The “SILENT KILLER”… not managed in >50% of adults – how many are under treated CPP’s ?

CDC: Control not achieved in more than half of US adults with hypertension

https://www.healio.com/cardiology/vascular-medicine/news/online/%7B0b2f8a78-bafe-48a6-bfd9-7750010bd446%7D/cdc-control-not-achieved-in-more-than-half-of-us-adults-with-hypertension

Less than half of U.S. adults with hypertension have their BP under control, according to a data brief released by the CDC’s National Center for Health Statistics.

“Despite progress in hypertension control that has been noted in the United States over the years, the goal of Healthy People 2020 (61.2% by 2020) has not been met,” Cheryl D. Fryar, MSPH, from the division of Health and Nutrition Examination Surveys at the National Center for Health Statistics, and colleagues wrote in the brief. “Currently just less than one-half of adults with hypertension have their hypertension under control (48.3%).”

Using NHANES survey data, the researchers found the overall prevalence of hypertension among U.S. adults from 2015 to 2016 was 29% and was similar in men and women (men, 30.2%; women, 27.7%). This prevalence grew more common with age, increasing from 7.5% among those aged 18 to 39 years to 33.2% among adults aged 40 to 59 years and 63.1% in those aged at least 60 years.

Although men had higher rates of hypertension than women among adults aged 18 to 39 years (9.2% vs. 5.6%) and aged 40 to 59 years (37.2% vs. 29.4%), men had lower prevalence of hypertension than women among adults aged at least 60 years (58.5% vs. 66.8%).

The researchers noted that hypertension prevalence was highest in non-Hispanic black adults (40.3%) compared with other races and ethnicities (non-Hispanic white adults, 27.8%; non-Hispanic Asian adults, 25%; Hispanic adults, 27.8%).

Among adults with hypertension, 32.5% of those aged 18 to 39 years had it controlled vs. 50.8% of those aged 40 to 59 years and 49.4% of those aged at least 60 years, according to the report.

Women were more likely than men to have their hypertension controlled (52.5% vs. 45.7%), especially in adults aged 18 to 39 years (62.6% vs. 15.5%).

Rates of hypertension control were higher in non-Hispanic white adults (50.8%) vs. non-Hispanic black adults (44.6%) and non-Hispanic Asian adults (37.4%).

According to the brief, there has been no significant change in hypertension prevalence among U.S. adults between 1999 and 2016. Although prevalence of controlled hypertension among those with hypertension rose from 31.6% in 1999-2000 to 53.1% in 2009-2010, it has not changed significantly since then, Fryar and colleagues wrote, noting the decline in controlled hypertension from 53.9% in 2013-2014 to 48.3% in 2015-2016 was not significant.

To believe or NOT TO BELIEVE… that is the question ?

I’ve Had to Swap My Stethoscope for a Magnifying Glass to Cope with Opioids

https://opmed.doximity.com/swapping-stethoscope-for-magnifying-glass-coping-with-the-responsibility-of-the-opioid-epidemic-61311957dc73

It should be simple, even if not so straight forward: If your patient is in pain, you treat them.

But what about a patient who’s been on opioids for years? How do you answer those who were led down the chronic opioid path by old school medicine, either rightly, or wrongly, so? Where do we draw the line?

Consider this example.

A patient walks in asking for a pain med refill. He’s had neck pain for years, and nothing has helped other than narcotics. His previous doctors gave him Percocets. Or Oxycontins. Or substitute whichever controlled substance you’d like here. What is my role in this given scenario, as his doctor? Classically, I’ve been trained to assess and treat the patient — simple as that.

But enter the dilemma of modern day medicine and the opioid epidemic. In this particular instance, as a PMD practicing today, I am expected to shed my doctor’s coat and stethoscope, while replacing them with the raincoat and magnifying glass of a sleuth. You can even add suspenders for dramatics. There’s only one problem: I have watched just a handful of episodes of Columbo in my youth and, while they were highly entertaining, I’m not quite ready to take on a role as understudy. I haven’t even rehearsed.

