Title:The Practicing Clinician and Regulatory Safety Concerns
Volume: 8
Issue: 1
Author(s): R.G. McAllister, Timothy Franson and Carl N. Kraus
Affiliation:
Keywords:
Communication, FDA, pharmacovigilance, REMS, risk:benefit, safety.
Abstract: Pharmaceutical agents are prescribed to produce a therapeutic effect, but safety concerns require constant
attention to the benefit:risk relationship inherent in their use and the needs of the individual patient. Such calculations
involve assumptions about the likely tolerability of harm, in that greater safety risks may be acceptable for use of a lifesaving
drug, compared with those acceptable for an agent providing only improved "quality of life.” Making such
assumptions is an activity integral to the bedside clinician’s role, is done during many (perhaps most) patient encounters,
and is often undertaken with inadequate information. The historical mandates for regulatory agencies, such as the Food
and Drug Administration (FDA) in the United States, have evolved over the past decades to include an intense focus on
drug safety. Communicating information about medicinal risk remains a major responsibility for the FDA and similar
bodies, but the initiatives undertaken have had variable, and often limited, effectiveness in penetrating the physicianpatient
interaction. Barriers to the successful communication of safety-related issues include the myriad of influences on
and within the FDA, the time constraints on physicians involved in clinical practice, and the methodologies used to share
information about both established and new drugs. Current efforts to assess the effectiveness of regulatory efforts at risk
communications should lead to changes in the approaches used and, ultimately, improvement in the safe use of both new
and established drugs.
