Studies and Reports

Antipsychotics Harm and Kill Elderly People with Dementia:

Title: The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial

First Listed Author: Ballard

Year: 2009

Message: Increased risk of death for elderly people with dementia on antipsychotics continues over long-term. At three years, about one-third of patients on antipsychotics are alive while about two-thirds of those on a placebo are alive.

Title: Facility and State Variation in Hip Fracture in U.S. Nursing Home Residents

First Listed Author: Zullo, Andrew

Year: 2018

Message: Nursing homes with higher psychotropic drug use have higher incidences of resident hip fractures.  Psychotropic drugs increase risk of falls and fractures.

Title: The Impact of Antipsychotic Drugs on Long-Term Care Dependency, Nursing Home Admission, and Death Among Dementia Patients

First Listed Author: Nerius, Michael

Year: 2017

Message: Antipsychotics are associated with increased debilitation (more care needs and more death) for dementia patients.

Title: Psychotropic Drug Prescription and the Risk of Falls in Nursing Home Residents

First Listed Author: Cox, Claudia A.

Year: 2016

Message: Psychotropic drugs are associated with a nearly 3-fold increase in falls for nursing home residents.

Title: Use of Antipsychotics and Risk of Myocardial Infarction

First Listed Author: Zheng-he Yu

Year: 2016

Message: Antipsychotic use is significantly associated with heart attack risk.

Title: Antipsychotics, Other Psychotropics, and the Risk of Death in Patients with Dementia

First Listed Author: Maust

Year: 2015

Message: Antipsychotics, Valproic Acid (Depakote), and Anti-Depressants are associated with increased risk of death in people with dementia. The absolute mortality risk of antipsychotics may be higher than previously reported and increases with dose.

Title: Antipsychotic Use in Parkinson’s Disease is Associated with Increased Mortality

First Listed Author: Weintraub

Year: 2015

Message: Antipsychotics increase the risk of death by 2.35 times over an 180-day period for people with Parkinson’s Disease.

Title: Falls and Fractures with Atypical Antipsychotic Medication Use

First Listed Author: Fraser

Year: 2015

Message: Antipsychotics given to elderly people increase risk of falls and falls with fractures by 50% within 90 days of administration.

Title: Number Needed to Harm: Antipsychotics and the Risk of Death in Patients with Dementia

First Listed Author: Maust

Year: 2014

Message: Mortality risks with antipsychotics are higher (at least double) than previously reported, particularly when patients are observed over longer periods of time. “The balance of benefit to risk of antipsychotic treatment in dementia continues to shift.”

Title: Psychotropic Medications, Including Short Acting Benzodiazepenes, Strongly Increase the Frequency of Falls in the Elderly

First Listed Author: van Strien

Year: 2013

Message: Elderly people taking a psychotropic drug (antipsychotic, anti-anxiety, anti-depressant) were twice as likely to report having fallen three or more times in the past year.

Title: Atypical Antipsychotic Drugs and the Risk for Acute Kidney Injury and Other Adverse Outcomes in Older Adults

First Listed Author: Hwang

Year: 2014

Message: Atypical antipsychotics significantly raise risk of acute kidney injury, hypotension, acute urinary retention, and neuroleptic malignant syndrome for older adults.

Title: Antipsychotic Therapy and Short-term Serious Events in Older Adults with Dementia

First Listed Author: Rochon

Year: 2008

Message: Older adults prescribed atypicals are 3.2 times more likely to suffer adverse events (i.e. hospitalization, fall, fracture, stroke, heart attack, death). Those prescribed conventional antipsychotics were 3.8 times more likely.

Title: Antipsychotic Agents and Sudden Cardiac Death – How Should We Manage the Risk?

First Listed Author: Schneeweis

Year: 2009

Message: Antipsychotics have no measured benefit on treating elderly people with dementia but enhance risk of death. Use should be reduced sharply.

Title: Atypical Antipsychotic Drugs and the Risk of Sudden Cardiac Death

First Listed Author: Ray

Year: 2009

Message: Current use of atypicals and conventional antipsychotics double the risk of sudden cardiac death.

Title: Risk of death associated with the use of Conventional versus Atypical Antipsychotic Drugs among Elderly Patients

First Listed Author: Schneeweis

Year: 2007

Message: All antipsychotics raise the risk of death for elderly with dementia but conventionals are worse than atypicals.

