In response to the opioid epidemic and the CDC’s call, 35 states (to date) have enacted a host of new opioid laws that limit initial prescriptions – either to a certain number of days, pills, or dosage. In some cases, prescriptions are limited by age and/or medical condition as well.
Obviously, these limits should cut down on the number of opioid prescription pills in the cupboards of homes across those states. However, have these bills fulfilled their intended purpose of cutting down on drug use and overdose?
The answer is: Maybe, but it’s complicated. From unintended consequences to a myriad of underlying factors to rising illicit opioid overdoses, we’re not out of the woods yet.
What the Statistics Tell Us
In June, the CDC released 2018 provisional data on overdose deaths. It reflected an improvement in overdose numbers, due mainly to a whopping 14% decrease in the number of deaths involving to prescription opioids (14,926 in 2017 versus 12,757 in 2018). It is the main driver in a nearly 5% total decrease in all overdose deaths.
It is important to note that this is provisional data, which can be underestimated. The CDC releases final data when it has received and reviewed all state death records.
The first glimmer of hope in stemming prescription opioids came in 2017. That year, while the number of overdose deaths increased to a record-breaking level (on top of a record-breaking 2016), the jump was largely driven by increases in overdoses due to the synthetic opioid fentanyl, according to the Centers for Disease Control and Prevention (CDC).
Deaths involving prescription opioids and heroin, however, stayed virtually the same in 2017 versus 2016. With so many factors at play, stopping an increase – on any front – can be seen as progress.
Could it be that these new laws are partially responsible for stemming – and, if the 2018 data holds – possibly reversing the trend of increasing overdose rates due to prescription opioids?
It could be.
Then, again, this could also be due to the wider availability and awareness of Naloxone – the drug that can stop an opioid overdose in its tracks. Also, constant media coverage on the opioid crisis has raised the level public awareness regarding the dangers of becoming hooked on opioids from misusing/abusing a prescription.
Prescription opioids are only a piece of the puzzle, however.
If the trends seen in the provisional data stick, we must also acknowledge that deaths involving other substances, including methamphetamine, cocaine, fentanyl and other synthetics, continue their meteoric rise.
We are also still dealing with an alarmingly high overdose rate of nearly 68,000 a year, or 186 per day. With fentanyl finding its way into more street drugs – and possibly fatal doses in any given batch – we still have a way to go before we can declare victory. In 2015, synthetic opioids surpassed prescription opioids in number of overdose deaths… and this trend persists.
How Long is Too Long: How Long Can People Take Opioids Before They Get Addicted?
There is no set amount of days of opioid ingestion that will automatically cause a person to become addicted.
However, studies have shown that the duration or length of an opioid prescription is a “major risk factor” for “ongoing use, misuse and abuse.” In other words, the longer the duration of the prescription, the higher the risk. That risk doubles at day six and quadruples at 12 days.
On the other hand, the CDC tells us that three days is sufficient to resolve more than 80% of cases of acute pain.
New Opioid Laws, State-by-State
A majority of states now have laws on the books to limit opioid prescriptions for acute (or temporary) pain.
Most of those impose a seven-day limit on initial prescriptions. These states include Alaska, Colorado, Connecticut, Delaware, Hawaii, Indiana, Maine, Michigan, Missouri, New Hampshire, Maine, Oklahoma, Ohio, Pennsylvania, Utah, Virginia and West Virginia.
In Arizona, New Jersey, North Carolina and South Carolina, it’s five days. Minnesota limits initial prescriptions to four days, but only for acute dental or ophthalmic pain.
The most stringent new opioid laws are in Florida, Kentucky and Tennessee, where initial prescriptions for acute pain are limited to only three days.
There are a patchwork of other state laws limiting initial opioid prescriptions for acute pain:
- Rhode Island limits the dosage of opioid prescriptions to 30 Morphine Milligram Equivalents (MME) per day.
- Nebraska and Washington limit the number of tablets – to 42 for those 21 and older and 18 for those 20 and younger in Washington, and to 150 tablets in 30 days for Medicaid recipients (and a seven-day limit on 19 and younger) for Nebraska residents.
- In Maryland, physicians and other prescribing providers must limit prescriptions to the lowest effective dose, while Oregon simply recommends it.
The legislative landscape is constantly changing, so other states may follow suit with new opioid laws in the future. It is important to note that these laws were not intended to be applied to patients who have chronic or cancer pain, who are in hospice care or on end-of-life treatment, who are receiving medication-assisted treatment (MAT) as part of an addiction treatment program, who have experienced physical trauma, as well as those who are in a hospital setting. Most states provide exceptions to these rules for patients in these circumstances.
