Good News? US Senators Seek to Cut Misuse of Antipsychotics

This is a controversial matter……. I don’t even know what to say about it……….. my mother is on antipsychotics that were given to her by a trained psychiatrist to “stabilize” her during her month-long stay at a geriatric psych unit. They do this……….. stabilizing…………… because many facilities (even the “memory care” units) won’t accept behavioral patients unless they are medicated……………… it’s a lose-lose situation, but it’s certainly not uncommon………………. And yes, we all know about “black box” warnings.

So what do you do? For those of us coping with a behavioral parent, our options are limited, and often the only course of action is Seroquel, Lithium, Depakote, Zyprexa, two or more of the above, and the list goes on………………………

Is it a disturbing practice? Yes.

Is there a choice? In our case, no. We had no choice.

Fortunately, Washington, with their first-rate, life-long health care, is on the case……………….

Inside voice…………… I wonder if the esteemed senators below would be willing to take in behavioral dementia patient who has been asked to leave yet another memory care unit or assisted living facility?

So, what do you think about antipsychotics?

U.S. Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn., today filed an amendment seeking to combat the costly, widespread and inappropriate use of antipsychotics in nursing homes.

“The overuse of antipsychotics is a common and well-recognized problem that puts frail elders at risk and costs taxpayers hundreds of millions of dollars each year,” Kohl said. “We need a new policy that helps to ensure that these drugs are being appropriately used to treat people with mental illnesses, not used to curb behavioral symptoms of Alzheimer’s or other dementias.”

“This amendment responds to alarming reports about the use of antipsychotic drugs with nursing home residents,” Grassley said. “It’s intended to empower these residents and their loved ones in the decisions about the drugs prescribed for them.”

“This measure is responsive to mounting evidence that antipsychotics are being misused and overused in the nursing homes we trust to care for our loved ones,” Blumenthal said. “The amendment will do what is necessary to curb this deeply concerning practice, putting the power to make key health care decisions back into the appropriate hands and eliminating unnecessary costs to taxpayers.”

The amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act would require the Health and Human Services Secretary to issue standardized protocols for obtaining informed consent, or authorization from patients or their designated health care agents or legal representatives, acknowledging possible risks and side effects associated with the antipsychotic, as well as alternative treatment options, before administering the drug for off-label use. While the Food and Drug Administration (FDA) has approved antipsychotic drugs to treat an array of psychiatric conditions, numerous studies conducted during the last decade have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. In fact, the FDA issued two “black box” warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia.

Last year, the Health and Human Services Office of the Inspector General (HHS OIG) issued a report showing that over a six-month period, 305,000, or 14 percent, of the nation’s 2.1 million elderly nursing home residents had at least one Medicare or Medicaid claim for atypical antipsychotics. The HHS OIG also found that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with a condition specified in the FDA box warning. Further, it showed that more than half of the 1.4 million claims for atypical antipsychotic drugs, totaling $116.5 million, failed to comply with Medicare reimbursement criteria. The amendment also calls for a new prescriber education program to promote high-quality, evidence-based treatments, including non-pharmacological interventions. The prescriber education programs would be funded through settlements, penalties and damages recovered in cases related to off-label marketing of prescription drugs.

>>Flickr pic by Ashley Rose

7 Comments

  1. I honestly hope that the sponsors of this bill have intimate knowledge of “Alzheimer’s or other dementias” behavior. I, too, didn’t like the idea of antipsychotics until my mother became aggressive, combative – even violent – with me. Her FTD has stripped her of any filter for inappropriate behavior. Her very small dose of Seroquel enables her to control some of her behaviors, not all of them, but it also enables my sister and me to enjoy her company again. I agree it’s a fine line but, hopefully, the government won’t make the nasty behaviors of FTD more difficult for caregivers.

  2. The newer generation so called ‘atypical’ antipsychotics have been heavily pushed by the drug companies,on children,veterans for PTSD and the elderly.
    Eli Lilly’s Zyprexa franchise made them $65 billion.Lilly was fined $1.4 billion for Zyprexa fraud.
    -Daniel Haszard FMI zyprexa-victims(dot)com

  3. anyone thinking that the use of anti-psychotics is questionable has never been bitten by their mother whilst she is experiencing a psychotic break…each time we attempted titrating down her dosage, she tilted. I believe in the use of anti-psychotics for the comfort and safety of the patient and those around them.

  4. My mother is off of Seroquel for the first time in 2+ years. She is now verbal again, shows emotion, hugs, kisses and responds to us appropriately. I know that this may be short lived, but I will take it. I too believe in the use of anti-psychotics for the comfort and safety of the patient and those around them — but I think that in my Mom’s case the drug was over used just for the convenience of the care givers so that Mom wouldn’t wander at night and slept when the staff was reduced overnight.

