Judiciary Committee Leaders Press Justice Department for Overdue Answers on DEA Foreign Operations

Judiciary Committee Leaders Press Justice Department for Overdue Answers on DEA Foreign Operations

https://www.grassley.senate.gov/news/news-releases/judiciary-committee-leaders-press-justice-department-for-overdue-answers-on-dea-foreign-operations

WASHINGTON – Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.), respectively ranking member and chair of the Senate Judiciary Committee, are seeking additional information about the Drug Enforcement Administration’s (DEA) oversight of its foreign operations, including the closure of a special DEA unit in Mexico that Mexican officials claim was infiltrated by criminals. The senators’ letter follows an unanswered inquiry from last November.
“After more than six months, and despite multiple follow-up requests from both of our offices, we have received neither the briefing we requested nor a response to our November 16, 2021, letter. By any measure, such an extended delay is unacceptable,” the senators wrote. “…Furthermore, recent developments in Mexico raise additional concerns and speak to an ongoing need for congressional oversight.”

In their letter to DEA Administrator Anne Milgram, the senators voice serious concerns about the DEA’s lack of engagement with its committee of jurisdiction and outline concerns stemming from the Mexican president’s announcement that a DEA sensitive investigative unit operating in Mexico was closed last year. Other media reports describe this unit as “deeply dysfunctional and constantly leaking to the cartels.”  The senators also ask the DEA to explain the circumstances surrounding the reported removal of an airplane used in DEA missions against drug cartels. This is the latest in a series of longstanding concerns about DEA’s oversight of its overseas operations.

An August 2021 report by the Justice Department’s Office of Inspector General (OIG) and a report from U.S. Office of Special Counsel (OSC) raised serious concerns about the lack of oversight of DEA operations abroad. Grassley and Durbin sought specific information about the status of some of these operations and the steps being taken to comply with OIG’s recommendations in November 2021. They raised specific concerns about operations involving a leak in Mexico, agents fraternizing with prostitutes in Colombia and two DEA-associated individuals in Haiti arrested or wanted by authorities in connection with the assassination of that country’s president. The senators have not received any substantive response from the DEA.
Full text of Grassley’s and Durbin’s letter to DEA can be found HERE.

Covid-19 deaths DOWN 1.2% HEADLINE: HOSP admissions increased 24% this week

COVID-19 admissions increased 24% this week: 9 CDC findings

https://www.beckershospitalreview.com/public-health/covid-19-admissions-increased-24-this-week-9-cdc-findings.html

The nation is now reporting more than 100,000 COVID-19 cases daily as hospitalizations continue to rise nationwide, according to the CDC’s COVID-19 data tracker weekly review published May 20.

Nine findings:

Cases

1. As of May 18, the nation’s seven-day case average was 101,130, an 18.8 percent increase from the previous week’s average. 

Hospitalizations 

2. The seven-day hospitalization average for May 11-17 was 3,250, a 24.2 percent increase from the previous week’s average. This marks the sixth consecutive week hospitalizations have increased.

Deaths

3. The current seven-day death average is 280, down 1.2 percent from the previous week’s average. Some historical deaths have been excluded from these counts, the CDC said. 

Vaccinations

4. The seven-day average number of vaccines administered daily was 388,308 as of May 18, a 0.5 percent decrease from the previous week.

5. As of May 18, about 258 million people — 77.7 percent of the U.S. population — have received at least one dose of the COVID-19 vaccine, and more than 220.7 million people, or 66.5 percent of the population, have received both doses. 

6. About 102.4 million additional or booster doses in fully vaccinated people have been reported. However, 49.1 percent of people eligible for a booster dose have not yet gotten one, the CDC said.

Variants

7. Based on projections for the week ending May 14, the CDC estimates the BA.2 omicron subvariant accounts for 50.9 percent of U.S. COVID-19 cases, while BA.2.12.1 accounts for 47.5 percent. Other omicron subvariants make up the rest.

Testing

8. The seven-day average for percent positivity from tests is 10.6 percent, up 2.01 percentage points from the previous week. 

9. The nation’s seven-day average test volume for May 6-12 was 798,164, up 0.9 percent from the prior week’s average. 

When a pain management practitioner – really could care less about really trying to manage a pt’s pain


I had a interesting conversation with a chronic pain pt yesterday. This pt shared with me a 18 minute recording of a office visit with a mid-level practitioner. This is suppose to be a pain practice and this pt has a torturous level of pain in each shoulder from two separate accidents.  The pain is so intense that the pt has very little use of both of their arms.   Just imagine the difficulty a person would have in doing personal care and/or simple chores around one’s house. Especially since the pt lived alone.

