GUEST POST from Arlen Meyers, M.D.

The Food and Drug Administration announced new rules for nutrition labels that can go on the front of food packages to indicate that they are “healthy.”

According to one source, a 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 it’s time to require package inserts for the prescriber and the patients.

Prescription digital therapeutics is also being added to the therapeutic armementarium and is raising several questions about safety, effectiveness, cost-effectiveness, ROI, reimbursement and regulatory requirements, including whether package inserts should be required, how they should be made available to patients, and what they should include.

What is in a package insert is described and required by the FDA and includes:

• Clinical pharmacology – tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various clinical trials (studies) and/or explanations of the medication’s effect on various populations (e.g. children, women, etc.).
• Indications and usage – uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called “off-label uses”).
• Contraindications – lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies
• Warnings – covers possible serious side effects that may occur
• Precautions – explains how to use the medication safely including physical impairments and drug interactions; for example “Do not drink alcohol while taking this medication” or “Do not take this medication if you are currently taking MAOI inhibitors“
• Adverse reactions – lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in “Warnings” section)
• Drug abuse and dependence – provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable)
• Overdosage – gives the results of an overdose and provides recommended action in such cases
• Dosage and administration – gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children)
• How supplied – explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (e.g., “Store between 68 and 78°F “)

Of course, there would need to be some modifications, like:

1. Safety and efficacy
2. Cybersecurity risks
3. Data security
4. Data , privacy, ownership and transfer rights
5. Side effects
6. Designation as a consumer product or a diagnostic or therapeutic device
7. Generic substitution possibilities
8. Adverse app reactions
9. App-app interactions
10. Compatibility with other drugs or devices

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.

Research shows that “Safety of apps is an emerging public health issue. The available evidence shows that apps pose clinical risks to consumers. Involvement of consumers, regulators, and healthcare professionals in development and testing can improve quality. Additionally, mandatory reporting of safety concerns is needed to improve outcomes.”

It is short-sighted, however, to let DTC medical apps slip under the regulatory radar. As described in a recent article for Nature, they could turn out to have costs which insurers or taxpayers might ultimately be responsible for.

But, the FDA is not the only agency with regulatory power. How about the Federal Trade Commission? Almost every promotion these days claims “AI-powered” What should be the truth in advertising standards to make that claim? Should there be something like a nutrition label ?

Medical student and resident education in clinical informatics, including artificial intelligence, is a good start. Here are some potential curricular and extracurricular learning opportunities for artificial intelligence in medicine.

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.

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