“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
The FDA put a Chinese biologics drugmaker on import alert and followed up with a warning letter after an inspection a year ago that found serious microbial contamination at its plant in Hebei.
The FDA posted the warning letter today for Hebei Yuxing Bio-Engineering, after putting the company on its import alert list on July 8, and so banning its products from entering the U.S.
It said the company, which bills itself as the world’s largest maker of Vitamin B12, documented 67 microbiological contamination deviations between January 1 and August 20, 2015. But the agency said that microbiological contamination has been “a persistent and unresolved problem” at the facility since 2013.
The FDA said that while the company believes it identified four possible causes, including failing to carefully sterilize tanks used to store supplements. Hebei Yuxing Bio-Engineering has not gotten to the root cause and resolved the issue in three years.
But its problems go deeper, including using “experimental” analyses of samples that were then deleted from the audit trail provided to the FDA if that did not pass. Investigators found more than 2,400 of these tests in a folder on a piece of equipment. “Your management provided different explanations in an attempt to justify the practice, including ‘fear’ that the sample results would not pass,” the FDA said in its letter.
The FDA acknowledged the company was taking steps to fix some of the problems, including acquiring some new equipment for testing. The FDA was not satisfied, saying none of those actions will fix the problems until the company establishes procedures that “ensure that your quality unit reviews all production and control data and associated audit trails as part of the batch release process.”
In fact, the FDA laid out a long list of steps the drugmaker must take before it can regain FDA approval for the facility.
The FDA has significantly stepped up its oversight of manufacturing facilities in China, issuing warning letters in recent weeks to a growing number of companies there. Earlier this month, the FDA issued a warning letter for a facility of one of China’s largest manufacturers, Zhejiang Hisoar Pharmaceutical, in Taizhou City. It said the company routinely failed to do microbial testing on APIs shipped to the U.S. while repeatedly deleting test results when batches failed the tests did perform. Zhejiang Hisoar was put on the FDA import alert list in January.
Nurse delayed teen from using EpiPen in favor of other medicine
A teen girl experienced a horrific event when her school nurse delayed her access to an EpiPen in the middle of a life-threatening allergic reaction. A trained medical professional elongated a terrifying experience for a child, and what’s worse is that no one can say why the nightmare happened.
Lia Sommer ate a turkey sandwich with pesto from the cafeteria at John Hersey High School in Illinois last month. The 15-year-old has a severe allergy to peanuts. Lia has dealt with a peanut allergy her entire life, and had already asked the cafeteria staff if their food had peanuts in it. They told her no, but when the teen grabbed her lunch that day the staff had substituted pine nuts in the pesto for peanuts. According to the U.S. Centers for Disease Control, when someone with Lia’s allergy is exposed they need epinephrine to avoid “a sudden and severe allergic reaction that may cause death.”
The teen knew immediately she had been exposed to peanuts and went straight to the nurse’s office. It was there that the person most in charge of our kids’ health while they’re at school completely failed. In a letter she wrote then read aloud to the Township High School District 214 Board of Education, Lia’s mom, Lonnie Joy Sommer, said: “the nurse on staff allegedly advised Lia to take an antihistamine, Benadryl. Lia refused, knowing from previous experience that her symptoms would be masked by the antihistamine, though the anaphylactic reaction would not be halted, and would continue to silently and dangerously escalate undetected,” the Chicago Tribune reported.
If you’ve never met one, kids who have severe allergies almost always 1. know that they have them and 2. exactly what to do during an allergic reaction. The nurse should have absolutely listened to the girl that stood in her office that day. What makes this situation even more terrible is that the school had a file on Lia’s allergy. “Instead of following Lia’s Allergy and Anaphylaxis Plan on file in the health office, which clearly states, ‘Give EpiPen First!’ the nurse opted to have her call me to confirm before administering epinephrine, with my daughter’s life held in the balance,” Sommer told the school district.
Once on the phone with the nurse, her mom asked if her daughter had been given the EpiPen and if 911 had been called. The nurse had done neither. “I was shocked that a trained medical professional was either unaware of the most up-to-date protocol for anaphylaxis, or unwilling to follow it,” the mom explained. “I told her administer the EpiPen and call 911 immediately.” Sadly, even after the school called 911 the stress compiled when school officials sent Lia to the hospital alone.
“It is ludicrous that a minor would be sent alone to a hospital during school hours with no personnel to represent her,” her mom shared. “I am horrified and saddened by the complete lack of common sense and compassion that predicated this decision.” It’s unclear what responsibility school administrators have when a student needs to go to the emergency room, but in such a life-threatening situation wouldn’t we all want someone to be with our child?
