Federal Prosecutors Warn Top Opioid Prescribers in Wisconsin

By Pat Anson, PNN Editor

Wisconsin’s two U.S. Attorneys have sent letters to 180 physicians, physician assistants and nurse practitioners in the state warning them that their opioid prescribing practices could result in prosecution.

None of the prescribers have been charged with a crime and it’s not clear if any are under investigation or have been linked to overdoses. Copies of the letters were not released and the recipients were not identified.

According to a news release, the letters warn doctors that they are prescribing opioids at “relatively high levels” that could lead to addiction and that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.”

“We know that for many, addiction began with opioids prescribed by a medical professional,” said Matthew Krueger, U.S. Attorney for the Eastern District of Wisconsin. “By sending these letters, we are asking medical professionals to join the fight against addiction and ensure they prescribe no more opioids than are necessary.”

“Opioid addiction has touched the lives of far too many families in our state,” said Scott Blader, U.S. Attorney for the Western District of Wisconsin. “Medical professionals play a pivotal role in stemming the flow of legal opioids into unlawful channels.”

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According to a spokeswoman, the 180 recipients of the warning letters were selected based on a review of Medicare prescription drug claims, which found that they prescribed opioids above the CDC’s highest recommended dose of 90 MMEs (morphine milligram equivalent). 

“They were identified through Medicare data for two years,” Myra Longfield, a public information officer in the Western District of Wisconsin, told PNN. “And from that data, practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain.” 

The 2016 CDC opioid guideline is voluntary and only intended for primary care physicians. Longfield said warning letters were not sent to pain management physicians, oncologists or those working in hospice or palliative care, where higher opioid doses may be needed to control pain. 

Chilling Effect on Prescribers

Federal prosecutors in Georgia and Massachusetts have sent similar warning letters to high prescribers. While the intent is to urge caution, critics say the letters are likely to intimidate other doctors.

“This will have a totally chilling effect. The abuse of statistics is pathetic. It would only be an ignorant person that would take the top prescribers and say that they are endangering lives,” said Mark Ibsen, MD, a Montana doctor who nearly lost his medical license over allegations that he overprescribed opioids.  

“After they lop off the top prescribing doctors, guess what that leaves? More top prescribing doctors. Until there are none. Soon we will be seeing tattoos on physicians, similar to POWs.”

“This is an egregious overreach and will lead to more deaths not fewer,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Using the CDC guidelines as a goal post is not what even the CDC recommended. Most opioid addictions do not begin with a legal prescription of opioids. It usually starts long before exposure to a prescription opioid. The major problem is with illegal opioids smuggled in from Mexico and China. 

“I am worried for tens of thousands of patients in Wisconsin. Many of them will be at risk of suicide or seek illegal drugs, where the real harm exists. Sad. Very Sad.”

Last year, the American Medical Association adopted resolutions opposing the “misapplication” and “inappropriate use” of the CDC guideline. The resolutions by the AMA House of Delegates warn that “no entity should use MME thresholds as anything more than guidance” and that physicians should not be disciplined or prosecuted for prescribing opioids at levels above those recommended by the CDC. The AMA said some patients “can benefit from taking opioids at greater dosages” and “such care may be medically necessary and appropriate.” 

Most opioid overdoses in the United States are now linked to illicit fentanyl and heroin, not prescription opioids. In Wisconsin, 916 people died of opioid overdoses in 2017. Most of those deaths involved either heroin or fentanyl.

FDA Expands Safe Prescribing Program for Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration will require that educational training in pain management and safe opioid prescribing be offered to all healthcare providers under a major expansion of the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program.

REMS is also being expanded to include immediate-release (IR) opioids such as hydrocodone, oxycodone and morphine. Until now, REMS regulations only applied to extended-release and long-acting (ER/LA) opioid analgesics, such as OxyContin and Exalgo. Warning labels will be updated for all IR opioids, which account for about 90 percent of opioid pain medications.

“Many people who become addicted to opioids will have their first exposure in the medical setting,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements.”

The REMS program was first established in 2012. It required manufacturers of ER/LA opioids to pay for continuing education programs for prescribers only. Updated educational content must now also be provided to nurses, pharmacists and other healthcare providers who seek it. The training will cover broader information about pain management, including alternatives to opioids for the treatment of pain.

The training is not mandatory, but the FDA is considering whether to require continuing educational programs in pain management and safe prescribing.

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“The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight,” the agency said.

“I think these changes to the REMS are very good and long overdue,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. “We know that the IR opioids are much more highly sought-after, versus ER/LA opioids, for purposes of abuse, and there is absolutely no reason why they (and their manufacturers) should be exempt from this requirement.  

