Two of the three largest PBM’s to limit opiates

Express Scripts mail-order pharmacy to limit opioids

www.ktar.com/story/1696130/express-scripts-mail-order-pharmacy-to-limit-opioids/

The nation’s largest pharmacy benefit manager will soon limit the number and strength of opioid drugs prescribed to first-time users.

The move by Express Scripts, which has offices in Tempe, was part of a wide-ranging effort to curb an epidemic affecting millions of Americans.

But the new program has drawn criticism from the American Medical Association. The organization said doctors and patients should decide the course of treatment.

 Federal health officials reported that an estimated 12.5 million Americans misused prescription opioids in 2015, and about 33,000 people died from overdoses.

Express Scripts wants to limit prescriptions to seven days for first-time users and require short-acting opioids.

The Missouri-based company also wants to monitor for potential abuse. The program excludes hospice, palliative care and cancer patients.

A competitor, CVS Caremark, has a similar program.

Flimsy evidence behind many FDA approvals

Flimsy evidence behind many FDA approvals

https://in.reuters.com/article/us-health-fda-approvals-idINKCN1AV23K

(Reuters Health) – Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association.

The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the usual amount of data has been collected to confirm their effectiveness and safety, Dr. Huseyin Naci from the London School of Economics and Political Science told Reuters Health by email.

“Drugs granted Accelerated Approval should be rigorously evaluated using convincing patient-centered clinical outcomes in rigorous studies,” Naci said. But, he added, “we have found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards.”

Naci’s team analyzed the FDA’s accelerated approval of 22 drugs for 24 medical conditions.

For standard approval, the FDA generally requires gold-standard randomized controlled trials (RCTs) that demonstrate a drug’s safety and effectiveness. Fourteen of these accelerated approvals, however, were exclusively based on less-rigorous trials.

Given the lower standard of evidence, the FDA required 38 more trials after approval to confirm the benefits of these drugs. Three years after approval, though, only 19 had been completed. Eleven more were underway and said to be on schedule, six others were delayed by more than 12 months, and two had been discontinued.

Most of these later trials still used outcomes that would not be acceptable for standard approval, and several studies failed to show a benefit or were terminated early.

For the 10 approvals that finally met the requirements established by FDA, the time to do so ranged from one to five years after the accelerated approval.

“Our findings suggest that expediency in drug development and approval can be successful but that drugs approved via the shorter route to market are rarely subject to tests even in the post-approval period that use established and clinically meaningful outcomes,” Naci said.

When the FDA approves medicines via its Accelerated Approval pathway, he said, the agency should clearly specify the data limitations and how required confirmatory studies are expected to compensate for these limitations.

A second report from Dr. Rita F. Redberg from the University of California, San Francisco, and colleagues paints a similar picture when approval is needed for modifications to high-risk medical devices.

“We expected to find generally high-quality evidence to support these changes, because these devices are important to health, and many are implanted and are difficult and/or dangerous to remove,” Redberg told Reuters Health by email. “We were surprised to discover that relatively few studies were randomized or blinded, which means that it is not known if the device was better than an alternative treatment (or better than no treatment), and whether any purported beneficial effect was actually due to the well-documented placebo effect of procedures and devices.”

“In addition, we were disturbed to find numerous discrepancies between the number of patients enrolled and the number of patients with data reported, indicating that there is loss (or incompleteness) of data evaluated by the FDA,” she said. “This raises concerns about missing data and selection bias.”

Of the 78 device modifications they studied, 71 were supported by a single clinical study, and half of these enrolled 185 or fewer patients. One in 12 studies did not specify what the researchers were looking to prove.

“I think the public assumes that medical devices currently on the market, particularly high-risk devices, have been approved based on a high standard to show safety and effectiveness before doctors can recommend and implant them,” Redberg said. “Our findings show that this assumption is often incorrect.”

Dr. Robert M. Califf from Duke University School of Medicine, Durham, North Carolina, who wrote an editorial related to these reports, told Reuters Health by email, “People should ask their doctors about the evidence for drugs and devices being prescribed or use, and they should support research and participate. In addition, they should encourage their doctors to participate; too many doctors just ‘go with the flow’ rather than demanding high-quality evidence about what they are prescribing and implanting, and actively joining into appropriate clinical trials.”

