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Trump’s four executive orders to lower drug prices: What to know
Posted on July 24, 2020 by Pharmaciststeve
Trump’s four executive orders to lower drug prices: What to know
https://www.foxbusiness.com/healthcare/trump-four-executive-orders-drug-prices
President Trump issued a handful of executive orders Friday that aim to lower prescription drug prices through a variety of methods, including allowing medications to be imported from other countries.
“I’m signing four sweeping executive orders that will lead to a massive reduction in drugs costs,” Trump said during a press briefing at the White House. “[The measures] will completely restore the prescription drug market in terms of prices.”
Trump claimed drug prices had fallen under his administration for the first time in more than five decades but added that he was determined to do more.
One of the orders introduced Friday would deliver rebates from drug companies directly to patients for insulin and Epipens in a bid to prevent providers from pocketing the discounts themselves while charging low-income patients unaffordable prices.
Trump said the price of insulin would come down to “pennies” per day.
The second order would allow wholesalers and pharmacies to legally import prescription drugs from Canada and other countries, where the president has repeatedly alleged identical drugs are available at costs as much as 90 percent lower than in the U.S.
The third order would bypass pharmacy benefit managers and other “middlemen” to deliver discounts for prescription drugs directly to patients. Trump said Friday that patients often never see these discounts from the manufacturer.
A final “favored nations” policy would require Medicare to purchase drugs at the same prices paid by foreign countries, which Trump said will prevent the U.S. from continuing to subsidize the cost of research and development for the entire world.
Medicare will leverage its purchasing power to negotiate prices – the goal would be to find a middle ground with other countries that allegedly pay less for the same prescription drugs.
This order will not be signed until the end of August, which would give the country’s largest companies time to come up with alternative solutions.
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Ukrainians admit selling fakes of Merck’s Keytruda in US
Posted on July 23, 2020 by Pharmaciststeve
Ukrainians admit selling fakes of Merck’s Keytruda in US
Two Ukrainian men have admitted to selling counterfeit cancer drugs in the US, including knock-offs of Merck & Co’s big-selling cancer immunotherapy Keytruda.
Maksym Nienadov (36) – the owner of a Ukrainian company called Healthy Nation – and employee Volodymyr Nikolaienko (33) pleaded guilty to conspiracy, trafficking in counterfeit drugs and smuggling goods into the US. Nienadov also admitted to introducing misbranded drugs into the US market.
Along with Keytruda (pembrolizumab), the men also admitted unlawfully selling counterfeits of Bristol-Myers Squibb/Celgene’s cancer drug Abraxane (nab-paclitaxel) as well as Epclusa (sofosbuvir/velpatasvir), a treatment for hepatitis C virus marketed by Gilead Sciences.
US enforcement agencies started investigating the pair in 2018, spending thousands of dollars on test purchases of all three medicines that Nienadov and Nikolaienko were offering for sale.
On receipt of the products, the samples were sent to the drug manufacturers for testing, and the packages and contents of all of them were found to be counterfeit.
Nienadov and Nikolaienko were taken into custody in April 2019, after they arrived in the US from Ukraine “to discuss future unlawful shipments of pharmaceuticals,” according to a Department of Justice statement.
The two men are due to be sentenced on 4 November, it says.
The case is another example of counterfeiters falsifying high-value pharmaceutical products in the interest of making a quick profit, regardless of the consequences on people’s health.
Often, counterfeit medicines don’t contain the active ingredient promised on the label, and can also contain contaminants that can cause toxicity or infection – particularly in the case of drugs like Keytruda and Abraxane that are administered by intravenous infusion.
Keytruda is on course to become the top-selling drug in the world in the next few years, topping $11bn in sales last year and expected to top $14bn this year thanks to a steady stream of new approvals.
A few years ago, falsified cancer medicines hit the headlines after a notorious case in which fake copies of Roche’s antibody drug Avastin (bevacizumab) was purchased by nearly 100 US physicians and is thought to have been administered to patients.
I have read that a single treatment of Keytruda can run an insurance/pt upward of $13,000. That has always seem to be a common denominator with fake meds found out in the marketplace …. the higher their wholesale cost … the more likely someone will try to create fake product and get it into the distribution system.
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20 minutes of working at CVS/Pharmacy
Posted on July 22, 2020 by Pharmaciststeve
ARRESTED after giving 60 MILLION in BRIBES!! – JUST IN OHIO !
Posted on July 22, 2020 by Pharmaciststeve
ARRESTED after giving 60 MILLION in BRIBES!!