Title: Risk of death in elderly users of conventional vs. atypical antipsychotic medications

First Listed Author: Wang

Year: 2005

Message: All antipsychotics raise the risk of death for elderly with dementia but conventionals are worse than atypicals. Atypicals: nearly double risk of death (60-70% higher), Conventionals’ risk of death is 37% higher than atypicals’

Title: Antipsychotic Drugs and the Acute Respiratory Distress Syndrome

First Listed Author: Wilson

Year: 2005

Message: Antipsychotics can cause neuroleptic malignant syndrome which may be associated with acute respiratory distress

Forget Dementia, Antipsychotics are Dangerous to Anyone Over 40

Title: Comparison of Longer-Term Safety and Effectiveness of 4 Atypical Antipsychotics in Patients Over Age 40: A Trial Using Equipoise-Stratified Randomization

First Listed Author: Jin

Year: 2012

Message: Antipsychotics caused high incidence of metabolic syndrome and serious adverse and nonadverse events. Antipsychotics are dangerous and not a favorable treatment, irrespective of diagnosis or drug.

Antipsychotics Don’t Do Much Good and Less Intrusive Measures Are Better:

Title: Impact of Person-Centred Care Training and Person-Centred Activities on Quality of Life, Agitation, and Antipsychotic Use in People with Dementia Living in Nursing Homes

First Listed Author: Ballard

Year: 2018

Message: Just one hour a week of additional social interaction for nursing home residents with dementia, along with staff training and reviews of antipsychotic drugs, reduced residents’ distress, improved their quality of life, and saved money.

Title: Effect of Intravenous Haloperidol on the Duration of Delirium and Coma in Critically Ill Patients (Hope-ICU)

First Listed Author: Page

Year: 2013

Message: Haldol proved no better than a placebo in managing delirium in an adult intensive care unit.

Title: Nonpharmacologic Management of Behavioral Symptoms in Dementia

First Listed Author: Gitlin

Year: 2012

Message: There is strong evidence for using nonpharmacologic treatment to yield high levels of patient and caregiver satisfaction and quality of life.

Title: Withdrawal Versus Continuation of Chronic Antipsychotic Drugs for Behavioural and Psychological Symptoms in Older People with Dementia

First Listed Author: Declercq

Year: 2012

Message: There is very little difference in “behavioral deterioration” for patients with dementia who are withdrawn from antipsychotic drugs versus those who are not. People with dementia can be withdrawn from antipsychotics without detrimental effects on their behavior. Care providers should incorporate plans to discontinue antipsychotic drugs into routine clinical care.

Title: Efficacy of Treating Pain to Reduce Behavioural Disturbances in Residents of Nursing Homes with Dementia

First Listed Author: Husebo

Year: 2011

Message: Agitation was significantly reduced for dementia patients who were administered regular acetaminophen.  Results compared well to best currently available drug therapy.  Pain management could reduce need for psychotropic drugs for treating dementia.

Title: A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)

First Listed Author: Ballard

Year: 2008

Message: Patients with Alzheimer’s Disease who were withdrawn from antipsychotics had no detrimental effect to their functional or cognitive status.

Title: Cost-benefit Analysis of Second-Generation Antipsychotics and Placebo in a Randomized Trial of the Treatment of Psychosis and Aggression in Alzheimer Disease

First Listed Author: Rosenheck

Year: 2007

Message: Placebo led to cheaper total health costs and no noticeable difference in quality of life or measures of function than when antipsychotics were used.

Title: Effectiveness of Nonpharmacological Interventions for the Management of Neuropsychiatric Symptoms in Patients with Dementia

First Listed Author: Ayalon

Year: 2006

Message: Non-drug interventions can be more effective than drugs and should be used first. Pain, fatigue, and other issues may be the cause of behavioral problems.

Title: CATIE-AD Trial – Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer’s Disease

First Listed Author: Schneider

Year: 2006

Message: Any benefits of atypicals for treating psychosis, aggression, or agitation in patients with Alzheimer’s are offset by adverse effects. Patients treated with drugs had more parkinsonism, sedation, confusion, and cognitive disturbances.

Title: Cognitive Effects  of Atypical Antipsychotic Medications in Patients with Alzheimer’s Disease: Outcomes from CATIE-AD

First Listed Author: Vigen

Year: 2011

Message: People with dementia who are given antipsychotics show significantly greater rates of decline in cognitive function than those who received a placebo.

Title: Effect of Enhanced Psychosocial Care on Antipsychotic Use in Nursing Home Residents with Severe Dementia

First Listed Author: Fossey

Year: 2006

Message: Facilities that dedicated themselves to non-medication alternatives reduced their drug usage by half with no significant differences in the levels of agitation or disruptive behavior in the residents.

Title: Pharmacological Treatment of Neuropsychiatric Symptoms of Dementia

First Listed Author: Sink

Year: 2005

Message: Psychiatric drugs are not particularly effective for the management of neuropsychiatric symptoms of dementia. The drugs should be used only as a last resort if at all and only after environmental causes of symptoms have been first ruled out.