“I’m not concerned, at this stage, about this change causing primary care providers to back off on prescribing, given that participation in the program is still completely voluntary for healthcare providers. If this voluntary status changes, and FDA finds a way to make REMS education mandatory, I will be concerned that some providers will opt out of prescribing opioids altogether.”

The FDA’s action greatly expands the number of opioid products covered by REMS from 62 to 347 opioid analgesics. The updated warning labels will strongly encourage providers to complete a REMS education program, and to counsel patients and caregivers on the safe use of opioid medication.

“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” said Gottlieb.

Opioid prescriptions in the United States fell sharply during the first half of 2018 and now stand at their lowest levels since 2003, according to data released last month by the FDA. The trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids.

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

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Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

10 Myths About the Opioid Crisis

By Roger Chriss, Columnist

There is no shortage of false statements being made about opioids. As the overdose crisis worsens, old and debunked claims reappear, while new claims rise up alongside them. Pundits, politicians and even physicians are perpetuating them, despite all evidence to the contrary.

So let’s set the record straight in order to promote an informed dialog about opioid medication, chronic pain, and the opioid crisis.

Myth 1: America has 5% of the world’s population but uses 80% of the world’s opioids.

Numerous politicians, such as Missouri Sen. Claire McCaskill and former New Jersey Gov. Chris Christie, as well as many journalists, have made this statement. It is demonstrably false.

In fact, the U.S. only uses about 30% of the world’s opioid supply. That estimate includes the addiction treatment drugs methadone and buprenorphine, both of which are opioids.

Myth 2: 80% of heroin addicts began by abusing prescription opioids.

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This myth is pernicious because it is based on a kernel of truth. The number is correct but the implication is wrong. Only 4 to 6% of people who misuse prescription opioids go on to use heroin. And the number of people who start heroin without taking prescription opioids first has been rising in the past year.

Myth 3: Addiction starts with a prescription.

This claim persists despite decades of data to the contrary. A 2010 study found that only one-third of 1% of chronic pain patients without a history of substance abuse became addicted to opioids during treatment. Most abuse begins when people take medication that was not prescribed to them, using pills that were stolen, purchased illegally, or obtained from friends and family members.  

Myth 4: Opioid use leads to pain sensitization or ‘opioid induced hyperalgesia.’

Addiction treatment specialists like to repeat the claim that long-term opioid use makes patients hypersensitive to pain. But hyperalgesia is poorly understood and often confused with opioid tolerance. One study found that chronic pain patients on opioids had no difference in pain sensitivity when compared to patients on non-opioid treatments.    

Myth 5: Opioid overdoses are killing 64,000 people per year.

Nearly 64,000 Americans died from drug overdoses last year, according to the CDC, so that part is true. But opioids were involved in only about two-thirds of those deaths – and most of those overdoses involved heroin and illicit fentanyl.

Myth 6: Reduced opioid prescribing will end the overdose crisis.

Reduced prescribing is clearly not working.The number of opioid prescriptions has been in steady decline since 2010, yet fatal overdoses have risen sharply ever since.

Myth 7: Medical cannabis will cure the opioid crisis.

This is a recurring myth, made popular again in 2017. Unfortunately, not only does the recent data show that medical cannabis is not helping in states where it is legal, the underlying assumption of this myth is that chronic pain care is driving the opioid crisis. This is not the case.

Myth 8: Banning opioid medication will fix the opioid crisis.

This was put forth again early in 2017 by New Hampshire attorney Cecie Hartigan. Setting aside the problem of banning illegal drugs like heroin and fentanyl analogues (they are already banned), opioids are simply too medically useful to give up. Moreover, prior experience with drug bans, from Prohibition to the current overdose crisis, shows that bans do not stop misuse or addiction.

Myth 9: There are lots of ways to treat chronic pain

This myth has become increasingly popular as states, medical facilities, and health insurers pursue policies to reduce opioid prescribing. Although some of these methods, from physical therapy to spinal cord stimulators, may prove helpful, that misses the fundamental point. Chronic pain disorders are so horrible that all effective options, including opioid therapy, need to be on the table.

Myth 10: Opioids are ineffective for chronic pain.

This is the biggest myth of all. There is an abundance of high-quality research showing that opioids can be effective for some forms of chronic pain. Here’s a partial list of recent studies:

Adding to these studies is a recent review in Medscape, in which Charles Argoff, MD, a professor of neurology at Albany Medical College, said that “in multiple guidelines and in multiple communications, we have a sense that chronic opioid therapy can be effective."