Also, many states now require electronic prescribing and maintain controlled substance prescription databases. For example, Iowa, which currently has no opioid prescribing limit, still requires doctors to use a prescription monitoring program and prescribe electronically as well.
These measures address the issue of “doctor shopping,” in which a patient visits multiple physicians to obtain multiple prescriptions of the same (or the same class of) drug. Doctor shopping gives the patient a stockpile of their drug of choice, or simply a supply to sell on the street.
Continuing medical education requirements now include opioid prescribing in many states in addition to all of the new opioid prescribing laws.
How common is it that opioid prescription use leads to harder drugs and/or addiction?
As the National Institute on Drug Abuse reports, the numbers were high years ago. Data from studies spanning 2002 to 2012 show that heroin use was 19 times more prevalent in those who had first abused pain medication (i.e., used them for non-medical purposes). Similarly, in 2011, 80% of heroin users in the U.S. reported starting with prescription opioids.
However, it was the exact opposite back in the 1960s, when more than 80% used heroin to start. And now, it may be flipping again. A study on patients entering opioid use disorder treatment indicated that one-third (33%) had started with prescription opioids. That’s a nearly 60% decline.
A 2017 study concluded that, as prescribed opioids are less available than in the past, people are turning to heroin as their first initiation into opioid use. From 2005 to 2015, those starting with oxycodone as their first opioid dropped 43% and those using hydrocodone first dropped 34%. Meanwhile, those starting with heroin has increased a whopping 383% in 2015 over 2005.
This can be disappointing news for those who hoped to put a significant dent in the overdose rate with a flood of new opioid laws.
The 2017 study even suggested that the “slight imprecision” in dosing typical of heroin use (and especially for those who are new to using opioids) could be a contributing factor to the high rate of heroin overdoses. As an illicit substance, heroin isn’t regulated, nor is it homogeneous – one batch can be more potent than another.
The potential presence of fentanyl is also a factor. So potent that two milligrams is certain death, fentanyl’s overdose risk is very real. The question of whether a particular dose is cut with these substances, and, if so, how much is present, can never be answered by end users – not without the help of a lab.
The pure form of fentanyl is deadly to the touch, according to the Drug Enforcement Agency (DEA). And what you find on the streets is not coming from prescription drugs. Rather, the supply is coming from China and Mexico.
What Drives Drug Use?
Unfortunately, our overdose problem is not so simple that it can be completely solved by just cutting off prescription opioids. Fighting the forces of overdoes is akin to playing a game of Whack-A-Mole – you successfully hit one issue, but there are many others that rear their heads and have to be addressed as well.
Put another way, the problem of overdose is symptomatic of the larger issue of addiction, which, itself, is just one symptom of even larger issues, namely trauma and mental illness.
Mental Illness & Addiction
Overall, about one in five (or two in 10) adults in the United States have a mental illness, according to the National Institute of Mental Health.
Among people with substance use disorder, the rate of mental illness is considerably higher – studies have shown that over 50% of those with mental disorders also abuse substances.
Several studies have shown that having mental illnesses puts you at an increased risk of substance use disorder. The more severe the illness, the higher the risk, as those with the most severe cases have the highest rates of substance use disorders. The largest population study to date found that the rate of substance use disorder was:
- 30% for people with anxiety or any other disorder
- 47% for people with schizophrenia
- 56% for people with bipolar disorder
Other studies have shown an even higher incidence of mental illness among those who abuse substances. For example, a 2008 study of substance abusers found that 66 percent had at least one co-occurring mental disorder. When compared to the substance use disorder rates among the general population of approximately 20%, these rates are incredibly statistically significant – more than double, according to some studies.
Further complicating matters is the fact that drug and alcohol addiction is considered to be a mental illness, and that illicit substance addiction can contribute to the development of a mental condition as well. Also, there could be a genetic component that leads to the development of both substance use disorder and mental illness.
Trauma & Opioid Use
It has been shown that traumatic experiences are linked to addiction – especially if they occur in childhood.
