Comment: Good intentions don’t mean good results. Laws& regulations can have unintended consequences that we’re seeing now. Despite the fact that most addicts are NOT getting their drugs illicitly, prescribers and legitimate patients are penalized. Education is better than regulation! Well-intentioned ignorance is best treated with education!
By KATE M. NICHOLSON, DIANE E. HOFFMAN, and CHAD D. KOLLAS
DECEMBER 6, 2018
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.
A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear
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, 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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