Articles Posted in Restraints

The regular use of physical restraints on patients in nursing home facilities without an appropriate medical reason or regard for their dignity and wellbeing is not only a strong indicator of poor quality of care, but also a sign of elder abuse and neglect.  Older adults with dementia in particular are affected by this organizational conduct and are vulnerable to debilitating physical and psychological side effects.  Moreover, it is a violation of their human rights. In the United States, a staggering 38% of senior patients in these types of facilities experience being physically restrained at least once every day.  Although a variety of organizations that strive to reduce or eliminate the use of physical restraints exists, most of their initiatives have not been successful.  However, a longitudinal, multidirectional psychosocial and educational program that was developed to promote patient-centered care for older adults with dementia and reduce the use of physical restraints was implemented in 41 nursing homes with positive results.

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Assisted living has become one of the primary providers of long-term residential care to the growing older adult population, especially elderly individuals with cognitive illnesses such as dementia.  According to statistics, close to one million adults reside in over 30,000 assisted living residences throughout the United States, with some housing more than 100 residents at a time.  Moreover, the use of health care resources is high among assisted living residents; an estimated 20% are Medicaid beneficiaries (although currently, only some states offer Medicaid support to assisted living residents); and recent statistics show that between 42 and 70% of residents are cognitively impaired, but only 13% of beds are designated for dementia special care units.  There are many concerns regarding the practices of prescribing medication for this patient population, and recent concerns have focused on the use of antipsychotic drugs to manage assisted living residents shoring dementia-based behaviors.

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Antipsychotic drugs are an increasingly common form of medication for elderly patients in health care facilities. Although these drugs treat a wide variety of health concerns, most prescribed are unnecessary, and have the potential to cause more harm than good. In an interview with the Wall Street Journal, a professor of psychiatry at the University of Pennsylvania Perelman School of Medicine states, “ Due to an influx of the geriatric population, coupled with increasing chronic health issues, antipsychotic medications will grow to be a severe problem that should not be ignored. Continue reading

A recent investigation in Michigan exposed the number of nursing home facilities in the state that were cited for significant medication errors. The resulting data from the investigation demonstrated that patients within nursing homes either failed to receive enough medication, were administered too much medication, or were administered incorrect medication. The Food and Drug Administration (FDA) reported that medication errors were responsible for injuring approximately 1.3 million people in the United States annually. Given the fact that many elderly individuals commonly take many prescription medications to treat various ailments and conditions, it is imperative that these individuals are provided with correct medication and dosages. The medications that are prescribed to these patients may be critical and vital to their well-being, and may make the difference between life and death.

The investigation noted several examples of medication errors taking place within these facilities. For example, one elderly man entered a nursing home facility for rehabilitation after receiving treatment for his abnormal heartbeat. However, he entered a diabetic coma and passed away after the nursing home failed to treat his diabetes, even though the nursing home knew the elderly resident was a diabetic. Another example involved an elderly woman who died from hypoglycemic brain failure after the nurse accidentally administered her roommate’s medication to her. Furthermore, while one elderly resident was prescribed eleven prescription medications to treat her medical conditions, she failed to receive any of these medications for over a week. The nursing home facility had come to realize their mistake only when the resident’s daughter brought this oversight to their attention. Other tragic cases that have resulted in resident death involved administering residents medication to which they were allergic, or failing to administer prescribed medication.

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According to a news release by the United States Department of Justice (US DOJ), pharmaceutical and health care giant Johnson & Johnson has agreed to pay more than $2.2 billion in a settlement to resolve criminal and civil liability to resolve accusations of health care fraud. Johnson & Johnson faced charges and allegations stating that the company had improperly promoted the use of prescription drugs such as Risperdal, an antipsychotic medication, and Invega, a newer antipsychotic medication, for uses that were not approved by the Food and Drug Administration (FDA) as safe and effective. Additionally, Johnson & Johnson was further charged with paying physicians and nursing homes kickbacks. Attorney General Eric Holder stated that the company’s conduct jeopardized the safety and health of vulnerable patients; as such drugs were marketed to control the conduct of elderly nursing home residents, children, and individuals suffering from developmental disabilities.

Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, had been promoting Risperdal to treat symptoms such as depression, hostility, anxiety, and confusion. The company admitted to promoting the drug to treat psychotic and other behavioral symptoms to those elderly patients who were non-schizophrenic, but suffering from dementia. However, Risperdal had been approved by the FDA to treat schizophrenia only. Furthermore, the government alleged that both Johnson & Johnson and Janssen were aware of the adverse health effects of taking such medications, such as the increased risk of strokes and diabetes, but had downplayed these risks when marketing them to the public. In addition, the company added incentives for the sales representatives who promoted the drug’s off-label use.

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A 2013 study conducted by BioMed Central Geriatrics found that there is a strong positive correlation between pain and disruptive behaviors displayed by the elderly suffering from dementia. It explains that such behavior is often expressed through aggression or agitation, which increases these patients’ risk for injuries and hospitalizations. In fact, agitation is a common behavioral symptom which occurs in up to 80 percent of nursing home patients suffering from any type of mental deficiencies, not simply dementia. However, because dementia is characterized by a decreased ability to verbalize pain due to memory impairment, it causes the sufferer’s pain to manifest itself through destructive behavior.

This discovery is significant because it emphasizes the need for nursing homes to address troublesome behavior by dealing with the root of its cause, rather than simply attempting to manage the symptoms. Many nursing home caregivers often attempt to deal with these symptoms by using psychoactive restraints which not only lead to falls and decreased mobility, but also offend the personal dignity of the elderly. Such practices are common because a sedated patient does not need to be checked on for long periods of time, allowing a chronically understaffed nursing home to continue running with their limited staff. Therefore, this unethical practice bolsters understaffing, which is an important cause of elder neglect.

The BMC Geriatrics study also found that 30% of the cost of care associated with dementia is attributed to the cost of controlling disruptive behaviors. In other words, learning how to adequately cope with elderly pain would significantly help to reduce the overall cost of caring for dementia patients. This cost reduction should serve as an incentive for understaffed nursing homes to hire and train more qualified caregivers, ensuring a higher quality of care for their residents.

In addition to uncovering the root of a serious issue, this study highlights the extent to which many nursing homes are ill prepared to aid their residents. Without proper and extensive training of their staff, nursing homes will continue their unethical practices of medicating their disruptive patients in order to calm their agitation or aggression. Using psychoactive restraints to sedate patients into a state of compliance is a gross violation of the elderly’s Patient’s Rights. Their cognitive and communicative deficiencies subject them to a torturous silence which must be broken. It is the nursing home’s responsibility to not only care for the patient’s physical well-being, but to ensure their emotional and mental comfort as well.

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A recent study observed polypharmacy in nursing home residents. While previous studies have confirmed the dangers of polypharmacy in the elderly, this study is unique because it specifically focuses on patients with cognitive disorders. Approximately 60% of nursing home residents suffer from some type of cognitive disorder. Patients with cognitive disorders, who are more likely to experience polypharmacy, are also at a heightened risk for suffering the dangerous side effects associated with polypharmacy. Patients with cognitive disorders such as dementia are often prescribed antipsychotic drugs. This leads to a complex type of polypharmacy because antipsychotic drugs can be particularly dangerous when mixed with other types of pharmaceuticals and lead to adverse drug reactions.

In this specific study, polypharmacy was considered in any residents taking five to nine drugs simultaneously. Patients taking over ten drugs at a time were categorized as experiencing excessive polypharmacy. All the patients included in the study suffered from advanced cognitive impairment. Of the 1,449 residents studied, 50.7% were observed with polypharmacy and 16.9% were observed with excessive polypharmacy. Patients in which polypharmacy or excessive polypharmacy were observed had a higher risk of developing heart disease, Parkinson’s, gastrointestinal disease, pain, and dyspnea.

The study makes it clear that polypharmacy should be avoided whenever possible. The use of pharmaceuticals must be minimized especially in patients who suffer from cognitive disorders. In dementia patients, use of antipsychotic drugs is known to trigger symptoms such as delirium and agitation. It important to note that these drugs are not intended to treat dementia. The Food and Drug Administration (FDA) does not approve of such use and warns of the dangers of using antipsychotics for off-label purposes. The Center for Medicare and Medicaid Services (CMS) has also recognized that antipsychotics are used rather excessively and unnecessarily in nursing homes and has initiated a program to reduce such use.
Understaffed nursing homes may use antipsychotic drugs for purposes of convenience to chemically restrain patients, who would otherwise require additional care and attention. While a non-pharmocological approach to treating dementia is always favorable, facilities that engage in neglect and elder abuse often sedate residents with antipsychotics before even attempting to use therapies that do not utilize pharmaceuticals. In addition to increasing the risks of polypharmacy unnecessarily, the use of antipsychotics as restraints violates your loved one’s Patients’ Rights. Non-profit organizations such as the California Advocates for Nursing Home Reform (CANHR) are working to end the abuse of antipsychotic drugs in skilled nursing facilities.

