A patient package insert is written information received when you purchase prescription drugs that tells what the drug is, how it should be used and how it works. It also contains information regarding any possible safety concerns or precautions necessary when taking the drug. This information may be enclosed in the medication box, or may be given as a printout from the pharmacist. The Food and Drug Administration calls this package insert the drug product label, and its exact wording must be approved before it can be printed and distributed. Similar information is available for non-prescription medications.
Although sections of the package insert were redesigned as of 2006 to make them more easily readable for the general public, they still contain many technical terms understandable only to medical professionals. For this reason, many patients never read the inserts, or simply throw them away. Since most mesothelioma patients may be taking a number of prescription medications, it is a good idea to read and keep these inserts in a medications file.
The information included in the package insert follows the same format for every drug, although different manufacturers may use slightly different wording in the section titles.
Each insert contains the following information:
- Brand name and generic name of the product.
(For example: Oxycontin = oxycodone).
This section gives the clinical name of the drug and shows a structural diagram of its components. It tells whether it is in tablet, capsule or liquid form, and tells how it should be given. Also listed are all inactive ingredients such as artificial colors or flavorings which could cause problems for those with food sensitivities.
- Clinical Pharmacology.
This section generally contains technical terms geared toward health care professionals, but tells basically how the drug works in the body, how it is absorbed and eliminated and what its effects at different concentrations are likely to be. It may also contain the results of various clinical trials.
- Indications and Uses.
This section lists the uses for which the drug has been approved by the FDA, and may list any ‘off-label’ uses as well. Off-label use is the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the FDA.
This section lists situations in which the drug should not be used, for instance, in those who have had allergic reactions to the same drug before, who may be taking other medications where interactions may be harmful or who have certain medical conditions that put them at greater risk of dangerous side effects.
This section discusses serious side effects that may be encountered by those taking the drug. If severe or life-threatening side effects have occurred in the past, a ‘Box Warning’ is included, and will be found on the first page of the insert, prominently displayed in capital letters and surrounded by a black box so it will not be overlooked.
This section tells how to use the drug safely and effectively. It may include guidelines regarding laboratory tests that should be performed before or during use, or activities such as driving that require extra caution while the drug is being taken. The most important part of this section deals with ‘Drug Interactions’, and tells the effects that this medication may have on other prescription or over-the-counter drugs, or that they may have on this one.
- Adverse Reactions.
This sections lists all side effects that were experienced by those who took the medication in clinical trials, and are grouped according to the part of the body affected. Although you shouldn’t be overly concerned with any rare or infrequent side effects, if you have an existing problem such as digestive issues, you may want to see how many people have encountered problems in that area. It is important to remember that you may experience few, or possibly none of the side effects mentioned.
This section defines what the results of a large overdose are likely to be, and what treatment should be administered. If you suspect you have taken an overdose, you should contact a poison control center or emergency personnel immediately.
- Dosage and Administration.
This section discusses the recommended dosages of the drug, usually recommending an initial dosage, and the timing of any increases necessary to reach an effective dosage without excessive side effects.
- How Supplied.
This section lists all available forms of the drug, such as tablets, capsules and liquids, and lists all available dosages. Each different form is described by color, shape and markings to be sure you have the correct one. Storage instructions are also included.
When you first receive your medicine from the pharmacy, review the package insert. If you have any questions about what you have read, make a list to discuss with your doctor, then file the insert where you can refer to it again if you need to. Do not substitute package instructions for those given by your doctor.