Cancer patients should be treated by their doctors, not pharmacy benefit managers

Cancer patients should be treated by their doctors, not pharmacy benefit managers

http://https://www.statnews.com/2019/05/09/pharmacy-benefit-managers-cancer-treatment

When I must tell a patient that she or he has cancer, that diagnosis comes with the explicit promise that I will provide timely treatment, including medicines aimed at curing cancer or extending life as long as possible.

But an insidious interloper now often comes between me and my patients. I’m talking about pharmacy benefit managers (PBMs), the middlemen that have introduced a bureaucratic and nightmarish system of delays and denials into filling prescriptions.

I’m not alone.

An oncologist in Florida determined that her patient with metastatic kidney cancer needed to start taking a standard, first-line oral medication. But the patient’s pharmacy benefit manager decided it knew better and refused to authorize the medication unless a surgeon first performed surgery to remove a tumor on the patient’s kidney — despite the fact that the patient’s surgeon had already determined that the procedure was too risky and the patient wasn’t a candidate for surgery, something the surgeon had previously told the PBM.

For three months, the patient’s oncologist and surgeon appealed the pharmacy benefit manager’s denial so the patient could receive the treatment he desperately needed. Although the PBM ultimately relented, the patient will never get those three months back. For anyone battling cancer, delaying treatment and allowing the disease to progress by even a week can mean the difference between life and death.

There’s the story of a young mother in Tennessee who was beating the odds against stage 4 pancreatic cancer but was left with a dangerously suppressed immune system. She was forced to delay critical treatment because the medicine she needed was on backorder at her pharmacy benefit manager’s mail-order pharmacy and the company wouldn’t pay for her to get it from her doctor’s office.

Working with cancer care providers across the country, the Community Oncology Alliance has compiled hundreds of these horror stories. They demonstrate time and again how pharmacy benefit managers come between patients and their doctors, with little regard for the pain and suffering they inflict.

Pharmacy benefit managers were supposed to help bring down the cost of drugs by negotiating with competing drug companies and by “encouraging consumers to use the most cost-effective drugs.” But they have done the opposite, fueling higher drug prices through manufacturer rebates and by extorting fees from pharmacy providers.

Those rebates and fees were the focus of a Senate Finance Committee hearing featuring top executives of five pharmacy benefit managers last month. The chair of the committee, Iowa Republican Chuck Grassley, noted that “the current system is so opaque that it’s easy to see why there are many questions about PBMs’ motives and practices.”

For health care professionals on the front lines of delivering timely care to people with cancer, there is no debate about the need for transparency: Pharmacy benefit managers are a roadblock to potentially lifesaving cancer care. For many of our patients, the groundbreaking cancer drugs they see in headlines are often out of reach because of PBM practices that restrict or delay access. While they won’t admit it, there is no doubt that every dollar a pharmacy benefit manager saves by stopping or redirecting a prescription means more upside for their profits.

The pharmacy benefit manager business model is built on a lucrative and shadowy network of drug manufacturer rebates and pharmacy fees squeezed from every level of the health care system. Congress is right to look into these rebates and fees to better understand exactly what roles pharmacy benefit managers play in the complex economics of drug prices.

A veneer of governmental indifference seems to be helping pharmacy benefit managers protect their egregious profits. But the system isn’t working for patients with cancer or the millions of other Americans who struggle to overcome red tape to get the medications they need.

Americans deserve better from our health care system and we should be able to count on our elected officials to support affordable, convenient, cutting-edge, patient-centered care. This includes access to the cancer therapies they need, when and where they need them.

The White House, members of Congress, policymakers, and the American public should ask themselves this important question: If your mom was facing breast cancer or your son had brain cancer, do you want a pharmacy benefit manager determining their care, or their doctor?

Jeff Vacirca, M.D., is CEO of New York Cancer and Blood Specialists and the immediate past president of the Community Oncology Alliance. The author reports being medical director of ION Solutions and on the board of directors of OneOncology, Odonate, and Spectrum Pharmaceuticals.

