I recently read an article posted by Dementia & Alzheimer’s Weekly (http://alzheimersweekly.com) which included a video with the article. The article was entitled “Depakote Fined $1.6 Billion for Sedating Dementia Patients.” Depakote is manufactured and marketed by Abbott Labs and is primarily prescribed (and approved by the FDA) by physicians as an antiepileptic medication to control seizures. (Permission to quote this article obtained)
The article talks about a plea agreement in a U. S. District Court (Western District of Virginia) case for “alleged use of illicit incentive payments by Abbott to physicians to encourage prescription writing of Depakote, as well as misrepresentations of the drug’s safety and efficacy, and off-label marketing.”
Physicians will quite often prescribe drugs “off-label” meaning the drug has never been tested and approved by the FDA for that purpose. Every, single drug being given to an elder with dementia to help control negative behaviors is being given off-label, and these psychotropic drugs all have black box warnings which means they have serious side effects and can hasten death. Common prescriptions written for psychotropic drugs for behavior control include Seroquel, Risperdal, Zyprexa, Haldol, and others. Anti-anxiety meds such as Valium, Ativan, Xanax, and Klonopin are also frequently used in this manner but always increase the risk of dizziness, falls and visits to the emergency room.
The reason these drugs are being prescribed is because there are no drugs approved by the FDA for behavior control in elders with dementia. What too many facilities have done for years, is use these drugs to medically restrain an elder with dementia who is acting out or causing staff extra time and attention. Thankfully, the tide is turning with regulatory agencies checking medication records for extended use of these medications and penalizing those facilities who automatically use drugs to control behaviors. These regulatory agencies are now aware that when facilities provide specific, on-going dementia training for the staff, the need for these medications drops dramatically.
The fine imposed on Abbott Labs is the second largest in history, with the largest fine being leveled against Eli Lilly & Company in 2008 for promoting the use of Zyprexa in dementia patients, as well as elders in general to “treat anxiety, irritability, depression, nausea, Alzheimer’s and other mood disorders.”
I believe there are times when the off-label use of these drugs in elders with dementia is appropriate to protect that elder from self-harm, or to protect families and staff. However, it has been proven time and again that when people know how to correctly re-direct an elder with dementia, or de-escalate their agitation, those meds are not necessary. So if the staff and the physician feel that elder truly needs that psychotropic medication, then they must extensively document reasons why, and every time it is given in an “as needed” (PRN) basis, they must document what other interventions were tried first and failed. An example would be if Bill, who has dementia is noted to be increasingly agitated this morning and has an order for a PRN Risperdal for agitation. After attempts at redirection, staff may document:
“Bill noted to be pacing and seemed agitated after breakfast; unable to verbalize what is upsetting him; denies need to use restroom or presence of pain; attempted to engage him in bowling activity and he refused; attempt to interest him in listening to his favorite music refused; walking with Bill for 15 minutes and conversing unsuccessful in decreasing his agitation; PRN Risperdal given resulting in decrease in agitation. Bill is currently engaged in group activity and appears calm.”
We must all continue to monitor the medications our loved ones with dementia are being given, whether they are at home or in a facility. We have an obligation to learn what we can about the dementia, as well as learn ways to control behavior that do not automatically require the use of a medication. It’s nice to see that two of these huge pharmaceutical companies have been made to pay for preying on frail elders.
Cindy Keith, RN, BS, CDP
M.I.N.D. in Memory Care