Two-thirds, or nearly seven in 10, of children report experiencing at least one traumatic event before turning 16, according to Substance Abuse and Mental Health Services Administration (SAMHSA). The list of traumatic experiences is long and wide-ranging:
- Abuse (Physical, Sexual or Psychological)
- Assault (Physical or Sexual)
- Domestic Violence (Witnessing or Experiencing)
- Violence in the Community or at School
- Sudden or Violent Loss of a Loved One
- Natural Disasters
- A Refugee Experience
- A War Experience
- A Life-Threatening illness
- A Serious Accident
- Having a Parent Deployed
- Loss or Injury Incurred to a Parent who is Deployed
Combine this with other traumatic experiences, such as being bullied at school (which one in five high school students report, according to SAMHSA), and you can see how pervasive trauma is to the human condition.
Once again, there are more complex relationships here. Using illicit substances can lead to a traumatic experience caused by risky behaviors. In turn, using illicit substances can also change the brain in such a way that it is more difficult to deal with future trauma.
Has the Pendulum Swung Too Far?
Even though the target of many of the new opioid laws is not chronic pain patients, these laws have nonetheless resulted in a serious clamp-down on opioid prescribing in general. Chronic pain patients who were stable at a high dose of opioids found themselves either being tapered against their will, with disastrous consequences, or cut loose entirely.
It all started with the CDC’s 2016 publication of the Guideline for Prescribing Opioids for Chronic Pain. This guideline called for prescribers to not increase opioid doses for new patients above 50 MME, and, for patients already on doses higher than 90 MME for maintenance, to review and document risks and benefits of continuing treatment at that level. Unfortunately, many well-meaning physicians took these as a mandate, and started tapering people who been maintained for years at those higher doses.
It’s not just that prescribers adopted the guidelines wholesale. Threats against “high prescribing physicians” have come from no less than regional U.S. attorneys.
As reported by NPR, Dr. Ako Jacintho of San Francisco, California, was one of more than 500 doctors who received letters from the state’s medical board as a part of the Death Certificate project. The letter informed Jacintho that a previous patient had died of an overdose due to methadone and Benadryl, and he was the doctor who wrote the last methadone prescription.
Now, Jacintho had two weeks to respond with a summary of the patient’s treatment and certified copy of the medical record, with a $1,000-per-day fine for noncompliance. If a violation was found, he faced anything from probation and public reprimands to having his license revoked.
The emotional impact of receiving such a letter was monumental. Jacintho told the interviewer that “his first reaction was grief. But then he grew afraid, then indignant. The letter seemed to presume he did something wrong – it used words like ‘compliant’ and ‘allegation.’”
Similar letters went out to North Carolina and Massachusetts doctors.
At the time with Jacintho wrote the prescription, the guidelines were to not let patients suffer in pain, and there were assurances as well that no practitioner would face sanctions from prescribing opioids.
Although there are some bad apples in every line of work, many doctors are in the same boat as Jacintho. They are caught in the middle of changing guidelines and laws, trying to do the right thing by their patients yet be compliant with the new opioid-prescribing paradigm and, of course, stay out of the crosshairs of law enforcement efforts.
And that’s precisely why all of these new opioid laws has had a chilling effect on prescribing. If it carries the risk of losing your medical license or being criminally prosecuted, why take it? Why not mitigate it by either taking those patients off your case load and/or not prescribing opioids altogether?
The NPR article confirms that there are doctors, Jacintho included, that have either lowered the dosage of opioids with patients or stopped their prescriptions entirely.
Sue Glod, MD, palliative medicine specialist at Penn State College of Medicine in Hershey, Pennsylvania agreed in an New England Journal of Medicine Catalyst article. As it stated, she “sees patients who are struggling with life-threatening illnesses such as advanced cancer. While her mission is pain relief, a flood of new prescribing rules severely limits her options and burdens her staff with extensive administrative hurdles.”
In the article, she recalled a breast cancer patient who “had trouble with a prior authorization policy” for an opioid prescription. The patient endured “several” days of pain, in addition to withdrawal symptoms, and had to go to the emergency room, all of which was completely avoidable.
Preliminary research conducted by the San Francisco Department of Public Health and cited by NPR suggested that patients on a long-term opioid prescription that are weaned off are twice as likely to use illicit substances for relief.
Those who don’t turn to illicit substances could be at increased risk of suicide.
Jay Lawrence was one of the them. As reported by Fox News in December 2018, Lawrence was a chronic pain patient with a debilitating back fracture injury, the result of a 1980 tractor-trailer crash. He told his wife, Meredith, that it felt like a “hot poker was shoved in his back and his hands and feet were on fire,” according to a Fox News video. However, his pain had been stabilized for years at a dosage of 120 milligrams of morphine.
