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Not enough space, not enough money. Jailers across Kentuckiana said they are burning holes in their financial pockets. They’re trying to keep up with treating inmates who are overdosing while in their care.
LEBANON, Kentucky (WHAS11) — It’s got that small-town feel and it’s where American pride is proudly on display. But, that Mayberry persona is masking a deadly and dangerous reality.
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http://www.modernhealthcare.com/article/20170520/MAGAZINE/170519844
As with so much else, the Trump administration has stumbled in its initial efforts to combat opioid addiction. Given the magnitude of the crisis, healthcare professionals have an obligation to speak out against ill-considered policies.
The more than 30,000 people who die each year from opioid overdoses—nearly two-thirds of which involve prescription drugs—are everywhere. They live in inner cities, rural communities and the suburbs.
Citizens of all political persuasions have cried out for a comprehensive approach to this scourge. Not only must the healthcare system reckon with its misguided approach to treating pain, policymakers must address the reality that the worst of the addiction crisis is being felt in communities experiencing economic decline, poverty, violence and despair.
Instead of unity in the face of those daunting challenges, recent statements by top Trump administration officials either ignored them or went against what public health officials recommend. They also were at odds with the sympathetic statements made by the president.
In late March, Trump unveiled a new Commission on Combating Drug Addiction and the Opioid Crisis. He tapped New Jersey Gov. Chris Christie to head the group. “We want to help those who have become so badly addicted,” Trump said during a listening session on opioid addiction. “The president and I both agree that addiction is a disease, and it’s a disease that can be treated,” Christie added.
In a welcome move toward bipartisanship, the president named North Carolina Gov. Roy Cooper and former Rep. Patrick Kennedy of Rhode Island, both Democrats, to the panel. Kennedy, the son of the late Sen. Edward Kennedy, repeatedly wrestled with substance abuse issues before leaving Congress to become an advocate for a more scientific approach to treatment.
He rounded out the panel with Massachusetts Gov. Charles Baker, a Republican, and Bertha Madras, a Harvard Medical School professor.
Yet before its deliberations even began, several high-ranking administration officials announced policy shifts that, if implemented, would completely undermine the commission’s work. The administration’s 2018 budget draft included plans to cut the Office of National Drug Control Policy, whose head is informally known as the “drug czar,” to just $24 million from $388 million, a 95% cut.
HHS Secretary Dr. Tom Price, during a listening tour stop in West Virginia, revealed his bias against medically assisted treatment, or MAT, with drugs such as buprenorphine and methadone. HHS expanded access to MAT last year, and most clinical practice guidelines have endorsed the approach. “If we’re just substituting one opioid for another, we’re not moving the dial much,” Price told the Charleston Gazette-Mail. He touted faith-based approaches to counseling and support, according to the newspaper.
More than 700 clinicians and public health officials immediately condemned his statement for stigmatizing addiction. “Medically assisted treatments meet the highest standard of clinical evidence for safety and efficacy,” they wrote.
Dr. Price sought to limit the damage. In a commentary posted on the CMS website, he touted community-based solutions such as finding ex-addicts jobs. “The first obstacle is finding an employer willing to hire someone with a criminal record.” He also called for helping people get access to recovery services, “including medication-assisted treatment.”
Of course, the first part of that equation won’t be made easier by Attorney General Jeff Sessions’ plan, still under review, to take the nation back to the days of mandatory minimum sentences for people convicted of low-level drug possession charges. That’s exactly the opposite of what medical professionals recommend. “Stop criminalizing substance use problems,” the clinicians’ letter said.
Downsize the agency fighting traffickers? Treat addicts like criminals? Stigmatize those seeking medical treatment? This isn’t the help that the “badly addicted” need.
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May 23, 2017
The U.S. Food and Drug Administration is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo. Sileo is a prescription gel that is given to dogs by mouth to treat noise aversion (signs related to anxiety or fear due to noise).
Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog. Overdose can result if the ring-stop is not fully locked. Therefore, it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.
Zoetis began marketing Sileo in May 2016. To date, the FDA has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose. In some cases, the entire contents of the dosing syringe were administered to the dog. In 15 out of the 28 reports, dogs experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or incoordination, low blood pressure, and muscle tremors. No deaths have been reported. At this time, the FDA has not determined if these overdoses were due to improper use of the ring-stop. Dog owners can trust Ridgeside K9 board and train to have their dogs trained by experts who treat your dog with the utmost care.
All prescribing veterinarians and users should be aware of the possibility for accidental overdose if the Sileo syringe is not properly locked before dosing. Veterinary staffs are strongly encouraged to provide education in proper operation of the syringe to dog owners before dispensing the drug. Dog owners should be aware of potential signs of overdose and they should contact their veterinarian if their dog exhibits any of these signs. Zoetis has also provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.com
, and for dog owners at Sileodogus.com.
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INDIANAPOLIS (WISH) — Prosecutors charged nine adults and several juveniles in federal court in a string of pharmacy robberies.
There were 24 robberies total, dating back to October 2014. The US Attorney’s office traced them back to a gang known as “The Mob.”
They said the gang’s actions were funneling drugs into the streets. An operation they say is now over.