This mid-level did not ask what the pt’s level of pain was, but told the pt that they were at the max dose by the CDC of opiates and that she was on Xanax (Alprazolam) and he referenced the Beers Criteria https://www.aafp.org/afp/2020/0101/p56.html and the risk that Beers stated was hazardous to cause falls and other MAYBE SIDE EFFECTS.  But Beers is specifically directed towards those 65+ y/o and this pt was 61 y/o.

What the pt told me that they were prescribed was NO WHERE NEAR the CDC guidelines of 90 MME/day and this was a pain practice, so those limits do not apply to pain specialists.

The pt point out to the mid-level that the CDC were only guidelines – which the mid-level acknowledged, but the managing MD over the practice had implement max daily MME levels that what he consider “safe”.  That OLD ONE SIZE FITS ALL.

The pt is going to try to find a new pain management practice and I suggested once they have left this practice to file a complaint with the Quality Improvement Organization (QIO) and when they get reviewer’s report back. If the reviewer believes that the pt was not properly treated. Take that report and file a complaint with the state AG’s office on the MD and the mid-level in the practice and file a complaint with CMS about the pt’s Medicare’s Advantage Prgm

Roe vs wade: how could it help/hurt the chronic pain community


https://www.foxnews.com/politics/what-is-roe-v-wade-leaked-supreme-court-draft-opinion

The 1973 landmark decision made abortion legal for women during their first trimester of pregnancy

Option 1: There has been a leak concerning that the SCOTUS is going to overturn Roe vs Wage.. If this comes to pass then an abortion falls back to the states rules/laws. Senator Manchin recently stated that there are abt 500 state laws on the books concerning abortions.

Option 2: The SCOTUS lets Roe vs Wade stand

Option: 3: Congress passes a bill that would make abortions legal and basically negates the 500 state laws that exists. Congress could put time limits that matches the first trimester that Roe vs Wade supported or make abortions legal until a woman goes into labor, or anywhere in between.

Unless Congress codifies that abortions are legal,  the protests are going to continue… with “My body, My choice”… and this past week a woman testified before a Congressional hearing https://www.msn.com/en-us/news/politics/abortion-witness-tells-congress-men-can-get-pregnant-and-have-abortions/ar-AAXrrRr

so, if this is true… everyone should be able to protest abt  “my body, my choice” and should be able to get medication to properly manage their pain ?

As I remember our Founding Fathers in our Declaration stated that we have the unalienable rights – Life, Liberty and the pursuit of Happiness – which the Declaration says have been given to all humans by their Creator, and which governments are created to protect.

I may be wrong, but from this statement, our Founding Fathers did not intend for their successors to REDEFINE – OR MICROMANAGE -THOSE UNALIENABLE RIGHTS.

Without proper pain management – NONE OF THOSE UNALIENABLE RIGHTS are attainable and the governments are doing more interring with than protecting ?

 

 

IV Tylenol Flops In Yet Another Pain Trial—To No One’s Surprise

IV Tylenol Flops In Yet Another Pain Trial—To No One’s Surprise

https://www.acsh.org/news/2022/05/20/iv-tylenol-flops-yet-another-pain-trial%E2%80%94-no-ones-surprise-16319

For reasons I cannot fathom, we are treated to yet another clinical trial about IV Tylenol and whether it can decrease the amount of morphine needed by pain patients in the ER. Here’s your hint: No.

Since I am nothing if not subtle, I was perfectly comfortable writing IV Tylenol As Good As Moose Urine For Post-Op Pain Control back in 2019, when I dissected a study that clearly showed that IV acetaminophen was thoroughly worthless in controlling post-operative pain following spinal surgery.

I fear that I will run out of ruminants long before IV Tylenol pushers run out of different body parts to study, hence the vegan title on this one.

So, what’s today’s Tylenol flop du jour? It’s a study (1) in the journal Academic Emergency Medicine that makes short order of the question: “Can IV Tylenol reduce the amount of morphine needed by patients who visit emergency departments for pain relief?” (2)

You already know where this is going so I’ll keep it short. 

