TENNESSEE OPIOID LAWS
In recent years, Tennessee policymakers have enacted a series of measures to combat the state’s growing opioid problem:2015: Lawmakers enact legislation tightening the requirements for medical directors and owners of pain management clinics. The new law requires medical directors or owners of pain clinics to be licensed physicians who hold required continuing medical education and sub-specialty certifications in pain medicine.2015: The Intractable Pain Treatment Act is repealed with the support of the state’s district attorneys and the Tennessee Bureau of Investigation. The 2001 measure included a “Pain Patient’s Bill of Rights,” which gave patients a great amount of responsibility to choose opiate medications as a first line of treatment and physicians were required either to provide requested opiate medication or refer patients to physicians who would.2014: Tennessee Gov. Bill Haslam announces a seven-point plan to address the state’s opioid abuse problem that includes public education, law enforcement and regulatory oversight of the medical community.2014: New guidelines issued by the Tennessee Department of Health set limits on the daily doses of opioids doctors may prescribe, and spell out protocols for giving the drugs to women of child-bearing age and establish new certification requirements for pain medication specialists.2013: Dispensing of controlled substances by pain management clinics is prohibited.2013: Tennessee begins to require health care professionals to check the Controlled Substance Monitoring Database before prescribing a controlled substance.2013: Legislation limits to 30 days prescriptions for drugs categorized as “Schedule II” and “Schedule III,” which include a range of opioid medications. The law also requires physicians to perform urine drug tests if they prescribe these medications beyond 30 days.2013: A new law to combat prescription fraud requires medical professionals to use tamper-resistant paper for all written prescriptions.2012: The Prescription Safety Act, sponsored by Sen. Ken Yager, R-Harriman, is the first sweeping legislation to address opioid abuse. It expanded the required use of the state’s prescription drug database, originally created as a research tool, requiring pharmacists to check the database before filling prescriptions, update the database once a week instead of once per month and making the database available to law enforcement. The law also allowed pharmacists and the Department of Health to share prescription information across state lines, and elevated some types of doctor-shopping to a felony.Source: The Tennessean
My cousin come up from Knoxville
And he taught me a thing or two
Now I'm headed nowhere but downhill
With the OxyContin blues
- Steve Earle, "OxyContin Blues"
You can trace the history of Tennesseans' problems with substance abuse by listening to their music.
In 1957, Robert Mitchum was roaring out on Thunder Road singing about "moonshine, moonshine to quench the devil's thirst."
By the 1980s, Steve Earle was back from Vietnam and warning the sheriff to stay away from his marijuana plants on Copperhead Road.
In 2007, Old Crow Medicine Show's drug of choice was methamphetamine.
And the following year, Earle had the OxyContin Blues.
"We seem to have a cultural predilection for outlaw status," said Dr. John "Rett" Blake, a pain specialist in Chattanooga and a member of the state task force that wrote the rules for how doctors should prescribe painkillers. "After Prohibition, we moved on to the next thing, and now it is illicit opioids."
The problem of painkiller abuse is not limited to Tennessee - it's a nationwide issue, one that is intertwined with heroin and counterfeit drugs.
But Tennesseans love their painkillers.
At their peak, doctors in the Volunteer State were writing 143 prescriptions for every 100 Tennesseans, tied with Alabama as the most in the U.S.
That's more than twice the rate as in California or New York.
Part of the reason may be that Tennesseans are sicker than people in most other states.
"Patients are older than they used to be, you have more people with more back and knee surgeries, and we have higher rates of obesity," Blake said. "Combine all of those things and you have more chronic pain, and you have more people wanting treatment."
For a while, painkillers, particularly OxyContin and hydrocodone, seemed like a panacea.
"People like simple solutions. Nothing is simpler than giving a tablet," said Dr. Peter Martin, an addiction psychologist and professor at Vanderbilt University School of Medicine.
"We want quick and easy fixes that don't involve going to the gym and exercising and eating properly," Blake said.