We were in middle school when we learned how to use an EpiPen. My brother and I don’t have any allergies, but our best friend’s allergy to milk and peanuts was so severe that her mom taught us how to use the medical device in case we needed to inject the critical medicine. Thankfully we never had to use it, but if we, as a society, can train our kids to know the value of an EpiPen then surely our medical professionals should be held to the same standard.
“The district sincerely apologizes for our mistakes. Student safety is always of the utmost importance, and we are working with the family to remedy the situation,” school district spokeswoman Jennifer Delgado told reporters. The school district agreed to cover Lia’s medical bills from the incident. The nurse who delayed Lia’s access to the EpiPen is still employed with the school district.
Liquid Oxycodone comes into two strengths 1 mg/ml and 20mg/ml .. and the latter is normally reserved for end of life cancer/pain pts and it is administered under the tongue… which causes it to “kick-in” quicker. With the Pharmacist’s statement “Because typically it is a medication that was reserved for a hospice-type treatment.” Which would suggest that the prescriber wrote for the 20mg/ml strength which would probably be lethal for a opiate naive pediatric pt. It was also stated that the prescribed dose was 50mg – which would also suggest that the dose was 2.5 ml and using the appropriate strength of Oxycodone… would have given this kid a 2.5mg dose… which depending on the child’s weight… could be an appropriate dose. IMO… especially with the Pharmacist making that statement… SCREWED UP and didn’t do her job.
NASHVILLE, TN (WSMV) –
One mother said her son accidentally overdosed after he was over-prescribed an opioid pain medication.
Shelley Slater expected her son would be given medicine at the hospital. She never anticipated her then 7-year-old son would overdose.
“I was so scared I was numb,” Slater said, recalling the episode from 2012.
Slater’s son, Ethan, went to the Monroe Carell Jr. Children’s Hospital at Vanderbilt for a tonsillectomy. When he had an allergic reaction to hydrocodone, doctors wrote him another prescription.
Slater said she’ll never forget when she handed the script to a pharmacist at Walgreens.
“She told me that it was somewhat uncommon to have this even in stock,” Slater said. “Because typically it is a medication that was reserved for a hospice-type treatment.”
The prescription was for liquid oxycodone. The Channel 4 I-Team obtained a copy of the script, which displays a warning.
The message states the dose prescribed to Ethan—300 mg/day—exceeded the higher range of recommended dosage by nearly 3.5 times.
The recommended range on Ethan’s script fell between 2.655 mg/day and 84.96 mg/day.
Slater was instructed to administer 50mg to Ethan every four hours.
She said by the time Ethan took his second dose, something had gone terribly wrong.
Ethan was again rushed to Vanderbilt.
What happened next is detailed in her lawsuit against the hospital and Walgreens.
Documents state Ethan was suffering from respiratory depression and cardiac arrest.
Slater said her son had to be treated with Narcan, a drug that addicts are sometimes given, to reverse the overdose.
Ethan regained consciousness the next day.
“It is not a feeling I wish upon anyone,” Slater said. “It’s devastating, and I was fortunate I was able to have my child back.”
“Why in this world wasn’t this prescription checked?” asked Ed Gross, an attorney representing Slater. “Why wasn’t something done?”
For this specific drug, the manufacturer issued a warning stating errors in dosing could result in overdose or even death.
Sheila McMorrow is a doctor who specializes in pediatric emergency medicine at TriStar Centennial Medical Center in Nashville. She said warnings that monitor dosages are to be heeded.
“It’s very important,” McMorrow said. “I think anyone can make a quick mistake if they’re putting something in the computer and that’s what the safeguards are kind of built for.”
Slater said over time, she noticed changes in Ethan.
She claims Ethan now suffers from fatty liver disease, gastrointestinal problems and assorted behavioral issues.
In court filings, attorneys for Vanderbilt denied their acts caused Ethan’s problems, even though they acknowledge, “Ethan Slater apparently suffered some short-term consequences of having received too much oxycodone.”
Walgreens also rebuked the allegations, denying they filled a “prescription of a lethal dose,” and were negligent in providing reasonable medical care.
But Slater said she plans to continue fighting for her son.
“I just want him to be happy and healthy and we’re doing everything we can every day to do that,” she said.
Attorneys for Vanderbilt and Walgreens declined to comment on this story, citing ongoing legal matters.
Gross said he believes a mediation is scheduled for November.