New myths appear regularly, but these persist despite all efforts to counter them. Like an ear-worm or viral meme, they cannot be eliminated. The only defense is knowledge.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Trump Commission Seeks More Limits on Rx Opioids

By Pat Anson, Editor

President Trump’s opioid commission released its final report Wednesday, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.   

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said in its report.

The president established the commission in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

“Our people are dying. One hundred seventy-five people a day, every day, are dying in the United States from this epidemic,” said commission chairman Gov. Chris Christie of New Jersey, one of five politicians who served on the six member panel.

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“If a terrorist organization was killing 175 Americans every day on American soil, what would you be willing to pay to make it stop? I think we’d be willing to do anything and everything to make it stop. And that’s the way we now need to see this, because this is an attack from within. We are killing ourselves.”

The commission’s 131-page report did not spell out how much money would be needed to implement the panel’s wish list of 56 recommendations.

Chief among them was to get drug makers and the National Institutes of Health to work together developing new non-opioid painkillers and addiction treatment medications.

“It is inexcusable that the major pharmaceutical companies in this country have stood on the sidelines during this crisis. And they have,” said Christie.

New Prescribing Guideline to Supplement CDC's

The commission is also recommending that a new set of guidelines for opioid prescribing be developed to “supplement” the guideline released last year by the Centers for Disease Control and Prevention.  It was not immediately clear if the new guidelines would replace, weaken or strengthen the CDC’s recommendations, or simply expand their use throughout the healthcare system.

“An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians,” the report says.

The commission recommended that federal regulators require patients to give informed consent about the risks and alternatives to opioid painkillers before the medication is prescribed to them. The panel also called for a new “national curriculum and standard of care” for opioid prescribers, and that pharmacists be trained to recognize and deny “inappropriate prescriptions.”

The commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing. Critics say the current data now being used by federal agencies is flawed or cherry-picked. 

“We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the report says.

No Limit on Opioid Supply for Acute Pain

The commission did not recommend that supply limits be placed on opioid prescriptions for short term pain, as many expected. Several states have already enacted 5 or 7-day limits on opioids for acute pain. The panel also did not endorse the development of marijuana-based medications, which many pain sufferers are now using as an alternative to opioids.

Most of the commission’s other recommendations deal with cracking down on drug traffickers and the illicit drug market, expanding the drug court system, and increasing access to addiction treatment.

Gov. Christie refuted criticism of President Trump for declaring the overdose crisis a public health emergency, instead of a national emergency. Only $57,000 in federal funding is currently set aside to deal with a public health emergency.

“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS (Department of Health and Human Services) to administer the funds, not FEMA (Federal Emergency Management Agency). No offense to FEMA. They’re busy with some other things and it’s not there area of expertise,” Christie said.

“Now it’s incumbent upon Congress to step up and put money in the public health emergency fund, so the president can utilize that. And that should happen without delay in the view of the commission.”

In addition to Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Florida Attorney General Pam Bondi, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

In its fifth and final hearing, the commission heard testimony from several people who lost loved ones to opioid addiction and overdose. The panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.

Painful Opioid Statistics

By Roger Chriss, Columnist

The opioid crisis continues to worsen, and media coverage continues to be overly simplistic.

Vox recently reported the U.S. “absolutely dwarfs” all other countries in opioid prescriptions, in a story headlined “America’s huge problem with opioid prescribing, in one quote.”

"Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States," Stanford psychiatry professor Keith Humphreys told Vox.

Although Humphreys’ statement is accurate, it is a misleading oversimplification that omits important context, including the rising rate of heroin and fentanyl-related deaths, and the shifting landscape of opioid prescribing.

First, this statistic represents an average (or mean). It does not include the variance, a measure of how many people use what quantity of opioids. The average person in the U.S. does not use any opioids at all. But people suffering from opioid addiction may use a large quantity of opioids every single day of the year.

In statistical work, reporting an average without the variance is considered sloppy at best, misleading or manipulative at worst.

Humphreys’ statement also fails to distinguish between the legal and illegal use of “pharmaceutical opioids,” a convenient term to refer to legally manufactured opioids, regardless of whether they are used for valid medical purposes, or diverted, shared or sold.

In other words, the much higher number of pharmaceutical opioids in the U.S. compared to Japan reflects both medical use and misuse.  

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Further, this statistic assumes that Japan’s level of pharmaceutical opioid consumption is somehow better. In fact, Japan has a well-documented history of undertreating pain because of fears about opioid addiction. Pain is so poorly treated in Japan, according to The New York Times, that the government launched a campaign in 2007 urging patients to request pain relief, with hospital posters urging patients to “Tell Us About Your Pain.”

