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Pharmacist Steve steve@steveariens.com 502.938.2414
WEDNESDAY, Jan. 13, 2016 (HealthDay News) — Infants are just as susceptible to accidental poisonings as older children are, especially when it comes to medication errors, new research reports.
A decade of poison control center calls in the United States showed that acetaminophen (such as Tylenol) was the most common medication mistake for infants. This was followed by H2-blockers (for acid reflux), gastrointestinal medications, combination cough/cold products, antibiotics and ibuprofen (such as Motrin or Advil).
The most common non-medication exposures were diaper care and rash products, plants and creams, lotions and make-up, the investigators found.
“I was surprised with the large number of exposures even in this young age group,” said lead author Dr. A. Min Kang, a medical toxicology fellow at Banner-University Medical Center Phoenix in Arizona.
“Pediatricians typically do not begin poison prevention education until about 6 months of age, since the traditional hazard we think about is the exploratory ingestion — that is when kids begin to explore their environment and get into things they are not supposed to,” Kang added.
The findings were published online Jan. 13 and in the February print issue of the journal Pediatrics.
Kang and colleague Dr. Daniel Brooks reviewed all poison control center calls in a national database from 2004 to 2013 that related to babies younger than 6 months old.
There were more than 270,000 exposures reported during that time, 97 percent of which were unintentional. About half the calls were general unintentional ingestions, which includes children exploring their environment. Over one-third (37 percent), however, were related to medication mistakes, the study found.
With medication exposures, 47 percent involved dosage mistakes, and 43 percent involved giving a medication twice or too soon, giving a child the wrong medication or similar errors, the authors explained.
Acetaminophen was involved in more than 22,000 medication exposures and nearly 5,000 general exposures. This high rate reflects its frequent use because it’s recommended instead of ibuprofen for infants, Kang pointed out.
“The concern with too much acetaminophen is liver failure although, luckily, young children are considered to be somewhat less likely to experience this than an adult because the metabolism is a little different,” Kang said.
One expert noted that this study covers a decade, and acetaminophen mistakes may have dropped in recent years. That’s because acetaminophen infant drops are now standardized across manufacturers, said Dr. Michael Cater, a pediatrician with St. Joseph Hospital in Orange, Calif. A U.S. government study last fall found that children’s ER visits for medicine overdoses have been declining.
The number of ibuprofen exposures, however, surprised Cater since ibuprofen isn’t recommended for those under 6 months old.
“Also surprising was the number of ethanol poisonings,” likely from parents leaving empty glasses or bottles of alcohol around, he said. “Low-lying plants, some of which are toxic, are a source of concern, and this was a bit of a surprise to me.”
Diaper creams and lotions likely top the list because they’re easily reachable by infants when left on the diaper-changing areas, Cater added.
The frequency of calls for cough/cold medications caught the attention of Dr. Emily Borman-Shoap, pediatric residency program director at the University of Minnesota.
“The American Academy of Pediatrics [AAP] does not recommend cough and cold medications for children under age 6, and the U.S. Food and Drug Administration has given a warning about the use of cough and cold medication for children under age 2,” Borman-Shoap said. “This suggests that there is room for ongoing education for parents about safe treatments for cough and cold symptoms in children.”
The AAP has a policy statement recommending that all liquid medications use metric units for dosing and that they include administration devices, such as syringes, to reduce the chance of an overdose.
Perhaps doctors should offer poison prevention education to caregivers earlier, even starting when a baby leaves the hospital, Kang suggested.
In addition, Kang said, parents should have the poison control phone number — 1-800-222-1222 — posted in their home and programmed into their cellphones, and should call for advice on any type of exposure.
Amid growing concerns about medical errors, the nation’s third-leading cause of death, Twitter could serve as a tool to collect data and improve patient engagement on the subject, according to a study published in the Journal of Patient Safety.
Researchers, led by Atul Nakhasi, M.D., collected more than 1,000 public tweets in English containing key phrases such as “doctor screwed up.” Eighty-three percent of the tweets, posted between January and August 2012, specified the type of medical error. Altogether, the researchers identified that 23 percent of the tweets concerned medication errors, 23 percent involved diagnostic mistakes and 14 percent involved surgical errors. Ninety percent were posted by patients and 9 percent were posted by family members.
A little more than half of the tweets involved an emotional response to the error, according to the researchers; a plurality of those tweets (52 percent) expressed frustration, 21 percent expressed humor or at least sarcasm and 14 percent expressed sadness. About 6 percent of all tweets also indicated the poster intended to sue for malpractice.
Researchers this week pinpointed the exact spot where 19 witches were hanged in Salem centuries ago: a wooded area now overlooking a Walgreens.
Salem Mayor Kimberley Driscoll plans to erect a small memorial at Boston Street between Proctor and Pope streets after seven scholars with the Gallows Hill Project confirmed it to be the location of the 1692 hangings.
Illustration of Martha Corey, who was found guilty and hanged in 1692.Photo: Getty Images
“This is part of our history and this is an opportunity for us to be honest about what took place,” she told The Boston Globe.
Previously, it was believed that the witches met their maker on Gallows Hill.
Researchers used aerial photography, eyewitness accounts and advanced mapping technology to make their determination of the area, known as Proctor’s Ledge, as the killing spot.
The work, which spanned five years, also relied on previous research done by historian Sidney Perley, who had also earmarked the area after extensive research.
Lead researcher Emerson “Tad” Baker and his team also used the 1,000 records from the Salem witch trials.
True believers have long suspected that it was where the witches were killed.
“[We] asked locals where they thought it was and every last one of them told us to go to this location,” said Wiccan Michele Ruscitti, who visited Salem in 2006 with her husband. “I found it odd, since the town embraces their history, that there were no markers there. None … just a Walgreens on the corner.”
Politicians are embracing court-ordered drug rehab to reduce prison crowding. The case of Martin Szczupak, a 21-year-old addict sent to a facility run by Phoenix Houses of New York, shows how good intentions can backfire when care falls short.
