VALIDATION INSTITUTE

Claim Assertion for Validation

By providing a temperature shield to medications in-use which degrade when exposed to temperatures exceeding “room temperatures” or below freezing, for patients that spend time outdoors with their medication, the VIVI CAP device can provide significant savings. Some of the savings is almost in real time due to reduced medication wastage. Longer-term savings include, among other things, reduced patient anxiety. Anxiety over meds effectiveness and their disease management, which often results in doctor visits.

Methods

Validation included checking the consistency of the arithmetic and the reasonability of the assumptions, and ensuring that the links provided supported those assumptions.

Findings & Validation

Many drugs require refrigeration, and the potency/efficacy is diminished or negated if not properly refrigerated. In a worst-case scenario, significant harms can result from improperly stored drugs. Hence drugs whose chain-of-custody includes ongoing temperature monitoring have a substantial advantage. Notification if refrigeration has not been consistent means the drugs must be thrown out, to avoid the aforementioned risks or harms.

In addition to preventing harms, research has shown that confidence in refrigeration significantly reduces clinical interactions driven by user anxiety.

While we don’t validate the actual technology of the TempraMed solution, we do validate the economics and savings calculations.
The model accurately captures the correct arithmetic and is pre-populated with reasonable assumptions, which in turn may be changed. It also offers among the most user-friendly interfaces in the Validation Institute community of metrics-validated organizations.