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The Food and Drug Administration (FDA) has consistently warned of the dangers of using pharmaceuticals for off-label purposes. Using a drug for off-label purposes means using it for purposes for which it has not specifically been approved by the FDA. Unfortunately, however, off-label use of drugs still accounts for 80% of prescriptions of antipsychotic drugs in nursing homes. Recently, there have been several lawsuits questioning the legality of pharmaceutical companies marketing their drugs for off-label uses.

Just recently, pharmaceutical sales representative Alfred Caronia was charged with promoting a drug for off-label purposes. Caronia argued that the FDA’s regulations prohibiting of the marketing of drugs for off-label purposes violated his rights under the First Amendment. The U.S. Court of Appeals accepted this argument, overturned his conviction, and ruled that “the government cannot prosecute pharmaceutical manufacturers and their representatives…for speech promoting the lawful, off-label use of an FDA-approved drug.” Nevertheless, the FDA maintains that off-label marketing of drugs should be considered “misbranding,” especially given the dangerous risks associated with the off-label use of pharmaceuticals. You can read more about this case in the article “Off-Label Marketing and the First Amendment” published in the New England Journal of Medicine.

In nursing homes, antipsychotic medications, which are intended to treat schizophrenia and bipolar disorder, are frequently used for the off-label purpose of treating dementia. These drugs have become popular in skilled nursing facilities because of their sedative effects. Patients with dementia often suffer from agitation and can sometimes become combative. Although numerous studies have concluded that the most effective treatments for dementia-related agitation are behavioral, understaffed nursing homes do not employ sufficient staff to carry out such therapies. Non-pharmacological alternatives, which include recreational activities, take up much more time than simply administering a pill.

Consequently, inadequately staffed nursing homes frequently resort to chemically restraining their patients. However, it is important for you to know that the use of chemical restraints, which often derives from the off-label use of antipsychotic medications, violates your loved one’s Patients’ Rights. Moreover, the use of antipsychotic drugs has deadly side effects, including an increased risk of strokes, falls, and mortality. This dangerous practice is so prevalent in nursing homes, in fact, that the Center for Medicare and Medicaid Services has adopted an initiative to reduce the use of antipsychotics for off-label purposes.

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A recent article published in the Journal of American Medical Directors Association titled “Antipsychotics and Dementia: A Time for Restraint?” reports on the usage of antipsychotic medications in nursing homes. It is true, indeed, that antipsychotic medications have in many ways improved quality of care for those with illnesses such as schizophrenia and bipolar disorder. However, the reality of the situation is that most of the time, antipsychotics are not being used to treat either of these disorders. Instead, antipsychotics are most frequently used for the off-label purpose of subduing patients with dementia. That being said, the Center for Medicare and Medicaid Services (CMS) has realized the reality of the situation, and has implemented an initiative to reduce the use of antipsychotic medications in nursing homes.

It is important to note that the Food and Drug Administration (FDA) does not approve of the off-label use of antipsychotics. In fact, pharmaceutical companies are required to place a label on their medications warning patients that use of antipsychotic medications for treatment of dementia nearly doubles the risk of mortality, and may also lead to side effects including strokes and delirium. Despite the warning on the dangers of these drugs, off-label use of antipsychotics still accounts for 80% of prescriptions in nursing homes.

This astonishingly large statistic indicates a wider issue that is prevalent in nursing homes nationwide: inadequate staffing . Past surveys have actually indicated a link between understaffing in nursing homes and an increased amount of federal and state deficiency citations for improper use of physical restraints. This is due to the fact that when there is insufficient nursing personnel to care for residents, nurses often resort to the use of restraints. Because dementia patients can be agitated and combative, nurses, especially when they are short staffed, may find it more convenient to chemically restrain such patients with antipsychotic drugs, which are known to have sedative effects.
Besides this being a direct violation of the Patients’ Rights, the use of chemical restraints does not effectively improve the quality of life for dementia patients in any way. Specialists actually recommend that non-pharmacological alternatives, such as recreational activities, instead be used to treat dementia. However, given that these activities require significantly more time than simply just administering drugs to patients, it is unlikely that residents of understaffed facilities are receiving the care and treatment they deserve.

