The Physicians’ Labeling Rule: An Evaluation of Compliance
Tóm tắt
The primary purpose of this study was to evaluate compliance of newly approved labeling with the Physicians’ Labeling Rule (PLR). Labeling (prescribing information) for 221 products in PLR format approved during the first 30 months following the regulation effective date were compared with requirements set by the PLR regulation, as well as with available FDA guidances and prespecified best practices. Although compliance with regulation and guidances was more than or equal to 95% for 54% of all parameters examined, there were several areas for improvement. Deviations from guidances were more likely than deviations from regulation, and the majority were related to content and redundancy issues rather than formatting. An evaluation of deviations by date of approval revealed a trend for an increasing number of deviations over time. Continued evaluation of compliance will be important to ensure that prescribing information remains in compliance with the PLR regulations.
Tài liệu tham khảo
Requirements on content and format of labeling for human prescription drug and biological products. Title 21. Code of Federal Regulations, Pt. 201.56. 2007 ed., 21–23.
FDA Poll: National Biosystems I. Focus Group Report: Physicians’ Perceptions of Prescription Drug Labeling Information. Focus Group. Plymouth. MN: National Biosystems; 1992. Report No. Contract #223-91-3501.
Food and Drug Administration. Transcript of public meeting on prescription drug labeling. Docket No. 95N-0314. October 30, 1995.
Dawes M, Sampson U. Knowledge management in clinical practice: a systematic review of information seeking behavior in physicians. Int J Med Informatics. 2003;71:9–15.
Requirements on content and format of labeling for human prescription drugs and biologics; requirements for prescription drug product labels. Federal Register. 2000;65(247):81082.
Requirements on content and format of labeling for human prescription drug and biological products. Federal Register. 2006;71 (15):3922–3997.
Specific requirements on content and format of labeling for human prescription drug and biological products described in §201.56(b)(1). Title 21. Code of Federal Regulations. Pt. 201.57. 2007 ed., 23–38.
Food and Drug Administration. Guidance for industry: adverse reactions section of labeling for human prescription drug and biological products—content and format. January 2006.
Food and Drug Administration. Guidance for industry: clinical studies section of labeling for human prescription drug and biological products—content and format. January 2006.
Food and Drug Administration. Guidance for industry: labeling for human prescription drug and biological products—implementing the new content and format requirements. Draft. January 2006.
Food and Drug Administration. Guidance for industry: warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. Draft. January 2006.
Kremzner ME, Osborne SF. An introduction to the improved FDA prescription drug labeling. http://www.fda.gov/Training/ForHealthProfessionals/ucm090801.htm (accessed November 10, 2010).
Behrman RE, Galson SK, Jenkins JK, Norden J. Slide presentation. In N. Smith (Chair). An Introduction to the Improved FDA Prescription Drug Labeling. Joint Drug Information Association and FDA Workshop, Bethesda, Maryland. April 17, 2006.
Bass SW, Burke L, Fava JM. Implementation of FDA’s new regulation for the content and format of the USPI and accompanying documents. Slide presentation. Symposium conducted at the 41 st meeting of the Drug Information Association. Philadelphia, Pennsylvania. June 19, 2006.
Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Federal Register. 2008;73(104):30831.
Waiver of labeling requirements. Title 21. Code of Federal Regulations. Pt. 201.58. 2007 ed., 39.
Food and Drug Administration. Guidance for industry: dosage and administration section of labeling for human prescription drug and biological products—content and format. March 2010.
Food and Drug Administration. Guidance for industry: clinical pharmacology section of labeling for human prescription drug and biological products—content and format. Draft guidance. March 2009.