Comments (2)
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Gabe Reissman
We need to know what we are taking to heal our body.
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Ashley Whitehead
Definitely agree with you
Package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly.
In the US the document is called "prescribing information" or the "package insert" (PI) and layperson's document is called the patient package insert (PPI). In Europe the technical document is called the "summary of product characteristics" (SmPC) and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet".
Given the confusion about 1)which digital health product to prescribe for any given patient, 2) the fact that many products are actually consumer products designated to provide information and education, not diagnosis or treatment, and 3) most are not clinically validated or cost-effective, perhaps its time to require package inserts for the prescriber and the patients.
What is in a package insert is described and required by the FDA and includes:
Of course, there would need to be some modifications, like:
One thing that will not be in the insert will be what all this costs to you or someone else who has to pay for it.
At this point you are probably thinking, "We have enough regulations and we love our APPs. So what if they don't make us any better." Go shove your insert. Next you'll be telling us it has to have all that cotton in the bottle too.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs on Twitter@ArlenMD and Co-editor of Digital Health Entrepreneurship.
We need to know what we are taking to heal our body.
Definitely agree with you
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