NEW YORK – Martin Szczupak had already been in and out of rehab when, for a misdemeanor possession charge, a judge sent the 21-year-old heroin addict to a century-old estate in the wooded hills of upstate New York for another chance to clean up.
Belle Terre, the former home of a 19th-century copper baron, housed the 168-bed Phoenix House Delaware County Center, a private, nonprofit residential drug treatment facility. When Szczupak arrived in June 2012, all was not well behind Belle Terre’s stately walls.
In the two years prior to Szczupak’s arrival, New York’s Office of Alcoholism and Substance Abuse Services (OASAS) had twice closed Belle Terre to new admissions after inspectors discovered illegal drug use, insufficient treatment and bad record-keeping, among many other regulatory violations. In each case, Belle Terre resumed admissions after Phoenix House submitted a “corrective action plan” to regulators.
Even so, residents and a counselor at Belle Terre when Szczupak was there said little had changed. Residents trafficked in drugs, cigarettes and other contraband. Nor were residents receiving the 40 hours a week of therapeutic services OASAS required.
“This place is basically a super minimum security prison camp,” Szczupak wrote in an Aug. 29, 2012, letter to a friend. “We do nothing all day.” Still, Szczupak was hopeful. “I’m gonna be out … before I even know it,” he wrote.
By December 2012, he had given up on the treatment program. He felt he would be stuck going from “dead end job and rehab and jail until I eventually drop dead,” he wrote in a letter to his fiancée. “You deserve better than that.” He didn’t want to use drugs anymore, he wrote, “but realistically the odds are against me.” When it comes to addiction issues get help from professionals from this source and overcome your issues.
Szczupak never sent the letter. Three weeks later, he walked out of Belle Terre without permission. One day after that, police visited Szczupak’s mother, Inez, at her Staten Island home to tell her that her son had been found dead from a drug overdose.
Sending addicts to a trusted rehab treatment center like the ones at luxuryrehab.org.uk rather than jail or prison for nonviolent offenses has become increasingly popular across the U.S. political spectrum. In the 2016 presidential campaign, candidates from Democrat Hillary Clinton to Republican Chris Christie have hailed drug treatment as a smart way to tackle the problems of prison overcrowding and excessive sentencing.
BETTER DAYS: A photograph of Martin Szczupak, provided by his fiancée. He initially expressed hopes for his treatment at Belle Terre, a Phoenix House facility. He soon despaired. REUTERS/HANDOUT/Priscilla Pardo
“This place is basically a super minimum security prison camp. We do nothing all day.”
Facilities like Belle Terre are part of that solution. Underwritten by taxpayers, they work with the courts and probation departments to rehabilitate offenders. In 2012, the U.S. criminal justice system sent 580,000 people to drug treatment.
There’s little doubt that quality care in drug rehab centers like confidentialrehab.co.uk can help. Multiple studies have shown that people who complete drug treatment court, a special court for drug addicted offenders, are less likely to reoffend in the first year or two after their release.
At Belle Terre, criminal-justice referrals account for the majority of residents. The facility is run by Phoenix Houses of New York, whose parent foundation is one of the nation’s largest drug treatment nonprofits, operating in 10 states and the District of Columbia. In the year ended June 20, 2014, the Phoenix House Foundation and its affiliates reported operating revenue of $141 million.
Phoenix Houses of New York is 95 percent publicly funded and enjoys star-studded endorsements. Beyonce donated a cosmetology center at a Brooklyn facility. Financier Pete Peterson chaired a summer fundraiser in 2013 in the posh Hamptons on New York’s Long Island.
But as the case of Martin Szczupak suggests, the system as practiced doesn’t always deliver on the promise in principle. A review of Szczupak’s journal and letters and of state regulators’ reports, as well as interviews with dozens of current and former Phoenix House employees and residents, reveal a respected institution that in recent years has consistently failed to provide the quality of care necessary to help addicts kick the habit.
The closures that preceded Szczupak’s arrival weren’t the last. And nor is Belle Terre an anomaly. In November last year, OASAS suspended admissions to Belle Terre and four other Phoenix Houses of New York facilities. In a letter to Phoenix House’s then-chief executive in November 2014, OASAS said Phoenix House had “persistent regulatory violations and resident/patient care concerns dating back several years.”
An OASAS site report on the five facilities went into graphic detail. The regulator’s findings at some or all of the facilities included use of marijuana, cocaine, heroin and other illegal drugs; sexual activity among residents; reports of violence and sexual assault; insufficient, inadequately trained or abusive staff; dirty premises; and lax security, with residents coming and going as they wished. Local std clinics here report an increase in activity since this program has started.
BLEAK HOUSE: The Belle Terre site, where Martin Szczupak was treated. On August 19, Phoenix House said it would be closing Belle Terre and another center. “These facilities do not lend themselves to our vision for a transformed Phoenix House.” REUTERS/HANDOUT/Gherman ClusanBLEAK HOUSE: The Belle Terre facility of Phoenix House of New York. REUTERS/HANDOUT/Gherman Clusan
In each case, OASAS allowed admissions to resume “based upon sustained systemic improvements,” the agency said in a written response to questions from Reuters.
On Aug. 19, Phoenix House said it would be closing Belle Terre and its 185th Street facility in New York City. In an open letter to staff, Phoenix Houses of New York’s president and regional director, Peter Scaminaci, cited a changing environment, “particularly as a result of health care and criminal justice reform,” as a reason for the closures. “These facilities do not lend themselves to our vision for a transformed Phoenix House,” he wrote.
In a statement to Reuters, Scaminaci said his organization was “engaged in a strategic effort to re-allocate our resources to locations where we can achieve the greatest impact.” Phoenix House, he said, is “collaborating closely with OASAS on designing better treatment programs, improving our standard of care and offering increased options for those suffering from substance abuse.”
