When POLITICIANS don’t know their “APPLES” from their “ORANGES”

Posted on July 6, 2019 by Pharmaciststeve

Trump Suggests Executive Order on Drug Prices, With a Scope That Is Unclear

https://www.nytimes.com/2019/07/05/upshot/trump-drug-prices-executive-order.html

www.nytimes.com/2019/07/05/upshot/trump-drug-prices-executive-order.html

He may be talking about a pilot program that would apply to only a small subset of drugs.

President Trump said Friday that the White House was writing an executive order to require pharmaceutical companies to offer the United States government among the lowest prices in the world, in comments that were not immediately clear to many experts on the country’s health care system.

“We’re working on a favored-nation clause, where we pay whatever the lowest nation’s price is,” Mr. Trump said to reporters Friday, specifying that an “executive order” was in the works. “Why should other nations like Canada — why should other nations pay much less than us? They’ve taken advantage of the system for a long time, pharma.”

The White House has made the high costs of prescription drugs a policy priority, and the Department of Health and Human Services has proposed a series of measures meant to help address that. But until today there had been no public mention of a broad executive order.

The administration is working on a plan that would use an index of international drug prices to set the price that Medicare pays for some drugs that are administered by doctors, such as cancer treatments. Last year, Mr. Trump used the phrase “favored-nation clauses” to describe that proposal, which would base the Medicare price on prices from more than a dozen countries, including Canada, Britain, Japan and Slovakia.

The price index idea, which the pharmaceutical industry and many medical providers have vigorously opposed, is still under review from the Office of Management and Budget and may begin as a five-year pilot program next year. But it would apply to only a small subset of the drug market, and would not affect the prices paid for more typical prescription drugs that are sold at retail pharmacies. An executive order on drug prices would most likely have no force of law on its own, but could direct the Department of Health and Human Services to pursue or expand this approach.

Outside of the doctor’s office or hospital, the federal government does not buy many medications itself. Under current law, Medicare’s main prescription drug program farms out its drug purchasing to private insurance companies, and is barred from negotiating with drugmakers directly. The federal government does buy drugs for some populations, including veterans and federal prisoners, but they represent only a small fraction of the nation’s drug market.

“The frustration that the U.S. pays much higher prices for drugs has been a persistent theme of this administration,” said Peter Bach, the director of the Memorial Sloan Kettering Center for Health Policy and Outcomes, in an email. “We will have to see what is ordered to understand what could actually be implemented by executive order. The scope will have to be pretty limited in that the government itself does very little purchasing of drugs. It is all done through intermediaries that we pay for the service.”

The Department of Health and Human Services published a white paper of possible drug pricing policies last year, and has begun rolling out regulations to help enact portions of it. Congress is also seriously considering a handful of measures related to drug pricing, some of which may become law this year.

A bill introduced by Senator Rick Scott, a Republican from Florida, has not advanced to a committee hearing, but comes the closest to what the president described Friday. Mr. Scott’s bill would link a drug’s approval by the Food and Drug Administration to a requirement that the drug’s retail list price in the United States be no higher than the lowest price charged in Canada, France, Britain, Japan or Germany.

Prices for major pharmaceutical stocks fell slightly just after the president’s remarks, but largely recovered by the market close. A policy that would substantially reduce the prices paid for drugs in the United States would have large effects on those companies’ earnings.

The White House press office said it had no comment on the president’s remarks. Riley Althouse, a spokeswoman for the Department of Health and Human Services, said both the president and the H.H.S. secretary Alex M. Azar II were “both firmly committed to pursuing any and every solution — including importation and most favored-nation policies — that will deliver real results and keep American patients safe.”

Trump and many other politicians seem to not know the difference between the other countries “APPLES” and our “ORANGES”..  yes the other countries have lower medication prices.  But they don’t have layers of publicly traded FOR PROFIT companies between the Pharmas’ and the pt or whoever is paying the final bill for the medication.

We have the Insurance company, the PBM and there is a 4th party that negotiates the discounts/rebates/kickbacks from the pharmas on behalf of the PBM’s – There is a post about this company .. somewhere on my blog.. but can’t find it out of the nearly 8000 posts on my blog..

The Veterans Administration is a good example of how these other countries function… the VA purchases medications on a bid basis with the Pharmas. There are no for profit middlemen in the distribution system between the Pharmas’ and the VA..  Some products are purchased via wholesalers but that industry works on a 5%-6% gross profit margin.

Some have stated that the insurance/PBM for profit industry and their infrastructure costs and net profits accounts for up to 50% of the cost the pt ends up paying.  When you consider that we fill abt 4 BILLION prescriptions at abt a average consumer price of $60 ..that is 120 BILLION that the insurance industry “sucks off” our healthcare system out of just the medication part of healthcare which is just 12% of our total healthcare bill – abt $10,000.00 per person.

If one looks back to the day when there was no PBM and most all insurance companies were not for profit mutual companies and most everything was brand name medications… before 1970 and apply the COLA/CPI for all those years… the average price would expected to be in the $30 range.. but now we have 80%-90% generics which is suppose to SAVE MONEY.. One would expect that the average Rx price would be in the 20’s.  But that is not our reality today.

Actually the FEDS are the ones that started all of this discount/rebates/kickbacks back in the 70’s.  The politicians decided that since Medicaid was such a large purchasers of medication that they deserved a “discount/rebate/kickback” from the pharmas’.  As I remember… it was a fairly modest amount 5%-10% from the brand name pharmas.