But what seemed at the time like a miracle cure, turned out to have a nasty side effect: the easy availability of the inexpensive pills fueled a new wave of drug addiction that pushed deaths from overdoses to an all-time high. Fatalities from prescription opioids, a class of painkillers that includes methadone, oxycodone (OxyContin), and hydrocodone (Vicodin), quadrupled since 1999, to more than 14,000 in 2014.
How did what seemed like a medical breakthrough in the treatment of pain turn into a nightmare of drug abuse?
Doctors in Tennessee say a drug company should take part of the blame. But they also point to a misguided effort to do more to help pain sufferers that resulted in overprescribing of painkillers. And they say physicians themselves are also at fault, for failing to question claims about new drugs that were just too good to be true.
Drugs made from the poppy plant have been used to alleviate pain since ancient times. Five thousand years ago, the Sumerians referred to it as the "plant of joy," and some historians claim Homer was referring to opium when he described the potion Helen of Troy poured into a jug of wine "to lull all pain and anger, and bring forgetfulness of every sorrow."
In the Civil War, morphine, an opium derivative, was a staple for doctors performing surgery in the field, and after the war, morphine addiction even had a nickname - the Soldier's Disease. Morphine was commonly prescribed for a variety of ailments until the early 20th century.
But that began to change shortly before World War I. The establishment of the Food and Drug Administration meant companies peddling miracle potions had to tell consumers what was in them - often narcotics. The Harrison Narcotics Tax Act of 1914 dramatically slowed sales of opiates, and heroin and morphine became synonymous with drug addiction.
That image began to change again in the 1990s.
In 1995, the American Pain Society, a nonprofit group of doctors and researchers, recommended that pain be treated as one of five vital signs doctors should consider when evaluating a patient, along with blood pressure, heart rate, respiratory rate, and temperature. That's the origin of the smiley-face cards many doctors and nurses use that ask patients to rank their pain on a sliding scale.
That effort to make pain a part of any diagnosis got a boost in 2001, when The Joint Commission, the powerful organization that accredits health care organizations in the U.S., published standards "in response to the national outcry about the widespread problem of under-treatment of pain." Doctors were urged to reconsider their efforts to treat pain, and for many, that included re-evaluating their reluctance to prescribe narcotics.
There was a laudable moral principle behind the push - "Our job is to treat pain and suffering," Blake said.
There was also a business incentive. Insurance companies were paying more attention to the quality of treatment in hospitals, and began asking patients about how well their doctors had managed their pain. "Patient satisfaction is one of the issues being assessed in terms of getting insurance companies to pay for hospital bills," said Dr. Daniel Sumrok, director of the University of Tennessee College of Medicine's Center for Addiction Science. "If the patient said it was unsatisfactory, hospitals pressured doctors to be more aware of the issue of pain management."
That meant doctors had to learn about narcotics, Sumrok said. The state medical association sent out guidelines for prescribing the powerful opioids. First, doctors needed to have a substantiated diagnosis that the pain was real.
"They should have some evidence from laboratories and X-rays, and it would help if they had letters from specialists saying that they had tried other things such as physical therapy," he said.
The idea was that physicians would pay close attention to the cause of the pain and carefully monitor the results.
"For a lot of doctors, and for me, too, that's a tough thing to do," Sumrok said. "That balance is tough to maintain with every visit, especially if you are pushed for time."
Purdue and Oxycontin
If doctors point to a villain in the saga of painkiller abuse, it is likely to be Purdue Pharma. Purdue won approval from the Food and Drug Administration in 1995 for a new opioid, OxyContin, to provide relief for moderate to severe pain that lasted more than a few days. The company launched a large-scale marketing campaign, meeting with medical leaders in Tennessee and elsewhere to tout the pill's promise.
According to a report by the U.S. Government Accountability Office, Purdue expanded its sales staff from 300 to 671 between 1996 and 2002, and added 300 more representatives through an agreement with Abbott Laboratories. Each sales rep had a list of between 105 and 140 doctors to call on, and was supposed to visit each one at least once a month.
