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Should signed consents be required to give nursing home residents antipsychotics?

Should signed consents be required to give nursing home residents antipsychotics?

Picture of William Heisel

What if you lived next to someone in a nursing home who was prone to threatening to kill people during psychotic episodes?

What if someone has been diagnosed with schizophrenia, taken antipsychotic drugs her whole life, then moved into a nursing home where she developed Alzheimer’s? Because the FDA recommends against using antipsychotic drugs on patients with dementia, should the nursing home stop giving her antipsychotics and let her slip into uncontrollable schizophrenic fits?

What if you had been diagnosed with depression, but the physician who visited your nursing home was careless and decided to give you antipsychotic drugs anyway, which caused you to have seizures?

These are all actual questions – and there are many more – that flooded my email and voice mail this week after I wrote about discussions in California to recommend new guidelines for informed consent around antipsychotic drugs.

First a little background: In August 2012, the Partnership to Improve Dementia Care in Nursing Homes – a group of nonprofits, government agencies, and private industry representatives – started meeting to discuss a range of possible improvements to skilled nursing care. The meetings were briefly facilitated by the California Department of Public Health and the U.S. Centers for Medicare and Medicaid Services, but those groups stepped out of a leadership role a few months in. The California Culture Change Coalition stepped in to keep the conversation going with the hope of generating a set of new guidelines that nursing homes could follow.

Tony Chicotel, a California attorney, is helping run the informed-consent meetings. He told me that in the beginning, participants broke into four work groups, one of which was informed consent. He wrote me in an email:

Informed consent emerged as one of the big four issues for a couple of reasons. One, several partnership members noted that one constant problem with antipsychotic (AP) misuse was lack of compliance with informed consent. Not only were nursing homes and resident prescribers using APs in questionable ways, they were not informing the residents. This was an affront to resident autonomy. Two, informed consent is perhaps our best filter against misuse because when residents (or their personal representatives) are given good information about risks, benefits, and alternatives, there is no one better to decide whether the AP is actually going to improve quality of life.

There also was another reason to emphasize informed consent. The partnership thought that prescribers would then be forced to go on the record with the reasons for recommending the drugs. This would lower the chances that someone with the wrong diagnosis would be given such drugs, the thinking went. Chicotel wrote:

In health care, as in so many areas, we often do what is easiest. If the easiest way to ‘deal’ with dementia is to give a sedating drug, that's what is often going to happen. If we make it harder, by requiring doctors to treat their patients as intelligent consumers and explain proposed treatments, then maybe fewer drugs will be prescribed. Also of course, requiring consent gives the resident a chance to say no – a chance that had often not been offered in nursing homes.

It’s telling that all the relevant parties have been talking about this issue for two years and have not arrived at a recommendation. The issue of whether and how to gather signatures for consent has been a big sticking point. Should the doctor have to get the residents’ signatures? Signatures from their family members? Should nurses be able to get signatures, too?

Jocelyn Montgomery, the director of clinical affairs at the California Association of Health Facilities, which represents nursing homes, said via email that one of the toughest questions to answer has been what to do when informing the patient adequately is impossible and family members or guardians are unavailable. Montgomery wrote:

California regulations require the facility to verify that the consent was obtained prior to administering the medication. They have to develop policies and procedures that specify how this will be done. Many facilities do this by asking the doctor and/or the resident’s representative and then documenting that in the chart. Facilities are reluctant to develop policies that require a decision maker’s signature as verification, because if the decision maker is not readily available to sign before the medication is administered, the facility will be in trouble for failing to follow their own policy.

So far, the partnership has not been able to arrive at a guideline or consent form that solves this problem.

In May 2014, the work group discussed whether to have two forms, one that included a space for getting a signature from residents or their families, and one without. The meeting minutes (pdf) state:

There was extensive discussion regarding whether or not a signature line should be included for the patient or their representative to verify that they had given their informed consent to receive antipsychotic medications. While all agreed it was the ideal, it is not required by law, and, even if a signature is there, it’s no guarantee that informed consent was actually given. Therefore, it was suggested to offer two sample forms: one with a place for the patient’s or their representative’s signature and one without.

The discussion continued, as the meeting minutes from August 19, 2014, show, with members explaining how hard it is to obtain written consent.

It was noted that it’s often very difficult to get a signature from the patient or their representative. Patients with dementia are often unable to sign, and family members are often located outside the immediate area. It was noted that nursing homes are very team-care focused. The physician is not always on location, and the informed consent is often gained by other members of the team. It is clear in the regulations that the “prescriber” has the responsibility to gain informed consent. It is not required by law that the patient or their representative sign the form, so this might be rejected by some groups.

