By Robert Pearl, MD | Forbes.com | March 17, 2016
Opioids, also known as opiates, serve as important prescription medications in medical practice. But within the last decade or so, because of their overuse, misuse and abuse, they’ve also emerged as a leading cause of addiction and death.
Sadly and surprisingly, those most instrumental in creating this epidemic–however unwittingly–are physicians and the pharmaceutical industry.
The question is, how could this crisis have happened? What responsibility should physicians take, and what culpability do drug companies have? And what’s the best solution to the different aspects of the problem?
Yesterday the Centers for Disease Control and Prevention issued the first-ever guidelines for opioids. Aimed at primary care physicians, the new national standards for these prescription painkillers are a definite step in the right direction.
Prescribing Run Rampant
Opiates are a class of powerful painkillers derived from morphine, and include drugs such as hydrocodone (Vicodin) and oxycodone (OxyContin). The use of opiates can be traced back to the third century B.C., when the Sumerians, living in what today is Iraq, cultivated poppies and extracted opium from the seed capsules.
Opiates do more than bring pain relief. They also produce euphoria, often leading to recreational abuse. And because they’re often much more expensive and harder to “score” than heroin, individuals whose chronic use of opioids has led to dependence increasingly are turning to street heroin to sustain their addiction.
Opioid users develop a tolerance after months or years–needing ever-higher doses to achieve the same level of relief or euphoria–and, if they try to stop, they suffer miserable withdrawal symptoms, making it extremely hard to kick the habit. Heroin often becomes a solution. As a result, four in five new heroin users started out using prescription opioids. And as a result, the rate of heroin overdose deaths in the U.S. has nearly quadrupled from 2000 to 2013.
Opioids are now the most common cause of death from injury in the United States. According to the Centers for Disease Control and Prevention (CDC), more than 15,000 people die annually from overdoses on opioid pain relievers, a 300% increase compared to 20 years ago. And for each person who dies, there are 825 recreational users of these drugs, 32 opioid-related emergency room visits and, subsequently, 10 opioid-related hospital admissions.
The Pain Conundrum
Chronic pain affects nearly one in three Americans. For patients with severe, acute discomfort, such as individuals recovering from surgery or suffering cancer-related pain, physicians have felt comfortable prescribing opioids ever since they became available. But in contrast, due to concern about abuse and addiction, physicians in the past were reluctant to recommend opioids for chronic pain unrelated to cancer, trauma or surgery.
The pendulum swung dramatically in the other direction in the 1990s. Some consumers and pain specialists worried that physicians might be undertreating patients for pain. Unfortunately, this legitimate concern led to out-of-control prescribing for almost any pain, at any cost, and at whatever dose was required.
Soon, the drug companies aggressively funded advocacy organizations committed to encouraging expanded use of opioids. These drug companies, in turn, funded pain management programs, with speakers extolling expanded use of the most potent and addicting agents. The companies then partnered with the advocacy groups to urge state medical boards to require all doctors to enroll in and complete Continuing Medical Educational (CME) programs on the treatment of pain.
This CME training used content skewed towards increased prescribing of pain medication. These educational materials, such as toolkits for assessment of pain levels, often conveyed the impression–despite much scientific evidence to the contrary–that patients in pain, unlike recreational users, faced no risk of dependence or addiction, and only minimal likelihood of an overdose. Doctors largely came to believe that the patients for whom they prescribed opioids would never get addicted or experience a life-threatening respiratory depression. But this belief proved wrong.
The CME material, produced by the drug companies that sold the products, communicated little about the frequent path from opioid dependence to the use of illegal substances like heroin. The pharmaceutical companies that sold these medications generated billions of dollars in profit, and some even touted opioids as safe to use when driving.
The extreme caution about opioid use that previously prevailed gave way to a relative laissez-faire attitude about excessive prescribing. Spending on these medications between 2006 and 2010 increased more than 40% to $8.4 billion.
Despite thousands of deaths each year, drug companies continue to promote these agents, even for relatively mild musculoskeletal pain. Indeed, during the most recent Super Bowl, the broadcast aired two drug ads for medications designed to treat “opioid-induced constipation,” a condition created by chronic opioid use. The implication was that high-dose, long-term use–except for the frequency of bowel movement–wasn’t a big problem, a view at odds with current understanding of this drug crisis.
The Truth About Opioid Addiction
We now know, of course, that a lot of the information about the safety of opioids was wrong. Opioids are, in fact, highly addictive. Taken in sufficient doses, they depress the respiratory center of the brain. Use opioids for more than 90 days and it’s difficult to stop. Take high enough doses and a person will stop breathing and die. Try to stop taking one of these addictive substances after prolonged use and you will experience withdrawal symptoms.
In addition, some physicians–a small percentage, to be sure–have exploited the opportunity, available to anyone with a medical license, to declare themselves pain specialists and set up a “pain clinic.” Some of these facilities are nothing more than cash-only “pill mills.” They offer easy-to-obtain, abundant prescriptions for opioids to anyone who shows up at their doors.
