why your prescription COSTS SO DAMN MUCH !

Posted on October 22, 2016 by Pharmaciststeve

Here’s how a $50 drug ends up costing you $700 in America’s healthcare system

http://www.businessinsider.com/pharmacists-blame-pbms-for-high-cost-of-nexium-2016-10

Pharmacists around the country are agitated.

For years they’ve been watching their customers struggle to pay for prescription drugs, even when they have generic or over-the-counter alternatives. These drugs are supposed to treat simple, everyday ailments, like acid reflux and heartburn.

In the case of acid reflux, the drug in question is Nexium, and it serves as an illustration of the pharmacists’ chief complaint.

Nexium comes in many forms, including a less potent over-the-counter version. That costs between $25 and $50.

There’s also a prescription version with twice the strength. If you’re getting that one through Medicare Part D, the government’s program for prescription drugs, it could cost as much as $700.

To try to understand why, we talked to pharmacists, and they all pointed to the same thing: It’s the pharmacy benefit managers, or PBMs.

PBMs are companies that manage insurance plans for the government, employers, and other payers. They’re middlemen. For the insurance companies and employers, they help manage prescription claims. They do this in part by creating lists of drugs that will or won’t be paid for and then use their scale to negotiate lower costs.

But they also get paid by the drugmakers, who want their product on the list of approved drugs. And, because some of their fees are pegged to the drug’s price, the PBMs can actually profit from higher prices too. To the pharmacists, these conflicts are made worse by the PBM’s secretive contracts.

“PBMs operate on the back side in secret deals with drug companies to keep their drugs being used and to keep market share,” said Tim Mitchell, a second-generation pharmacy owner who operates Mitchell’s Drug Stores in southwestern Missouri.

This, Mitchell alleges, is what is going on with Nexium, a drug that has been off-patent for almost two years.

“In our contracts they say you can’t talk to the press. You can’t talk to the patients. You can’t talk to the payers. You can’t talk to anyone. Well, I’ll tell you what, I don’t care. I’m tired of them scamming Americans,” Mitchell told Business Insider. “They’re not decreasing drug costs. They’re driving drug costs.”

To be clear: The reason pharmacists have an ax to grind with PBMs is that they feel the PBMs are squeezing profits out of every part of the industry — the insurers, the drugmakers, and the pharmacists — while providing little value.

They believe that the slices that the PBMs are taking only inflate the ultimate cost of prescriptions drugs. Sometimes the PBMs even claw back profits from pharmacies. Either way, the pharmacy owners can barely say a word about their relationships with PBMs because of restrictions in their pharmacy provider agreements.

They aren’t the only ones concerned about the growing power of PBMs either. PBMs are being sued by some customers for double dealing, and they’re now also starting to draw the attention of Congress. Perhaps the biggest threat of all: They’re facing a backlash from America’s largest employers, a group of which is working on a way to rewire the system.

What’s Nexium?

The reason I’m talking about Nexium is that I take the drug. In 2004, I had an invasive surgery to re-angle my stomach. I was born with it tilted the wrong way, so stomach acid was moving up through my esophagus and over time it wore away the lining to the point that my esophagus collapsed in three places.

For a while the surgery was enough to keep me comfortable, but as I’ve gotten older I’ve had to take Nexium every day. I take the over-the-counter Nexium 24HR, which is a 20 mg dose rather than the 40 mg prescription.

Nexium Nexium at Wal-Mart. Wal-Mart

I asked AstraZeneca, the maker of Nexium, to explain the differences between Nexium and generic Nexium, and they told me simply that, well, one is branded and one is a generic, according to the FDA.

From the company’s representative:

“With regards to your inquiry on the difference between branded and generic Nexium, in general there are differences pertaining to the requirements for FDA approval. To support the approval of branded medicines the FDA requires efficacy and safety data from in human, well-controlled clinical trials.

In contrast, according to the FDA, the generic drug manufacturer must prove their drug is the same as, or bio equivalent to the brand name drug by measuring the amount of drug in the bloodstream and comparing that to the brand.

It’s important to know that not all medications, brand name or generic, work the same for all patients, which is why it is important for healthcare providers and patients to determine the best treatment option on an individual basis.”

All righty then. If that’s it, then that’s it.

Nexium buyers, like pharmacies and wholesalers, have sued AstraZeneca, accusing the company of being involved in a “pay for delay” scheme. That means a drug company pays off a generic drugmaker — in this case a company called Ranbaxy — to get it to delay putting a generic version of their drug in the market. In 2014 the drug companies prevailed, but the plaintiffs are appealing that decision.

There’s more. In 2015, AstraZeneca had to pay a $7.9 million fine after allegedly paying kickbacks to PBM Medco Health. The government’s allegation was that AstraZeneca paid kickbacks to ensure that Medco kept Nexium on its formulary.

From Law360:

“According to the government, AstraZeneca agreed to give Medco about $40 million, largely in the form of discounts on other drugs, in exchange for Medco’s agreement to maintain Nexium’s ‘sole and exclusive’ status on its list of approved drugs, and the pharmaceutical company then submitted claims for reimbursement under the Retiree Drug Subsidy Program in violation of the False Claims Act.”

“No one knows with the PBMs what kind of discounts their getting from the manufacturers, and then what they turn around and tell the patient,” J. Randle House, a pharmacist at Metier Pharmacy in Arizona, told Business Insider. “It’s a highly corrupt industry if you really look at it from afar, and then when you really dive into it you’ll see that one and two doesn’t equal three.”

Another way

The three largest PBMs control about 80% of the market. Generally, they get paid per prescription. But some smaller PBMs manage far fewer formularies than the big three, which is to say they have fewer, and usually smaller, clients. These PBMs get paid a flat fee for managing programs, and also tend to be transparent about how much they make on drugs.

One of those PBMs is Detroit-based MeridianRx. When I asked its CEO, Andrew Miller, why formularies might include prescription Nexium, he sounded perplexed.