Nexium Lawsuit Filed By Bernstein Liebhard LLP On Behalf of Illinois Man Who Developed Chronic Kidney Disease Allegedly Related to Use of the Proton Pump Inhibitor
NEW YORK, Sept. 19, 2016 /PRNewswire/ — The nationwide law firm of Bernstein Liebhard LLP announces that they have filed a Nexium lawsuit (http://www.nexiumlawsuit.com/) on behalf of an Illinois man who developed chronic kidney disease allegedly related to the long-term use of the proton pump inhibitor. The complaint, which was filed on August 26th in the U.S. District Court, Eastern District of New York, alleges that AstraZeneca Pharmaceuticals LP and AstraZeneca LP were aware of reports linking Nexium to chronic kidney disease and other renal complications, yet continued to represent that the drug did not pose any risks to the kidneys. (Case No. No. 16-04801)
“Our Firm has been contacted by hundreds of people who allegedly suffered kidney disease, renal failure, and other kidney complications due to their use of Nexium and other proton pump inhibitors. We are continuing to investigate potential cases,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP. The Firm is now offering free legal reviews to individuals who were diagnosed with chronic kidney disease, kidney failure, acute kidney injury, or acute interstitial nephritis following extended use of prescription or over-the-counter proton pump inhibitors.
Proton Pump Inhibitors and the Kidneys
Proton pump inhibitors like Nexium are indicated for the short-term treatment of ailments related to the excess production of stomach acid, such as gastroesophageal reflux disease (GERD), dyspepsia, acid peptic disease, peptic or stomach ulcers, and Zollinger-Ellison syndrome. Other prescription medications in this class incude:
Prilosec (omeprazole)
PrevAcid (lansoprazole)
Dexilent, Kapidex (dexlansoprazole)
Aciphex (rabeprazole)
Protonix (pantoprazole)
Vimovo (naproxen and esomeprazole magnesium)
Zegerid (omeprazole and sodium bicarbonate)
Over-the-counter versions, including Nexium 24HR, Prilosec OTC, and PrevAcid 24HR, are also available.
According to the complaint filed by Bernstein Liebhard LLP, Nexium is AstraZeneca’s largest-selling drug, with sales exceeding $5.2 billion in 2008. In 2013, more than 15 million Americans used prescription proton pump inhibitors, at a cost of more than $10 billion. However, it has been estimated that between 25% and 70% of these prescriptions have no appropriate indication.
Several recent studies have suggested that Nexium and other proton pump inhibitors may pose a risk to the kidneys. In April, researchers writing in the Journal of the American Society of Nephrology reported that long-term users of proton pump inhibitors may be 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease compared to patients using another class of heartburn drugs called H2-blockers. A study published in JAMA Internal Medicine in January also suggested that proton pump inhibitors might increase the risk of chronic kidney disease by as much as 50%.
In 2014, the U.S. Food & Drug Administration required all manufacturers of prescription proton pump inhibitors to add new information regarding acute interstitial nephritis to their product labels. This sudden inflammation of the kidney tubules is often the result of an allergic reaction to a medication. Untreated, the disorder can lead to kidney disease and renal failure.
In April 2015, a study published in CMAJ Open linked proton pump inhibitors to a 3-fold increase in the risk for acute interstitial nephritis, as well as a 2.5 times higher risk of acute kidney injury.
Individuals who were diagnosed with serious kidney complications following treatment with Nexium or another proton pump inhibitor may be entitled to compensation for medical bills, lost wages, pain and suffering, and any other injury-related damages they incurred. To learn more about filing a Nexium lawsuit, please visit Bernstein Liebhard LLP’s website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal’s “Plaintiffs’ Hot List,” recognizing the top plaintiffs firms in the country. This year’s nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP 10 East 40th Street New York, New York 10016 800-511-5092
“One out of five, when the peer pressure hits, tries it. And then that person who tries it, one out of four is immediately addicted. That’s how scary this is,” Wichern said.
It would appear that the FEDS are renewed strategy is identifying the links between prescription drug addiction and heroin use… Does this suggest that they have little/no clear evidence of a sold link between legal prescriptions and addiction ?
They claim that 10,000 die from Heroin overdose but “We have more people die from drug overdose deaths than automobile accidents,” BUT. .what are the OTHER DRUGS that causing the other 30K – 40K deaths… only made public on a NEED TO KNOW BASIS and the public don’t need to know ?
CHICAGO (WLS) —
Heroin poses a serious threat in the U.S., causing an increasing number of overdose deaths, according to data released Monday by the Drug Enforcement Agency.
