Zdrowie i gospodarka · 24/08/1995

Prescription Drug Product Labeling; Medication Guide Requirements

Inadequate access to appropriate patient information is a major cause of inappropriate use of prescription medications, resulting in serious personal injury and related costs to the health care system. The Food and Drug Administration (FDA) believes that it is essential that patients receive information accompanying dispensed prescription drugs. This information must be widely distributed and be of sufficient quality to promote the proper use of prescription drugs. Therefore, FDA is proposing performance standards that would define acceptable levels of information distribution and quality, and to assess supplied information according to these standards. Preliminary evidence suggests recent increases in the distribution of privately-produced patient medication information with dispensed prescriptions. Unfortunately, estimated distribution rates indicate that significant portions of patients do not receive information with their medications. FDA analyses also indicate that there is a high variability in the quality of this information. FDA believes that, with greater encouragement and clear objectives, the private sector will substantially improve the quality and distribution of pati