Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

Renu Lal; Mary Kremzner

Disclosures

Am J Health Syst Pharm. 2007;64(23):2488-2494. 

In This Article

The New Labeling

The new labeling reorders and reorganizes sections found in the previous labeling format (Figure 1).[1] Under the new system, a label is divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI. In this article, "labeling" or "label" refers to the entire prescription drug label (highlights, contents, and the FPI), and "FPI" refers only to the FPI portion.

Figure 1.

Comparison of previous labeling format with revised format. (Subheadings may vary for various drugs. )

Highlights

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2).[4] This section provides immediate access to the information most crucial for a drug's safe and effective use and contains numerical cross-references to more details in the FPI. The highlights section is not simply a verbatim repetition of selected information from the FPI or a repetition of the contents section. In designing the highlights section, FDA used established techniques to enhance the communication of large amounts of complex information. Highlights summarizes the information from the FPI that is most important for prescribing a drug safely and effectively and logically organizes it to enhance accessibility and retention. The design combines multiple textual and graphic elements (e.g., tables, bulleted lists, boldface, italics).

Figure 2.

Example of highlights section (for a fictitious drug).

Limitations Statement. Highlights does not include all the information necessary touse a drug safely and effectively. For this reason, it is prefaced with a limitations statement that reads, "These highlights do not include all the information needed to use drug X safely and effectively. See full prescribing information for drug X. "

Product Names and Date of Initial FDA Approval. The listing of other names for the product can be important to avoid confusion. The date of approval provides context on the relative newness of a product, since there may be limited clinical information about a new product compared with one that has been on the market for some time.

Boxed Warning. Many drug product labels contain a boxed warning, often referred to by health care practitioners as a black-box warning, to emphasize certain risks. The boxed warning that appears in the highlights section may be a condensed version of the complete boxed warning in the FPI and is limited to 20 lines.[1] Cross-references maybe made to additional safety information in the FPI.

Recent Major Changes. Changes that have been made to certain sections of the FPI are listed. Marginal notations appear in the corresponding sections of the FPI to indicate where the changes occurred.

Indications and Usage. Listed are the indications for use of a drug, the major limitations to use, the pharmacologic class, and the mechanism of action.

Dosage and administration. The recommended dosage regimen for the given indications is provided, along with the starting dosage, dosage range, whether the drug should be taken with or without food, critical differences among population subsets, monitoring recommendations, and significant clinical pharmacologic information.

Dosage Forms and Strengths. The available dosage forms and strengths are detailed.

Contraindications. No relative contraindications are listed, only circumstances when the drug should absolutely not be used. The contraindications statement must be included even if there are no contraindications.

Warnings and Precautions. An abbreviated summary of the most clinically significant adverse drug reactions (ADRs), how to monitor them, and how to treat them is provided.

Adverse Reactions. Listed are the most common ADRs, their frequencies, and how they should be reported to the manufacturer and to FDA.

Drug Interactions. The drug interactions are briefly described.

Use in Specific Populations. This section, which was previously integrated into the precautions section, summarizes important information about use in specific populations.

Patient Counseling Information. The practitioner is reminded of information important to convey to the patient.

Contents

The contents section serves as a navigational tool that references all the sections and subsections in the FPI, some of which may not be referenced in highlights (Figure 3). The contents sectional so allows for hyperlinks in electronic formats.

Figure 3.

Example of contents section (for a fictitious drug).

FPI

Changes in Content. The clinical pharmacology section describes drug-drug interaction study results and alerts practitioners to the extent of particular interactions.

The contraindications section now describes only known hazards and no longer includes the statement "allergic to any component of the drug." A contraindication exists only when the risk from use clearly outweighs any possible therapeutic benefit. "None"is stated when no contraindications are known, and no relative or hypothetical contraindications are listed. The order in which contraindications are listed is based on their likelihood and the size of the population affected.

The warnings and precautions sections are consolidated into one section containing the most critical safety information. This new section also includes clinically significant ADRs that require discontinuation of the drug, dosage adjustment, or addition of another drug; that could be prevented or managed with appropriate patient selection or avoidance of concomitant therapy; and that significantly affect patient compliance.

The adverse reactions section, which follows the warnings and precautions section, consolidates risk information and helps put into context the relative seriousness of the adverse reactions discussed. ADRs observed in post marketing clinical trials are included with the clinical trial experience. Post marketing spontaneous-ADR reports are listed separately. This section no longer contains extraneous events or a "laundry list" of ADRs. It provides additional detail on the nature, severity, and frequency of ADRs and their relationship to dosage and patient demographics. Contact information for reporting ADRs is provided.

Some product identification information (color, scoring) is located in both the how-supplied section and the dosage forms and strengths section to preserve the integrity and enhance the understanding of both sections.

The clinical and nonclinical toxicology sections, which were previously optional, are now required.

A separate section on patient-counseling information has been added in response to the requirement that all FDA-approved patient information be reprinted in or accompany drug product labeling. The purpose of this change is to increase the prominence of patient information. The requirement regarding the inclusion of all FDA-approved patient information also applies to older products not otherwise subject to the new content and format requirements. These requirements do not change the content or format of FDA-approved patient information, including medication guides.[1] FDA-approved patient information and patient-counseling information serve distinct purposes. Patient information (including patient package inserts and medication guides) is designed to communicate to patients in understandable language the most important information they need to use a product appropriately. Patient-counseling information is specifically written for health care practitioners to inform them about what information is important to convey to the patient at the time of prescribing for the drug to be used safely and effectively.

Changes in Format. The new labeling reorders and reorganizes sections found in the previous format. Sections previously located in the precautions section (drug interactions, use in specific populations, and patient-counseling information) now appear as new sections. Other information formerly found in the precautions section is located in sections devoted to use in specific populations, drug interactions, and patient-counseling information.

Some of the sections include subsections that make finding information much easier. Information may appear in more than one section, or it may be repeated based on type and clinical relevance. One section may contain detail, whereas another section may contain a brief description with a cross-reference. For example, drug interaction information appears in the drug interactions section and the clinical pharmacology section. The drug interactions section lists other drugs or classes of drugs and foods that interact with or are predicted to interact with the drug in clinically significant ways. This section also includes practical instructions for preventing or decreasing the likelihood of an interaction and indicates when the interaction rises to the level of a warning, precaution, or contraindication or necessitates a dosage adjustment. Drug interactions may appear in all of the following sections: drug interactions, contraindications, warnings and precautions, boxed warning, dosage and administration, and clinical pharmacology.

Changes in Order of Information. The information practitioners refer to most frequently and consider most important (e.g., boxed warning, indications and usage, dosage and administration, dosage forms and strengths, and storage and handling) is located at the front of the prescribing information. As a result of feedback from two national physician surveys,[1,2] the indications and usage section and the dosage and administration section are now at the beginning of the FPI.

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