New OU study profiles the ‘changing face’ of suicide

Posted on May 17, 2019 by Pharmaciststeve

Average Annual Suicide Rate per 100,000 Population, 2008-2017

New OU study profiles the ‘changing face’ of suicide

https://www.athensmessenger.com/news/new-ou-study-profiles-the-changing-face-of-suicide/article_dbfd1a33-10e6-5218-9da3-9b24f6080277.html

Where does suicide live in Ohio? How old is it? What does it look like?

According to a new study released by The Ohio Alliance for Innovation in Population Health (The Alliance), its identity is increasingly comprised of individuals both young and old. In the past 10 years, suicide rates have risen more than 30 percent for those ages 20 to 29 and approximately 57 percent for those aged 60 or older.

The data also revealed a troubling reality unfolding across Appalachian Ohio, which is home to nine of Ohio’s 10 counties with the highest suicide rates per 100,000 population over the past 10 years. Meigs County experienced the highest suicide rate in the state at 21.5, followed by Jackson County (19.9) and Hocking County (19.7).

Such trends are disturbing to mental health organizations across Ohio, including the Ohio Department of Mental Health and Addiction Services.

“The data in this report is very relevant to the work of the Ohio Department of Mental Health and Addiction Services,” said Lori Criss, director of that state department. “Suicide is a serious public health issue. Tackling this issue in Ohio will require collaborative efforts that cross state government, private partners, community mental health and addiction boards and providers, colleges and universities and others.”

The Alliance is a collaborative effort created by Ohio University’s College of Health Sciences and Professions (CHSP), the University of Toledo’s College of Health and Human Services and now including 28 partner organizations. The Alliance recently completed a review of suicide fatalities in Ohio based on data provided by key state partners between January 2008 and December 2017.

Rick Hodges, director of The Alliance, said that 526,501 years of life expectancy was lost in Ohio between 2008-2017 due to suicide. He noted that this sobering figure is largely attributed to the increase in suicide rates of individuals 29 years of age and younger.

“The Alliance’s research indicates that the suicide rate within our state’s younger population (29 and younger) has increased by 33 percent since 2008,” Hodges said. “Our ultimate hope is that this study will help to inform state- and community-level discussions surrounding how the risk of suicide can be reduced in Ohio and beyond.”

Hodges also referenced a June 2018 Alliance study that calculated more than 500,000 years of life were lost in Ohio between 2010 and 2016 due to opioid overdose.

Orman Hall, executive in residence for CHSP and author of the study, said that The Alliance’s research revealed a total of 15,246 suicide fatalities in Ohio between 2008-17, an overall increase of approximately 24 percent per 100,000. White individuals who reside in economically distressed Appalachian communities continue to exhibit the highest suicide rate in Ohio.

Hall emphasized that the intent of The Alliance’s study was not to serve as an exhaustive study of cause and effect, but rather to analyze the scope of suicide fatalities and to identify key demographic characteristics of decedents for this serious and growing problem.

Although the highest suicide rates were experienced in Ohio’s Appalachian region during the 10-year period that was studied, it is important to note that both rural and suburban areas experienced the greatest increase in the rate of suicides per 100,000 population. Cuyahoga (1,461) and Franklin (1,408) counties were home to the highest total number of suicide fatalities in the study.

Tony Coder, director of the Ohio Suicide Prevention Foundation (OSPF), reported that OSPF trains as many community members and healthcare providers as they possibly can across the state. He said collaborative partnerships with various agencies are in effect or are being built to create a state suicide strategy with the goal of reducing suicide attempts and death.

Ohio University College of Health Sciences and Professions Dean Randy Leite shared that the University is doing its part to train the nation’s next generation of mental health professionals.

“Clinicians often encounter mental health clients experiencing crisis; such distress can increase a person’s risk of suicide,” Leite said. “Our college is dedicated to educating the best healthcare professionals in the country and doing everything within our power to help alleviate this serious and growing problem. It is time we recognize suicide as the serious public health issue it is and do all we can to prepare future health and human service professionals to respond to those who may be at risk.”

Joan Englund, executive director of the Ohio Mental Health and Addiction Advocacy Coalition, said that The Alliance’s most recent study shines an important light on a growing need for suicide treatment and prevention services.

“Local, state and federal decisions and actions can reduce the growing number of Ohio suicides. In order to help change the current upward trajectory, all Ohioans must have timely access to appropriate mental health and substance use disorder prevention, treatment and support services,” Englund said. “This report provides public officials and other community leaders with critical data that can be used to inform strategic and impactful policymaking, support the system of care and target this alarming trend.”

