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!

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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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Grieving mother urges more oversight for pharmacies that make errors

Posted on October 20, 2016 by Pharmaciststeve

Melissa Sheldrick is shown with son, Andrew, 8, who died in March of a toxic overdose of a prescription drug. The family is suing a Mississauga pharmacy alleging his prescription was substituted for another medication "in error."Grieving mother urges more oversight for pharmacies that make errors

https://www.thestar.com/news/gta/2016/10/20/grieving-mother-urges-more-oversight-for-pharmacies-that-make-errors.html

As she had done so many times before, Melissa Sheldrick helped her 8-year-old son Andrew get ready for bed one Saturday evening last March.

Andrew, who was diagnosed by a doctor with a sleeping disorder, was on a regular prescription for tryptophan, a drug that helped regulate his sleep cycle. After taking his usual dosage, Andrew went to bed at 9:30 p.m.

He never woke up.

“The next morning, we found him in his bed. He was gone,” his mother said. “We were frantic. We called 911 and the paramedics came and said there was nothing, any kind of medical intervention they could do. It was like something out of a nightmare.”

Andrew was mischievous, caring and funny, his family recalls. He loved sports, playing video games on his Xbox, and above all, his family and friends.

Until July, his family didn’t know why he died. Sheldrick, her husband Alan and 14-year-old daughter Samantha found out through a coroner’s report that Andrew died of a toxic overdose of baclofen, a muscle relaxant drug.

The coroner’s report concluded that the bottle of medication Sheldrick had picked up for her son at the pharmacy that same Saturday, March 12, contained no traces of the sleeping drug he had been prescribed.

“Logic would dictate that baclofen was substituted for tryptophan at the compounding pharmacy in error,” the report states. Peel Regional Police are “addressing this issue” with Floradale Medical Pharmacy in Mississauga, where Sheldrick had received the drug for her son, according to the report.

 The family is now suing Floradale, seeking $4 million in damages. In a statement of claim filed Tuesday, they allege “that baclofen was substituted for tryptophan at Floradale in error.”

Andrew had consumed about three times the amount of baclofen considered toxic in an adult, according to the coroner’s report.

The family is also asking Ontario Health Minister Dr. Eric Hoskins to implement a law that would increase oversight and tracking upon pharmacies that make errors.

With the hope of effecting change so that no other families face a similar tragedy, Sheldrick is in the process of requesting a coroner’s inquiry, which could produce recommendations for how pharmacies can reduce the risk of human error.

Andrew had taken tryptophan for two years. The only reason Sheldrick had gone to Floradale was because it is a compounding pharmacy, meaning it could take the pill form of Andrew’s medication, which he had trouble ingesting, and make it into a liquid.

The statement of claim names Floradale and its owner and manager Amit Shah as defendants, as well as a “Jane/John Doe pharmacist” who allegedly made the error. The family has been unable to identify who had prepared the medication.

“As a result of the negligence of the Defendants, which includes but is not limited to, their failure to properly compound the prescribed medication, Andrew died,” reads the statement of claim.

After several calls to pharmacies operated by Shah, he did not respond to requests for comment, but told the CBC News in an email “at this time we have no comment.”

“The family has retained counsel. The matter is being addressed,” he stated.

The lawsuit alleges the pharmacy permitted “unqualified and incompetent staff” to attend to patients and failed to keep accurate records.

Sheldrick is in the process of filing a complaint with the Ontario College of Pharmacists, the regulatory body for pharmacy practice in the province.

“There has to be a body that oversees this,” Sheldrick said.

Hoskins told reporters on Thursday he would look into the request along with the Ontario College of Pharmacists.

“I will be looking specifically, in light of this tragic situation, to see if there’s more that can be done in a transparent and accountable way,” he said. “Certainly if there are any allegations or complaints or suggestions of misconduct or errors that have been made, I would encourage Ontarians to report that to the college. It’s their responsibility to investigate.”

