By Ron Conte, Pharm.D.
Drug information can be found just about anywhere. Up to date data can be extracted from the internet—PubMed, Medscape, and others; from your pharmacist; your physician or other healthcare providers; your health insurance hot line and related publications; as well as from magazines and journals; and your local poison control center. Not so up-to-date information can be read in books at libraries and the Physician Desk Reference (PDR). The PDR slants information based on the drug manufacturer’s claims, supported on some basis by clinical studies, but still biased.
There are other ways to find out information about a medication: 1) Drug Package Insert, 2) Patient Package Insert, 3) Medication Guide, and 4) Instructions for Use. These forms of drug information are constructed by the drug manufacturer and are approved by the FDA. Each publication has a specific objective for informing either a healthcare provider or the general public about medications. Let’s briefly review each of these publications.
The Drug Package Insert (DPI) contains detailed information about a specific drug for healthcare providers. Each time a drug is delivered to a pharmacy, or to any other healthcare provider who has a license to dispense medication, the packaging for the drug contains a DPI. Table One outlines the elements and content contained within a DPI.
The Patient Package Insert (PPI) is designed and written in a style that the general public can understand. Oral birth control drugs, estrogen-containing products, specific antibiotics, and phenytoin (generic Dilantin) for seizures are required to have PPIs. Many of the elements contained in the DPI are also in the PPI, but concentration is on drug administration and adverse effects.
The Medication Guide (MG) is designed to alert the patient to the severe adverse effects of a drug and how to prevent them. Patient adherence to directions for the use of the med are also included in the MG.
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Instructions for Use (IFU)
This form contains information about complicated dosing regimens and how to properly take the drug
To find out specific information about Patient Package Inserts, Medication Guides, and Instructions for Use, please go to Drugs@FDA. If you suspect an unusual or debilitating side effect of a drug, please contact your healthcare provider.
In addition, you can go to MedWatch on the internet and list your side effect since several new drug side effects may be uncovered after the drug is made available to the public.
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For more information: [email protected]