hydroxychloroquine and chloroquine can prevent COVID-19

https://www.medscape.com/viewarticle/933227

HCQ Trial to Resume

A global randomized controlled trial testing whether the antimalarial drugs hydroxychloroquine and chloroquine can prevent COVID-19 in healthcare workers or other high-risk workers will resume, Reuters reports. The UK Medicines and Healthcare Products Regulatory Agency had paused the COPCOV trial after another British trial found hydroxychloroquine to have no benefit for already-infected COVID-19 patients.

“Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomized controlled trial,” said the trial’s co-leader. “The question whether (it) can prevent COVID-19 or not remains as pertinent as ever.”

NACDS urges mandatory electronic prescriptions for controlled substances

NACDS urges mandatory electronic prescriptions for controlled substances

https://drugstorenews.com/nacds-urges-mandatory-electronic-prescriptions-controlled-substances

The National Association of Chain Drug Stores is urging the Drug Enforcement Administration to make electronic prescriptions for controlled substances, or EPCS mandatory.

In comments on the reopening of the Interim Final Rule for EPCS, the organization described the significant benefits associated with EPCS and recommendations on how best to achieve them.

“For more than 20 years NACDS has collaborated with DEA on the development and implementation of policies and standards for EPCS. We remain committed to the use of electronic prescriptions for all medications, especially controlled substances,” NACDS wrote.

NACDS noted that further DEA action would build on an NACDS-backed federal law that requires electronic prescribing of controlled substances in Medicare Part D, beginning in 2021. It also would build on NACDS-backed action by more than half of the states to require electronic prescribing of opioids, all controlled substances, or all prescriptions.

In addition, the organization also strongly supports the use of electronic prescribing as an important tool to improve safety and security in the prescribing process and to combat the abuse, misuse and diversion of controlled substances.

Significant benefits of electronic prescribing include: safeguards against unauthorized changes, reproduction and diversion of controlled substance prescriptions; further reductions in medication errors; improved patient care and outcomes — including clinical decision-making at the point of care; enhanced workflow in healthcare settings; and cost savings due to improved patient outcomes.

NACDS’ recommendations for enhancing the rule flow from the fact that pharmacies have been engaged in the effective use of electronic prescribing for quite some time and modifications in the rule are necessary to reflect the advancements that pharmacies have made. NACDS recommends changes to the audit requirements for software applications to make them consistent with pharmacies’ current practices in ensuring the use of the latest technologies, and to prevent duplicative and unproductive audits.

“Pharmacies remain absolutely committed to serving as a part of the solution to opioid abuse and addiction,” NACDS president and CEO, Steve Anderson said. “Considering the significant and substantial benefits of EPCS, further action by the DEA to make electronic prescriptions mandatory is the logical next step in helping to address this ongoing issue, and in improving patient health outcomes in every community.”

While the DEA allows a pharmacy to legally do a electronical transfer a C-II prescription to another pharmacy, if the first pharmacy receiving the electronic Rx from the prescriber doesn’t have stock or the Pharmacist is “not comfortable” filling the Rx.  They cannot print out a valid C-II Rx because to be legal it has to have a signature from the prescriber.   The potential catch here  if the pharmacy can’t/won’t fill the C-II, is that their computer software has not been updated to allow the electronic transfer to another pharmacy and/or a particular state has laws that prohibit such transfers and/or not updated their state laws to conform with national DEA laws.

There is also the possibility that some pharmacists that don’t like to fill controlled meds could tell the pt that there is no way that they can transfer the Rx or give the pt a copy and they are out of stock.

Other electronically sent controlled substance Rxs (C-III thru C-V) and other Rxs for all other Rx only meds can be verbally transferred to another pharmacy, if the first pharmacy can’t/won’t fill the Rx.

COVID-19 drug remdesivir to cost $3,120 for typical patient on private insurance

COVID-19 drug remdesivir to cost $3,120 for typical patient on private insurance

https://www.foxbusiness.com/healthcare/covid-drug-remdesivir-private-insurance

Gilead Sciences Inc. detailed its pricing plans for Covid-19 drug remdesivir, saying it will charge U.S. hospitals $3,120 for a typical patient with commercial insurance.

