Back to: How to Read an Insert Training Course
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Most FDA-approved medications will have this section. It is intended for healthcare providers, however as a patient or parent, you have the right to read what the manufacturer says about their product to make an informed decision. This section is a summary of the full insert. Here is a template from the FDA:
Let’s dig deeper into each section.
In the upper left corner of the summary, you’ll find the proprietary name (or trade name), the nonproprietary name (or generic name), the form of the product (tablets, injection, etc), and route of administration (oral use, intramuscular or subcutaneous use, etc). The controlled substance symbol is a drug classification that describes the abuse/addiction level of the product. For example, OxyContin is a Schedule II drug meaning it is highly addictive with dangerous potential for abuse.
The next section contains recent major changes to the insert, however changes to only five sections of the insert will be summarized here: boxed warning, indications and usage, dosage and administration, contraindications, and warning and precautions. Recent major changes are only required to be listed for one year after the change.
The indication (or reason) the product has been approved is listed under Indications and Usage. If a product is used other than what the manufacturer indicates in the insert, then it is being used “off-label.” Using a product for any other reason than what it has been approved for is incredibly risky. Some inserts will have multiple indications listed based on product versatility.
The Dosage and Administration section will list recommended starting dosage/frequency, maximum dosage, dosage in specific populations (pediatrics, pregnancy, renal impairment, etc), any modifications due to drug interactions, and discontinuation instructions. If your healthcare provider prescribes a product, make sure it is within dosage guidelines on the insert.
Contraindications (con·tra·in·di·ca·tions) are conditions in a recipient that increases the risk for a serious adverse reaction to this product. A product should not be administered when a patient has a listed contraindication.
Some inserts will have a boxed warning about serious adverse reactions that may lead to death or serious injury. In addition to boxed warnings, the Warnings and Precautions section includes clinically significant adverse reactions or risks.
According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.
Adverse reactions, per the CDC, are undesirable medical conditions that have been demonstrated to be caused by a medical product. The Adverse Reactions section in the Highlights of Prescribing Information is only a summary and not exhaustive. Later on, the manufacturer will provide more information about two kinds of adverse reactions. The first is Clinical Trials Experience where reactions from the product’s clinical trials are listed. However, arguably the most important section of the entire manufacturer insert is listed under Postmarketing Experience. This section is populated from adverse reactions that patients report to the manufacturer or federal government after the product has gone to market. We’ll go more in depth soon!
If you are on any other medications, pay attention to the Drug Interactions section. All clinically significant drug interactions are listed here as well as practical instructions for preventing or managing any interactions that may occur. It might list interactions with foods too.
In the Specific Populations section, information is provided on the use of the product in pregnant/lactating females, females/males of reproductive potential, pediatric patients, geriatric patients, and patients with certain coexisting conditions (for example, renal or hepatic impairment).
Below the summary, the Table of Contents will list the sections within the insert. We will go through the main sections in the following lessons.
