs on seniors, particularly those with multiple health problems, because they carry their own risks, including gastrointestinal bleeding.
2018Perfect Setup for Bad Things’
Coumadin is tricky to manage even for otherwise healthy patients who don’t live in nursing homes. A study published last year by the lab company Quest Diagnostics found that patients taking Coumadin or its generic had lab results showing that the drugs had the desired effect only 54 percent of the time.
A 2011 report in the New England Journal of Medicine found that the drug accounted for some 33,000 emergency hospitalizations among the elderly from 2007 to 2009, more than twice as many as the next highest drug, insulin. The study did not look exclusively at nursing home residents.
Given Coumadin’s challenges 2014 and the coordination required among doctors, nurses, pharmacists and laboratories 2013 nursing homes are the “perfect setup for bad things happening,” said Jerry Gurwitz, chief of geriatric medicine at the University of Massachusetts Medical School. Since the 1990s, when he first wrote about the problems of Coumadin in nursing homes, “very little, unfortunately, has changed,” he said.
Federal inspection reports repeatedly cite the same types of problems: patients not getting the drug as ordered, or given the wrong doses, or given without a doctor’s order.
A Texas nursing home resident received Coumadin for 34 days “without a physician order or adequate monitoring.” Blood was pooling in his mouth when he was sent to the hospital. A patient at a Minnesota home needed three surgeries for a blood clot in the left leg after not receiving 17 doses of the medication.
Failure to monitor the drug can lead to dangerous side effects. At a North Carolina home, a patient on Coumadin wound up in the hospital after no clotting tests were done for a month. An internal review found that a nurse “mistakenly put the February labs on the wrong month.”
Sometimes, the tests were done, but nursing homes didn’t alert doctors when the results were abnormal. At a Maine nursing home, a doctor wasn’t told when lab results showed a resident’s blood took too long to clot. Days later, when staff assisted the resident to the bathroom, the resident passed out and had no heartbeat. It is unclear if the resident survived.
In several cases, patients taking Coumadin fell, and nursing homes were cited for not doing enough afterward to ensure their safety. In Arkansas, a resident on the drug fell and hit his head during exercise class. A nurse said she didn’t call his doctor because the doctor “didn’t like to be called at night unless it was an emergency.” The resident died from the consequences of massive bleeding in the brain.
Vigilance Difficult to Enforce
Most patients who are taking Coumadin need it, experts agree. But problems with monitoring occur even at facilities trying to be vigilant.
A report published last year in The Consultant Pharmacist journal found that 12 New York nursing homes given tools to improve how they handled patients on Coumadin 2014 including staff education programs 2014 largely failed to improve their management of the drug.
“Improvements were not seen despite active intervention,” the report’s authors wrote. “If long-term care facilities are unable to voluntarily implement necessary improvements, then regulatory changes may be necessary to assure patient safety regarding anticoagulant use.”
David Gifford, senior vice president of quality and regulatory affairs at the American Health Care Association, said Coumadin errors can’t be viewed in isolation. “Those that approach one area at a time, they’re chasing their tail and they’re not going to see improvements,” he said. “This week, the soup du jour is Coumadin errors 2026 then next week, it’s insulin errors.”
The association recently announced a quality initiative aimed at, among other things, reducing “unintended health care outcomes” 2014 a broad category that covers various types of errors, including those involving medication.
Some long-term care associations say it would be better for CMS to work with the nursing home industry to change its practices rather than to take each incident in isolation, using citations and other sanctions to bring homes in line. Another concern is not to discourage doctors from prescribing Coumadin.
“It may be distorting a little bit to look at the immediate jeopardy outcomes [cited by regulators] without looking at the overall population that’s on it and needs to be on it,” said Cheryl Phillips, senior vice president of public policy and advocacy at LeadingAge, an association of nonprofit senior service organizations. “In fact, to not put people on blood thinners is a huge risk and in many cases malpractice.”
2018Things Didn’t Get Any Better’
Peters, a retired factory worker, moved into Villa del Sol in 2011 with his wife of more than 60 years, Arleta, who had fallen and could no longer walk on her own.
In September 2013, during a weeklong hospital stay, Peters was diagnosed with a variety of abnormal heart rhythms and sent back to the nursing home on Coumadin, the government’s inspection report said.
Both the hospital and Peters’s doctor left instructions for the nursing home to give him a particular test to assess his clotting rate. But it was never done. Instead, the staff gave him a different test intended for patients taking heparin, another blood thinner.
One nurse told inspectors that “it never occurred to her to look to see if the blood work was for what the physician ordered.” Another said “it never occurred to her that this resident was on Coumadin” and needed his blood monitored, according to the government report.
In the first two weeks of October, staff members made several notes in Peters’s chart about bruises on his body. Several entries mentioned scattered bruising; one noted a large bruise on the right abdomen that was purple in the center, green and yellow on the outside. The nurses decided among themselves that the bruises must have been from the lift they used to transfer him, the inspection report said.
