California Nursing Home Abuse Lawyer Blog

U.S. Court of Appeals Ruling Protects Marketing of Off-Label Uses of Pharmaceuticals

December 13, 2012 | by Law Offices of Ben Yeroushalmi

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.

Performance-Based Payroll Programs Can Improve Quality of Care and Reduce Mortality

November 30, 2012 | by Law Offices of Ben Yeroushalmi

Nursing homes and hospitals around the world have long operated on experience-based pay scales. Only recently, however, have various hospitals begun adopting performance-based payroll systems to improve the quality of care. The results are especially crucial for American health providers, who will move towards pay for performance in 2013 when it is officially introduced by Medicare. Although opposition to pay for performance has cited that little evidence exists connecting performance-based incentives to patient wellbeing, a more recent report published by the New England Journal Medicine (NEJM) reveals a strong correlation between pay for performance programs and reduced mortality rates. These findings pave the way for further research into better incentives for health care providers.

A common denominator among deaths in hospitals and nursing homes is understaffing. Most injuries and deaths are preventable through competent and sufficient caretakers. Understaffing refers not only to a lack of qualified staff available but also to the amount and quality of care and lack of effective staff. It is crucial that healthcare workers provide optimal attention to all patients and follow all policies and procedures to uphold a high standard of care.

In 2008, the National Health Service introduced Advancing Quality, a pay for performance program, to northwestern English hospitals. Based on the Hospital Quality Incentive Demonstration program in the US, Advancing Quality was designed to promote better quality of care by rewarding good performance with additional pay. The system was organized in a “tournament” format, providing bonus payments to only the top performers according to a set of standards. Poor performers were not penalized. Altogether, $7.5 million dollars were awarded in the first 18 months.

The NEJM study focused on comparing hospitals under Advancing Quality to hospitals that had not yet adopted the program. It scrutinized the 18 months prior to and 18 months following the introduction of Advancing Quality, analyzing mortality rates due to acute myocardial infarction, pneumonia, and heart failure. Taking into account chances of death due to patient history, age, sex, and stage of ailment at the time of hospital admittance, the study compiled data on over a million patients. This was charted next to the hospitals’ Advanced Quality rankings, or lack of one. In this way, they tested the effect of incentives on mortality rates.

The results demonstrated that risk-adjusted mortality rates for the three conditions decreased significantly with the introduction of the pay for performance program. With an overall 1.3% decrease in mortality rates, this was equal to 890 fewer deaths out of 70, 644 patients over an 18 month period. This is an especially positive outcome as opposed to the other hospitals, which had little to no change in mortality rates before and after the introduction of Advancing Quality.
The introduction of performance-based pay systems in the world of healthcare is a tremendous step towards improving the quality of care provided. A lower mortality rate is a definite sign of better treatment and standards, achievable through financial incentives, as demonstrated by this study. Understaffed facilities suffer from carelessness and neglect, often due to a lack of vigilance on the workers’ parts. Quality of care is the top priority at nursing homes, and can only be achieved through motivated staff. Burnout occurs when staff members feel overworked and disconnected from their jobs, which often leads to reduced attention to care. Financial bonuses provide incentive for adhering to high standard of care in nursing homes.

It is important to note, however, that providing pay incentives may also have negative consequences, and we often find that nursing homes will place profits over people. For example, an administrator may receive a bonus if he or she works within a certain budget, and of course, the easiest way to stay within budget is to shortstaff. That being said, this report by the NEJM, if nothing else, serves to reinforce that fact that many injuries that occur in health care facilities are preventable – the real underlying problem is that caregivers are just unmotivated or do not have the time to make the effort to take these preventative measures.

A Report by the Care Quality Commission Reveals Universal Problems in Long-Term Care Facilities

November 27, 2012 | by Law Offices of Ben Yeroushalmi

The Care Quality Commission recently published a report called “The state of health care and adult social care in England” that reveals problems that are universal to long-term care facilities. The report concluded that three factors can be linked to low quality of care in nursing homes: a culture where substandard care is the norm; care that is task based rather than specially tailored to meet individual resident needs; and high turnover rates or poor deployment of staff.