A large stack of data in the newly released National Heroin Threat Assessment shows new trends that federal drug agents are seeing. As a result, DEA agents hope to increase awareness about the heroin problem.
“We have more people die from drug overdose deaths than automobile accidents,” said Dennis Wichern, Chicago DEA special agent in charge.
The astounding statistics were collected from the last few years and shows that more than 10,000 Americans died from heroin-related overdoses in 2014 — more than triple compared to 2010. The drug is now available in larger quantities and is being used by more people.
“Two people every day die in Chicagoland and Cook County from a drug overdose, either from heroin or some other drug,” Wichern said. “In the collar counties, approximately one person dies every three days from either a heroin or an opioid overdose,” Wichern said.
In fact, he says when it come heroin and opioid, the Chicago region had the second-highest user problem in the country in 2012. Part of the federal government’s renewed strategy is identifying the links between prescription drug addiction and heroin use.
“It starts with the painkiller and the belief that this pill, made by a pharmaceutical company, is better and safer and less addictive,” Wichern said. “Once you’re addicted, you can no longer afford the cost of it because the heroin, eventually, is cheaper than that prescription painkiller.”
For Chicago agents, heroin is now their No. 1 priority. Wichern said he wants everyone, especially parents, to know that heroin has one of the highest addiction rates.
“One out of five, when the peer pressure hits, tries it. And then that person who tries it, one out of four is immediately addicted. That’s how scary this is,” Wichern said.
The Northeast and Midwest were two regions with the highest threat, according to the National Heroin Threat Assessment.
All 94 U.S. Attorney’s Offices will be getting a memo from the U.S. Justice Department urging prosecutors to more readily share information across state lines to identify traffickers and trafficking routes more quickly.
Last week, President Obama declared that this Sunday would be the first day of the Prescription Opioid and Heroin Epidemic Awareness Week as another of the recent measure to reduce heroin and opioid epidemic that affects Americans by education and law enforcement.
The statement was made during an official proclamation by Barack Obama, as a reaffirmation of his continuous pledge to educate Americans and raise awareness among them about substance abuse and addiction. The president encourages people to keep track of the ceremonies and activities that are programmed for this week. The Prescription Opioid and Heroin Epidemic Awareness Week will start Sunday, September 18 to September 24, 2016.
As President Obama declared it, the Prescription Opioid and Heroin Epidemic Awareness Week will start Sunday, September 18 to September 24, 2016. Photo credit: Rob Kunzig / Morning Consult”During Prescription Opioid and Heroin Epidemic Awareness Week, we pause to remember all those we have lost to opioid use disorder, we stand with the courageous individuals in recovery, and we recognize the importance of raising awareness of this epidemic”, stated Obama through the proclamation.
The White House said that the cabinet members and federal agencies would be working to approach the epidemic across the United States.
Raising awareness about the outbreak is key
The abuse of and addiction to opioids as heroin, morphine and painkillers is an increasing problem that affects the economy, health and the social environment of around 26.4 and 36 million people worldwide. In America, it is believed that around 2.1 million people are dealing with the abuse of these substances related to prescription of opioid painkiller. The consequences are devastating. In the US, the number of unintentional overdose death have more than quadrupled since 1999.
Deaths from an overdose, just considering painkillers and heroin, in the United States are more than those caused by traffic accidents. The US Centers for Disease Control and Prevention estimates that the number of drug overdose deaths were 28,000 in 2014, the highest ever recorded. At what is more concerning is that prescription drugs caused at least half of them.
Due to that, the Federal Government has taken several measures to combat the use and abuse of heroin and opioid referring to it as an epidemic, by increasing the funds for treatment, urging doctors to be very careful when prescribing opioid pain relievers, and of course promoting education and awareness about the problem among society.
The abuse of and addiction to opioids as heroin, morphine and painkillers is an increasing problem that affects the economy, health and the social environment of around 26.4 and 36 million people worldwide. Photo credit: PharmEasy
What’s up for this Week?
For this week the White House is hosting parents who have lost children to drug abuse and addiction. As well, the U.S. Attorney’s Offices around the states will be engaged in more than 160 different events, according to the White House Office of National Drug Control Policy
But declaring this week as the Prescription Opioid and Heroin Epidemic Awareness Week is not the only measure that the president has referred to, he also called on the Congress to approve $1.1 billion as new funds to fight the epidemic, also making opioid overdose antidote naloxone more accessible for citizens and police officers. Nonetheless, the new funds haven’t been approved yet.
