Toxic Medicine: What You Should Know to Fight the Misuse of Psychoactive Drugs in California Nursing Homes

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Introduction

Nursing homes often conjure an image of elderly people lying in bed or slumped in wheelchairs completely detached from the world around them.  Many visitors and even staff members believe that unresponsive residents are the sad evidence of unavoidable mental declines brought about by dementia or simple old age.  However, the poor quality of life for many nursing home residents is often caused not by the symptoms of their disease but by the side effects of their medications.

There is rampant misuse of psychoactive drugs in nursing homes. Astonishingly, four-of-every-five long-stay nursing home residents – 80 percent – are given psychoactive drugs. Many of these drugs have dangerous side effects, especially antipsychotic drugs.

Hundreds of thousands of nursing home residents with dementia receive powerful antipsychotic drugs (a class of psychoactive drugs that are frequently misused) that are not intended or approved for their medical conditions. Rather, the drugs are often used to sedate and control them, a terrible substitute for the individualized care they need and deserve. The U.S. Food and Drug Administration (FDA) has issued its most dire warning – known as a black box warning – that antipsychotic drugs cause elders with dementia to die.

Antipsychotics don’t just hasten death, they often turn residents into people their own families barely recognize by dulling their memories, sapping their personalities and crushing their spirits. When families win battles to take residents off these drugs, they sometimes find that the person they’ve always known is still there. As one resident’s daughter told us, “I got my dad back.”

The horrific misuse of psychoactive drugs in nursing homes is accompanied by an epidemic disregard for the rights of residents to give or withhold their informed consent.  All California nursing home residents or their representatives must receive information about psychoactive drugs before they are administered and also have the right to refuse any drugs.  Despite these legal requirements, the informed consent of residents or their representatives is often ignored.

It is no secret that nursing homes are drugging massive numbers of residents into submission every day. Federal investigators have condemned the practice for decades. In one federal investigation in 2011, the HHS Inspector General expressed outrage over the rampant drugging of residents with dementia and government inaction. A federal partnership was established then to address the crisis but did very little to stop it. California officials have done no better.

Yet it is possible to stop a loved one from being drugged by a nursing home. This guide gives important facts about psychoactive drugs and advice on how to stop their inappropriate use.

What are Psychoactive Drugs?

Psychoactive drugs – sometimes called psychotropics or psychotherapeutics – contain powerful chemicals that act on the brain to change a person’s mood, personality, behavior, and/or level of consciousness. Although these drugs have positive uses, many nursing homes routinely use them as a substitute for needed care and as a form of chemical restraint.

Federal regulations define a psychoactive drug as any drug that affects brain activities associated with mental processes and behavior. They include, but are not limited to, drugs in the following categories: antipsychotic, antidepressant, antianxiety and hypnotic. 42 CFR §483.45(c)(3).

Antipsychotics are often the drug of choice to chemically restrain residents with dementia. These extraordinarily dangerous drugs are approved to treat schizophrenia and psychosis, but nursing homes often use them instead to sedate and subdue residents who have dementia. Nearly one of every four California nursing home residents is given these drugs.

There are many brands of antipsychotic drugs, which are divided into two categories: conventional and atypical. Haldol (haloperidol), Mellaril (thioridazine), and Thorazine (chlorpromazine) are examples of conventional antipsychotic drugs. Abilify (aripiprazole), Clozaril (clozapine), Risperdal (risperidone), Seroquel (quetiapine) and Zyprexa (olanzapine) are examples of atypical antipsychotic drugs that are commonly given to nursing home residents.

Antianxiety drugs – such as Ativan (lorazepam), Valium (diazepam) and Xanax (alprazolam) – are also often used to sedate and restrain residents. Like antipsychotic drugs, they are often prescribed for unapproved uses and can cause serious side effects.

About a third of California nursing home residents are given antidepressant drugs, often in combination with other psychoactive medications. These drugs too can pose high risks of adverse consequences, such as increasing resident falls. Antidepressants are often mis-prescribed to address resident sadness that is a natural response to depressing conditions in their nursing homes. Instead of resolving the depressing conditions, some health care providers think it’s easier to prescribe an antidepressant. Zoloft (sertraline), Celexa (citalopram), Remeron (mirtazapine), and Prozac (fluoxetine) are examples of antidepressants.

Hypnotics are sleep inducing drugs such as Halcion (triazolam) and Restoril (temazepam).

Other types of medication are considered to be a psychoactive drug when they are used as substitutes for psychoactive medications. 42 CFR §483.45(c)(3), SOM Appendix PP at F758*.

One example is Depakote. Use of anti-seizure drugs (anticonvulsants) like Depakote (divalproex sodium) and valproic acid has skyrocketed in recent years as nursing homes have switched to them because their use as chemical restraints is poorly monitored.