Of course, the brand name pharmas started raising their prices to compensate for the money that they had to “give back” to Medicaid.  Then Congress decided to “change the rules” to help more generics to come to the marketplace and pharmacies were reimbursed by PBM’s/Medicaid on price based on AWP (Average Wholesale Cost) plus a dispensing fee … typically, back then, $2-$3 dollars per Rx.

There was a lot of “game playing” with the publish AWP… pharmacies were able to purchase generics much below the published AWP, but they billed the PBM’s based on the published AWP.

Once again, Congress had to address the perceived problems in how much Medicaid was being charge for medications… so they created MAC’s (Maximum Allowable Cost) on the most popular generics… this replaced the industry standard of AWP for generics for pharmacies to bill from.  Of course, pharmacies … to protect their profit margins… only purchased a particular generic from the company that had the lowest price under the MAC price.

If Trump/politicians/bureaucrats believe that our system can function with the prices that other countries are functioning on without changing the inherent cost/profit structure of our system… someone is going to be hurt… it could be those employed by the insurance/PBM industry, it could be the community pharmacy system, it could be pts.

The insurance industry has one of the largest “pots of money” for lobbying, and they are not going to take cuts to their profits laying down.  After all it was this industry that convinced Congress to turn the entire Part D & Medicare Advantage program over to private insurance industry and prohibited negotiating Rx medication prices.

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It’s OKAY

Posted on July 6, 2019 by Pharmaciststeve

It’s OKAY !!!

Filed under: General Problems | 2 Comments »

Arsenic found in bottled water sold at Target, Walmart

Posted on July 5, 2019 by Pharmaciststeve

Generic bottled water (MGN Online)Arsenic found in bottled water sold at Target, Walmart

https://www.fox10tv.com/news/us_world_news/arsenic-found-in-bottled-water-sold-at-target-walmart/article_4858cbd1-dcca-591f-ac6f-25dd9343723e.html

ATLANTA, Ga. (CBS46) — High levels of a potentially poisonous chemical have been found in certain brands of bottled water sold at Target, Walmart and Whole Foods stores.Well for avoiding hazardous or poisonous water there are many water purifier.There are water softener reviews as well which can give clear idea about them.

According to USA Today, tests conducted by the California Center for Environmental Health found high levels of arsenic in Penafiel, owned by Keurig Dr. Pepper and Starkey, owned by Whole Foods.

Back in April, an article in Consumer Reports said the Food and Drug Administration had known about the high arsenic levels in Penafiel since at least 2013.

Consumer Reports updated their story on May 3, reporting the FDA had still not issued a recall for the product.

On June 18, the Center for Environmental Health announced their independent testing found high levels of arsenic.

In some cases, arsenic can cause cancer and organ damage.

So far, the water has not been recalled.

 

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Kansas patients can finally win big in doctor malpractice suits. But at what cost?

Posted on July 5, 2019 by Pharmaciststeve

Brenda Lundeen went in for routine surgery to relieve heavy periods.

What the Overland Park mom and grade school teacher got was a nightmare, as a medical mistake caused 194-degree water to pour through a hole in her uterus and scald her insides.

After three surgeries to remove parts of her burnt colon and intestines, months defecating into a colostomy bag and years of trauma, a jury awarded Lundeen $2 million in a medical malpractice lawsuit for noneconomic damages, commonly called “pain and suffering.”

That number was immediately knocked down to $250,000 — the maximum allowed under Kansas law at the time.

“I have felt since this began that I should try to speak up against the cap,” Lundeen said. “Not for me, but for all the people whose cases are way worse than mine.”

That cap on noneconomic damages is now gone — struck down in a Kansas Supreme Court ruling last month.

Doctors say that ruling will open the floodgates to high-dollar lawsuits that will drive up the cost of care for everyone. But patients like Lundeen and plaintiffs’ attorneys say Kansas doctors have for too long been shielded from responsibility for mistakes that cause a lifetime of suffering.

Both sides agree: It’s a new ballgame after the court’s decision in Hilburn v. Enerpipe.

“I think it definitely changes the landscape for any pending cases or any future cases,” said Michael Rader, a personal injury lawyer in Leawood.

In the past, Kansas lawyers often wouldn’t even take on medical malpractice claims, Rader said, because unless there were extensive economic damages (countable costs like lost wages and medical bills) the cost of going to trial might exceed the amount they could recoup if they won.

But now anybody who has gone to a lawyer and been turned down for that reason should go back and ask again, Rader said.

Lundeen said she spent two years looking for an attorney who would take her case, and that lawyer, Mike Hodges, warned her that it wouldn’t bring a financial windfall.

“We did not go into it obviously for the money, because we knew there wasn’t going to be any,” Lundeen said. “I really just wanted to not have another woman go through went I went through.”

Lundeen’s story

Lundeen had her surgery in 2010, on her 40th birthday. An endometrial ablation, in which a layer of the uterus is removed, can be done several ways, and Lundeen said she didn’t think her doctor fully explained the risks of the hydrothermal route.

When her uterus was perforated and the super-heated water flowed into her abdominal cavity, she said she woke up at the surgical center in indescribable pain and was taken by ambulance to the neighboring Menorah Medical Center.