What these three factors have in common is that they all have to do with the nursing home’s staff. The quality of a nursing home’s staff is central to providing your loved one with the care the he or she needs and deserves. Unfortunately, however, the study found 25% of nursing homes to be understaffed. Although California law requires a minimum of 3.2 nursing hours per patient day, having sufficient numbers of staff cannot be so simply quantified. The study considered inadequate staffing to be any level of staffing that prevented the facility from providing a high quality of care to its patients.

This proposes an alternative approach toward staffing levels that is instead based on patient acuity needs. David Behan, chief executive of the commission, asserts that “Health and care services need to rise to the challenge of responding to the increasingly complex conditions suffered by our ageing population. That means delivering care that is based on the person’s needs, not care that suits the way organisations work.” In fact, it is your loved one’s right under Health and Safety Code 1599.1 (a) to reside in a nursing home that is staffed to meet the needs of all residents at all times. Any breach of this duty on part of the nursing home affects the allocation of staff and resources and negatively impacts the care provided to all residents of the facility.

The study focused on mismanagement of drugs as a result of understaffing, which occurred in 22% of skilled nursing facilities. This can include chemical restraints, polypharmacy, and the use of drugs for off-label purposes, which can all lead to dangerous adverse drug reactions.

Also considered when evaluating the quality of care of a nursing home was dignity and nutrition. Many residents were spoken to condescendingly, did not receive privacy, or could not reach their call lights. In fact, the study found that 15% of nursing homes did not employ staff that treated its patients with respect. Some other common injuries that can be indicative of poor quality of care in nursing homes are pressure sores, dehydration, and infections.

Medicare and Medicaid Pushing for a Reduction in the Use of Antipsychotic Medications in California Nursing Homes

November 16, 2012 | by Law Offices of Ben Yeroushalmi

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.

Recent Study Confirms the Link between Understaffing and Falls

October 24, 2012 | by Law Offices of Ben Yeroushalmi

A new study that was published in the May 2012 edition of the Journal of the American Geriatrics Society was the first national study to assess fall rates among newly-admitted nursing home residents. Researchers for the study, which was spearheaded by University of Southern California gerontology and occupational science researcher Natalie Leland, evaluated data from over 230,000 first time nursing home residents in the year 2006. This data was obtained when patients who had stayed at the nursing home facility for at least thirty days completed a minimum data set (MDS). A MDS is a federal prescribed clinical evaluation of all residents in a certified nursing home that serves to assess each patient’s health needs and functionalities.

The data shows that approximately 21% of the patients studied (over 47,000 patients) experienced one or more falls within the first thirty days after admission to a nursing home. The study also identified characteristics of nursing homes that reported fewer incidents of falls suffered by newly-admitted residents. Most important to a lower fall incidence was a higher ratio of certified nursing assistants to residents. Most first-time nursing home residents are faced with unfamiliar surroundings and people. The constant presence of attentive staff is vital to residents adjusting to their new life and ensuring their safety. Qualified staff are needed to accompany new residents around the facility, orient residents with important procedures (such as use of call buttons), and to take notice of the residents’ former and current health issues.

Even with this study confirming the obvious – that higher staff-to-patient ratios reduce the incidence of falls – it is an unfortunate fact that many nursing homes continue to operate chronically understaffed to the detriment of the welfare of its residents. A properly staffed nursing facility is not just essential for the transitioning of newly admitted residents. Existing long-term residents also need the staff’s attention in monitoring changes in their conditions and assisting with basic activities of life.

To have an understaffed facility is to have distracted and overwhelmed workers which could lead to careless acts or omissions. Staff will most likely struggle to attend to the unique needs of all its residents, and therefore puts them all at risk of suffering not only preventable injuries like falls, but also preventable ailments such as pressure ulcers and infections. Furthermore, understaffing creates potential situations where staff may choose convenience over what is right for the resident.

Adequate staffing levels are so important to the well-being of elderly residents in nursing homes that specific ratios are codified into the California Health and Safety Code as a resident’s enforceable right. The California Health and Safety Code section 1430(b) provides strong statutory authorization for a plaintiff to seek civil relief from nursing home facilities if this or any other rights within its provisions are violated.

