Informed consent: A process
Informed consent is an essential feature of most medical treatment ( Table 2 ). 13 Informed consent is especially important when—as with using SGAs for behavioral disturbances in dementia—you want to prescribe a drug off-label in a context for which the FDA has required a boxed warning.
Patients in early stages of dementia may retain their decision-making capacity and ability to give informed consent.14 If the opportunity presents itself, this is an ideal time to discuss the possible future need for SGAs and to make sure the patient has designated a proxy decision-maker who can make treatment choices if the patient loses capacity. If a patient’s decision-making capacity is questionable, obtain consent from a surrogate (often a relative).
Informed consent is a process, not a printed form. It involves taking time to be sure that the patient or surrogate decision-maker understands and accepts the risks associated with a proposed treatment. Thinking of informed consent as a process facilitates communication, acceptance of treatment, and trust between prescribers and recipients of care.
Table 2
Essentials of informed consent
| Elements | Patient has the capacity to consent, has received adequate information about the proposed treatment, and has not been coerced |
| Information to disclose about the proposed treatment | Expected benefits, risks (common and serious side effects), alternatives, and expected outcomes of treatment and no treatment |
| Source: Reference 13 | |
Involving family
When appropriate, include a patient’s family in informed consent and treatment planning processes. Providing written material, such as Treatment of dementia and agitation: a guide for families and caregivers, 15 can help educate persons whose loved ones suffer from dementia. These resources often improve care and build relationships with family members that sustain treatment alliances when adverse outcomes occur. Also, well-engaged and informed families are less likely to initiate malpractice lawsuits when adverse events occur.16
Monitor for side effects
Older patients are especially vulnerable to physical harm during agitated or aggressive behavior, but they’re also quite vulnerable to medication side effects. Before starting SGAs, note the patient’s alertness, activities of daily living, movement abnormalities, and EKG abnormalities. Knowing this “baseline” helps you assess the effects of medication and monitor for side effects. Brief assessment scales—such as the Montreal Cognitive Assessment Test,17 the Abnormal Involuntary Movement Scale,18 and the Instrumental Activities of Daily Living Scale19 —can help you quantify baseline functioning, monitor symptom response, and detect adverse effects.
For patients receiving SGA therapy, reassess benefits and risks at least every 3 months, and preferably more often.11 In geriatric patients, titrate dosages slowly, maintain medications at the lowest effective levels, and discontinue them once they are no longer necessary. When doubt arises about the effectiveness of SGA therapy, stop the drug.12
Remember to document
Because older patients have high rates of medical problems and medication side effects, negative outcomes always are a risk. Good documentation is a key risk management strategy that can help if a bad outcome requires you to defend your treatment plan in court ( Table 3 ).2 ”
Table 3
What to document
| Your reasons for starting treatment with SGAs |
| Other treatments that were tried unsuccessfully |
| Other treatments that were considered but deemed inappropriate |
| The patient’s baseline medical, physical, cognitive, and functional status, including consideration of cardiovascular, cerebrovascular, pulmonary, and metabolic risk factors |
| How and when you will monitor side effects |
| For a patient who resides outside a nursing home, send a letter to the primary care provider stating that the patient is on SGA therapy and requesting assistance in monitoring for medical problems |
| For a patient who resides in a nursing home, describe the monitoring system for identifying adverse events (eg, regular EKGs, pulmonary exams, and lab tests) |
| Collect and keep copies of literature supporting your treatment choice |
| SGAs: second-generation antipsychotics |
| Source: Adapted from reference 20 |
Drug Brand Name
- Memantine • Namenda
Disclosure
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.