Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients

www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline/#comments

During the recent Interim Meeting of the American Medical Association, the organization’s president, Dr. Barbara McAneny, told the story of a patient of hers whose pharmacist refused to fill his prescription for an opioid medication. She had prescribed the medication to ease her patient’s severe pain from prostate cancer, which had spread to his bones. Feeling ashamed after the pharmacist called him a “drug seeker,” he went home, hoping to endure his pain. Three days later, he tried to kill himself. Fortunately, McAneny’s patient was discovered by family members and survived.

This story has become all too familiar to patients who legitimately use opioid medication for pain.

Since the Centers for Disease Control and Prevention published its guideline for prescribing opioids for chronic pain in March 2016, pain patients have experienced increasing difficulty getting needed opioid medication due to denials by pharmacists and insurance providers.

More troubling are recent press reports, blog posts, and journal articles that describe patients being refused necessary medication or those dismissed by their treating physicians, who practice in fear of regulatory reprisal. At the interim meeting, the AMA responded to these developments, passing several resolutions against the rash of laws and mandatory policies that limit or prevent patient access to opioid painkillers.

The CDC designed its guideline as non-mandatory guidance for primary care physicians. But legislators, pharmacy chains, insurers, and others have seized on certain parts of its dosage and supply recommendations and translated them into blanket limits in law and mandatory policy. Today, in more than half of U.S. states, patients in acute pain from surgery or an injury may not by law fill an opioid prescription for more than three to seven days, regardless of the severity of their surgery or injury.

Although many of these laws exempt patients with chronic or cancer pain, in practice they often affect those with long-term pain, like McAneny’s patient. Some insurance companies and major pharmacy chains, like Walmart, Express Scripts, and CVS, also have mandatory restrictions on the opioid prescriptions they will fill. In addition to imposing supply limits, insurers and pharmacies are increasingly using the CDC’s dosage guidance (the equivalent of 50 to 90 milligrams of morphine a day) as the basis for delaying or denying refills for long-term pain patients, even though the CDC guidance is intended to apply only to patients who have not taken opioids before.

The Drug Enforcement Administration and some state medical boards are also using this dosage guidance in ways that were never intended, such as a proxy or red flag to identify physician “over-prescribers” without considering the medical conditions or needs of these physicians’ patients. As a result, some physicians who specialize in pain management are leaving their practices, while others are tapering their patients off of opioids, solely out of fear of losing their licenses or criminal charges.

The laudable goal of these laws and policies is to stem the tide of unprecedented overdose deaths and addiction in the U.S. But here are three interesting facts: Opioid prescribing is currently at an 18-year low. The rate of prescribing opioids has dropped every year since 2011. Yet drug overdose deaths have skyrocketed since then.

Recent data from the CDC suggests that illegally manufactured fentanyl, its analogs, and heroin are responsible for well over half of all overdose deaths. Stimulants like cocaine and methamphetamines are responsible for another third. Deaths related to prescription opioids come next in line, although many of those who died were not the intended recipient of the prescribed medication. In addition, most deaths involve multiple substances that are used in combination, often including alcohol.

The vast majority of people who report misusing prescription opioids did not get them from a doctor under medical supervision, and as many as 70 percent reported prior use of substances like cocaine and methamphetamines.

Conflating the misuse of opioids with their legitimate medical use, and treating all opioids — illegal or prescription — alike is stigmatizing patients for whom opioid painkillers are necessary and medically appropriate.

There’s no question that taking opioid medications carries risks: The CDC places the risk of addiction with the long-term use of opioids at 0.07-6 percent. The risk of addiction justifies judicious prescribing, trying other forms of treatment before prescribing opioids, and carefully screening patients for a history of addiction and mental health issues when opioids are being considered.

But most patients who use opioid medication for pain do not become addicted, although they may develop physical dependence. Addiction is the compulsive use of a substance despite adverse consequences. Appropriate medical use is just the opposite, use on a set schedule as prescribed with benefits to health and function.

Nearly 18 million Americans currently take opioids long-term to manage pain; many of them have complex medical conditions. When appropriately prescribed opioids are denied, patients whose pain has been well-managed by them may experience medical decline, lose the ability to work and function, and resort to suicide. Denying opioids to patients who have relied on them — sometimes for years — may cause some to turn to street drugs, thereby increasing their risk of overdose.

Dr. Terri Lewis, a researcher and rehabilitation specialist, recently conducted a nationwide survey of 3,000 pain patients. More than half of those surveyed (56 percent) reported disruptions in care or outright abandonment by their physicians. Among those reporting disruption or abandonment, many experienced adverse health consequences (55 percent) as well as hopelessness or thinking about suicide (62 percent) as a result. In other surveys, physicians said that they were prescribing fewer opioids or ceasing treatment of pain patients altogether because of regulatory scrutiny, even in cases where they believed that doing so would harm their patients.