Additional key data points within The Alliance’s study include:

  • The lowest suicide rates per 100,000 population in the state were reported in Holmes County (6.85), Delaware County (9.87) and Hardin County (10.29).
  • Men accounted for an average suicide rate over the 10 years of 21.4 deaths per 100,000, compared to a rate of 5.36 for women.
  • Suicide rates for Caucasians were higher (14.6) than African-Americans (7.37).
  • Between 2008 and 2017, 161 suicides occurred among those 14 years of age or younger. Senior citizens experienced the highest suicide rate increase by age cohort, climbing from 12.4 deaths per 100,000 in 2008 to 19.5 in 2017 — a 57 percent increase.
  • The data show 3,459 people were 60 or older when they died by suicide and nearly 70 percent of those over age 60 used a firearm.
  • Firearms accounted for 50.9 percent of all suicide fatalities for the 10-year period, followed by “other” (33.3 percent) and “self-poisoning (overdose)” (15.8 percent).
  • “Other” causes of suicidal death included, but were not limited to, cuts or pierces, drowning, falls, machinery and motor vehicle traffic.

“We need to come together as a field to address this problem,” Coder said. “We know that opiates are a big issue, but with suicide being the second-leading cause of death for individuals ages 10-24, this is a public health crisis in which we need to assign the appropriate resources and manpower.”

Additional resources for the study include the Bureau of Vital Statistics, the Ohio Death Certificate File and the Centers for Disease Control.

According to the National Alliance on Mental Illness, warning signs may include threats or comments about suicide, increased alcohol and drug use, aggressive behavior, social withdrawal, dramatic mood swings, talking, writing or thinking about death and impulsive or reckless behavior. If you or someone you know are having thoughts of suicide, contact the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).

The Ohio Department of Mental Health and Addiction Services offers suicide prevention guidance for veterans, school-age youth, faith-based groups, older adults and behavioral health providers.

The Buckeye Firearms Association works to emphasize education that encourages suicide prevention and helps to identify potential suicide warning signs; they often collaborate with county and state partners, including Franklin County LOSS and the Ohio Department of Mental Health and Addiction Services, to help share their message.

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hospital invoked a law allowing it to deny further care to a Texas woman

Posted on May 17, 2019 by Pharmaciststeve

Texas woman taken off life support against family’s wishes – then a pro-life group stepped in

https://www.foxnews.com/health/texas-woman-plug-pulled-life-saving-escape

A Texas woman was taken off life support Monday, against her family’s wishes, after the hospital invoked a law allowing it to deny further care.

But a pro-life group stepped in and helped her “escape” to a place that was willing to provide care. She is now in stable condition.

Donald Jones and his daughter, Kina, were preparing their final goodbyes earlier this week as their wife and mom, Carolyn Jones, 61, who suffered a stroke in 2017 and has been transferred between different rehabilitation facilities, was denied life-saving care by the ethics committee at Memorial Hermann Southwest in Houston.

Texas Right to Life and other pro-life groups in the state rallied together after the plug was pulled and the hospital refused to give Jones dialysis. They were able to get her out Wednesday night using a private ambulance.

“It’s kind of crazy that you try to get someone out of a hospital so their life could be saved,” Mark Dickson, director and vice president of Right to LIfe East Texas, who was with Jones, told Fox News.

Carolyn and Donald Jones have been married for 40 years. Donald had to fight to get his wife out of a hospital that refused her life-saving care. (Texas Right to Life)

The lead pastor of SovereignLOVE church in Longview felt God call him to drive the several hours it took to help rescue Jones. He read her Psalm 71, “about people that are trying to take your life” and encouraged her to keep fighting — that God nor they would abandon her.

“We never thought we’d have to arrange an escape from a hospital,” Dickson recalled. “But we did.”

On Thursday, Jones began receiving dialysis at the new hospital.

Her daughter, Kina, said her mom is in stable condition and looks like herself once again.

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Few prescription medications MADE IN THE USA

Posted on May 17, 2019 by Pharmaciststeve

Heart-Drug Suppliers for Millions Faulted Over Data, Bugs and Dirt

https://www.supplychainbrain.com/articles/29738-heart-drug-suppliers-for-millions-faulted-over-data-bugs-dirt

A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues.

Cadila Healthcare Ltd. and Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. market. Neither company made any of the recalled valsartan, but both companies have recently been cited by agency inspectors for quality-control failures that echo problems at other drugmakers — renewing questions about the safety of some of the world’s most widely prescribed medicines.

Workers ignored testing data showing product flaws; destroyed records indicating that drugs were failing key quality measures; and didn’t properly clean equipment, FDA inspection reports stated. Inside one factory, inspectors said they saw swarms of insects.