“Why don’t they just take omeprazole?” he asked me, referring to the generic name for other acid-reflux medications (you probably know it as Prilosec).

“We don’t have Nexium on our formulary because there’s no point,” he said. Other PBMs “have an incentive to keep it on there because the rebate is big,” he said.

Because of Meridian’s pricing model, Miller is willing to show his clients exactly how much he makes off of every drug. He also frowns on the vertical integration going on in the industry.

Big PBMs also sometimes own pharmacies. Miller does not, and he says Meridian avoids this practice because it gives PBMs “an incentive to fill inappropriately.”

So what would he do with the industry to fix this high-cost mess?

“You need true pricing transparency from everyone in the industry, including wholesalers, drug companies, pharmacies, and PBMs. Outlaw drug commercials, outlaw co-pay coupons,” said Miller.

Customers shop in the pharmacy department of a Target store in the Brooklyn June 15, 2015. REUTERS/Brendan McDermid Customers in the pharmacy department of a Target store in the Brooklyn, New York. Thomson Reuters

Doughnut holes

The real danger of taking Nexium, at least for millions of Medicare Part D patients, is that it can put them in something called a doughnut hole.

That’s when your out-of-pocket expenses start unexpectedly skyrocketing as a result of the structure of the Part D program. Unexpectedly, because most of the time patients don’t know how much drugs cost insurers, they just know what they have to pay as a co-pay.

Here’s how the doughnut hole happens: Most Medicare Part D patients have what’s called a coverage gap. That means after Medicare Part D pays a certain amount (say, $2,000) the patient’s co-pays go up from between $5 and $20 to half of what the drug costs.

“This means patients may find themselves in a situation where their initial co-pay of $10 for a 90-day supply of Nexium will exponentially increase to an out-of-pocket cost of $350 or more,” said Melissa Kiguwa, a spokeswoman for Pharmacists United for Truth and Transparency, or PUTT. For a lot of Americans, that $350 is a lot of money, especially if they don’t see it coming because they thought Medicare Part D was taking care of the full cost of Nexium.

PUTT sees no difference between Nexium and EpiPen, the life-saving antiallergy drug that has gone from costing $100 in 2007 to $608 in 2016. The drug’s cost has caused a nationwide uproar, and in an interview with CNBC, CEO Heather Bresch placed part of the blame on “middle men” — on PBMs.

More from PUTT:

“The EpiPen drug hike exposed part of the problem when Mylan Pharmaceuticals CEO attempted to expose how PBMs, brokers, and insurers pocketed more than $280 per prescription within the drug supply chain. The payer pays more in the end, the patient pays a higher copay or higher cost of the medication, and the rebates may or may not go back to the ultimate payer. Yet, in standard contracts with PBMs, providers are forbidden to discuss these tactics and pricing abuses with the ultimate payers or to any one else.

While the Nexium or EpiPen story is not unique in healthcare today, PBMs are quick to refute claims that they are adding to the overall prices of expensive brand drugs with Rx rebates. However, PUTT believes this is happening for most expensive brand drugs— including insulin, inhalers and even expensive specialty medications. Interestingly enough, these are also the fastest growing part of Rx drug plans.”

Just look at Nexium’s list price. While it has gone up year after year, it isn’t close to $700. In fact, the wholesale acquisition cost, or WAC, set by AstraZeneca has topped out at about $250. And the generic competition means the company’s revenue from Nexium is falling. Sales declined by 18% to $1 billion in the first half of the year.

This is possible because WAC isn’t even close to the whole story when it comes drug pricing. It’s just the price of the drug before manufacturers do their deals with insurers and PBMs.

Ask the PBM

That is why AstraZeneca’s representative suggested over email that we ask the many PBMs running Medicare Part D plans why the drug costs so much (emphasis added):

“AstraZeneca does not disclose specific details in regards to rebates for any of our products. The best determinant of a patient’s out of pocket cost is their individual insurance plan and the respective formulary placement for a medicine.

Nexium is currently covered for about 60% of Medicare Part D patients. Preferred drug lists are often made publicly available by PBMs, and it may be helpful to inquire with them as to the tier coverage of Nexium and/or generics, which will give you a better sense of the out of pocket cost for an individual patient on a plan managed by that PBM.”

For what it’s worth, we did ask the PBM lobby about Nexium, and they gave us the same response they always give: They encourage lower cost drugs, but clients ultimately pick what they want.

And with that we should add that PBM clients have been getting mad at them lately. Earlier this year, some of America’s biggest employers — including American Express, Macy’s, and Coca-Cola — created an organization called the Health Transformation Alliance with the aim of breaking with “existing marketplace practices that are costly, wasteful, and inefficient, all of which have resulted in employees paying higher premiums, copayments, and deductibles every year.”

Other clients are just flat out suing. Anthem Insurance, a client of the largest PBM in the country, Express Scripts, is suing the PBM for failing to negotiate its 10-year contract “in good faith” and is seeking $15 billion in damages.

congressman doug collins Congressman Doug Collins (R-GA). YouTube

Meanwhile, in Washington

Pharmacists aren’t the only ones concerned about the lack of transparency. A number of people in Congress have grown tired of the PBMs and are calling for more transparency in their dealings.

OmnicareRx, owned by UnitedHealth, is the largest PBM managing Medicare Part D formularies, and congressman Doug Collins (R-GA) called them out for anticompetitive actions in a congressional hearing last year.

“Tricare” — the Defense Department’s healthcare program — “did a study where it found that, if it eliminated PBMs from the Tricare program, it would save roughly $1.3 billion per year,” he said. “We are up here arguing about problems in our budget, and we could save this much money?”

He — along with Rep. Buddy Carter (R-GA), the lone pharmacist in Congress — believes the PBMs are especially targeting small pharmacies. They wrote a letter to the Center for Medicare and Medicaid Services (CMS) warning of predatory pricing driving small pharmacies out of business. They accused insurer Humana, which owns a PBM, of amending its pharmacy provider agreement to squeeze out little guys.