Her doctor was supposed to follow her there immediately, but according to the lawsuit didn’t show up for three hours. The hydrothermal ablation machine used in her procedure was later determined to have disappeared.

The next day she had surgery to remove 6 to 8 inches of her burned colon and appendix. It wasn’t enough. She got a serious infection and five days later was back in surgery. This time she had 21 inches of intestine removed and the colostomy bag installed.

Lundeen lived with the bag for 11 months, going back to work in her classroom and trying to ignore the odor that would sometimes waft out of the bag. Other times the bag of feces was impossible to ignore.

“I had what they call ‘blowouts’ where it would completely detach from me and I would have to rush home (to change clothes),” she said.

Finally, she went to the Mayo Clinic for a last-ditch surgery to try to reconnect her bowels — a procedure she said even the staff at Mayo wasn’t sure would work.

It did, and she no longer needed the colostomy bag. But she will have to take several medications for the rest of her life, including one for ongoing nerve pain, and she has had to cut dairy products completely out of her diet and and can tolerate only small amounts of red meat or fried foods.

It was a grueling journey that she had to relive when her lawsuit went to trial. The verdict in 2015 was a huge relief.

“It was disbelief, really, that A: we got the verdict in our favor and, B: to hear what the jury awarded us,” Lundeen said. “Obviously I knew we weren’t getting that, but just the fact that that amount validated all the pain and suffering and everything we’d gone through. I have the physical ailments, but my husband, my girls my parents, they all were affected.”

The Supreme Court

Kansas legislators passed the $250,000 cap on noneconomic damages in 1986. It initially applied only to medical malpractice cases — the idea being that the state could better recruit and retain doctors if they knew their legal liability was limited.

The courts quickly ruled that the cap couldn’t apply only to that small subset of cases, though, and in 1988 the Kansas Legislature expanded it to all personal injury cases.

The cap stayed at $250,000 for decades, even after inflation cut the actual buying power of that amount of money by more than half.

From the beginning, plaintiffs’ attorneys argued that it was unfair.

It was first challenged just four years after it became law, by a Fort Riley soldier paralyzed in a head-on crash caused by a semi-truck driver. The court upheld the cap but said it had concerns that it discriminated against those most severely injured.

In 2012 the state’s highest court handed down another verdict in a challenge brought by a woman whose doctor had removed the wrong ovary, rendering her infertile later when the ovary that was actually causing her pain also had to be removed. A lower-court jury had awarded her $575,000 in noneconomic damages, which the cap cut by more than half.

By a 5-2 decision, the justices upheld the cap again, but expressed concern that it hadn’t been raised since it was enacted.

That led the Legislature to embark on a multi-year effort to step it up slowly: to $300,000 by 2014, to $325,000 by 2018 and finally to $350,000 by 2022.

That didn’t sway the court when it took up the case of Diana Hilburn, another Kansan injured by a semi-truck driver. This time the justices ruled — by a 4-2 vote in June — that the cap was unconstitutional, that it violated Kansans’ rights to a jury trial.

The reaction

The ruling caught the entire business community by surprise, coming so quickly on the heels of the 2012 decision.

Health care providers were among the first to express concern.

Tom Bell, the president of the Kansas Hospital Association, wrote that the ruling “will undoubtedly create upward pressure on medical liability insurance rates, and it will certainly not help how Kansas is perceived during the recruitment of healthcare providers.”

The Kansas Medical Society, which represents doctors, said the state “has enjoyed a stable medical malpractice environment for many years” but that was about to change thanks to the “unfortunate and costly decision by the court.”

“The elimination of the caps on pain and suffering awards will soon translate into increased insurance premiums for physicians, hospitals and health care professionals which will ultimately be passed on to patients,” the group said in a statement released the same day the decision was published. “Health care is already a major part of every household and business budget and today’s decision will result in significantly higher liability costs for the health care system, which in turn will drive up health care costs already paid by Kansans.“

The two groups both said they were still analyzing the decision before deciding on next steps, which could include lobbying the Legislature to enact new caps that are structured differently, or pursuing an amendment to the state constitution (which would require two-thirds votes in the House and Senate, rather than simple majorities).

The full Legislature doesn’t return to Topeka until January, but legislative leaders have already taken note of the decision.

Senate Majority Leader Jim Denning, a Republican from Overland Park, said during a recent interim committee meeting that he heard that medical malpractice insurance rates went up 6% almost immediately after the decision was published.

Gov. Laura Kelly, a Democrat, has predicted it will be a major issue when lawmakers reconvene.

“I think it guarantees us a really exciting 2020 legislative session,” she told The Topeka Capital-Journal. A spokeswoman for her office declined to elaborate.

Kansas could explore other ways to structure a cap that have been upheld in other states. Missouri, for example, gives juries more leeway to take into account the severity of a case, with a cap of about $400,000 that can be increased to about $750,000 if the patient’s injuries are deemed “catastrophic.”

Other states peg their caps to inflation so they increase automatically. Or they lift the cap in cases where the medical practitioner was grossly negligent, committed fraud or intentionally harmed the patient.

The result

The impact the Hilburn decision will have on medical costs is hard to predict, but clues can be found in data from other states.

There are now 21 states (including Kansas) with no cap on noneconomic damages, according to the Center for Justice and Democracy at New York Law School.

In those states, the average annual cost of medical malpractice insurance is $10,445.57, according to Capson Physicians Insurance Company.