The Study

  • 220 patients who visited the emergency department at Cantonal Hospital of St. Gallen in Switzerland were randomized into two equal groups, placebo and intervention (treated with Tylenol).
  • Both groups were blinded.
  • All had a Numerical Rating Pain Scale score of 4 or higher.
  • Patients in the morphine-only group received 0.1 mg of morphine per kilo of body weight) plus placebo (IV).
  • Patients in the treatment group received 0.1 mg of morphine per kilo of body weight plus 1.0 grams of Tylenol (both IV).
  • All the patients were dosed every 15 minutes until their pain scores were reduced to less than 4.

The Results (such as they are)

  • The Tylenol-plus-morphine group required a mean morphine dose of 0.15 mg ± 0.07 mg/kg and a total dose of 13.1 mg.
  • The morphine-only group required a mean morphine dose of 0.16 mg ± 0.07 mg/kg and a total dose of 11.7 mg.
  • These numbers are the same.

Other measured outcomes included the time required to control pain, the time for it to reoccur, and the frequency of side effects. Same. Same. Same.

The group also broke down the pain into different categories. Likewise, within these subgroups, there was (big surprise) no difference between the morphine and morphine + Tylenol groups:

Same. Same. Same. Same. Same. Same. Same.

  • No one got addicted (2).

Conclusions:

Let’s have the authors speak for themselves:

 In ED patients, acetaminophen had no additional effect on pain control or morphine sparing effect at the time of first morphine administration. Titrated morphine with the algorithm used was highly effective, with 80% of all patients reporting pain relief within 60 minutes of starting therapy.

Minotti, et. al.,  Acad Emerg Med (2022 May 2), doi: 10.1111/acem.14517. Online ahead of print.

Seriously, Folks

Don’t you think that it’s about time to knock this off? Do we really need to conduct more studies in the desperate attempt to find some use for Tylenol, especially if it can result in a reduction of one-bazillionth of a milligram of morphine? Knock it off. Please. I’m begging you.

NOTES:

(1) It’s probably no accident that this trial took place in Switzerland. I can almost hear the screaming voices of the hoards of people who went to EDs with legitimate pain from legitimate medical issues only to be sent away with a healing crystal and pack of Tylenol (they work equally well). 

(2) Although I just made this up, I’m pretty sure no one got addicted from a lousy 17 mg of morphine. In fact, I’m so sure that I’m willing to bet my IRA against that of Dr. Andrew “Big Bling” Kolodny, who probably believes otherwise.

Feds Ask for Covid-19 “Misinformation” — Indiana Attorney General Sends Them CDC Remarks

Feds Ask for Covid-19 “Misinformation” — Indiana Attorney General Sends Them CDC Remarks

https://thenewamerican.com/feds-ask-for-covid-19-misinformation-indiana-attorney-general-sends-them-cdc-remarks/

When the U.S. Surgeon General’s office asked states to supply it with examples of Covid-19 misinformation, it probably did not expect what it got from Indiana Attorney General Todd Rokita: a list of false statements from Centers for Disease Control and Prevention (CDC) officials.

Rokita’s letter, dated May 2 but released to the public Monday, was compiled with the help of his co-signatories, Stanford University medical professor Jay Bhattacharya and former Harvard University medical professor Martin Kuldorff.

In their letter, the three “agree” with the Surgeon General “that misinformation has been a major problem during the pandemic,” but they contend that much of the misinformation has come “from the CDC and other health organizations.” To prove it, they cite several categories of such disinformation.

First on the list is the vast overcounting of Covid-19 deaths and hospitalizations. “CDC has not distinguished deaths where COVID-19 was the primary cause of death, where COVID-19 was a contributing cause of death, or where the death was entirely unrelated to COVID-19, but they incidentally tested positive,” the authors write. Various studies, which they cite, have shown that Covid-19 prevalence has been overcounted in both the United States and other developed countries.

Officials downplayed or denied that natural immunity exists while pushing the vaccines partly on the basis that they would prevent transmission of the virus. These assertions were baseless given that the existence of natural immunity was established early in the pandemic and that the vaccine trials “were not designed to determine whether they could also limit transmission or prevent death,” the letter reads.

School closures harmed children, potentially for the long term, without providing any real benefits, assert Rokita and company. The decision to shutter schools, they note, “was based on false claims that it would protect children, teachers, and the community at large.” Yet Sweden’s example of keeping schools — and most of the rest of society — open with no negative consequences put the lie to such notions by mid-2020, even as U.S. school closures dragged on.