In Nova Scotia, pharmacists must report all errors to the Institute for Safe Medication Practices Canada. It’s the only province in the country that requires such reporting and Hoskins said he would look to Nova Scotia to determine if it’s the right approach.

Julie Greenall, the institute’s projects and education director, said she’d like to see Ontario adopt the same process.

“I think that would be helpful, particularly for critical incidents,” she said. “I think the more information we have about errors that are happening means the more we can learn about how to prevent them in the future.”

The institute is co-ordinating with the Ontario Coroner’s Office to investigate Andrew’s case to determine contributing factors and how to prevent future harm in pharmacies across the country. A report will be delivered to the coroner’s office in the coming weeks.

“This is a terrible situation,” Greenall said.

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Are There Times When a Legal Duty Not to Dispense Exists?

Posted on October 20, 2016 by Pharmaciststeve

Are There Times When a Legal Duty Not to Dispense Exists?

http://www.pharmacytimes.com/publications/issue/2016/October2016/Are-There-Times-When-a-Legal-Duty-Not-to-Dispense-Exists

While there are a lot of details of this lawsuit missing… but.. the courts ruling that a Pharmacist could be held liable for failing to refuse to fill prescriptions over a time period.  Once again we are talking about treating “subjective disease”  – “stress syndrome”… where dosing can vary and stress/anxiety/depression can go hand in hand… and we all know that pts with these medical issue are at a higher risk of suicide.  I wonder if the Pharmacist had INSISTED with the doc to be more “truthful” with what the pt can take per day… would have exonerated the Pharmacist ?

ISSUE OF THE CASE
When pharmacists at a community pharmacy repeatedly honored prescriptions for controlled substances before the supply previously dispensed should have been exhausted, may a lawsuit be maintained by the representative of the patient’s estate for breach of a legal duty owed the now deceased patient?

FACTS OF THE CASE
A patient in a southern state consulted a physician, who gave a diagnosis of stress syndrome, and, therefore, prescribed alprazolam and either hydrocodone with acetaminophen or oxycodone with acetaminophen. Over a 2-year period, these prescriptions were repeatedly issued to the patient before the last refills should have been consumed. It was alleged that at least 30 such prescriptions were dispensed at the same pharmacy and no questions were raised by the pharmacist. This lack of questioning the refill requests persisted even when the prescriptions were “issued too closely in time and days before the preceding prescription should have been exhausted.” The patient died shortly before the 2-year anniversary of being on this regimen, with the cause of death identified as “combined drug intoxication with alprazolam and hydrocodone.”

An individual representing the estate of the now deceased patient filed suit against the physician and the pharmacy, with the physician settling the claim out of court. The legal complaint filed to initiate the lawsuit against the pharmacy alleged 7 different types of breaches of legal duty by the pharmacy. An abbreviated description of some of those claims is that the pharmacy and pharmacist have a legal duty to (1) use due and proper care, (2) exercise the level of care and skill recognized by reasonably prudent and similar pharmacists, and (3) not honor prescriptions that were unreasonable as presented.

The attorney representing the pharmacy filed a motion with the state trial court hearing the case, stating the matter should be dismissed based on earlier cases, decided by courts in that state, that established precedent that pharmacists had no legal duty to do the things the plaintiff alleged. The trial court granted that motion, and the representative of the patient’s estate filed an appeal of that dismissal with the state court of appeals.

THE COURT’S RULING
Following review and discussion of the decisions in a number of prior cases in the state, the appellate court ruled that the lawsuit should not be dismissed.

THE COURT’S REASONING
The appellate court began by pointing out that the trial court judge had concluded that the pharmacy owed no duty to the patient that would support the lawsuit. The appeals court emphasized that if a legal duty to act were absent, there could be no successful claim of negligence. However, in the view of the appellate court, there was a legal duty to act, so the dismissal was an error.

The principal point of departure for the court was that “pharmacists are required to exercise that degree of care that an ordinary prudent pharmacist would do under the same or similar circumstances.” Further, it reviewed an earlier decision by the court of appeals, which had concluded that “a pharmacy that fills a prescription that is unreasonable on its face may breach its duty of care, even if the prescription is lawful as written.”

