“I have explained to the patient the reasons for prescribing the above medication, the expected benefits and potential side effects, the treatment alternatives and possible risks and benefits of the alternatives, and the expected course w/o treatment. The patient asked appropriate questions and appeared to understand the answers. (I discussed off-label use.) I provided information from the manufacturer (or some other source). The patient has decided to try this medication and to be followed.”
Caveats. Avoid “cutting and pasting” language for each informed consent discussion into each medical record. Make your discussion and its documentation reflect each individual’s treatment plan. If you use a preprinted consent/medications side-effect form (as required by many institutions and clinics), consider entering a personalized notation into the progress notes as needed, such as when:
- you prescribe medications with high risk for serious side effects
- you use off-label prescribing that is not customary
- a patient needs extra assistance to follow the treatment plan.8
Table 2
Informed consent: Pertinent points to document
| Proposed treatment |
| Potential side effects (most common) |
| Potential side effects (most dangerous) |
| Potential side effects that might make a patient anxious, such as those included in recent FDA statements, changes in labeling, or advertisers’ consumer marketing messages |
| Alternatives, including their potential side effects |
| Course without treatment |
| Demonstration of patient’s comprehension of warnings and opportunity to ask questions |
- include all significant and material risks on the form
- state on the form that the risks “include, but are not limited to” those listed on the form
- have thorough informed consent discussions with patients
- enter into the medical record your discussion and a copy of the form signed by the patient.
- What information would I want a physician to disclose to my loved one (parent, child, spouse, etc.) if I was not present and my loved one needed to give consent to a treatment recommendation?
- Is this information of the type that a reasonable person could say: “I wouldn’t have consented if the doctor had told me that”? If you think so, then provide this information to your patient.
- Food and Drug Administration (FDA). Information sheets on hundreds of FDA-approved drugs, listed alphabetically. www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.
- FDA. Drug safety information for consumers and healthcare professionals. www.fda.gov/cder/index.html.
- Aripiprazole • Abilify
- Olanzapine • Zyprexa
- Quetiapine • Seroquel
- Risperidone • Risperdal
- Ziprasidone • Geodon
Dr. Kaye receives research support from Pfizer Inc. and Takeda Pharmaceutical and is a consultant to and speaker for Pfizer Inc., AstraZeneca, and GlaxoSmithKline.
Jacqueline Melonas is a full-time employee of PRMS, Inc. PRMS, Inc. contracts with Eli Lilly and Company to provide risk management content related to the management of medical malpractice liability.