In the 29 states that have a cap, the average annual cost is $8,702.79.

But it’s an imperfect comparison because the caps vary widely from state to state (from $250,000 in California and Montana to more than $2 million in Nebraska) and because juries tend to be more generous in some states than others.

Rader, the personal injury lawyer, said Kansas juries tend to be more sympathetic to doctors.

“The juries are very conservative on medical malpractice cases,” Rader said.

That’s borne out in state data.

Only 14 medical malpractice cases went to jury trial in Kansas in the fiscal year that ended July 2017 (the most recent report available), and the jury found for the plaintiff in only two of them. In the previous year there were 13 medical malpractice jury trials in Kansas and the plaintiffs won only one.

Rader said other businesses, like trucking companies, are likely to be harder hit by the loss of the damages cap. But medical providers will still see their costs go up.

“Kansas doctors have been able to maintain the minimum amount of liability insurance because their exposure to damages in excess of coverage was slim,” thanks to the cap, Rader said. “Now that these doctors can be held accountable for their errors, they’re all under-insured now, no doubt about it. They’re going to have to purchase more insurance.”

The Kansas Supreme Court decision doesn’t apply retroactively, so people like Lundeen can’t go back and seek the full judgments juries awarded them.

But Lundeen said she’s glad others will have a chance to be made whole financially.

“My lawyers told me about cases with way worse physical ailments than mine that still only got the cap, and that is not fair. It’s not right,” Lundeen said. “They gave me examples of people who have become paraplegic, quadriplegic, and it’s just like a joke that they’re supposed to sustain themselves for their lives on that amount.

“I’m hoping this means that they’re going to be more pro-patient than pro-doctor. We all know people make mistakes, but when it uproots your life as you know it I think there needs to be responsibility taken so we can continue living life the best that we can.”

Includes reporting by Jonathan Shorman of the Wichita Eagle.

Filed under: General Problems | 4 Comments »

76-Year-Old Veteran Denied Care, Commits Suicide In VA Parking Lot

Posted on July 5, 2019 by Pharmaciststeve

www.tinyfeed.fun/76-year-old-veteran-denied-care-commits-suicide-in-va-parking-lot/

Some of our veterans gave their lives in defense of this country. It takes a very brave person to be willing to sacrifice themselves for their country.

Sadly, many veterans are not being treated very well by their country. The man you see in this photo is 76-year-old Peter A. Kaisen.

Kaisen served in the United States Navy from 1958 to 1962. He was standing outside the Northport Veterans Affairs Medical Center when he took his own life.

veteran takes his life

He was a recurring patient at the hospital but had been denied service.

Thomas Farley, Kaisen’s friend for 40 years, said Kaisen went there for help with depression.

Kaisen retired from the Navy and became a Long Beach Police Officer.

In the 1960s, he was in a car accident and was permanently disabled. Kaisen had gone to the ER for help and didn’t get any.

So, he went outside to his car and took his life. What kind of a hospital turns away someone who is asking for help with a mental illness?

 

 

 

 

 

 

veteran takes his life

Who dropped the ball? The hospital stated that Kaisen didn’t go to the ER for help.

Are we to believe that he just drove to the hospital and shot himself in the parking lot?

veteran takes his life

Kaisen’s family is hoping that by sharing this story, it brings awareness to how the VA is treating our veterans.

Something needs to change – now. The past several years has revealed that many VA hospitals are falling short in their treatment of veterans.

Filed under: General Problems | 7 Comments »

The FDA Safety Information and Adverse Event Reporting Program

Posted on July 5, 2019 by Pharmaciststeve

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.

TOPIC: Multiple Ophthalmic Products by Altaire Pharmaceuticals Sold at Walgreens Stores: Recall – Due to Potential for Non-sterility

AUDIENCE: Consumer, Health Professional, Risk Manager, Pharmacy

ISSUE: Altaire Pharmaceuticals, Inc., announced on July 3, 2019 that it is voluntarily recalling the Over-the-Counter (OTC) drug products sold at Walgreens during the time period as indicated below:
• Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL. Lot Number 19095, Expiration Date: 04/21, Manufacturer Ship Date: 05/14/19.
• Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL. Lot Number 19095, Expiration Date: 04/21, Manufacturer Ship Date: 05/14/19.
• Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram. Lot Number TCI, Expiration Date: 03/21, Manufacturer Ship Date: 05/08/19.
• Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL. (Two Lot Numbers) (1) Lot Number 19105, Expiration Date: 04/22, Manufacturer Ship Date: 05/24/19 and (2) Lot Number 19050, Expiration Date: 02/22, Manufacturer Ship Date: 05/23/19.
• Lubricant Eye Ointment PF Soothing Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram. Lot Number TBD, Expiration Date: 04/22, Manufacturer Ship Date: 05/24/19.
The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
Read Alert

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The ADA requires the government to make “reasonable accommodations” to ensure people with disabilities have equal opportunities to access public services and benefits

Posted on July 5, 2019 by Pharmaciststeve

Urgent Care: How Attorneys Are Battling The Opioid Crisis

https://www.law360.com/access-to-justice/articles/1171390/urgent-care-how-attorneys-are-battling-the-opioid-crisis

When recovering opioid addict Jacob was called into court in Clinton County, New York, for violating a restraining order, the judge told him he had 90 days to quit using his addiction medication, Suboxone.