Other Classes of Psychotropic Drugs Are Deadly for Elderly People in Nursing Homes; In Fact, More Deadly than Atypical Antipsychotics:

Title: Risk of Death and Hospital Admission for Major Medical Events after Initiation of Psychotropic Medications in Older Adults Admitted to Nursing Homes

First Listed Author: Huybrechts

Year: 2011

Message: After looking at 10,900 nursing home residents over a 10 year period, conventional antipsychotics, antidepressants, and anti-anxiety drugs were associated with greater risk of death than even atypical antipsychotics.

Title: Effect of Anxiolytic and Hypnotic Drug Prescriptions on Mortality Hazards: Retrospective Cohort Study

First Listed Author: Weich

Year: 2014

Message: People taking anti-anxiety or sleeping drugs in the first year died at a rate more than three times greater than those who didn’t. Over 7.6 years, the death rate of those taking the drugs was twice as high of those who didn’t. The death rate of the studied people taking the drugs was 26.46 out of 100.  For those who didn’t take the drugs, the death rate was 16.82 out of 100.

Anti-Anxiety Drugs Associated with Increased Risk of Dementia:

Title: Benzodiazepines and Risk of Alzheimer’s Disease

First Listed Author: Yaffe

Year: 2014

Message: Use of anti-anxiety drugs such as Xanax, Ativan, Klonoppin, and Valium are associated with significantly increased risk of Alzheimer’s Disease.

Title: Benzodiazapene Use and Risk of Alzheimer’s Disease: Case-Control Study

First Listed Author: Billioti de Gage

Message: Long-term use (over 90 doses – even if spread out over years) of benzodiazapenes correlated with much higher incidence of Alzheimer’s Disease. 180-plus doses nearly doubles the risk of Alzheimer’s.

Anti-Depressants Are Ineffective and Dangerous for Treating Depression in Dementia:

Title: Fall and Fracture Risk in Nursing Home Residents with Moderate-to-Severe Behavioral Symptoms of Alzheimer’s Disease and Related Dementias Initiating Antidepressants or Antipsychotics

First Listed Author: Yu-Jung Wei

Year: 2016

Message: Antidepressant users with dementia who live in nursing homes experienced significantly higher risk for falls and fractures than even antipsychotic users.

Title: Dose-response relationship between Selective Serotonin Reuptake Inhibitors and Injurious Falls: A Study in Nursing Home Residents with Dementia

First Listed Author: Sterke

Year: 2012

Message: Use of SSRI anti-depressants are associated with significant increases in fall risks for nursing home residents with dementia. The higher the dose, the greater the risk.

Title: Sertraline [Zoloft] or Mirtazapine [Remeron] for Depression in Dementia (HTA-SADD): a Randomised, Multicentre, Double-blind Placebo-controlled Trial

First Listed Author: Banerjee

Date: 2011

Message: Anti-depressants are no better than a placebo than treating depression in people with dementia. Due to the increased risk of adverse events associated with the use of anti-depressants, they should not be used as a first-line of treatment of depression in dementia.

Depression is Significantly Over-Diagnosed:

Title: Clinician-Identified Depression in Community Settings: Concordance with Structured-Interview Diagnoses

First Listed Author: Mojtabai

Year: 2013

Message: More than 60% of people diagnoses with depression do not meet the clinical criteria for depression. Depression is overtreated (with antipdepressants).

Facilities Drug Use Rates are Driven by Staff Convenience and Facility Culture, Not Residents’ Needs:

Title: Variation in Nursing Home Antipsychotic Prescribing Rates

First Listed Author: Rochon

Year: 2007

Message: Large variation in rate of drugging in nursing homes cannot be explained by variation in residents. Some nursing homes must be better than others.

Title: Exploring the Link Between Organizational Climate and the Use of Psychotropic Medicines in Nursing Homes: A Qualitative Study

First Listed Author: Sawan

Year: 2017

Message: A facility’s organizational climate heavily influences its psychotropic drug usage, with staffing levels and training, managerial expectations, and teamwork the three most influential dimensions.

Title: Unexplained Variation Across US Nursing Homes in Antipsychotic Prescribing Rates

First Listed Author: Chen

Year: 2010

Message: Facility level prescribing rates depend on the facility, not the resident. Facility preferences determine its drugging rate. 16.4% of residents with no clinical indication for antipsychotics nonetheless received them.

