Several years ago, I went to a funeral of a soon-to-retire police officer in Pittsburgh. At the time, he was looking forward to the upcoming college graduation of his youngest daughter. The death was attributed to an acute myocardial infarction. What was certainly a major contributory factor was the long-term lack of adherence to a prescribed statin for what was described as a “very high LDL cholesterol” level and a family history of coronary disease.

Research suggests low adherence drives total economic costs of $300 billion in the US health-system. Legacy medication adherence programs include pharmacy calls, text based messaging, disease management outreach and a variety of apps. But these interventions are based on data coming from refills, not day to day ingestion data. Take, for instance, a one-tablet, once-per-day therapy. A patient may pick up the prescription every month (100% MPR based adherence) and take it every day, but some days take it at 11 pm and the next morning at 9 am (which may lead to toxicity or a period of lack of effectiveness). Our reliance on the MPR is somewhat akin to monitoring diabetes using urine dipsticks instead of the currently available continuous glucose monitoring made available by technology.

I have spent much of my professional life attempting to understand and, in turn, change, adherence. Reasons for failing to adhere to a drug are as numerous as the stars in the sky and include a variety of social reasons, problems with adverse events, unfulfilled expectations, lack of knowledge, trust in the physician, memory lapses… the list goes on and on.

One of the major issues in actually improving adherence is lack of data on when the adherence lapse actually takes place and a proximal “stimulus-response” mechanism to activate the patient to take the prescribed medication. This data could then be used to develop more effective outreach programs.

An innovative company, Compliance Meds Technologies, founded by Moses Zonana has come up with what I feel is a revolutionary solution. He calls his device the CleverCap.

CleverCap is a device but also a platform that combines patient adherence monitoring, reporting and visualization for people taking oral products in the outpatient setting. With CleverCap patients get reminders of when to take their medication while managed care (payers, IDNs and/or ACOs) monitor therapy adherence in real time. It consists of basically three components:

• Dispensing Device: Attaches to standard bottles and vials, alerts patients visually and audibility at time of dosing. Tamper detection and child safety features are incorporated. Audio and Visual components create redundancies that consider vulnerable populations like the blind and the deaf and forgetful.

• Notification Platform: Communicates to all stakeholders that an event has occurred… such as ‘dose taken’, ‘dose missed; ‘dose taken off-schedule’. Stakeholders can include providers, integrated delivery systems/networks, managed care, ACOS, caregivers, patients themselves and other support systems. These customizable notifications are communicated in real time via text, email and phone and are compliant with all regulatory guidelines.

• Reporting/Analytics: Offers providers, managed care, patients and caregivers an intuitive user interface to monitor behavior in a secure HIPPA compliant 21-CFR-Part-11-Validated way under a cloud-base system.

CleverCap PRO dispenses pills through a lockable sliding door that prevents accidental or intentional over/under dosing. With CleverCap PRO, patients get a control system for daily medication utilization while caregivers and health systems are equipped with feedback on medication behaviors in real time for more informed decision-making.

CleverCap aggregates a unique “compliance to regimen” score called the CleverScore. Unlike all other existing calculations for medication compliance such as MPR or PDR, the CleverScore bases its calculation on actual medication being taken and the pattern is measured on a daily basis. The CleverScore offers a new means for controlled, quantitative assessment of medication utilization in the outpatient setting.

Some use-case scenarios:

• Pain Medication Drugs.
• Oncology Drugs.
• Antidiabetic Drugs.
• Anticoagulant Drugs.

Beyond these examples, think about how a deep set of data could assist in the management of Parkinson’s, high cost therapies like Hepatitis C, MS, RA…

CleverCap has to-date observed 95%+ regimen adherence levels. Its system is easy to implement, operationalize and market ready (both in the US and abroad). When coupled with an adequate support infrastructure CleverCap can change outcomes, both financial and clinical.

I often think about that police officer and his wife, daughters and now grandchildren and how a device such as CleaverCap may have changed his future. That police officer was my younger brother, Dave… and he is missed.

Author: Thomas Morrow MD
Originally Published By: Managed Healthcare