Officials’ suggestions that “everyone is equally at risk … from COVID-19 infection” when, in reality, “there is more than a thousand-fold difference in the risk of hospitalization and death for the old relative to the young,” led the public to wildly overestimate the dangers of the virus and to demand lockdowns and other harmful policies, says the letter.

The authors also criticize the notion that “there was no reasonable policy alternative to lockdowns,” pointing to their recommendations in the Great Barrington Declaration and again to Sweden, which has “had near-zero overall excess death” during the pandemic. “Lockdowns,” they declare, “are an aberration — a sharp deviation from traditional public health management of respiratory epidemics — and a catastrophic failure of public health policy.”

“Contrary to assertions by some public health officials, mask mandates have not been effective in protecting most populations against COVID-19 risk,” write the three men. Cloth masks are useless, and even N95s have only limited effectiveness, particularly when worn by untrained individuals.

Mass testing of asymptomatic persons combined with contact tracing and quarantining, the letter argues, have “failed to substantively slow the progress of the epidemic” but have “imposed great costs.” Asymptomatic individuals rarely pass the disease on to others, the PCR tests are flawed, and tracing the contacts of everyone who tests positive overwhelms the system. “In the U.K., an official government review determined that its 37 billion pound investment in contact tracing was a waste of resources.”

Finally, the authors scold “public health leaders” for making “the suppression of COVID-19 spread to near-zero levels the endpoint of the pandemic” because “SARS-CoV-2 has none of the characteristics of a disease that can be eradicated.” The technology to eradicate it does not exist, lockdowns are unfeasible and would have to be imposed worldwide even to have a chance of being effective, the vaccines lose efficacy over time, and many animals can host the virus and transmit it to humans.

If the CDC wants to be taken seriously again, it ought to heed the words of Rokita’s missive because, as he and his co-authors observe, the government’s falsehoods regarding Covid-19 “have shattered the public’s trust in science and public health and will take decades to repair.”

CMS Proposal to Suppress Hospital Safety Data Angers Advocates

CMS Proposal to Suppress Hospital Safety Data Angers Advocates

Agency says COVID disruptions, staff shortages hamper ability to fairly score poor performers

https://www.medpagetoday.com/special-reports/exclusives/98843

Large employer coalitions and consumer advocates are angrily pushing back against a Centers for Medicare & Medicaid Services (CMS) proposed rule to suppress public reporting of key measures of preventable hospital-caused harms, such as pressure ulcers or falls resulting in hip fractures.

If the rule is finalized, CMS would not calculate scores under the Hospital-Acquired Condition Reduction Program (HACRP). Hospitals would still report on some safety measures, but certain scores — in particular those for the 10-measure Patient Safety and Adverse Events Composite (PSI 90), a key component of the HACRP — would be hidden from public data files and would not appear on the CMS Hospital Compare website.

Furthermore, CMS would not dock hospitals in the worst-performing quartile 1% of their Medicare reimbursement, as it usually does, and would end up paying these hospitals what would normally be withheld — an estimated $350 million — an amount that would be lost to the Medicare trust fund.

The agency gave several reasons — all related to COVID-19 — why hospitals need to be let off the hook, including wide variation in performance scores; unprecedented changes in clinical guidelines, treatments, and drugs; and rapid changes in what clinicians understand about a pathogen of unknown origin. In particular, they noted huge shortages of healthcare personnel and high rates of burnout, specifically among nurses, which could affect a variety of measures, such as infection rates and avoidable falls.

CMS began suppressing some measures at the beginning of the pandemic in 2020, and many assumed that would be the end of it.

‘Outrageous’ and ‘Ludicrous’

The CMS proposal “is outrageous,” Bill Kramer, executive director for health policy at the Purchaser Business Group on Health, told MedPage Today.

“Patients will be unable to know whether the provider they want to go to has more patient safety problems, more risky providers, so clinicians as well as purchasers and policymakers will be unable to identify and help patients choose those hospitals with the best patient safety record,” he said. Without that information, patients are more likely to suffer from avoidable accidents, “and some of them will die as a result.”

James Gelfand, executive vice president of public affairs for the ERISA Industry Committee, a trade association representing about 100 of the nation’s largest self-insured employers who purchase health benefits for their employees and families, called the CMS proposed rule “ludicrous.”