However, this growing epidemic expects me to do just that, to put on my detective gear and start interrogations.

But how can I do that? What if I miss an addict, and they in turn pass away of an overdose the following day? Or even worse, suspect ill of a patient and miss treating his real pain? And what of the patient’s opinion of me? Who would stay with a physician who constantly questions their honesty?

It’s a lose-lose.

The truth of it is that assessing for pain is tough. It’s subjective. If someone says they’re in pain, we often expect them to look like they’re in pain. But I know better, not only because I myself have held back pain, but also because I feel like I should trust my patients.

Then there’s the issue of physical examination. I use it as an investigational tool, but it certainly has its limitations. A patient who is seeking drugs can simply make up an ‘ouch.’ Think about it. You move the leg up, a patient utters in pain or grabs his backside. Who am I to judge if that grimace is real? It’s enough to have to scan through a myriad of possible diagnoses in my head, all by memory, gained through years of education and training, but to also have to call a bluff? Even the best of poker pros make mistakes. Plus, in real life, it’s easier to give people the benefit of the doubt. We want to believe them. I mean, sure, many of us in the field can recount instances in which patients theatrically put on a show to get what they want. But what about the instances that weren’t quite so obvious? I guarantee numerous Oscar-worthy performances could fool even the most seasoned of practitioners. And we are, after all, medical providers, not detectives.

But, this isn’t what I signed up for.

Let’s dissect the nature of filling a controlled substance request for a moment. Are you familiar with the procedure?

At some point during a 15 minute office visit, I must check on my patient’s previous and current usage of controlled substances by logging on to a separate databank on the web, a step mandated by the state. Once in it (after manual insertion of full name and date of birth), I peruse through a patient’s ‘record.’ Even grandma Louise must be subjected to such a search. This is no simple task and can take up quite a bit of time. I must then interpret information gained and determine if said patient is legitimately asking for the medication or possibly requesting their next easy fix. Followed, by the way, by a two-step verification process in which the medication is actually ordered. The details are lengthy and involve not only entering my system password once again but also providing a virtual ‘key,’ a 6-digit number I obtain by using an app installed on my iPhone.

*gulp*

Is this really what I signed up for when I took the Hippocratic Oath?

Yes, because I’ve promised to do no harm. If a patient is abusing, I should identify their addiction. I should help them with awareness, admission, and recovery.

But also, no. I want to heal, but I’m not quite ready for police work.

And when I do identify potential abuse, just how difficult can it be to tell someone they may have a problem? Extremely. How often does a patient actually admit to an addiction? Rarely. The very nature of coming in and asking for the mediation is the cycle of abuse in action. If I ever suggest there may be a problem, no one openly embraces my suspicion with open arms and a smile, or with a weeping confession. Unfortunately, this scenario is only encountered on Hollywood big screens or in the dreams of naive medical students. Addicts don’t admit. Addicts lash out. They deny. They are genuinely surprised. They threaten. They scream.

They even kill. Just read about Dr. Todd Graham of Indiana, 56 years old when he died for saying no to such a script.

It may seem easy, to anyone on the outside, to identify those who may be abusing. But no one walks into my office and says, “Doc, please give me oxy to feed my addiction,” or, “Send a prescription in so I can get back on the streets and sell. My supply is running low.”

No, I didn’t sign up for this. I signed up to go to work every day and to heal. To help identify illness. To help alleviate medical conditions. To have a good rapport with those who seek my advice. To come to work with a smile and to leave with a gratifying sense of achievement.

I signed up to heal.

Dr. Reddy’s, fighting to recover from FDA warning letter, recalls 500K heartburn tablets

Dr. Reddy’s, fighting to recover from FDA warning letter, recalls 500K heartburn tablets

http://www.fiercepharma.com/manufacturing/dr-reddy-s-fighting-to-recover-from-fda-warning-letter-recalls-500-000-heartburn

Still struggling to turn its manufacturing around, Dr. Reddy’s is recalling 569,000 store-brand famotidine tablets in the U.S., thanks to failed tests for impurities and degradation. It’s the India-based company’s second recall of the same medication since last July.