 

Georgia: Gov Brian Kemp signed two PBM anti-steering bills into law yesterday

In a huge victory for patients and pharmacists, Georgia governor Brian Kemp signed two PBM anti-steering bills into law yesterday. HB 233 is a bill that prohibits pharmacies from profiting off of prescriptions “steered” from their PBM and insurance affiliates, and HB 323 restricts PBM and insurer patient “steering,” strengthens anti-mandatory mail order, adds additional audit protections, prohibits PBMs from knowingly misleading patients, and restricts mining of patient data. These bills are the first in the nation of their kind to become law. Congratulations to the Georgia Pharmacy Association and all the Georgia pharmacists who worked hard to get these bills passed.

As seen on the web 05.08.2019

https://www.facebook.com/jenningssheriff/photos/a.2135502443167571/2312972582087222/?type=3&theater

Corporate pharmacy practicing medicine without a license ?

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

 

asked to share

FDA is on our side   they need to to have a better head count and understand this is millions not thousands  as a recent paper reported

also they need to know other drugs are being abruptly tapered

maybe you could spread the word?

i think this would work:

info@fda.gov  as a portal

brief messages:

  1. name, state, phone number (so they can verify)  I trust them
  2. pick one disease
  3. was tapered off without consent when    list all meds   tapered

one paragraph  mainly want then to count the replies and list the other drugs being tapered

 ideas for other groups to contact?

what do you thinks

Final Thoughts: Democrats Delete God

Great-grandmother with CBD oil arrested at Disney World

Great-grandmother with CBD oil arrested at Disney World

https://www.foxnews.com/travel/grandmother-cbd-arrested-disney-world

Disney World may be the most magical place on Earth, but it turned into a legal nightmare for a great-grandmother with arthritis.

A 69-year-old woman was arrested at a Disney World checkpoint when an Orange County DeputyImage result for Mickey Mouse Policeman found CBD oil in her purse. She then spent 12 hours behind bars before being released on a $2,000 bond.

Hester Jordan Burkhalter, a great-grandmother from North Carolina, began using CBD oil for her arthritis after her doctor recommended it, Fox 35 in Orlando reported. She even had a note from the medical professional in her purse at the time of arrest, but it didn’t matter.

Burkhalter told Fox 35 that she had been planning on the trip for two years. “I have really bad arthritis in my legs, in my arms and in my shoulder,” she said. “I use (CBD oil) for the pain because it helps.” When she was stopped by security outside of the Magic Kingdom, however, she was arrested. “I’ve never had one speeding ticket in my life.”

Despite the fact that it’s sold on store shelves across the state, CBD oil is still technically illegal in the state of Florida (unless the user has a prescription). This has created a confusing situation in the Sunshine State.

Jennifer Synnamon, a Florida attorney, told Fox 35, “a little drop of oil, with the CBD, is a felony. Meanwhile, you can have up to 19.9 grams of leaf-marijuana, and it’s a first-degree misdemeanor.”

While the Orange County Sheriff’s Office told Fox 35 that their deputy was just following the law, the charges against Burkhalter eventually dropped.

Amid opioid epidemic, report finds more doctors stealing prescriptions

Amid opioid epidemic, report finds more doctors stealing prescriptions

https://www.cbsnews.com/news/amid-opioid-epidemic-report-finds-more-doctors-stealing-prescriptions/

When Lauren Lollini went to the hospital for kidney surgery in 2009, she was shocked when she left with hepatitis C and a liver infection.

“My life dramatically changed because now I am a 40-year-old woman with a 1-year-old daughter who is so fatigued I can’t work,” Lollini said.

Hospital technician Kristen Parker had infected Lollini and at least 18 others by stealing their pain medication and then leaving contaminated syringes for reuse. She’s now serving 30 years in jail.

