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Am Fam Physician. 2011;83(1):8

Author disclosure: Nothing to disclose.

Original Article: Evaluating the Safety and Effectiveness of New Drugs
Issue Date: July 1, 2010
Available at:

to the editor: It was with great pleasure that I read the article by Mr. Pegler and Mr. Underhill. As an educator of future family physicians and pharmacists, I have been using the STEPS (safety, tolerability, effectiveness, price, and simplicity) approach to teach about new drugs for some time. I use this structure to teach students how to assess a patient's current or potential drug therapy, and to discuss risks versus benefits of drug therapy options by replacing “price” with “patient preference,” which still includes the cost of the drug. When used in this manner, the STEPS approach helps to inform the shared medical decision-making process.1 For example, when discussing options to treat a patient with newly diagnosed hypercholesterolemia, a physician would review the known safety and tolerability (risks) data and patient-oriented effectiveness (benefits) data for a given medication in a nonjudgmental, nonbiased manner. From this point, the physician may put into context the patient's baseline risk of cardiovascular disease and the benefit expected from the medication (i.e., absolute risk reduction), and solicit the patient's preference about starting the drug or attempting therapeutic lifestyle modifications (simplicity).

By employing the STEPS approach in this way, the physician fulfills several key needs to enable patient participation in medical decision making: patients' need to be adequately informed; physicians' explicit encouragement of patient participation; appreciation of the patient's responsibility/right to take an active role in decision making; and awareness of choice.2 Although not all patients prefer to take an active role in the decision-making process, for those who do, applying the STEPS approach is one way to attain patient satisfaction with the process and enhance the therapeutic relationship.

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This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

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