Drugs Are Often Given Without Clinical Indications:

Title: Increasing Off-label Use of Antipsychotic Medications in the United States, 1995-2008

First Listed Author: Alexander

Year: 2011

Message: Use of antipsychotic drugs has risen dramatically from 6.2 million “treatment visits” in 1995 to 14.3 million in 2008. Use among the elderly increased 23% during that time. Off-label use more than doubled from 4.4 million treatment visits to 9.0 million and the costs of off-label drugs increased 7.5-fold from $0.8 billion to $6.0 billion.

Title: The Quality of Antipsychotic Drug Prescribing in Nursing Homes

First Listed Author: Briesacher

Year: 2005

Message: Use of antipsychotics has risen. Most atypicals prescribed outside of prescribing guidelines for doses and indications. Only 41.8% has appropriate dosage and indications for use. 23.4% no indications for use, 17.2% too high doses, 17.6% had both problems. Those on antipsychotics had no appreciable difference in quality of life.

Title: Provision of Psychopharmacological Services in Nursing Homes

First Listed Author: Molinari

Year: 2009

Message: 70% of all Medicaid residents receive a psychoactive within three months of admission even though most have no psychiatric diagnosis nor any prior use.

Title: Use of Antipsychotics among Nonagenarian Residents in Long-term Institutional Care in Finland

First Listed Author: Alanen

Year: 2006

Message: Residents with socially disruptive behaviors are mush more likely to receive an antipsychotic than those with good social skills

Title: Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges

First Listed Author: Crystal

Year: 2009

Message: Most use for residents is without an FDA diagnosis. 22.6% of residents with dementia but no psychosis and no behavioral symptoms receive an antipsychotic. Physicians responding to pressure that “something needs to be done.”

Title: Off-Label Use of Second-Generation Antipsychotic Agents Among Elderly Nursing Home Residents

First Listed Author: Kamble

Year: 2010

Message: 23.5% of the country’s nursing home residents in 2004 received at least one prescription for a second-generation antipsychotic drug and that 86.3% of the use was off-label. Only 56.9% of the off-label use was evidence-based; 43% of off-label use “was without strong scientific support, suggesting a less than optimal quality of care in nursing homes.” The off-label use could be due in part to pharmaceutical promotion, growing scientific support, and prescribers’ training and personal experience.” Residents with a diagnosis of dementia were 3.2 times more likely to receive off-label drugs; 71% of residents taking off-label drugs had a diagnosis of dementia.

Informing Patients of Drug Risks Leads to Decreased Use:

Title: Trends in Antipsychotic Use in Dementia 1999-2007

First Listed Author: Kales

Date: 2011

Message: Use of atypical antipsychotic for outpatient treatment of dementia began to decline in 2003 when FDA Black Box warnings were required. Nursing home patients were not part of the study.

Title: Impact of FDA Black Box Advisory on Antipsychotic Medication Use

First Listed Author: Dorsey

Year: 2010

Message: FDA Black Box warning label on atypical antipsychotics was associated with decreased use, especially among elderly patients. Informing patients of drug risks could reduce misuse of antipsychotic drugs.

Some nursing homes must be better than others.

Title: The Impact of OBRA-87 on Psychotropic Drug Prescribing in Skilled Nursing Facilities

First Listed Author: Borson

Year: 1997

Message: New federal laws targeting nursing home quality of care, including psychotropic drug use, decreased use of antipsychotic drug use by almost 35% from 1989-1992.  Focused reform efforts can reduce use.

Education Programs Will Reduce Psychotropic Drug Rates:

Title: A Randomized Trial of a Program to Reduce the Use of Psychoactive Drugs in Nursing Homes

First Listed Author: Avorn

Date: 1992

Message: Educational outreach program to nursing homes designed to increase the selectivity of psychoactive drug use was associated with significant reduction of use. Resident cognition also improved in the educated nursing homes.

Title: Reducing Antipsychotic Drug Prescribing for Nursing Home Patients: A Controlled Trial of the Effect of an Educational Visit

First Listed Author: Ray

Year: 1987

Message: One-time personal visits by trained physician counselors to doctors who were frequent prescribers of antipsychotic drugs in nursing homes did not reduce antipsychotic drug prescriptions. The authors concluded that nursing staff (not physicians) may be key to therapeutic decisions and that more intensive interventions than a single educational visit is needed to change prescribing habits.

Increased Regulatory Scrutiny Lowers Antipsychotic Use:

Title: Response to Regulatory Stringency: The Case of Antipsychotic Medication Use in Nursing Homes

First Listed Author: Bowblis

Year 2011

Message: A ten-percentage point increase in the proportion of facilities that receive a deficiency for unnecessary drug use decreases the proportion of residents who receive an antipsychotic by 0.45 percent.



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