The Culture of Medical Information Gaps in Skilled Nursing Facilities

October 18, 2012 | by Law Offices of Ben Yeroushalmi

Milta O. Little’s article, “Climbing Out of the Black Hole of Subacute Care”, explores the existence of a medical information gap that is aptly comparable to a black hole in outer space: once a patient is moved out of a hospital and into a subacute care facility, their medical profile ceases to exist to the rest of the health care community. Subacute care is implemented for patients who need health care that can be provided on a long-term basis, and can apply to many medical conditions that require the patient to rely on 24-hour nursing care. As a result, many of the patients who disappear into this ‘black hole’ are the frail and elderly who are neither well enough to live independently at home nor ill enough to continue staying at a hospital.

Much of the information pertaining to a transitioning patient’s current condition is crucial in a nursing home’s ability to truly help the patient through a full recovery while maintaining good health. It is disparaging that vital information needed to fully understand a patient’s needs is often lost or disregarded during a patient’s transition from a hospital to subacute care. As a result, nursing homes often neglect to provide detailed care to patients that need special attention. The loss of that information usually results in the aggravation of a patient’s condition that could have easily been prevented in the first place. Vulnerable patients are also at high risk of reentering a hospital from the facility, thus creating an influx of residents who are constantly being transitioned from the facility to the hospital and back again. This is a situation that is often avoidable if subacute care facilities give the proper amount of attention to their patient’s medical information and employ properly trained nurses. Studies have also shown that constant transitioning between a hospital and a nursing facility is directly harmful to the patient’s health, as patients tend to become despondent. Errors are also more likely to occur as various health providers and care sites become involved in the process.

A large amount of the information loss can be attributed to a lack of communication that is perpetuated and encouraged by the current work environment of nursing facilities. The majority of people who feel that they or their loved ones have suffered from abuse or neglect within the nursing home environment complain that the facility and nurses withhold important information concerning the patient and simply do not communicate any problems or issues that the patient may currently be facing. This lack of communication is an indication of the low quality of care that exists in many nursing homes.

There are many health problems that occur within the nursing home environment that are preventable, given that the nurses and staff are adequately trained and the facility employs the proper amount of staff. When a nursing home is understaffed, a few preventable health issues will start to trend within the facility’s patients. Pressure ulcers, which are sores and bruises that occur on the skin if a patient is not adequately moved around, become a common occurrence, and infections are easily spread from patient to patient through improper handling and poor hygiene on the part of the nurses providing care. Both infections and pressure ulcers are easily preventable and are often signs of elderly neglect.

Non-Pharmacological Alternatives Provide Better Treatment for Neuropsychiatric Symptoms of Dementia

September 13, 2012 | by Law Offices of Ben Yeroushalmi

The neuropsychiatric symptoms of dementia (NPS), which are characterized by psychological and behavioral problems, have a rather large presence within nursing homes as about 60% of the elderly individuals living in long term care have been diagnosed with dementia. The majority of the individuals of this group will go on to develop NPS at some point of their illness. Dementia is a chronic brain syndrome that affects a person’s brain function so that their emotional behavior, cognitive skills, memory, and speech are slowly corroded. Most dementia types are degenerative and cannot be reversed. However, even though the effects of dementia cannot be reversed, they can be slowed or treated through two different methods: psychotropic medications or non-pharmacological alternatives. In 2012, JAMDA conducted a study examining the effect of non-pharmacological alternatives as a means of treatment for dementia in comparison with the use of psychotropic medications within long term care facilities.

The guidelines associated for neuropsychiatric symptoms of dementia often strongly recommend the use of non-pharmacological interventions to treat elderly patients, some of which include but are not limited to: mental health consultation and treatment planning, staff training in NPS management strategies, recreational activities, music therapy, exercise, and other forms of sensory stimulation. However, some skilled nursing facilities rely instead on the use of psychotropic medications in order to subdue, or chemically restrain their patients. When psychotropics are combined with other drugs such as benzodiazepines, antipsychotics, or other sedatives, all of which are commonly used to treat NPS, polypharmacy can occur.

Chemical restraints are unjustly used in nursing facilities where understaffing and lack of correctly trained staff is a prevalent problem. The study found that by increasing the number of nursing staff available and ensuring that the staff is properly trained, the facility is able to better process the many demands that long term care staff must fulfill in order to provide sufficient care to their patients. This further opens up the amount of time that staff can engage in non-pharmacological activities that may help reduce NPS in dementia patients. There was evidence that pointed to the idea that NPS was further aggravated by unmet needs, and thus residents would use the symptoms as an expression to relieve needs such as uncomfortable sensations and pain, and a reduced threshold to stress. Chemical restraints do nothing to solve the needs of the elderly; instead, it takes away their ability to even express discomfort or pain.

