Education Campaigns

Engaging people in the fight against medication harm

Ask, Read, Report – an education campaign to create more informed consumers who talk about (and report) adverse drug reactions

“Ask, Read, Report” is a consumer safety campaign to help lower a person’s risk of experiencing a serious adverse drug reaction. The message of “Ask, Read, Report” encourages people to talk with their healthcare providers, to read critical drug safety information and to report their drug safety issues directly to the U.S. Food & Drug Administration (FDA). Learn more about these 3 actions that can help save lives & create a safer medicated America.

Ask

There are so many questions to ask your pharmacist, or your prescribing healthcare provider. Here are 4 key questions that you should know the answers to before taking any medication:

What is the name of the medication being prescribed? Ask for both the generic and brand names (and then make sure this is the same medication you’re picking up at the pharmacy to avoid a medication error).

Am I being prescribed an “off-label” drug? Off-label drugs have been approved by the FDA, but not to treat the condition or illness your provider is prescribing it for. Off-label prescribing is legal, but you should know about any off-label prescriptions written for you because there are no laws to require you are informed about these types of prescriptions and research data has shown off-labels could increase a person’s risk for safety issues.

Are there any black box warnings? These warnings (also called “boxed warnings”) are the most serious warnings that can be issued by the FDA. These are found on FDA-approved drug labels and the warnings often detail a potentially life-threatening safety risk. You may not be told about a black box warning on your medication. So, always ask.

Does this medicine come with an FDA-approved Medication Guide? See below for more on Medication Guides.

Read

Sometimes it may not be enough for you to just ask your healthcare provider questions. Here are some materials you can read, on a regular basis, for more information about any prescribed medication:

Package Inserts – Typically, you can find these in the drug manufacturer’s packaging. Inserts may be folded sheets inside of a medication’s box or packaging. If you can’t find it, ask your pharmacist.

Medication Guides – These are “patient friendly” FDA-approved handouts with very helpful information about your medication. However, Medication Guides are not available for every medication on the U.S. market. So, if your drug comes with one, it likely has certain serious risk factors or instructions for use that you should definitely know about. (Find out if your medication comes with a Medication Guide and, when possible, try to check the FDA’s website about a medication in advance of your prescription pick-up.)

Patient Information Sheet – This is a leaflet, or printed sheet, that is normally provided by your pharmacy and may be attached to your prescription bag. It may also be found inside your prescription bag. (Note: these are not FDA-approved materials and are developed by private companies. Therefore, we advise against relying solely on this material for important drug safety information, in the event critical FDA-issued safety information is missing.)

Container Label – These stickers are normally placed on your pill bottle. To avoid a potential medication error, always check to make sure the name of the medication is the same medication your provider said they were prescribing for you.

TIP: Visit our Resource page to access DailyMed for FDA-approved safety information about any medication.

Report

Sadly, most adverse drug reactions in America are never reported. It happens for numerous reasons but the effect is clear. Lack of reporting can delay critical regulatory action to address life-threatening drug safety issues. Without reports, it is very difficult for the FDA to identify new safety issues that need to be added to drug labeling and then shared with healthcare providers and consumers who need to know. Here are 3 ways you can help report to the FDA today:

Phone: Call the FDA directly toll-free at 1-800-332-1088. (Tip: If you regularly take certain medications for any chronic conditions, add this phone number to your contact list.)

Online: Find the FDA’s reporting website by Google searching for “FDA MedWatch” or by clicking here.

Mail or Fax: From the same website, access the Medwatch Form 3500B (if you are filing a consumer report or filing one on behalf of a consumer) by downloading the paper version of the reporting form.