CVS asked us to fill out a “safety” survey and how well our teams adhered to policies and procedures for safe practices… Then they left a comment space at the end, which I dutifully filled in.

This is a CVS pharmacist’s response to the corporation’s how Rx dept staff are:

how well our teams adhered to policies and procedures for safe practices

This is just one of their pharmacist’s opinion but from what I have heard others share to a major degree the same feelings and you as a pt… are you putting your health/safety at risk by having your prescriptions filled there ?

Here is a link to help you find a independent pharmacy – by zip code – where you will be dealing with the pharmacist/owner

http://www.ncpanet.org/home/find-your-local-pharmacy

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Bayer, J&J settle thousands of US Xarelto lawsuits for $775 million

https://www.mdlinx.com/pharmacy/top-medical-news/article/2019/03/26/7561883/

Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 US lawsuits alleging that their blockbuster blood thinner Xarelto (rivaroxaban) caused unstoppable and in some cases fatal bleeding for a total of $775 million, court documents on Monday showed.

The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement.

The settlement will resolve all pending US lawsuits over rivaroxaban, which plaintiffs claimed caused uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of patients. Plaintiffs accused the drugmakers of having failed to warn about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.

Bayer in a statement on Monday said it continues to believe the claims are without merit. “However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,” the company said. Lawsuits over rivaroxaban began piling up in 2014, and the companies had so far won all six trials over rivaroxaban’s alleged bleeding risk.

J&J in a statement said it continued to believe in the safety of rivaroxaban but that the settlement was the right thing to do for patients and their doctors.

Rivaroxaban is Bayer’s best-selling drug. It contributed 3.6 billion euros ($4.07 billion) in revenue to the German group’s pharmaceutical business last year. Bayer said its share of the settlement amount will be partially offset by product liability insurance.

Bayer jointly developed rivaroxaban with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States. J&J reported 2018 rivaroxaban sales of $2.47 billion.

The US Food and Drug Administration approved rivaroxaban in 2011. It is prescribed for people with atrial fibrillation, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolism. The companies in the past have said rivaroxaban’s warning label provides “complete, accurate, and science-based information on the medicine’s benefits and risks.”

The majority of the claims were consolidated in New Orleans federal court, where three cases were selected as so-called bellwether trials, aimed to help determine the range of damages and define settlement options. The companies won those three trials throughout 2017. J&J and Bayer were also cleared of liability in three other state court trials in 2018.

Rivaroxaban is among a class of oral blood thinners, including Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), that are alternatives to decades-old warfarin. Most of the lawsuits over apixaban have been dismissed by US judges.

A similar drug, Boehringer Ingelheim’s Pradaxa (dabigatran), also became the subject of thousands of lawsuits claiming the company understated its bleeding risk. Boehringer in 2014 reached a $650 million settlement to resolve more than 4,000 of those cases.

Why did these companies agree to make these settlements ??.. because in MY PROFESSIONAL OPINION – they are dangerous…  A number of years ago, Barb had A-Fib and her then cardiologist wanted to discharge her from the hospital on one of these “new oral anticoagulants” that – at the time – had no way to reverse of a pt started bleeding… I reluctant to allow her to be discharged on the one that could at least be reversed with dialysis  – on top of that  – the particular med he wanted her on has a LEVEL ONE DRUG INTERACTION with one or more of her other meds – LEVEL ONE is DO NOT GO THERE.

Once I got her into the PCP… I got her switched to Warfarin… our PCP really kinda of defended using these new meds but he caved to my persistence. Thru a medical procedure, Barb was able to get her A-Fib correct and no longer on Warfarin…

A few years later, I showed up with some clots and had to go on a blood thinner and our PCP – either remembered me be “hard-headed” about using Warfarin  – or he had seen the problems with these new blood thinners and never discussed me being on anything but Warfarin.  A Warfarin bleed can be quickly reversed with Vit K and while there is a new reversal agent for these blood thinners… the studies I have seen suggests that it works so slow that 17% of the pt will still BLEED OUT !