Another example is Nuedexta. It is approved to treat a rare disorder marked by sudden and uncontrollable laughing or crying, known as pseudobulbar affect. Yet, it was widely marketed to nursing homes as a substitute for antipsychotic drugs to control residents with dementia.

The manufacturers of Depakote and Nuedexta paid large criminal and civil penalties to the federal government for targeting marketing on frail nursing home residents with dementia.

Risks Galore, Including Death

Psychoactive drugs have numerous, potentially fatal side effects. Some of the most common include tremors, over-sedation, toxicity, anxiety, confusion, delirium and insomnia.

Perversely, psychoactive drugs often cause the agitation and anxiety they are prescribed to treat, leading to even more drugs or higher doses. Elderly nursing home residents are especially at risk of harmful drug interactions because most take many other medications and are in poor health. The use of psychoactive drugs puts them at greatly increased risk of falls and serious injuries that lead to immobility and often death.

Antipsychotic drugs are not a treatment for dementia. These drugs endanger the lives of persons who have dementia. The U.S. Food and Drug Administration (FDA) issued an advisory in June 2008 to healthcare professionals that states:

  • Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.
  • Antipsychotic drugs are not approved for the treatment of dementia-related psychosis. Furthermore, there is no approved drug for the treatment of dementia-related psychosis. Healthcare professionals should consider other management options.

The risk of death from antipsychotic drugs cannot be overstated. The FDA issued its most dire warning – known as a black box warning ­– that antipsychotic drugs cause elders with dementia to die.

Sample FDA Black Box Warning for Risperdal. This warning applies to all antipsychotic drugs.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA­ RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA­ RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Residents Have Rights to Be Free from Chemical Restraints and Unnecessary Drugs

Nursing home residents have the right to be free from chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms. 42 USC §1396r(c)(1)(A)(ii), 42 CFR §483.10(e), 42 CFR §483.12, 22 CCR §72527(a)(24).

Federal regulations also require nursing homes to protect residents from unnecessary drugs. An unnecessary drug is any drug when used: (1) in excessive dose; (2) for excessive duration; (3) without adequate monitoring; (4) without adequate indications for its use; or (5) in the presence of adverse consequences which indicate the dose should be reduced or discontinued. 42 CFR §483.45(d).

There are additional protections on use of psychoactive drugs. Nursing homes must ensure that –

  • Residents who have not used psychoactive drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
  • Residents who use psychoactive drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
  • Residents do not receive psychoactive drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record;
  • PRN (as needed) orders for psychoactive drugs are limited to 14 days subject to exceptions;
  • PRN orders for antipsychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.

42 CFR §483.45(e).

Measured by these standards, most antipsychotic drugs and other psychoactive drugs used by nursing homes to control residents with dementia are both unnecessary and a form of chemical restraint.

Why Are So Many Nursing Home Residents Being Drugged?

If antipsychotics and other types of psychoactive drugs are so dangerous and government standards are quite protective, why is drugging so common in so many nursing homes?

Sadly, there are many reasons. Nursing home operators may profit from using these drugs as a substitute for needed care. Facilities are often understaffed and caregivers poorly trained. Drug companies heavily promote misuse of psychoactive drugs through illegal marketing campaigns directed at doctors and nursing homes. Absentee doctors often rubber-stamp drug orders requested by nursing home staff. Consultant pharmacists meant to stop inappropriate drugging often enable it instead. Resident or family consent is rarely sought and almost never truly informed. State and federal regulators do little to enforce the laws against drugging.

Despite these challenges, there are ways for residents and their representatives to fight back against dangerous drugging practices. They usually begin with residents learning about and asserting their right to informed consent.

Psychoactive Drugs Cannot Be Used Without Informed Consent

Informed consent is a legal right that requires doctors to respect the decisions of their patients.  As the term suggests, the concept has two components: information and consent.

The information part of informed consent requires doctors to explain any proposed treatment to their patients and, if applicable, to their patients’ legal representatives. 

The consent part of informed consent simply requires that patients or their representatives agree to any form of health care treatment before it is undertaken. Failure to obtain consent before administering treatment is battery against the patient.

Prescribing doctors must disclose the following information when seeking consent from nursing home residents or their representatives for the use of psychoactive drugs:

  • The reason for the particular psychoactive drug;
  • The medical condition for which the drug is needed;
  • How long and how often the drug will be used;
  • How the resident’s medical condition will be affected;
  • The nature, degree, duration and probability of known side effects;
  • The reasonable alternative treatments and risks; and
  • The resident’s right to accept or refuse the psychoactive drug and, if he or she consents, the right to revoke consent for any reason at any time.

The key informed consent regulations are found at sections 72528 and 72527(a)(4) &(5) of Title 22 of the California Code of Regulations.