Any suggestion that consent without a signature be allowed has been rejected by a wide array of patient advocates. But that last sentence’s assertion that a consent signature is “not required by law” is worth more discussion. I’ll write about it in a future post.

Photo by Ann via Flickr

Comments

Picture of <span class="username">Guest (not verified)</span>

Who is looking at physician prescribing practices for these vulnerable people? Some doctors in California are giving anti-psychotic drugs to more than 90% of their patients over 65, when the average for their medical specialty is 1%. Who is doing peer review? Probably no one. Here's the data for California docs' prescribing rates that will knock your socks off:
http://projects.propublica.org/checkup/states/california/specialties/207...
Rosemary Gibson, Author, The Treatment Trap
www.rosemarygibson.org

Picture of Robert Oshel

The idea of an informed consent form which does not require the patient or the patient's representative to sign that an explanation was provided and consent was given is ludicrous.  Such a form should be titled "Decision to administer drugs or treatment with no evidence of patient consent."  

Certainly there are times when it is medically necessary and in the best interest of the patient to administer drugs or provide treatment without informed consent, but the practitioner doing so should sign a form explicitly stating that is being done and accept responsibility for the decision to do so rather than falsely claim through a non-signed "consent" form that the patient somehow consented.  Use of such a form is actually falsification of medical records and should be illegal.

Picture of <span class="username">Guest (not verified)</span>

Over-prescribing of antipsychotic drugs to the elderly in nursing homes is a well recognized problem. These drugs are an invasion of the patient's frail body no less so than many surgeries would be. There is no excuse for not having a responsible party, having been well informed of the drug's advantages, side effects, and alternatives, to sign a formal document for permission to administer the proposed prescription. If I were the patient's advocate, I would also ask for a written plan of how the effects of the drug are going to be monitored.

Picture of <span class="username">Guest (not verified)</span>

Thank you for another wonderful article, Bill! Informed consent is a basic human right. Any time when a drug treatment carries significant risks, healthcare providers have both a moral and legal obligation to inform patients and their families about the drug risks. Unfortunately, often healthcare providers including medical quality review organizations and regulatory agencies ignore the fact that patients and families need to be informed to make the right medical decision and to avoid preventable medical harm.

My father was killed after he was given an unnecessary medication that carried two documented contraindications for his medical conditions, and the hospital pharmacist warned the doctor of a risk of anaphylaxis. Yet, all of these critical drug risk information were withheld from my father and my family despite that we specifically asked about the drug treatment risks to my father before the first dose.

My father's case is an example of a blatant, serious violations on patient’s rights and informed consent. However, our local QIO and the state medical boards all ignored the doctor’s violations and failed to uphold my father's rights, claiming that drugs given in hospitals do not need consent; they conveniently ignored the “informed” part and they ignored the fact that many drug treatments, such as off-label or antipsychotic drugs, post significant risks to patients in particular vulnerable elderly.

So, as a society, we still have a long way to go to protect the basic human right for patients to be informed about all treatment risks involving both invasive surgeries and drug treatments. As patients and families, we must stand up and demand our rights to be informed.

Picture of <span class="username">Guest (not verified)</span>

Thank you, Bill, for this excellent article. Our family may soon be facing the decision to place a parent in a nursing home. For this loved one, and one day potentially for myself, I do not want any treatment prescribed without informed consent. Such consent should require being presented wth a written explanation from the prescribing doctor as to reason for prescribing, risk/benefit, and plan for monitoring and resolving any potential side effects. There should be an avenue to ask questions of the physician, and written consent should be provided by patient or representative. A documented phone call is insufficient. Our elderly citizens are human beings with dignity - even if they cannot remember or communicate. To continue current practices is to say that they are nothing more than an incovenience. Remember, the pathway we choose today is the treatment we will one day receive ourselves. Informed consent without information and signature means the patient is being ignored and the practice is simply dangerous!

Picture of <span class="username">Guest (not verified)</span>

The first sentence in this article asks, "What if you lived next to someone in a nursing home who was prone to threatening to kill people during psychotic episodes?" Why the heck, in the USA, are frail, elderly, sick patients put in a room with the psychotic patient described in that question? Who the heck made that decision and should they be making the decision about the patient's use of anti-psychotics or should they be taking anti-psychotics? Seriously.

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