a new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks.Some of the most significant changes include: Revised for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find it quickly. This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information."
#FDA ABBREVIATED TABULAR FORMAT NFP HOW TO#
"This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively. We have hit a point of information overload and the public health message is being diluted," says Surgeon General Richard H. "Americans are overwhelmed with the complexity of health information. By making these changes, the FDA is seeking to simplify the information on prescription drug labels, making the labels more useful for physicians and their patients. Therefore, the new prescription label provides the most important information about a prescription product in a format that is better-understood, more easily accessible, and more memorable for physicians. Research shows that prioritizing the warning information has a greater impact on reducing such events. "By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients."Įach year, about 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information. "Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare," says Health and Human Services Secretary Mike Leavitt. The new format also will make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.
To manage the risks of medication use and to reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. In January 2006, the Food and Drug Administration unveiled a major revision to the format of prescription drug information, commonly called the package insert.
0 kommentar(er)
