Prescribing Information – PI
Prescribing Information – PI, known also as a Package Insert or Product Labeling, is an obligatory medicine description for prescription drugs in USA. For OTC drugs see: Drug facts label.
It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug.
The prescribing information includes such details about the drug as:
- Its chemical description
- How it works
- How it interacts with other drugs, supplements, foods, and beverages
- What condition(s) or disease(s) it treats
- Who should not use the drug
- Serious side effects, even if they occur rarely
- Commonly occurring side effects, even if they are not serious
- Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations
Sometimes, manufacturers draft prescription drug information designed for patients that the FDA approves. These are often called “Patient Package Inserts,” “Patient Product Information,” or “PPIs.” When the information is for an especially risky or difficult to use drug, it is called a Medication Guide. Patients should be given this information when they fill their prescription. Patients may also get information that is produced independently of the FDA and the drug company.
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