SILVER SPRING, Md. — GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.
GSK created a prototypical healthcare kiosk that channeled a patient through nine algorithms and assisted him or her in making an appropriate treatment decision for use of an OTC statin, in this case Mevacor — branded Cardiocare as part of the presentation.
And while GSK's prototype was housed in an actual kiosk, GSK VP wellness category, global regulatory and quality David Schifkovitz noted this kind of funneling program, where each screen poses a question and directs the consumer to the most-appropriate next screen depending upon the answer, easily can be translated to a smartphone app.
In the example of "Cardiocare," the questionnaire walked patients through a series of questions such as their gender, age, knowledge of cholesterol condition and contributing risk factors to their condition — is there a history of heart disease in their family? Based on the patient's answers, the end screen would either recommend use of the statin or explain why this statin may not be appropriate for self-selection.
Funneling patients toward the most appropriate self-selection conclusion isn't the only advantage to a program like this, Schifkovitz said. "There's the ability with this technology to incorporate education into the algorithm itself."
GSK's experience with developing a Mevacor-based question protocol was borne out of the company's partnership with Merck when that company last attempted to switch Mevacor in 2007. The absence of appropriate self-selection helped scuttle that switch application. Merck had improved self-selection scores in a consumer label-comprehension study from two years prior (2007 vs. 2005). To help consumers with self-selection, Merck made label revisions, including a highlighted age-exclusion graphic on the front of the package and a stronger warning against the use of Mevacor Daily in women who are pregnant or could become pregnant.
In the usage study based on consumers' knowledge of their LDL levels, 98% of consumers appropriately chose not to take the medicine, but only 16% of those who chose to take the medicine did so appropriately.