 The meds were sold at CVS pharmacies as CVS Pharmacy Acid Controller and at Walmart under the Equate label, according to the FDA’s latest Enforcement Report. It’s a Class III recall, meaning the suspect drugs aren’t likely to cause injury to humans.

Dr. Reddys pulled more than 84,000 famotidine tablets, also produced for CVS, last July. In both cases, the company found an out-of-specification result during routine stability testing. The new recall is nationwide.

The latest recall comes as the generics maker continues to suffer FDA citations at multiple manufacturing plants, including some included in a 2015 warning letter. Its ongoing manufacturing problems triggered a decline in U.S. sales, making a dent in its fiscal 2017 results announced in May.

That same month, Dr. Reddy’s reported that an inspection of its Bachupally formulation plant in Hyderabad resulted in an FDA Form 483 with 11 observations.

 That notice came as Harvard Drug Group recalled about 9,200 cartons of the antifungal drug fluconazole manufactured at the Bachupally plant. And it followed two other Form 483s, one in April and another in February, citing problems at active pharmaceutical ingredient (API) plants in Srikakulam and Miryalaguda that had featured in that 2015 warning letter.

The company’s manufacturing issues also prompted a fraud lawsuit from South Korea’s Mezzion. The FDA had rejected Mezzion’s drug candidate udenafil because of manufacturing problems. Mezzion alleged that Dr. Reddy’s repeatedly said it was compliant with FDA regulations when it was not and that Dr. Reddy’s “was the sole reason given by the FDA” for denying udenafil’s approval.

Rep. Keating Introduces Bill Repealing 2016 Opioid Distribution Law

Rep. Keating Introduces Bill Repealing 2016 Opioid Distribution Law

https://www.capenews.net/bourne/news/rep-keating-introduces-bill-repealing-opioid-distribution-law/article_e77b6119-0528-5133-a998-fd47ef0e0164.html

US Congressman William R. Keating, a Democrat from Bourne whose district includes Cape Cod, will introduce legislation repealing the Ensuring Patient Access and Effective Drug Enforcement Act of 2016.

As the House of Representatives is not currently in session, the bill will be introduced at the next opportunity, according to a release from Rep. Keating’s office on Monday, October 16.

Rep. Keating is a member of both the Congressional Addiction, Treatment, and Recovery Caucus, and the Bipartisan Heroin Task Force.

The Washington Post and “60 Minutes” jointly reported earlier this week that last year Congress helped derail the US Drug Enforcement Administration’s ability to keep addictive opioids off US streets. Their report followed an interview with Joseph T. Rannazzisi, who ran the DEA’s Office of Diversion Control, the division that regulates and investigates the pharmaceutical industry.

Mr. Rannazzisi told “60 Minutes” that Congress, lobbyists and the drug distribution industry helped allow the spread of hundreds of millions of pills to “rogue pharmacies” and pain clinics.

A handful of members of Congress, The Washington Post said, “prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills.” The DEA had long opposed the effort.

A chief advocate of the law was Rep. Thomas Marino, a Republican from Pennsylvania whom President Donald J. Trump had nominated as the nation’s next drug czar.

The president announced Monday that Rep. Marino had withdrawn his name from consideration for the position.

 Rep. Keating said the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 made it harder for law enforcement officials to crack down on unsafe practices in the pharmaceutical industry.

“Recent media reports have shown the law severely impeded the DEA’s ability to suspend opioid distributions when the agency detected suspicious activity, allowing an oversupply of opioids in the marketplace,” he said.

Rep. Keating’s legislation, the release said, “would help restore the effectiveness of the DEA’s efforts to protect the members of our communities at risk of overdose from prescription opioids.”

“We are in the throes of an epidemic, and we need every tool available at our disposal,” Rep. Keating said. “We cannot be making it unnecessarily harder for our law enforcement agencies to do their job.”

