Evaluate liability risks in prescribing
Assuming that Mr. B is taking topiramate for an off-label purpose, an appropriate question to ask is, “Does professional literature support use of topiramate in Mr. B’s circumstances?” Also, given everything known about Mr. B up to this point, is topiramate a good treatment choice?
Appropriate monitoring
As every clinician knows, medications can cause problems. Monitoring topiramate therapy involves periodic lab testing and assessment of effectiveness. Dr. A should feel reasonably sure that Mr. B—assisted by a family member or close friend, if necessary—can and will cooperate with monitoring requirements. Dr. A also should verify that Mr. B can grasp and follow instructions designed to avert complications—such as ample hydration to reduce risk of nephrolithiasis—and will promptly address problems if they occur.
Informed consent
Informed consent is especially important when a patient receives a treatment that has a known risk. Although the Physician’s Desk Reference does not list previous kidney stones as a contraindication to topiramate therapy, it urges caution under these circumstances.4 Therefore, if Dr. A wishes to prescribe topiramate for a patient with a history of kidney stone, the patient should meaningfully collaborate in the treatment decision.
Informed consent for treatment requires that patients not feel coerced by the doctor or setting and have the mental capacity or competence to give consent. Under the conceptualization developed by Appelbaum and Grisso,9 competent patients can:
- express a consistent choice
- understand medical information provided to them
- appreciate how this information applies to them and their condition
- reason logically about treatment.
What information should patients receive before giving consent? The legal standard varies, but in most U.S. jurisdictions, patients “are entitled to material information about the nature of any proposed medical procedure. For example, patients are entitled to information about the risks of the procedure, its necessity, and alternate procedures that might be preferable.”1 Topiramate’s manufacturer instructs physicians to question and warn patients about the risk of kidney stones—which Dr. A did in Mr. B’s case. When you prescribe a drug off-label, you may want to tell patients this, but explain why the drug is appropriate nonetheless.
Table 2
Evaluating a patient’s capacity to consent to treatment
| Is this patient able to? | Questions to ask |
|---|---|
| Express a clear treatment preference | What treatment have you chosen? |
| Understand basic information communicated by caregivers | Can you tell me in your own words about your condition and the treatment options I have told you about? |
| Appreciate his or her medical condition and how information about treatment applies | What do you think is wrong with your health now? Do you think you need some kind of treatment? What do you think treatment will do for you? |
| Reason logically when choosing treatment options | Why did you choose this treatment? Why is it better than your other treatment options? |
| Source: Adapted and reprinted with permission from Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med 2007;357:1834-40 | |