I can do home testing with a meter http://www.coaguchek.com/coaguchek_patient/landing and with Medicare and a Supplement… the cost is paid 100% and it takes maybe a total of 5 minutes to do the test

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For those who are skeptical about how important the $$$ collected by the FEDS using CIVIL ASSET FORFEITURE ACT…  here is a list from SEVEN DIFFERENT FEDERAL AGENCIES and the lists of property that was seized/confiscated by the FEDS

https://www.forfeiture.gov/

https://www.forfeiture.gov/pdf/ATF/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/DEA/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/FBI/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USAO/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/CBP/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USPS/OfficialNotification.pdf
https://www.forfeiture.gov/pdf/USSS/OfficialNotification.pdf

Does it remind you of the WILD WILD WEST ?

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https://www.washingtonpost.com/national/health-science/purdue-pharma-state-of-oklahoma-reach-settlement-in-landmark-opioid-lawsuit/2019/03/26/69aa5cda-4f11-11e9-a3f7-78b7525a8d5f_story.html

Purdue Pharma and the state of Oklahoma have agreed to settle a lawsuit over the drugmaker’s role in the deadly opioid crisis, a milestone in the legal effort to force pharmaceutical companies to pay some of the costs of the epidemic, people familiar with the matter said.

The deal, which is scheduled to be announced at a news conference Tuesday, will require Purdue and the family that owns the company to pay approximately $270 million. Most of the money will fund a new center for research, education and treatment of addiction and pain at Oklahoma State University in Tulsa.

Oklahoma is free to continue its lawsuit against two other defendants and their subsidiaries — Johnson & Johnson, the 37th-largest company in the United States, and Teva Pharmaceutical Industries, an Israel-based manufacturer that focuses mainly on generic drugs. The two companies, which have asked to be tried separately from Purdue, are slated to go to trial on May 28.

Lawyers in the case and a spokesman for Purdue declined to comment ahead of the planned announcement Tuesday.

[Oklahoma could provide first test of who will pay for the opioid crisis — and how much]

Oklahoma contends that Purdue, Johnson & Johnson and Teva bear some responsibility for thousands of opioid deaths across the state, in addition to the health care, law enforcement and treatment costs of the state’s addiction crisis. Purdue and others face similar claims in several other courts, and the first major settlement in the flood of lawsuits could help set the bar for compensation sought by hundreds of states, cities, counties and Native American tribes for the costs incurred in responding to the epidemic.

About 1,600 of those cases are consolidated in one enormous case — known as multidistrict litigation — before a federal judge in Cleveland. That action targets companies that manufactured, distributed and dispensed narcotic painkillers across the country, and those cities, towns and tribes are seeking damages in what some believe is the most complex litigation in U.S. history.

Thirty-six states have chosen to bring separate lawsuits in their own court systems, believing they have better chances there.

Purdue’s recent acknowledgment that it is considering bankruptcy as an option could influence strategy in those lawsuits; Oklahoma’s settlement ensures it will receive at least some compensation for its claims.

[Purdue Pharma CEO says bankruptcy is ‘an option’ as company faces opioid lawsuits]

Under the terms of the settlement, Purdue will contribute $102.5 million to establish the new addiction center. Members of the Sackler family, who own the company but were not defendants in the case, will pay another $75 million in personal funds over five years, people familiar with the agreement said. Purdue also will provide $20 million worth of treatment drugs, will pay $12 million to cities and towns, and will cover about $60 million in pay to private attorneys from two law firms that have represented Oklahoma in the case.

The addiction center would be housed at Oklahoma State University’s Center for Wellness and Recovery and would be overseen by an independent board.