Peters was taken to the emergency room after midnight on Oct. 15, 2013, because of the bleeding from his gums. There, a quick test showed that his blood took so long to clot that he might never stop bleeding on his own 2014 a result his doctor told inspectors she’d never seen before.
The doctor later told an inspector that Peters’s bruises were so “horrible” she asked the hospital to take pictures of them. (Photos were taken, said Jeffrey Pitman, an attorney for Peters’s family.)
“They had to have noticed the bruises, and why didn’t they do something about it?” said Finch, Peters’s daughter, who is considering a lawsuit against the home.
At the hospital, doctors gave Peters vitamin K to try to counteract the Coumadin.
He grew confused, agitated, almost belligerent. He had trouble breathing.
“It just got to a point where things didn’t get any better,” said Finch, 59. “I asked his doctor: 2018What really is going on here? Do we have any hope of getting Dad back?’2009[The doctor] said, 2018You know he’s pretty weak.'”
As hopes for Peters faded, his wife, too, became ill and was taken to the same hospital. Peters’s family decided to move him to his wife’s room so they could be together for his final hours.
When Peters was wheeled into the room, he was “pretty much unresponsive,” inspectors wrote. “However, when they put [his] spouse’s hands in [his], the resident woke up and was able to talk.”
He died the next morning; Arleta, three weeks later.
“When Dad passed away, she quit,” Finch said. “She just broke down and she screamed, 2018I am so mad at him, he didn’t take me with him.'”
Look up a nursing home’s record using ProPublica’s Nursing Home Inspect tool.
by Charles Ornstein, ProPublica. This story was co-published with The Washington Post.
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The federal government released detailed data on nearly 1.4 billion prescriptions dispensed to seniors and disabled people in the Medicare program in 2013, bringing more openness to the medication choices of doctors nationwide.
The data release comes two years after ProPublica reported that the Centers for Medicare and Medicaid Services had done little to detect or deter hazardous prescribing in its drug program, known as Medicare Part D. ProPublica analyzed several years’ worth of prescription data, obtained under the Freedom of Information Act, and created a tool called Prescriber Checkup that lets users compare individual physicians to others in the same specialty and state.
But Medicare itself hadn’t made this information easily accessible—until now.
“This transparency will give patients, researchers, and providers access to information that will help shape the future of our nation’s health for the better,” said acting CMS Administrator Andy Slavitt in a statement accompanying the data’s release.
The information released by CMS is part of the agency’s data transparency initiative. In recent years, CMS has released data on hospital charges, geographic variations in the way health care is delivered, and Medicare’s payments to doctors. The payment data, first released last year, came after the Wall Street Journal and its parent company challenged a long-standing legal injunction that had kept the information private.
Medicare changed its approach to overseeing Part D after the ProPublica reports.
Before, agency officials insisted that monitoring problem prescription patterns fell to the private health plans that administer the program, not the government itself. Congress never intended for CMS to second-guess doctors – and didn’t give it that authority, officials said.
Doctors didn’t even have to be enrolled in Medicare to prescribe to patients in Part D, making it impossible for the program to know basic facts about whether the prescriptions these doctors wrote were appropriate.
Since our reports, CMS has moved to fix Part D’s excesses and blind spots. In May 2014, the agency gave itself the authority to expel physicians from Medicare if they are found to prescribe drugs in abusive ways. Beginning next month, the agency also will compel health providers to enroll in Medicare to order medications for patients in Part D, closing the loophole that has allowed some practitioners to operate with little or no oversight.
Medicare Part D is popular among seniors for helping to lower their drug costs. But experts have complained that since Part D began in 2006, Medicare has placed a higher priority on getting prescriptions into patients’ hands than on targeting problem prescribers. The U.S. Department of Health and Human Services’ inspector general has repeatedly called for tighter controls.
Among ProPublica’s findings:
- Medicare had failed to use its own records to flag doctors who prescribed thousands of dangerous, inappropriate or unnecessary medications.
One Miami psychiatrist, for example, wrote 8,900 prescriptions in 2010 for powerful antipsychotics to patients older than 65, including many with dementia. A black-box warning on the drugs says they should not be used by such patients because it increases their risk of death. The doctor said he’d never been contacted by Medicare.
ProPublica also found that many of the top prescribers of the most abused painkillers had been charged with crimes, convicted, disciplined by their state medical boards or terminated from Medicaid. Nearly all remained eligible to prescribe in Medicare.
- Medicare wasted hundreds of millions of dollars a year by failing to rein in doctors who routinely give patients pricey name-brand drugs when cheaper generic alternatives are available.
- The top prescribers of some drugs received speaking payments from the companies that made them.