Jacob, whose last name Law360 is withholding for privacy reasons, said he was “heartbroken” and afraid of possibly relapsing. But his court-appointed lawyer didn’t object, so he figured he had no choice but to get off the medication he had used to treat his opioid addiction for 13 years.

“When [the judge] told me that, I was just devastated. I didn’t even know what to do, because I know how hard it is to come off of them,” Jacob said. “I had a court-appointed lawyer, and he didn’t even care. So I figured I was done. I had to do it.”

But five attorneys working pro bono helped convince the judge to let Jacob stay on his medication — just one way in which attorneys and legal advocates around the country are stepping up to help people affected by opioid addiction.

One of Jacob’s attorneys, Sally Friedman, is among over 30 lawyers and advocates from across the country who have come together to work on an opioid task force convened by the Legal Services Corp., the federally funded nonprofit that distributes funds to over 130 independent nonprofit civil legal aid programs around the country.

The task force released a 53-page report on June 10, with a suite of recommendations about how legal aid providers and the judiciary can fight the opioid crisis by helping people with opioid use disorders tackle legal problems that interfere with recovery and by standing up for them when they do head to court.

“The change is far too slow, but there is change happening. I’m on numerous task forces that are seeking to educate the legal community and courts about this issue,” Friedman said. “That’s huge. I mean, none of that was happening three years ago even.”
The Power of Legal Aid

In Jacob’s case, it was essential for the court to understand that forcing someone off Suboxone “dramatically increases the chance of relapse and possibly death,” said Friedman, who is vice president of legal advocacy at the Legal Action Center, a nonprofit that fights discrimination against people with addiction, HIV/AIDS or criminal records.

Jacob and others with opioid use disorders face the unique challenge that some of the medications that are prescribed to treat their addiction use opioid-based compounds, drawing the ire of judges and employers.

Fighting a Crisis

This month, a task force convened by the Legal Services Corp. released a 53-page report with numerous recommendations for how legal aid providers and the judiciary can fight the opioid crisis. Here are some of those proposals.

Legal aid providers should develop medical-legal partnerships with health care providers.

  • Legal aid providers should build other partnerships with local organizations that serve those affected by the opioid epidemic.
  • Legal aid providers should obtain training on the science of opioid use disorders and recovery.
  • LSC should work with legal ethics bodies and health law experts to develop policies and materials that address privacy and ethical issues related to helping clients impacted by the opioid crisis.
  • Courts should consider expanding alternate court options to assist people with opioid use disorders.
  • Correctional facilities should collaborate with civil legal aid attorneys to decrease obstacles facing people who are returning to society from incarceration.

Suboxone, for example, contains buprenorphine, a partial opioid agonist that binds to opioid receptors in the brain, preventing cravings and withdrawal syndromes without providing a full opioid effect, according to the National Alliance on Mental Illness.

Jacob, then 34 years old and the sole provider for an infant daughter, said he’d been taking his two Suboxone each morning to “live a normal life” and overcome an addiction to the opioid painkiller Percocet. That addiction started when he was prescribed the drug for roughly two years following an all-terrain vehicle accident in the early 2000s.

It’s an all too common story when it comes to the opioid epidemic burning across the country.

There were over 47,000 deaths related to opioid overdoses in 2017— two-thirds of all overdose deaths in the country, according to the Centers for Disease Control and Prevention. Over 2.1 million Americans had an opioid use disorder in 2016, according to the Substance Abuse and Mental Health Services Administration.

Regional legal aid providers have been making efforts to combat this epidemic through existing programs and new initiatives. The LSC’s task force was aimed at bringing the lessons learned through successful local efforts onto the national stage so they can be applied around the country.

One of the most prominent of these regional efforts has been the medical-legal partnerships pursued by civil legal aid nonprofit Indiana Legal Services, whose managing attorney, Jay Chaudhary, has become recognized as a national leader on the issue. Through these partnerships, attorneys are embedded with health care providers to help people fix various legal problems affecting their health.

“Civil legal aid in my view works best as a value-add to everything else, whether it’s mental health, health care, substance abuse treatment and recovery,” he said. “Legal aid is a necessary component, because barriers arise to whatever the end goal is, sobriety or living with recovery.”

A civil legal aid attorney can help someone keep their housing, reduce excessive child support obligations, negotiate a debt repayment plan, or get their driver’s license back so they can get back to work, Chaudhary said.

Even knowing how to craft a letter can make a difference in confronting the fallout from opioid addiction. Chaudhary recalled putting his writing skills to work to help convince a homeless shelter to take in people using opioid-based addiction medications like Suboxone.

For people who are trying to stay in recovery, homelessness can push them into relapse, but those who are evicted from their homes are unlikely to do the research to know if their eviction is legal, and don’t know how to fight it, Chaudhary said.

Most people with a substance abuse disorder, even when facing these issues, wouldn’t think to look to an attorney to help them in their recovery, said Brandon George, the director of the Indiana Addiction Issues Coalition.

As an addict in long-term recovery himself, George is painfully aware of that reality for many the coalition tries to assist.

When George stopped using heroin and crystal meth, he had an enormous amount of credit card debt, was behind on child support payments and had a suspended driver’s license, he said.

“I thought I was just bad with money and had baby mama issues,” he said. “I had no idea that these were legal issues. My brain just did not connect the dots.”