California Hospital Sued for Refusing to Assist Suicide

California Hospital Sued for Refusing to Assist Suicide

www.nationalreview.com/corner/450438/california-hospital-sued-refusing-assist-suicide

This lawsuit is a little before its time. Should assisted suicide become widely accepted in this country, activists will try to force all doctors to participate–either by doing the deed or referring to a doctor known to be willing to lethally prescribe. But it isn’t yet, and so the pretense of the movement that they only want an itsy-bitsy, teensy-weensy change in mores and law continues as SOP. But sometimes they show their true intentions. Thus, when UCSF oncologists refused to assist a cancer patient’s suicide, the woman died of her disease. Now, her family is suing–using the same attorney (Kathryn Tucker) who tried (unsuccessfully) to obtain an assisted suicide Roe v Wade in 1997 and has brought other pro-assisted sucide cases around the country. From the San Francisco Chronicle story: Judy Dale died of cancer in her San Francisco home in September, in agony, after being denied the pain-relieving medication she might have received under the state’s aid-in-dying law that had taken effect three months earlier. Bias alert! Pain relieving medication is palliative, to ease pain or other very uncomfortable. Dale was not issued a lethal prescription intended to kill her. That’s not the same thing. Back to the story: A lawsuit by her children will determine whether UCSF Medical Center, where Dale first went for treatment, was responsible for her suffering by allegedly concealing its oncologists’ decision not to provide life-ending drugs to patients who ask for them. More broadly, their suit illuminates the inner workings of a law that confers new rights on terminally ill patients, but few obligations on their health care providers. Specifically, doctors and hospitals are provided clear and explicit conscience protections in the law. No hospital or physician can be forced to participate or refer in an assisted suicide Demonstrating the disingenuousness of the lawyers bringing suit, that provision was–as the story reports–required to induce the California Medical Association to go neutral on the law, without which it almost surely would never have passed. The primary claim is elder abuse. If that theory prevails, not helping kill a patient would become a form of abuse! Unthinkable. The plaintiffs also contend that the hospital had assured Dale she would be able to receive assisted suicide, and then failed to follow through. I don’t know if that kind of statement would be actionable or not since there is no legal duty to do the deed, as it were. But this I do know: The lawsuit illustrates where the assisted suicide/euthanasia movement wants to go. As in Ontario, Canada, they want doctors and hospitals to be forced to participate in assisted suicide or get out of medicine.

 

CDC: the guideline’s recommendations reflected weak scientific evidence.

Strict limits on opioid prescribing risk the ‘inhumane treatment’ of pain patients

www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/

Amid a rising toll of opioid overdoses, recommendations discouraging their use to treat pain seem to make sense. Yet the devil is in the details: how recommendations play out in real life can harm the very patients they purport to protect. A new proposal from the Centers for Medicare and Medicaid Services to enforce hard limits on opioid dosing is a dangerous case in point.

There’s no doubt that we needed to curtail the opioid supply. The decade of 2001-2011 saw a pattern of increasing prescriptions for these drugs, often without attention to risks of overdose or addiction. Some patients developed addictions to them; estimates from the Centers for Disease Control and Prevention range from 0.7 percent to 6 percent. Worse, opioid pills became ubiquitous in communities across the country, spread through sale, theft, and sharing with others, notably with young adults.

The prescribing tide has turned: Private and governmental data show that the number of prescriptions for opioids has been falling since 2012. Reassuringly, federal surveys show that misuse of pain relievers bottomed out in 2014-15.

Nevertheless, the CDC produced a guideline in 2016 that recommended shorter durations for opioid prescriptions and the use of non-drug treatments for pain. It also suggested keeping opioid doses lower than the equivalent of 90 milligrams of morphine. As the guideline acknowledged, its recommendations reflected weak scientific evidence. Problematically, it was silent on how to care for patients already receiving doses higher than the 90 milligram threshold.

Unfortunately, these mitigating features were undermined by intemperate publicity that vilified opioids for pain. Opioids for pain “are just as addictive is heroin,” proclaimed CDC Director Dr. Tom Frieden. Such statements buttress a fantasy that the tragedy of opioid overdoses and deaths will be solved in doctors’ offices, primarily by upending the care of 5 to 8 million Americans who receive opioids for pain, even when most individuals with opioid addiction did not start as pain patients.

The progression of the guidelines from “voluntary” to “enforceable” has culminated in a draft policy from CMS. It would block all prescriptions above the CDC threshold of 90 milligrams unless complex bureaucratic barriers are surmounted. Many pharmacy plans are already enforcing this approach. Under that plan, many patients suffering with chronic pain would lose access to the medicines they are currently taking, all in the name of reversing a tide of death increasingly defined by non-prescribed opioids such as heroin and fentanyl.