‘RAMPANT DRUG USE’
Belle Terre’s recent run-ins with regulators date back to at least May 2010. That’s when Albany City Court Judge Thomas Keefe, who had sent three addicts there, became concerned by stories of “rampant” drug use and high staff turnover at the facility.
Keefe, long a proponent of drug treatment as a way to stop addicts from cycling in and out of jail, called the facility’s director, Jerome Pryor. He was surprised by what he described as Pryor’s cavalier attitude and “virtual non-action to address the problem,” Keefe told state regulators in a subsequent 2010 complaint to OASAS. Believing his “addicts were in danger,” the judge had them reassigned to other facilities.
REPEATED VIOLATIONS: Reports from Belle Terre’s regulator show similar problems in 2010, 2011 and 2014. REUTERS/Kristina Cooke
Later that year, Jessica Deagan, now 26, started a court-ordered 9-month stay at Belle Terre to treat her heroin addiction. “It was like the street inside of a building,” she said. “There was a great amount of access to drugs. I used heroin, angel dust, Xanax, whatever was in there for the week.”
Former residents said dealers would throw drugs over the stone wall around the property or hide them along nearby hiking trails for residents to retrieve.
On Aug. 11, 2010, three months after the judge’s initial complaint, a team of OASAS inspectors descended on Belle Terre unannounced. As the inspectors introduced themselves to a staff member, who was leading a house meeting, residents began shouting, “Shut this place down,” and “Get us out of here,” according to the regulator’s report, a copy of which Reuters obtained New York’s Freedom of Information Law.
OASAS recommended halting new admissions, citing widely available illegal drugs, unsupervised outings, sexual activity among residents, diversion of medications, unavailability of staff members, and lack of group counseling.
Belle Terre Director Pryor, according to the OASAS report, attributed most of the problems to the recent loss of five staff members. Four new employees, he told the regulators, lacked experience in treating chemical dependency.
KITCHEN CASUALTY: Jordan Nedlik, a former resident at Phoenix House’s Belle Terre facility, was stabbed in the back by another resident while on kitchen duty. “There was no staff.” REUTERS/Brett CarlsenIN THE DARK: Inez Szczupak says her son was optimistic at first. “And then all of a sudden everything went down the drain, and every phone call that I got was, ‘I can’t stand this place, this is bullshit, they don’t treat me fair.’” REUTERS/Shannon Stapleton
Pryor declined to comment.
A month after admissions were stopped, OASAS conducted a follow-up visit and determined that the facility had stabilized. Admissions resumed.
Two weeks after that, Jordan Nedlik, a resident on kitchen duty, was stabbed in the back by another resident unhappy with the size of his meatball supper. “There was no staff,” Nedlik said. Nedlik returned to Belle Terre after a brief hospital stay. He was sent back to Belle Terre in 2012, after failing a urine test, and later spent time in prison for his initial grand larceny charge. He said that as of August 2015, he has been clean for 14 months.
In September 2011, inadequate staffing prompted counselor Mary Moynahan to quit. In her resignation letter, a copy of which she sent to OASAS, she complained that nonviolent, often very young offenders were mixed with residents who were “not addicts, but rather, hardened criminals avoiding jail time.” She added: “The bottom line is the understaffing.”
SUSPICIOUS RECORDS
Some former counselors told Reuters they lacked the training required to provide the individualized, holistic drug and alcohol addiction treatment Phoenix House promised on its website. Group sessions were haphazard, often pieced together from information gathered through Google searches the night before, they said.
Treatment records were suspect. “There were times when I would say, ‘I didn’t write this. That’s not my handwriting,’ ” said Glenn Williamson, a former counselor and military veteran.
Another counselor, who asked not to be identified for fear of losing her license, recalled chasing a young man high on the synthetic opioid fentanyl around the grounds to keep him out of sight during an OASAS inspection.
In November 2011, OASAS again halted admissions. The agency cited insufficient clinical and mental health services, strip searches conducted without consent, and failure to file incident reports. Residents drove program vans and stayed up all night as “night watchman,” which kept them from participating in group therapy.
OASAS also found that Belle Terre’s new director, Henry Bennett, obstructed their request for records in an attempt to modify them before handing them over. Phoenix House fired Bennett. Bennett, who went on to work for various treatment providers before retiring in Georgia, said he had not been aware that the records were being altered.
Bennett said Phoenix House “took their eye off the prize” by emphasizing business considerations over “things they need such as clinical functions and a good medical records system.”
About 75 percent of Belle Terre residents at the time were on psychotropic medications, state records show, but the only psychiatric care for residents was a four-hour drive away in New York City. A van took seven residents there twice a week.
Myke Champlin, a 2011 resident with borderline personality disorder, said he stayed clean for his first four months at Belle Terre, but by the time he graduated, “I was smoking more K2 [synthetic marijuana] and everything than you could imagine.”
Courts rely on treatment providers for updates on offenders’ performance. If offenders don’t comply with a treatment provider’s rules, the court can use sanctions such as short jail stints or can extend their time in treatment. In some cases, offenders end up spending more time incarcerated than if they had eschewed drug treatment.
At Belle Terre, the threat of reporting infractions could become a tool of abuse. As is common practice in many rehab programs, residents were assigned jobs in a hierarchy, from the lowest cleaning crew to managing other residents’ schedules. This system, which counselors and residents called “the Structure,” was meant to help residents break bad habits and prepare for working life.
Former residents said the system became a means of settling personal scores. Higher-ranking residents could punish others for minor infractions, such as talking in the medication line. Infractions could result in cancellation of family visits, or could be reported to the courts.
PARTNERS IN ADDICTION
This was the milieu Martin Szczupak entered in the summer of 2012.
Szczupak grew up in the New York City boroughs of Brooklyn and Staten Island. In middle school, he met Priscilla Pardo, with whom he shared a love of punk rock. “Punk rock is angry and abrasive, and for several years, so was I,” Szczupak wrote in his journal.
Szczupak was addicted to heroin by age 15, Pardo said. She was hooked at 18. Still, they managed to start college. He studied biology. She studied mortuary science. They missed a lot of classes, mostly to get high, Pardo said.