When George was first asked in his role as coalition director to work with Chaudhary in an addiction treatment training project at Indiana University, he was skeptical. He said he thought the attorney “stuck out like a sore thumb.”

Once the group began handling case studies, however, George said he instantly realized how useful legal aid could be, from helping support people in their housing and financial situations to helping sort out child custody issues.

George also touted the key role attorneys can play by helping people obtain felony conviction expungements. “People pay lifetime sentences socioeconomically because of felony convictions,” he said, which in turn can hinder recovery.

Now, George is working on connecting recovery organizations to civil legal aid attorneys nationwide, establishing a model where people coming in to the recovery organization can have their legal problems identified and receive a referral to an attorney, or learn when an attorney will be available on-site.

On the Front Lines

In providing these services, legal aid attorneys have a first-hand look at how the courts’ response to the opioid crisis can impact those struggling with addiction.

Friedman said she saw another client go through “tremendous” pain when, like Jacob, she was ordered to stop using medication-assisted treatment and began tapering down the dose.

“They just slog through their days not knowing if they’re going to end up in jail in two weeks, or relapse and overdose,” she said. “The human toll is devastating.”

As they did in Jacob’s case, lawyers are turning to the Americans with Disabilities Act to keep people with opioid dependency from being ordered off buprenorphine, according to Melissa Trent, an attorney with Brooklyn Defender Services and another onetime member of Jacob’s legal team. The ADA requires the government to make “reasonable accommodations” to ensure people with disabilities have equal opportunities to access public services and benefits. 

“You can’t be denied participation in a probation program because you have a wheelchair,” she said. “People who have opioid addiction are people who have a disability under the Americans with Disabilities Act. … The argument is that the reasonable accommodation would be their medication-assisted treatment.”

Groups like the Legal Action Center are also working to spread awareness and best practices in other ways.

This means suing employers that fire employees for using medication to treat their opioid dependence, lobbying for laws like 2008’s Mental Health Parity and Addiction Equity Act, which requires insurers to designate funding for treatment services, and creating informational materials so that other attorneys know how to defend their clients’ right to stay on opioid-based medication, according to Friedman.

That theme of education runs through several of the recommendations in the recent LSC report. Among other proposals, the task force calls for the development of new medical-legal partnerships, getting specialized training to aid attorneys, increasing education about opioid use disorders in the courts and improving collaboration between state agencies and treatment providers.

Of course, funding remains a pressing need, according to Chaudhary, who said more diverse funding could help spread legal aid programs to drug courts and community recovery organizations.

Legislation known as the Support for Patients and Communities Act, which targets the opioid crisis and was signed into law in October, made many federal funding streams newly available to support civil legal aid, according to Stefanie Davis, assistant general counsel in the office of legal affairs at the LSC.

However, Davis added, “the funding that we are able to get even as it increases is not nearly enough to meet the need that exists for legal aid.”

That funding matters for people like Jacob, who says that without the pro bono legal help he received, he might have ended up relapsing or in jail, instead of raising a family.

“It saved my butt, I know that. It saved my life pretty much. Who knows what would have happened?” he said. “It’s a happy ending for sure.”

–Editing by Aaron Pelc.

Have a story idea for Access to Justice? Reach us at accesstojustice@law360.com.

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national medical malpractice advocacy association

Posted on July 4, 2019 by Pharmaciststeve

National Medical Malpractice Advocacy Association

national medical malpractice advocacy association

https://www.nmmaa.org/

As an advocate for social justice, NMMAA empowers the community through education and activism. With active NMMAA patient advocates throughout the country, informed citizens organize and protest injustices, raise awareness, educate, inform, and build coalitions.

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The majority of generic drugs are manufactured overseas, and “the FDA was essentially regulating on an honor system

Posted on July 4, 2019 by Pharmaciststeve

‘Scary World’ of Generic Drug Manufacturing, Revealed

https://www.medscape.com/viewarticle/914067#vp_1

In 2008, investigative journalist Katherine Eban started digging into the generic drug industry after hearing stories of patients whose generic drugs were not working properly for them. They had been stable on a branded drug, but then relapsed once switched to a generic version or experienced troubling side effects when switched between generics. She detailed her findings in a series of articles in the magazines Self and Fortune, and her new book, Bottle of Lies .

Katherine Eban. Robert Falck

The majority of generic drugs are manufactured overseas, and “the [US Food and Drug Administration] FDA was essentially regulating on an honor system,” Eban told Medscape Medical News. The agency would announce its inspections of overseas manufacturing plants weeks or months in advance, giving companies an opportunity to prepare to put on a good face and mislead inspectors with fabricated data.

In the course of Eban’s reporting, she obtained 20,000 internal FDA documents that “revealed that the FDA’s investigators have grave doubts about the quality of the drugs being manufactured at these plants,” she said. But FDA officials minimized the investigators’ findings.

Eban spoke with Medscape Medical News about the implications of her findings for clinicians. The following is a lightly edited account of the conversation.

Medscape Medical News: What do you think doctors and other healthcare professionals need to know about the state of generic drugs?

Katherine Eban: In the book I feature several doctors from the Cleveland Clinic who struggled with this question of the quality of generics. A number of heart transplant patients suffered organ rejection after being switched to a generic tacrolimus. And also a number of patients who were followed by a cardiologist who became very intently focused on this question and felt he couldn’t stabilize them on certain generics.