“Under this proposal, a pharmacy could meet most of the CMS benchmarks, provide quality customer care, and still not be reimbursed by Humana,” the letter read. “Humana’s criteria has little to do with patient care, and everything to do increasing their profit and driving community pharmacies out of the market. Some of these metrics, including ‘patient adherence’ are beyond the control of the pharmacists. Pharmacies already compete for customers and business, let’s not set a precedent to make them compete for reimbursement by insurance companies as well.”

But that’s exactly what they’re doing, and it’s driving some decades-old family businesses around the country to the brink.

“I love being a pharmacist, I love living in the community that that I grew up in, I love taking care of people that took care of me when I was a kid here,” Mitchell said by phone on his way to pick his kids up from football practice.

“But I may not be around forever. I may have to go work for a big chain … I love what I do, but the PBMs are taking that away from me. I think the time has come for small pharmacies and large pharmacies to stand up to big PBMs and make a difference for our profession and in our patients lives.”

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Vermont Governor Proposes Limits on Painkiller Prescriptions

Posted on October 21, 2016 by Pharmaciststeve

Vermont Governor Proposes Limits on Painkiller Prescriptions

www.nytimes.com/2016/10/20/us/vermont-governor-proposes-limits-on-painkiller-prescriptions.html?

I wonder how many of the 45 million “Nicotine addicts” and 35 million “Alcoholics” live in Vermont  and I wonder how many of the 540,000 people that die every year from the use/abuse of those two drugs live(d) in Vermont ? Didn’t read anything in this article about RATIONING either of these two drugs ?

They blame prescription opiates – particularly Oxycodone – on the opiate epidemic… No one seems to have a answer as to what is the “gateway drug” for Nicotine and Alcohol addiction ?  Maybe because of the 15%-20% of those addicts are ALSO POLITICIANS AND BUREAUCRATS… and they would not begin to pass laws that deal with the addiction of those two drugs…. because it would affect them directly/personally ?

Gov. Peter Shumlin of Vermont on Wednesday announced proposed limits on the number of painkillers that could be prescribed, the latest measure his administration has taken to combat the opioid crisis that has ravaged the state in the last five years.

At a news conference outside the Vermont Department of Health in Burlington, Mr. Shumlin and Dr. Harry Chen, the state’s health commissioner, spoke for about half an hour about proposed regulations, which they said represented a cutting-edge approach to combating the crisis.

Under the proposal, the severity and duration of pain would be used to determine the specific limit for a prescription of opioids. For example, for a minor procedure producing moderate pain, a provider would be limited to prescribing nine to 12 opioid painkiller pills, depending on the medication. The limits would be higher for more complicated procedures, and there would be exceptions for the treatment of severe pain.

The limits are proposed amendments to an existing rule and would be official in December if approved after a period of public comment and review by a state legislative committee, said Scott Coriell, a spokesman for the governor. Mr. Shumlin proposed the rule in his State of the State address in January, and he set its passage as one of the chief priorities in his final year in office.

The governor, who announced last year that he would not seek a fourth term, spoke in a phone interview about Wednesday’s announcement in the larger context of his battle against the flood of opioids. He said that when he took office in 2011, he very quickly realized that “we had a full-blown health crisis on our hands.” Three years later, in his State of the State address, he pledged to fight that crisis.

He said that limiting the number of opioid pills that could be prescribed would be an effective way to cut down on addiction.

 
The prescription drug hydrocodone, also known as Vicodin. The governor of Vermont has proposed limits on the number of painkillers that could be prescribed. Toby Talbot/Associated Press

Asked whether he hoped his successor would continue the fight, Mr. Shumlin said, “This is not a hard problem to solve.”

“We didn’t have a heroin crisis in America before OxyContin was approved and started being handed out like candy,” he said. “If politicians would lead a more rational conversation about how we manage pain in America, we could fix the majority of this problem with a click of our fingers.”

Dr. Chen stressed that the rule announced Wednesday was designed to combat the prescription of opioids for cases of “acute pain.”

“These are people who don’t normally take opioids,” he said. “We want to reduce the variability in terms of what prescribers are prescribing.”

Some critics said Wednesday’s proposals might backfire. Liz Evans, the executive director of the New York Harm Reduction Educators, a group that works to promote access to safe equipment and health care for people who use drugs, said that although she was “sure that the governor is motivated by kindness,” she was worried that the proposed regulations might not have the intended effect.

“I think prohibiting access to pain medication can result in pushing people to using more illicit drugs in a more dangerous way without being paired with existing evidence-based public health strategies that are known to work,” she said.

Dr. Chen agreed that a public health approach was necessary and said it was something that Vermont aimed to employ.

“It’s a community problem,” he said. “It needs to be solved on a communitywide basis.”

 

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After son’s heroin overdose and oxycodone prescription, parents search for answers

Posted on October 21, 2016 by Pharmaciststeve

After son’s heroin overdose and oxycodone prescription, parents search for answers

http://www.charlotteobserver.com/news/local/article109589897.html

Someone who has been “fighting opiate addiction” for TWENTY YEARS… the most dangerous time for a recovering addict is after being in rehab… when their tolerance has been reduced.. and they are discharged… back into the environment from where they came from and where they were an opiate abuser… They fall off the wagon and go back to using the amount that they had used previously and typically OD.  This is an excellent place for the use of the 28 day Vivitrol therapy..  Which would limit or prohibit a person from getting high or ODing from reverting back to abusing…  Recidivism after going thru a rehab program is quite high.  Who believes that “Chip” would not have found something to abuse.. even if the prescriber had not written him some prescriptions ?

After Gray and Susan Kimel’s son, Douglas “Chip” Kimel III, died from an accidental heroin overdose, they went after answers. The Kimels went up against the state pharmacy and medical boards trying to learn why their son’s doctor had prescribed more than the recommended dosage of oxycodone and why Chip’s pharmacist continued filling the prescriptions.

