Document informed consent: Rosen

Media reports of widespread use of antipsychotic drugs in Ontario nursing homes have highlighted the need for practitioners to thoroughly document the fact that they have received informed consent for medications, says Toronto health lawyer Lonny Rosen.

“Recognizing that this has been identified as a wide-ranging concern, physicians should review the medications that each patient is on (as they normally would do) and consider whether indeed they have documentation confirming that they have obtained informed consent for that treatment,” he tells

Rosen, partner at Rosen Sunshine LLP, made the comments as the Toronto Star reports that the newspaper conducted its own investigation and found that some long-term care homes in Ontario are “routinely doling out risky” antipsychotic drugs to seniors in an effort to “calm and restrain” patients who wander, become agitated and aggressive.

The newspaper says that roughly half of the residents in more than 40 homes in Ontario are on the drugs and at nearly 300 homes, more than a third.

The article also suggests that practitioners may be inappropriately prescribing the medication because it isn’t for the indicated use.

But Rosen notes that physicians may still in fact be prescribing the drugs in accordance with the standard of practice of the profession and in accordance with the standard of care.

“The fact that it’s being used on an off-label basis doesn’t necessarily mean that it’s not being prescribed appropriately,” he tells the online legal news service.

The lawyer says there may be cases where family members or substitute decision makers gave informed consent to treatment with antipsychotic medication on the basis that the medication may prevent aggressive behaviours, which may result in the patient seriously harming themselves or another or in their being removed from a nursing home. Provided the treatment is indicated and informed consent is obtained for the treatment, even anti-psychotic medication may appropriately be prescribed, he says.

Rosen says if physicians are prescribing medication without informed consent, “then there’s a concern.” That means informed consent of the patient – or if the patient isn’t capable of consenting, then informed consent of that person’s substitute decision maker.

He says the seemingly high number of long-term care home residents taking such medications may be partially explained by the fact that some could have been prescribed the antipsychotics prior to arriving at the home.

“That may be a cause of so many people being on the medication, but the physician who’s responsible for the patient’s treatment in the nursing home must still review whether the medication is indicated,” he says.

The requirement for informed consent, Rosen stresses, means the physician has to give the patient, or the substitute decision maker, all of the required information in order to make an informed decision to consent to, or refuse, the proposed treatment. That includes information about the purpose of the treatment, the nature of the treatment, the expected benefits of the treatment, the material risks, the material side effects and alternative courses of action, as well as the likely consequences of not having the treatment.

“And remembering that consent is not simply a form, but a process, the person must have received responses to any questions he has about these matters," he says.

He says the consent form is really just “evidence” that a discussion took place.

Rosen says the coverage in the Star is a “good reminder for health care practitioners that in every case, they should document the informed consent process.

“They should document the indications for prescribing the medication; they should document the discussion of the risks and benefits and side effects,” he says. "And they should document any questions asked and answers given."

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