To most people, the printed “package inserts” that accompany prescription medications might as well be in ancient Greek. The wording is dense and complex, reading more like a legal document than a guide to prescribing medications safely and appropriately. In this report, Johns Hopkins explains how to read and benefit from the "highlights" section.
The U.S. Food and Drug Administration (FDA) recently took steps to make the package inserts more clear, concise, and effective at communicating to doctors and patients the proper use, benefits, and risks of a given medication. Although the new inserts are not specifically designed for non-physicians, consumers who obtain them at their local pharmacy or on the Internet will find them more comprehensible and useful than the former versions.
Most pharmacies do not attach the package insert when they fill prescriptions, instead opting for non-FDA-approved, commercially prepared consumer information. However, if you ask for a copy of the package insert, the pharmacy will give you one. These inserts are also available on the National Library of Medicine (NLM) website at www.dailymed.nlm.nih .gov.
Once you have a copy of the package insert, your first stop should be the Highlights section. Here you can read in less than a page a summary of the most important things to know about a medication -- its approved indications, the recommended dosage, how to take it, who shouldn’t take it, warnings and precautions, the most common side effects, and any recent updates to the drug label.
If you then want to learn more about anything mentioned in the Highlights, go to the Table of Contents to find the appropriate section or subsection. Do not be frustrated if the Highlights section is still unclear —it was written for doctors, not consumers.
Fortunately, some package inserts have an added patient section at the very end; sometimes it is on a separate sheet. To quickly get to this feature in the NLM database, simply click on the “Patient Package Insert” tab. This document is specifically for you, the consumer. It is important to note that written information cannot and should not replace a discussion with your doctor about your medications. But if you take the time to look at medication package inserts, they may help you frame the right questions to ask your doctor and can help you fully participate in decisions about your medications.
Reading the Highlights -- If the headings in the Highlights section are too technical, here’s a short glossary of some of the terms.
- Boxed Warning. Not all package inserts have this feature, but if your medication does, you should read it, because it contains crucial safety information.
- Indications and Usage. Here you can learn about the diseases or conditions the medication is approved for by the FDA. But keep in mind that doctors often prescribe medications “off label” for indications not included in the original FDA approval.
- Dosage and Administration. This section outlines the recommended dosages of the medication for the approved indications and whether dose adjustments need to be made for certain people, for example, those with liver or kidney disease. It also explains how the medication is administered -- for example, orally, by injection, or inhaled -- as well as other details on how to take it -- with food, for instance.
- Contraindications. Here’s where you can find in which patients or situations a medication should not be prescribed because the risks (sometimes life-threatening) clearly outweigh the benefits.
- Warnings and Precautions. This section spells out general precautions for using the medication, such as undergoing regular blood tests, as well as serious harmful effects the medication may cause and what to do in the event that one of these side effects occurs. If the warning is particularly strong, it will appear as a prominent “black box” warning at the top of the Highlights page.
- Adverse Reactions. This section states the most common side effects of the medication. Just because a side effect is mentioned, however, does not mean that you will necessarily experience it.
- Drug Interactions. These are the medications, dietary and herbal supplements, and foods that, if taken concurrently with your medication, can cause undesirable effects. Some of these interactions warrant only caution; others can cause serious problems, such as liver damage or precipitous drops in blood pressure.
- Use in Specific Populations. This section refers to special instructions for certain groups of individuals, for example, pregnant women, children, the elderly, or those with liver or kidney problems.
