Rx down & OD deaths up – CDC in Denial

Opioid Crisis Continues to Pressure Physicians, But Patients Bear the Pain – Pain Medicine News – NOVEMBER 7, 2017 – by David C. Holzman

The efforts to crack down on opioids are coming to a head. As a result, patients are hurting—literally.

Payors and legislators are limiting physicians’ ability to prescribe, said Joseph Ranieri, DO, an addiction medicine and pain specialist who is medical director of Seabrook House, in Newell, N.J.

Moreover, even where rules are absent, the specter of monitoring has many physicians caught between protecting their practices and protecting their patient.  

“The pressure on physicians is already intense,” Stefan G. Kertesz, MD, wrote in The Hill (Let’s not kill pain patients to “save” patients with addiction).

The crackdown had been brewing for most of the decade, but things heated up in the spring of 2016, when the Centers for Disease Control and Prevention (CDC) issued the “Guideline for Prescribing Opioids for Chronic Pain” (MMWR Recomm Rep 2016;65:1-49).

The recommendations, the pain physicians who commented on this article mostly agree, were not unreasonable, although the evidence for many was scant, by the CDC’s own admission. The problem was that they were oft interpreted to be rules, rather than guidelines.

For example, a proposal from the National Committee for Quality Assurance followed last winter that was seen as creating an incentive for physicians to unilaterally reduce doses among patients receiving more than 120 morphine milligram equivalents (MME) of opioids

Eighty pain physicians, including Dr. Kertesz, responded to that agency, stating that such dose reductions had “never been tested in prospective trials and … could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death) … and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.”

The Centers for Medicare & Medicaid Services proposed similar measures concurrently. However, that proposal appears to have been softened

This change appears to be in response to a letter signed by 83 professionals, including four who worked on the CDC guideline.

Ironically, the ratcheting down of opioid prescriptions may be aggravating the problems it was meant to reduce.

From 2010 to 2015, overdose deaths involving natural and semisynthetic opioids fell from 29% to 24% of all overdoses. But these were swamped by the rise of overdose deaths from heroin and synthetic opioids, excluding methadone, which tripled to 25% and doubled to 18% of the total, respectively.

Unfortunately, suicide and medical harm after an involuntary dose reduction “are not usually recorded in any database, and therefore, it is very hard for health authorities to measure the size of this new problem,” Dr. Kertesz said. “All we have now are anecdotes.”

Patients Hurting

In March, a year after release of the CDC guideline, an online survey of more than 3,000 patients, physicians and health care providers conducted by Pain News Network found that the guideline had “harmed pain patients, reduced access to pain care, and failed to reduce drug abuse and overdoses,” commented Lynn R. Webster, MD

That survey, Dr. Webster noted in his comments to Pain News Network, found that “over 70% of pain patients say they are no longer prescribed opioid medication or are getting a lower dose. … Eight out of 10 patients say their pain and quality of life are worse.”

In a survey of 72 patients with arachnoiditis or Tarlov cyst disease, conducted by the Arachnoiditis Society for Awareness and Prevention, slightly more than half said they’d been completely cut off from their opioids.

In another portent, in articles published with comments sections, such as one in the Boston Globe health publication STAT by Dr. Kertesz and Adam J. Gordon, MD, some commenters have expressed a desire to die by suicide, or have described considering it, in the wake of the crackdown. “That suggests we are in some really dangerous territory,” Dr. Kertesz said

The medical community had long undertreated pain. In the early 1990s, physicians, finally recognizing the problem, turned to opioids in an effort to mitigate that epidemic. Prescriptions rose steadily, tripling at 219 million in 2011.

By 2010, the profession had become concerned, and in 2012, the number of prescriptions for opioids fell.

The March 2016 CDC guideline hit the media with a splash. Former CDC Director Tom Frieden, MD, was quoted saying that “opioids are just as addictive as heroin,” a statement widely interpreted as implying that most opioid addiction originates in pain patients, a controversial view.

Nonetheless, the CDC was “extremely careful” not to directly mandate dose reductions in patients “evaluated as benefiting from opioid prescriptions,” Dr. Kertesz said.

However, legislators are enshrining these provisions as law, and many insurers are using them to determine coverage.

Among other states that have enacted legislation, seven—California, Colorado, Indiana, New Hampshire, Ohio, South Carolina and Vermont—have soft limits on doses, which lack force of law, but can be used to assess a physician’s practice. Besides Maine, Massachusetts and Washington have hard limits.