When I tell you this prescription drug system is rigged to extract hundreds of Billions from the economy annually by a few monopolistic companies that use , Illegal, immoral, unfair business practices to eliminate competition while bilking every consumer, taxpayer and employer, most people ask “ How can that even be possible in the United States?” This is how!!! MONEY AND CORRUPTION!!! Ohio’s TOP PBM LOBBYISTS arrested for racketeering after giving 60 MILLION in BRIBES !!! 60 MILLION!!!
This is the association that represents the entire prescription benefit managers in this country… of course, the top 3-4 controls about 70%-80% of the entire business. These PBM’s started in 1970 and it has only been in the last few years that state legislatures have been able to impose some rules/regulations to make these companies’ financial dealing more transparent. However, there is a lot more that has to be done to get this group of businesses “in line”.
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Attorney General Nessel Joins Lawsuit Against Federal Government for Allowing Health Care Discrimination
Posted on July 21, 2020 by Pharmaciststeve
Attorney General Nessel Joins Lawsuit Against Federal Government for Allowing Health Care Discrimination
https://www.michigan.gov/ag/0,4534,7-359–534497–,00.html
Contact: Courtney Covington 517-335-7666
Agency: Attorney General
July 21, 2020
LANSING – Michigan Attorney General Dana Nessel has joined 22 other attorneys general in filing a lawsuit to stop the U.S. Department of Health and Human Services’ (HHS) finalized regulation, “Nondiscrimination in Health and Health Education Programs or Activities” (Section 1557 Rule) which rolls back protections put in place in 2016. Section 1557 is an anti-discrimination provision of the Affordable Care Act (ACA) that prohibits discrimination in health care based on gender, race, ethnicity, sex, age or disability. The lawsuit — filed Monday against HHS, HHS Secretary Alex Azar, and the head of HHS’s Office of Civil Rights, Roger Severino — argues that the new rule emboldens providers and insurers to discriminate against communities of color, women, LGBTQ individuals, those with limited English proficiency, and people with disabilities by undermining critical legal protections prohibiting discrimination in in the provision of health care services.
“By striking down anti-discrimination protections for women, minorities, LGBTQ individuals and others, this new rule exposes a deliberate and persistent theme of prejudice by our federal government under the Trump administration, and it is something I am obligated to oppose,” Nessel said. “The original intent behind the Section 1557 provision in the Affordable Care Act is to prevent discrimination in our nation’s health care system, yet this administration’s new rule instead revokes those protections and advances an agenda that welcomes bigotry. At a time when we’re reminded every day of how barriers to health care threaten the lives of adults and children alike, the federal government continues to show a blatant disregard for those most at risk. My colleagues and I have no other choice but to challenge this rule in court.”
Before the rule was finalized, the coalition previously called on the Trump administration to withdraw the rule. The coalition submitted a comment letter to HHS in August, and then sent another letter to HHS in April asking that they not finalize the rule while the nation is in the midst of a public health crisis.
The Obama administration’s HHS issued regulations implementing Section 1557 of the ACA in 2016 to stop the ongoing threat of discrimination in the nation’s health care system. HHS itself has long noted that discrimination within the health care system contributes to poor coverage and health outcomes, and exacerbates existing health disparities in underserved communities. Individuals who have experienced discrimination in health care often postpone or forgo needed care, resulting in adverse health outcomes.
Specifically, Section 1557 prohibits discrimination by any health care program — including providers and insurers — against individuals on the basis of race, color, national origin, sex, disability or age. Federal courts have also held that the statute’s prohibitions on sex discrimination protect transgender and other LGBTQ+ individuals from discrimination, which was confirmed in last month’s Supreme Court decision in Bostock v. Clayton County. In Bostock, the Supreme Court held that discrimination based on sexual orientation and transgender status are forms of sex discrimination prohibited by federal civil rights law.
Despite numerous failed legislative and legal battles to repeal and dismantle the ACA, the current administration’s new rule would now eliminate many of the express protections contained in the Section 1557 regulations, unlawfully exclude many health insurers from Section 1557’s scope, and would allow health care providers and health insurers to deny care and insurance coverage. The new rule would also impose unreasonable barriers and impede timely access to health care for Americans, in violation of Section 1557 of the ACA.
In the lawsuit — filed in the U.S. District Court for the Southern District of New York — the coalition argues that HHS has unlawfully ignored the harms that the new rule will impose on vulnerable populations. The coalition additionally contends that HHS has failed to justify why it abandoned its prior policy, which, among other things, explicitly prohibited discrimination in health care and required health entities to provide meaningful language assistance services to individuals with limited English proficiency, including notifying them of their rights to translation and interpretation services. The lawsuit also alleges that the Trump administration was motivated by animus toward the transgender community in issuing this rule.