During the first five years OxyContin was marketed, the company sponsored more than 40 pain management and speaker training conferences, generally in resort locations, according to the GAO report, and funded more than 20,000 pain-related educational programs through direct sponsorship of physicians or through grants that allowed them to earn required continuing education credits.
And the program was an unqualified success. By 2001, sales of OxyContin exceeded $1 billion - 90 percent of Purdue's total prescription sales.
Purdue marketed OxyContin as a safer pill than its predecessors because it released its painkiller over a period of several hours, instead of all at once. That would prevent abuse because users would not get an instant high. And there was no worry of addiction, the company claimed.
Many doctors were convinced.
"I'm not going to malign them," Martin said. "They felt they had created a compound that was less likely to be abused, so more patients could have the benefits of opioids."
The delayed release feature was a big deal, said Dr. Thomas Miller, a veteran pain management specialist and head of the Addiction Subcommittee for the Hamilton County Health Department. Older drugs lasted for only three hours, while OxyContin's effect might last for two or three days.
"It was a godsend," he said.
He also downplayed the idea that the drug company was somehow bribing doctors to use their product.
"They would take us to resorts," he said, "But we would have lectures and they were really good. There was nothing fun about it."
Besides OxyContin there was hydrocodone, a generic opiate that was easy to prescribe.
"A nurse could authorize it over the phone," Miller said. "There was a guy who lost his license finally after they found his nurse kept authorizing hydrocodone for a year and never saw the patient for a year. Somebody would just call in and say, 'I need a new prescription.'"
"Doctors are not pharmaceutical people," said Terri Lewis, a health care activist from Tennessee who has spent years researching the painkiller problem. "They know little about research and they rely on pharmacists and the FDA's approval practices to be the gatekeeping system by which people are allowed to approach them."
And painkillers also met doctors' increasing need for a treatment that could be administered quickly. Today, most physicians spend no more than 15 minutes with a patient.
"[Painkillers are] one of the things that doctors can do for patients in a short time to make them happy," Vanderbilt's Martin said. "So we have this rapid patient turnover, with doctors trying to help patients but not having enough time with them, and then having available something so wanted by patients."
It also helped that they were affordable. "Particularly for people who didn't have big medical resources, you could go to a pharmacy and pay $4 for a prescription," Lewis said.
They were also profitable.
"You had some well-intentioned doctors who were trying to do the right thing for patients, and here in Tennessee, we have had some not-so-well-intentioned doctors trying to make a buck with people who wanted painkillers," Blake said. "And you had a pharmaceutical industry doing what any big company would, maximizing profits, which was not so great."
Some doctors discovered it was very profitable to set up clinics that were little more than pill mills, cranking out prescriptions with few questions asked. That was good for profits, but lousy for the patients.
"You really have to get very personally involved with people who have a drug dependency in order to help them," said Dr. John Standridge, a Chattanooga addiction specialist who is the medical director for the Council for Alcohol and Drug Abuse Services.
But then things began to fall apart.
Reports began to surface in Tennessee and elsewhere of teenagers raiding their grandparents' medicine cabinets for painkillers as a way to get high. Addicts discovered they could get around OxyContin's slow-release property by grinding up the pills or dissolving them in water.
An illegal market sprang up, with painkillers selling for as much as $30 or more a pill. Patients soon learned they could get a prescription from one clinic and then drive down the street and get a second doctor to write another, a process known as "doctor shopping," and sell the pills on the street.
Miller said one of the first places where prescription abuse got out of hand was in the coal country in eastern Tennessee.
"They hurt, they have a lousy life," he said of the residents.
For a while, the miners loaded into cars or vans or buses and headed for Fort Lauderdale, Fla., the mecca for pain pill mills.