Japan continues to struggle with high levels of chronic pain. A 2015 review found a “high prevalence and severity of chronic pain, associated factors, and significant impact on quality of life in the adult Japanese population."

The Vox article also fails to point out that opioid prescribing in the U.S. peaked in 2010 and has been declining ever since. Yet opioid addiction and overdose deaths have been steadily rising, fueled largely by illegal opioids such as heroin and illicit fentanyl.

Vox is not alone in oversimplifying a complex problem. CNBC, for example, reported last year that “80 percent of the global opioid supply is consumed in the United States.”

Many others have repeated that claim, including Missouri Sen. Claire McCaskill, who recently tweeted that, "We have 5% of world population. 80% of opioids."

PolitiFact ran a fact check on McCaskill’s numbers and found them “greatly exaggerated.”

“While the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False," PolitiFact said.

This is a significant issue in the opioid crisis. While some journalists, politicians, and even physicians name villains, people suffering from opioid addiction continue to get substandard treatment. And people who benefit from opioid therapy are struggling more and more to find physicians willing to prescribe and pharmacies willing to fill opioid prescriptions so they can have a reasonable quality of life.

No one is suggesting that the U.S. needs more opioids, particularly in the acute care setting. Opioids should be prescribed with close monitoring by physicians with experience in pain management. The research literature and public health studies agree that over-prescribing occurred, especially in pill mills and dubious pain clinics. In addition, drug theft and diversion are huge problems.

So while a statistic that invokes multiple doublings for comparative purposes sounds impressive, its context is much more important. We need to focus on the crisis as it really is, without exaggeration, if we hope to have meaningful progress ending it.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A Pained Life: Pennsylvania’s Opioid Law Ignores Us

By Carol Levy, Columnist

Recently I received an email update from my state senator. He wanted to let me know about  efforts in the Pennsylvania legislature to address the "opiate crisis.”

I have written before that I believe some of what has been proposed throughout the country makes sense, a prescription monitoring database, for instance. Much of what is being considered in Pennsylvania also makes sense to me:

  • Labels on opioid prescription bottles warning of their addictive nature
  • Written consent from parents in order for their children to receive prescription opioids
  • A safe opioid prescribing curriculum in Pennsylvania’s medical schools to better educate future doctors about proper opioid prescribing practices
  • Insurance plans to provide access and share the cost of abuse-deterrent opioids
  • Mandatory reporting of all heroin and opioid overdoses where naloxone was administered
  • Implementation of opioid prescribing guidelines developed by a state task force
  • Healthcare providers to discuss the risks of opioid addiction and overdose with patients and to receive written consent from a patient before prescribing them

But there are two provisions of the law I find very concerning, one being a requirement that coroners and medical examiners report the death of any person resulting from a drug overdose.

One of the issues surrounding the reporting of deaths arising from opioids is that other medical conditions, such as the use of alcohol or illegal drugs, are often ignored and the death is counted as an opioid overdose.

That is not only poor research, but gives a false picture of what is the effectual cause of the death. Ignoring those other factors means ignoring other issues that the law needs to be addressing.

The second issue I have with the law is alarming: limiting the prescription of opioids to seven days. This ignores chronic pain sufferers and the long-term need for opioid medication, which is often our only or last available treatment.

The change we saw, in many states, was requiring a visit to the doctor for a new prescription every 6 months to needing one every 3 months. That was bad enough.  I recall needing to go only once a year, but that was in the 1970's and 80's.

If you have trouble moving, tolerating the weather or other issues, being forced to go see the doctor every three months is an issue. In addition, co-pays rise, insurance companies pay more for extra visits and may raise your rates as a result, and the cost to the state and federal government through increased Medicaid/Medicare billing soars.

I decided to research this. I found that New York State has imposed a 7-day limit on prescriptions, but the law contains exceptions for those with chronic pain or who are receiving hospice or palliative care for life threatening illnesses. Unfortunately, Pennsylvania legislators have decided to ignore those in chronic pain. The bill includes exceptions only for hospice and patients receiving palliative care.

The government has acted as doctor in many other instances; such as women's health care, declaring some drugs illegal, and allowing certain medications and procedures while denying others. I understand that. There needs to be limitations and oversight.

But this is not oversight or limitation.  This is a frenzied and illogical response to an “epidemic” that is not caused or perpetuated by those of us with chronic pain, but is nevertheless being taken out on us.

Politicians who point at us and claim they are handling the crisis are ignoring the real culprits, which is those who abuse drugs illegally.

The question has to be asked. 

How in the world does this law address the opioid epidemic, as opposed to merely blaming and punishing those with chronic pain?

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.