He actually identified drugs that were particularly problematic, and after he identified them, lo and behold, the FDA went into the plants, found egregious conditions, and those drugs were recalled. So he was observing something that really is going on.

What I think physicians need to understand is, if their patient is not responding as anticipated from a medication, they need to consider the possibility that it is the medication that is the problem. So instead of just increasing a dose, or switching a patient to a different therapy altogether, I think they need to consider, is this the manufacturer of this generic? Is there a better generic that I can get the patient switched to? Or do I need to make a case to the patient’s insurance company that they should be on the brand? And it’s just a kind of category of thought that physicians need to have.

What role did physicians play in helping these issues come to light?

The doctors that I’ve talked to who have become aware of this, and have petitioned the FDA about this, I think [they] played a major role in having this come to light.

I think without their clinical vigilance, I’m not sure it ever would have come to light. But it’s no accident that it took me essentially 10 years of reporting to produce this book. It’s very complicated. And it requires a lot of connecting of the dots, from clinical symptoms, to the global drug supply, to regulatory failures, to what’s actually happening in these manufacturing plants. It’s a lot of data points to line up. And I think that’s one of the reasons why it hasn’t really come to light before this.

What discovery from your reporting for this book surprised you the most?

The level of data fabrication is really extraordinary. I’ll give you an example.

Because of some of the findings in the plants, the FDA ran a pilot program in India, from 2014 to mid-2015. They decided all the inspections were going to be unannounced or on very short notice, which obviously should be the standard. Once they started going into these plants completely unannounced, what they discovered was just staggering.

The plants operate data fabrication teams that come in in advance of FDA inspections. They alter data, they invent documents, they even invent standard operating procedures that don’t exist. One plant steamed them overnight to make the documents look old. They found out another plant was completely fabricating its testing to prove that the plant was sterile. There were no tests. The laboratory that was doing this was testing nothing, and all their data were perfect. So that’s an example of the kind of depth and extent of the fraud in these plants. It’s shocking.

Is there anything that doctors can do to help their patients avoid these poor-quality generic drugs?

Once doctors become aware of this issue, as their patients have symptoms, or as they have difficulty, I think [doctors] will find that there are certain manufacturers where they have repeated problems, and then when they switch to different manufacturers, everything is OK.

As difficult as it sounds, I think that doctors really have to get to know some of these manufacturers. I think the medical community and the patient community have taken it pretty much on faith from the FDA that all the drugs are interchangeable. That you can just switch from one brand to a generic or between generics and it’s all the same, except that’s really not the case. Once doctors become aware of that, I believe you’re going to find that drugs from certain companies are pretty reliable, and drugs from other companies are not, and that becomes a way to get to the bottom of this more quickly.

What is the role of listening to patients about their reactions after switching to a new generic drug?

Listening to patients is absolutely vital. In the first article I wrote about this, I interviewed this woman who was switched at the pharmacy from a brand name to a generic antidepressant, and had just a horrible set of reactions and side effects. [She] ended up going from doctor to doctor to try to treat all those side effects because she didn’t realize that it was her generic. She finally went online and began doing her own research and began to connect the dots and realize that the onset of her symptoms was at the point that she was switched to a new medication. She called her doctor’s office and the nurse at the doctor’s office said, “Yeah, we hear this from a lot of patients.” Had she had that information previously, she would not have been on this horrible medical odyssey.

Doctors can play a huge role in helping patients with this. Frankly, we need new legislation around this, but that’s not going to happen anytime soon, most likely. So until these problems can get addressed, doctors are really the front line in dealing with it.

What about the role of pharmacists?

My impression is that most pharmacists don’t really know about these issues, and that they also don’t really know where drugs are manufactured. It’s not their fault. What they know is what they have on the shelf at any given time, which is in these big bottles that they’re filling prescriptions from. I think a lot of states don’t even require pharmacies to maintain records of which manufacturer they dispense. The recalls often don’t even get down to the patient level because of that.

To the extent that they talk to consumers, I think [pharmacists] can play a key role in helping them. For example, there are manufacturers whose drugs I won’t take. And my pharmacist knows that I’m a bit of a pain when I go to fill a prescription, but there are just certain companies — because I know that they fabricated data, that their plants are not sterile, that they’ve gotten FDA warning letters — I won’t take a prescription filled with their medicines. And my pharmacist knows that. They let me switch to a different manufacturer. I often am requesting specific generic manufacturers that I trust more than others. But I think if the pharmacist doesn’t understand these issues, that’s going to seem like very strange behavior to them. So it’s something I think that they need to be educated about, too.

One thing that I know a lot of experts in this space really think is important is putting the country of origin, of manufacturing, on dispensing labels. Why shouldn’t consumers know where the active ingredient and the finished drug are made? Why isn’t that information passed along to patients? That is something that could be a sort of educational tool for everybody in this space.

In addition to your book, what are some other key resources to keep up to date on what’s happening with generic drugs at the FDA and which manufacturers have an issue?

On the FDA website there are links to warning letters and import alerts. There’s another site that I like a lot called FDAzilla, which has all of the documents related to FDA inspections on it. If your patient is reacting badly to a drug made by company X, you could go into FDAzilla and look up the inspection record of that company. But for busy physicians, it’s not so easy.

