Make sure you get the correct prescription drug information from your pharmacist


Every time you fill your prescription at the pharmacy you should receive written information about the medication you are taking. This information is called Consumer Medication Information (CMI) and is written by drug information companies and provided by the pharmacies that use their services. Pharmacies sometimes modify this information to make it shorter and easier to read. The Food and Drug Administration (FDA) does not currently approve or review CMI. Pharmacies typically provide CMI with every prescription that they fill.

There are however, some medications that have mandatory paperwork that must be given to the consumer. If the FDA determines that a particular drug or drug class is associated with certain risks, a Medication Guide for that drug is required. Medication guides are paper handouts that are developed by the manufacturer and approved by the FDA. These higher risk medications that are required to have a medication guide must be accompanied by the guide every time the drug is dispensed to the patient. The FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:

  • certain information is necessary to prevent serious adverse effect

  • patient decision-making should be informed by information about a known serious side effect with a product, or

  •  patient adherence to directions for the use of a product are essential to its effectiveness.

Unfortunately, these important medication guides do not always get distributed and even when they do, may be missed or accidentally discarded by the patient.

It is important to be aware if one of the drugs you are taking has a medication guide because the FDA has determined that the drug is linked to a particular risk. In addition, some medications that have medication guides also have an even higher level of risk associated with them. These drugs require special warnings to alert the consumer that very serious or life threatening risks have been associated with that drug. The warnings are outlined in a black box on the medication guide and are appropriately titled a “box warning.”

The information contained in the guides is intended to help patients avoid the adverse events and risks associated with the drug. The FDA has recently updated its medication guide list. Click here to link to the page. All links in the table go to documents in PDF format.

Created on December 3, 2010

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