The drugmaker on Monday disclosed its pricing plans as it prepares to begin charging for the drug in July. The U.S. has been distributing remdesivir donated by Gilead since the drug was authorized for emergency use in May.

Ticker Security Last Change Change %
GILD GILEAD SCIENCES INC. 74.56 -0.01 -0.01%

Under the company’s plans, Gilead will charge a higher price for patients with private insurance in the U.S., and a lower price for U.S. government health programs like Medicare and all other developed countries that insure their patients directly.

The government price will be $390 per dose or $2,340 per patient for the shortest treatment course and $4,290 for a longer treatment course.

Gilead said in the U.S. it will charge nongovernment buyers such as hospitals about $520 per dose, or a third more than the government price, for patients who are commercially insured. That works out to $3,120 for a patient getting the shorter, more common course of treatment, and $5,720 for the longer treatment duration.

The U.S. is the only developed country where Gilead will charge two prices, Gilead Chief Executive Daniel O’Day said in an interview. In other nations, governments negotiate drug prices directly with drugmakers. “The logic is that we wanted a single government price around the developed world,” Mr. O’Day said.

In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the U.S. (Gilead Sciences via AP)

The higher price for U.S. commercially insured patients is because government health programs such as Medicaid typically receive statutorily-defined discounts off the prices companies receive in the private market.

“This medicine is priced far below the value it brings to health-care systems and that’s true for private payers and government payers,” Mr. O’Day said.

On average, the drug should help reduce hospital costs by $12,000 per patient, he said. Gilead estimated the savings based on data showing that each day of hospitalization costs $3,000 and that patients taking remdesivir are discharged four days sooner than those receiving standard treatment, Mr. O’Day said.

Covid-19 patients get two doses of remdesivir by infusion on the first day, and one dose daily afterward. The shortest treatment course is five days, while a longer treatment course takes 10 days.

Currently, 90% to 95% of patients receive five-day treatment courses, Mr. O’Day said.

Remdesivir is the first antiviral drug shown to be effective at treating Covid-19 in a major clinical trial, reducing patients’ recovery times by four days compared with the placebo group in a large study funded by the National Institute of Allergy and Infectious Diseases.

So far, few other drugs have proven in human testing to help coronavirus patients. One drug that recently produced positive results in a clinical trial was the steroid dexamethasone.

The drug, which treats Covid-19 by a different mechanism than remdesivir, has been on the U.S. market for decades to treat other diseases. It hasn’t been authorized in the U.S. to treat Covid-19, but doctors are allowed to prescribe it “off-label” under U.S. regulations.

Given its unique status, remdesivir’s pricing has been widely anticipated–and hotly debated–among doctors, health insurers and investors. It could serve as the starting point for other drugs that eventually prove to safely treat coronavirus patients.

The Institute for Clinical and Economic Review, a nonprofit group that analyzes pharmaceutical prices, said last week that a cost-effective price for remdesivir would be $2,520 to $2,800 per patient if dexamethasone becomes a standard medication for Covid-19.

Without dexamethasone, a cheap generic medication, remdesivir would be cost-effective at a range of $4,580 to $5,080 a patient, ICER said.

The U.S. Food and Drug Administration on May 1 authorized emergency use of remdesivir through the course of the pandemic. Gilead plans to seek a full, permanent approval.

In July, Gilead will start charging for the drug, but federal and state officials will continue deciding which hospitals receive it. In September, Gilead expects to have enough supply to meet demand and will distribute the drug in the same way it distributes other medicines.

One issue that has already factored into debate over what remdesivir should cost is the U.S. government’s role in funding its development.

The NIAID funded the study that showed it sped the recovery of hospitalized Covid-19 patients, and expects to spend at least $30 million on the study through the end of the fiscal year, an NIAID spokesman said in February.

