Part One

Many factors — some well-known, some not — have contributed to America being in the tailspin it is in today with the national epidemic of opioid and heroin abuse, says a top toxicology expert.

Over-treating pain. The explosive marketing of profit-surging pharmaceuticals. Uneven regulations.

And there are underlying reasons, too: physicians worrying about patient-satisfaction scores. And the elevation of pain as a “fifth vital sign.”

Everyone is talking about the misuse of the drugs, how we got off-kilter in trying to balance treatment of severe and chronic pain with powerful and addictive drugs, resulting in too many overdoses and deaths. There is much blame to go around.

“The lesson is the danger of unintended consequences,” says Leslie R. Dye, MD, FACMT, Editor-in-Chief, Point of Care Content for Elsevier and president of the Medical Toxicology Foundation Dye also is the immediate past president of the American College of Medical Toxicology.

“Well- meaning people, medical and non-medical, develop regulations and perverse incentives that have repercussions. We over aggressively treat pain as mandated and addiction increases,” Dye adds. “We change our prescribing habits, as mandated, and give fewer prescriptions for opioids, and addicts then turn to heroin.”

In a powerful webcast in November, Dye told the story of “Opioids: the Next Death Penalty,” about the evolving problems of opioid abuse, its overwhelming challenges, and hopes for the future. From the 1950s to today, she told how the “pendulum has swung” about the debate of how many opioids should be prescribed: that it was OK, not OK, and back and forth, until where we are now: definitely not OK. In between, there has been intense marketing, sales promotions, questionable governmental and physician practices relating to the dispensing of the drugs.

Opioid-involved deaths have continued to increase in the U.S – and in a shocking way. Overdose deaths have quadrupled since 1999, according to the  Centers for Disease Control and Prevention.

 Leslie R. Dye

Misguided policies

Who would think some insider-baseball designations, such as “patient satisfaction” scores and a term as a “fifth vital sign” would have an impact on opioid use, and possibly misuse? It appears they have. “All these things created a snowball effect,” Dye says.

Over the years, some patients, particularly those having potential addiction issues, demanded opioids, and physicians too often relented, she said. Dye knows first hand of patients asking for drugs. During a period she was working several shifts in the emergency department at a hospital in rural Ohio, many patients asked her for more opioids. Her answer to their requests – and sometimes demands – was “no.”

“I would take the time and talk to them, and tell them why I wasn’t going to give them the prescription,” Dye recalls. “Ninety-five percent of the time they stormed out angry,” she said.

Then, Dye checked with her physician colleagues, many who were prescribing the number of opioids patients sought. “I asked them, ‘what’s the deal?” Dye recalls of her conversations with fellow doctors. “Many of these physicians were overworked – working 12 to 14-hour shifts, working five days in a row in overcrowded emergency departments,” she said. For them, it “wasn’t practical for them to take the time and not give (the patients) the medication,” Dye says.

And there was something else: “They were getting part of their bonuses based on patient satisfaction scores,” she says.

Patient satisfaction scores could have an impact on funding for healthcare systems. The better the score, the more money they get. The patient satisfaction scores could be dependent on anything such as the bedside manner of the physician, and whether the patient would recommend the facility to someone else. It was then not unusual for a physician to relent on a demanding patient – even if they wanted more medications.

“Yes, healthcare is a business, but our customers, the patients, don’t always know what is best for them,” she says. “It is my belief that giving incentives for patient satisfaction encourages many problems – not only unnecessary prescriptions for pain medicine and antibiotics but for ordering unnecessary tests.”

When Dye refers to the “fifth vital sign,” she refers to emphasizing pain as significant as blood pressure, for instance, which has resulted in many repercussions, including over medication, experts say.

The “fifth vital sign” was initiated by the Joint Commission for its Pain Management Standards in 2001, according to.MedPage Today. It required that healthcare providers ask every patient about their pain, on the theory at the time that pain was undertreated, the online magazine said.

“We were told, physicians and nurses, we should consider the pain scale as important as if it was blood pressure or pulse,” Dye said. “If their level of pain was zero to 10 (10 being the worst pain of your life),” she indicated it was recommended that the patient should be medicated to reduce the pain. There was a problem, though: “It wasn’t long before we saw patients eating chips and talking on their cell phone and reporting pain levels of 10,” she says. “Pain is very subjective, it’s hard to determine, but this pain scale; I think few people ended up using it.”

Quite typically, the debate has raged over the pain scale, but not resolved – for years.

In 2007, a  paper from the Journal of the American College of Surgeons said it all in its title: “Kindness kills: the negative impact of pain as the fifth vital sign.” The authors wrote: “The current emphasis on pain assessment as the fifth vital sign and the use of unscientific pain scales is causing serious injury and death from overmedication.”

The American Medical Association last year adopted a resolution recommending removal of pain as the “fifth vital sign,” because of overprescribing, according to Modern Healthcare

Pendulum Swinging Back and Forth

In 1980, a pivotal moment that advanced opioids came, in part, as a result of an academic letter published in the  New England Journal of Medicine, Dye says. “We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction,” said the Jan. 10, 1980 piece in the New England Journal of Medicine.

“If you look at this letter, it says, ‘if the patient is not an addict, you are fine,’ and that may be a simplistic way of looking at it, but it really changed the way we looked at addiction,” she says. When I asked her further about it, Dye says: “The most important thing is that it was a letter to the editor about a study and not a formal peer-reviewed study. It does tell me that we really need to evaluate the literature before we change our beliefs and practices.”

During that period, “people were starting to treat pain more aggressively. Prescriptions for pain were much more easily attainable,” she says.

Then, there evolved the “pill mills” – when a physician’s office might be right next door to a pharmacy, and they were selling lots of opioid medications, Dye says. “Physicians were making lots of money just by patients requesting pain medication and filling out the prescriptions,” she says. For some patients desperate for the drugs, they didn’t care how far they had to go to obtain them. Dye recalls a patient who drove from rural Ohio to Florida for her supply of drugs.

The marketing of drugs was tied more to sales, and opioids were given a great boost, especially in 1995 when the FDA approved Oxycontin (oxycodone controlled-release formulation), Dye says. Eventually, advertisers tried to convince doctors to prescribe medications, “and drug reps would come to (doctor’s) offices trying to get them to prescribe,” she says. Before that, “physicians were concerned about addiction; it was difficult to get them to prescribe at all,” Dye adds.

“OxyContin would soon become a focal point of opioid abuse issues that would continue to escalate into the late 2000s and beyond,” the FDA noted.

The company reformulated OxyContin in recent years, making it far more difficult to abuse, but it is still reckoning with lawsuits stemming from “its earlier, oft-abused iteration,” according to Forbes.com

Through the ups-and-downs of opioid sales and marketing, there was another, far more personal failure in recognizing the needs of people who have taken or even abused the drugs.

“There is the failure of many medical and lay people to recognize that addiction is a disease,” Dye says. “Acceptance that addiction is a disease and not a moral failing and treating it like one should help make a dent in the problem. Treatment of addiction is key.”

— Joe Cantlupe