“My message now is clear: the days of the mob ruining the neighborhood is over,” said Josh Minkler, the US Attorney for Southern Indiana.
The individuals are now charged with racketeering, robbery, drug distribution, and firearms charges.
Minkler says they robbed pharmacies and then sold the stolen drugs on the streets.
They would even recruit juveniles, some as young as 12-years-old, and then intimidate them using social media.
One of the posts came from Facebook. Minkler says it read: “He got to die, if he testify. We do not work with the FBI.”
This investigation began in 2015, after someone shot and killed a 19-year-old in connection to a pharmacy robbery.
This is the same year Indiana ranked #1 for pharmacy robberies.
“Indianapolis never wants to be number 1 in those categories,” said Bryan Roach, the IMPD chief.
Authorities say the actions of the mob helped to contribute to the state’s opioid addiction problems.
“Criminal drug trafficking organizations exploit the addicted, poison our streets, and leave a trail of violence throughout our communities,” said Greg Westfall of the Drug Enforcement Agency. The lawyers for wrongful death cases from The Law Offices of Thomas J. Lavin are usually there to help citizens deal with the legalities of a case.
One fugitive, Duwan Byers remains on the loose.
They say their work will continue even after he is captured.
“Community, we heard you. We saw a problem, we addressed the problem. We’re not done yet,” said Trevor Velinor of the Bureau of Alcohol, Tobacco, Firearms and Explosives.
Since the early – mid 70’s it has been a FEDERAL CRIME – the same as robbing a bank – when a pharmacy is robbed and controlled substances are involved. This is the first incident – that I have seen – where that 40 y/o Federal Law is being used against those robbing a pharmacy. Did it take 24 pharmacies being robbed to get the FBI to act ?
Where is the Board of Pharmacy, FBI, DEA taking no action against these pharmacies – mostly chains – that have been reluctant to make their Rx depts more physically robbery resistant. What are they waiting on… Rx dept staff or customers to get hurt/killed ? More robberies that are allowing more drugs on the streets ?
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By: Scott Gottlieb, M.D.
As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.
Today, I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal. With this, my first post to the FDA Voice blog, I also wanted to share my plans with you.
I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.
Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.
While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.
As a first step, I am establishing an Opioid Policy Steering Committee that will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis.
I have asked the Steering Committee to consider three important questions. However, the Committee will have a broad mandate to consider whatever additional questions FDA should be seeking to answer. The Committee will solicit input, and engage the public. I want the Committee to go in whatever direction the scientific and public health considerations leads, as FDA works to further its mandate to confront the crisis of opioid addiction.
The initial questions I have tasked the Steering Committee to answer are:
These are just some of the questions I will be asking this new Steering Committee to consider right away, given the scope of the emergency we face. In the coming days, I’ll continue to work closely with the senior leadership of FDA. I want to know what other important ideas my colleagues at FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic.
Despite the efforts of FDA and many other public health agencies, the scope of the epidemic continues to grow, and the human and economic costs are staggering. According to data from CDC and SAMHSA, nearly 2 million Americans abused or were dependent on prescription opioids in 2014, and more than 1,000 people are treated in emergency departments each day due to misusing prescription opioids.
Opioid overdose deaths involving prescription opioids have quadrupled since 1999. In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids.
We know that the majority of people who eventually become addicted to opioids are exposed first to prescription opioids. One recent study found that in a sample of heroin users in treatment for opioid addiction, 75% of those who began abusing opioids in the 2000s started with prescription opioid products.
This March, a study published in CDC’s Morbidity and Mortality Weekly Report, found that opioid-naïve patients who fill a prescription for a one-day supply of opioids face a 6% risk of continuing their use of opioids for more than one year. This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6% to about 35%.
Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.
Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
Follow Commissioner Gottlieb on Twitter @SGottliebFDA
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http://www.fox9.com/news/256247742-story
(KMSP) – A Fox 9 Investigation looks at mistakes at Minnesota pharmacies and how complaints are on the rise.
In one instance a customer was given the wrong prescription, and a blood clot formed and a paralyzing stroked occurred. The damage was permanent.
A confidentiality agreement prevents the person from talking about it publicly.
The Executive Director of the MN Board of Pharmacy, Cody Wiberg, said they don’t know with certainty how often errors occur.
Drug stores are filling more prescriptions than ever, at some locations as many as 800 a day, and it’s not uncommon for some pharmacists to work 14 hours straight.
Volume often makes up for lower reimbursements from insurance.
CHAOS IN THE PHARMACY
Pharmacist Lyla Aaland is able to speak freely because she is now retired.
The Fox 9 Investigators contacted her after reviewing a file obtained from the pharmacy board.
She was among dozens of pharmacists who wrote the group to share concerns about working conditions.
“Chaos in the pharmacy, busy, phone calls, drive thru, too many interruptions, that’s what it is,” she said.
The records checked by Fox 9 offer rare insight into what’s going on behind the drug store counter.
“14 hour days with no breaks are extremely exhausting and lead to errors,” wrote one pharmacist in the reports.
Another wrote “there is no question that fatigue becomes a problem.”