States throughout American are joining to the activities of the week
States are also using the declaration made by Obama about the Prescription Opioid and Heroin Epidemic Awareness Week to introduce activities aimed to reduce the deaths and the abuse caused by the opioids, which have devastated families and dreams along the US. For example, the New Hampshire Government has admitted that opioids are an increasing problem for the state’s population, and they expect that this announcement made by Obama will be beneficial to improve access to information, treatment, and recovery.
The state has been facing an increasing number of overdoses, around 400 people died last year because of that, and the authorities believe that the number will not be reduced in 2016. They consider that a potential culprit in these cases of overdose is the fentanyl, which is a pain reliever similar to morphine, the problem is that it might be 50 to 100 times stronger that morphine, as the National Institute explained it on Drug Abuse.
In New Mexico, the authorities are eager to complete a plan that includes a series of educational events with high school students and tribal leaders for this week to reduce the stats of opioid-related deaths. It is part of the New Mexico Heroin and Opioid Prevention and Education (HOPE) Initiative, which was created last year by U.S. Attorney Damon Martinez and New Mexico Health Sciences Center Chancellor Dr. Paul Roth. The HOPE initiative include education, prevention and law enforcement as the top issues to address.
In New Mexico almost 90% of the 540 overdose deaths were caused by heroin or prescription painkillers in 2014, making the state the second to record the highest rate of drug overdose-related deaths after West Virginia. They will be promoting the use of naloxone to reverse the effects of the opioids in the organism, and they will be training, with the support of the University of New Mexico medical personnel, on how to use the drug.
What do you mean that you can’t see the first one ? It has been stated over and over that there are 116+ million chronic painers out there in our country.
Maybe you can’t see any because nearly all – for some reason – refuse to STAND UP.
Remember… all 116 million chronic painers are part of the WAR ON DRUGS… the DEA/CDC is stating that anyone taking/using opiates > 90 days (legally/Illegally) is suffering from the disease of “opiate use disorder”… their NEW TERM for addict/junkie.
The DEA tells the media over and over… how bad the war on drugs is… just look at all the PRESS RELEASES that the 24 district office and HQ routinely spew out. https://www.dea.gov/pr/news.shtml
The bureaucracy, politicians, media are moved by NUMBERS… just look at the White Petition progress .. it takes 100,000 signatures for the White House to just “CONSIDER” a submitted petition..
How many different petitions have been started on the White House site… concerning issues on chronic pain treatment ?…. A COUPLE OF DOZENS… how many have gotten more than 5,000 signatures in 30 days ? NONE ????
If you were a member of Congress or part of the bureaucracy… how would you interpret “the optics” of all those petitions that few bother to sign.. when there is suppose to be 116 million chronic pain pts being adversely affected by the actions of the DEA/CDC/Surgeon General.
Would you believe that all that many are being adversely impacted by current rules/regulations/guideline ?
It is a fact that those within the bureaucracy depend on “NUMBERS” to get the needle to move… Keep in mind that 116 million chronic painers represents ONE OUT OF THREE people in our society… or about TWO OUT OF EVERY FIVE ADULTS..
From a optic’s perspective.. is every attempt to grab attention against the actions of the DEA and others from the alphabet soup of federal agencies… doing more long term harm than good when few take any sort of action of support… even if it is just signing a petition ?
An important date for everyone suffering from chronic pain is Nov 8th… our national election day… No matter who is elected President… if those in Congress running for re-election get re-elected… the path of cutting opiates prescribed to pts with a valid medical necessity will continue for some time – AT LEAST..
If you are a chronic pain pts and your opiate meds have not yet been cut yet… you can be pretty much assured that they will be over the next 1-2 yrs.
Once your meds have been cut… lots of luck… getting them back.. or finding another prescriber to take your dosing back up… remember you are now labeled as having a “opiate use disorder” … the same label that is used to describe those use to be called addicts/junkies.
You can register to vote by mail and you can vote by mail… most states have early voting… when there are no lines..
When you cast your vote to keep the incumbents in office or don’t vote at all… when your necessary opiate medication(s) are cut… you need to look in a mirror to see who is part of the reason for your uncontrolled pain.
CLEVELAND, Ohio — The head of the U.S. Drug Enforcement Administration says that the answer to the explosion of deaths attributed to heroin, fentanyl and other powerful opioids isn’t as simple as locking the problem away in prison cells.
Chuck Rosenberg, the former federal prosecutor who now heads the DEA, made the remark Monday while meeting with a small group of reporters in Cleveland, a city within a county that saw a record number of drug overdose deaths in August.