Even under soft limits, “doctors feel it increases liability,” Dr. Fudin said. “And even if the prescriber has documentation, they are being scrutinized. … They can be called on by state regulatory agencies to explain any patients with morphine equivalent daily dosages (MEDD) that fall [beyond] a predetermined limit. … The clinician may reduce the dosage to meet the state MEDD limit because they don’t want to deal with it.”

Payors

Meanwhile, “insurance companies are incorporating guidelines into what they’re willing to pay for under any circumstance, thus driving a lot of clinical decision making on what are supposed to be guidelines applying only to primary care doctors,” said Edward Michna, MD, director of the Pain Trials Center, Brigham and Women’s Hospital, in Boston, and a board member of the American Pain Society. All this is done “under the guise of patient safety, but it’s really about saving money.”

Similarly, some insurance companies will not pay for extended release, or “have created incredibly lengthy red tape” that must be navigated before payment, in response to the CDC guideline’s fourth recommendation to avoid extended-release opioids when starting therap

Worse, insurance companies often require prior authorization anew when a patient already on opioids switches physicians, Dr. Silverman said.

“Some insurance companies—WellCare in Florida is one—don’t even cover extended release, long acting in the formulary,” despite the fact that it often works better for patients, and it is less prone to diversion, Dr. Silverman said. (WellCare did not return phone calls for this story.)

Big Pharmacy Chains

Even when an insurance company covers a high dose, a pharmacy may refuse to dispense the dose or the drug. Pharmacies have grown wary following instances when the authorities have legitimately clamped down on them.

In one instance, Dr. Silverman had to spend 20 minutes convincing a pharmacy staff member that it was legal to give an opioid-naive patient a short-acting opioid. “This is only one of millions of stories,” he added.

Walgreens created a lengthy checklist that staff members must use when filling opioid prescriptions, which includes 11 items (e.g., “quantity is 120 units or less; or 60 units or less if paid by cash or cash discount card”) and more than two pages of “procedures,” in small type. (Walgreens’ media relations did not respond to a phone call and email.)

(See Walgreens’ “secret checklist” reveals controversial new policy on pain pills)

Physicians in the Middle

“For physicians wishing to stay out of the firing line, the implicitly encouraged step is involuntary dose reduction, even if the patient is functionally stable on their current dose,” Dr. Kertesz said. “That course of action has absolutely no trial data to support it,” he added

But with the growing medical-legal liabilities, “more and more primary care practices are saying they won’t offer opioids for any reason,” Dr. Michna said. The restrictions “have driven up the amount of time you need to spend, and with all these laws and regulations, there hasn’t been a concurrent increase in reimbursement.”

Crisis/Opportunity

All this notwithstanding, the opioid crackdown represents an opportunity to educate pain physicians to approach mitigating chronic pain more creatively, said Melanie Rosenblatt, MD, director of pain management at Broward Health North, in Pompano Beach, Fla.

For many patients, doses sufficient to numb the pain frequently numb the rest of living, Dr. Rosenblatt noted.

Frequently? Most of the pain patients I know only reduce their pain enough to be functional – certainly not enough to “numb the rest of living”.

Conclusion

As the opioid crackdown continues, two ironies remain.

First, “this is the safest time in recent history to prescribe opioids,” said Steven Passik, PhD, vice president of scientific affairs, education and policy at Collegium Pharmaceuticals, in Canton, Mass.

“We have potentially safer drugs, abuse-deterrent drugs, buprenorphine, etc. We also have prescription drug monitoring in almost every state. And urine drug tests now come back in 24 hours, with accurate results. Give-back programs and counseling programs have shown efficacy in clinical trials in helping people to avoid abusing. And screening tools are available to ascertain someone’s risk of abusing.”

The second irony: Although opioid prescriptions have dropped tremendously, abuse and overdoses continue to rise.

The primary drugs of abuse are no longer prescription opioids but heroin and illicit fentanyl, and their abuse is driven partly by desperate patients who have lost access to opioids.

Yet the CDC remains firmly impervious to this information and our legislators are competing to see who can clamp down the hardest on prescription pain medications.

Meanwhile, the kids down the street are OD’ing on fentanyl-laced heroin after repeated stints in expensive, yet ineffective, AA rehabs that don’t offer the scientifically proven medication therapy that would give them the best chance at recovery.

Thus both patients suffering from pain and people suffering in the grip of addiction are left medically untreated and in misery, thinking about suicide, and unable to contribute to society.

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