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The Truth About Fail First Policies and Pain

Rebecca West is fighting two difficult battles. Every day she lives with chronic pelvic pain, a condition she has endured for more than a decade. And now, she faces an uphill battle to maintain access to the medications that help her manage that pain.

“I can’t find a doctor who will prescribe me a long-term opioid,” West said, noting that every physician she’s seen agrees that an opioid therapy will help her manage her pain, yet won’t prescribe it because of the current climate. “I can’t find help and I don’t know what to do anymore.”

Shaina Smith understands. Smith lives with chronic pain, a sensation that radiates through her body due to a condition she will always have. Despite receiving a crushing, chronic diagnosis, she feels lucky. Because, she doesn’t need opioids to manage her pain.

Smith, the director of state advocacy for the U.S. Pain Foundation, knows the frustrations and fear that have settled across the pain community due to an opioid epidemic that is claiming more than 90 American lives every day. Smith’s friends who need opioids to manage pain are scared that their physicians will scale back or remove their opioid prescriptions in response to the current crisis and national conversation.

“Chronic pain patients don’t want to be on opioids. Sometimes it’s the only thing that helps them get through the day,” Smith said. “It’s the only mechanism that allows them to tolerate their pain.”

To say the water is choppy is to be forgiving when describing the landscape that the pain community is currently forced to navigate. Between regulations, reluctant healthcare providers and required step therapy from insurers, the pain community is effectively enduring both their physical ailment along with a battle to acquire the medications they need to manage it.

“All patients deserve at least an option,” Smith said.

Some patients simply can’t endure it all. Psychology Today and the Pain News Network, citing anecdotal evidence, report that suicides among chronic pain patients are on the rise, with a rate that is twice as high within the chronic pain community than outside of it. By that standard, it is plausible to estimate that up to 20,000 Americans are taking their own lives every year due to chronic pain.

And that’s the heavy fallout, according to pain advocates, that comes from limited access to pain management tools.

“There is a real tendency to trivialize pain now,” Dr. Steve Passik, Vice President of Scientific Affairs at Collegium, said. “We have a cultural belief that we’re all supposed to be John Wayne and sort of tough it out.”

Passik watched as his mother, a woman who lived with debilitating osteoarthritis, faced seemingly endless challenges when trying to obtain the pain treatment she needed. And she wasn’t alone in her struggle. Insurers have implemented “Fail First” or step therapy guidelines that require patients to progress through failed treatment options before receiving coverage for alternate options that may be safer or more effective, and may be the treatment their physician originally prescribed.

“No one intervention is right for everybody,” Passik said. “Opioid therapy is not a one-size-fits-all thing.”

But it appears regulators and payers are treating it that way.

For Amy Goldstein, the anxiety for all stakeholders in the pain community is palpable. As director of the State Pain Policy Advocacy Network under the Academy of Integrative Pain Management, she is hearing apprehension from every angle. She hears from chronic pain patients who are nearly defeated about their inability to access the medication they’ve used for years.

“In the current environment, opioids are scary to a lot of people,” Goldstein said, noting that providers are also discouraged by their inability to effectively treat people with chronic pain. “A lot of providers are just not comfortable prescribing opioids right now.”

Steve Adler, a physician assistant specializing in pain management in Arizona, would classify the current environment as “frustrating.” Adler, who has practiced in pain management for 13 years, has rarely found a chronic pain patient who becomes an addict. Yet, his patients tell him daily that they feel they’re being penalized by stiffer regulations due to an addiction crisis which they haven’t influenced.

Dr. Jeffrey Fudin, a pharmacist and professor of pharmacy in New York, said the co-liability that pharmacists now agree to when filling opioid prescriptions, knowing the drugs could potentially fall into the wrong hands, makes the job more challenging than it already is. He said the “Fail First” policies used by insurance companies do not guarantee a safer prescription, and he believes the regulations adopted by the insurance industry are contradictory.

“It pits the pharmacists against the prescribing physician,” Fudin said of current guidelines related to opioid prescribing. “Some of these patients are being cut off. They’re in a panic. There’s really two epidemics. There is an opioid abuse epidemic. But there is also an epidemic of undertreated pain patients. It is horrible.”