 

 

 

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Kentucky jail using new drug treatment for inmates addicted to opioids

Posted on October 21, 2016 by Pharmaciststeve

http://www.cbsnews.com/news/kentucky-jail-pioneering-treatment-for-inmates-addicted-to-oipoids/

Kentucky jail using new drug treatment for inmates addicted to opioids

I have been suggesting using Vivitrol as part of a substance abuser’s therapy… for at least a year… maybe someone in Kenton county KY… may have read some of my postings on my blog  ???

COVINGTON, Ky. — Every jail is full of stories.

“Me and my brother we turned to stealing and doping,” one Kenton County, Kentucky jail inmate said. “Being a drug addict was something I thought I needed to be,” said another.

While the stories the inmates are telling may not sound like it at first, they are all stories of hope.

Jeremy Westerman is serving seven years for dealing drugs to support his own opioid habit.

axelrod-prison-opiod-x.jpg

Jeremy Westerman speaks to a group of fellow inmates

CBS News

“You come in here, your hope comes back. You get your wits back,” he said.

Jason Merrick is a reformed addict and former inmate who took hard lessons and translated them into a new substance abuse treatment program, an innovative approach to kicking opiates for good.

axelrod-prison-opiod-x-transfer3.jpg

Jason Merrick

CBS News

Merrick said it is easy to identify inmates that are in jail because of an opioid addiction. “Eighty-three percent of our intakes are directly or indirectly related to substance use,” he said.

Merrick combines the traditional tools of psychotherapy and 12-step support groups with a new one: Inmates are given an injection of the drug Vivitrol just before they’re released and then once a month after they get out.

“Essentially it blocks the effects of opiates, including heroin, morphine, oxycodone, for up to 30 days,” Merrick said. “If they take a normal dose of heroin, they will not feel the effects.”

Vivitrol, he said, gives them a fighting chance when they reintegrate into society.

“Once you are released from Kenton County, you have a 70 percent chance of coming back here,” Merrick said.

But for inmates in his program, the recidivism rate drops to ten percent. “This is what keeps people safe while they’re building those foundations of recovery,” he said.

axelrod-prison-opiod-x-transfer4.jpg

Vials of Vivitrol

CBS News

Not even a near-fatal overdose kept Jordan West from using again. He eventually ended up in the Kenton County jail for 90 days on a possession charge. He signed up for the program, and the Vivitrol.

“Before my perspective was, when I wasn’t on this stuff, it was, ‘drugs, drugs, drugs. Who can I manipulate? Who can I steal from? Who can I lie to? Who can I deceive?’” West said.

“And with this Vivitrol, when it’s blocking the cravings, it’s, ‘What can I do for the next man? How can I help somebody else out?’”

Jail offers addicts a shot at getting clean, and Vivitrol offers a chance of staying clean. West is now back in school.

axelrod-prison-opiod-x-transfer2.jpg

Jordan West

CBS News

“It’s all about the steps you take when you get out. If you get out and you keep on doing the same things, you’re going to keep on getting the same results. It’s called insanity,” West said.

If the inmates in Kentucky are as successful as West, families and neighborhoods devastated by the epidemic of opiate addiction may finally have a way to combat it.

“Giving them that extra level of support is essential to keeping them alive and building stronger communities.” Merrick said.

Vivitrol is designed to be taken for a year or two after release while the addict gets on his or her feet. Since February, 22 Kenton County inmates have completed this program and none have re-offended. That is why the white house is considering it as a model for prisons nationwide.  

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Warning message from a reader from my blog

Posted on October 21, 2016 by Pharmaciststeve

Please inform all contacts from your list not to open a video called the “Dance of the Hillary”. It is a virus that formats your mobile. Beware it is very dangerous. They announced it today on BBC radio. Fwd this msg to as many as you can!

Filed under: General Problems | Leave a Comment »

State health inspectors detect more than 30 medical errors at Wisconsin Veterans Home

Posted on October 21, 2016 by Pharmaciststeve

King Marden Center (copy) (copy)State health inspectors detect more than 30 medical errors at Wisconsin Veterans Home

http://host.madison.com/ct/news/local/govt-and-politics/state-inspectors-issue-citations-to-wisconsin-veterans-home-at-king/article_d7bb843b-36b3-5cc9-b2a0-acb402bba474.html

State health inspectors have found more than three dozen instances of medical errors at the Wisconsin Veterans Home at King, according to its latest review of the facility.

The findings are a part of a review conducted last month by inspectors from the state Department of Health Services, which investigated complaints at King’s four residence halls, each of which has its own license.

Gov. Scott Walker ordered the review after a Cap Times investigation in August revealed concerns from employees and residents about conditions and quality of care at the state-run home in Waupaca County.

 

The medical errors are a part of 14 total federal citations issued to the home following a two-week inspection in September. The citations are issued by the Wisconsin Department of Health Services on behalf of the federal government. DHS contracts with the federal government to inspect and certify nursing homes statewide that receive Medicare and Medicaid funding.

The average number of federal citations, or deficiencies, for nursing homes nationwide was 5.7 in 2014, the most recent year data was available, according to a 2015 report from the Centers for Medicare & Medicaid Services. That average has been decreasing steadily since 2008, when the average was 7.1, according to CMS.

Inspectors issued four federal citations at King’s MacArthur Hall and 10 at Olson Hall, according to its report. Federal law requires the home respond to citations with a plan of correction or risk losing its federal funding. The home has submitted a correction plan, and said the problems have been fixed or are being monitored. The correction plan is the nursing home’s written response to the inspection report, but is not an admission that the citations are accurate or valid. 

Officials at the Wisconsin Department of Veterans Affairs, which operates the King veterans home, did not immediately respond to a request for comment, but they have maintained that concerns over the quality of care there are unsubstantiated.

Veterans agency Sec. John Scocos has disputed accounts by employees, former employees and residents, and has said the home is of the highest quality, citing its repeated four- and five-star ratings from the Centers for Medicare & Medicaid Services. A five-star rating is the highest rating a nursing home can receive in the CMS ranking system.

