With a recent, federal study showing nearly half of all Americans use at least one prescription drug in a month's time, it's more important than ever for consumers to get useful, easy-to-read information about their medications.
The Food and Drug Administration (FDA) says that doesn't always happen. According to consumer and professional groups and the FDA's Risk Communication Advisory Committee, patients often get information that’s incomplete or difficult to understand.
"FDA has determined that the current system is not adequate to ensure that patients receive the essential medication information that is needed to use the drug safely," FDA says in the meeting notice.
Now, that system is set to change. The agency is moving to develop and adopt a standard format to deliver consumers essential information about uses, possible side effects, drug interactions, and proper storage for every prescription medication they buy.
And FDA wants you to help.
Right now, consumers may get as many as three types of written information with prescription medications—a Consumer Medication Information sheet developed by the private sector and voluntarily given to patients; a Patient Package Insert, labeling that's developed by the drug maker or private vendor; and a Medication Guide, required labeling for some drugs that FDA believes pose a "serious and significant" public health concern.
FDA is proposing that medication information leaflets be streamlined into a single, FDA-approved Patient Medication Information sheet that would be given to the patient the first time a prescription is filled and for subsequent refills.
But before anything happens, FDA is asking consumers for feedback at a Sept. 27-28 hearing at FDA offices in Silver Spring, Md. Complete details about the hearing are posted athttp://www.fda.gov/Drugs/NewsEvents/ucm219716.htm. At the hearing, consumers and organizations will be able to weigh-in on more than a dozen questions related to prescription drug information for consumers, including
- Should the medication information be given to patients if the medicine has been administered in a health facility?
- How can the process be monitored to ensure patients are receiving the information?
- What accommodations are needed for special populations, such as the elderly, vision impaired, low literacy, and limited or non-English proficient?
- Should there be a process for monitoring distribution of the information?
- What functions should FDA and drug makers perform?
To learn more about FDA's effort to streamline prescription drug information, please see theFederal Register notice, which was posted Aug. 27.
Anyone interested in attending the hearing should see details posted athttp://www.fda.gov/Drugs/NewsEvents/ucm219716.htm
For those unable to attend, the meeting can be viewed on the Internet using Adobe Connect Pro from 8:30 a.m. to 4:30 p.m. Webcast participants will not be able to ask questions.
Join the meeting by using the following links:
https://collaboration.fda.gov/p15d109272010/ on September 27
https://collaboration.fda.gov/p15d209272010/ on September 28
If you have never attended an Adobe Connect Pro meeting before, test your connection at:https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
This article appears on FDA's Consumer Updates page which features the latest on all FDA-regulated products.
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