In the video, his wife recalled that the doctor had told Lawrence that he was going to go from 120 milligrams to 90, due to the 2016 CDC’s prescribing guidelines. “’These guidelines will become law eventually. So we’ve decided as a group that we’re going to take all of our patients down,’” she recalled the doctor telling them. When her husband’s pain returned, he went to the couple’s primary care physician to a pain clinic, and was told that it would take at least six weeks to be seen. On the day of his next appointment with his original doctor, when his dosage was to be reduced again, he instead committed suicide. In the same park where he and his wife had renewed their vows, Lawrence held his wife’s hand and shot himself.
No one knows how exactly many chronic pain patients have turned to suicide as the final answer after forced tapering or the removal of access to opioids.
One doctor, though, is keeping “the list.” As reported by the Journal of the American Medical Association (JAMA), Dr. Thomas Kline of Raleigh, North Carolina, has been accepting the patients that other doctors have drastically tapered or completely cut off their opioid prescriptions.
He also has a running online list of chronic pain patients who are believed to have committed suicide after experiencing a withdrawal or a reduction of their opioid prescriptions. To date, the list has over 40 people on it, but as Kline told Journal of American Medical Association (JAMA), it doesn’t have all patients that even he knows about, as he states “’The problem is a lot of families don’t want this public. I have to respect that.’”
The JAMA article also referred to a Stanford research study that drew the conclusion that “many rules limiting opioid prescriptions would increase deaths over a five- to 10-year period because they will drive some prescription opioid users to switch to illicit heroin or fentanyl.” They also wrote that the legislation, however, would prevent enough new addictions that would “outweigh the harm:”
“The accompanying editorial, titled ‘We Cannot Treat the Dead,’ questioned whether the marked increase in US suicide rates might be related to inadequate pain treatment, as a CDC study noted that 22% of suicides in 2015 reportedly occurred among people with documented physical health problems.”
In April, 2019, the CDC responded to the outcry from chronic pain patients with an article in the New England Journal of Medicine. The piece was co-authored by Debbie Dowell, MD, MPH, Chief Medical Officer, National Center for Injury Prevention and Control, who leads the CDC’s Opioid Response Coordination Unit (ORCU), Tamara Haegerich, Associate Director for Science at Centers for Disease Control and Prevention, along with Roger Chou, M.D.. It stated that:
“Efforts to implement prescribing recommendations to reduce opioid-related harms are laudable. Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering for drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice. The panel also noted the potential for misapplication of the recommendations to populations outside the scope of the guideline. Such misapplication has been purported for patients with pain associated with cancer, surgical procedures, or acute sickle cell crises. There have also been reports of misapplication of the guideline’s dosage thresholds to opioid agonists for treatment of opioid use disorder. Such actions are likely to result in harm to patients.”
The authors also acknowledge that patient care should be individualized, which takes “time and care,” but that some physicians are simply dismissing high-dose opioid patients, referring them elsewhere, or not prescribing opioids at all.
As mentioned previously, there are good reasons why this is so, not to mention that already overloaded plate of physicians – who, after all, are already under more time pressure than ever – doesn’t have much more room to pile on more responsibility, particularly if it comes with the possibility of criminal charges.
A Deeper Look
Taking everything into consideration, it is clear that we can’t legislate ourselves out of this overdose and opioid epidemic.
Underlying factors driving the high overdose death rate persist, despite new opioid laws.
Unfortunately, there will always be people in pain. Also, unfortunately, people continue to experience trauma – whether it be mental, physical or spiritual – as well as co-occurring disorders such as anxiety and depression that lead them to turn to drugs.
If the goal is to reduce the rate of overdose, new opioid laws limiting initial prescriptions (in patients with acute pain, that is) is not the complete answer. The front line has inarguably shifted to fentanyl from prescription opioids.
Perhaps turning the same legislative and criminal justice energy currently focused on going after prescribers to stopping the flow of fentanyl from Mexico and China could help. Or perhaps improving access to treatment for those who are already addicted can stem the rate of overdoses, as well as providing counseling for those affected by trauma and mental illness will prevent addiction from developing in the future. Or, we could even take a cue from other countries who have decriminalized addiction for users and instead turned their attention to the drug dealers, with some success.
No one can deny that we are facing a multi-faceted problem. And this multi-faceted problem deserves a multi-faceted, well-thought-out and implemented answer (or many). It’s a big undertaking, but it’s worth it. When it comes to overdoses, even one is too many.