Delving further into case precedent, the court also identified an earlier decision ruling that “negligence liability can be imposed on a pharmacy for failing to use due and proper care in filling prescriptions, even if the prescription is filled in accordance with the physician’s instructions.”

The appellate court in this case concluded that “a pharmacist’s duty to use due and proper care in filling a prescription extends beyond simply following the prescribing physician’s directions.” Continuing, the court said, “We refuse to interpret a pharmacist’s duty to use ‘due and proper care in filling a prescription’ as being satisfied by ‘robotic compliance’ with the instructions of the prescribing physician.”

This court looked at the precedent from an earlier case involving a pharmacist’s failure to act on a patient’s medication allergies. In that case, there was an allegation of negligence based on the pharmacist’s failure to alert a patient that a prescription contained a substance to which the customer was allergic, and the court ruled that the “pharmacy has a duty to use proper care in filling a prescription, beyond simply following the prescribing physician’s directions.”

At the end of its published opinion, the appellate court pointed out that further proceedings were required to determine whether the plaintiff would prevail once the trial was concluded, along with all testimony and evidence, but at least a legal duty to act to protect the patient was present in the facts presented.

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Much of World Suffers Not From Abuse of Painkillers, but Absence of Them

Posted on October 20, 2016 by Pharmaciststeve

Much of World Suffers Not From Abuse of Painkillers, but Absence of Them

www.nytimes.com/2016/05/18/world/much-of-world-suffers-not-from-abuse-of-painkillers-but-absence-of-them.html?

By RICK GLADSTONE

 
An H.I.V. patient cooling off at a treatment center on the outskirts of Yangon, Myanmar, in 2012. The use of opioid analgesics to relieve pain is low in Asia and much of the developing world. Alexander F. Yuan/Associated Press

While Americans are confronting an epidemic of prescription drug abuse, particularly for addictive painkillers, the reverse problem prevails in much of the world.

Many ill people with a legitimate need for drugs like oxycodone and other narcotics known as opioid analgesics cannot get them and are suffering and dying in pain, according to health officials, doctors and patients’ rights advocates.

In Russia, India and Mexico, many doctors are reluctant to prescribe these painkillers, fearful of possible prosecution or other legal problems, even if they believe the prescriptions are justified.

In Kenya, health officials only recently authorized the production of morphine, one of the most effective drugs for pain relief, after criticism that it was available in only seven of the country’s 250 public hospitals. In Morocco, the advocacy group Human Rights Watch reported in February, only a small fraction of physicians are permitted to prescribe opioid analgesics, which the country’s law on controlled substances identifies as poisons.

And in most poor and middle-income countries, these drugs are restricted and often unavailable, even for patients with terminal cancer, AIDS or grievous war wounds.

The reasons include an absence of medical training, onerous regulations, costs, a focus on eliminating illicit drug use and, in some cultures, a stoic acceptance of pain without complaint. The problem has been amplified, public health experts say, by the stigmatization of the drugs, partly from fear of what has happened in the United States, where opioid misuse is a growing cause of death.

Reinforcing this view has been publicity about high-profile users like Prince, the pop star who died last month at his Minnesota mansion as friends sought help from an addiction specialist to treat what was apparently a dependence on opioid painkillers.

“While clearly there are issues with some prescribing practices, there’s also clearly a risk to vilifying these medicines,” said Diederik Lohman, associate director of the health and human rights division at Human Rights Watch.

In some countries, Mr. Lohman said, “a clerical error in a morphine prescription” can lead to criminal inquiries. “The fear associated with prescribing a medicine under strict scrutiny makes physicians afraid,” he said.

Afsan Bhadelia, a visiting scientist and palliative care expert at the Harvard School of Public Health, said “the biggest misconception” internationally regarding opioids was the need for tighter control.

“People do not have access to pain control for basic surgery,” she said. “People are going into the operating room and not having anyone mitigate their pain. It is a great injustice.”

