Overview of the Med-ic® Electronic Compliance Monitor (ECM©)
Patient non-compliance with prescribed medications costs the US health care system an estimated $300Bn per year and is responsible for over 100,000 deaths and 1,000,000 hospitalizations. Measuring patient compliance has long been the goal of researchers and clinicians. Information Mediary Corporation (IMC) has achieved this goal with the revolutionary Med-ic ECM.
Med-ic integrates seamlessly into standard industry blister package configurations and production runs, leaving its electronics hidden in a stock-appearing package. The patient does not have to do anything but take the medication in the usual way and Med-ic records the times of dose removal. These data can then be downloaded with IMC’s proprietary RFID reader and stored for further analysis and/or displayed graphically. If desired, Med-ic can also be read with any NFC-enabled smart phone or tablet, a slightly less secure but field-friendly function.
Each Med-ic package has a unique ID number to facilitate track and trace throughout its life cycle. The ID also facilitates authentication and detects tampering. Med-ic can be customized to record temperature, humidity, and exposure to light, shock and radiation. Med-ic can also support auditory and visual reminders and printed patient diaries.
Med-ic is environmentally friendly, being powered by a nontoxic lithium watch battery.
Med-ic in Clinical Trials
Med-ic ECM is designed to increase the power of clinical trials by minimizing the biggest source and error variance – patient non-compliance with dosing protocols. Med-ic allows non-compliance to be identified and addressed – by remedial education, by screening, by identifying grossly aberrant outliers or by co-varying non-compliance out in the primary outcome analyses. ECM streamlines data acquisition via an easy-to-use contactless reader and encrypted software. Non-compliance data may identify biases in a clinical trial that might not show up in the usual statistical analyses. Med-ic also reduces clinical trial costs by eliminating the need for medication counting, medication diaries, and associated data entry. Most importantly, the Med-ic ECM can help avoid erroneous decisions to abandon or continue clinical trials.
Med-ic in Clinical Settings
The Med-ic ECM works in any clinical setting where blister packaged medication is used and where patient compliance is of interest to the clinician. The information available to the physician or pharmacist at follow up will facilitate rational assessment of the effectiveness of treatment and dictate further treatment strategies. For example, a poor clinical response in a non-compliant patient might discourage a physician from switching antibiotics unnecessarily.
Both chronic and as required (prn) medications are candidates for ECM. Medications with high toxicity or dependence liability can benefit from compliance monitoring. ECM is particularly useful in populations know to have trouble with compliance such as the elderly, patients with addictions, psychiatric patients and home care patients on complicated medication regimens. The return on investment with Med-ic increases with the cost of the drug, making ECM ideal for drugs used to treat orphan diseases and those requiring medication at long intervals.
Knowledge about a patient’s compliance allows the physician or pharmacist to target such patients with remedial education strategies.
Med-ic in Custom Applications
Med-ic can be customized for situations where it is desirable to monitor the environmental conditions in which packaged medication is stored or transported. The Med-ic ECM can be adapted to monitor medication that is temperature, vibration, shock, humidity, radiation or light sensitive. Visual and sound devices can be used to warn of medication expiry dates, time for next dose, or give instructions on what to do about a missed dose. It can also incorporate printed diaries to record the patients’ state at the time of dosing.
Med-ic ECM in Secure Applications
The Med-ic ECM is also useful in the prevention of counterfeiting by storing an encrypted unique identification in its memory module. This secure ID can be used to track grey-market activities or unauthorized sale. It can warn of expiration, facilitate recalls, and generally provide information of interest from marketing, safety and logistics points of view.