“These entities have said that our homes are among the best in the country … if issues arise during these inspections, corrective action plans are put into place urgently so that we may make the improvements,” Scocos told the Joint Legislative Audit Committee in September. “We are still the very best in the country.”

In the DHS report, the most serious citations include 38 instances of medical errors in MacArthur Hall, including residents being given the wrong medication, incorrect dosages or never receiving needed medicine. In some instances, prescriptions were transcribed incorrectly, but several mistakes were attributed to changes in the nursing home’s software for administering medicine, according to inspectors. There were also instances of incorrect medical record keeping.

One resident in MacArthur Hall who was supposed to receive 12 units of insulin was given 100 units, according to inspectors. The licensed practical nurse who made the error told an inspector that she erred because she did know how to use the nursing home’s new software. She was trained on the program a month before the incident, but then went on vacation. When she returned, she was told by a supervisor that she did not have to get additional training and could just “wing it,” according to the report. The nurse said that when she asked another supervisor questions about the program, the supervisor told her “I don’t know what to tell you.” The nurse said the resident did not experience a negative impact from the insulin error, according to the report.

Another MacArthur resident who was ordered by a doctor to be off of blood thinners and aspirin was given the medicine anyway.

In another case, a resident mistakenly received someone else’s medicine: 5 milligrams of Zolpidem, a sedative used to treat insomnia; 300 milligrams of Gabapentin, a nerve drug to treat epilepsy; and 5 milligrams of Atorvastatin, used to treat high cholesterol.

The King veterans home changed its software system for administering medication in June, but inspectors said they caught medication errors that occurred both before and after the change. The report also included accounts from nurses and nurse aides who said the software change has been rolled out “inadequately” and said the transition has been “frustrating.”According to inspectors, King management acknowledged the software problems and said they are “working on it.”

In its plan of correction, the home’s administrators said they would update its electronic charting system to document errors and follow up. A nursing supervisor in MacArthur Hall will also audit medication errors for three months and re-train nurses and aides on the software, according to the correction plan.

There were more than 70 instances of food safety violations in Olson Hall’s kitchen which had the potential to affect all of the residents there, according to the DHS report.

 Olson Hall was also cited for failing to give residents treatment to prevent bed sores from developing or treatment to prevent urinary tract infections. Inspectors also found instances of nurses and aides failing to follow cleansing protocol when washing residents.

Inspectors also cited Olson Hall for failing to provide a fire alarm system in several rooms in violation of the Life Safety Code, a national standard for buildings from the National Fire Protection Association.

Otis Woods, who oversees nursing home inspections at DHS, said the agency is fair, thorough and independent in its review of the King veterans home despite being a state agency reviewing a nursing home run by another state agency.

DHS acts in dual capacities when regulating nursing homes in Wisconsin. Its inspectors review nursing homes in order to issue or renew a home’s state license, but DHS also inspects homes on a complaint-driven basis to determine whether it should receive federal Medicare and Medicaid dollars. Both kinds of on-site inspections typically take a week.

The agency must meet the terms of its contract with the federal government to ensure money is being spent appropriately, Woods said.

“Our responsibility is to protect and promote the safety and welfare of the citizens of Wisconsin,” he said. “Because we are a regulatory body, we are as independent as you can potentially get.”

DHS has teams of inspectors located at regional offices throughout the state who are dispatched to conduct investigations of nursing homes. Inspectors are extensively trained and examine records, interview staff and residents when reviewing a home, Woods said. When reviewing complaints, inspectors investigate how widespread the problem may be, how severe, if there is a pattern and how many people it could affect.

The agency delivers its inspection results to the federal government, which checks the information and ultimately determines the outcome of a citation.

State auditors have also begun reviewing complaints at the Wisconsin Veterans Home at King. The audit, approved by lawmakers from both parties last month, is expected to take at least six months.

 

 

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Colorado marijuana’s potency getting ‘higher’

Posted on October 21, 2016 by Pharmaciststeve

newimprovedColorado marijuana’s potency getting ‘higher’

http://www.cnn.com/2016/10/21/health/colorado-marijuana-potency-above-national-average/index.html

Denver (CNN)More than two years after Colorado began selling marijuana for recreational use, cannabis consumers have access to pot that is more potent than ever.

There are dozens, if not hundreds, of different strains among thousands of plants grown legally under bright lights and fans in giant warehouses across the state.
“I think we’re the best industrial growers of cannabis in the world,” Medicine Man Marijuana CEO Andy Williams said of his company.
Colorado visitors are using pot and ending up in the ER

 
Colorado visitors are using pot and ending up in the ER
Williams owns a high-tech cannabis grow facility. He gave CNN a glimpse inside one section of it: a 12,000-square foot operation with machines that regulate temperature and humidity, and filter the air to create the best environment for fine-tuning cannabis concoctions.
“While we don’t do genetic engineering here, we’re constantly looking for better genetics. That means good, big and fast. So, it’s been a constant evolution of our genetics over time,” Williams said.
Canna Tsu, Cookies and Cream, Purple Dream and Screaming Gorilla are among the 50 to 60 different strains grown by Medicine Man. Levels of THC, marijuana’s psychoactive component, vary from strain to strain, ranging from 6% THC in Canna Tsu to 28% THC content in Williams’ Screaming Gorilla.
“It’s one product that’s fairly old-fashioned, compared to the hundreds that all these manufacturers and growers in Colorado are currently creating,” said Dr. Kari Franson, a clinical pharmacologist and pharmacist and the University of Colorado Skaggs School of Pharmacy. “They’re kind of creating a Frankenstein cannabis.”