Insiders said that as it all adds up, it becomes more likely that mistakes will happen.
MORE COMPLAINTS
“We’re getting more complaints than we’ve ever received,” Wiberg said.
When he joined the pharmacy board more than a decade ago, consumers filed maybe 100 complaints a year.
Now he said the number has nearly tripled.
“We also know that for every complaint that we get, there are many more errors that are never reported to us,” he said.
On occasion, the state has fined a drug store for giving a medication to the wrong patient. But regulators really have no idea when errors happen, unless someone registers a formal complaint with the pharmacy board.
That’s because drug stores are not required to report that data.
They are, however, supposed to keep an internal log of mistakes. An industry trade group said that approach “emphasizes correcting and preventing future errors.”
Aaland said while she always reported any mistakes, some of her colleagues did not, primarily because they were so busy.
SILENCE AFTER A SETTLEMENT
When mistakes cause serious injury or even death, the cases are often settled out of court with a clause that no one can talk about it.
Personal Injury Attorney Jeff Sieben had a client who was mistakenly given pain killers instead of diabetes medicine. It impaired his driving, causing a crash and injury.
“They don’t want the general public to know of a problem,” he said.
He added the case involved a well-known drug chain, but couldn’t disclose the name due to the settlement terms.
CONSULTS ARE KEY
Druggists are supposed to discuss every new prescription with the customer.
It’s a way to prevent errors by confirming the medication in the bag is appropriate.
“[Consults] supposed to [happen] and people will say they are doing it. But it’s the one thing that I think gets put by the wayside,” said Aaland.
According to state regulators, lack of consults is one of the main reasons why pharmacists might be disciplined; it’s considered such a crucial step in the safety process.
Fox 9 asked the National Association of Chain Drug Stores for an interview.
They declined but in a statement said “Patient safety is a pharmacy’s top priority…Pharmacies constantly pursue opportunities to improve safety..”
PHARMACISTS’ HOURS TO BE LIMITED
Under a new rule by the Pharmacy Board starting July 1, Minnesota will no longer allow pharmacists to work more than 12 hours in a row, and they’ll be required to get mandatory breaks.
“This is an attempt to relieve that stress that we acknowledge is out there so pharmacists are less likely to make errors,” said Wiberg
Customers have a safety role in all of this too. When the pharmacist asks questions, they should take the time to answer. Studies show that it’s during those discussions that mistakes come to light.
Full statement from the National Association of Chain Drug Stores:
Patient safety is a pharmacy’s top priority. Recognizing that human error is a possibility in any profession, pharmacies constantly pursue opportunities to improve safety. One example is updating and enhancing quality assurance and training programs for pharmacy personnel. Another example is using workflow and technology innovations to help reduce the chances of human error. Scanning technology is used in some instances to verify that the medication that has been prescribed matches the medication actually being dispensed. Also, the use of electronic prescribing is on the rise. E-prescribing can reduce the risk of errors from prescribers’ handwriting and from incorrectly entering prescription information.
In addition to patient-safety-focused processes and technology, community pharmacies have provided feedback to the Minnesota Board of Pharmacy on the pharmacist work rule surrounding breaks. As responsible and highly educated professionals, pharmacists’ judgments are more effective than rigid rules when it comes to decisions about breaks. The work rule taking effect July 1 reflects input provided by community pharmacies to the Minnesota Board of Pharmacy. The Board arrived at a reasonable approach in its final work rule, and we appreciated the opportunity to provide context throughout their process. In the end, everyone agrees that the best policies should be consistent with a pharmacist’s ability to meet the needs of patients and put safety first.
Also, the pharmacy community supports legislation that fosters quality assurance programs and patient safety for all healthcare providers, including pharmacies. Further, we support voluntary reporting of medical and prescription errors in a non-punitive forum, with a focus on strategies and education to help identify an error’s root cause. This approach, common among healthcare professions, emphasizes correcting and preventing future errors.
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http://www.refinery29.com/2017/05/154770/what-are-opiate-drugs
When taken on a daily basis long-term, opioids are really lousy drugs.
As we responded to this brilliant campaign and as opioid prescribing took off, it led to a public health catastrophe.
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being prepared for a “job” that doesn’t exist… and NOT PREPARED for the “job” that does exist ?
I begged my pharmacy school (a relatively new one) to spend some actual practical time on drug interactions, high doses, overdoses, and basic toxicology. They just weren’t interested! One professor said that they were considering an interaction elective!!!! An effing ELECTIVE for an important part of our job! RIDICULOUS!
Modern pharmacy schools are obsessed with turning us into mini-doctors instead of the “drug experts” that they kept claiming we would be upon graduation! Myself and a number of students were quite vocal about our rudimentary instruction in drugs, while we spent hours upon hours learning to diagnose diseases when no one was gonna ask us to so in the real world!
Couple that BS with working at break neck speed or being told that they’ll replace you with someone faster…….it’s a recipe for disaster!
we spent so much time basically triaging imaginary patients and developing detailed care plans it was ridiculous. But when I’d say, “are we gonna cover proper dosing, or adverse drug events, etc,” they say, “well that stuff is really learned in practice later on.” WTF?
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