Included with your prescription medicine you may find several different types of medical information, including a thin folded sheet of paper inside the package — the Prescribing Information or the Package Insert (PI for short). Have you ever unfolded that piece of paper and felt overwhelmed by the lines of small type? If you answered yes, you're not alone. It's written primarily for physicians, so it may use terms that are intended for a medically trained reader. However, you can think of the PI as a kind of "operating manual" for the medicine. It's important that you either read the PI yourself or ask your doctor to help you understand its most important information.
For many medicines, the PI does include a section written for you, the patient — so that is something to look for first! This part of the PI may be called a Medication Guide or Patient Summary of Information section. Typically, it is at the back of the PI. Other sections of the PI help guide your doctor in the use of the medicine.
Overall, the PI, including the parts that are specially written for patients, is filled with information provided by makers of the medicine and required and approved by the Food and Drug Administration (FDA), the U.S. government agency that regulates medicines. Pharmacies don't always include the PI when you pick up your prescription. If not, you can ask for it — but the best place to find it for brand-name medicines is on the product website or the website of the company that makes the medicine. These websites have the most up-to-date information available.
Here's some of the useful information in the PI:
Medication Guide or Patient Summary of Information Section — While not all PIs have this, if it is there (it's often at the end), it is the first place you should go, as this section is written especially for you, the patient. It covers the important information that the FDA and the makers of the medicine want you to know. This includes directions on the safe use of the medicine and information about possible side effects.
Patient Counseling Information — This is the part of the PI with the information that the makers of the medicine and the FDA suggest that your doctor discuss with you. While this is written in more technical language than sections written especially for patients, if the PI doesn't have a section written for patients, then this is an important section to read.
If you find that understanding the Package Insert is too difficult, or you have any questions, you can ask your doctor or pharmacist to explain the information. Also, many companies that make medicines provide online resources and free help lines where you can speak with medical information specialists. Pfizer, other pharmaceutical companies and the FDA are continuing to work together on ways to deliver information about medicines as clearly as possible. In the meantime, the PI can be valuable to all of us in our jobs as "Chief Medical Officers" for ourselves and our families.
My children are adults now, but when they were growing up, there wasn't a job more important to me than keeping them healthy, and helping them get well when they were sick. This included giving them their medications properly and reviewing the parts of the PI that are written for patients. So unfold that piece of paper, read away, and ask any question you need to. Your health, and the health of your family, is too important to settle for anything less.
After reading this article, how likely are you to speak with your doctor or pharmacist about understanding the Package Insert for your medication?