Elder abuse is a practice that is far too prevalent in California and Los Angeles skilled nursing facilities. The initiative by CMS discussed in this report is not the first to address the prevalence of nursing home neglect in skilled nursing facilities. Past initiatives include incentives to nursing homes for reducing incidents of preventable injuries, such as falls and pressure ulcers.

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Falls occur very frequently within nursing homes and usually result in bone fractures, broken hips, or head injuries. These injuries often require hospitalization and can be prevented with proper attention and supervision, along with a decrease of environmental hazards within nursing homes that contribute to the problem. The Centers for Disease Control and Prevention (CDC) documented that a typical nursing home with 100 beds would report as many as 100 to 200 falls in a year, and many falls still go unreported. Falls can greatly affect a nursing home resident’s happiness and self-assurance, as the resulting disability, functional decline and reduced quality of life can cause depression, social isolation, and feelings of helplessness.

A risk factor study on falls among older residents in nursing homes was recently conducted by the Journal of the American Medical Directors Association (JAMDA). It differed from most risk factor studies, which usually focus on a smaller scope of cognitive or physical performance, in that the study was a more comprehensive examination of the various medical, psychological, and physiological factors that could affect the fall risk for older patients who suffer from cognitive impairments while residing in residential care. The main objective of the study attempted to better understand potential fall risk factors and their causes while providing possible methods that could help lower the chances of a falling accident. Data was collected in three to four interview sessions with participants from seven different South London care homes, and any additional information was obtained from care staff interviews and medical records.

The study results showed that there was a definite correlation between the patients who fell more often and the amounts of medication administered. The researchers were concerned with the possibility that medications affecting the central nervous system had a large impact on fall risk through a direct affect on balance control. Fallers were more likely to be taking psychotropic medications, which are often used to treat mental disorder symptoms such as depression, dementia, bipolar disorder, and other anxiety disorders. These medications include sedative hypnotics, antipsychotics, and antidepressants, which are commonly overused by understaffed nursing homes as a tool to subdue the more difficult patients that require larger amounts of attention. The medication essentially becomes what is known as a chemical restraint, the negative aspects of which greatly outweigh any positive aspect that could be determined. The simultaneous usage of too many drugs on a patient, known as polypharmacy, can actually aggravate dementia further, and even double the risk of death in dementia patients. Despite this evidence, some nursing homes still persist in using antipsychotics as a chemical restraint on their patients.

The study also found that older people diagnosed with dementia and cognitive impairment often have either double or triple the annual fall incidence in comparison with their peers who were considered to be cognitively-intact. Because patients with dementia often require more care and supervision, understaffed facilities are usually unable to monitor these residents closely enough to prevent falls from occurring. Instead, they are often chemically restrained, by psychotropic medications, which increases the risk of falls, as discussed above.

Based on these findings, the researchers were able to identify four significant, independent predictors of falls: poor attention and orientation, anxiety, antidepressant use, and increased postural sway with eyes closed. The fact that researchers were able to identify four predictors of a falling scenario shows that nursing homes are more than capable of reducing the amount of falls that happen every year. Because falls can usually be avoided provided that proper care and supervision is given by the caretakers of the nursing homes, understaffing plays a large role within a facility’s means to prevent a fall from occurring. A nursing facility is required under California law to provide a minimum of 3.2 nursing hours per patient per day, but older patients often need more time and care than the bare minimum requires. For this reason, the law also requires that nursing homes provide sufficient staff to fully tend to the needs of its patients, even if this requires a staffing level higher than 3.2 nursing hours per patient per day.

The study highlighted potential interventions that nursing homes should put into practice in order to lower fall risks for residents, such as medication review, exercises that improve balance ability, and the employment of better strategies in order to understand and manage wandering behaviors, agitation, and poor attention. Researchers also emphasized that, more than anything else, the reduction and minimization of psychotropic medication usage plays an important role in reducing fall risk among nursing home residents.

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