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Introducing Medscape Safe Use

Authors: Carl Kraus, MDFaculty and Disclosures

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Posted: 2/19/2012

How do physicians make informed and effective decisions in the treatment of patients? How do patients decide what sorts of treatments would be best for them? These issues arise in almost every physician-patient interaction, yet the outcomes are usually based on imprecise estimates of the likelihoods of benefit and harm. There is a desperate need for readily available and relevant information to inform the process for both the physician and the patient, with the end that benefit results and the chance of harm is diminished.

The definition of disease has become exceedingly complex over the past several decades, as sophisticated understandings of pathophysiology have begun to unravel the mechanisms involved in activation of immune responses to external organisms (bacteria, viruses, and environmental toxins) and internal disruptions (degeneration, cell mutations, and autoimmune disorders). In this environment, therapeutic interventions of all sorts – but particularly those involving drugs – have also become increasingly complicated, with the constant demand for simultaneous consideration of (1) the processes underlying a disease's natural history, (2) the interaction of pharmacologic manipulation on those processes, (3) understanding the differences in therapeutic outcome based on baseline patient variables, (4) the ability for physicians to weigh these disparate factors when making treatment recommendations to their patients, and (5) the patient's emotional and psychological needs. In this circumstance, assessment of benefit and harm, the essential basis for all treatment decisions, is often inadequately guided by well-based information.

This difficulty is reflected in the understanding of the responsibilities assumed by regulatory agencies such as the FDA. In the 1999 FDA Task Force report on "Risk Management," a safe product is defined as one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available. Therefore, "safe" simply means that the benefit-to-risk ratio is "reasonable." But what does this mean in the daily interactions between physicians and patients? How can physicians determine that a therapeutic intervention is "safe" and that the risk of potential harm to a patient is sufficiently low to justify the treatment? Adding to the complexity of the medical decision-making is the need to assess a patient's emotional and psychological responses, i.e., will the physician's perception of the value of a treatment be in conflict with a patient's own feelings of health?

As a resource to help both physicians and patients in their efforts to understand the components involved in decisions regarding therapeutic interventions, the goal of Medscape's Safe Use Center is to provide the information, updates, and commentary needed to support an appreciation of the aspects of these complex processes, and, at the same time, to foster both patient informed consent and physician informed prescribing through a greater emphasis on considerations of the benefit:harm relationship of marketed pharmaceuticals.

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