This week, The American Medical Directors Association (AMDA), issued a letter (Click for Article) to nursing home medical directors asking them to join with Centers for Medicare & Medicaid Services (CMS) in their national initiative to reduce the use of unnecessary and potentially dangerous drugs in nursing homes. This is another step in the right direction. Medical directors are uniquely situated to influence policy in nursing homes, and lead interdisciplinary team meetings, so that nursing homes are truly evaluating behavior changes and fostering person-centered care, rather than resorting to powerful antipsychotic drugs to control unwanted behaviors.
Recently in Chemical Restraints & Unnecessary Medications Category
On Monday, I blogged about our class action case regarding the over-medicating of nursing home residents. Today, the local press has helped us spread this important message.
The FRONT PAGE coverage can be viewed at this link Local News Ventura County Star.
The lawsuit seeks to correct the practice of over-prescribing and mis-prescribing medicines in nursing homes, especially the misuse of anti-psychotics and narcotics with known side-affects in the population of elderly patients.
Today, April 30, 2012, in a Class Action case here in Ventura County, AARP Foundation Litigation attorney Kelly Bagby has joined us, the Law Offices of Jody C. Moore, APC and the Law Offices of Gregory L. Johnson to help advocate for residents in an Illegal Drugging Class Action Lawsuit against Ventura Convalescent Hospital.
A copy of the press release follows:
Informed Consent and Overdrugging In the National Headlines Again this Week: Johnson and Johnson Fined over $1 Billion Dollar for Not Disclosing Risks Associated with Antipsychotic Drug, Risperdal.
Risperdal has been on the market since 1994. It is considered a "second generation" or "atypical" antipsychotic and, as such, is supposed to have less side effects and risk as "first generation" or "typical" antipsychotics, like Haldol. The drug was a blockbuster for J&J, earning it billions of dollars before its patent expired generic equivalents became available.
In 2004, the Food and Drug Administration (FDA) recognized the dangers associated with this drug, particularly when used in elder demented patients, including increased risk of death and stroke, as well as seizures, weight gain, diabetes and high blood pressure. J&J was forced to revise its drug labeling to reflect these risks.
The Centers for Medicare and Medicaid Services will announce via webcast its "National Initiative to Improve Behavioral Health & Reduce the Use of Antipsychotic Medications in Nursing Home Residents" on March 29, 2012 at 10:00 a.m. PST. (CMMS Link to Webcast). Advocates have been working to raise awareness about the misuse of these powerful drugs, right here in our own backyard.
The Ventura County Long Term Care ombudsman program, spearheaded by Sylvia Taylor Stein and in coordination with California Advocates for Nursing Home Reform (www.CANHR.org) hosted a symposium in Oxnard, "Toxic Drugs - the Problem with Drugging as a First Resort in Dementia Care" in March of 2011. It was the first of its kind and was well attended by over 250 health care providers, consumers, and advocates.
Please make plans to attend one of these free seminars to learn more about this important issue which affects many seniors.
Study of Psychotropic Medications in Nursing Homes: Confirms Off-Label Use, Use in Patients With Dementia, and Unnecessary Use
Atypical antipsychotic drugs are approved by the FDA for treatment of mental illness, including schizophrenia and bipolar disease. Side effects include an increased risk of death in the elderly population with a diagnosis of dementia. Under Federal Medicare Guidelines, only drugs being used for medically accepted indications are eligible for reimbursement. Federal Medicare Guidelines also set standards to ensure that nursing home residents are free from unnecessary drugs, such as drugs used in excessive doses or for excessive durations.
With this background in mind, the Office of the Inspector General collected data relating to atypical antipsychotic use in nursing homes during the year 2007 to determine compliance with the guidelines. Click here for the official OIG report.
The study includes the following findings:
In prior posts, I talked about the use of psychoactive medications in nursing homes, the principles of informed consent, and the ban on using these medications as a "chemical restraint". This post will cover the other regulations governing nursing homes and the circumstances under which they can or cannot use psychoactive medications.
No unnecessary drugs. According to 42 CFR 483.25(l), a nursing home may not use "unnecessary drugs." Unnecessary drugs are described as those used:
1. In an excessive dose;
2. For excessive duration;
3. Without adequate monitoring;
4. Without adequate indications for use; and
5. In the presence of adverse consequences which indicate the dose should be reduced or discontinued.
The guide to surveyors who oversee nursing homes in California, includes the following description of "inadequate indications for use": wandering; poor self care; restlessness; impaired memory; mild anxiety; insomnia; unsociability; inattention; fidgeting; uncooperativeness; behavior that is not dangerous to others. See Guidelines section §483.25(l) "Unnecessary Drugs", page 344.
Gradual dose reduction. According to 42 CFR 483.25(l), a nursing home must take steps to gradually reduce the use of antipsychotic drugs and behavioral interventions, unless clinically contraindicated. The presumption is that the use of these medications should be reviewed periodically and reduced, unless there is some evidence to show reduction will adversely affect the resident. Maintaining the status quo is not a reason to keep someone on a medication. For example, if someone is placed on an antipsychotic to control behavior of "combativeness" or "resistive to care" and they have no episodes of combativeness or resistance for a month, the presumption is to reduce the medication and see what happens. The fact that there have been no episodes is not a justification to keep using the medication, given the potentially harmful side effects.