“I’ve been saying this ever since I was brand-new (Assistant U.S. Attorney) 25 years ago: we’re not going to prosecute or enforce our way out of this mess,” he said. “Prosecution is enforcement is a big part of it, but we’ve got to do a much better job of getting the word out about how dangerous this stuff is.”
Rosenberg was in Cleveland as his agency is working in tandem with the U.S. Justice Department in launching a multi-faceted effort in treating the overdose epidemic by partnering with local hospitals, rehabilitation clinics and educators to try and inform the public about cutting down on the use of prescription painkillers.
Rosenberg said the agency is also urging doctors across the country to cut down on prescribing unnecessary painkillers to patients, who sometimes end up addicted to the drugs or turn to more dangerous forms of opioids, such as heroin, once their prescriptions end.
How does a law enforcement agency go about determining when a opiate prescription is UNNECESSARY for a patient?
Rosenberg, appointed in March 2015 by President Barack Obama to lead the DEA, said they’re urging less prescriptions and for less pills. He said they’re also trying to teach parents that teenagers prescribed painkillers for sports injuries or other ailments don’t necessarily have to fill the prescriptions.
“You don’t have to come home with with 60 pills of substance X or 30 pills of substance Y when five or 10 pills will do,” Rosenberg said. “We have to be much more thoughtful and restricted in how we prescribe medication.”
Brett Taylor, a former quarterback at Akron’s North High School, died June 20 of an overdose of heroin and other drugs. He was 30.
The local task force is also trying to find a way around the provision in Medicaid law called the Institutions for Mental Diseases exclusion which limits federal funding to short-term in-patient service providers with more than 16 beds for people fighting heroin and other drug addictions.
The in-patient services are proving more effective in treating heroin addiction than out-patient services, U.S. Attorney Carole Rendon said. But wait times for beds can take weeks or months since providers tend to stay under the 16-bed limit to keep Medicaid funding.
“Our treatment providers need the ability to treat more people at the same time,” Rendon said. “One of the things they want addressed is that exclusion, especially in the midst of this epidemic. As a community we need to figure out a way to do that; as a nation we need to be able to figure out how to do this.”
Cuyahoga County recorded a record-high 52 opioid deaths in August and could surpass that total in September, Rendon said. The county is on pace for more than 500 overdose deaths in 2016 and has already surpassed the 2015 record high of 228 deaths.
New drugs being cut into the heroin have contributed to the deaths, beginning several years ago with fentanyl, which is about 50 times more potent than heroin.
Now, carfentanil, sedative for large animals, is being cut into heroin sold in northeast Ohio. The opioid is between 2,500 and 5,000 times more potent than heroin and has been linked to a dramatic increase in deaths in the Akron area. The drug is trickling into the Cleveland area, with the first two confirmed carfentanil deaths in Cuyahoga County coming in August.
Carfentanil is so powerful, Rosenberg said, that even a small amount accidentally inhaled or absorbed through the skin by first responders could be deadly.
Rosenberg said they’ve trained their agents on distributing the opioid overdose remedy Narcan, not so much for victims, but to treat first responders or fellow law enforcement officers who handle the drugs and are the first to arrive to the scene of an overdose death.
“We’ve sent out an alert to all cops, all sheriffs, all first responders about the lethality of handling this or handling something that might contain fentanyl or carfentanil,” Rosenberg said.
Rendon said the county is dealing with another new drug trend: fentanyl-laced cocaine which resulted in 70 overdose deaths in the county this year. There were 17 cocaine-fentanyl deaths in Cuyahoga County last year, Rendon said.
“So if you think you’re buying cocaine and it’s really a mixture of cocaine and fentanyl, the likelihood of overdose is going to increase exponentially,” Rendon said. “We’re seeing this crisis change and morph from painkillers, to heroin, to fentanyl to carfentanil and all of these various mixtures.”
Rosenberg, who went to Toledo later in the day and planned to visit Detroit on Tuesday, said the version of fentanyl sold on the streets first made its deadly mark on the country about 10 years ago.
The DEA tracked the source to a single lab in Mexico and shut it down. The drug largely disappeared until several years ago, when dealers in China began making the drug available to dealers across the world via the internet.
“Your return on your, I hate to call it an investment, but your investment for fentanyl is many, many times higher,” Rosenberg said. “It’s easier, cheaper and more plentiful.”
Tracking online sellers is more complicated and a decline in DEA agents is hindering investigators ability to quickly find the suppliers, Rosenberg said.