THC percentages getting ‘higher’

In 2012, Colorado and Washington became the first states to legalize recreational marijuana, with Colorado implementing it first. There are currently no regulations in Colorado limiting THC levels.
Earlier this year, some Colorado state legislators proposed an amendment to limit THC to 16% in marijuana and marijuana products sold in the state.
Proponents expressed concerns about the effects of THC on adolescent brains, among other health and safety issues.
Who's minding the marijuana? Banned pesticide found in Colorado testing

 
 
But their effort to set a THC-limit failed to get enough support. Marijuana industry insiders say setting a limit could fuel the black market. Williams likened it to the end of prohibition of alcohol.
“Those types of actions would be similar to saying we can’t have alcohol on the shelf other than beer, and people who don’t like beer, that want spirits, that want wine, are going to have to make it themselves,” Williams said.
Colorado state regulators do require recreational marijuana be tested for potency at third-party state licensed laboratories for labeling.
“The biggest issue is protecting the public’s health and safety and making sure this industry is based on sound accurate science,” said JJ Slatkin, director of business development at TEQ Analytical Laboratories.
TEQ has tested more than 100 different strains from more than two dozen clients, Slatkin said. His lab tests marijuana flower, concentrates and pot-infused products such as edibles.
While the tests measure potency of five different cannabinoids or components of the plant, THC is the cannabinoid connected to making people feel “high.”
Slatkin pulled up a recent test report showing a flower with about 32% total THC, acknowledging that it’s one of the highest THC levels he had seen in tests at TEQ. CMT Laboratories, another state-licensed testing facility, reported test results with THC content as high as 28%.
In states where marijuana is still illegal, “they’re only growing or getting access to kind of low-grade marijuana,” said Franson.
 
 
Customers wait in a long line for their turn to buy recreational marijuana outside the LoDo Wellness Center on Wednesday, January 1, in Denver. Colorado is the first state in the nation to allow retail pot shops.

 
 
 

 
 
 
 
Marijuana plants thrive in the grow room of the LoDo Wellness Center.

 
Nationwide the average THC content found in confiscated marijuana has dramatically increased in just the last couple of decades.
“In the early 1990s, the average THC content in confiscated cannabis samples was roughly 3.7% for marijuana,” according to the NIH National Institute on Drug Abuse. “In 2013, it was 9.6%.”
Another study that analyzed samples from pot seized by the US Drug Enforcement Administration from 1995 to 2014 also showed an increase in potency of “illicit cannabis plant material” from 4% THC content in 1995 to 12% in 2014, which is still far below what marijuana testing facilities are finding in Colorado and other states where recreational marijuana is sold.

Taking a health toll

These increasingly potent strains hit inexperienced users hard.
Data analyzed by the Colorado Department of Public Health and Environment (PDF) found that emergency room visits for marijuana-related incidents increased 29% from the years just before commercialization to 2014 through mid-2015.
Another study found that for Colorado residents, marijuana-related ER visits rose from 70 per 10,000 in 2012 to 101 per 10,000 in 2014 — a 44% increase.
More Colorado kids in hospital for marijuana since legalization, study says

 
Kids and marijuana: Colorado hospital visits up since pot legalization
While those numbers can’t be attributed solely to highly potent pot, Franson believes that’s part of it “for those few who unfortunately take too much in and have an adverse affect.”
“These people are getting so anxious and uncomfortable with how they feel. They sometimes have a feeling of impending doom and they’re like, ‘Oh my gosh, I’m going to die,’ so they go to the emergency room and seek assistance,” Franson said.
Marijuana users can also build a tolerance to THC. So higher potency can become necessary to achieve the desired effect over time, according to medical experts.
However, Williams said THC potency is not the only focus for growers or consumers. Some people use pot to help relax, for pain relief, even to help energize. Different components of the marijuana plant can have different impacts.
 
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For example, Williams said some of his customers prefer a pot product with higher concentrations of CBD, another cannabinoid, believed to help treat epilepsy and other serious conditions.
Williams said he remains focused on growing the best variety to meet different needs. “Having that range of products that has great flavor, that has great effect, that’s repeatable and consistent for our consumers is what our goal is,” said Williams.
 
 

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Anti-inflammatory pills tied to heart failure risk

Posted on October 20, 2016 by Pharmaciststeve

Anti-inflammatory pills tied to heart failure risk

http://www.foxnews.com/health/2016/10/20/anti-inflammatory-pills-tied-to-heart-failure-risk.html

Widely used non-steroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of heart failure— even in people without a history of cardiac issues, a recent study suggests. Which is a great amount of good news when you consider all the lawsuits being had. http://sideeffectsofxarelto.org covers the happenings of xarelto lawsuits, anyone interested may find relevant information.

Overall, the odds of a hospital admission for heart failure was 19 percent higher for people who used NSAIDs in the previous two weeks than for individuals who didn’t take these drugs, the study found.

Not all NSAIDs carry the same risk, however. The increased odds of a heart failure hospitalization were, for example, just 16 percent for naproxen but 83 percent for ketorolac. Many NSAIDs, including celecoxib (Celebrex), were tied to little or no increased risk. Arlington CPR Certification Classes is what one can consider taking in case they want to be prepared to help someone in trouble.

“There is difference between the NSAIDs in risk of heart failure and higher dosages are associated with increased risk,” said Dr. Gunnar H. Gislason, chief scientific officer of the Danish Heart Foundation and author of an editorial accompanying the study.

“NSAIDs increase risk of heart failure independent of sex or previous heart failure status,” Gislason added by email.

“However, if you have established heart disease, heart failure or carry many cardiovascular risk factors, your risk associated with NSAID use is more pronounced – thus especially the elderly and patients with any heart condition should avoid NSAIDs,” Gislason said.

While plenty of previous research has linked NSAIDs to an increased risk of heart failure, the current study sheds new light on the risk of individual drugs in this family of medicines, researchers note in The BMJ.

To assess the cardiovascular safety of these medicines, researchers analyzed data on 27 different NSAIDs taken by adults in the Netherlands, Italy, Germany and the U.K. between 1999 and 2010. The best way to learn about it is to read about Center for Vascular Medicine, where you can get all information you require, about cardiovascular health.

The analysis included more than 92,000 people admitted to the hospital for heart failure and a control group of more than 8.2 million similar individuals without a record of hospitalization for this condition.

A total of 16,081 people, or 17.4 percent, with a heart failure hospitalization were current users of NSAIDs, as were 14.4 percent of the individuals without a this history, the study found.