Nearly 400,000 people in the United States died of opioid overdoses between 1999 and 2017, according to the Centers for Disease Control and Prevention, including a record 47,600 in 2017. Purdue is widely blamed for helping to start the epidemic after it introduced the powerful opioid OxyContin to the market in 1996. The company allegedly persuaded doctors to prescribe — and overprescribe — the drug for a wide variety of ailments. In 2007, Purdue and three of its executives pleaded guilty to misconduct in their marketing of OxyContin and paid more $600 million in fines.

Authorities have argued that Purdue used deceptive marketing tactics and a sizable workforce of representatives to repeatedly visit physicians to sell them narcotics, assuring them that the drugs were rarely addictive. Many patients became addicted to the potent painkillers, and large amounts of the drug were diverted to the black market.

More than 2 million Americans now suffer from an opioid use disorder, according to government data. The epidemic has evolved to encompass illicit use of fentanyl, a synthetic ultrapowerful opioid that has caused a spike in overdoses and fatalities.

[The fentanyl failure: Obama administration did not take extraordinary measures to confront extraordinary crisis]

Three years ago, the CDC estimated the cost of the opioid epidemic at $78.5 billion for calendar year 2013. In 2017, the White House Council of Economic Advisers placed the price tag much higher, at $504 billion for 2015.

A consultant’s report that Oklahoma filed in court estimated that abating the opioid crisis in that state would cost more than $8.7 billion during the next 20 years.

Oklahoma Attorney General Mike Hunter sued the three drug companies in June 2017, and the two sides have been taking depositions and jousting over pretrial issues for nearly two years. As other cases lagged, Oklahoma judge Thad H. Balkman set a May 28 trial date, agreed to televise the proceedings live and refused drug company requests to postpone the trial. That ensured that the Oklahoma case would be the first major test of whether the companies would be forced to pay for the crisis.

According to a lawsuit filed by the state of Massachusetts, Sackler family members received nearly $4.3 billion in payouts from Purdue between 2008 and 2016. But the family-owned company has suffered heavy blows to its image in recent months as litigation has advanced. Three museums in Britain and the United States have turned down donations from the Sacklers, longtime patrons of the arts, in recent days.

And documents released in the Massachusetts lawsuit, brought by state Attorney General Maura Healey, depicted some of the Sacklers as insatiably greedy and uncaring about the human toll of their product.

“Millions of dollars were not enough. They wanted billions,” the lawsuit charges. “They cared more about money than about patients, or their employees, or the truth.”

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It’s OFFICIAL the VA has now fully tapered my dad. His last RX is coming and that’s the end. Their intentions were all along to kill my father, even after the family begging them not to take away his pain medication. It was the VA who put my father on the pain program now they are taking away their promise to treat him.
I hold the VA and the #opioidhysteria responsible for the extreme suffering my father is going through. I will be outside the VA center everyday in protest and will shame this facility for the entire Pensacola area to see!!!!!

Another Vet left being tortured by the VA & the govt that promised to take care of him.
Please speak up and share this post, this has to end. I’m sure this woman would appreciate some help in protesting outside the VA in Pensacola as well, if anyone is in the area, contact her or stop by & show some support for those being harmed by #opioidhysteria and the false narrative being perpetuated by Andrew Kolodny, his cohorts at PROP, their PR team and the CDC & DEA who is their own personal terrorist army.
Please join the special class action lawsuit against the govt and help stop the torture! Visit www.sickofsuffering.com for more info!

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A Federal Court Says Your Prescription Records Aren’t Really Private. The Supreme Court Might Have Something to Say About That.

https://www.aclu.org/blog/privacy-technology/location-tracking/federal-court-says-your-prescription-records-arent-really

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https://www.watchdog.org/minnesota/opioid-bill-ignores-real-problem-creates-host-of-new-ones/article_6f73481c-4c18-11e9-bc8c-9b551bb84e55.html

A Minnesota bill seeking to establish an Opioid Stewardship Fund doesn’t address the root cause of the opioid crisis – the illegal sale of narcotics – and will only increase costs to taxpayers, insurance companies and their customers, critics argue. And while well-intentioned, it potentially could drive pharmaceutical companies out of the state, they say.