They didn’t know it, but they were part of a resurgence of heroin abuse in the U.S. In 2013, 517,000 Americans abused or were dependent on heroin, more than twice as many as in 2007, according to the National Survey on Drug Use and Health. Staten Island had the highest rate of heroin-related deaths among all New York City boroughs in 2012. Local officials have called it an “epidemic.”
SWEETHEARTS: Martin Szczupak and Priscilla Pardo met in middle school. They shared a love of punk rock and, eventually, of drugs. “Punk rock is angry and abrasive, and for several years, so was I,” Szczupak wrote in his journal. REUTERS/Handout
MOTHER’S MEMENTOS: Photographs and belongings of Szczupak kept by his mother, Inez, at her home in Staten Island, New York. REUTERS/Shannon Stapleton
LIFE INSIDE: A December 2012 letter from Martin Szczupak to Priscilla Pardo. “I’m going to be stuck going from dead end job to dead end job and rehab and jail until I eventually drop dead.” REUTERS/Robin Respaut
Pardo nearly died from an overdose in 2011. That “scared the crap out of Martin,” Pardo said. He persuaded his girlfriend to admit to their parents that they had a problem.
Szczupak finished a stint in rehab in March 2011. On his way home, according to the account he gave to his mother and Pardo, the rehab facility van he was riding in made a stop. Szczupak, woozy and disoriented from prescribed medications, stepped out of the van. When he returned, he told Pardo and his mother, he mistook another vehicle for the rehab facility van.
According to the police report on the incident, Szczupak was pulling on the vehicle’s door handle and shouting, “open the door.” Inside the Ford Explorer sat a woman and her 3-year-old son. She called the police. Szczupak was charged with attempted grand larceny and resisting arrest. Records show Szczupak told the police that he “wanted to take the car home.”
Szczupak later told police he had no recollection of the incident. He pleaded guilty and agreed to go to treatment. A year later, he relapsed. He was arrested for possession on Staten Island, a probation violation. In court, the judge agreed to give him another chance at treatment.
When Szczupak arrived at Belle Terre in June 2012, the facility was still short-staffed. Residents at the time described the lack of counseling and widespread use of illegal drugs that OASAS staff had cited over the prior two years.
“CIRCUS SHOW”: Brian Moody, a former resident of Belle Terre who befriended Martin Szczupak, says the facility was in chaos. “There were people who were high. It was a circus show.” REUTERS/Brett Carlsen
Brian Moody, 33, a former Bank of America contractor who had been remanded to Belle Terre after violating probation on a drug-sales charge, said the place was in chaos. “There were people who were high,” he said. “It was a circus show.”
Moody said he befriended Szczupak, whom he described as smart and determined. “He wanted to change,” but felt he was getting no help, said Moody, now working as a debt-collection agent.
Szczupak at first rose within the Structure. He was assigned to computer work, where he spent days listening to music, according to a letter to a friend.
“I hoped this one would work, mentally he wanted it to work, he was pretty optimistic,” said his mother, Inez. “And then all of a sudden everything went down the drain, and every phone call that I got was, ‘I can’t stand this place, this is bullshit, they don’t treat me fair.’ But I never understood what happened.”
In December 2012, Szczupak was demoted within the Structure for disrespecting a staff member, his treatment records show. The details are unclear.
Szczupak told friends that the time already spent in treatment was worthless and that he would end up going to jail anyway.
According to treatment records, Szczupak was given the option of starting over again in drug court, but he refused, saying he had heard “nightmare stories” from others.
“This whole episode here has pushed back my completion of this shit,” he wrote in an undated entry that ends his journal. “This whole drug court thing has got me frustrated.”
When Pardo spoke with Szczupak on Thursday, Jan. 3, 2013, six months after his arrival at Belle Terre, he seemed “really mad at the world, very dark, not making any jokes,” she said. “He seemed like a shell.”
The next day, Moody said, Szczupak told him he would rather be in jail, with a clear end-date. He packed his belongings and walked out without approval.
That Saturday, police were called to a Brooklyn house where they found Szczupak, dead from a heroin overdose.
In November 2014, regulators again suspended admissions at Belle Terre, as well as four other Phoenix House facilities. State regulators noted high staff turnover and need for improved clinical practices and Rehab Center Reputation Management at Belle Terre.
OASAS let Belle Terre reopen in January 2015. Three of the other centers were reopened with limited admissions in late 2014 and early 2015. The Shrub Oak teen residential treatment facility was closed permanently in June 2015.
In March, OASAS inspected Belle Terre again, prompted by unspecified complaints against director Alan Hargrove, OASAS reported. Phoenix House then fired Hargrove, based on OASAS’s feedback.
Hargrove declined to comment.
Phoenix House announced on Aug. 19 that it would be closing Belle Terre and the 185th Street facility.
Pardo, now 24, lives with her parents on Staten Island and works the night shift at a convention center. She has been sober for three years after receiving treatment at Mount Sinai Beth Israel Medical Center in New York City.
Addiction to painkillers, the kind that are prescribed such as oxycontin, or illegal, such as heroin, is on the rise in the United States.
While a recent report from Nevada says cases of overdoses are on the decline, that is not the case for heroin. Heroin overdoses rose from 19 in 2010 to 52 in 2014. And for years, Nevada has ranked near the top in the number of deaths from painkiller overdoses per 100,000 people.
That’s the backdrop for a recent decision by the federal Centers for Disease Control.
The CDC was all set to release a new set of guidelines in two weeks for prescription painkillers.
Then, it changed its mind.
Now the CDC will do something it has never done before. It is holding public hearings, and taking comments online about its proposals.
The question becomes: what does the public know about addiction that scientists who study addiction don’t?
And does it even matter, especially in Nevada?
Las Vegas Doctor Mel Pohl has treated those with opioid addiction for decades. He has also authored last year’s, “The Pain Antidote,” which prescribes managing pain rather than drowning it out with drugs.