- Medicare’s process of flagging fraud was so convoluted and ineffective that the program was losing millions of dollars to schemes. Though the number of prescriptions attributed to Florida kidney specialist Carmen Ortiz-Butcher more than quadrupled in a year and the cost of her drugs to Medicare spiked from $282,000 to $4 million, Medicare didn’t ask any questions until Ortiz-Butcher realized that her prescription pads had been stolen and falsified.
The data released by Medicare today includes summary information, such as the total number of prescriptions written by each doctor in 2013, as well as more detailed information about each drug a doctor prescribed. It covers prescriptions worth more than $103 billion, not including rebates that lower the cost by an undisclosed amount.
The top prescribed drug in the program in 2013 was the blood pressure drug Lisinopril, prescribed 36.9 million times, including refills. Medicare spent the most on Nexium, $2.5 billion, not including rebates. The drug taken by the most Part D patients was the narcotic hydrocodone-acetaminophen. More than 8 million users filled at least one prescription for it.
Eric Hammelman, a vice president at the consulting firm Avalere Health, said the prescribing data could unlock clues about differences in how doctors practice medicine. Take, for instance, antibiotics, he said, which are often prescribed for inappropriate reasons. While the new data won’t show which prescriptions are inappropriate, it may flag providers who should be asked questions because they prescribe the drugs to a high proportion of their patients.
Beyond that, if consumers compare the prescribing data to data on the payments drug companies have made to doctors, they can see how often doctors prescribe products sold by companies with whom they have financial relationships.
“Knock on wood, these files are coming out on a regular basis. I think some of the doctors and manufacturers would prefer this goes away,” Hammelman said.
Robert M. Wah, president of the American Medical Association, said in a statement that the data “is much more complex than initially meets the eye. The limitations of it should be more comprehensively listed and highlighted more prominently so that patients can clearly understand them.”
ProPublica will be analyzing the information in coming weeks and incorporating the data into our Prescriber Checkup tool.
by Charles Ornstein, ProPublica
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The Affordable Care Act was passed in 2010 and we’re now in the second year since health insurance exchanges got up and running. So, how’s the law doing? That’s a complicated question.
With the help of senior reporter Charles Ornstein, we’ve curated a list of Obamacare must-reads. Some give analysis of the five-year-old bill. Some point to specific problems – the troubling Medicaid gap in Mississippi, a government staff drowning in paperwork. All show a complicated fight that still has a long road ahead.
We also want to hear about your Obamacare experience. As the ACA launched, we asked you to help us report that story. We are continuing this effort in 2015. If you didn’t enroll, are you now facing tax penalties? If you enrolled, how is your plan working out?
“After a year fully in place, the Affordable Care Act has largely succeeded in delivering on President Obama’s main promises, an analysis by a team of reporters and data researchers shows. But it has also fallen short in some ways and given rise to a powerful conservative backlash.”
“Republicans are significantly more likely to believe these three Obamacare myths than Democrats, a sign of how politics colors the public’s perception of how Obamacare actually works. Republicans, for example, are 25 percent more likely to believe that undocumented workers can get financial help under Obamacare and 15 percent more likely to believe end-of-life panels exist.”
“But there are still huge gaps in the system: As many as 3 million Californians remain uninsured, … the ACA’s implementation continues to be bumpy, too. This year’s tax filings are proving to be complicated, and potentially financially painful, for many people who signed up for coverage through the ACA’s exchanges. The Supreme Court may rule this summer that subsidies are illegal on HealthCare.gov, a decision that could force millions of Americans to drop coverage.”
“…efforts to repeal the law politically have repeatedly failed, perhaps because large majorities of Americans approve of the law’s features – and, according to surveys, tend to like their new insurance, even as polls show pluralities disapprove of the law itself.”
“A heavy workload caused by the Affordable Care Act, government technology limits and staff shortages are causing unusually long delays in filling public records requests, federal health officials say. The waits in some cases could stretch out a decade or more.”
“Under the Affordable Care Act, people who remained uninsured last year must either pay a penalty with their taxes, one of the most contentious elements of the law, or claim an exemption. The Obama administration has said up to six million people would owe a penalty of $95 or 1 percent of their household income, whichever is greater.”
“The more significant drag on sign-ups, though, was Mississippi’s decision not to expand Medicaid. The state’s low standard of living means many people earn less than the federal poverty limit but too much for Medicaid; under the health law, they can’t buy insurance on the exchange, leaving 138,000 Mississippians who fall into what has come to be known as the Medicaid gap.”
“Remarkably, the growth of health care costs has slowed down significantly in recent years, enough so that budget analysts are having to reconsider their fiscal outlook of the law. It remains to be seen whether the health care law is the cause of these sweeping changes within the industry, and it may be too early for advocates of the law to claim victory.”
by Annie Z. Yu, ProPublica, March 27, 2015, 3 p.m.
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