The bill, HF 400, passed the state House by a vote of 94-34 and awaits action in the Senate. If passed into law, it would create an opioid stewardship fund, an opiate product registration fee, and modify provisions related to opioid addiction prevention, education, intervention, treatment and recovery.

Rep. Tony Albright, Assistant Minority Leader, who voted against the bill, has proposed several alternatives over the years, including better access to treatment and prevention resources.

The fund’s revenue would come from fees on manufacturers and wholesalers of opioid medication. Board members of the Opioid Stewardship Fund would determine fees based on its $20 million annual budget.

But imposing arbitrary fees on pharmaceutical distributors will only increase costs for everyone and do nothing to address the opioid crisis, Grover Norquist, president of Americans for Tax Reform, argues.

HF 400 “could even make the opioid crisis worse,” Norquist says. “The legislation would impose a harmful new tax that would hurt patients in need of medicine by driving up costs directly and causing supply problems that would further hike costs and create access issues.”

Action 4 Liberty, an advocacy group that opposes the bill, argues “government should not get involved in the decision-making of prescribing pain medication from medical professionals.”

The bill dictates how much opioid pain medication a doctor can prescribe to patients who’ve had surgery or undergone a major trauma. It states, “when used for the treatment of acute pain associated with a major trauma or surgical procedure, initial prescriptions for opiate or narcotic pain relievers listed in Schedules II through IV of section 152.02 shall not exceed a seven-day supply.”

The bill also adds mandated acupuncture coverage to Minnesota health insurance plans: “health plans must cover acupuncture services for the treatment of pain and ongoing pain management.”

The new regulations are misplaced and overly burdensome, the Washington, D.C.-based advocacy organization, Citizens Against Government Waste (CAGW), argues.

“Because the opioid crisis is primarily driven by illegal narcotics like fentanyl and heroin, it would be prudent for legislators to focus their efforts on preventing those drugs from being trafficked, instead of placing further regulations and taxes on the legal pharmaceuticals that Americans use every day,” Elizabeth Wright, CAGW’s director of health policy, said.

According to a study published this month by economics professors at Union University in New York, any costs to comply will be passed on to taxpayers. When evaluating a similar opioid tax proposed in New York, the researchers found that “the proposed tax will encourage residents suffering from opioid dependence to switch to cheaper illegal opioids, including heroin and fentanyl, with increased rates of accidental overdose.”

The opioid tax would drive up prices for consumers and insurers, the researchers found, and not actually address the drug-addiction crisis.

None of these initiatives address the root of the opioid problem, critics argue.

Approximately 26,000 people died nationwide from fentanyl sold on the black market originating from China and Mexican cartels in 2017, according to a Bloomberg News report. According to Centers for Disease Control (CDC) data, the sale of illicit fentanyl poses the greatest risk in the opioid crisis.

Critics point out that because the tax demands an arbitrary amount of fees, once one fee-paying pharmaceutical company leaves the state, the rest will end up paying more, and then also might consider leaving. Suppliers would then leave the state, opponents of the bill fear, creating another crisis altogether – less access to medication.

“Taxpayers should make their voices heard and demand that policies related to the opioid epidemic are focused on the cause of the crisis, not on a political scapegoat,” Wright added.

