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.

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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.

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The AMA’s recent resolutions formally push back against what the AMA calls the misapplication of the CDC’s guideline by regulatory bodies, legislators, pharmacists and pharmacy benefit managers, insurers, and others. The resolutions underscore that dosage guidance is just that — guidance — and that doses higher than those recommended by the CDC may be necessary and appropriate for some patients.

The AMA also took issue with the recent practices of regulatory bodies that subject physicians to oversight and potential sanction solely because of the opioid dosages they prescribe. Medicine involves treating patients individually, and weighing the specific risks and benefits of treatment in each case. Taking this capacity away from physicians hamstrings their ability to treat their patients — as does requiring them to practice in an environment of fear.

Epidemics instill fear, but physicians have a responsibility to rise above fear and advance the interests of their patients. The AMA’s action in advocating for patients and for the right of physicians to practice individualized care is an important effort in beginning to rebalance the scales in the joint goals of reducing pain and opioid addiction.

Kate M. Nicholson, J.D., is a civil rights and health policy attorney who served for 20 years in the Department of Justice’s Civil Rights Division, where she drafted the current regulations under the Americans with Disabilities Act and managed litigation nationwide. Diane E. Hoffmann, J.D., is a professor of health law at the University of Maryland School of Law, director of its Law & Health Care Program, and a former Mayday Scholar. Chad D. Kollas, M.D., chairs the American Medical Association’s Pain and Palliative Medicine Specialty Section Council and is the medical director in palliative and supportive care at the Orlando Health UF Health Cancer Center.

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  • No need to repeat what has been said. The article states it well and the comments are descriptive of tens of thousands. Shameful that those in power to stop this overzealous attack on physician’s rightf to decide what is best for their patients dudnt do so before this mess evolved.
    Where were the ‘studies’ before the recommendations snd why are pharmacists allowed to berate an embarrass patients and/or deny them medication.
    Who determine that cancer pain was the only legitimate pain?
    Anyone at the CDC awake enough to look as t and compare their own statistics? Like prescriptions for opioids going down and suicides going up? And use of street drugs also increasing? Heckofa job there Brownie.

  • Thanks alot for article, Kate. Its one of the most honest and informative out here. As a chronic pain patient myself, like so many others in this country, who have been responsible and did not abuse our opioid medications…I think were we went wrong as a group is being silent to long when for instance, parents of children who died as a result of their selfish and recklace behavior…when they were going on tv and all over the news and basically blaming everyone, including us, for their child’s death! We should have never let them get away with that. But, we never had thought that it would go that far. The powers that be need to stop being naiive, and misinformed about this whole issue.

  • Herion will be the new medication. People like me can’t afford what Larry flint was treated. Chronic to cut the cord.

  • I am one of the many patients described here. I have had numerous surgeries, gun shot wound to my abdomen that left me with chronic pain, nerve damage and gun pellets, bone fragment. and staples in my abdominal cavity. I also have ongoing health issues to deal with. I recently had to find a new doctor, and of course tapering my pain med along with anxiety medication was the first topic and procerdure. It is difficult for me. I have been on some form of opioid pain medication for nearly 20years. This all new revisions and include help for myself and others.

    • Ginger, would it help if you took this article into your Doctor? Tho’ my Doctor is understanding, I am still going to show it to her. Maybe it would aid him/her in understanding it’s okay to prescribe and even a breaking of their oath to NOT treat their patients with the medication needed to relieve their chronic pain!

  • I’m a 55 yr old disabled vet living in TN. I’ve suffered chronic pain for over half my life.
    It took me 14 yrs to get my pain treated by the VA, the 1st in my generation in Knoxville, and after 13 yrs of treatment they took the “guidelines” as gospel and stopped treating any veteran who wasn’t dying of cancer.
    I’ve since had my dosages cut by 2/3 by the civilian pain Dr I go to. My quality of life has been reduced to literally living in my bed…and while I couldn’t do it to my son, suicide is never far from my thoughts. The way pain sufferers are treated is a national disgrace…especially since the misuse of the guidelines was never intended to be used in the manner they have been. It’s inconceivable that as they’ve realized their mistakes that it’s not been corrected yet. I hope I don’t lose more years before they do. My disgust knows no bounds at the state of things as they are. My mental and physical health have both deteriorated as it is.

  • Yes, it may be unethical to reduce the dose on a patient you deem is qualified as having chronic pain. Yet, I can’t get pharmacies to even fill certain long-acting drugs, or go above a certain amount of pills per month of the short-acting drugs. I have had patients demeaned at the pharmacy counter, out in the open, just to have their medication filled. If I were to complain to the pharmacy board, I would then have the potential retaliation of having a Medical Board review ALL of my patients, potentially losing my prescribing ability. Where does that leave my patients then?

    No one questions the corporate practice of medicine by CVS, Rite Aid, WalMart, Walgreens etc. when they ban filling narcotics above the “limit”. In Califiornia, that is expressly against the law. The California Medical Association would not support me reporting this activity to the Pharmacy Board.

    So, with no legal support or representation, I am supposed to stand up to the Medical Board of California to ethically represent the needs of my patients? I am supposed to go into financial ruin to fight for my patient’s rights? Very unlikely. The quarterly Medical Board report is littered with actions against the licenses of physicians for “improper prescribing of controlled substances”.