Millions of Americans take valsartan for high blood pressure and heart failure. Since last year, pharmacies have pulled many formulations of it, as well as other medications in the same class of drugs, after some were found to contain potential cancer-causing contaminants. Some versions of valsartan are now in short supply.

Most of the tainted drugs originated in India and China, which have become popular sources of generic medications and active-drug ingredients as producers and health-care providers try to hold down costs.

Those forces have left regulators scrambling to police an expanding global supply chain. Some of the plants that made the contaminated drugs were flagged by FDA inspectors prior to the valsartan recalls for attempting to cover up manufacturing problems, as reported by Bloomberg News earlier this year.

But the generic drugmakers cleared by the FDA to make versions of valsartan since the recall have many of the same red flags.

No Control

Records obtained through a public-information request show that a year before the FDA cleared Alkem on March 12 to sell generic valsartan in the U.S., agency inspectors noted numerous issues at one of the company’s two main manufacturing plants in India.

At a plant in Daman, India, inspectors found that workers destroyed logbooks or deleted data on quality testing and ignored signs that drugs made there contained impurities. In less than a month, workers deleted 2,000 files that appeared to include failing quality-test results, according to the inspection records. Data issues were so widespread that inspectors wrote that “there is no quality control unit” at the plant.

Inspectors also observed flying insects, including mosquitoes and gnats, that were “too numerous to count,’’ according to the reports.

Despite the array of problems described in the inspection, Alkem’s plant received a clean bill of health. The FDA revisited Daman in January, nine months after its initial, troubling inspection and gave the plant a pass. Two months later, the agency approved Alkem’s valsartan.

Alkem said its version of the drug was made in India but wouldn’t confirm at which plant. The company said the January visit from the FDA didn’t produce a list of any problems at the factory, an indication that the matter is closed.

It’s almost unheard-of for the agency to sign off so quickly on fixes by a plant with extensive problems, according to Massoud Motamed, a former FDA inspector who conducted inspections in China and India and now works in the drug industry.

“That’s not realistic to fix that in nine months,” said Motamed, who left the agency in 2017 and had no role in the Alkem inspection. “Working for industry, I can tell you it’s impossible.’’

An FDA spokesman, Jeremy Kahn, said in an email that the agency can inspect a facility at any time and does so based on risk factors including when the last inspection took place and the prior inspection history. The FDA also considers the need to maintain sufficient supply of a particular drug, he said.

“The agency followed an appropriate timeline given the factors relevant to this firm,” he said. “Generally, FDA can expedite inspection of facilities and assessment of drug applications for drugmakers that want to produce drugs in short supply so they can become operational as soon as possible.”

Quality Concerns

Cadila received approval from the FDA on March 16 to sell valsartan combined with another blood-pressure drug, hydrochlorothiazide. About a month later, records show, FDA inspectors tallied a lengthy list of quality concerns at a plant in Ahmedabad, India, that is making that drug combination.

Inspectors found in April and May that equipment at Cadila’s facility wasn’t cleaned appropriately to prevent contamination and that workers ignored signs of impurities.

A representative for Cadila didn’t respond to a request for comment.

Those issues are similar to problems FDA inspectors flagged at the company in China that’s at the center of the recall. Zhejiang Huahai Pharmaceutical Co. Ltd. was found to have ignored impurity indications in its valsartan. In a November warning letter, the FDA said that if the company had investigated further, it might have been alerted to the presence of the carcinogen NDMA sooner than the original recall, in July 2018.

The NDMA may have been in the valsartan as long as four years, the FDA said at the start of the recall. The agency is looking into whether the manufacturing process may have led to the contamination.

The FDA has estimated that for every 8,000 people who took the highest dose of valsartan, there would be one additional case of cancer.

China Echoes

In 2017, Motamed, the former inspector, discovered that Zhejiang Huahai workers omitted from official records quality-test failures, including ones that flagged impurities in unnamed drugs the company didn’t attempt to identify.

Motamed wanted to impose strict penalties on Zhejiang Huahai but was overruled by senior FDA officials, who allowed the company to attempt to address the problems. A year later, another generic drugmaker that bought valsartan from the manufacturer found an impurity that was determined to be potential carcinogen NDMA — kicking off the wave of recalls, which continues to expand.

The recall has heightened scrutiny of the safety of generic drugs, which are used to fill nine of every 10 prescriptions in the U.S., according to the FDA. Competition from generics has been a key part of the Trump administration’s push to lower drug costs.

