The Adherence Measurement Institute is a Non-Profit organization that is passionate about the need of more precise patient drug dosing data. Currently, there are a significant number of companies that provide electronic technologies that can accurately record the date and time of a drug dosing events. These solutions provide the most accurate measure of how a patient takes their prescribed medicine in their home, away from the clinic. The measured data sets are exceptionally reliable and rich in data points allowing for a more comprehensive understanding of drug exposure and a deeper understanding of a patient’s actual dosing behavior.

The Adherence Measurement Institute endorses the use of the International Society of Patient Adherence’s EMERGE Guidelines and the adoption of the organization’s taxonomy that defines medication adherence as “the process by, which patients take their medications as prescribed.” the taxonomy divides Patient Adherence into 3 different but related phases:

• Initiation – (Late or Incomplete Initiation or Non-initiation)
• Implementation – (Late. Skipped. Extra. or Reduced Doses or Drug Holidays)
• Persistence – (Early Discontinuation)

Since the statistics that defines each phase are different. each phase has its own methodological challenges related to how medication use is operationally defined, measured, and analyzed. Our focus is on the measurement of dosing implementation. Much of the “folklore” of why regulatory agencies, drug developers, researchers and prescribers currently accept and operate with poor adherence data (and a subsequent overestimation of drug exposure) is that historically the healthcare value chain did not have access to precision measurement techniques. Healthcare is notoriously slow in adopting “new” tactics that change established methods – our goal is to shine a light on research methods and technologies that can precisely measure and analyze how a patient and when a patient takes their medicine.

The philosophy of the Institute is that multiple electronic adherence measurement technologies are needed within the healthcare value chain. We consult with individuals and teams to help them find the most appropriate solution for their specific study design or patient program. We often do this through a tradeoff analysis that focuses on:

• Program budget
• Data requirements
• Patient burden
• Operating logistics and workflows

Pharmaceutical Drug Development and R&D Teams

• We help Trial teams understand the cost/benefit tradeoffs of using various technologies and help handcraft a measurement solution specifically tailored to the clinical trial protocol
• We work with Clinical Packaging to provide a qualified list of smart packaging and measurement device solutions based on drug formulation and product format
• We work with Clinical Operations to understand how the introduction of a measurement solution will change executional logistics. We provide guidance on how to limit disruptions and drastic changes to existing workflows during clinical trial kit production, inventory management, and patient training and onboarding at clinical sites
• We help study teams design measurement programs that limit patient burden
• We design solutions that can link various measurement technologies to IT solutions that can analyze data to determine

Commercial Rx Brand Teams

• We help Pharma Brand and Specialty Pharma distribution teams understand the cost/benefit tradeoffs of using various technologies.
• We provide guidance on how to scale measurement programs across different Pharmacy IT solutions and tailor to existing pharmacy workflows.
• We create patient intervention pro grains using the patient’s own recorded drug dosing histories. We work with brand. medial and regulatory to design triage rules based on a drug’s PK profile to identify patient dosing behaviors that is determined to be sub-optimal.

Accountable Care Organizations (ACO)

• We help ACO’s design programs to measure patient adherence remotely for numerous different disease states and medication form factors. Data can provide insight to prescribers to better understand if patients are non-responders or not adherent.
• We provide guidance on how to seek reimbursement for providing remote patient management using the Centers for Medicare and Medicaid Services’ Medicare Fee Schedule for Chronic Care Management (CCM), Remote Physiologic Monitoring (RPM) and Principle Care Management (PCM).
• Using CPT® Codes: 99453. 99454, 99457, 99458 and 99091

Academic Researchers

• We provide advice on selecting the most appropriate measurement solution for your specific research design
• Once a measurement strategy is selected, we will work with our partner network to source a financial quote and other related information required for Research Grant submissions