From The Carlat Child Psychiatry Report, May 2018, Psychotropic Risks in Children and Adolescents

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Informed consent is a foundation for good clinical practice and can provide legal protection. But informed consent is more than defensive medicine. It is a vehicle for framing good care.

How often do people use the consent process? Malpractice companies recommend that the patient (or parent) sign consent whenever a medication is started. This might be a new page in the record or initialing an amendment to a more permanent form. Here is a link to a sample of an informed consent form. Some clinics build informed consent into the electronic health record (EHR) or paperwork. Do you spend time on it, or do you just get the signature?

The scant research available suggests that—at least among internists and family practice providers—the depth of the informed consent discussion is quite limited (Braddock CH et al, J Gen Intern Med 1997;12(6):339–345).

Lawsuits against child psychiatrists often focus on poor medication outcomes (Psychiatry-Edgmont 2009;6(8):38–39), and the absence of good documentation of informed consent can lead to awards and even charges of battery. The California Medical Board regularly reports actions taken when consent is absent (see: http://www.mbc.ca.gov).

But the informed consent process also helps us organize care. At every follow-up appointment, we should review medications in the context of the overall treatment plan, in continual family guidance. The elements of informed consent can foster a climate of collaboration and should include the following:

Demographic information: Like every other page in a chart, the informed consent form should have the patient’s name, the patient’s date of birth, and the dates of all entries.

Diagnoses: DSM and ICD-10 diagnoses are a limited reflection of a patient’s actual situation. Still, list relevant diagnoses and other important medical conditions (eg, neurological, gastrointestinal, respiratory), as well as important V-code circumstances such as recent moves, divorce, or school problems. These impact the patient’s presentation and are relevant to the overall treatment plan.

Target symptoms: In child psychiatry, it is usually more relevant to focus on target symptoms than diagnoses. I work with families to prioritize target symptoms so that we focus on issues important to them while keeping in mind good medical approaches. For instance, a family may worry about their teen’s depressed feelings while you might place the patient’s alcohol use on par, in which case you would explain to the family that the teen’s alcohol use will need to be addressed to treat the depression.

Treatment protocol: Lay out the specific plan for medication, including medication name(s), dosage, timing, and additional information such as plans for titration. Make clear what the family needs to do.

Alternative treatments: List the other medications or treatments discussed. For example, when considering inattention or impulsivity, you might have talked about stimulants, alpha-adrenergic agents, and other non-stimulant medications. Documenting these options helps you to remember to talk with families about them.

Possible results of no treatment: Make clear what the results of not treating might be. Sometimes it is serious, such as untreated psychosis or mania. Or it may be murkier, such as when a medication might be helpful but has less clear efficacy—in treating depression in children, response rates are often indistinguishable from placebo (Garland EJ et al, J Can Acad Child Adolesc Psychiatry 2016;25(1):4–10). We may attempt treatment anyway, hoping to help severe depression, but we should proactively discuss the possibility of limited efficacy with families to manage expectations and avoid surprises.

Discussing side effects: Review common problems that come up— issues with eating, sleeping, weight, etc. There is no clear need to discuss unusual side effects. But note the important things to watch for, such as extrapyramidal symptoms and syndromes with antipsychotics (tardive dyskinesia, akathisia, neuroleptic malignant syndrome), or Stevens-Johnson syndrome with lamotrigine (see: https://www.nimh.nih.gov/health/topics/mental-health-medications/index.shtml).

FDA labeling: Child psychiatrists often prescribe outside of the FDA indications. Discuss this with families and patients (the latter as developmentally appropriate), and document the discussion. Ensure that you have reasonable evidence, record your rationale, and note that while the plan is considered experimental by FDA standards, you judge it to be safe based on use in other populations or situations.

Consent and assent: Note that parents sign consent for treatment, and children of about 7 and up may assent (agree) to treatment. Try to get the child on board in understanding that the medication is being used to help specific things. Listen to what the child says is helpful and, conversely, what the child does not like. This makes for a more effective treatment process. If you are dealing with a custody situation, pay attention to issues of shared medical decision-making. You often need both parents to sign off on the medication plan, except in certain emergency cases.

Comments, questions, and concerns: Here, note follow-up plans and additional aspects of treatment (eg, therapies, school liaison, and follow-up testing).

Affirmation of understanding and signature block: Families sign that they understand and commit to the plan, consent to the treatment, will work with you on it, and will read the package insert for the medication(s) involved.

Space for updates: I incorporate a flow sheet to add new trials, which is dated and initialed as the informed consent process develops.

CCPR Verdict: Informed consent is ongoing, not a one-time event. It’s a framework for care. The document can be a touchstone to focus follow-up care, reminding us to ask about the specifics of the clinical situation, effects of the current plan, and treatment options.