Last month, the FDA posted a list of 43 versions of valsartan and similar drugs that don’t contain carcinogens. The FDA hasn’t updated the list, which names another 386 drugs that still need to be evaluated.

Alkem’s valsartan and Cadila’s combination pill aren’t listed in either category. The list will be updated on a periodic basis, said Kahn, the FDA spokesman.

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Purdue cannot control how individual patients use and respond to its products

Posted on May 17, 2019 by Pharmaciststeve

North Dakota to Appeal Ruling in Suit Against Opioid Maker

www.nytimes.com/aponline/2019/05/15/us/ap-us-opioids-lawsuit-north-dakota.html

BISMARCK, N.D. — North Dakota Attorney General Wayne Stenehjem said the state will appeal the dismissal of the state’s lawsuit against the maker of OxyContin over opioid abuse.

South Central District Judge James Hill on Friday threw out the state’s claim that Connecticut-based Purdue Pharma minimized risks and overstated benefits of long-term use of narcotic opioids including OxyContin.

North Dakota sought unspecified damages and attempted to hold the company liable for opioid overused and addiction in the state.

The Bismarck-based judge ruled the drug maker doesn’t control its product after it enters the market.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products, regardless of any warning or instruction Purdue may give,” the judge wrote.

North Dakota and five other states filed lawsuits a year ago accusing the pharmaceutical company of using deceptive marketing to boost drugs sales that fueled opioid overdose deaths.

The North Dakota ruling is the first in which a court has tossed a state’s claim in its entirety, though a Connecticut judge dismissed lawsuits earlier this year that were brought by several municipalities, saying the local governments didn’t have standing to sue.

Purdue spokesman Bob Josephson said in an email that the company was pleased with the North Dakota ruling.

“As the judge stated in his decision, one company cannot be held accountable for a complex public health issue such as the opioid crisis,” he wrote.

Stenehjem said in a statement that he believes the case will reach a different result in the state Supreme Court.

“I am confident that the state has strong claims against these defendants, whose unconscionable actions demand they be held accountable, and there are well-reasoned arguments that support our position,” Stenehjem said.

At least 39 states have filed lawsuits seeking to have Purdue, the Connecticut-based maker of OxyContin, held accountable for an opioid addiction and overdose crisis. The most recent, filed this month in Pennsylvania, was announced on Tuesday. In March, Purdue and the family that owns the company settled a lawsuit with Oklahoma for $270 million before trial; the company also settled with Kentucky for $24 million in 2015.

In all, about 2,000 state, local and tribal governments have sued players in the drug industry over the toll of opioids. About 1,500 of those claims have been consolidated under one judge in Cleveland. The judge is pushing for a settlement but has scheduled the first trial for October.

Opioids, including prescription painkillers, heroin and fentanyl, were factors in nearly 48,000 deaths in the U.S. in 2017, according to the U.S. Center for Disease Control and Prevention. That’s more deaths than car crashes were responsible for that year.

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Is it time to change more of the nomenclature ?

Posted on May 15, 2019 by Pharmaciststeve

They have already in the process of changing from using the term opiate EPIDEMIC to opiate crisis – because  the term  epidemic suggests that we are dealing with a contagious disease and neither pain nor substance abuse is contagious.

They have also seemed to be in the process of getting rid of the term dependency and addiction and anyone taking/using a opiate (legally/illegally)  > 90 days is now claimed to  have a opiate use disorder.  Does this give the DEA a bigger “body count” ?

They are now also seeming to no longer using the term “accidental opiate death”… now anyone having a opiate showing up in their toxicology one of their causes of death will be “opiate related death” and this could also add to the “body count” for the DEA

Who believes that there is ‘over prescribing of opiates” ?  Especially since the number of opiate Rxs have been declining since 2012.  Maybe the term should really be “careless opiate prescribing”…  some of it being fueled by greed others where the prescribers gives out 2-3 times the days supply that the pt dealing with acute pain really needs and/or abruptly cutting off pts that have been given too many doses and/or too many refills and they are thrown into cold turkey withdrawal and they and their family come to the conclusion that they are “addicted”…  when in reality if they were properly weaned… there really was no real addiction being dealt with.

