As noted last week, the practice of prescribing opioids to treat pain is symbolic of what has been called one of the largest shifts in the culture of medicine to occur over the past three decades, a shift that appears unrelated to any significant change in disease burden or the burden of pain in the U.S. It is part of an onslaught of new approved, highly marketed pharmaceuticals and over-the-counter drugs. Between 1991 to 2011, the volume of new opioid formulations (including OxyContin) and opioid prescriptions in the U.S. more than tripled. As a result, we are in the midst of an opioid epidemic, as opioids continue to this day to be overprescribed.
To reverse this trend will not be easy. The idea of dropping unnecessary medications in general, or “deprescribing,” began appearing in the medical literature about a decade ago. The concept seems to only now be starting to take hold as evidence intensifies about the dangers of taking multiple, perhaps unnecessary, medications. Taking five or more drugs concurrently, also known as “polypharmacy,” is now a common practice.
Geriatricians and researchers have warned for years about the potential hazards of polypharmacy and what the New York Times has referred to as “the ever-mounting pile of pills” that are being pitched to the American public. According to a report by the IMS Institute for Healthcare Informatics, global spending on medicines will reach $1.2 trillion in 2017. Combining medications has reached disturbingly high levels among older adults.
According to an article published in JAMA Internal Medicine, more than a third of people 62 to 85 surveyed were taking at least five prescription medications. But older people don’t just take prescription drugs. Of those surveyed, almost two-thirds were using dietary supplements and nearly 40 percent took over-the-counter drugs. Such use increases their chances of dangerous side effects.
Research shows many people, especially those over 50, don’t read the labels. According to the JAMA Internal Medicine report, one in five of those surveyed also admitted to using more medication than the label indicated. This creates an environment primed for unintended drug interactions and overdoses. In one study, 50 percent of participants older than 50 years of age failed to notice a warning label on prescription vials.
Today, the National Academy of Medicine estimated about one-third of adverse events in hospitalizations now include a drug-related harm. It is estimated there are 400,000 preventable adverse drug events in hospitals each year. One-fifth of patients discharged from the hospital have an often-preventable drug-related complication after returning home. Senior citizens are among the greatest at risk population. According to a New York Times report, more than 8 percent of older adults in 2005 and 2006 were susceptible to a major drug interaction. Five years later, the number exceeded 15 percent.
What is becoming clearer is that an increasing number of older Americans, many with multiple chronic conditions, are taking drugs and supplements they don’t need that could interact with one another in harmful ways. It is estimated at least one in five older patients are on a wrong medication. Some studies cite that number to be an even higher number – as much as 60 percent. A recent randomized trial found that frail and older people could drop an average of two drugs from a 10-drug regimen with no adverse effects.
So why isn’t deprescribing more widely considered? Why do far too many patients leave the hospital on more medications than when they entered it?
At least a part of the answer to those questions is found in a recent investigative report conducted by CNN. The detailed report describes how one pharmaceutical company has generated hundreds of millions of dollars a year by aggressively peddling a pill to frail and elderly nursing home residents for whom the drug may be unnecessary or possibly harmful.
The drug, known as Nuedexta, is produced by Avanir Pharmaceuticals. It is approved to treat a disorder known as pseudobulbar affect, a condition that afflicts less than one percent of the population. The disorder’s symptoms are sudden and uncontrollable laughing or crying. The problem is that this drug’s financial success is being driven not by treatment of pseudobulbar affect, but by an intensive sales effort to expand its use among elderly patients suffering from dementia and Alzheimer’s disease. A key component of this effort, according to the CNN investigation, is high-volume prescribing and advocacy efforts by doctors receiving payments from the Avanir Pharmaceuticals.
According to CNN, since 2012, more than half of all Nuedexta pills have ended up at long-term care facilities. The number of pills flooding these facilities rose to nearly 14 million in 2016, a jump of nearly 400 percent in just four years. This increase helped Nuedexta sales to reach just under $300 million that year.
Nuedexta is increasingly prescribed in nursing homes even though the drug maker acknowledges in its prescription information that it has not been extensively studied in elderly patients. It is currently only approved by the Food and Drug Administration for patients who have pseudobulbar affect, and the condition has been shown to be extremely rare in dementia patients. Even though there are currently no Food and Drug Administration approved drugs for treating dementia-related agitation (the use it is said to be addressing) and other drug makers have been penalized for marketing drugs for this use.
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