“Essentially what they’re saying is that patients got treated badly, so they’re going to report badly, and so the hospitals are going to score badly. And, therefore, we have to keep the data secret,” he said.

“The federal government has data that would be really useful in making decisions about plan design and decisions about whether to steer people to a particular hospital or health system, but they’re not going to give it to you because it’s bad for the hospitals? I can’t express to you how alarming that is,” he noted.

Leah Binder, president and CEO of the Leapfrog Group, which uses the CMS data to score hospitals with safety grades from A to F, told MedPage Today that she worries that not only will this proposed rule be finalized, but that CMS will extend the suppressed public reporting indefinitely, because they don’t want “to make hospitals unhappy with them.”

“The American public trusts hospitals to deliver care, and not to cause them to suffer unnecessarily,” she said. “As a hospital or as a hospital worker, you have a job that’s difficult, that requires you to keep your patients safe.”

“It scares me,” she continued. “I know enough to be frightened … if hospitals are not able to manage their operations in order to protect their patients.”

However, a spokesman for the American Hospital Association told MedPage Today, “we agree with the agency that it would be unfair to base hospital performance on data that have been distorted by the pandemic.”

“To the best of our knowledge, the current methodologies for most quality report cards that use CMS quality measurement program data are based on individual measures, and not the overall scores from the HACRP and Hospital Value-Based Purchasing program,” the spokesman wrote in an email.

PSI 90

The PSI 90 score measures in-hospital serious and potentially fatal pressure ulcers, falls resulting in hip fracture, and several preventable postoperative complications, such as sepsis, respiratory failure, and hemorrhage. CMS proposed to suppress individual metrics for each, meaning that consumers would not be able to compare, for example, an individual facility’s postoperative pulmonary embolism rates or perioperative hemorrhage rates.

Binder pointed to a February 17 Perspective in the New England Journal of Medicine, authored by CMS and CDC officials, which showed that after years of quality improvement on a variety of safety measures, infections and other complications soared during the pandemic, completely reversing the progress that had been made.

For example, central line-associated bloodstream infections decreased 31% in the 5 years before the pandemic, a trend “totally reversed by a 28% increase in the second quarter of 2020,” the authors wrote. Increases were also reported in catheter-associated urinary tract infections, ventilator-associated events, and methicillin-resistant Staphylococcus aureus bacteremia.

These are some of the very measures whose scores will no longer be available to the public under the agency’s proposed rule, Binder pointed out.

Kramer said that PSI 90 scores are also used by insurers and employers to identify preferred provider networks and to monitor quality of care, so they can let employees know if there’s a problem with a particular hospital or system.

Nurse Burnout

Nurse burnout and personnel shortages could negatively affect the way patients respond to CMS-required Hospital Consumer Assessment of Healthcare Providers and Systems surveys on how they perceived the quality of their care, which CMS proposed to suppress because of hardships during the pandemic.

Because patient volumes and personnel shortages affected facilities’ rates of adverse events, the agency noted that they are “concerned … that we will not be able to score hospitals fairly or reliably for national comparison and payment adjustment purposes.”

However, Binder said that she is adamant that hospitals with poor quality scores should not be given a pass on accountability.

“If hospitals had a problem — that they didn’t have enough staff or had a high rate of problems with patient safety, that they were killing some patients — that needs to be made public and people need to know and be able to choose to not go to a hospital that’s under this kind of stress and is not safe,” she noted.

Gelfand and Binder said they understand that hospitals had staffing problems during the pandemic, and that in some facilities, a shortage of staff physically capable of assisting patients may have meant a higher number of complications, such as preventable falls.

“But when I judge a hospital, one of the things I judge them for is, are they able to roll with the punches,” said Gelfand. “And when I hear things like, ‘well, we dropped people because we made decisions about staffing,’ what I’m hearing is that they’re not capable of making decisions and planning to provide a safe environment.”

The proposed rule is also worrisome because it assumes that this pandemic is unique, and that hospitals won’t ever have to face such extreme circumstances again, he noted.

“As much as we would like to think that this is the only pandemic that we’re ever going to experience, that’s just not very likely. If the facts of the matter are that certain systems aren’t up to it, not able to keep people safe during a pandemic, we need to know that and they don’t have the right to keep that secret,” he said.

