A few news reports on psychotropic drugs have come across my desk recently and, although completely unrelated, they share a common thread. Each case documents either widespread overuse or gross abuse of a powerful drug. And in each case, the abuse or overuse could have been reduced through a more person-centered approach.
Here is a summary, with my comments:
- Yesterday, the FDA recommended lowering the dose of the popular sleep medication zolpidem (brand name Ambien). They felt that the usual 10 mg dose was too high for many people, particularly women, as many people have persistent blood levels in the morning that could interfere with activities, such as driving to work. The levels were highest with the extended-release forms.
This is emblematic of a recurring problem for drug manufacturers: namely, recommending a higher-than optimal dose and not being willing to give people the option to start lower.
Companies often refuse to produce scored tablets that can be easily split, probably to maximize profits. Ambien is such a pill (though there is now a 5 mg pill available as well, also un-scored).
I recall my old private practice days when Prozac first came out. It was only available as a 20 mg. dose and I had many patients, particularly younger women, who complained that it made them feel too anxious. Many of them solved the problem by taking the pill only every 2-3 days. Prozac has a long half-life, and I have avoided using it in older adults for that reason.
We need to adhere to the maxim of “start low and go slow”, and produce lower doses, and/or pills that can be easily split, to reflect the diversity of our population.
- McKnight’s posted an article this week about a former Director of Nursing from California who was sentenced to prison for “elder abuse”, having freely used the anti-seizure/mood-stabilizing medication Depakote to sedate a number of people with dementia when they declined direction, such as going to the dining room for meals. There were 23 people judged to have suffered adverse consequences, and the medication was felt to have contributed to three deaths. The doctor who signed off on the orders and the former CEO received sentences of 300 hours of community service each.
There was a bit of a dustup in the Comments section about the fact that Depakote was referred to as an “antipsychotic” (which it is not), and McKnight’s changed the wording of the article accordingly. Here’s the comment I later posted on the site:
“The bigger issue is the inability to realize that much distress comes from our institutionalized, dehumanized approach to care for people with dementia. The real problem lies not so much with one particular class of drugs, but rather the idea that ANY pill is the solution to unmet needs or environmental stressors. This article reflects the dangers of ‘drug diversion’ to other potentially harmful classes of drugs simply to avoid antipsychotics.”
- What about that New England Journal study? If it seems I have been strangely silent about a study from the October 18th New England Journal of Medicine, it’s because I wrote a Letter to the Editor that was accepted for publication, and I agreed not to pre-release my comments. They were published last week.
To catch you up, the researchers studied people with dementia living in nursing homes who were taking an antipsychotic (in this case, risperidone) for various forms of distress. After randomizing the group, half were continued on the medication while the other half were quickly switched to a placebo. Guess what? Those who were switched to the placebo had a greater increase in distress.
There was no effort to identify unmet needs or to create individualized non-pharmacologic approaches. The meds were simply stopped. The authors’ conclusion that the study indicated that there was some ongoing need for antipsychotics was the final straw for me.
Many of my colleagues also wrote letters objecting to this study; three were published, including mine and one from Alice Bonner’s CMS team. The authors did not dispute my concerns, but rather stated that while there was a role for person-directed approaches, it had yet to be elucidated in head-to-head trials.
What I couldn’t fit into the allotted space was the multitude of problems with our dominant paradigm that continue to infuse and inform our research. There are so many assumptions made here that a person-directed approach contradicts—that those who were quieter on risperidone were necessarily better off (rather than sedated to varying degrees); that education alone is adequate to test as an “intervention” (without considering supportive operational transformation); that a simple “head-to-head” trial of meds vs. “non-pharmacological interventions” would be adequate to test this approach; and viewing those non-pharmacological interventions wholly from a reactive perspective, rather than proactively working to create well-being.
However, the above study did have one important implication that should not be ignored: It showed that simply reducing psychotropic drugs without offering a better path to well-being is likely to fail. Those who have pledged to reduce antipsychotics in their nursing homes without a clear plan to help staff care differently should take note!