ProPublica’s Nursing Home Inspect: Bringing Light to Elder Abuse in Your Area

September 11, 2012 | by Law Offices of Ben Yeroushalmi

Elder abuse and neglect within America is very common in nursing facilities, but is a largely ignored issue. However, a new online tool has recently been introduced that promises to change the way elder patient safety and abuse is monitored and understood. Created by ProPublica, Nursing Home Inspect now allows anyone with an internet connection the ability to check the nursing homes in their surrounding area for their most recent government inspection reports, with the statistics compiled together. Also included is a tipsheet on how to use Nursing Home Inspect to the best of its ability. It differs from the records found on the official U.S. Center for Medicare and Medicaid Services (CMS) website, as it allows you to search by keyword, city, and home’s name and also allows you to search all of the government reports at one time. Overall, the website is very convenient and user friendly. These government inspection forms are important, as they note potential abuse and neglect found through documentation of deficiencies within specific nursing homes.

The ProPublica database conducts its searches such that it allows the user to look for a pattern of problems that might exist in the nursing homes within his of her area. This is extremely useful to those doing research on the nursing homes within their area to see what kind of situations they might be placing their loved ones in. There are many common problems that exist within nursing homes, most of which can be linked to understaffing or lack of proper training within a nursing facility. Both lead to the substandard care of the elderly, which in turn cause diseases and injuries that could have been preventable in the first place.

One such problem is the development of pressure ulcers, which are open wounds that form when constant pressure cuts off a patient’s blood supply to a certain area of the body. Usage of the Nursing Home Inspect database to search for the phrase “pressure sore” turned up over 2,000 results, which is an alarming number of incidents considering that pressure sores are preventable. The inability of a facility to prevent pressure ulcers from development and aggravation usually is a clear indication of neglect occurring within the nursing home.

The Existence of Rituals of Abuse in Nursing Homes

September 7, 2012 | by Law Offices of Ben Yeroushalmi

It has been estimated that with the “baby boom” generation now approaching retirement age, nearly 25% of the elderly population aged 65 years or older will spend part of their life residing within a nursing home. While the elderly should both expect and receive excellent, loving care at a facility where they will possibly spend the remainder of their life in, most patients are instead abused and neglected. They are treated not with dignity and compassion, but with contempt and ridicule. With such a large influx of potential patients looming on the horizon, nursing homes desperately need to change the means by which they function and treat their patients.

In the Journal of Women and Aging, a book review was recently conducted on a source concerning the ritual of abuse that currently exists within nursing home systems. The studies actually found that abuse suffered by the elderly most often occurred through four different ways: medical abuse, personal abuse, emotional negligence, and verbal abuse. Many caretakers within the study saw their nursing home residents as “‘unemotional work products’ rather than people in need”. More often than not, this abuse occurs because of a nursing home’s <a href="”>understaffing problems or lack of adequately trained staff. When a facility is understaffed and incapable, they cannot provide the proper amount of care or attention that a resident might need which could result in the development of pressure sores, falls, and even death. The elderly are also more susceptible to dehydration and malnutrition and need to be properly monitored to ensure that they keep up their daily intake.

What is extremely frustrating is that with enough attention and proper care, all of these diseases and health issues can be preventable. The correlation drawn between adequate staffing and the prevention of diseases from developing is not pure conjecture, but has been proven in various studies. One such study highlighted that if nursing home workers are actually trained through a mandatory program, overall communication is improved and hospitalizations can be prevented from occurring in the first place. There is a general consensus that America’s elder care industry is currently broken by the blatant abuse that occurs every day in nursing homes.

The Patients’ Bill of Rights claims that any skilled nursing facility has the obligation to provide their residents with a safe living environment, and to treat them with respect and consideration. It is a grossly unfair situation to the residents of such nursing homes that unfortunately cannot protect themselves from being neglected.

The Impact and Prevention of Chemical Restraints on Falls in Nursing Facilities

September 4, 2012 | by Law Offices of Ben Yeroushalmi

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.