Coast2Coast Swim School revealed that nine NSAIDs had a significantly higher risk of heart failure for current users: ketorolac, etoricoxib, indomethacin, rofecoxib, piroxicam, diclofenac, ibuprofen, nimesulide and naproxen.

These nine drugs were associated with an increased risk of heart failure in both men and women and regardless of whether or not there was a previous heart failure diagnosis.

Current users of very high doses of diclofenac, etoricoxib, indomethacin, piroxicam and rofecoxib had more than twice the risk of heart failure than past users, the study also found.

One limitation of the study is that researchers lacked data on over-the-counter NSAID users, which means some patients classified as non-users in the analysis might actually take nonprescription versions of the drugs, particularly ibuprofen, the authors note. This might understate the impact of NSAIDs on heart failure risk.

Another drawback is the potential for some heart failure admissions to be linked to other cardiovascular problems, with hospital discharge records noting a different reason for the admission, the researchers point out.

Even so, the findings add to a growing body of evidence pointing to the risk of heart failure associated with NSAIDS, the authors conclude.

Patients in pain also have other options – such as acetaminophen, known as paracetamol outside the U.S., or a weak opiate – that don’t carry the same risk of cardiovascular disease as NSAIDs, Gislason said. Physical therapy, exercise, or weight loss can also help with some situations, he said.

“If you need NSAIDs for pain or arthritis, you should consult your physician who could advise about alternative pain management,” Gislason added.

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HFM responds to drug deaths lawsuit

Posted on October 20, 2016 by Pharmaciststeve

HFM responds to drug deaths lawsuit

http://www.htrnews.com/story/news/crime/2016/10/20/szyman-drug-death-lawsuit-manitowoc-holy-family-memorial/92477902/

Another situation where BIG NUMBERS are quoted… so that they can SOUND BAD…

If you use the “minimum of 400 pts” and abt 15 month period.. and 19,250 prescriptions… if you do the math… that would amount to abt an average of 3+ Rxs/person/month… presuming that each was for a 30 day supply …  if you figure that appropriate therapy for chronic pain pts would include a long acting and a short acting opiate… that would account for between 50% -66% of all those prescriptions. 

I find it amazing that they know EXACTLY how many Rxs were written… but .. make a GUESS of how many pts the prescriber was seeing/prescribing for.

How many chronic pain pts take – on average – more than 3 Rxs/month ?

 

MANITOWOC – Holy Family Memorial President and CEO Mark Herzog has given a written statement in response to a lawsuit against Holy Family Memorial Hospital Pharmacy and 13 other defendants, including Dr. Charles Szyman, a doctor who was accused earlier this year of over-prescribing painkillers while he worked for Holy Family Memorial Hospital.

“Holy Family Memorial has a 117-year history of care rooted in our core values of stewardship, excellence and respect,” Herzog said in his statement. “Our hospital and employees are committed to providing compassionate care to all those we serve. We believe this does not overshadow all of the other incredible work we do and the care we provide. Our focus remains on helping patients and serving the community.”

The lawsuit was filed Oct. 4 by nine plaintiffs and alleges Szyman caused the deaths of Heidi Buretta, Monica Debot, Mark Gagnon and Alan Eggert through his practice of prescribing narcotics.

Buretta, Debot and Eggert died from mixed drug toxicity, while Gagnon died from injuries linked to his use of narcotic pain medication. All four were prescribed high dosages of painkillers by Szyman, the lawsuit alleges.

The lawsuit states, “Over the course of more than a decade, Dr. Charles Szyman began engaging in the practice of prescribing narcotic pain medication to patients at a level far beyond any medically legitimate, reasonable, or recognized level with said practice falling outside the standard of care which any reasonable doctor would exercise under the same or similar circumstances.”

The lawsuit also alleges employees of Holy Family Memorial Hospital Pharmacy knew about Szyman’s practice of over-prescribing pain medications, but did nothing to stop it and continued to fill the prescriptions, which generated millions of dollars in revenue for the hospital.

The complaints came as Szyman faces 19 charges of drug trafficking, which he pleaded “not guilty” to in June. If convicted, Szyman could be sentenced to up to 20 years in prison per charge.

In an earlier USA TODAY NETWORK-Wisconsin report, Lt. Dave Remiker, of the Manitowoc County Sheriff’s Metro Drug Unit, said Szyman was likely working with at least 400 patients before he was indicted. The indictment from June 21 lists 19,520 drugs prescribed by Szyman between Nov. 21, 2013, and Feb. 10, 2015.

Szyman worked with Holy Family Memorial Hospital as a pain specialist until his medical license was suspended Oct. 21, 2015, by the state Department of Safety and Professional Services Medical Examination Board. He was terminated from his position with Holy Family Memorial Hospital as a result of the suspension.

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Federal bureaucratic “over sight creep” ?

Posted on October 20, 2016 by Pharmaciststeve

spiderwebWalnut: This Popular Nut Slashed Breast Cancer Risk in Mice by 50%

http://articles.mercola.com/sites/articles/archive/2012/03/07/fda-says-walnuts-are-drugs.aspx#

How long before every part of our individual lives are controlled/regulated by some part of the Federal bureaucracy… Federal oversight seems to be growing like a “spider web”

By Dr. Mercola

As unbelievable as it sounds, current law makes it illegal for food producers to share certain types of scientific information with you.

So when Diamond Food relayed health information about the omega-3 fats in walnuts on product packaging and also on their Web site, the U.S. Food and Drug Administration (FDA) attacked.

Even though the information was entirely true, and backed by peer-reviewed scientific research.

If a Food Can Prevent a Disease, it Must be a Drug

This is the backward thinking that goes on at the FDA, where regulations currently prohibit manufacturers of dietary supplements or producers of food from referring to any scientific study documenting the potential effect of the substance on a health condition, punishable by large fines and even jail.

Disclosure about the benefits of a dietary supplement or food, no matter how credible, places the food in the category of an “unapproved drug.”