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http://www.mywhatever.com/cifwriter/library/eperc/fastfact/ff63.html

Title: Fast Fact and Concept #63: The legal liability of undertreatment of pain

Author(s): Warm, Eric; Weissman, David E

It is well recognized that physician’s fear of fear of regulatory scrutiny (DEA, state medical boards), is a major contributor to the problem of under treatment of pain. A recent landmark lawsuit should be a wake-up call for all physicians that this type of practice poses its own legal liability. An 85-year-old California man with metastatic lung carcinoma spent the final week of his life in severe pain. Three years after his death his children sued his doctor alleging that the physician had failed to prescribe drugs powerful enough to relieve their father’s suffering. This was one of the first U.S. cases in which a doctor has gone on trial for allegedly under-treating a patient’s pain. By a 9 to 3 vote the jury decided that the physician’s lack of attention to pain constituted elder abuse, awarding the family $1.5 million (the amount was reduced to $250,000). To win, lawyers convinced the jury that under-treatment of pain was “reckless negligence”. Until recently, lawyers would have considered such a suit un-winnable. Given politically savvy aging baby boomers, as well as the preponderance of sound scientific evidence for the proper assessment and treatment of pain, we can probably expect more such verdicts. Here are some tips for how physicians can better protect themselves from charges of under-treatment of pain?

• Review your own practice–are you currently meeting JCAHO standards? Find out at: http://www.jcaho.org and AHQR (a.k.a. AHCPR) http://www.ahrq.gov/clinic/cpgarchv.htm pain guidelines?
• Improve your knowledge and skills in pain assessment and treatment. (Some states, such as California, now require mandatory pain CME).
• Learn about and utilize your local consultation resources for pain management.
• Improve your knowledge and skills in assessing substance abuse disorders; learn about and utilize your local resources for substance abuse referrals and treatment.
• Improve your understanding of the drug regulatory system and how it functions- learn about the common triggers for regulatory review . Go to: http://www.medsch.wisc.edu/painpolicy/ for information about federal and state regulatory laws and regulations.
• Become active in your hospital pain improvement efforts-check with your hospital QI department and their efforts to meet the new JCAHO pain guidelines.
• Become active with your state Cancer Pain Initiative; go to http://www.aacpi.org/ to find information about your state activities.

Ideally physicians should not use the fear of lawsuits to help guide medical care, but evidence shows that they do. In a way, this attention on improved pain management may become a silver lining in the black cloud of our litigious society.

References

Stieg RL, et al: Roadblocks to effective pain treatment. Med Clin N Amer, 1999;83(3): 809-821.

Okie, S. Doctor’s Duty to Ease Pain At Issue in Calif. Lawsuit. Washington Post.May 7, 2001; Page A03

Crane M, Treating pain: damned if you don’t? Med Economics, Nov 19, 2001, pp 67-69.

Weissman DE, Doctors, Opioids and the law: The Effect of Drug Regulations on Cancer Pain Management. Semin Oncol 20(Suppl A): 53-58, 1993.

Gilson AM, Joranson DE. Controlled substances and pain management: Changes in knowledge and attitudes of state medical regulators. Journal of Pain and Symptom Management. 2001;21(3):227-237.

Joranson DE, Maurer MA, Gilson AM, Ryan KM, Nischik JA. Annual review of state pain policies, 2000. Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center. Madison, Wisconsin; February 2001.

Jacox A, Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guideline No. 9 AHCPR Publication No. 94-0592, Rockville, MD. Agency for Health Care Policy and Research, U.S. Department of Health and Human Services, Public Health Service, 1994.

Acute Pain Management Guideline Panel. Acute pain management: Operative or Medical Procedures and Trauma Clinical Practice Guideline. AHCPR Publication No. 92-0032. Rockville, MD. Agency for Health Care Policy and Research, US Department of Health and Human Services, Public Health Service, 1992.

Copyright and Referencing Information: Users are free to download and distribute Fast Facts for educational purposes only. Citation for referencing. Fast Facts and Concepts #63 The legal liability of undertreatment of pain. Warm E and Weissman DE. March, 2002. End-of-Life Physician Education Resource Center www.eperc.mcw.edu.

Fast Facts and Concepts was originally developed as an end-of-life teaching tool by Eric Warm, MD, U. Cincinnati, Department of Medicine. See: Warm, E. Improving EOL care–internal medicine curriculum project. J Pall Med 1999; 2: 339-340.