The category of findings related to falsification is called data integrity. The whole idea behind “good manufacturing practices” is that you can’t test the quality of a million pills in a batch. So consequently, good manufacturing requires a kind of minute-by-minute creation of data that accompanies each step of the manufacturing practice. And that data is considered the cornerstone of good manufacturing practices. Without that data, there’s no way to vouch for a drug’s quality. If a company has data-integrity issues, it’s a pretty scary world. It means that there is a real possibility that they’re committing fraud. Not a guarantee, because you can have data-integrity findings that are not necessarily fraud, but negligence, or just problems, but it’s kind of a red flag. And that’s something for doctors to be aware of.

Doctors who are inclined to be political about this should contact their lawmakers. Because it’s really a very difficult, almost intolerable situation that we’re in. I think there needs to be medical activism on this issue.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube, and follow Ellie Kincaid on Twitter at @ellie_kincaid.

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Another example of LEO believes laws are not for them to obey and enforce ?

Posted on July 3, 2019 by Pharmaciststeve

Utah nurse reaches $500,000 settlement in dispute over her arrest for blocking cop from drawing blood from patient

https://www.sltrib.com/news/2017/10/31/utah-nurse-arrested-for-blocking-cop-from-drawing-blood-from-patient-receives-500000-settlement/

University Hospital nurse Alex Wubbels has agreed to a $500,000 payment to settle a dispute over her arrest by a Salt Lake City police officer after she barred him from drawing blood from an unconscious patient, her attorney said Tuesday.

Attorney Karra Porter said at a news conference that the agreement with Salt Lake City and the University of Utah covers all parties and takes the possibility of legal action off the table. “There will be no lawsuit,” she said.

The arrest drew widespread condemnation after Porter released police body camera and hospital security footage of the encounter on Aug. 31.

Wubbels will use a portion of the money to help people get body camera footage, at no cost, of incidents involving themselves, she said at the news conference. In addition, Porter’s law firm, Christensen & Jensen, will provide for free any legal services necessary to obtain the video.

“We all deserve to know the truth and the truth comes when you see the actual raw footage and that’s what happened in my case,” Wubbels said. “No matter how truthful I was in telling my story, it was nothing compared to what people saw and the visceral reaction people experienced when watching the footage of the experience that I went through.”

Wubbels said she also will make a donation to the Utah Nurses Association and will help spearhead the #EndNurseAbuse campaign by the American Nurses Association.

Porter said she hopes the discussion about the need for police body cameras continues and noted that the footage also protects law enforcement officers.

The July 26 encounter leading to Wubbels’ arrest began when she refused to allow Salt Lake City Detective Jeff Payne to draw blood from an unconscious patient who had been involved in a fiery crash in Cache County earlier in the day.

Wubbels pointed out that the crash victim was not under arrest, that Payne did not have a warrant to obtain the blood and that he could not obtain consent because the man was unconscious.

Payne insisted he had implied consent to get the blood and eventually arrested Wubbels. He handcuffed her and placed her in a police car outside the hospital, then released her after about 20 minutes. Charges were never filed against the nurse.

Wubbels is heard on footage of the incident asking a University police officer to protect her because Payne had threatened her with arrest. The U. officer informed the nurse that if she interfered with Payne’s investigation, she would be obstructing justice and he would not prevent the detective from arresting her.

The footage shows that as Payne moves to arrest Wubbels — grabbing and chasing her — she screams and backs into the U. police officer. The officer places a hand on Wubbels’ shoulder, apparently assisting Payne. (Other hospital employees appear to try and talk Payne down as the arrest is taking place.)

On Sept. 13, Salt Lake City Mayor Jackie Biskupski announced an internal affairs investigation had found Payne and Lt. James Tracy violated several department policies during their interaction with Wubbels. A review by the city’s independent Police Civilian Review Board also found the officers violated department policies.

The two reports also single out U. officers and security for not trying to defuse the situation.

Police Chief Mike Brown fired Payne on Oct. 10 and demoted Tracy to the rank of officer. Both men have appealed the punishment to the Salt Lake City Civil Service Commission.

Wubbels said Tuesday she hopes the disciplinary measures are upheld. “I will
be very disappointed if they aren’t,” she said.

The patient at the center of the controversy was 43-year-old William Gray, a full-time truck driver and a part-time reserve officer with the Rigby, Idaho, police department. He was severely burned on nearly half of his body in the July 26 crash and died Sept. 25.

A man in a pickup truck who was fleeing from the Utah Highway Patrol collided head-on with Gray’s semi on U.S. 89/91 near Sardine Canyon, according to Logan police, who investigated the crash. The pickup’s driver, Marcos Torres, 26, died at the scene.

After the crash, Logan police requested that Salt Lake City police obtain a blood sample from Gray.

Greg Skordas, Payne’s attorney, has said a federal regulation requires a blood sample when a driver with a commercial driver license (CDL) is involved in a fatal accident, and that by getting a CDL, a driver is assumed to have consented to a blood draw. Gray had a CDL and Payne wanted the sample so the injured man could keep that license, according to Skordas.

Porter has countered that the CDL regulation covers what an employer — not a law-enforcement officer — is supposed to do after an employee is in an accident. Another CDL regulation adopts states’ implied consent law but Utah’s statute specifically requires reasonable suspicion that a person was intoxicated before a sample can be taken, she said.

A criminal investigation into the arrest — which involves the Unified Police Department, the FBI and the Salt Lake County District Attorney’s Office — continues.

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