“She was taking them off surgical trays, using them for herself, her own use, and then filling them with saline and putting them back on trays,” Lollini said. “I really was angry at the broken system. The hospital that hired her — unbeknownst to them that she had been let go from other jobs.”

A new report that will be released Tuesday by data firm Protenus finds that this so-called “opioid diversion” is a growing problem. In 2018, more than 47 million doses of legally prescribed opioids were stolen, an increase of 126 percent from the year before.

Protenus found 34 percent of these incidents happened at hospitals or medical centers, followed by private practices, long-term care facilities and pharmacies. Only 77 percent of the cases identified a particular drug, but the most common was Oxycodone, followed by hydrocodone and fentanyl.

Sixty-seven percent of the time, doctors and nurses are responsible. Dr. Stephen Loyd of Tennessee was one of them.

“What I didn’t realize was how quickly it would escalate. Going from that half of a five milligram Lortab, to within three years about 500 milligrams of Oxycontin a day. That’s about 100 Vicodin,” he said.

For three and a half years, he siphoned drugs away from his patients.

“There was no requirements on what happened to those pills. They could go down the toilet or they could go in my pocket,” Loyd said.

He warns that people who work in the health care industry are at high risk of abuse.

“They’ve got high stress jobs. A lot of them, like myself, have workaholism. And not only that, you have access,” Loyd said.

He’s now been clean for 15 years and was the director of Tennessee’s Mental Health and Substance Abuse Services division before running a rehab facility in Murfreesboro, Tennessee. Loyd implores addicted health care workers to admit they need help, which he knows was the hardest part for him until he was confronted by his own father.

After confessing to his dad fears of losing his house, car and career should he come clean, his father responded, “None of those things are gonna do you any good if you’re dead.”

Kira Caban of Protenus said the firm’s findings are likely a “tip of the iceburg” considering only a fraction of opioid diversions are uncovered because an addict admits to the behavior or a patient gets sick. The Department of Justice established an Opioid Fraud and Abuse Detection Unit to combat this issue, but it’s operational in less than a third of the country.

 

What a new rule in Ohio means for people getting pain meds

What a new rule in Ohio means for people getting pain meds

https://www.cincinnati.com/story/news/2019/05/06/naloxone-opioid-prescriptions-chronic-pain-ohio-medical-board-rule/3564150002/

Do you or does someone you know have a pain pill prescription? Did naloxone come with the prescription?

More Ohioans can expect to discuss that option as a result of a new rule for doctors.

Doctors who regularly prescribe pain patients high doses of opioids are now required to talk to them about opioid safety, including the use of naloxone.

The State Medical Board of Ohio made the rule that went into effect late in December. It’s for patients receiving new, high-dose prescriptions for pain lasting more than six weeks.

“It is meant to safely manage pain,” said Tess Pollock, spokeswoman for the medical board. “We are not taking opioids away from patients who need them.”

Pollock said that’s something the medical board has been careful about during the opioid epidemic, which has been blamed in part on the overprescription of pain pills. The state continues to try to educate the public about the dangers of opioid medications, and the new rule is one way to prevent accidental overdose deaths, she said.

Naloxone is a non-narcotic that blocks the effects of opioids, restoring breathing in overdosing patients. Higher doses of pain pills, or even an extra pill taken by mistake, can induce overdose.

A recent survey shows that most Ohio pain-pills patients (81%) know if their prescribed medication is an opioid. Most (82%) have heard of naloxone. And most (70%) think it’s a good idea to have it around for safety. 

But among those surveyed, few had heard any of that from their physicians.

“We have strong majorities having heard of naloxone, but a small fraction had heard from their own providers,” said Doug Usher, a partner of the research group, Forbes-Tate Partners of Washington, D.C.

The survey wasn’t only for people who get high-dose pain-pill prescriptions, so respondents didn’t necessarily fit the profile of patients who fall under the state’s rule. The minimum strength for the rule is an 80 morphine equivalent dose.

