No signature required to give nursing home residents antipsychotics

We sign to vote.

We sign (and sign and sign) to buy a house.

We sign to pick up a prescription at the drug store.

But in California and many other states, skilled nursing facilities do not have to secure a signed consent from a resident or family member to administer any drugs.

This may cause some brow furrowing, but think about this from a logistics perspective first. If you have been in the hospital, you likely have been given a variety of drugs, usually with a health care provider explaining to you what they were going to give, you saying “OK,” and then being asked to swallow a pill, take a shot, or endure a second of pain while they inserted an IV. You get the care you need. Things generally move along quickly and smoothly.

But if you or a loved one is in a nursing home, that quick conversation about drugs may be entirely one-sided. The health care provider may not fully understand your condition because of your inability to communicate effectively, and you may not understand the consequences of taking the drug. Getting a consent – let alone a signature for a consent – can be difficult.

This has particular ramifications with antipsychotic medications. Despite their intended effects of calming a person down and keeping delusions at bay, they can also have serious side effects, such as seizures, nausea, and even death.

A few states, such as Massachusetts and Wisconsin, do require signatures before administering antipsychotics and any other psychotropic drugs.  

In California, that’s not the case. So what is required to gain informed consent? It could be face-to-face verbal consent, a head nod, or a phone call with a family member. And what triggers an informed-consent conversation? As Tony Chicotel, staff attorney for California Advocates for Nursing Home Reform, explained to me:

Under general state and national common law principles, informed consent is required for any health care treatment, regardless of setting, in which the risks, benefits, and alternatives are not commonly understood. So aspirin, in most cases, will not require informed consent. Surgery always does.

Interestingly, in California, the consent for many surgeries must be signed. This is true in other states as well. But, again, antipsychotics do not require a signed consent.

Chicotel’s group sued the state of California more than two decades ago, prompting the state to develop rules that spell out how informed consent can be obtained. It’s important to note, though, that those rules do not require a signature by the resident or anyone else. Facilities do have to create a policy for informing patients about the risks associated with psychotherapeutic drugs (and physical restraints) and for obtaining consent to use them.

These are the policies that the Partnership to Improve Dementia Care in Nursing Homes is hoping to influence with the guidelines it is creating.

One of the areas the partnership may clarify is when consent is not required at all. There are three explicit exceptions in California law:

…[If] there is documentation within the patient's health record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain …

[If] the patient or patient's representative specifically requested that he or she not be informed of the risk of the recommended treatment or procedure…

[If] the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment …

The nursing homes are supposed to thoroughly assess each situation before they decide not to seek consent and are supposed to document the reasons for skipping the consent step. But those are truck-sized exceptions that patient advocates around the country would tell you have been used to run right over patients’ rights.

At the federal level, the list of protected patients’ rights in nursing homes is quite long. And federal rules spell out the right to refuse treatment:

The resident has the right to refuse treatment, to refuse to participate in experimental research, and to formulate an advance directive …

U.S. law includes the act of giving someone mind-altering drugs in its list of prohibited forms of torture. And the United Nations also issued a Convention Against Torture, ratified by the United States in 1994, that says that it is considered torture to give someone mind-altering drugs against their will.

But states have their own sets of policies and court precedents that they are following.

Just to put this discussion into a bit of context, albeit extreme in nature, consider the case of Jared Loughner, the Arizona man who had paranoid views about the government and shot U.S. Rep. Gabby Giffords and others in parking lot attack.

A judge had to rule on whether Loughner could be given antipsychotic drugs. The U.S. Bureau of Prisons had been giving Loughner the drugs. His attorneys sued to stop them from doing so, which likely would have made him unfit to stand trial. The judge ruled on the side of the prison:

I defer to the medical judgment, that's what I choose to do. … I have no reason to disagree with the doctors here. I am not trained in medicine and these folks are. I agree it’s an anathema to free people to have narcotics and heavy drugs forced on them, it takes a powerful justification for government to do that.

Marian Hollingsworth, who has been participating in the nursing home partnership’s discussions and comes down squarely on the side of obtaining signed consent from a patient or a patient representative in all cases, told me:

It seems that political prisoners and deranged shooters have more rights than elderly patients in nursing homes when it comes to antipsychotic drugs. … In this day and age of emails, scanners, fax machines and the like, it is possible to obtain signatures quickly. Without a signature of the patient or representative, there is no proof that informed consent was truly obtained.  

I asked Dr. David Juurlink about the issue on Twitter. Juurlink is head of the division of Clinical Pharmacology and Toxicology at Sunnybrook Health Sciences Centre in Toronto and writes a lot about drugs and the issues surrounding them. Here’s what he said, translated from Twitterspeak:

There are many material risks with antipsychotics, especially with regular use. Getting consent would be a hassle, but it’s hard to argue against it otherwise.

I countered that the hassle actually could do a lot of damage. If you ask nursing home administrators about this, they point out that patients can be a threat to themselves and others. There may not be an available representative to give consent before the resident does harm.

Juurlink’s response:

That’s true. But the simple act of seeking consent would reduce unnecessary use of antipsychotics in long-term care. An easy net plus.

What do you think? Net plus or unnecessary paperwork? Tell me via Twitter @wheisel.

Photo by Garry Knight via Flickr.