“I think it’s absurd that a governmental agency that’s based in science that looked at the scientific data and came up with a proposed set of guidelines is now being subjected to this really reactionary response that has frankly been somewhat politically and economically motivated,” Dr. Pohl said. Support comes from
He said many people have come to believe that painkillers are the only way for them to control their chronic pain; however, Pohl said studies have shown that people using opioids over the long term do not see an improvement in function or ability to live their lives.
“Here we’re looking at a very emotional response of people who suffer chronic pain and who have been mislead to believe that this is a good solution,” he said.
Dr. Andrew Kolodny, senior scientist at Brandeis University; current chief medical officer at Phoenix House, a drug addiction treatment center, has no doubt pharmaceutical companies who profit from American’s opioid addictions are behind the delay by the CDC.
“This is not something the CDC wanted to do,” Dr. Kolodny explained, “The CDC wanted to release its guideline in January. The reason they opened up the docket is because they were pressured to do so by industry-funded organizations.”
He said the opioid manufactures see the guidelines as an economic threat. According to Kolodny, the pharmaceutical companies have seen profits from opioids soar over the past several years and new guidelines could threaten that profit stream.
Dr. Kolodny believes the reason there is an epidemic of painkiller use is doctors started aggressively prescribing opioids without knowing the risks of addiction.
“Most of the prescribers were acting with good intentions, they were responding to a brilliant marketing campaign that mislead the medical community about the risk of putting patients on opioids medicines long term, especially the risk of addiction was minimized,” he said.
He said many doctors are eager for the new guidelines as a way to push back against patients who are pressuring them to write more prescriptions.
According to Kolodny, many patients feel like the CDC is trying to “take their painkillers away from them.” He said those patients believe the opioids are helping them, when in reality, many are actually harmed by the painkillers.
“Some of these patients truly believe these opioids are helping them, because when they don’t take their opioids they’re feeling pain and discomfort,” Kolodny said, “Whether that means the opioid is really treating their pain, or whether the opioid is treating withdrawal pain is difficult to say.”
He said the general public doesn’t realize that opioids have the same impact on the brain as heroin. He believes if they did, they would have a different reaction to guidelines.
“If the public and the prescribers understood that these were essentially heroin pills, they would be in favor of much more cautious use,” Kolodny said. Guests:
Dr. Mel Pohl, author of “The Pain Antidote”; Dr. Andrew Kolodny, senior scientist at Brandeis University; current chief medical officer at Phoenix House, a drug addiction treatment center.
Oren Fells from Georgia recently filed a Xarelto uncontrollable intracranial or brain bleeding lawsuit in the U.S. District Court for the Eastern District of Louisiana. The lawsuit was filed against Bayer Healthcare, Johnson & Johnson, and its Janssen subsidiary, the manufacturers of Xarelto.
Catastrophic Xarelto Brain Bleeding Allegations
Fells began taking the newer anticoagulant or blood thinner Xarelto in 2013, for the treatment of atrial fibrillation, a common heart rthym problem. Fells suffered a brain bleed in January, 2014, causing him to develop life long permanent injuries.
Many lawsuits have been filed against Xarelto’s manufacturers, Bayer and Johnson & Johnson and the plaintiffs claim that the companies failed to warn patients and doctors about the risks associated with Xarelto and the lack of an antidote to help stop the bleeding.
What is Xarelto?
Xarelto (rivaroxoaban) was FDA approved in 2011 as an alternative for Coumadin (warfarin), which has been the gold standard anticoagulant treatment for the past 60 years. Xarelto is one of several new-generation blood thinners, which have been promoted as easier to use than warfarin. Unfortunately, several thousand Xarelto bleeding problems have been reported since the medication was used.
Xarelto Federal MDL Litigation
According to the latest federal court census, there are almost 2,500 lawsuits filed, alleging that Xarelto caused patients to develop serious bleeding injuries. The Xarelto litigation is consolidated and centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of Multidistrict litigation (MDL) since December 2014.
Lawsuits against Bayer and Johnson & Johnson are consolidated in two courts, a multidistrict litigation court in the Eastern District of Louisiana and a mass tort litigation court in Philadelphia.
As is common in pharmaceutical multi-district litigation, a small group of Xarelto injury cases are scheduled to go through case-specific discovery and be set for early test trials, these are known as “bellwether trials.”
4 Xarelto Bellwether Trials Set
Judge Fallon set a series of four bellwether trials to go before juries in the Spring of 2017. The number of Xarelto lawsuits continue to increase and be filed by individuals across the United States, alleging severe and deadly bleeding complications.
Bellwether Trials in Louisiana, Mississippi and Texas
The first two trials will be held in the Eastern District of Louisiana, on February 6 and March 13, 2017. The third trial will be held in Mississippi on April 24, 2017 and the fourth trial will be held in Texas on May 30, 2017.
According to Judge Fallon’s order, the cases that will go before juries on these dates will be pulled from a pool of 40 lawsuits to be selected in January 2016. These cases will be trial ready, with case-specific discovery, including depositions of plaintiffs, prescribing doctors, treating physicians and sales representatives of the drug makers.
Pradaxa MDL Settlement
Pradaxa, the first new-generation anticoagulant to hit the market was also exposed to several thousand bleeding complication lawsuits. More than 4,000 Pradaxa injury lawsuits were filed, and Boehringer Ingleheim, the manufacturer agreed to settle the claims without any trials and paid $650 million in Pradaxa settlements, with an average of about $150,000 per claim.
INDIANAPOLIS, Ind. (Jan. 12, 2016)– Three people, including an IMPD officer, were arrested Tuesday in connection with an ongoing narcotics investigation.
Christopher Reed, 33, Victoria Purdy, 41, and Nikolas Layton, 35, face preliminary charges including suspicion of dealing in cocaine, conspiracy to deal cocaine, dealing in a controlled substance and possession of cocaine.