State and federal regulations exist to protect nursing home residents from mis-use of powerful medications. However, the system will only work if residents, doctors, and nursing homes are educated about the proper and improper uses and abide by these laws.
Informed consent for use of psychoactive medications occurs when a doctor and a resident or the resident's decision maker have a conversation. The doctor has a duty to inform the resident or resident's decision-maker of the proposed treatment, including: (1) the reason for the particular medication; (2) the medical condition for which the drug is needed ; (3) how long and how often the drug will be used; (4) how the resident's medical condition will be affected; (5) the nature, degree, duration and probability of known side effects; (6) reasonable treatment alternatives; and (7) the resident's right to accept or refuse the medication. The key informed consent regulations are found at 22 C.C.R. § 72528 and § 72527(a)(4) and (5).
Even if "consent" is given for a psycho-active medication, it is never proper to use a psychoactive drug as a "chemical restraint". A chemical restraint is any drug imposed for discipline, or staff convenience or a drug not required to treat a medical symptom. Wandering, restlessness, and anxiety are not considered "medical symptoms" justifying the use of antipsychotic medications. When a psychoactive medication is used to treat dementia-related psychosis (improper) and/or to make a resident more calm, pleasant, subdued, or easy to care for, it can be classified as an unlawful chemical restraint.
In this writer's experience, the principles of informed consent are often overlooked in the nursing home setting. The law requires participation of the doctor, the resident or their decision-maker and the nursing home to fully complete the chain of consent.
Last week's symposium on Toxic Medicine was so informative, I thought I would take the opportunity to post a few blogs capturing the laws and regulations governing the use of psychoactive medication in California Nursing Homes.
1. What is a psychoactive medication?
This type of medication includes anti-depressants (e.g. Zoloft, Prozac), anti-anxiety medications (i.e. Ativan, Valium), hypnotics (e.g. Halcion, Restoril), and anti-psychotics (i.e. Haldol, Seroquel, Zyprexa, Risperdal). The most controversial psychoactive medication is the anti-psychotic. As the name implies, this class of medication was designed to treat serious mental illness - i.e. psychosis like schizophrenia. They are not approved by the FDA for treatment of dementia related psychosis. In fact, the FDA has issued its strongest warning, a "black box" warning, guarding against the use of anti-psychotic medications for treatment of elderly patients, experiencing dementia-related psychosis, and cautioning that the use of this class of medication increases the "risk of death" in elderly patients.
2. Why are these medications used in a nursing home setting?
Typically, a psychoactive medication will be used to "manage behavior", such as restlessness, agitation, resisting care, or being combative toward staff. Oftentimes, they are used as a first response to the behavior, though the law requires the medication be used to treat a specific medical condition and be used only after alternative therapies have failed. Too often, they are prescribed within hours of admission, when a nursing home patient is confused, disoriented, likely in pain, in fear or anxious.
3. Under what circumstances can a psychoactive medication be used in a nursing home?
Two basic requirements should be met before administration of a psychoactive medication. First, psychoactive medications are to be used as a last resort for treating behavioral symptoms only after non-drug alternatives have been tried and failed. To do this, however, requires adequate numbers of well-trained staff to respond quickly to the physical needs of residents, such as help with toileting, getting in and out of bed, bathing, hunger, or thirst. If staffing is not adequate, and resident needs go unmet, it is more likely the resident will suffer from anxiety and agitation and act out. Second, if medications are ordered, the physician must obtain informed consent and the nursing home must document that the physician obtained informed consent to administer the medication either from the resident (if competent) or their responsible party.
More information regarding informed consent will follow in the next post.
Ventura County Long Term Care Ombudsman and CANHR Join Forces in Campaign to Stop Drugging Our Elders
I wanted to share the story, linked below, regarding an amazing symposium put on by the Ventura County Long Term Care Ombudsman and CANHR regarding Toxic Medicine and the inappropriate and unnecessary use of psychotropic medications in nursing homes. The program featured very strong presentations by Tony Chicotel and Christopher Cherney , as well as an administrator from Beatitudes, an Arizona long term care facility known for adopting a "culture of comfort" for patients with advanced dementia.
I found the presentation particularly empowering. Tony impressed the audience with a primer on nursing home regulations relating to informed consent, unnecessary drugs, and battery. He also walked the line by presenting to a packed audience of nursing home providers and Department of Public Health enforcement officials, calling for more stringent enforcement of the clear regulations. Only by enforcing principles of informed consent are we truly honoring each residents' rights.
Christopher related well to the audience, bringing his perspective of nursing home administrator to the group and empathizing with the provider perspective that many residents do have difficult behaviors that must be addressed. But drugs are not the answer. He spoke about the particularly harmful effects of psychotropic medications on the brain. He also issued a challenge and pledged $1,000 of his own money to send Robert Whittaker's book, Anatomy of an Epidemic, to every SNF Medical Director in the state. The use of these medications is enabled by physician orders, and the movement to curb (if not eliminate) these drugs needs to include educating the prescribing physicians.