Congress normally passed 200-400 new bills every  year and when is the last time that anyone heard of Congress REPEALING a law that they have passed in the previous Congressional session.

When is the last time that you are told about a very antiquated law on the books that is no longer appropriate and no longer enforced… BUT… there is never a consideration on repealing those antiquated laws ?

With reports coming out that legal opiate prescriptions have been declining since 2012 and recent data on OD’s continue to increase and in some areas illegal opiates are found in up to 99% of the toxicology of those who OD’d.

It would appear that the legal distribution channel(s) of prescription opiates are not part of the current problem…BUT… there is more money to be had by the DEA from that group of DEA licensees…

Has anyone noticed that the Pharmas and pharmacy wholesalers… never had assets seized… none are put out of business … no exec of these corporations every go to jail… the DEA just fine the crap out of them…  The same thing happens with the chain pharmacy industry..

HOWEVER, when they go after a prescriber or independent pharmacy… they PUT THEM OUT OF BUSINESS… seize all their assets and the individual goes to JAIL for sometimes DECADES…

There is little/no money for the DEA – and more likely to be shot at — by going after drug cartel and seizing illegal substances.

My money is on that  Rep Keating being an ATTORNEY – part of the judicial system – doesn’t want his fellow “fraternal brothers and sisters” and our judicial system to be at risk of losing some of their budgets and the number of employees gets reduced.  We may also find out that Rep Keating has a family member or friend or some friend with a family member that has been caught up in the opiate crisis because they suffer from mental health issues.

 

What We Lose When We Under treat Pain

 

Kate Nicholson was working as a civil rights attorney for the Justice Department when a surgical error left her unable to sit or stand, largely bedridden, and in severe pain for almost 20 years. Using opioids as an appropriate pain management tool, she continued to function as a high-level federal prosecutor. In this talk, Kate pivots from her inspiring and excruciating story to examine the under-treatment of pain, showing how our approach to opioid abuse by 2.5 million Americans is hurting 50 million people in severe or persistent pain. Kate Nicholson served in the Civil Rights Division of the U.S. Department of Justice for more than 20 years, practicing health-related civil rights law and securing powerful victories including in the U.S. Supreme Court. She is currently writing a book about her personal experiences with severe chronic pain. Kate is also an arts writer and enthusiast who helped found the new non-profit, Tilt West, www.tiltwest.org, recently named by Westword as the “best think tank for arts and culture” in the area. Kate was a Senior Fellow at Dartmouth College and is a graduate of Harvard Law School. This talk was given at a TEDx event using the TED conference format but independently organized by a local community

Justice – FRONTIER STYLE ?

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ILLEGAL FENTANYLS increased 2600% in FOUR YEARS in TN

TBI issues public warning: Cocaine samples test positive for Fentanyl

http://whnt.com/2017/10/20/tbi-issues-public-warning-cocaine-samples-test-positive-for-fentanyl/

NASHVILLE – The Tennessee Bureau of Investigation’s Drug Investigation Division (DID) is urging public caution, especially among recreational drug users, following recent evidence submissions to two TBI crime laboratories.

Several sample of cocaine, submitted by law enforcement agencies in Middle and East Tennessee in recent months, also tested positive for fentanyl, a powerful, narcotic painkiller, or one of its dangerous analogs. Previously, fentanyl had primarily been identified in samples of heroin or in clandestine pills compounded to resemble legitimate prescription opioids. The recent submissions mark the first time samples of cocaine have tested positive in a TBI laboratory for fentanyl. The investigation into the origins of the submitted samples remains active and ongoing by the local law enforcement agencies.

“For some time now, we’ve warned about the dangers surrounding fentanyl for those struggling with opioid or prescription drug addiction,” said T.J. Jordan, Assistant Director of the TBI’s Drug Investigation Division. “This submission, however, changes the game. It proves the serious risk now also applies to recreational drugs beyond opioids. To be blunt: What you might buy and use, thinking it’s a good time, could cost you your life.”

