Can Drug Labeling Be Made User-Friendly? PDF Print E-mail

We read or hear them all the time. “Do not take this medication if you have a history of liver disease, use MAO inhibitors, have ever had an allergic reaction, are predisposed to low blood pressure, plan to become pregnant or need to operate heavy machinery.”

The average person cannot make heads or tails of these warnings. Labeling could be made clearer by dividing this information into two categories – “what everyone needs to know” and “information for special situations”.

Analysis
I have some experience with drug labeling and drug marketing. Let me say at the outset that the FDA takes this very seriously and does a very good job trying to make sure that prescribers and patients receive appropriate information about medications Even with the best of intentions, the challenge is that there is way too much information about a drug to be conveyed in any meaningful manner.
This is especially the case with warning information. The FDA wants to make sure that all relevant warning information is available. However, if you are presented with a long list, it is far too easy to quickly tune out. By dividing the warnings into 2 categories, users should be able to focus on relevant information.
Some warning information is critical for ALL patients using that medication. Examples include, not to lie down for 30 minutes after using certain medications; always take with meals; avoid sun exposure; and, do not take this medication if you plan to drive. This information is broadly applicable to everyone taking the medication and should be indicated as such.
By contrast, there is a large body of information that relates to use of medications in specific circumstances. These warning are important because failure to adhere to these warnings can be dangerous, even life threatening. Examples of this type of warning include, do not use this medication with MAO inhibitors; do not use this medication if you have a history of allergy to sulfa medications; and, do not use this medication if you have a history of liver disease. This information is critical to specific populations, but not necessarily broadly applicable. Unfortunately, sometimes patients fail to take appropriate medications because they are concerned about warnings that they do not understand and that do not even apply to them.
By dividing the warning information into 2 categories, the FDA and drug manufacturers can highlight which information applies to ALL patients and which information you only need to worry about if you fall into a special group. There are many challenges to making drug information more user friendly, but it would help if the labels at least were user-friendly enough to let you know which parts might apply to you.

Source from: GLG
 

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