U.S. dealers are also finding they make more money from users by selling the more potent form of heroin to customers seeking a more powerful high, Rosenberg said. The traffickers also save on costs from not having to grow and cultivate poppy plants that are turned into heroin.
“That’s why we’re also focusing on the demand side,” Rosenberg said.
CSPI Asks FDA for Labels Warning of Heart Attack, Convulsion, and Other Adverse Reactions Linked to Energy Drinks
Documents obtained from the Food and Drug Administration show that since late 2012, 17 previously unreported deaths have been linked to the controversial caffeinated beverages known as energy drinks. According to adverse event reports collected by the agency since 2004, a total of 34 deaths have now been linked to energy drinks. Of those, 22 deaths have been linked to 5-Hour Energy, 11 deaths have been linked to Monster, and one death, a first, has been linked to Rockstar. Excluding a suicide, these deaths include the 17 deaths previously disclosed by the agency and reported on by the New York Times and other media outlets in the fall of 2012. And these deaths don’t necessarily include other deaths reported in the media, such as that of 16-year-old Lanna Hamman of Arizona, who died on vacation on June 14 in Mexico after consuming several cans of Red Bull. And, of course, some deaths might have been caused by energy drinks without doctors making that association.
The reports do not prove that energy drinks actually caused the deaths. Two years ago the FDA told Congress that it was investigating the reports that it had received, but it has not yet released a report to Congress or the public.
In addition to the newly disclosed deaths, 56 previously undisclosed injuries have been reported to the FDA through its adverse event reporting system. These and other serious events resulted in 54 hospitalizations, as recorded in the adverse event reports, with consumers experiencing high blood pressure, convulsions, heart attacks, and other problems after drinking energy drinks. The documents were obtained under Freedom of Information Act requests by the nonprofit Center for Science in the Public Interest and a lawyer representing the parents of a Maryland teenager who died after consuming two 24-ounce Monster beverages.
“As I see in my medical practice, energy drinks are clearly causing symptomatic arrhythmias,” said Dr. Stacy Fisher, director of complex heart diseases at University of Maryland School of Medicine. “These new reports of deaths and other injuries raise the level of concern about the adverse effects of energy drinks.”
CSPI today asked FDA commissioner Margaret Hamburg to require warning labels on energy drink containers notifying consumers of the risk of heart attack, convulsion, and other adverse reaction to energy drinks. As a further precaution, the group asked the agency to require manufacturers to lower caffeine levels in the drinks to 0.02 percent, or 71 milligrams per 12 ounces—the maximum amount the FDA considers safe in cola-style beverages. Also, CSPI asked the agency to require careful studies on the health effects of the various chemical and herbal ingredients (such as taurine, glucuronolactone, carnitine, ginseng, ginkgo biloba, milk thistle extract, and guarana seed) used in energy drinks and their possible interactions with caffeine.
Warning labels such as this one on energy drink containers would inform consumers of their dangerous–and possibly deadly–risks.
“How many deaths will it take to get the FDA to protect consumers from energy drinks, with their high levels of caffeine and untested herbal and chemical ingredients?” said CSPI executive director Michael F. Jacobson. “Since the first batch of adverse event reports became public, the death count has essentially doubled, with dozens more injured. Yet the FDA is just standing by—no public warnings, no regulations, no testing required—nothing.“
Besides the health risks posed by the combination of caffeine and supplement ingredients in energy drinks, some products are also high in sugars. One 8.4-ounce of non-diet Red Bull contains 110 calories from almost 7 teaspoons of added sugars, a 16-ounce can of Monster has 200 calories from 13.5 teaspoons of added sugars, and a 24-ounce can of Rockstar has 420 calories from 23 teaspoons of added sugars. To put those numbers into context, the American Heart Association recommends that men consume no more than nine teaspoons of added sugars per day and that women consume no more than six teaspoons. Sugar-sweetened beverages promote weight gain, obesity, diabetes, heart disease, and other health problems.
When I chronic pain pt ends up in a ER with a “pain crisis” .. if the pt is denied any treatment at all… is the healthcare professional/hospital in violation of theThe Federal Emergency Medical Treatment and Labor Act determining if a valid (EMC) emergency medical condition is can be a thin line and probably is a good reason for audio/video recording of what is say/done or not said/not done. To document if the determination that a EMC does or does not exist is based on FACTS and not personal biases of the healthcare professional. Besides the possibility of violating this Federal law, there is also the possibility that the pt is denied care and their insurance and the pt is charged as if care was provided… which could be considered insurance fraud. If the pt is not aware of these laws, they will be discharged/leave the hospital without realizing that they have been denied care that Federal Law guarantees them and may end up paying out of pocket (deductible/co-pays) for charges that should not have been incurred.