In certain doses, fentanyl can be 50 to 100 times as potent as morphine. The drug doesn’t necessarily need to be ingested to have an effect. It can absorb through the skin, so touching the substance can quickly put an individual at risk of opioid overdose.

The submission of substances submitted to TBI’s laboratories testing positive for fentanyl and its analogs continues to increase. In 2013, the TBI processed just 12 samples that tested positive for fentanyl. In 2016, the TBI’s Forensic Scientists tested 209 samples that tested positive for fentanyl or one of its analogs. With more than two months remaining in 2017, lab submissions of samples testing positive for fentanyl or one of its analogs total 320.

“Drug dealers don’t care about the lives of their customers. They only care about making money,” said TBI’s Tommy Farmer, who oversees the Tennessee Dangerous Drugs Task Force. “What you think might be high-quality cocaine may very well have been cut with any number of substances, some of them potentially deadly. Why take the risk with something that could kill you?”

Anyone struggling with drug addiction issues should contact the Tennessee REDLINE at 1-800-889-9789.

OHIO: PMP adding “score” pt’s risk of overdose & addiction

New Ohio prescription tracking tool scores patient’s risk of overdose and addiction

www.wkbn.com/2017/10/19/new-ohio-prescription-tracking-tool-scores-patients-risk-of-overdose-and-addiction/

COLUMBUS, Ohio (WKBN) – Ohio will begin using a new tool in its fight against prescription drug abuse.

An upgrade to the state’s prescription drug tracking system will now include scores that calculate a patient’s possible risk of overdose and addiction. The scores will act as red flags to alert prescribers of potential safety issues.

The new tool offers several features, including interactive visualization of prescription data, messaging options to communicate with other healthcare providers and the ability to search for local addiction treatment providers.

The system will be made available at no cost to Ohio healthcare providers who use the Ohio Automated RX Reporting System.

“Ohio has been a national leader in tracking the dispensing of prescription drugs to patients,” said Ohio Department of Medicaid Medical Director Dr. Mary Applegate. “This upgraded drug monitoring platform will offer critical information to Ohio clinicians to help them provide better and safer treatment for their patients.”

Ohio has been strengthening its prescription drug monitoring program to give prescribers and pharmacists greater ability to prevent opiate abuse. As a result, doctor shopping – where individuals see multiple prescribers to obtain controlled substances illicitly – has decreased substantially and the total number of opiates dispensed to patients is down 20 percent over a four-year period. according to Ohio Board of Pharmacy.

Is this going to be another “guideline” to force prescribers/pharmacists into compliance … and/or used as a “gauge” for the bureaucracy to go after prescribers/pharmacists for being a “pill mill”… Once again this appears to be focusing on the “few” … while denying care to the many who have a valid medical need for this category of medications.  Forget a pt’s CYP-450 liver enzymes that can cause a pt to metabolize opiates faster and/or the severity of pain of a particular pt. So is Ohio adding a “scoring system” on top of the DEA’s “red flag” system

Pharmacist reprimanded for seeking Prince’s medical records

Pharmacist reprimanded for seeking Prince’s medical records

http://www.tribstar.com/news/local_news/pharmacist-reprimanded-for-seeking-prince-s-medical-records/article_38e15c67-b180-5a49-b19e-4ab74a821ee2.html

An Indianapolis pharmacist has been reprimanded by the state for trying to access the medical records of the late pop singer Prince.

Katrina Kalb was issued a letter of reprimand by the Indiana State Board of Pharmacy after she accessed the state’s Indiana Scheduled Prescription Electronic Collection and Tracking (INSPECT) system. INSPECT keeps electronic records of controlled substance prescriptions; the information is supplied by pharmacists.

She accessed the system on April 22, 2016, at 6:44 p.m. She typed in the name of Prince Nelson and the singer’s birth date of June 7, 1958.

 Prince died at his Minneapolis studio and home on April 21. News media had reported that Prince died of an accidental overdose of the opioid fentanyl.

At the time, Kalb was “not providing medical or pharmaceutical treatment or evaluating the need for providing medical or pharmaceutical treatment to Prince,” the board said in its finding.

