Experts still tussle with proper prescribing of opioid painkillers

pillslotsa-150x150As the opioid abuse and drug overdose crisis rages, experts — after decades now of experience with powerful painkillers — continue to struggle with their proper handling and prescribing.

The federal Centers for Disease Control, on the one hand, has softened its earlier tough guidelines on the medications, while a  top government commission assailed the spiking U.S. overdose deaths and called synthetic opioids like fentanyl and the damage they cause a threat to the “national security and well-being.”

The U.S. Supreme Court also is scheduled to consider when doctors cross a line and act in criminal fashion in prescribing drugs — a professional privilege with wide latitude. The justices, in taking up this issue, consolidated two criminal appeals from doctors whom federal authorities convicted of running pill mills or distributing drugs resulting in death.

CDC revises its opioid prescribing guidelines

Lest laypeople or physicians have any confusion, the CDC re-emphasized from its 2016 crackdown and guidelines issued then that treatment of severe and chronic pain should emphasize first and foremost the many options besides opioids, the Washington Post reported:

“Like the landmark 2016 guidance, the new recommendations strongly urge care providers to first choose non-opioid alternatives for all kinds of pain, including over-the-counter drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), massage, acupuncture, and physical therapy. They also offer expanded advice on treatment of acute pain (pain that lasts less than one month), based on research in recent years … “

The newspaper explained that authorities knew years ago that they needed to take significant action against the opioid crisis, which has killed 500,000 Americans in a decade and an estimated 100,000 more last year alone:

“[The agency’s] 229-page updated proposal comes almost six years after the CDC belatedly tried to curb the liberal use of opioid pills, a treatment approach that developed in an era when caregivers were pressured to treat pain aggressively and drug companies were downplaying the chances of addiction. Doctors complained that they were dispensing large quantities of painkillers without the training on how to do so and that painkillers sometimes proved to be a gateway drug for the use of heroin and illegal street fentanyl.”

The CDC advised doctors to cap the number of days patients took opioids and the agency offered numeric dosage limits, including a recommendation for these to not exceed equivalents of 90 morphine milligrams.

Critics say the fearful practitioners calcified the numeric recommendations to the detriment of individualized treatment for patients in real suffering with constant pain. Those attacking the guidelines included advocacy groups and opposition efforts that experts said were promoted by Big Pharma. The American Medical Association also had sought revisions to the guidelines, which CDC officials said would give doctors at the frontline greater flexibility to weigh the risks and benefits of opioids for their individual patients and their complex situations.

As the Washington Post also noted:

“The new guidelines, published … in the Federal Register, are not binding on prescribers and are not intended to apply to end-of-life pain care, or pain care for diseases such as cancer and sickle cell anemia.”

Commission warns of great threat from synthetic opioids

Even as the CDC was issuing its revised guidelines, the Commission on Combating Synthetic Opioid Trafficking recommended dozens of steps that the Biden Administration and Congress should take to attack the perils posed by synthetic opioids, notably illicit supplies criminals are trafficking from Mexico and China.

The commission urged the nation to use its diplomatic muscle and to aid those countries to cut off the flow of street fentanyl, a painkiller that packs a wallop in the tiniest of doses. Law enforcement and federal and state drug combatting agencies report that criminals across the country are lacing all manner of illicit drugs, including marijuana, with fentanyl to increase users’ high — but putting the unsuspecting at substantial risk of overdoses and death.

The commission, according to the news site Politico, reported this:

“In terms of loss of life and damage to the economy, illicit synthetic opioids have the effect of a slow-motion weapon of mass destruction in pill form,” the report said. “U.S. and Mexican efforts can disrupt the flow of synthetic opioids across U.S. borders, but real progress can come only by pairing illicit synthetic opioid supply disruption with decreasing the domestic U.S. demand for these drugs.”

The 15-member commission — co-chaired by David Trone, a Democratic congressman of Maryland — had other counsel, Politico reported:

“The commission’s recommendations also include proposals to reduce the demand for illicit opioids in the U.S. Among them: increased federal funding for mental health support services and a national public health campaign highlighting the dangers of counterfeit pills. The commission also wants a dramatic expansion of public access to harm-reduction tools, including distribution and availability of the opioid overdose reversal medication naloxone and fentanyl test strips that reveal the presence of the chemical in illicit street drugs.”

Justices weigh when MDs cross lines to criminal prescribing

Doctors, of course, have played a giant role in the opioid crisis, and efforts to slash problematic prescribing — including with the tough earlier CDC guidelines — had significant effects, as the Washington Post reported, quoting the agency’s data:

“Collective action has dramatically reduced opioid prescriptions from a peak of 255 million in 2012 to 143 million in 2020.”

Still, some physicians clearly exceeded not only best professional practices but far outside accepted standards in prescribing opioids, which are a controlled substance. When criminally charged, they have insisted they were trying to help patients and acted in “good faith.”

Law enforcement, prosecutors, and courts have disagreed and the high court — pushed, in part, by advocacy groups for patients dealing with chronic pain — will consider the boundaries of doctors’ now-expansive prescribing privileges. To be sure, doctors must follow specific rules when prescribing controlled substances, including opioids and narcotics. But the law also gives licensed MDs considerable leeway to prescribe prescription medications approved by the federal Food and Drug Administration, including ordering them for patients in off-label use.

The convicted doctors whose cases the justices will review aren’t model citizens or medical practitioners, the medical news site Stat reported:

“Xiulu Ruan of Alabama … was sentenced to 21 years in prison in 2017 after being found guilty of running what the Justice Department called a pill mill, and Shakeel Kahn of Wyoming …was sentenced to 25 years in prison in 2019 for crimes including drug distribution resulting in death … Ruan and Kahn ‘simply cloaked themselves in medical garb while acting as drug dealers, lining their own pockets by dispensing addictive, dangerous, and lethal drugs, aware all the while that their profit-seeking came at the expense of their patients’ health,’ the government wrote in a brief.”

But Kelly Dineen, director of Creighton University’s health law program, Dineen co-wrote a brief with a group of other health law and policy professors, arguing that that the federal Controlled Substances Act “has been weaponized against practitioners in reaction to the overdose crisis,” Stat reported. The news site also quoted this argument in a brief from the National Pain Advocacy Center (which says it does not take funding from Big Pharma): “Honest providers fear being mistaken for bad actors.”

In my practice, I see not only the harm that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs.

The opioid crisis took time to blow up, fueled by Big Pharma and abetted by doctors, nurses, hospitals, insurers, and many others in health care. While progress appeared to have been made in dealing with this mess, this public health menace exploded anew during the coronavirus pandemic. It demands a full-on, urgent response to put down.

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