Layton is a full-time IMPD officer. He is a 10-year veteran currently assigned to the hit-and-run investigation unit. Layton is also the son of Marion County Sheriff John Layton.
IMPD Chief Troy Riggs suspended Layton without pay and will recommend he be terminated.
Sheriff John Layton issued the following statement:
This is obviously a heart breaking moment as a parent, especially as a parent who is also the Sheriff, and even more as the father of a police officer. I have never tolerated this kind of alleged behavior in law enforcement. I have full faith in the criminal justice system, and I feel certain that justice will be done.
there is a old saying on “The Hill”… “.. horror stories don’t make good policy…but.. they do make policy ..” Combine that with the quote about “…never let a crisis go to waste” and here we are… dealing with a trumped up opiate epidemic
By Denise Molohon, Guest Columnist
I think the minute anyone without bias or personal agenda began reading through the CDC’s proposed guidelines for opioid prescribing, they must seriously question many things.
Chief among them, the highly suspect “low to very low quality” evidence being presented to support their “strong recommendations,” but also their dangerously skewed data; which ultimately could leave millions of chronic pain sufferers critically ill, without sound medical treatments, and with little to no quality of life.
In a recent CDC Morbidity and Mortality Weekly Report (MMWR) on drug and opioid overdose deaths, I found myself doing the exact same thing — seriously questioning the data. In 2014, the report found that 28,647 people died of drug overdoses involving opioids, including heroin, a 9 percent increase over the previous year.
However, the CDC admits in the MMWR, that “some overdose deaths may have been misclassified and the data has limitations.” I wondered how much was misclassified? Exactly what data has limitations and why?
I believe the American people have a right to transparency and full disclosure, not flawed data that is often presented in a confusing manner, such as the following qualifiers in the MMWR:
“At autopsy, toxicological laboratory tests might be performed to determine the type of drugs present; however, the substances tested for and circumstances under which the tests are performed vary by jurisdiction.”
“The percent of overdose deaths with specific drugs identified on the death certificate varies widely by state.”
“Approximately one fifth of drug overdose deaths lack information on the specific drugs involved. Some of these deaths might involve opioids.”
“Heroin deaths might be misclassified as morphine because morphine and heroin are metabolized similarly, which might result in an underreporting of heroin overdose deaths.”
If heroin deaths are being misclassified as morphine, which results in the “underreporting” of heroin overdose deaths, then wouldn’t the opposite also hold true? That there is “over-reporting” of morphine deaths, which are then misclassified as prescription opioid deaths?
According to the Washington Post, CDC Director Tom Frieden admitted some heroin overdose deaths were counted twice!
Another egregious misclassification, which I find grossly unjustified, is the following:
“Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as ‘prescription’ opioid overdoses.”
On the surface this statement doesn’t appear too concerning. Until you begin to take a closer look at what has been happening over the last 3-5 years with heroin and illicit fentanyl overdose deaths, and how both illegal and legal opioids have been lumped together into one category.
All opioid pain reliever deaths are counted as “prescription” opioid overdoses. Why?
“Natural opioids” includes those heroin deaths that were misclassified as morphine related overdose deaths, which no doubt contributed in some degree to that 9% increase in opioid overdose deaths in 2014.
But how many of these heroin deaths were misclassified? We may never know. The DEA reported last year in its National Heroin Threat Assessment Summary that, “Many medical examiners are reluctant to characterize a death as heroin-related without the presence of 6-monoaceytlmorphine (6-MAM), a metabolite unique to heroin, but which quickly metabolizes into morphine. Thus many heroin deaths are reported as morphine-related deaths.”
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“Synthetic opioids” includes not only prescribed fentanyl, which is a potent pain reliever, but illicit fentanyl overdoses, which have skyrocketed over the last two years. Because most medical examiners and coroners did not routinely test for fentanyl in 2014, many illicit fentanyl/heroin overdose deaths were also probably counted as prescription opioid overdoses.
Medical examiners and coroners are just now beginning to test for fentanyl because of the sharp rise in overdose deaths in the U.S. and Canada. Both the CDC and the DEA issued advisories about illicit fentanyl overdoses last year, but we don’t know exactly how many deaths there were.
Why is the data about opioid overdoses so flawed and what is the government doing about it?
A federal agency called the Substance Abuse and Medical Health Services Administration (SAMHSA) brought together groups of experts four times in 2003, 2007, 2010, and again in 2013. All agreed uniform standards and definitions were needed for classifying opioid-related deaths. Guidelines were developed in July 2013 by SAMHSA to provide uniform standard procedures for medical examiners, coroners and other practitioners.
The CDC is not only aware of these guidelines, but it recently recommended medical examiners and coroners in all states implement them “to ensure death reports are complete and accurate.”
“It is especially important to include the word ‘fentanyl’ on the death certificate when the drug is a contributing cause of death,” the CDC said in a Health Advisory distributed on October 26, 2015.
Why fentanyl? Based on reports from states and drug seizure data, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl, which is often combined with heroin or even sold as heroin.
David J. Hickton, U.S. attorney for western Pennsylvania and co-chair of the Justice Department’s National Heroin Task Force, told the Washington Post that “fentanyl and more potent heroin appear to have contributed to the 2014 spike in fatal overdoses.”
According to the DEA’s National Heroin Threat Assessment Summary, the overwhelming number of fentanyl overdose deaths are not attributable to pharmaceutical fentanyl but rather illicit fentanyl.
“There have been over 700 overdose deaths reported, and the true number is most likely higher because many coroners’ offices and state crime laboratories do not test for fentanyl or its analogs unless given a specific reason to do so,” the report warns. “While pharmaceutical fentanyl (from transdermal patches or lozenges) is diverted for abuse in the United States at small levels, this latest rash of overdose deaths is largely due to clandestinely-produced fentanyl, not diverted pharmaceutical fentanyl.”
Note that the DEA is making a critical distinction between an illegal drug and a legal prescription drug. Why isn’t the CDC doing this?