Forbes-Tate surveyed 511 Ohioans in February who’d either been prescribed pain medication or had a family member prescribed it. The market research was commissioned by Adapt Pharma, the maker of Narcan, the brand for naloxone.

Thom Duddy, spokesman for Adapt Pharma, praised Ohio for creating the rule for doctors, noting, “There’s a significant percentage of patients out there that are at risk every day.”

He said Adapt Pharma’s concern isn’t just the prescription of Narcan. “I don’t care if they prescribe syringes and vials of naloxone instead of Narcan,” Duddy said.

The company has committed to the opioid-overdose fight, he said. In 2017, Adapt Pharma provided 25,000 free Narcan kits to Hamilton County alone as part of the region’s initiative to expand access to try to cut overdose deaths.

These days, chronic pain patients often are prescribed opioids at lower doses than that, said Dr. Harsh Sachdeva, who practices at UC Health West Chester and is the director of the pain fellowship program at UC College of Medicine.

“In our chronic pain practice, 70 percent of our patients are under that dose,” Sachdeva said. Patients get additional pain help, including spinal implants and psychological intervention. 

Regardless, Sachdeva said his patients are being prescribed naloxone as a safety measure to prevent unintentional overdose. 

Not all of them want it, he said.

“I hear it all the time. ‘Why are you giving it to me?’ ” Sachdeva said.

But Ohioans and others nationally might have to get used to the idea of having naloxone awaiting them at a pharmacy along with their pain pills.

The practice of prescribing the two together probably will become routine, medical professionals say.

Young doctors are being taught about the state rule, said Dr. Michael Binder, assistant professor of clinical medicine at UC College of Medicine.

But that’s not all:

“We’re teaching them to have a discussion with all patients about the risks and benefits of their opioid prescriptions,” Binder said. “That’s standard now.”

Study Finds Prescription Drug Monitoring Programs Ineffective at Curbing Overdoses

Study Finds Prescription Drug Monitoring Programs Ineffective at Curbing Overdoses

https://www.ajmc.com/newsroom/study-finds-prescription-drug-monitoring-programs-ineffective

Prescription drug monitoring programs (PDMPs) are now in place in response to rising levels of overdoses involving opioids and synthetic opioids. But a new study that sought to clarify the relationship between PDMPs and their effectiveness in attacking the nation’s drug problem found limited to no evidence that they actually work. In addition, 3 of the studies reviewed found an increase in heroin overdose deaths after the programs began.
Prescription drug monitoring programs (PDMPs) are now in place in all 50 states and the District of Columbia in response to rising levels of overdoses involving opioids and synthetic opioids. But a new study published in the Annals of Internal Medicine that sought to clarify the relationship between PDMPs and their effectiveness in attacking the nation’s drug problem found limited to no evidence that they actually work.

In addition, 3 of the 17 studies reviewed found an unintended consequence, in that heroin overdose deaths rose after the programs began.

“Prescription drug monitoring programs have become a hallmark of any policies that have been put into place, “ said lead author David S. Fink, MPH, a doctoral candidate in epidemiology at Columbia University, in an interview with The American Journal of Managed Care® (AJMC®).

The programs all vary in what they require of both doctors and pharmacists. Some are voluntary and some are not. So far in 2018, 36 states have so-called “mandatory use” policies, which mean that providers must register and use the program.

This review of 17 studies about PDMPs sought to clarify what would make such a program effective, since they are all implemented differently, all with their own nuances, he said.

Although 10 of the studies suggested that PDMP implementation had some low evidence tying it to reductions in fatal overdoses, the evidence was not enough.

“There’s no evidence to say a PDMP works,” Fink said, adding later, “PDMP programs alone are not going to be sufficient to reduce overdoses.”  