The logic of doing this is untested. There have been no prospective clinical studies to show that discontinuing opioids for currently stable pain patients helps those patients or anyone else. While doing so could help some, it will destabilize others and likely promote the use of heroin or other drugs. In effect, pain patients currently taking opioids long-term have become involuntary participants in an experiment, with their lives at stake.

Turning the voluntary guidelines into strict policy is unfortunate for three reasons.

Second, we have alternatives to bureaucratic controls. These include promoting and paying for treatments that de-emphasize pills. Important work by the Department of Veterans Affairs shows how to identify patients with elevated risk for harm from opioids and how to mitigate the risks.

Third and most troubling is the increasingly inhumane treatment of patients with chronic pain. Fearing investigation or sanction, physicians caring for patients on long-term opioids face a dire choice: to involuntarily terminate prescriptions for patients who are otherwise stable, or to carry on as embattled, unprotected professionals, subject to bureaucratic muscle and public shaming from every direction.

In this context, we cannot be surprised by a flurry of reports, in the press, social media, and the medical literature describing pain patients entering acute withdrawal, losing function, committing suicide, or dying in jail. The CMS policy, if adopted, will accelerate this trend.

Many of our colleagues in addiction medicine tell us they are alarmed by the widespread mistreatment of pain patients. We receive anecdotes every week from physicians and pharmacists, most of them expert in addictions, describing pain patients who have involuntarily lost access to their pain medications and as a result have been reduced from working to bedridden adults, or who have become suicidal.

This loss of access occurs several ways. A pharmacy benefit program may refuse to cover the prescription because it has already enacted the changes that CMS is proposing to make mandatory. A physician may feel threatened by employers or regulators, and believes his or her professional survival depends on reducing opioid doses — involuntarily and without the patient’s consent — to thresholds that the CDC itself described as voluntary and not mandatory. Or state regulators have imposed such burdensome requirements that no physician in a given region can sustain prescriptions for their patients. Such patients are then “orphaned,” compelled to seek treatment from other physicians across the country.

Given the expertise in addiction among these physicians, it should be particularly worrisome that they believe the present pill-control campaign has gone too far. And yet, the ethics are clear: It should never be acceptable for us to countenance the death of one patient in the avowed service of protecting others, even more so when the projected benefit is unproven.

Surgeon General Dr. Vivek Murthy made an underappreciated declaration in a recent interview with the New England Journal of Medicine. “We cannot allow the pendulum to swing to the other extreme here, where we deny people who need opioid medications those actual medications. … We are trying to find an appropriate middle ground,” he said.

As addiction professionals, we agree wholeheartedly.

Oligoanalgesia in the emergency department

Oligoanalgesia in the emergency department

http://www.medscape.com/medline/abstract/2803357

Oligoanalgesia: Underuse of analgesics in the face of valid indications–eg, intense bone pain of terminal CA–for its use.

A review of the charts of 198 patients who were admitted through the emergency department with a variety of acutely painful medical and surgical conditions revealed that 56% received no analgesic medication while in the emergency department. In the 44% of patients who received pain medication, 69% waited more than 1 hour while 42% waited more than 2 hours before narcotic analgesia was administered. In addition, 32% initially received less than an optimal equianalgesic dose of narcotic when compared with morphine. This study demonstrates that narcotic misues, in the form of oligoanalgesia, is prevalent and is the shared responsibility of both emergency physicians and housestaff consultants.

New Ky. law limits prescriptions for certain pain meds to 3-day supply

New Ky. law limits prescriptions for certain pain meds to 3-day supply

http://www.wdrb.com/story/35790831/new-ky-law-limits-prescriptions-for-certain-pain-meds-to-3-day-supply

LOUISVILLE Ky. (WDRB) — A new law that limits how much pain medicine doctors can prescribe in Kentucky is now in effect. 

The new law that took effect Thursday is designed to help fight the opioid epidemic that’s sweeping the nation. Under the new law, prescription painkillers will be limited to a 3-day supply in an effort to prevent abuse. 

The idea behind HB 333 is to prevent extra opioid pain pills from entering the illegal drug market. The bill underwent intense debate by Kentucky lawmakers before it was passed earlier this year. 

The bill’s sponsors say the goal is to get drugs like fentanyl and carfentanyl off the streets and out of the hands of drug traffickers. Penalties for anyone caught trafficking the drugs are now elevated to a Class C Felony for a first offense. 

The biggest concern over the new law centers on the 3-day pain pill limit, which prohibits doctors from issuing a prescription for more than the three days for Schedule II narcotics like OxyContin. 

Some patients who truly need the medication say the law makes it too difficult for them to get pain medication for legitimate reasons. 

