What is a Package Insert?

The package insert or patient information leaflet is an important paper that accompanies most medicines, whether they are available over the counter or prescribed. Different countries may have diverse requirements on what this insert must list, but it has a twofold purpose in places like the US. Not only does it list many informative details about a medicine, including its appearance, side effects, special warnings, action, and more, but it also is used to create the Physician’s Desk Reference, which doctors use as information when prescribing medicines so that they avoid prescribing ones that may interact with others or that would be contraindicated. In other countries, similar reference manuals or online information sites are created from information leaflets.

As mentioned, there are a number of details included in a package insert and many of them are quite complex. Exactly what gets included is usually governed by regulatory agencies. For instance, in the US, the Food and Drug Administration (FDA) and US laws determine what inserts must include, and the list is lengthy. People will notice this as they examine an insert. The tiny print contains a wealth of information about many aspects of the drug it discusses.

Some of the things that the FDA demands be available in the package insert are information about how the drug works in the body and how it is metabolized, basic information that describes the drug’s appearance, and the approved uses of the medicine. It is necessary for manufacturers of the medicine to include statistical details based on trials regarding the percentage of people who have side effects and what types they have, interactions with other drugs, contraindications, special warnings, how to handle an overdose, and extra precautions. Details about dosage for different conditions or for different populations, like pediatric and adult populations, usually needs to be listed too, and is useful as a reference point for physicians.

All content of the package insert is split into titled sections. People can find areas of interest, such as warnings or contraindications, and read that section only. There also is useful basic summary of important details like side effects and warnings that are a little easier to digest for medical laypeople.

One of the criticisms of the package insert is that the language is medical, and may be difficult to read for people who don’t have a medical background. This is why pharmacies very often create drug information printouts for prescription drugs that are easier to follow. With many prescription drugs, people don’t necessarily get a package insert, but they will get a printout from the pharmacy that summarizes major warnings, side effects, contraindications and et cetera. If people are interested in a more extensive treatment of drug details, they may be able to get the real insert from their pharmacist, and many drug companies also have full package inserts for the drugs they manufacture available online.