Hospital Liability & The Federal Emergency Medical Treatment and Labor Act in Florida
Imagine taking a loved one to the hospital for an emergency only to be turned away because you cannot afford the treatment. You know that without immediate medical care he or she may not survive. Can a hospital refuse to treat a patient simply based on that person’s ability to pay? Luckily, federal law known as “EMTALA” prohibits hospitals from doing so. This article provides an overview of EMTALA in Florida.
What is EMTALA?
The Emergency Medical Treatment and Labor Act, EMTALA, is known as the “anti-dumping” statute for its ban on patient dumping. Congress passed EMTALA in 1986 in response to a number of widely reported horror stories about emergency rooms turning away seriously ill or injured patients who had no insurance and no money to pay for treatment. Prior to EMTALA, there was no requirement that hospitals treat everyone who came to the emergency room and, in many states, hospitals were not held responsible for damages caused by their refusal to treat patients. A hospital could choose not to treat a patient who lacked insurance or enough money to pay for the required medical treatment. In some cases, patients died or suffered serious injuries because of a transfer or delay in treatment.
Does EMTALA Apply to All Hospitals?
EMTALA applies to all hospitals that have emergency rooms and participate in the Medicare program. Since almost all hospitals, public and private, receive Medicare funds, nearly all hospitals are covered by EMTALA.
What Actions Must a Hospital Take Under EMTALA?
EMTALA imposes two essential obligations on hospitals:
When a person seeks treatment at a hospital emergency room, the hospital must provide an appropriate medical screening examination (MSE) to determine whether an emergency medical condition (EMC exists). Generally, an EMC is a medical condition where failure to provide immediate medical attention could reasonably be expected to result in serious harm to bodily functions, serious damage of a bodily organ or part, or serious risk to the health of an individual and/or unborn child.The hospital does not have an obligation under EMTALA to treat the patient if after the MSE the hospital determines there is no EMC.
If the MSE reveals an EMC, the hospital must treat the patient and “stabilize” the medical condition before transferring the patient to another hospital or discharging the patient from the emergency room. Under EMTALA, “stabilized” means that no significant worsening of the patient’s medical condition is likely to result because of a transfer or discharge. In the circumstance of a woman in active labor, stabilization means the woman has delivered the child and placenta. An unstabilized patient may be transferred if the hospital cannot further stabilize the patient and a different facility has the necessary treatment. Hospitals must follow very specific procedures for such transfers.
What If a Hospital Does Not Follow EMTALA?
If a person is injured because a hospital did not provide an MSE or because it did not stabilize the patient before release or transfer, the patient may sue the hospital for money damages based on a violation of EMTALA. Suing a hospital under EMTALA is different than suing for state medical malpractice. EMTALA is not a substitute for suing for a wrong diagnosis or improper performance of a medical procedure.
Generally, if a patient is properly given a MSE but misdiagnosed, the hospital has followed EMTALA but may be responsible for damages under state malpractice law. However, an inadequate MSE may still violate EMTALA. Many courts have concluded that an appropriate MSE is one that the hospital would have offered to any other patient with the same symptoms, regardless of whether the patient was insured or could pay for the medical screening. Therefore, a hospital violates the MSE requirement of EMTALA only when individuals who are perceived to have the same medical condition receive different treatment.
Similarly, EMTALA’s stabilization requirement is intended only to regulate a hospital’s care of a patient immediately after admitting the patient for emergency care. Once a patient is admitted to the hospital and placed under the care of physicians, state medical malpractice law, not EMTALA, covers the actions of hospital and doctors.
What Does a Patient Have to Prove in a Lawsuit?
In a lawsuit, the patient must establish that the hospital treated him or her differently from other patients. Some courts have determined that in order to prove he or she did not receive an appropriate MSE, the patient must show there was an improper motive on the part of the hospital. That means, the decision as to what type of screening to provide was motivated by improper factors such as the inability to pay, race, or the sex of the patient. The majority of courts, however, no longer apply the “bad motive” requirement. The United States Supreme Court has ruled there is no such bad-motive requirement to establish that a hospital failed to adequately stabilize a patient before transferring or discharging.
Is There a Penalty for Violating EMTALA?
Depending on the facts of the case, hospitals or physicians that violate EMTALA are subject to fines and may lose Medicare provider agreements.
If you are concerned about how you were screened or treated at a hospital emergency room, you should seek the advice of an experienced attorney.
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