In other words, if a product makes a medical claim, it’s automatically classified as a drug.

This is how the FDA got away with sending Diamond Food a warning letter1, stating:

“… we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.

The following are examples of the claims made on your firm’s website under the heading of a web page stating “OMEGA-3s… Every time you munch a few walnuts, you’re doing your body a big favor … “

These claims are backed by science2, but it doesn’t matter under FDA rules, which are so counter to rationality and logic that it boggles the mind. The FDA letter goes on to list several health claims made by Diamond Foods regarding omega-3 fats, claims such as:

  • “Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses.”
  • “[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats… “
  • “[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons.”
  • “The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States.”

Walnuts are “New Drugs”

Because Diamond Food dared to let consumers know that natural substances in a natural food may offer some health benefits and protections, the FDA views this as a new drug. In their eyes, only FDA-approved drugs are capable of offering such protections …

The FDA stated in the warning letter3:

“Because of these intended uses, your walnut products are drugs… Your walnut products are also new drugs … because they are not generally recognized as safe and effective for the above referenced conditions. Therefore … they may not be legally marketed with the above claims in the United States without an approved new drug application.

Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded… in that the labeling for these drugs fails to bear adequate directions for use… “

The FDA’s current position is that foods such as walnuts, cherries, broccoli, turmeric, green tea and the like should be subjected to the full FDA approval process. But obtaining a new drug application, as the FDA suggested, can cost billions of dollars. And let’s face it — walnut growers cannot come close to affording that!

Is it Not a Constitutional Right to Share Truthful, Scientific Information?

This is so ridiculous, as censoring a food producer’s right to inform others about scientific research is in violation of the first amendment. The American Association for Health Freedom (AAHF) states:

“The FDA ignores first amendment protections and censors the communication of valid scientific information. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests.”

Can you imagine the drug companies not being permitted to tell you what their products could do for you… do you think they would roll over for that? Not a chance, but they don’t have to simply because they are the ones who can afford the FDA’s approval process. With few exceptions, it’s impossible for food producers to assume such costs for natural and therefore non-patentable products.

It’s ludicrous for the FDA to require natural products to be “vetted” the same way as drugs. In nearly every case, natural products are safer and more effective than synthetic drugs, as science has shown, time and time again. Not to mention that natural agents are much less expensive than pharmaceuticals, and can even be grown in your backyard!

It’s unfortunate that the FDA is so beholden to the drug industry that it would waste it’s time to attack a walnut manufacturer for citing scientific research while allowing Frito Lay to claim that its Lay’s potato chips are “heart healthy.”

And walnut producers are not alone. Cherry growers have also been threatened by the FDA with jail time if their websites even contain links to scientific studies from Harvard and elsewhere, outlining the health benefits of cherries for gout or arthritis pain.4 Green tea growers have received similar threats. As I said, it truly boggles the mind…

What Should You Know About Walnuts?

The FDA was sure worried that you might get wind of the truth — that a food might confer health benefits that drugs currently lay exclusive claim to. Walnuts are good sources of plant-based omega-3 fats, natural phytosterols and antioxidants that are so powerful at free-radical scavenging that researchers called them “remarkable.”5 Plus, walnuts may help reduce not only the risk of prostate cancer, but breast cancer as well.

In one study, mice that ate the human equivalent of 2.4 ounces of whole walnuts for 18 weeks had significantly smaller and slower-growing prostate tumors compared to the control group that consumed the same amount of fat but from other sources. Overall the whole walnut diet reduced prostate cancer growth by 30 to 40 percent. According to another study on mice, the human equivalent of just two handfuls of walnuts a day cut breast cancer risk in half, and slowed tumor growth by 50 percent as well6. Other research has shown walnuts may:

Now this is the type of information that we need to hear more of as, no doubt, if people were made aware of these potential benefits, and similar ones in other whole foods, they may be tempted to snack on a handful of whole walnuts instead of a bag of potato chips or pretzels.

You Can Still Support HR 1364 for Free Speech About Science

Congressmen Jason Chaffetz (R–UT) and Jared Polis (D–CO) have introduced the Free Speech about Science Act (HR 1364), a landmark legislation that would allow the flow of legitimate scientific and educational information.7 The new bill provides a limited and carefully targeted change to FDA regulations so that manufacturers and producers may reference legitimate, peer-reviewed scientific studies without converting a natural food or dietary supplement into an “unapproved drug.” According to Rep. Chaffetz’s website, the provisions of HR 1364 do the following8:

  • Allow dietary supplements and healthy foods to cite legitimate scientific research
  • Provide a clear definition of the types of research that may be referenced by growers and manufacturers
  • Ensure that referencing such research does not convert a food or dietary supplement into an “unapproved (and therefore illegal) new drug”
  • Retain the authority of FDA and FTC to pursue any fraudulent and misleading statements

According to Rep. Chaffetz9:

“It is important for individuals and families to take charge of their personal health by making the right decisions to get and stay healthy. This includes accessing information so that individuals can adjust habits, eat healthfully, and take appropriate dietary supplements to prevent and even treat health conditions.

The Free Speech About Science Act helps insure their access to legitimate scientific research to make the necessary decisions to improve their personal health and the health of their families.”

Rep. Polis adds10:

“Today’s science has shown that vitamins and nutritional supplements can offer successful, natural alternatives to drugs. As we begin to reform our nation’s healthcare system, supplements are an innovative way to help reduce costs.

The Free Speech About Science Act is a common sense act that will make it easier for doctors and consumers to learn about the cheaper, healthier alternatives to costly medicines that food and nutritional supplements provide.”

As of December 2011, HR 1364 is in the first step in the legislative process and has been referred to committee. The majority of bills never make it out of committee, so we need your help.

Please lend HR 1364 your support by signing on as a co-sponsor TODAY.

Use the Alliance for Natural Health’s HR 1364 page to send a letter to your representative in support of this bill.11 And forward or post this article to all of your friends and loved ones who care about their health and their right to informed consent. With your combined influence we can be a powerful force for much-needed change.

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