Yet, many of those on the front lines of the opioid crisis believe there is a different way forward.

An emerging technology within the pharmaceutical industry involves developing and employing abuse-deterrent formulas (ADF) for medications that have the ability to effectively treat a patient yet also have the potential of being abused or misused. But, like any pharmaceutical advancement, the availability of these ADFs depends on insurance companies.

Bill Carpenter sees the benefits of ADFs with clarity. As the father of a son who struggles with an addiction to heroin and as the mayor of a Massachusetts town that has been hit hard by addiction and the crimes associated with it, he can empathize with both sides of the crisis.

“There are folks with chronic pain who need pain relief and who these opiate painkillers make sense for,” he said. “How do we protect the rights and help the suffering of people who are suffering from chronic pain, without flooding the streets of the city with painkillers that are going to be abused?”

ADFs represent an advancement, significantly hindering its users from being able to manipulate a medication, resulting in misuse or potential abuse. Yet, insurers require patients to fail other treatment options first, before being granted coverage for an abuse-deterrent formula.

Progress on the acceptance of abuse-deterrent formulas is slow, but it is moving forward as influential thought leaders begin to pool their voices on the subject. The Food and Drug Administration (FDA) released a statement in November that supported the development and use of opioids with abuse-deterrent properties, calling the innovation a “promise for a meaningful public health benefit.”

And, more than a dozen states have passed legislation regarding the process and exceptions to “Fail First” policies, which is a start.

“There’s a strong interest in the opioids that are available with ADF qualities to limit the potential tampering of those for an unintended use,” Goldstein said. “Our concern is there may be prescribers who aren’t comfortable prescribing opioids if they don’t have an ADF. So, we need to make sure those are available.”

Opioids: A Complex Crisis

For most people, it’s hard to imagine a circumstance where it would be dangerous to reveal your real first and last name. Or openly talk about a prescription you use.

Olivia can not only imagine it, she lives it. As a chronic pain patient who uses opioids to help manage her pain, Olivia is worried that someone might try to steal the opioids she relies on to make her excruciating back pain at least palatable.

“You feel like a target,” she said.

Olivia’s concerns don’t end at her safety. They include what many pain patients see as a narrowing window of accessibility to medication due to tighter regulations that came as a direct result of opioid abuse. She’s watched as pharmacists hesitated to fill her prescriptions, she has endured skeptical looks and she even had to stomach an ill-informed suggestion that she may need to check into a drub rehab facility.

“If you take away pain medication, you’re just going to have a whole new epidemic of people in pain,” she said. “Live one day in the life of somebody that deals with it and your mind would be changed.”

Roy Barnes understands. He prescribes pain medication with a watchful eye because he has seen the New England town that he lives in change. He’s seen it slide. And that slide has inspired a worry within him, one that sometimes pulls the light from his voice and leaves him feeling uneasy about the future.

Barnes is a family physician. He has been for 30 years. And he’s conflicted. Now more than ever, he hesitates when he feels it is necessary to prescribe an opioid-based painkiller to one of his patients.

“I’m seriously worried about home invasion at this point in my community,” Barnes said of the town of 12,000 where he lives. “Desperation is the mother of invention. You just have to have enough time to find your way out of your dilemma.”

Of course, pain patients are not the only ones facing a dilemma. Physicians are, too. Regulations make it difficult for them to effectively treat chronic pain, while the undercurrent of possible abuse looms with every prescription.

“Doctors are fearful to prescribe pain medication if the patient requires it,” Cindy Steinberg, the national director of policy and advocacy for the U.S. Pain Foundation, said of the physicians she talks to. “It’s gotten to the point that doctors don’t want to even treat patients with chronic pain.”

Opioids certainly are a desperate dilemma. Pain patients need them, and sometimes unknowingly misuse them. Addicts abuse them, and will go to great lengths to get them. Policymakers debate about them and often just want to eliminate them altogether, while advocates work to educate the public about them. Pharmaceutical companies are trying to improve them, and public health organizations are collecting statistics and reporting on them.