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Retired Navy Chief Chris Fowler funeral fund

Posted on May 15, 2019 by Pharmaciststeve

https://www.gofundme.com/f/retired-navy-chief-chris-fowler-funeral-fund

From Valorie Hawk:

I am in a state of shock. Chris Fowler was a good man, and no one should have to raise money to do this. His wife Nicole Howe Fowler was one of my first ‘mom friends’ in Hawaii, as we were in a baby hui together. Nicole was/is (we haven’t seen each other in over a decade, but keep in touch) a very good friend, and an enormous support to Jack and I during some very difficult times, as was was Chris. Please share this, especially to any military groups you might be in, as it’s wrong to have this kind of stress on top of grief and shock. The military will pay for the funeral, but they must get his body cremated and get to where the funeral/burial site is. RIP Chris

 

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The future of getting the right medication to the right pt

Posted on May 14, 2019 by Pharmaciststeve

www.dnamedmatch.com/

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AARP accused of fighting Trump proposal that could help seniors with more affordable prescriptions

Posted on May 14, 2019 by Pharmaciststeve

AARP accused of fighting Trump proposal that could help seniors with more affordable prescriptions

www.bizpacreview.com/2019/05/14/aarp-accused-of-fighting-trump-proposal-that-could-help-seniors-with-more-affordable-prescriptions-754466

AARP is reportedly opposing a proposal by the Trump administration that could help seniors better afford their prescription drugs.

Practicing Physicians of America co-founder Dr. Marion Mass told The Daily Caller that AARP has aligned itself with “being for kickbacks that are costing the American patient money at the pharmacy counter.”

Critics of the current drug payment system in the U.S. say that middlemen, called pharmacy benefit managers (PBMs), are adding significant cost to drug prices. AARP is closely tied in to one of those PBMs and, according to Mass, that is why the non-profit group that boasts 38 million members and says its mission is to “empower people to choose how they live as they age” is fighting the plan that would help seniors.

Drug manufacturers pay rebates to PBMs, Medicare Part D plans, and Medicaid managed-care organizations to get their pharmaceuticals on health plans’ formularies–lists of drugs that payors cover. Health and Human Services (HHS) Secretary Alex Azar rightfully calls them “kickbacks.”

The proposed rule would end an exception currently in place that protects PBMs from certain parts of the Anti-Kickback Statute being enforced against them. The rule would still permit rebates “for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs,” according to a January Health and Human Services news release.

AARP believes drug manufacturers, not PBMs, are to blame for high drug costs, a spokesman for the organization told The Daily Caller. “We strongly agree with President Trump on the need to address soaring drug prices, but on the rebate rule, (the Congressional Budget Office) has said it would raise all seniors’ Part D premiums, cost Medicare nearly $200 billion, and have little impact on drug prices.”

Mass countered that AARP’s stance is tied directly to its partnership with UnitedHealth Group (UHG), which runs PBM Optum Rx. “AARP, in your relationship with mega PBM Optum, you’ve defined yourself as being for kickbacks that are costing the American patient money at the pharmacy counter and in hospitals, Mass charged. “You don’t stand for America, you stand for yourselves.”

According to AARP’s financial statement, in 2017, the group derived $627 million in royalties from UHG, well over twice the amount it collected in membership dues.

“The two of those together are an absolute powerhouse in the Medicare industry. We believe that it’s almost criminal what the two companies do. They coordinate to make additional profits when AARP plays itself out to be an organization to benefit and help seniors save money, so it’s a big farce,” said Paul Cornell, CEO of AARP competitor American Seniors Association, in a phone interview with The Daily Caller News Foundation.

The new HHS rule does not go far enough, according to Mass. “No manufacturing, no development, no distribution even,” she said. “(The PBMs and group purchasing organizations) just simply decide who’s going on the formularies and what products are used in hospitals and nursing homes. Why should anyone have legalized kickbacks? There’s three giant PBMs, there’s four giant group purchasing organizations, and these companies are pretty much running the American pharmaceutical supply.” For senior citizens there are 24/7 Assisted Care that can help them during their tough times.

AARP has been a controversial group for decades, with many claiming that it has no business being a non-profit. In the 1990s, the U.S. Senate investigated AARP’s non-profit status, but uncovered insufficient evidence to strip the group of that status. Just a few years ago, in an interview with the Des Moines Register, former Senator Alan Simpson indicated that he was still “troubled by AARP’s practices.” He called AARP “the biggest marketing operation in America and money-maker” and an organization with market practices that are “the greatest abuse of American generosity I witnessed in my time in the U.S. Senate.”

Just have to follow the money trail.. is AARP really about helping seniors and fighting legislation that best for seniors or more interested in helping put money in their own coffers ?

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Does this demonstrates the War on drugs – a lot of wasted actions/movements… little/no OUTCOMES ?

Posted on May 14, 2019 by Pharmaciststeve

Filed under: General Problems | 7 Comments »

The chronic pain community is SPEAKING are the bureaucrats LISTENING ?

Posted on May 14, 2019 by Pharmaciststeve

Filed under: General Problems | 2 Comments »

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