Liliana De Lima, executive director of the International Association for Hospice and Palliative Care, a Houston-based advocacy group, said that global publicity about the American opioid epidemic “had brought this problem to the people, and that has had an effect on the fears.”

Despite international protocols dating back decades that entitle patients to pain relief and palliative care, access remains limited or nonexistent for many.

A report published in February from the International Narcotics Control Board, a United Nations agency, showed that most growth in the use of opioid analgesics has been in North America, Central and Western Europe, and Oceania. It remains low in Africa, Asia, Central America, the Caribbean, South America, and Eastern and Southern Europe.

 
A man addicted to heroin and the opioid fentanyl, in a tent city along the Merrimack River in Lawrence, Mass. Katherine Taylor for The New York Times

“Many low-income and middle-income countries continue to fail to provide adequate opioid analgesic medicine for pain,” the report said.

Stefano Berterame, who leads the board’s narcotic control and estimates section, said officials in many of these countries attributed the shortages to the expense of the drugs and a lack of suppliers. He also said that in some Asian countries, pain relief through the use of opioids or other drugs was an alien concept.

“They believe you can sustain the pain, work through the pain,” he said.

The pain-relief problem was addressed by the World Health Organization in a report published in advance of a United Nations summit meeting on international drug policy in April, the first such review in nearly two decades.

“Ensuring the adequate availability of controlled substances for medical and scientific purposes,” the W.H.O. said, was a commitment made by member states that had “yet to be universally achieved.”

It estimated that 5.5 billion people live in countries with “low or nonexistent access to controlled medicines for the treatment of moderate to severe pain.”

Dr. Dingle Spence, an oncology and palliative medicine physician in Jamaica, said that although opioids are available in her country, the supply is disrupted by so-called stockouts — demand exceeding supply — because of bureaucracy.

“There’s not enough understanding about timely ordering,” she said. “The amount of permits needed to bring them into the country slows down the timely flow.”

Still, Dr. Spence said Jamaica was fortunate compared with other countries in the region. In Trinidad, for example, she said, officials refused to allow “the simplest type of morphine” for pain relief. “It seems to be they are bound by the opiate-phobia problem,” she said.

Morphine consumption data from the International Narcotics Control Board, she said, tells part of the story. In 2013, the global average for 139 nations was 6.27 milligrams per capita. The only Caribbean nation above the mean was Barbados. In Jamaica, consumption was 1.63 milligrams; in the Bahamas, 0.24 milligram.

“That means there’s a ton of people in pain,” Dr. Spence said.

Felicia M. Knaul, an international health economist and expert in Latin American health systems, criticized what she described as a widespread overemphasis on the addictive risks associated with opioids. Although fear of opioids may be fed by American tragedies like Prince’s death, she said, strict regulations also are responsible for the pain-relief crisis elsewhere.

“It’s not that we shouldn’t be concerned about addiction,” she said, but “we basically have zero access in most countries around the world. You don’t go from zero to the situation in the United States.”

Ms. Knaul, a breast cancer survivor and global advocate of cancer patients, is chairwoman of the Lancet Commission on Global Access to Pain Control and Palliative Care, a group of experts created in 2014, in part to help integrate pain relief into health systems around the world. A major concern of the commission is the disparity between patients in rich and poor nations who have access to painkillers, which it called “an ongoing crisis that plays out almost entirely to the detriment of poor people.”

In Mexico, a 2009 amendment to its health law that required hospitals to offer palliative care to terminally ill people was basically ignored for years, prompting Human Rights Watch to issue a scathing report in October 2014 asserting that “tens of thousands” of Mexican patients entitled to pain relief were not getting it.

Ms. Knaul, who has worked extensively in Mexico, said that there had been “huge improvements” there more recently, but that drugs for palliative care remained difficult to obtain in many remote areas. She said Mexico’s war on drug cartels had actually increased illicit use of opioids.

“The irony for a pediatric oncologist is that it’s much easier to buy on the street than go to a hospital,” she said. “That’s what people turn to when they don’t have the appropriate means available.”

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