As part of the state’s order, Kalb is to undergo 12 months of continuing education in the area of ethics and 12 hours of community service during the next six months.

 The order states that she generated an INSPECT report but does not indicate if Kalb was successful in tracking Prince’s prescriptions.

According to a LinkedIn website, Kalb had been a pharmacist for a Marsh pharmacy west of Indianapolis.

I wonder how many complaints that have been filed with the Indiana Board of Pharmacy over HIPAA violations by community pharmacists speaking loud enough for other pts in the Rx dept area to over hear HIPAA protected personal health information (PHI) and the complaint(s) are dismissed without any action against the “offending Pharmacist” ?

DOJ Indicted two illegal opiate producers — THAT CAN’T BE EXTRADITED and FACE CHARGES ?

Chinese nationals indicted on illegal drug manufacturing

http://www.wpxi.com/news/national-news/ap-top-news/chinese-nationals-indicted-on-illegal-drug-manufacturing/625955091

WASHINGTON (AP) – Two Chinese nationals have been indicted on charges they manufactured tons of fentanyl and other powerful narcotics that were then peddled in the United States, killing at least four people and seriously injuring five others, Justice Department officials announced Tuesday.

Authorities said the men controlled one of the most prolific international drug-trafficking organizations, but with no extradition treaty with China, the chances are slim they will ever be brought to the U.S. to face the charges.

The men, who are not in custody, are accused of separately running chemical labs in China that produced the drug and other illegal opioids for sale online to Americans who were often unaware of its potency and susceptible to overdose. At least 21 other people were also indicted on charges they trafficked the drugs across the U.S. and Canada, often through the U.S. mail.

The announcement comes as the Trump administration suffered a setback in its efforts to call attention to the nation’s drug crisis. Its nominee to be the nation’s drug czar withdrew Tuesday from consideration following reports that he played a key role in weakening the federal government’s authority to stop companies from distributing opioids.

It also comes amid growing pressure on President Donald Trump to fulfill his pledge to declare the nation’s opioid epidemic a “national emergency,” as a commission he’s convened on the subject has urged him to do. An initial report from the commission in July noted that the approximate 142 deaths each day from drug overdoses mean the death toll is “equal to September 11th every three weeks.”

A sign of White House interest in the issue, presidential counselor Kellyanne Conway quietly attended Tuesday’s news conference at the Justice Department.

Robert W. Patterson, acting administrator of the U.S. Drug Enforcement Administration, said the Chinese case represents “one of the most significant drug threats facing the country” because they were able to produce a wide array of synthetic drugs and hide their tracks with web-based sales, international shipments and digital currencies like bitcoin.

The Chinese men indicted were Xiaobang Yan, 40, and Jian Zhang, 38, who worked separately but similarly, authorities said.

Yan, who operated at least two chemical plants in China that were capable of producing tons of fentanyl, would monitor drug legislation and law enforcement actions in the U.S., changing the chemical structure of his drugs to avoid prosecution, Deputy Attorney General Rod Rosenstein said. A 2013 traffic stop in Mississippi unearthed a domestic drug ring linked to Yan.

Zhang, along with five Canadians, two people from Florida and New Jersey man, were indicted in North Dakota for conspiracy to import the drugs from Canada and China. Prosecutors say Zhang ran at least four labs and sold the drug to American customers online. Investigators became aware of him after police officers responded to a deadly overdose in Grand Forks, North Dakota and traced the supply chain, officials said.

Rosenstein, who discussed the problem with Chinese officials last week during a high-level dialogue on law enforcement and cybersecurity, would not say whether the labs have been shut down. He said he was hopeful Chinese authorities would hold the men accountable.

Federal authorities are increasingly warning of the dangers of fentanyl, which can be lethal even in small amounts and is often laced with other dangerous drugs. The Centers for Disease Control and Prevention estimated that more than 20,000 Americans were killed by the drug and its analogues in 2016, and the number is rising, Rosenstein said.