Gilead has also invested in researching remdesivir. The company previously developed the drug to treat Ebola patients, but it didn’t work as well as other drugs. Gilead and other researchers explored remdesivir’s Covid-19 use after the virus emerged.

Gilead has said it spent about $50 million on research and development related to the drug in the first quarter, or about 4.5% of its total R&D spend. Through the end of 2020, Gilead expects to spend more than $1 billion on developing and manufacturing remdesivir, Mr. O’Day said.

Some generic drugmakers have said they plan to charge less than $1,000 per treatment course in India and Bangladesh, where Gilead has licensed rights to sell the drug. ICER estimates that the raw materials needed to make remdesivir cost about $10 per patient for a 10-day treatment course, citing a recent academic paper

Write to Joseph Walker at joseph.walker@wsj.com

Here is another EPIDEMIC… chain pharmacists… JUST SAYING NO to filling controlled Rxs

Sir I’ve been trying To get my prescription  filled,, but the pharmacy keeps turning it down  C V S, Walgreens,  and Walmart.. I’m a amputee with Fandom  pain and constant burning, plus on  Dialysis 3 times a week.. I’ve been on my pain killers for over 5 years and now they don’t want to give them to me. What options do I have.  please  Help me

Are we drifting back to the “Reagan years” ? Maybe the spirit of Nancy Reagan is haunting many that have a pharmacy/pharmacist license.  This woman is from Texas and I wonder why people keep going back to chain stores ? Do they like to be abused and intimidated ?

Once again here is website that will help “abused chain pts” to find a independent pharmacy  https://ncpa.org/pharmacy-locator

A recent study found steroid injections for a common condition could be causing more harm than good

 

some chain pharmacy generating business by making sick employees to keep on working ?

Hello there, I’m reaching out to you because I feel that there is seriously something wrong with Walgreens right now. I wish to remain anonymous please.

I’m in the DFW area and as you may already know, Texas has had a huge surge of COVID-19 cases. Saturday night, I had 3 of my techs coming down with symptoms. I asked Walgreens what to do? “Go see their primary care doctor and pharmacy stays open.” Is there a way to get them fast tracked for testing? “They need to see their primary care doctor first.” With how my tech’s symptoms are and THREE of down coming down with the same symptoms at the same time, I am positive that it is COVID19 yet Walgreens has refused to do anything. No doctors are going to be open on the weekend for such late notice COVID testing. Walgreens will not close the pharmacy, they will not do a deep cleaning, they do not allow us that extra time to clean before and after closing. I’m so tight on hours that if I have my techs stay after closing to clean, I would be over my budget. I’m really damned if I do damned if I don’t. I had to advise my other techs to make an appointment at CVS to get themselves tested for COVID because it takes 2-3 days to make an appointment. Isn’t that sad? As Walgreens employees we have to go to CVS to get tested. My worst fear is, there is a technician at another store who tested positive, that Walgreens still is operating like normal. Nothing was done. Walgreens does not care about its customers nor their employees by pretending that there’s nothing wrong when there is a positive COVID case. I feel like we need to call out this behavior because it really is detrimental to our community as a whole. Who knows how many other Walgreens is doing this?

The Rapp Report – Dr Thomas Kline

https://therappreportpodcast.podbean.com/e/e12-interview-with-dr-thomas-kline-md

In this episode, we interview Thomas Kline, MD.

Dr. Kline lives in Raleigh, in the Great State of North Carolina. He not only treats patients suffering with chronic pain, but also advocates for them. Many of whom rely on opioid analgesics to survive. 

He has more than 40 years experience with long-term diseases, and has a very distinguished resume, including as the former Chief of Hospital in Home Service at Harvard Medical, a physician at Boston Children’s Hospital, his MD from The University of Maryland, completed his residency at the distinguished Stanford University, and he also has a PhD from The University of Oregon.

Dr. Kline has also authored several publications, been quoted in various medical articles, has been a guest on the Roy Green Radio Show, and is featured in a number of YouTube videos. 

