Prescribing information (PI)

This document includes a great deal of technical medical detail intended to inform health care professionals who might prescribe or dispense a medicine. The PI of any approved medicine is publicly available and anybody may obtain it (from the manufacturer or from FDA, for example), but a PI is written for a professional audience. Whatever your level of scientific and/or mathematical
training, reading the PI cannot substitute for a discussion with a health care professional regarding the risks and benefits and appropriateness of a medicine in your individual circumstances.

Manufacturers typically make the PIs of their medicines available on the Web, and must include the PI as a printed “package insert” with any medicine that is sold in a box or other type of package. Note that a package insert may also include other material in addition to the PI (although you may see the
terms “package insert” and “prescribing information” referred to interchangeably in general discussion).

Given the large amount of information to be provided, newer medicines must now have a two-part PI to make it easier to find and review the information. The first part, titled Highlights of the Prescribing Information, usually takes up less than one page, but may be longer, depending on the complexity and extent of the relevant information. This section excludes much of the technical detail,
charts/graphs, and less broadly applicable information about the medicine. The second part is the full PI, with specifically labeled and numbered sections.

Although PIs for the older products cover the same types of information as for new products, some of the sections are arranged and labeled a bit differently. For instance, in PIs of older medicines, the topics Medicine Interactions, Use in Special Populations, and Patient Counseling Information are subsections of a separate Precautions section. In PIs of newer medicines, each of these three topics is presented as a separate section, and Precautions is part of a combined Warnings and Precautions section, rather than being its own section.

Some of the more important sections of the PI relating to the safe and effective use of a medicine are:
a)Indications
b)Contraindications
c)Warnings
d)Boxed Warning
e)Precautions
f)Information for patients/patient counseling information
g)Medication Guide