In Southern California recently, Dr. Hsiu-Ying “Lisa” Tseng was criminally charged for reckless prescribing of opioids that led to the deaths of at least three of her patients. In a case that shocked the medical community, she received a sentence of 30 years to life.
Efforts in regulation, enforcement and education to address the crisis are now underway.
But she and doctors like her are the exception. Most significantly, DEA officials have linked opioid overprescribing mainly to well-intentioned physicians doing what they were previously taught.
The DEA recently reclassified hydrocodone (Vicodin), the most commonly prescribed opioid, as one of the most commonly prescribed drugs in the U.S., in the more restrictive category of controlled substances. This designation is reserved for the most addictive drugs, such as morphine and oxycodone, with the highest potential for abuse. Drug makers added black box warnings, and the Food and Drug Administration now requires closer post-marketing surveillance. Finally, the authorities are getting tougher on “pill-pushing” enterprises that increasingly face more aggressive federal and state prosecution.
Even with all we have learned about these drugs–and about the devastation they wreak–the pharmaceutical industry continues to attempt to obstruct efforts at legislative and regulatory reform. Most recently, lobbying by drug manufacturers blocked federal legislation to provide consensus guidelines on prescribing opioids, including dosage maximums.
The Key to Preventing Overprescribing
Beyond regulatory and legislative reform, more can be done to protect patients, and physicians have a real opportunity to take a role in leading this effort. For many practitioners, obtaining the most up-to-date information and becoming educated on the risks and dangers of these medications will allow them to practice safer medicine.
Our medical group, The Permanente Medical Group (TPMG), began an aggressive educational effort to combat the problem in 2012. Under the leadership of Drs. Sameer Awsare and Carol Havens, TPMG experts in disciplines ranging from chronic pain, addiction medicine, primary care and mental health to physician education, quality, pharmacy, technology and surgery created evidence-based guidelines about opioid prescribing and embedded them in the electronic health records (EHRs).
The result was decision support tools, created by the clinical experts, to educate all physicians at the time of prescribing, to increase patient safety and recommend safe alternatives for pain control. The guidelines, for example, include recommended starting doses based on assessments of opioid addiction risk and screening for depression and alcohol use. The training impressed on physicians the importance of developing a written treatment plan and creating medication agreements that designate one physician to be the sole prescriber for a particular patient. In addition, when appropriate, all physicians queried the State of California Controlled Substance Utilization Review and Evaluation System before putting a patient on an opioid, to ensure they were not already receiving opioid prescriptions from multiple providers.
In tandem, TPMG’s Technology Group created easy-to-use links to the different assessment tools and developed applications to help physicians document the required steps. Health educators produced patient materials in multiple languages to enable patients to understand the risks from these medications and the alternative treatments available. Patients were offered convenient access to addiction medicine specialists and mental health experts. Physicians received reports on the number of patients in their practice on high-dose opioids, and how frequently they were being seen for follow-up and monitoring. This gave doctors the opportunity to identify which of the individuals under care faced the highest risk of addiction and overdose.
To date, more than 2,000 of our primary care and ER physicians have received training. They’ve learned how to calculate the risk of an opioid complication for any specific patient and how best to communicate with patients about this complex subject. Physicians who want more expertise can obtain individual communication coaching, complete with videotaping. The current plan is to train physicians in every specialty whose practice includes prescribing medications to treat pain.
The results of this initiative are remarkable. Overall opioid prescribing has dropped by 37%, with scripts for Oxycontin, one of the most addictive and abused opioids, lowered by 75%. Most important, the patients taking the highest doses of opioids, and therefore the most at risk of overdose and death, experienced effective pain relief and saw the biggest reductions in use.
A Blueprint Toward an Answer
The opioid and heroin epidemics will require a combination of solutions. Legislative and regulatory reform, such as the FDA’s recently announced plan to review its process for approval of increasingly powerful opioid painkillers, will be important. So will intensified enforcement measures against “pill mills” and the few physicians engaged in reckless and excessive prescribing. Broad educational initiatives for physicians and public service announcements for consumers can help everyone understand the risks from opioids. And expanded use of alternative methods of pain control for chronic, non-cancer discomfort will allow patients to address their pain needs in safer ways.
In the future, all physicians will need to query patients about past or current drug and alcohol use before prescribing opioid medication, and when appropriate check state prescription drug monitoring programs. And when they prescribe an opioid, it should be at the lowest effective dose, and only be for the quantity likely to be required.
Across the nation, we will need physicians to refer patients with substance-abuse disorders to effective substance-abuse treatment services. And in conjunction, patients currently addicted to opioid painkillers or heroin should use FDA-approved alternatives such as methadone, buprenorphine and naltrexone.
We can reverse this opioid crisis. But the time for us to take action is now, before thousands more die unnecessarily. Maybe next year, for starters, our televisions could show a different kind of Super Bowl commercial about opioids. A public-service ad could warn about the serious risks of chronic, high-dose opioid use, and alert Americans to the alternatives available. In trying to stop this epidemic, that would truly get us all closer to crossing the goal line.
This article appeared on Dr. Pearl’s column on Forbes.com.