Am Fam Physician. 2003 Dec 15;68(12):2342-2348.
Sorting through the myriad of claims to figure out if you should add a new drug to your arsenal is not that difficult or time consuming, providing you take the right STEPS. STEPS, one of the newest additions to American Family Physician, offers an easy way to remember the four attributes to consider when weighing the purported advantages of one drug over another: Safety, Tolerability, Effectiveness, Price, and Simplicity.
The safety profile of a drug applies to the risk of long-term or serious side effects caused by the drug. An older, more established drug may have more risks identified with it than a new drug that has been studied only in a limited number of patients. However, unlike the old saying, what we don't know really can hurt us. When safety is an issue, “watchful waiting” for the first year or so after a new drug is released will allow you to benefit from the experience of others without exposing your patients to unnecessary risk.
Tolerability focuses on the less serious but bothersome side effects of a drug such as drowsiness or insomnia. Determining relative tolerability of two drugs can be difficult if you try to sort through long lists of reported side effects. Pooled dropout rates, the percentage of patients who stopped taking a particular drug during clinical trials, is a better indicator of the relative tolerability of two drugs. For example, headache or nausea may occur less often with a new drug, although, overall, patients are no more likely to stop taking the new drug because of side effects than the older drug.
The best effectiveness data will compare the new drug against the drug in current use. However, this type of direct comparison may not be available when a drug is first marketed. If it is, make sure it shows similar effectiveness as measured in terms of results that patients care about (and not the relative effects on cellular receptors, their in vitro activity, or effects on various blood levels).
Cost can be a complex subject. Does the price, if higher than the agent you currently use, justify the added benefits of the new drug? Included in your price considerations also should be the cost of additional monitoring that might be necessary with the new agent.
Oftentimes, a new drug will offer greater simplicity. It can be taken less often, does not require special handling (e.g., refrigeration), or does not interact with other commonly used drugs.
The categories making up STEPS are not always equal; sometimes effectiveness will be more important than the other characteristics; other times safety or tolerability will be paramount.
Sorting the information available into the five STEPS categories helps determine what is known about a new drug, what is not known, what information is superfluous, and how it all adds up.
Allen F. Shaughnessy, Pharm.D., is director of medical education at Pinnacle Health System, Harrisburg, Pa. He is also the series coordinator of STEPS in American Family Physician.
Address correspondence to Allen F. Shaughnessy, Pharm.D., Pinnacle Health System, P.O. Box 8700, Harrisburg, PA 17105. Reprints are not available from the author.
Copyright © 2003 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact firstname.lastname@example.org for copyright questions and/or permission requests.
Want to use this article elsewhere? Get Permissions