Of the programs that were most effective, they shared these characteristics, which all indicate signs of a robust and aggressive program, he said:

  • Mandatory review of PDMP data by healthcare providers before writing prescriptions 
  • Frequent, or weekly, updates of data 
  • Provider authorization to access PDMP data 
  • Monitoring of noncontrolled substances, even over-the-counter pain relievers.

These factors are meant to combat issues like “doctor shopping,” where a patient seeks multiple opioid prescriptions from different providers, but both Fink and a critic of PDMP programs had concerns about the impact of the programs, albeit different ones.

Fink said his concern is “that when you take away a primary drug that somebody is dependent upon, what’s going to happen in that next stage if a [rehabiliation] program isn’t provided to help those individuals?”

“We saw the same thing when abuse-deterrent OxyContin came out and we saw the switch in heroin overdoses. With PDMPs we seem to be finding the exact same thing,” he said.

Part of the problem is there is a shortage of doctors who are trained in addiction medicine, especially medication-assisted treatment (MAT), including buprenorphine, which is used to prevent relapse in people with opioid dependence.

“Our systematic review found that 3 of the 6 studies that have examined the postimplementation effect of PDMPs on heroin found an increase in heroin overdose deaths following PDMP implementation,” Fink wrote in a follow-up email. “Although the mechanism is unknown, it is possible that restricting the supply of prescription opioids to opioid-dependent persons might drive them to illicit heroin. Thus, policies that can restrict the supply of opioids, such as PDMPs, should be implemented within a suite of policies that can identify and treat those who are opioid-dependent to prevent them from moving to illicit heroin.”

Fink said it would be beneficial for doctors to increase their proficiency with MAT, as well as developing greater empathy for patients who may be seeking care from multiple doctors. The patient may be reported to authorities but without a referral for treatment, he said.

Some experts have started to call for primary care doctors to get involved in MAT to help address the shortage, which in turn may increase the chances that patients will seek treatment from a doctor they know and trust, the Commonwealth Fund reported last year.

But more often than not, PDMP programs are a law enforcement tool to catch doctors and patients, said a frequent critic of the programs in an email to AJMC®.

“Sixty percent of ‘doctor shoppers’ are actually legitimate patients with pain disease, not those with addiction, who are being purposely undertreated and need to look for adequate pain medicine doses by going to more than one doctor,”  said Thomas F. Kline, MD, a geriatrician in North Carolina. “This issue was not addressed as an unintended consequence.”

In addition, Kline said PMDPs are being used to send “raw data to law enforcement for further raids and persecution, shaming and blaming medical professionals and their patients whose profiles do not fit the law enforcement view of proper practice of medicine.”

Fink said that there are very few, if any, data on the effects that policies intended to address rising overdose deaths are having on chronic pain or palliative care patients. Most of what he has heard is anecdotal, but it is clear that the “pendulum is swinging in the other direction,” he said, referring to prescribing patterns by doctors.

Major medical associations are in favor of PDMPs, but want them used for patient care first and not as a law enforcement tool, as evidenced by these guidelines from the American Academy of Hospice and Palliative Medicine. Fink’s study did not address provider responses to PDMPs, but he said it is possible that some doctors might report patients as a way of practicing defensive medicine in anticipation of a negative law enforcement response, and that more research is needed in this area.

The 17 articles reviewed for this study were pulled from 2661 records that met the inclusion criteria. In addition, the authors ranked the studies according to a risk of bias, ranging from low to moderate to severe. Most of the studies fell into the moderate to severe category.

Fink and his fellow researchers used state-level and national data to pull information about nonfatal and fatal overdoses. 

All of the studies examining the association between PDMP implementation and overdose had methodological shortcomings, including inadequate confounding factors and no adjustment for competing laws and policies that might affect overdoses, such as Good Samaritan, naloxone distribution, or medical marijuana laws.

Fink said more research needs to be done to see if medical marijuana is helping to reduce opioid overdoses.