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Evaluating the Safety and Effectiveness of New Drugs

Pegler, Scott BPharm (HONS); Underhill, Jonathan BSc (HONS)

doi: 10.1097/AOG.0b013e3181fe61f4
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Prescribers seek to provide their patients with access to the latest innovations in medicine to maximize their health status. When a new drug comes to market, it often has not been as widely tested as other available therapies, and its effectiveness and safety cannot be fully evaluated. To address this problem, physicians can use the STEPS (Safety, Tolerability, Effectiveness, Price, and Simplicity) mnemonic to provide an analytic framework for making better decisions about a new drug's appropriate place in therapy. A key element is to base this evaluation on patient-oriented evidence rather than accept disease-oriented evidence (which may be misleading), while avoiding inappropriate reliance on studies that report only noninferiority results or relative-risk reductions. The primary question to ask for each new drug prescribing decision is, “Is there good evidence that this new drug is likely to make my patient live longer or better compared with the available alternatives?” (Am Fam Physician. 2010;82 (1):53–57. Copyright © 2010 American Academy of Family Physicians.)

Scott Pegler, BPharm (Hons), is the medicines information manager at Morriston Hospital, ABM University Health Board, Swansea, United Kingdom, Jonathan Underhill, BSc (Hons), is the head of evidence-based therapeutics at the National Prescribing Centre, Liverpool, United Kingdom.

Address correspondence to Scott Pegler, BPharm (Hons), Medicines Information Centre, Morriston Hospital, Swansea, SA6 6NL, United Kingdom. Reprints are not available from the authors.

Reprinted from Am Fam Physician 2010;82(1):53–57. Copyright © 2010 American Academy of Family Physicians.

This is one in a series of “Clinical Pharmacology” articles coordinated by Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency at Cambridge Health Alliance, Malden, Mass.

Author disclosure: Mr. Pegler has received honoraria for attending advisory board meetings for Pfizer, Inc.; GlaxoSmithKline; and Grünenthal. Mr. Underhill has nothing to disclose.

© 2010 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.