The law does include exceptions for cancer patients, people diagnosed with chronic pain and patients receiving end-of-life care.

  How bright does a politician have to be to come to the conclusion that by limiting the legal prescribing of opiates will somehow stop the flow of ILLEGAL OPIATES from being on the street ?

 

A new addition to our family

I know that my blog has been very quite for a few days..  Last Thursday we drove from our Indiana home to Durham, NC (550 miles) to visit with our Daughter and grandson and to celebrate our Daughter’s birthday – which is actually today (Aug 15). My laptop and IPad remained safely in my backpack.. I didn’t even attempt to get them out…  I tried to scan my emails using my phone and “trashing” the emails that were more or less spam..

I went “cold turkey” and really didn’t have any side effects.. of course keeping up with a 10 y/o grandson.. there was no time to think about anything… we were either “going” or trying to “recover” from all the “going”

Monday we took off for our beach home – 800 miles –  This sweet  little girl ( 7 y/o Shih Tzu name Cuddles) in the picture, lost her “forever home” on July 15th when her Daddy (James) died.

None of his adult children wanted her and before she could be tossed into the “recycle bin” we reached out to his “girl friend” offering to “rescue her”.

We had been friends with her Daddy and her Mommy – who died in May 2011 – for over two decades.

This is not the best picture of her, she apparently doesn’t like to have her picture taken… and there are really two eyes in that “black mask” on her face, but today we “officially” adopted her and she is in her last “forever home”. And she can continue to live in the style which she had become accustomed to.

We still have to find out what kind of “traveler” she is… since James did not travel with her except to the vet and groomer and within a week we will be head back to Indiana with another long (650 mile) trip.  It may end up being a new experience for all of us 🙂

 

 

Zynerba Shares Plunge as Cannabis-Based Epilepsy Gel Fails Study

Zynerba Shares Plunge as Cannabis-Based Epilepsy Gel Fails Study

https://www.doximity.com/doc_news/v2/entries/8719011

Zynerba Pharmaceuticals Inc’s stock lost more than half its value on Monday after the U.S. drug developer said its synthetic cannabis-based gel for epilepsy failed a mid-stage study.

Zynerba’s gel contains a synthetically processed formulation of cannabidiol (CBD), a non-psychoactive component of the cannabis plant.

Although many U.S. states have sanctioned the medical and/or recreational use of cannabis, drugs derived from the plant could take longer than others to hit the market.

Under U.S. federal law, marijuana is considered a dangerous substance with no medicinal value, making additional approvals for marijuana-derived treatments necessary prior to launch.

Two doses of Zynerba’s ZYN002 gel were tested against a placebo in the study.

Neither dose induced a statistically significant improvement in seizure frequency versus the placebo in patients who were already on up to three anti-epileptic medications.

The 188-patient study comprised adults suffering from epilepsy with partial seizures, which occurs when epileptic activity takes part in a localized part of the brain.

FDA Warns Against Use of Any Liquid Product From PharmaTech

FDA Warns Against Use of Any Liquid Product From PharmaTech

http://www.medscape.com/viewarticle/883981

Clinicians and patients should not use any liquid product manufactured by Pharma Tech LLC and distributed by Rugby Laboratories because of Burkholderia cepacia contamination and the potential for severe patient infection, the US Food and Drug Administration (FDA) advised today in a safety communication. 

Dicto Liquid. Photo courtesy of the FDA

On August 3, Rugby Laboratories, of Livonia, Michigan, announced a voluntary recall of two oral liquid docusate products — Diocto Liquid and Diocto Syrup — manufactured by PharmaTech, of Davie, Florida.

“Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator,” the FDA advised.

 

The agency acknowledges that it might be tough to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. Healthcare facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, should check with their supplier to determine who manufactured the product, the FDA said. 

According to the FDA, laboratory testing of PharmaTech’s oral liquid docusate, conducted by the Centers for Disease Control and Prevention (CDC), found a strain of B cepacia, which has been linked to recent infections in patients.

In 2016, the CDC and the FDA advised against using any liquid docusate drug products.

An investigation into a 2016 multistate outbreak identified B cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B cepacia in the water system used to manufacture the product, the FDA said.

This year, the agency said it has received reports of “several adverse events” related to oral liquid docusate sodium products. 