"At one point, 80 percent of the OxyContin in the U.S. was prescribed in Broward County," where Fort Lauderdale is located, Miller said. A filmmaker captured it all in a documentary, "The OxyContin Express."
But it didn't take long for the number of prescriptions written in Tennessee to soar.
"That's not just pain medicine doctors," Standridge said. "That included family physicians, surgeons, internal medicine doctors. You have surgeons who will do a procedure and then prescribe 60 days of oxycodone or hydrocodone and then they refill them and refill them."
Unless they were pain specialists, most doctors in the state had never been trained in medical school on how to deal with opioids.
"They knew everything about how blood pressure and heart medicines worked, but nothing about opioids and how opioids work," Miller said.
Faced with one of the highest rates of painkiller use in the nation, Tennessee passed the Prescription Safety Act of 2012 to require all doctors who prescribe painkillers to register with the state. As of January, they are required to enter all prescriptions for opioids such as Vicodin, OxyContin or Percocet into the database.
That program appears to be working, with the number of prescriptions written dropping by 7 percent between 2013 and 2014. Before, those numbers had risen by about 10 percent a year for the previous decade, according to Dr. Mitch Mutter, the Chattanooga cardiologist and state medical director for special projects who heads the opioid database program.
For its part, Purdue was forced to admit that its marketing plan was deceptive. In 2007, the company agreed to pay a whopping $600 milli0n penalty to the federal government for misleading doctors about OxyContin's risk of addiction. Kentucky officials won a separate $24 million in a settlement announced in December.
Tennessee is now placing new restrictions on pain clinics, with a new law that went into effect July 1 requiring the doctors who manage them to have advanced degrees and certifications. The hope is that clinics where the doctors and staff don't provide patients with proper treatment will go out of business.
Doctors are being urged to try new approaches before prescribing painkillers. Both the state and the federal Centers for Disease Control and Prevention (CDC) have passed guidelines telling doctors they should consider options for treating pain other than pills.
New versions of painkillers seem to be safer and more resistant to abuse, according to Miller.
"I think what we are seeing now is that Tennessee doctors have caught on to the notion of an opioids epidemic," said UT's Sumrok.
There is even some concern that the crackdown on overprescribing is making it difficult for those who need the pills to get a prescription. Primary care or family doctors, worried about the increased law enforcement oversight of their medical practices, are getting out of the pain business and referring patients to the shrinking number of pain specialists.
But even if the push to reduce the number of pills being prescribed succeeds, the surge in painkiller use over the past decade has created a huge population of users with a craving for pills.
"You can't go for a couple of months without a narcotic if you have been taking them for 10 years," Sumrok said. "I am guaranteeing you that person will go out to find street drugs."
Some are turning to cheap heroin, with overdoses nationally rising from 2,000 to more than 10,000 since 2010, according to the CDC.
But others are turning to something more ominous, counterfeit painkillers and heroin spiked with fentanyl, a powerful opioid that is blamed for the death of rock star Prince. Heroin mixed with fentanyl was blamed for a rash of more than 100 drug overdoses in West Virginia, Ohio, Kentucky and Indiana over the last two weeks in August.
The counterfeit drugs are inexpensive to make and hard to detect, since they often are exact copies of legitimate pills such as OxyContin. For now, production seems to be centered in China, coming to the U.S. through Mexico. But authorities worry that the labs could shift to the U.S.
Pain specialists and addiction experts believe they are making progress in slowing the flood of unneeded painkiller prescriptions. But there is still a long way to go. "We're heading in the right direction; however, there's an awful lot of water still in the boat," said Vanderbilt's Martin. "And we're shoveling it out with a coffee mug."
Overall, there is an understanding that the headlong push to prescribe opiates for a variety of pain was a mistake.
"Morphine is God's own medicine," UT's Sumrok said, quoting legendary physician William Osler's thoughts on opiates.
"It is for the first day or two after a hip replacement," Sumrok said. "But after a week or so, it turns out to be a double-edged sword that can turn into the devil's medicine."