Nursing homes are required to verify that consent has been given for psychoactive drugs, even when the drug was prescribed before the resident’s admission. Consent is not required in an emergency.

Questions to Ask Doctors and Nursing Homes When Psychoactive Drugs are Proposed

  • What specific, documented symptoms prompted the need for the proposed drug?
  • Have all possible medical or environmental causes been ruled out? (e.g., pain, dehydration, infection, sleep disruptions)
  • Has the doctor recently physically examined the resident to determine the need for the drug?
  • What alternative treatments have been tried? Are other options still available?
  • What are the risks and side effects of the drug?
  • Has the FDA issued black box warnings for this drug?
  • Has the FDA approved the use of this drug for this purpose?
  • How will side effects be monitored? Who will do it?
  • Will the proposed drug interact with any of the resident’s other medications?
  • Is the proposed drug duplicating other current medications?
  • Will the resident start on the lowest possible dose of medication?
  • When and how often will the need for the drug be reassessed?

Advocacy Tips When Psychoactive Drugs are Proposed

  • You do not have to accept a doctor’s recommendation to use psychoactive drugs.
  • Do not give consent if the doctor has not directly examined the resident to determine the need for the drug.
  • Antipsychotic drugs can be deadly. Don’t consent to their use unless you are certain that all other care and treatment options have been exhausted.
  • Insist that the doctor or nursing home provide written information on adverse consequences of the proposed drugs, including black box warnings.
  • Carefully review and consider the written information before making a decision.
  • Be aware that sudden discontinuation of some psychoactive drugs can cause serious withdrawal symptoms. If such a drug is being stopped, the doctor should write an order to gradually discontinue it.
  • Consider seeking a second opinion from a trusted physician or advocate if you have doubts about giving consent to a psychoactive drug.

Request a care plan meeting to discuss the need for proposed psychoactive drugs: The nursing home should hold a care plan meeting because the need for psychoactive drugs signals a significant change in the resident’s condition. Residents and their representatives have a right to attend and participate in these meetings. 42 CFR §483.21(b). Use the care plan meeting to determine if the drug is really needed and whether the home has carefully considered all alternatives. Before the meeting, review CANHR’s fact sheet, Making Care Plans Work, to learn about care plan rights and effective meeting strategies.

Insist on high quality dementia care: Be mindful that federal regulations set a high standard for nursing home care of persons with dementia and use it to advocate for non-drugging options to meet the resident’s needs. Nursing homes must ensure that a resident who has dementia receives the appropriate treatment and services to attain or maintain his or her highest practicable physical, mental and psychosocial wellbeing. 42 CFR §483.40(b)(3). Do not let a nursing home use inability to provide safe and effective dementia care as an excuse to drug a resident.

Review medication records: Periodically request a complete list of current medications from the nursing home and/or review the resident’s medication administration records kept by the facility, especially if unauthorized drugging is suspected. Residents and their representatives have the right to review their records within 24 hours of a request and to obtain copies of records within two working days of a request. 42 CFR §483.10(g)(2). For more information on this right, see CANHR’s fact sheet, Access to Medical Records in California Nursing Homes.

Exercise the right to refuse treatment: Residents have the right to refuse psychoactive drugs and, if they have provided consent, to revoke it for any reason at any time. 22 CCR §72528. A nursing home may not retaliate or try to evict a resident who exercises the right to refuse psychoactive drugs. SOM Appendix PP at F758, F626 and F656.* A resident’s representative may exercise the right to refuse if the resident lacks capacity to make a decision. Persons who may act as a resident’s representative include a conservator, an agent designated under a valid advance health care directive or power of attorney for health care, resident’s next-of-kin, or someone appointed by a court for this purpose. 22 CCR §72527(d).

Behavior Problem or Cry for Help?

Behavior problem. Combative. Agitated. Difficult. These are just a few of the negative ways often used to describe the residents experiencing distress that is common for people with dementia. The key to preventing the distress, it turns out, is to use it and other information as a means to identify and resolve the root causes of the anguish a person is experiencing.

Behavior is communication, not a disease. Dementia diminishes a person’s ability to communicate verbally, so people with this condition often compensate by communicating behaviorally. Rather than drugging residents to suppress signs of distress, nursing home caregivers must try to figure out what the signs mean and respond appropriately.

Looking at residents who are in distress from this perspective can make a world of difference.  

Some nursing homes have led the way in showing that drugs are not needed to prevent resident distress. Their caregivers know the residents, their needs and preferences well enough that they can prevent or diminish distress before it becomes a big problem. These facilities show that behaviors aren’t so challenging when residents are comfortable, live in a pleasant environment, get timely medical care and are supported by well-trained caregivers who care about them.