Healthcare professionals are encouraged to report problems related to these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

Independent Pharmacies, Coupons Result in Big Savings on Drugs

Independent Pharmacies, Coupons Result in Big Savings on Drugs

www.pharmacyschool.usc.edu/price-shopping-for-prescription-medications-can-yield-considerable-cost-savings-usc-study-finds/

After finding that prices for some common antibiotics can vary in price by up to $100 in one metropolitan area, USC experts suggest that patients could save money by shopping for their drugs online or in independent pharmacies. However, few Americans actively comparison shop for health care, according to a separate study by USC and Harvard Medical School researchers.

Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, USC researchers have found.

The cash price for a commonly prescribed generic antibiotic can vary, on average $52, within a single ZIP code, according to the study published in the American Journal of Managed Care.

In a survey of 535 pharmacies in Los Angeles County’s highest and lowest-income ZIP codes, USC researchers found that the prices were lowest at independent pharmacies and when using online coupons compared to the prices found at grocery, big-box or chain stores. The researchers said they would expect similar results in other areas of the country.

The study indicates that patients can potentially save significant amounts simply by comparison shopping within their neighborhood or by using discount coupons available online.

“Consumers typically know the price of a product and have some information about its quality before purchasing. That’s rarely the case in health care,” said lead author Geoffrey Joyce, director of health policy at the USC Leonard D. Schaeffer Center for Health Policy and Economics and associate professor at the USC School of Pharmacy.

A separate study released Monday in the journal Health Affairs further confirmed that health care price shopping is uncommon. USC Schaeffer Center and Harvard Medical School researchers found that few Americans actively obtain price information before going to the doctor.

2 antibiotics, 82 ZIP codes

The research team called pharmacies in the highest and lowest income ZIP codes in Los Angeles County between July and August 2014. Explaining that they were calling on behalf of an uninsured patient, the researchers asked for the cash price for two commonly prescribed generic antibiotics, levofloxacin and azithromycin, which treat community-acquired pneumonia.

They then analyzed variation in the price quoted across and within 82 ZIP codes, as well as by type of pharmacy, including chain drug stores, independent pharmacies, grocery stores, or big-box stores. Researchers also obtained prices for the two medications from GoodRx, a popular online service that aggregates discounts and coupons.

In low-income areas, the price for levofloxacin ranged from a low of $4 to a maximum price of $149. In high-income areas the range was $5 to $229. The patterns were similar for azithromycin, though on a smaller scale: the price range was $2 to $26 in low-income ZIP codes, and $4 to $30 in the high-income areas.

Additionally, Joyce and his colleagues found the type of pharmacy affected the price variation. The average price for levofloxacin at an independent pharmacy or purchased with a GoodRx coupon cost less than half the price quoted at a big-box store and less than one fourth the discounted price at a chain drug store.

Overall, the average price difference between the highest and lowest-cost pharmacies in a ZIP code was more than $100 for levofloxacin and $30 for azithromycin.

“When physicians learn about the magnitude of price variation they will be stunned,” said co-author Sanjay Arora, a physician and associate professor of clinical emergency medicine at the Keck School of Medicine of USC. “When a patient says they could not afford a prescription medication, we assume it is just an expensive medication when in fact they may have just gone to an expensive retail outlet.”

With such wide variations in prices, price-shopping for prescription medications can yield considerable cost savings. “The extent of price variation within a market is an implicit measure of the benefit of price shopping,” Joyce says.

Consumers need transparency

Though policymakers have latched on to the idea of consumer-driven healthcare as a way to reduce rising costs, in practice it has proven challenging to realize. This is due in part to the lack of transparency in pricing medical services as well as the challenge of assessing quality.

In terms of quality, prescription drugs are much easier to understand- consumers know that no matter where they fill their prescription, they are going to get the same medicine.

“The wide variation in prices shows that pharmacies are exploiting the fact that sick patients do not have the time to shop around for their drugs,” explained Neeraj Sood, a co-author on the study and professor at the USC Price School of Public Policy and director of research at the USC Schaeffer Center. “Our study suggests that consumers can do two things to save money: shop online at websites like GoodRx or go to your local independent pharmacist.”

Though the uninsured rate has improved with the passage of the Affordable Care Act, many individuals still pay the cash price for their prescription drugs. This includes more than 32 million consumers who remain uninsured as well as the increasing number of individuals who have high-deductible plans with limited prescription benefits.

The study found that the amount of money that consumers could save is no small sum, especially for low-income consumers who are also more likely to be uninsured or in high-deductible plans.

“Education on this issue should become part of routine discharge planning,” noted Arora.

Policies that encourage greater price transparency as well as campaigns to educate consumers about the potential for price variation would go a long way towards reducing this sort of excess spending.

Sophie Terp, assistant professor at the Keck School of Medicine, also co-authored the study.