The CDC guideline and its progeny of laws and policies have created chaos and confusion in the medical community. Some physicians are telling their patients that changes in the law are the reason they are tapering them to a preset dosage of opioids or off of opioids altogether. Yet the specific dosage thresholds in the CDC guideline were never intended to apply to patients currently taking opioids. Indeed, nothing in the current legal or regulatory environment justifies forcibly tapering a patient off of opioids who is doing well, and there is no solid evidence to support such a practice.

Some physicians are also using the CDC’s dosage thresholds, or simply their patients’ use of opioids, as a reason for abandoning them. Abandoning pain patients out of fear of regulatory reprisal may violate a physician’s ethical duty to place a patient’s welfare above his or her own self-interest. If serious harm results from abandoning a patient’s care, it may also serve as a basis for discipline or malpractice claims. In addition, physicians and pharmacies have responsibilities under the Americans with Disabilities Act not to discriminate on the basis of a patient’s condition, including chronic pain, or a perceived condition, as when a person with pain is erroneously regarded as a person with opioid use disorder or addiction when there is no clinical basis for that perception.

10 Responses

  1. WHERE ARE ALL THE LAWYERS????

    • I dont know but I’ve always said they would make mega bucks over this illegal bullcrap!

    • Well they hear they will be going up against the DOJ/AG and they melt like butter, all but the very very bravest… We will have to do it ourselves with out advocacy and our other strong groups like Red Lawhern, ATIP, CAW, CIAAG, DPPR and Dr. Kline and Cheek and Ibsen and PharmD Steve. I say we got to put the CDC back in its place, which is no where near dose suggesting, Sue the Gov somehow, and Get a Congressional and Senatorial Judiciary Hearing on the floor, not in a back room. We don’t need no stinking lawyers…

  2. It is LONG past time for CDC to step up and 100% clarify EXACTLY what the 2016 “guideline” is “supposed” to mean. Not a half hearted explanation but, a real clarification. At this point it seems the DEA is unstoppable at the evident persecution and death being indirectly caused by the over zealous agency or is that the true……intent of the guideline? To allow search/seizure, and disciplinary action of each states medical regulators (boards) against our physicians who are attempting to treat real pain issues with the last medication that is effective when alternative therapy fails to manage known pain generation by disease, injury and of course…..failed surgery. Seizure of a patients documentation? For what, to hide truth?!

    • Well the first thing is to establish, or re-establish, that the CDC NEVER HAD AUTHORITY to suggest dosing of ANYTHING. Complaining about them just cements their rogue influence and lets the fully liable FDA off the hook. There is nothing else to talk about regarding the CDC except that they have no scope here unless they want to report accurately on how many are prescription opiate untimely deaths. But they can’t even do that. The CDC in regards to opiates should be denounced and sued.

      • I agree but, sue a federal agency? We all know how that goes. Public sentiment when the :”majority” of people in this country don’t have a clue what life is like “living” in crippling pain? WE, the patients have VERY little to say about public policy or the “guideline” even if it was unlawful for CDC to publish a “guideline” mean to be enforced. Right?

        • Thank you for your reply. I enjoy all of your comments. Well that fellow with the advanced Lyme Disease diagnosing tests was granted to sue the CDC just recently. It can be done with the right judge.

          We have everything to say and get what we want, but how do we say it? Some of our best efforts now will mix Kratom in with our rallies. That will not help but emasculate and destroy the opiate recovery movement which recovery is the goal. We might as well throw in LSD too.

          The CDC by law is out of dosing instructions from the start. Why complain for one word about how this or that guideline ‘should be said this way’? Or beg an apology from Andrew Kolodny? The persecuted doctors haven’t come close to satisfying a criminal standard or have deviated from the standards of care of their peers. Attorneys are job one for them. William Mangino said if we can spring one doc the rest will get out and the AGs will be damn scared to arrest another one with their railroad technique.

          We don’t have any choice but to do what is hardest first and last because our enemy takes no prisoners. (Yes I have hollered at the CDC, a lot, but I suffer, like the rest of us, from the idea that men are all reasonable and I am an idealist, and hollering our lungs out is uncivil). The more on topic we are the faster we win. I am prepared to stay with the effort no matter what road it goes down, but I get these silly notions about optimizing things.

          No one has to tell me how much we are suffering, I am gonna massive MI any day here.

        • Yep!

    • I refuse to accept that the CDC will ever be part of what the proper use of opiates are. The labeling that comes with ever prescription opiate are from FDA peer reviews. That’s where dosing instruction come from.

  3. “Chain of custody” is in effect in the US and all of the time. It is the DEA that oversees the “Chain of custody”. So they know when it comes in and when it goes out and where and how much.

    With the flood of illicit opiates that we have had recently and from which money can not be had by lawsuits, isn’t it ‘funny’ that pharm mfg is being sued?

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