Least Medicating Approach

Psychoactive drugs should always be the last resort for treating symptoms of dementia, not the first option. Nursing homes should look first to treating underlying medical problems, relieving pain, improving the environment, personalizing care, engaging the resident in pleasurable activities, and doing everything possible to make residents feel comfortable and at peace. This “least medicating” approach is the key to better dementia care.

Ask the doctor to assess possible medical causes of behavioral concerns. Agitation and confusion may be caused by untreated infections, dehydration, malnutrition, adverse medication reactions, pain, and other medical problems. If the doctor won’t conduct a thorough medical examination, explore options for replacing the physician or consulting with a geriatrician.

Individualized care and more attention are the best substitutes for drugs. Insist that your loved one’s care be customized by adapting personal care, sleep schedules, meals, bathing methods and other services to his or her preferences. Urge the facility to consistently assign caregivers who work well with your relative.

Staffing must be adequate to respond quickly to needs such as help with toileting, getting in and out of bed, hunger and thirst. If staffing is inadequate, encourage the administrator to improve it.

Improving and simplifying the environment can relieve resident anxiety. Nursing homes must offer a homelike environment. Insist that they do so. For example, distracting noises (such as intercoms and buzzer systems) should be eliminated. Temperatures should be comfortable. So should seating. No one wants to sit in a wheelchair all day. Hallways should be uncluttered. Lighting should be pleasant. Decorate and furnish your loved one’s room to make it comfortable.

Help the facility staff plan to engage your relative in pleasurable activities throughout the day with whatever he or she likes, such as walks, music, exercise, reading, visits from pets, group activities, and singing. People are much happier when they have a sense of belonging and purpose.

Roommate problems may trigger conflict. If this is a problem, ask the facility to find a compatible roommate or, if available, offer a private room.

Encourage patience and understanding. Common symptoms of dementia such as restlessness, pacing, and repeated questions should be expected and accepted.

Comfort Care Can be a Solution

Life in a nursing home can be a very difficult adjustment, especially for someone who is forgetful or easily confused due to dementia. Surrounded by new faces and new routines, institutional care can be disorienting and isolating.

Enlightened care providers are increasingly turning to “comfort care” to enhance the quality of life for residents who have dementia. As its name suggests, comfort care strives to keep residents comfortable through a nurturing, individualized approach that focuses on their emotional, social and spiritual needs, as well as their medical and personal care needs. The goal of comfort care is to keep each resident comfortable and free from distress by:

  • Anticipating their needs;
  • Knowing them so well that basic needs never become major problems;
  • Embracing a philosophy of individualized care;
  • Adjusting the pace, approach and communications with them to suit the needs of people with dementia;
  • Recognizing and treating pain aggressively; and
  • Treating family and friends as partners in care.

CaringKind has published an excellent consumer guide on comfort care, Finding Comfort: Living with Advanced Dementia in Residential Care, A Consumer Guide.

Urge your nursing home to learn about and adopt comfort care practices if it has not already done so. There is no need to chemically restrain residents in facilities that successfully use this approach.

Remedies to Illegal Drugging

If a California nursing home is using or threatening to use psychoactive drugs without consent, call CANHR at 1-800-474-1116 to discuss actions you can take to protect your rights.

There are a variety of actions you can take, including using the suggestions in this guide to seek change from the facility and the physician. Other options include:

Seek help from local advocacy organizations: The local long term care ombudsman office may be helpful. The ombudsman program helps nursing home residents resolve concerns about care and rights, however, it does not have any direct authority over facilities. Local legal service programs may also be able to offer advocacy assistance. Contact CANHR for information.

File formal complaints: The California Department of Public Health (CDPH) inspects and investigates nursing homes and enforces state and federal standards. CANHR’s fact sheet, How to File a Nursing Home Complaint, explains how to file a complaint with CDPH and with the Division of Medi-Cal Fraud & Elder Abuse within the California Attorney General’s Office. Complaints against doctors who prescribed the drugs can be filed with the Medical Board of California.

Inform state legislators: CANHR is working to strengthen California laws against the drugging of nursing home residents. You can help by informing your assembly member and state senator about the inappropriate use of psychoactive drugs. Find your legislators here.

Sue the facility and doctor: Legal actions can help enforce your rights and seek damages if you or a family member has been harmed. Call CANHR to discuss referral to a qualified elder abuse attorney.

Alert the media: Nothing gets a nursing home’s attention faster than the local media. If other options fail, consider asking the media to help expose dangerous drugging practices.

Resources

On misuse of antipsychotic drugs:

On nursing home drugging data:

On caring for older adults with dementia without relying on psychoactive drugs:

On investigations:

Related CANHR fact sheets:

* “SOM Appendix PP” is an abbreviation for the Center for Medicare & Medicaid Services’ State Operations Manual, Appendix PP – Guidance to Surveyors for Long Term Care Facilities