The coalition specifically argues that the new rule is arbitrary, capricious and contrary to law under the Administrative Procedures Act (APA), and that it violates the equal protection guarantee of the Fifth Amendment.
Nessel joins the attorneys general of Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin, and the District of Columbia in filing this lawsuit.
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Rapp Report: Interview With Dr. Linda Cheek, M.D.
Posted on July 21, 2020 by Pharmaciststeve
E16: Interview With Dr. Linda Cheek, M.D.
https://therappreportpodcast.podbean.com/e/e16-interview-with-dr-linda-cheek-md/
Linda S. Cheek, MD is a retired family practice/pain management physician. Trained in conventional medicine, she found quickly in her practice that it doesn’t heal disease, so she studied multiple traditional (and futuristic) forms of healing medicine, from herbal to energetic and incorporated those into her practice.
Linda was born in Northern Virginia, just outside Washington, DC, graduating from George C. Marshall High School. She got her Bachelors in Biology at the University of Texas at Austin. She then became a secondary science teacher in her first life as she moved around the country and world as an Air Force wife. She also got a Masters in Guidance and Counseling at Phillips University.
Many of her years as an Air Force wife were spent in San Antonio, Texas. Deciding there to fulfill her dream of becoming a doctor, she got her Doctor of Medicine degree from the University of Texas Health Science Center at San Antonio.
Finally achieving her ambition to become a doctor, she did her residency in Family Practice at Roanoke Carilion Hospital. She moved to rural Southwest Virginia to serve the underserved, and set up practice in Pulaski County, at the edge of Appalachia.
Through the course of her practice, she led many patients to healing their chronic diseases, from fibromyalgia to heart disease and diabetes.
Learn more on Linda’s website: https://lindacheekmd.com/
And at Doctors and Patients of Courage: https://doctorsofcourage.org/
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CVS Addresses Complaints of Under staffing, Prescription Errors
Posted on July 21, 2020 by Pharmaciststeve
CVS Addresses Complaints of Understaffing, Prescription Errors
https://www.drugtopics.com/view/microbiome-research-calls-for-due-diligence-in-pharmacy
CVS defended its actions, but still settled with the Oklahoma Board of Pharmacy, after the pharmacy board charged the drugstore chain with prescription errors, inadequate staffing, and other offenses.
The pharmacy board fined CVS Health $125,000 after receiving multiple complaints about errors and overwhelmed staff members, The New York Times reported last week.1 The board inspected 4 pharmacies in particular from mid-2019 to early 2020.
https://www.nytimes.com/2020/07/16/business/cvs-pharmacies-oklahoma.html
CVS Pharmacy agreed to Board Orders from the Oklahoma Board of Pharmacy to resolve the complaints filed against the 4 pharmacies, the retailer said in a statement provided to Drug Topics®. “The agreement is not an admission to the allegations within the complaints. We’ve agreed to settle this matter to avoid the time and expense of a protracted hearing process and to foster a positive working relationship with the Oklahoma Board of Pharmacy,” CVS Pharmacy said.
According to the article, in an audit, inspectors discovered an error rate of approximately 22%, or 66 errors out of 305 prescriptions. Some of the errors were minor, but others were more significant.1
At 1 CVS store in Bartlesville, Oklahoma, inspectors found a 6% error rate, including the wrong dose of an antibiotic for a 1-year-old and multiple errors involving the frequency of a narcotic.1
At the store, inspectors “witnessed a chaotic scene including the phones ringing almost all of the time, along with constant foot traffic and drive thru traffic,” according to a complaint, The New York Times reported.
The head pharmacist noted that she had lost a considerable amount of her support staff, so she “was not terribly surprised that an error could have occurred,” according to The New York Times.1
In its statement, CVS said that patient safety is the company’s “highest priority and we have an excellent safety record, however we are committed to continually improving by using technology and training to enhance accuracy, regularly measuring the quality of our pharmacy services, monitoring our performance to improve processes, and listening to feedback from our pharmacists and pharmacy teams.”
“Our decisions about staffing, labor hours, workflow process, technology enhancements and other operational factors are all made to ensure that we have appropriate levels of staffing and resources in place at each pharmacy for the safe and accurate filling of prescriptions. If a pharmacist has a legitimate concern about working conditions, we make every effort to address that concern in good faith,” CVS added.
CVS also agreed to distribute a memo to its pharmacists in Oklahoma highlighting a law that requires them to take action if working conditions in their pharmacies could lead to problems safely filling prescriptions, The New York Times reported.1 “The memo is to make clear that they are not to face retaliation for documenting and reporting such issues.”