Disclaimer: Fast Facts provide educational information, this information is not medical advice. Health care providers should exercise their own independent clinical judgment. Some Fast Fact information cites the use of a product in dosage, for an indication, or in a manner other than that recommended in the product labeling. Accordingly, the official prescribing information should be consulted before any such product is used.

Creation Date: 3/2002

Format: Handouts

Purpose: Instructional Aid, Self-Study Guide, Teaching

Audience(s)

ACGME Competencies: Medical Knowledge

Keyword(s): Addiction, Chronic non-malignant pain, Controlled substance regulations, Pain, Pain assessment, Pain treatment

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Association of Tramadol With All-Cause Mortality Among Patients With Osteoarthritis

https://jamanetwork.com/journals/jama/article-abstract/2727448

Question  Is tramadol prescription associated with a higher risk of all-cause mortality than other pain relief medications among patients with osteoarthritis?

Findings  In this cohort study that included 88 902 patients with osteoarthritis, initial prescription of tramadol was associated with a significantly increased risk of mortality over 1 year compared with initial prescription of naproxen (hazard ratio [HR], 1.71), diclofenac (HR, 1.88), celecoxib (HR, 1.70), and etoricoxib (HR, 2.04), but not compared with codeine (HR, 0.94).

Meaning  Tramadol prescription may be associated with increased all-cause mortality compared with commonly prescribed nonsteroidal anti-inflammatory drugs, but further research is needed to determine if this relationship is causal.

Importance  An American Academy of Orthopaedic Surgeons guideline recommends tramadol for patients with knee osteoarthritis, and an American College of Rheumatology guideline conditionally recommends tramadol as first-line therapy for patients with knee osteoarthritis, along with nonsteroidal anti-inflammatory drugs.

Objective  To examine the association of tramadol prescription with all-cause mortality among patients with osteoarthritis.

Design, Setting, and Participants  Sequential, propensity score–matched cohort study at a general practice in the United Kingdom. Individuals aged at least 50 years with a diagnosis of osteoarthritis in the Health Improvement Network database from January 2000 to December 2015, with follow-up to December 2016.

Exposures  Initial prescription of tramadol (n = 44 451), naproxen (n = 12 397), diclofenac (n = 6512), celecoxib (n = 5674), etoricoxib (n = 2946), or codeine (n = 16 922).

Main Outcomes and Measures  All-cause mortality within 1 year after initial tramadol prescription, compared with 5 other pain relief medications.

Results  After propensity score matching, 88 902 patients were included (mean [SD] age, 70.1 [9.5] years; 61.2% were women). During the 1-year follow-up, 278 deaths (23.5/1000 person-years) occurred in the tramadol cohort and 164 (13.8/1000 person-years) occurred in the naproxen cohort (rate difference, 9.7 deaths/1000 person-years [95% CI, 6.3-13.2]; hazard ratio [HR], 1.71 [95% CI, 1.41-2.07]), and mortality was higher for tramadol compared with diclofenac (36.2/1000 vs 19.2/1000 person-years; HR, 1.88 [95% CI, 1.51-2.35]). Tramadol was also associated with a higher all-cause mortality rate compared with celecoxib (31.2/1000 vs 18.4/1000 person-years; HR, 1.70 [95% CI, 1.33-2.17]) and etoricoxib (25.7/1000 vs 12.8/1000 person-years; HR, 2.04 [95% CI, 1.37-3.03]). No statistically significant difference in all-cause mortality was observed between tramadol and codeine (32.2/1000 vs 34.6/1000 person-years; HR, 0.94 [95% CI, 0.83-1.05]).

Conclusions and Relevance  Among patients aged 50 years and older with osteoarthritis, initial prescription of tramadol was associated with a significantly higher rate of mortality over 1 year of follow-up compared with commonly prescribed nonsteroidal anti-inflammatory drugs, but not compared with codeine. However, these findings may be susceptible to confounding by indication, and further research is needed to determine if this association is causal.

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