In my opinion, for the CDC to lump all opioids together as “prescription” opioids or as “pain relievers” shows a highly dangerous bias, an unwillingness to address the soaring number of heroin and fentanyl overdoses, and a lack of competence in taking a responsible leadership role.
If the CDC can’t be counted on to clearly report on the data, sources and causes of overdose deaths, how can we trust their opioid prescribing guidelines?
Have you ever felt like the government doesn’t really care what you think?
Professors Martin Gilens (Princeton University) and Benjamin I. Page (Northwestern University) looked at more than 20 years worth of data to answer a simple question: Does the government represent the people?
Their study took data from nearly 2000 public opinion surveys and compared it to the policies that ended up becoming law. In other words, they compared what the public wanted to what the government actually did. What they found was extremely unsettling: The opinions of 90% of Americans have essentially no impact at all.
This video gives a quick rundown of their findings — it all boils down to one simple graph:
Princeton University study: Public opinion has “near-zero” impact on U.S. law.
Gilens & Page found that the number of Americans for or against any idea has no impact on the likelihood that Congress will make it law.
“The preferences of the average American appear to have only a miniscule, near-zero, statistically non-significant impact upon public policy.”
One thing that does have an influence? Money. While the opinions of the bottom 90% of income earners in America have a “statistically non-significant impact,” economic elites, business interests, and people who can afford lobbyists still carry major influence.
Nearly every issue we face as a nation is caught in the grip of corruption.
From taxation to national debt, education to the economy, America is struggling to address our most serious issues.Moneyed interests get what they want, and the rest of us pay the price.
They spend billions influencing America’s government. We give them trillions in return.
In the last 5 years alone, the 200 most politically active companies in the U.S. spent $5.8 billion influencing our government with lobbying and campaign contributions.
Those same companies got $4.4 trillion in taxpayer support — earning a return of 750 times their investment.
It’s a vicious cycle of legalized corruption.
As the cost of winning elections explodes, politicians of both political parties become ever more dependent on the tiny slice of the population who can bankroll their campaigns.
To win a Senate seat in 2014, candidates had to raise $14,351 every single day. Just .05% of Americans donate more than $10,000 in any election, so it’s perfectly clear who candidates will turn to first, and who they’re indebted to when they win.
In return for campaign donations, elected officials pass laws that are good for their mega-donors, and bad for the rest of us.
Our elected officials spend 30-70% of their time in office fundraising for the next election. When they’re not fundraising, they have no choice but to make sure the laws they pass keep their major donors happy — or they won’t be able to run in the next election.
Healthcare has no doubt made giant strides in patient safety in recent years: According to an HHS report released in December, hospital-acquired condition rates dropped 17 percent from 2010 to 2014, leading to 87,000 fewer patient deaths in hospitals. However, there is always room for improvement in the journey toward zero patient harm.
Several issues arose in 2015 that shed new light on patient safety threats.
The Becker’s Infection Control & Clinical Quality editorial team chose the following 10 patient safety issues for providers to consider in 2016, presented below in no particular order, based on the events and trends from 2015.
Medication errors. The Agency for Healthcare Research and Quality calls medication errors “one of the most common types of inpatient errors,” as nearly 5 percent of hospitalized patients are affected by adverse drug events annually. New evidence uncovered in 2015 shows that medication errors are not just a problem for inpatients: They abound during surgeries as well.
In fact, medication errors occur in some form in nearly half of all surgeries, according to research from Massachusetts General Hospital published in October. Mistakes in labeling, incorrect dosage, neglecting to treat a problem indicated by a patient’s vital signs, and documentation errors were the medication errors that occurred most frequently.
“We definitely have room for improvement in preventing perioperative medication errors, and now that we understand the types of errors that are being made and their frequencies, we can begin to develop targeted strategies to prevent them,” said Karen Nanji, MD, lead author of the study.
Diagnostic errors. Diagnostic errors were thrust into the spotlight late in 2015 thanks to an Institute of Medicine report titled “Improving Diagnosis in Health Care.” The report asserts that diagnostic errors account for 6 to 17 percent of hospital adverse events and roughly 10 percent of patient deaths, indicating definite room for improvement in this space.
“The report launched an important conversation about a serious patient safety issue with broad impact across the continuum of care,” Tejal Gandhi, MD, president and CEO of the National Patient Safety Foundation, wrote in a December blog.
The new year provides an opportunity for hospitals to focus efforts to improve this serious patient safety issue. The IOM report outlines several possible solutions to remedying diagnostic errors, including partnering with patients and their families, as well as fostering teamwork between and among healthcare providers. It’s also crucial to consider ASA security services in Hong Kong to ensure comprehensive safety protocols are in place.
Discharge practices to post-acute, home care. Hospital discharge can be a critical moment in a patient’s care. A study from the early 2000s found nearly 20 percent of patients experience an adverse event within three weeks of discharge, and many of those events could be prevented.
This important safety issue necessitates more attention in 2016 thanks to the launch of the Comprehensive Care for Joint Replacement model in April. The CCJR will make hospitals responsible for the care quality and cost of joint replacement patients for a full 90 days post-discharge, giving hospitals a financial incentive to focus on this important patient safety issue.
Workplace safety. It is hospitals’ duties to keep patients safe, but some experts argue patients cannot be safe unless healthcare workers feel safe themselves.
“If healthcare providers are safe, then we will have safer patients,” says Deborah Grubbe, a healthcare consultant with DuPont Sustainable Solutions. “Because healthcare providers won’t have to focus on their own safety and thinking they’ll get hurt, [they’ll] be able to spend all their energy and alertness in providing good care for the patient.”
This sentiment applies to a myriad of worker safety issues, from needlestick injuries to injuries from lifting patients to fear of being assaulted by a patient.
Unfortunately, these staff safety issues are still a problem moving into 2016. To that end, the U.S. Department of Labor’s Occupational Safety & Health Administration launched a webpage in December 2015 providing information and strategies for healthcare workplace violence awareness and prevention.
