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 (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.

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. 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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  • I have been making many comments.. because I’m stuck in this prison of pain..why are addicts so important and pain patients are not? An addict will always find something else. You can’t force an addict to get clean. But these laws are forcing pain patients to follow the addict into the streets. Our concerns are not that we may become, or even if it’s a given that we will, addicted to our pain meds. There is no cure for our conditions, so yes we will be taking pain meds aka opioids to the grave. Cutting our relief will not fix us or help us all it’s doing is bringing us to that grave a lot faster than we would get there on our own. I do hope that something changes, before more of us take our leave.

  • Some help needs to come to us, chronic pain patients, before we are forced to take our leave. Why is the government in my medical business? They know nothing about my pain, nor do they care. I gave DDD and arachnoiditis the pain is constant torment, yet the doctors keep reducing my pain meds. I have but 2 choices, since I cannot take this pain I am forced to go to the streets, or take my leave. This is not freedom this is a prison of pain. This United States government has turned chronic pain into a terminal illness ..

  • Nikki, I would complain to the hospital administrators. The patient is supposed to come first. Show them a copy of the CDC Guideline. No where does it state that opioids are not to be prescribed. Given your condition, your rights as a patient are being violated. Cheryl, Walmart is misapplying the prescribing mandates, which are not supposed to pertain to patients on long term opioid therapy. Look up the rules in your location, and if this is the case, point it out to them. If they refuse to listen, find a pharmacy that will follow the law and not arbitrarily create their own. If you find they are in violation of the law, report them to your state pharmacy board. Keep us informed.

  • I’ve been taking tramadol for over 15 years for long term pain relief. Wal-Mart pharmacy will only prescribe 7 days worth at a time. I use to get 180 tramadol for $14.00. Now I’m paying $4.00 for 21 tramadol. I don’t mind getting a 1 week supply at a time but now they’re charging me 3 times what I was paying. The pharmacies policies are making them even more money.

  • I have been on crutches for 7 months since a bicycle accident, my foot got caught, foot stopped, the rest of me kept going – for a while anyhow. Torn muscles and hams, separation from the bone, everything on one side stretched from foot to rib cage – that’s pretty well healed but I am left with a “significant” herniation of the L5/S1 disk resulting in debilitating sciatica, weakness and scoliosis. I cannot walk more than 10 feet without crutches. I have just had my second spinal injection and the next step is surgery. I’m 68 so on medicare so what doctors can and can not do is pretty regulated. I had a flareup 3 weeks ago and I had 4 days of 10 pain, screaming and begging not to have to get out of bed – my doctors gave me anti-inflammatories, steroid and non, and when they found out I was allergic to gabapentin and could not tolerate Ibuprophen, recommended acetamenopen and ice. For 10 pain. Because I was in so much pain I asked for pain killers so now I am labeled a pill seeker and can get nothing. So now the spinal doctors want to do surgery to trim the disk – I KNOW they will not give me opioid pain killers for more than a day or two after the surgery if even that much. So I am afraid to have the surgery. As someone who has been in so much pain that they tried to crawl away from their hip, who has gone weeks with no more than an hour or two of sleep at a time, the idea of more pain and no relief is not acceptable. I do not trust my doctors. They will not help me. How can I let anyone operate on me with that lack of trust? As I said, I am 68, I have been through a lot and have never gotten addicted to pain killers. I have never abused any prescription. I do not understand why the DEA is stopping doctors from doing their jobs. The reason the medical profession came about is to relieve suffering. The idea that I cannot rely on any medical person to provide proper care is terrifying.
    Lying in bed screaming while they “protect” me from potential addiction is not proper care.

    • Nikki,

      If you don’t trust your physician don’t do any procedure, get a second opinion.

      Don’t feel pressured or intimidated.

  • Molly, I’d say whomever voided your script and didn’t have a discussion with your doctor because they think they ARE the doctor should have so explaining to do.

    • Lance and Timothy- This is a great article. Sending to the pharmacy board of Mississippi to ponder along with second complaint that they have jeopardized my health and life along with HIPPA violations. I’ll keep filing every few days til someone responds with some sense.

      Everyone needs to file complaints in their state with this info. Maybe just maybe state by state we can get the medical community back to practicing smart medicine.

  • Good morning everyone, please check out an article I read yesterday that should give us all some hope….see: mustreadalaska.com, after receiving many complaints from patients about pharmacists refusing to fill legitimate prescriptions, the Alaskan pharmacy board issued a letter to all pharmacists ordering them to fill all legal prescriptions. There are a list of mandates that were issued. Further proof that we must take action.

  • Pharmacies like Walmart and Walgreen (and others) need to stop being valentines in this fake crisis. The crisis is that pain patients are being denied filling legitimate valid prescriptions by medical doctors.
    Addicts do not get prescriptions filled. They steal from real pain patients (parents, grandparents, friends parents and grandparents or buy stolen medications from professional thieves.

  • Just read a report today were researchers at aimed alliance surveying 600 physicians in a poll that shows their ‘frustration over insurer policies and delays that doctors say could be leaving patients in prolonged pain’…I’m thinking, is this what the main problem is with pain patients having such an almost impossible time trying to get prescriptions because of insurance company greed? How sickening to think that they would put their profits above and beyond another human beings suffering. So hard to believe that this could be true.

    • Part of the problem is that prescriptions often cost hundreds of times as much as cost to manufacture. With opioids over regulation undoubtedly contribute to their high cost. A ten fold markup over the manufacturing cost should be enough to generate a fair profit.

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