  5. My husband’s grandmother was able to stay at home with her son and his wife ONLY because a tiny amount of the antipsychoitic Risperdal (risperidone) reversed her increasing paranoia, anxiety, and delusional thinking. Back in the early nineties before she visited us for a couple of months she was on her way to a nursing home. A few days after she after she was prescribed a tiny amount of risperidone, she stopped telling us the son’s wife was poisoning her (my husband’s father was having his septic system pumped out monthly from all of the ‘food being flushed down), asked to have us help her dye her hair and take her out for dinner instead of barely brushing her hair and never eating very much, started to tell us of her life growing up, started to laugh again, and on one Saturday afternoon at our request and using no notes, instructed my husband step by step how to make tuna croquettes. Upon returning home , where she died a decade later of likely multi-infarct dementia, she now joined the rest of the family at the dinner table to eat, only now allowed someone there to help her bathe, and after a couple of years flew from the USA to Europe to meet with her lawyer there to tell him in person with full command of her facultes that despite his pressure and that from others that she had decided not to sell her land.
    Antipsychotics exist for he patients’ well-being. Psychiatrists get this. They know the doses; they know to combine tiny doses of multiple meds if need be to avoid side effects. They are already under the threat of constant lawsuits and big pharma has announced that it will be suspending development of new CNS drugs as the public and the personal injury lawyers care more about suing than learning how the brain works (NIMH grants are funded at a 12% rate). So let’s all save our outrage for things we know about… like the importance of letting the person who knows the most make the clinical care decisions- not me, not a lawyer, not a hospital administrator– in this case apsychiatrist take care of a patient with a psychiatric health problem. Having her be at home was cheaper for society and help preserve her freedom and dignity. We already have enough of those who know a little making big decisions that end up costing us our freedom and more money. for the Off-label means in part -that FDA has not gotten a big chunk of change and that the approved meds fall pretty short for many people and that big pharma is not wiliing to pay for the FDA pipeline as they know clinicians will risk their license to use eds that are evidence-based, but not profitable enough for Pharma to pay the R & D. Given our national budget, paying more taxes for increased numbers of objective drug trials is unlikely to suddenly become a higher level priority for most of the public. So what are the choices? I suggest a pause and reflect which makes more sense, to have Senators “educate” the doctors draft a rigid prescribing scheme that does not include several thousand dollars in genetic tests for the many known genetic differences in metabolism and receptors affected by second-generation antipsychotic medications or have the doctors and scientists educate all of us so we know that black boxes are issued appropropriately some times and some times they are appropriate but the doctor and patient need to decide the best tradeoff. The “father of modern pharmacy” was a physician who became aware of the potential conflict of interest of the clinician prescribing and selling sso advocated creating the separate occupation of pharmacist. It’s not a perfect split either I learned when I wasted 4 hours in a hospital for an iiron transfusion prescribed by my doctor, but objected to by the hospitalpharmacist as he didn’t thought the previous infusions were enough. So more entities and regulations always come with a price, just like a medicine. So, go volunteer to be bitten or hold someone from shaking from anxiety has the sun sets. Get some new information and insist on those who know the most make the call. You can always just send in a Senator to prescribe a better medication.
    WHAT IS SHOCKING TO ME, is that most doctors still have to risk their license to treat the patients with the best meds available, while the patient and their family wait in the wings ready to sue the doctor for any bad outcome, regardless of the etiology of the bad outcome.
    So now we, the public, need to “train” this stupid doctors and have politicians pick a few folks who are MDs think for all of them. When you show up at the ER with a gut ache or hearing voices, you can just type in your symptoms and the computer program based on the thinking of a few physicians who refuse to prescribe ‘off-label’ for even uses proven in peer-reviewed literature but not bankrolled through the FDA pipeline.

    I want better healthcare than that. I know the best doctors are not the same ones following two-year old ‘best-practice’ that are based upon 1000 subjects who not prescribe something not FDA approved, even if there was overwhelming data supporting its use and no FDA approved viable choices. It might save money in the long run, but pain and diesase cost our country more than letting physicians do their job. Only recently have medical students been exposed to knowledge about novel treatments with big “Disclosure” slides at the beginning of the lecture. The professor knows our society NOW cares more about legal liability than training minds. Do you want a mind or an FDA program treating you? I want the kind of informed, smart care my delightful husband’s grandmother received– someone treating me as patient who knows more than is in print and is not paralyzed by the political “black box” labels that has led to an increase, not a decrease in adolescent suicide. I want a trained, well-read mind thinking about my symptoms not thinking about “legally safe” care or taking time to fill out another form or using CME time to be trained in mediocrity rather than in using some of the drugs we already have for new purposes (e.g., a cancer drug to treat dementia) By the way, using a drug we already have to treat an additional disease, not tested for by the company that patented the drug got the FDA approval is the definition of “Off Label.” The FDA does not get a penny of this process so the doctor takes a legal risk when s/he treats your depression with a drug for narclepsy… Why does this happer? As the drug comes off-patent, there is no economic incentive for any one company to pay for the entire FDA process again. So if you want all of the many drugs useful available for your off-label problem to go through the FDA system, you will need to help push NIH/pharma collaborations to make it happen and get others to provide with you some serious cash to go through the FDA process for all of the hundreds of drugs out there that are actually helpful for more than one thing or your could realize most of the time, you need to either trust your doctor or if when you are not volunteering at the closed unit in the nursing home nearest your home you need to plan on hanging out with the Senators and writing some software code for yet another reason for your doctor to try away from listening to you to click some buttons on a computer form verifying cliniician understanding about pharmaceutical issues already known to the masses to make yourself feel like you are not not a pawn of the evil medical pharma complex, or just decide the risk is not for you but allow others and their doctors and their patients, some of whom will have unique physiology (e.g., a person who has a genetically specified efficient metabolic enzyme that creates the need for a higher dose than the Senators migth allow) as that possibility might not addressed by the algorithms based a small subset of the population so that individual might never be allowed a therapuetic dose since such a dose might be larger than usual. Over-medication is wrong and unnecessary. Having additional constraints educational constraints appears caring and feed the fallacy that all bad can be prevented with a few more rules,but, in reality, tying the hands of those that are the most informed is wrong, unnecessary, and short-sighted as really would lighten the medical bag of many established treatments.

  6. Hey there! This is my 1st comment here so I just wanted to give a quick
    shout out and say I really enjoy reading through your blog posts.
    Can you suggest any other blogs/websites/forums that deal with the same subjects?
    Thanks for your time!

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