Hospital facility safety. Issues with hospitals’ facilities can sometimes put patient safety at risk. Several times in 2015, the safety of hospital patients was compromised or nearly compromised because of building or maintenance problems. For instance, a Florida Agency for Healthcare Administration report released in April cited one Florida hospital’s handling of a sewage leak as a patient safety issue, including its failure to ensure the sewage was cleaned up properly and failure to conduct an infection control risk assessment. The investigators also reported finding live rats above the affected ceiling tiles and air conditioning supply vents leaking condensation over food prep tables.
Legionnaires’ disease is another issue tied to the structure of a hospital, as Legionella outbreaks “are commonly associated with buildings or structures that have complex water systems, like…hospitals,” according to the CDC.
In 2015, several organizations from the healthcare, construction and engineering industries formed a task force to create uniform guidelines for the heating, ventilation and air condition of operating rooms, sterile processing departments and endoscope procedure rooms to ensure patient safety.
In light of these issues and events, hospitals may wish to consider re-evaluating the maintenance protocols for their facilities to ensure patient safety this year.
Reprocessing issues. The issues surrounding certain medical scopes and their link to infections resurged in 2015 and are sure to carry over in to 2016 as healthcare providers hone best practices to prevent further scope-related incidents. In fact, the ECRI Institute listed “inadequate cleaning of flexible endoscopes before disinfection” and the resulting risk of infection at the top of its 2016 Top 10 Health Technology Hazards list.
Experts have emphasized the importance of using the right tools and following protocol to the letter to prevent infection, while some hospitals have begun culturing scopes after reprocessing to check for bacteria. Meanwhile, some members of an FDA advisory panel recommended mandatory sterilization of duodenoscopes to prevent spread of infection.
Sepsis. According to the CDC, more than 1 million cases of sepsis occur each year, and up to half of people who get sepsis will die, making it the ninth leading cause of disease-related deaths. While sepsis is not a new patient safety concern, it gets a new spotlight for 2016 thanks to CMS: The agency added the Severe Sepsis and Septic Shock Early Management Bundle to the fiscal year 2016 Inpatient Prospective Payment System Final Rule.
“What’s driven much of CMS’ response to sepsis is the gradual increase in sepsis across the nation,” Edward O. Blews III, MD, assistant professor of infectious disease and associate medical director of hospital epidemiology at Loma Linda (Calif.) University Medical Center, said in a December webinar on sepsis protocols.
Hospitals that meet compliance with the sepsis early management bundle can help lower sepsis mortality as well as costs associated with treating sepsis (which, according to Mike Abrams, president and CEO of the Ohio Hospital Association, can reach anywhere from $22,000 to $57,000 per case).
“Super” superbugs. Superbugs — defined by Brian K. Coombes, PhD, of McMaster University in Ontario as bacteria that cannot be treated using two or more antibiotics — continue to pose a threat to patients, and they appear to be getting stronger: A CDC report published in December revealed a particularly dangerous set of CRE strains is cause for public health concern in the U.S. “Newly described resistance in Enterobacteriaceae…highlight[s] the continued urgency to delay the spread of CRE,” the report reads.
The strains have been named the “phantom menace” by some scientists, and they aren’t the only superbugs infectious disease specialists and healthcare providers will be keeping an eye on in 2016 — researchers in China published data on a bacteria found in pigs, broiler chickens and humans that contains a gene that makes it resistant to all forms of antibiotics, including “last resort” drugs used to beat the toughest antimicrobial resistant bugs. The gene responsible for resistance is called mcr-1, and has also been identified in Denmark. The gene has been found in E. coli and Klebsiella pneumoniae bacteria, according to the Chinese study.
Small steps — like boosting the focus on antibiotic stewardship — can be taken this year to help combat the spread of these surreal-sounding organisms.
The cyber-insecurity of medical devices. In July 2015, the U.S. Food and Drug Administration issued an official warning to hospitals asking they reconsider using the Hospira Symbiq Infusion System, a computerized pump that is widely used to deliver general infusion therapy, after it became apparent that with some ease, hackers could remotely access the device and alter dosages.
But experts have been sounding the alarm on the cybersecurity of medical devices for some time now. In 2011, Jay Radcliffe, senior security consultant and researcher for security data and analytics company Rapid7, wowed audiences at the Def Con hacking conference in Las Vegas when he hacked his own Medtronic insulin pump.
Cybersecurity concerns have graduated from a health IT-specific worry to one that carries patient safety risks serious enough to be on everyone’s radar. Many medical devices connect to and operate on hospital networks that are already rife with vulnerabilities, and even if the goal isn’t to hurt patients who may be connected to the devices, hackers can hopscotch onto the network from the device’s entry point, gathering protected health information and exploiting vulnerable data.
In the next year, there will likely be some organized pushes to secure those devices — or at least a push to put manufacturer, federal and healthcare providers’ feet to the fire to start drumming up solutions.
Going transparent with quality data. Most health systems query patients about their experiences and satisfaction with physicians during their hospital stays. But few opt to put those ratings online for all to see, although there’s reason to believe the practice can improve patient safety.
“When everyone — physicians, patients, institutions, and the press — is privy to data on performance, physicians will develop a greater sense of accountability to deliver quality care,” Ashish K. Jha, MD, a patient safety researcher at Harvard University’s School of Public Health in Cambridge, Mass., wrote in a post on Harvard Business Review in October.
Aggregated ratings can be helpful learning tools for reviewing individual employee performance, and they also incentivize medical staff to double check their work and pay more attention to areas where slip-ups can impact their ratings, and ultimately the safety of those in their care. At some institutions, ratings are displayed internally, enabling side-by-side comparisons that might produce insights into best practices or encourage a healthy sense of competition.
In the future, this kind of openness could become a necessity for hospitals and health systems who want to compete in a market with an increasing focus on transparency.
In addition to fostering quality improvement, facilitating this kind of feedback and discussion has the capacity to highlight low points in patient care of which administration may not have previously been aware.