Butler Pharmacy Graduates Earn Highest Pass Rate on the NAPLEX® Licensure Exam

Butler Pharmacy Graduates Earn Highest Pass Rate on the NAPLEX® Licensure Exam

https://stories.butler.edu/butler-pharmacy-graduates-earn-highest-pass-rate-on-the-naplex-licensure-exam/

If student outcomes ultimately define the quality and rigor of a college’s curriculum, as many people assert, then Butler University’s College of Pharmacy and Health Sciences (COPHS) has a claim to being the best of its kind in the nation.

Graduates of Butler University’s prestigious Doctor of Pharmacy (PharmD) program passed the North American Pharmacy Licensure Examination (NAPLEX®) in their first attempt at a higher rate than graduates of any other university in the country. Of the 91 Butler graduates who took the exam for the first time in 2021, 97 percent passed. Of the 144 PharmD programs located in the United States, none had a higher first-time pass rate than Butler University.

“In the face of the pandemic, our faculty and staff remained committed to ensuring that our students received the education they deserved, were able to complete rotations, and stayed on track toward graduation,” Dr. Robert Soltis, Dean of COPHS, said. “Despite site closures and other challenges, every single student in that class graduated on time, and they had the highest pass rate in the nation on the licensure exam. It’s an amazing achievement, and speaks volumes about our commitment and dedication as an institution. I could not be prouder of, or happier for, our faculty and our students.”

According to its website, the NAPLEX® is designed to evaluate general practice knowledge and is taken by recent college of pharmacy graduates shortly after they receive their degree. The NAPLEX® is just one component of the licensure process and is used by the boards of pharmacy to assess a candidate’s competence to practice as a pharmacist. The six-hour exam is composed of 225 questions that are delivered in a computerized, fixed form. The exam results are reported as pass or fail, and candidates are allowed five attempts to pass the exam.

Butler PharmD graduates have a history of scoring well on the NAPLEX®. In each of the past three years, at least 93 percent of Butler graduates passed the exam on their first attempt.

The results come at a critical time; in Indiana and across the nation, there is a significant shortage of pharmacists, especially among the national chains. Some pharmacies have had to reduce hours or even close for one day a week due to reduced staffing. Both CVS and Walgreens have announced they are increasing salaries in hopes of recruiting more pharmacists to their locations.

“Just five years ago, we were talking about a surplus of pharmacists in this country, but the pandemic quickly changed that situation,” Dr. Soltis said. “Now, the increased demand for vaccinations has resulted in increased demand for pharmacists. Graduates of Butler’s pharmacy program are going to find an improving job market and more opportunities to use their skills to serve patients.”

When I decided to attend Butler University and major in pharmacy,  I had been told that NO BUTLER GRAD HAD FAILED TO PASS THE ” Indiana Pharmacy board”  My class was the first year that the  North American Pharmacy Licensure Examination (NAPLEX®) was usedThere was nothing available to prepared for the exam, there was no one to ask what was on the board the previous year…  My Butler class had ONE that didn’t pass the boards, but that year was the first year for the MILITARY DRAFT LOTTERY and this poor fellow drew a very low number and his draft board had been after him to be drafted but the Indiana pharmacy board wasn’t until Sept or Oct after the graduation in May.  Perhaps the stress and distraction of trying to keep the draft from drafting him.  After all, the Vietnam was on going and soon after this time.. it started ramping up.

Yours truly’s lottery number was 360 – SIX FROM THE BOTTOM… since the lottery pool was every male between 18 and 35 y/o… the number of “bodies” in that lottery pool was VERY LARGE.

 

One in Four Medicare Patients Harmed in Hospitals, Nearly Half Preventable

One in Four Medicare Patients Harmed in Hospitals, Nearly Half Preventable

CMS needs to do more to penalize facilities with avoidable adverse events, report says

https://www.medpagetoday.com/special-reports/exclusives/98701

Medicare patients continue to experience harm during hospital stays, even after a decade of intensive efforts to decrease provider-caused adverse events, according to a report from the HHS Office of Inspector General (OIG).

Among the roughly 1 million Medicare patients who were discharged from hospitals in October 2018, a total of 258,323 experienced an adverse or temporary harm event during their stay.

And 12% experienced events that led to longer stays, lifesaving interventions, permanent harm, or death. “This projects to 121,089 Medicare patients having experienced at least one adverse event during the 1-month study period,” the report stated.