These can be found at https://thomasklinemd.com/

He is also on JATH Educational Consortium at https://www.jatheducational.com/

Opioids in America: Misconceptions and Misperceptions https://www.youtube.com/watch?v=qJZOqbbro-8

Any questions for Dr. Kline? You can reach him via email at thomasklinemd@gmail.com

 

FDA names five companies recalling NDMA-contaminated metformin

FDA names five companies recalling NDMA-contaminated metformin

https://www.raps.org/news-and-articles/news-articles/2020/6/fda-names-five-companies-recalling-ndma-contaminat

The US Food and Drug Administration (FDA) announced on Thursday that five companies have now voluntarily recalled extended-release metformin drugs because of elevated levels of N-nitrosodimethylamine (NDMA), a potential carcinogen.

The five companies who were notified of the agency’s testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are:

  • Apotex – all lots
  • Amneal – all lots
  • Marksans, branded as Time-Cap – one lot (XP9004)
  • Lupin – one lot (G901203)
  • Teva, branded as Actavis – 14 lots

There are additional companies that manufacture ER metformin and supply a significant portion of the US market, whose products are not being recalled at this time,” said FDA. Immediate release metformin formulations have not contained NDMA in the FDA’s testing thus far. The substance is ingested in low levels through normal dietary pathways but can raise the risk of cancer with long-term elevated exposure.

(RELATED: FDA recalls some ER metformin for NDMA impurity, Regulatory Focus 29 May 2020)

The agency has now posted updated results of its NDMA testing in a sortable tabular format that includes all companies whose product has been tested, which formulations and lots were tested, and what levels, if any, of NDMA were found.

A second testing method using liquid chromatography-electrospray ionization-high resolution mass spectrometry has been posted by the FDA “to provide an option for regulators and industry to detect eight different nitrosamine impurities in metformin drug substances and drug products,” said the agency.

Companies manufacturing ER metformin should evaluate the risk that it contains NDMA at elevated levels. Companies should conduct per-batch testing, notify the FDA of any test results showing NDMA above the acceptable intake limit, and not release that batch to the US market.

EVERY AMERICAN SHOULD SEE THIS VIDEO. IT SUMS UP BEAUTIFULLY HOW CORRUPT OUR CONGRESS IS!

Which agency is the least efficient .. DEA or IRS ?

IRS spent millions on audits that returned no revenue, report finds

https://www.foxbusiness.com/personal-finance/irs-spent-millions-on-audits-that-returned-no-revenue-report-finds

About half of large business returns audited were closed without change

The IRS is wasting time paying employees to audit returns that generate no additional revenue for the agency, a watchdog report released Thursday found.

Of the 10,755 returns that were analyzed – and closed – during fiscal years 2015 through 2018, a report by the Treasury Inspector General for Tax Administration found that 47.2 percent were closed with no change to the return. The agency estimated that – accounting for the costs of examining the returns – about $22.7 million was spent on these returns, which generated no additional revenue for the government.

These returns were examined in the IRS’ large business and international audit group, which is responsible for the tax administration of domestic and foreign businesses with assets exceeding $10 million.

Among these businesses with assets over $10 million, the no-change rate of returns examined ranged from 44 percent to 66 percent across all total asset amount ranges. Theoretically, there should be a lower no-change rate for categories of businesses and individuals with a higher risk of noncompliance, which TIGTA largely did not observe from the data.

The division’s closure rate was also 37 percent lower in fiscal 2018 when compared with fiscal 2015, according to the report, which was attributed to a decline in employees.

TIGTA suggested the division could better allocate its time and resources, spending less time on “no-change work.” It also said that due to the evolving nature of the business environment – including the implementation of the Tax Cuts and Jobs Act and an expanded use of virtual currency – the group needs to update its formula to better identify companies that are at higher risk of noncompliance.

In a response to the report, the IRS said it did not agree with the watchdog group’s monetary estimates based on the hours it assumed workers spent on no-change work. It also did not agree with some of the recommended policy changes.

The IRS estimates the average annual gross tax gap for tax years 2011 through 2013 is $411 billion, with the largest percentage stemming from under reporting