Your pharmacist hands you information about medication your doctor prescribed for you. The complexity of the information depends on the level of printed material and your ability to understand medical language. You may also get a neatly folded copy of the drug’s prescribing information. This is printed on white paper in very small print. It requires a magnifying glass to read it, a medical dictionary to define the terms, and training to understand it.
This piece of paper is the prescribing information (PI). It is also called the package insert. The Food and Drug Administration (FDA) requires all manufacturers to supply this with their drugs. You don’t always get one with your prescription, but you can always locate it on the internet or request a copy from the drug’s manufacturer. You find the PI under “prescribing information” or “information for healthcare professionals.” Try to use the drug’s brand name rather than its generic name for your search. For instance, Lipitor® is the brand name for generic atorvastatin. It’s like Coca Cola® and Pepsi® are the brand names for cola.
Today’s blog offers tips on how to crack the code in the PI. It will tell you what to look for, what to avoid, what to fear, and what not to fear.
Most medications have information written specifically for patients. This is a good starting point as it will give you a broad overview of the most important information. After you read the basic information, you may want to read the entire PI.
Using Lipitor as an example, let’s take a PI tour. The first things you will read are the drug’s trade name, generic name and manufacturer. Sometimes, this is followed with a box with text bold type. This is called black box information. This has to be predominately displayed and carries a serious message. Lipitor doesn’t carry a black box warning.
Norco carries a black box warning. If you do nothing else, read and understand every word in the black box. If any of it applies to you, do not take that drug unless your health care provider has adequately explained why you may take it.
If there were recent changes to the drug, this is usually listed after the black box. It’s a good place to find anything new about a drug.
Next is a summary of the drug’s highlights. This information is explored in detail later in the PI, but it is a good place to begin reading. It includes:
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Warnings and Precautions
- Adverse reactions
- Drug interactions
- Use in specific populations (this isn’t always listed in the highlights)
The full prescribing information follows. Here are some key things to know:
The indications and usage section lists the medical conditions the drug treats. Sometimes physicians will use a medication to treat a medical condition that the drug wasn’t approved for. This is called off-label use and it is legal although insurance will not always cover the drug’s expense.
Read the information about the dosage to be sure you are taking the medication properly. Your doctor may prescribe a different dose for you than is listed, and if so, confirm that you are on the dose she intended for you.
The contraindications section is really important to know. In contraindications, all the patients who should not take the drug are discussed.
In the warnings section, you’ll find the situations in which patients can take the drug but need to be closely monitored. If the PI has a black box in the beginning, this information will be repeated in the warnings section along with additional cautions. Again, if you think information in this section applies to you, talk to your health care provider before you start taking the drug.
Precautions come next. This is important because it gives more information about the safety of the drug. Advice to patients is in this section, such as if you need to drink lots of water or take medication with food. If your doctor needs to monitor your safety with periodic lab tests, this will be listed here.
Try to read the adverse reactions section. When you want to know the drug’s side effects, go to this section. The adverse reactions section may scare you but its bark is usually worse than its bite. This is where everything that is known to have happened is listed and informs patients about the drug’s risks. Look for the most common adverse reactions.
Keep an open mind and don’t be thrown by adverse reactions. If a research patient was irritable for one day that counts as an adverse event. Even if nearly everyone reported an adverse reaction does not mean that those reactions were constant or intolerable.
The drug interactions section is next, and is important to read. Listed here are the drugs that are known to interact with the drug you are considering. If you are taking a drug that is on the list, tell your provider.
The specific populations section is next. This addresses pregnancy, nursing mothers, pediatric use (infants and children), geriatric use (older adults) and if the drug works differently between genders. People with kidney or liver disease may find information here.
The rest of the PI supplies information about overdose and clinical information. You will also find clinical study information here. This is the data that proves why the drug works. You can also ask your medical provider to summarize the parts that apply to you.
Taking a new medication can be both frightening and exciting. Fear can be reduced when sound judgment is applied to solid information. It takes practice, but if you read the PI every time you are prescribed a medication, you will be a pro in no time.