Of these adverse events, 45% were said to have been preventable. According to the report, such events were linked to substandard or inadequate care — for example, using more aggressive pain management regimens after surgery than necessary, or unnecessary delays in scheduling surgeries.

In one of many case studies and patient stories included in the report, a patient required surgery to remove dead tissue from the small intestine. “However, providers unnecessarily delayed surgery for 5 days while the patient continued to deteriorate. This delay led to a cascade of harms that included worsening of the small intestine, contamination of the abdomen with pus, septic shock with an associated kidney injury, and delirium,” the report noted.

Ten percent of adverse events contributed to patient deaths, translating to 1.4%, or 14,800 patients, during the 1-month study period.

Leah Binder, president and CEO of the Leapfrog Group, which routinely grades hospitals on various safety measures, called the report’s findings “outrageous.”

“None of us would drive a vehicle or check into a hotel if we thought we had a one in four chance of being harmed from the experience,” she said.

The report also showed that 13% of patients experienced temporary harm, which required intervention but did not prolong their hospital stay or require life-sustaining measures, and over 40% were determined to be preventable. However, such events were sometimes serious and could have caused further harm had providers not noticed and quickly intervened, the OIG said.

Common adverse and temporary harm events included those related to medication use, involving delirium or other mental status changes; pressure ulcers or injuries; complications from procedures or surgeries such as intraoperative hypotension; and hospital-acquired infections (HAIs).

Of particular concern, the OIG found that patient harm events were almost as widespread as they were found to be in 2008 among a similar sample size. Back then, 27% of the patients sampled experienced a harmful event. However, the report noted that the 2018 population had a greater prevalence of comorbidities than the 2008 sample, with more “being treated for more clinically complex conditions and diagnoses than in the past.”

Adverse events result in higher costs for beneficiaries who have to pay more in deductibles and co-payments because of additional care required. The report estimated that for some treated beneficiaries, additional expenses amounted to more than $40,000. “Combined, we estimated the cost for all events to be in the hundreds of millions of dollars for October 2018,” the report stated.

The OIG noted that CMS has two policies designed to deter hospital-acquired conditions (HACs), including cuts in reimbursement to hospitals with higher rates of such conditions. However, “because the policies use narrowly scoped lists of HACs and employ specific criteria for counting harm events, they have limited effectiveness in broadly promoting patient safety,” the report said. “Of the harm events we identified, only 5% were on CMS’s HAC Reduction Program list and only 2% were on CMS’s Deficit Reduction Act HAC list.”

Furthermore, when CMS counts infections associated with a surgical procedure in its formula to penalize hospitals, it counts only those involving the colon or an abdominal hysterectomy, so many other infections go uncounted, such as those occurring after a laminectomy.

Additionally, the report found that hospitals often omit specific codes that CMS uses to monitor the occurrence of HACs, thereby limiting the agency’s awareness of some events in Medicare-certified hospitals.

According to the OIG and Binder, CMS should include more types of harm events in its formula for penalizing hospitals. The current policy shift appears to be steering the agency away from that, Binder noted.

“Though in the report CMS concurred with this recommendation, the agency is moving rapidly in the opposite direction, not growing the number of measures, but removing all the HACs and HAIs from payment consideration. CMS’s Proposed Rule calls for suppressing all HACs and HAIs from use … and replacing them with nothing,” she said.

The report noted that “only the worst 25% of performers receive the 1% reduction each year.” Furthermore, “hospitals that routinely are in the top three quarters of performance do not have a financial incentive through the HACRP [HAC Reduction Program] to improve more.”

Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

The Prescription Drug User Fee Act reauthorization is being used to give the FDA even more power to threaten kratom and all supplements

First off, we understand this is getting into the legislative weeds, but this is incredibly important as it could change how all supplements and kratom are controlled by the FDA. 

The Prescription Drug User Fee Act or PDUFA is up for reauthorization, and proposed changes to it could give the FDA power to deny registration of all supplements; granting them power to require kratom to be registered, and therefore the power to deny registration and effectively ban all kratom products

Please contact your congressional representatives today! Go to Protectkratom.org/congress using the link below to complete the email contact for to tell Congressional officials not to support any attempts to require supplement registration.

Supplements are not prescription drugs, and shouldn’t be treated the same.  

NOTE: The House Committee on Energy & Commerce is meeting on the PDUFA regulation for the House so we’ve created an additional contact form to be used for them as well.