    If I continue my current prescribing patterns, I will lose my license to prescribe them, even if I somehow manage to keep my license to practice. If I at least show I am “complying” with the “current” recommendations of reducing narcotic usage (whether or not evidence based), then I can keep my DEA certificate and my license.

    If surviving is unethical, then I have to choose to be unethical. Having no DEA or medical license does no service to my patients

    • Really? I guess some of us like the money more than the patients. Funny thing, without patients the money won’t be there, either. But, if a doctor ignores the needs of his chronic pain patients, he can continue a rather nice lifestyle. All while denying his patients compassionate care. I am glad that I don’t swim with the sharks any more!

    • There is no question that doctors are under siege from all sides in treating pain today. The ethics discussion came into play in the area of patient abandonment – simply dismissing patients as liabilities.

  • The misapplication and misreporting on opiates is killing people. Pain patients are choosing suicide over living with chronic pain, as they are stigmatized, demeaned and criminalized by physicians and family members. At the same time, no treatment was available for the addicted. leading to even more deaths.
    The focus on prescription drugs is killing people, as the illegal drug trade expanded the use of fentanyl. While mass media was lying and misreporting on prescription opiates, sensationalizing misinformation, Andrew Kolodny, following Dr Drew Pinskies rise to wealth and fame, peddling expensive and ineffective treatment centers. They made as lot of money with “Celebrity Rehab” back in 2004, even though at least 5 of their reality stars died.

    No one looks at how the so called opiate epidemic became a marketing extravaganza and an opportunity to peddle everything from pseudo science, to alternative medicine. The numbers and facts tell us that people are still dying, even though the media presented all of this as a “good Investment.”

    Industry insiders with financial or ideological motivations created the “Guidelines’ with no input from pain physicians or patients. Pharma cashed on on alternatives that were dangerous and innefective, while they misinformed the public.

    The death rates indicate that this market based approach is not working. The FDA and CDC creqated a whole new Epidemic, now Fentanyl and it’s analogues are available everywhere, and even Meth contains Fentanyl. The FDA created the guidelines to protect industry and interfere with healthcare. Places where these guidelines were exceeded years ago saw a rising death rate, yet no reaction for the FDA or CDC. They did create a market for Fentanly and it’s analogues, which anyone could have predicted. Apparently ignorance is not goood policy.

    Sarah G. Mars, Daniel Rosenblum, Daniel Ciccarone. Illicit fentanyls in the opioid street market: desired or imposed? Addiction, 2018; DOI: 10.1111/add.14474

  • T. Trust asks “Who has caused the opioid crisis? Who has prescribed the opioid medication?”

    I suggest with every intention of courtesy that you’ve mixed up two unrelated things. The opioid crisis has multiple social and economic “causes,” none of them significantly related to prescriptions. Mortality attributed to prescription opioids — either taken by patients OR diverted — is such a small fraction of total overdose mortality caused by street drugs that it doesn’t even jog the meter. With rates of prescription 250% higher than people under 30, seniors over 50 have the lowest rate of opioid overdose related mortality of any age group. And it’s been stable for 17 years while mortality in kids and young adults has skyrocketed. Likewise overall opioid mortality has continued to rise by leaps and bounds even as the total numbers of opioid prescriptions have dropped by ~45% since 2010.

    Over-prescribing is an urban legend — a myth! Pain patients remain hideously under-treated, and those who ARE treated are almost never abusers.

    • Great comment Doctor! Are they ever going to listen to rational, professional people like you who has a total understanding about the issue?

    • The news media is spreading this vicious rumor, “80% of heroin addicts started off by using prescription opioids”. Not true. The majority started by being introduced to them by a friend/acquaintance/relative.

  • I am a legally/ medically disabled chronic long term elder orphan female patient/human barely existing financially physically mentally and emotionally in central Florida who got treated like a a convicted junkie by my NEW pain management Dr on my last regular monthly appt which i wish i would’ve recorded on my fone. Without giving u a lengthy scenario of how i was horribly”assessed😠!!!! I would like to know if there are any single or class action lawsuits available for me to pursue. I had such a good repoir with the Dr he suddenly replaced-left the pain clinic. This new Pain Dr threatened/bullied me horribly and i left crying and started stuttering terribly again. He didn’t believe anything i said even tho all my records are in there puter files and wants me to have 2 more invasive MRIs see an ortho pedic specialist have physical and step therapy and take otc meds that are harmful to me-all by my upcoming monthly visit in a few weeks. My car is down and transportation thru my crappy health plan is a chaotic nightmare to say the least. He is also understand investigation in this state for medical fraud and overprescribing a heavy opioid. Could someone, perhaps the civil liberties union, be of help to me? Or??? I have way more details/names/info that I can discuss with whoever. Thanx in advance if someone compassionate reads this with empathy too. My email is posted.🙏

  • Typical. Anyone would have to be blind not to have seen this coming. Give the Government a inch, they take a mile.
    It’s always Black & White. No Gray when it comes to our Government. Anything to make criminals & drug addicts out of patient’s. Helps to fill more jails & prisons. Which helps to make sure we NEED more Government oversite… on & on it goes.
    Or, better yet, something much easier to do, with faster results: Scare Medical Professionals into thinking they will be made into criminals for carrying out their ethical duties.
    Creating even more panic & misery all across the land.
    Mission accomplished!

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