Why It Matters
There’s plenty of anecdotal evidence for positive patient outcomes, but not enough of the validated, standardized data FDA wants to see. The OutcomeMD platform will help change that, allowing APC to aggregate patient-reported outcome data while providing compounding pharmacy owners granular data on how their formulations are working for patients.
“The OutcomeMD platform is something long-needed in compounding: A means of collecting and aggregating patient outcomes data in a way that’s not just useful to the pharmacy but useful to the profession,” said APC’s CEO Scott Brunner, CAE.
Via a smartphone app, patients respond to questions about how their specific therapies are working. Owners in turn get data about those formulations using the same validated measures used in clinical trials (and that FDA uses in its database). And, with the owners’ permission, APC gets access to the aggregated metadata — scrubbed of HIPAA-protected details, of course — to share with FDA and demonstrate how patients benefit from compounded therapies.