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Illusions in our life – PART TWO
Posted on July 21, 2020 by Pharmaciststeve
The illusions in our life
Yesterday I made the above post and reached out last night to a recently retired Pharmacy Professor and he introduced me to https://www.valisure.com/
Valisure
833-497-7370
hello@valisure.com
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The illusions in our life
Posted on July 20, 2020 by Pharmaciststeve
President Reagan’s words back abt 40 yrs ago … seems now to apply to many and many more industries and not just to our government. Our our insurance industry – and not just health – are more than willing to take your money and then use “vague terms” within the policy not to pay a claim. Our Florida condo got hit by Hurricane Michael (Cat-5) .. only the 3rd-4th time a Cat-5 had come ashore in the USA… I did not pay for wind or flood insurance because our unit is on the top floor and I put 150 MPH windows which was covered by 120 MPH metal hurricane shutters. But Michael took part – abt 20%- of the roof off of the complex – of course the roof was blown off over the top of our unit.
The ceiling our our condo is a concrete slab and was built in 1984 and no one had bothered to seal the penetrations and conduit runs… so water ran into our unit.. and we had a few inches of water in our unit because the water just kept running on down to the units below us, but all the flooring, all the baseboards, all the drywall from the floor and up 4′.. had to be replaced. Our insurance told us that the water in our unit was INDIRECTLY WIND DRIVEN – NO COVERAGE… I though OK… the Association was responsible for the roof… but the FL legislatures in 2009 passed a law that no association nor their insurance was responsible for any damage to a owner’s unit cause by failure of the common property – like the roof !
Being a pharmacist, I was always under the impression that the FDA was over the safety & purity of medications in our system. Well my faith in that federal agency has been totally shattered. I got one of Barb’s long acting pain meds filled in FL and for the first time she got some made by Rhodes Pharma (Purdue pharma company). When she started talking them she claimed that she was not getting an relief from them – the technical term is lacks efficacy – She had been taking this particular med for years and this is the first time this had happened… This med is a “12 hr dose – long acting med – and 2-3 hr after taking a dose – NOTHING… so thinking that it could be a solubility issue … so I instructed her to cut a tablet in HALF and take both halves. Another 2-3 hrs passed and NOTHING…. so I instructed her to CRUSH a tablet and take it… 2-3 hrs later NOTHING..
I filed a complaint/report with FDA MedWatchhttps://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program – of which I did not even receive an acknowledge from filing the complaint… let alone no follow up or any concern that this medication totally lacked efficacy.
I have had other pts tell me that their medications – different opiate – from Rhodes pharma – DID NOT WORK…
I reached out to Rhodes Pharma, figured that they would want to analyze these tablets… at first the person I talked to was a little hesitate to have them analyzed but I asked the question that the Rhodes had no concern that this would suggest that raw opiate material may be being diverted at their manufacturing facility.
Reluctantly he agreed to pick up the tablets…. and having waited a month since they were returned, I reached out to Rhodes pharma to get the results of the analysis. I had to leave a voice mail for 5-6 days in a row before anyone would return my call. I asked when I was going to get a copy of the analysis of those tablets and was told – somewhat in a matter of fact tone that they were not going to analyze those tablets and that they were standing behind the analysis reports at the time of being manufactured.
So the fact that Barb took THREE TIMES HER NORMAL DOSE within 6-9 hrs without any noticeable efficacy was of little concern to them.
So not to be deterred, I reached out to Division of Pharmaceutical Quality Operations III Office of Regulatory Affairs U.S. Food and Drug Administration Office: 313-393-8189 and talk to a representative and this office handles only Michigan & Indiana. Sent the representative all the information that I had concerning this particular med… got a couple of emails from the representative but now a week or so later … can’t get a voice mail return call nor a response to a email.
Have you ever seen a picture or demonstration of a room that has a large family of roaches residing and when you turn the lights on…. they all scatter back into the hiding places ? That is the mental picture that I am getting on this particular issue.
I have read stories about pharma manufacturing plants overseas where various mandated documentation involving the production of medications have been proved to be falsified/fabricated and no actual reality as to what was really done.
Is it just an illusion that those working for the Feds and in turn for US… really don’t give a crap about the actual duties of their job ?
I have already advised our PCP of this issue – who had been prescribing this to her for years – and I hope that he will share with the 5 other prescribers in his practice. I would recommend to any pt that is being prescribed Rhodes Pharma products to request a product provided by one manufactured by a different pharma.
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