And the statistics are, at best, unsettling. At worst? Absolutely crushing.

The Centers for Disease Control (CDC) reports that 142 Americans die every day from drug overdoses, of which two-thirds are linked to opioids. More Americans died from heroin-related causes than from gun-related homicides and car accidents combined, according to data collected by the CDC in 2015.

To offer perspective, the number of fatal drug overdoses in the U.S. is equal to this country enduring the losses it did on September 11th every three weeks.

“Our nation is in a crisis,” reads an initial report released in August 2017 by the President’s Commission on Combating Drug Addiction and the Opioid Crisis. “The opioid epidemic we are facing is unparalleled.”

Barnes is on the front line of that unparalleled epidemic. He practices in a part of the country that has been ravaged by opioid addiction, yet the town he is in isn’t that different than any of the other small towns that have been impacted by the same problem. He’s heard the heartbreaking stories of loss, and he’s seen the desperation illustrated by someone who is chasing their next high. It is with that knowledge that he worries for the safety of his elderly pain patients. He’s concerned they, and their full bottles of prescription medication, may become a target.

“There definitely is this undertow of drug abuse. There is a lack of respect for drugs,” Barnes said. “There’s a big problem in this country, but not everyone is on board on how to put this in a corner and make it go away.”

Dr. Steve Passik has seen it, too. His mother lived with debilitating, chronic pain and she ultimately succumbed to complications fro diabetes. His friend’s son became addicted to and eventually died from an overdose of opioids. So he can see the opioid crisis from both sides of the spectrum, one that needs a tough response to save lives and one that hopes that response doesn’t impact their quality of life or that of their loved ones.

And, as vice president of scientific affairs at Collegium, a pharmaceutical company that has developed an abuse-deterrent opioid, Passik wraps himself around an integrated view of the crisis.

“On both sides of the aisle, we are sort of united in grief,” Passik, referring to suffering chronic pain patients and families living with addiction. “No one wants to see someone go through the loss.”

Passik watched as chronic pain chipped away at his mother, an “amazingly persistent” woman who lived with diabetes and osteoarthritis for years. And he knows that due to the undertow of abuse, and rampant overdoses, that many doctors and pharmacies are leery of prescribing opioids, a medication that benefits untold numbers of the estimated 100 million Americans living with chronic pain.

Regulations designed to curb overdoses are pinching off accessibility for pain patients, many of whom rely on opioids to get through their day. Limited accessibility is one of Steinberg’s big concerns. As someone who lives with chronic pain due to a catastrophic back injury 17 years ago, Steinberg knows what patients go through to try and get the treatment they need.

Steinberg classified the current status of the delicate relationship between suffering pain patients and physicians who are skittish about prescribing opioids as “sad.” It seems, she said, that policymakers have prioritized the need to reduce overdoses by abusers at the expense of chronic pain patients like herself.

“Opioids don’t help everybody. They aren’t the only solution for pain, but they are an important option for pain,” Steinberg said. “I want them to remain available to people living with pain.”

Back at his New England practice, Barnes navigates pain management with a metered approach. If a certain opioid doesn’t work for one of his patients, he doesn’t automatically increase their dose. He reels it back in and looks for alternatives.

He knows, that as a physician, he is not obligated nor is he often able, to eliminate all of a patient’s pain. He also knows that some of the same opioids that help his patients could be deadly to those who abuse them and those who unknowingly misuse them.

It is the very definition of a quandary. And he hopes someone finds a remedy.

“I wouldn’t mind seeing a day when this is no longer a problem,” he said. “Is there a way to pull this back to center? That would be wonderful.”

Passik is hopeful. He sees grief as a common denominator, on all sides of the crisis.

“One of these days, I just wish that the advocates on both sides would realize we are all motivated by grief, and if we came together in that grief, we might be able to come up with some solutions for the opioid crisis and the pain crisis that didn’t, sort of, put one person’s pain at a higher position than the other’s,” Passik said.