By federal law, Controlled Substances are strictly tracked and managed by federal agencies. However, tracking ends once the patient leaves the pharmacy with their medication. [ref]
The Divert-X system is designed to “close-the-loop” by monitoring the individual doses. Divert-X picks up where DEA scrutiny ends by adding an additional monitoring loop that begins and ends at the pharmacy. White papers are available to explain many aspects of the system.
We believe that several sets of information are needed to detect prescription misuse and trafficking - the time and location each dose is accessed, along with other measures.
Vatex is developing medication dispensers designed to be location aware and to wirelessly transmit data each time a dose is removed from the packaging.
How the Divert-X System Links Patient Behavior to Identify Abuse
Vatex believes that technological innovations can significantly reduce prescription misuse and trafficking.
To impact trafficking, several essential sets of data are required - the time each dose of medication is accessed, the location of access, and other measures:
- The location of medication access will be tracked to determine whether the medications are near appropriate locations.
- The time each dose is accessed will be tracked to determine whether the prescribed dosing schedule is being followed.
If too many doses are accessed too quickly or in unregistered locations, then non-compliant behavior is identified and red flagged. Other measures are included to calculate a medication-use risk score. This information will be accessible to the patient’s doctor and pharmacist and can be used to initiate intervention.
The flow of the integrated system and review process is illustrated below:
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Divert-X: a Solution to Reduce Drug Abuse and Trafficking
Divert-X represents an industry-wide solution that can be applied to all types of medications by creating packaging suitable for a variety of pills, tablets, capsules, patches and syringes. Divert-X is compatible with any dose, dosage form, and dosage manufacturing source that a pharmacy has in stock. This flexibility and breadth of applicability is key to reducing trafficking and misuse.
Trafficking of prescribed Controlled Substances has become a national criminal industry. Divert-X will evolve along with attempts to game it; the ease of evolution is very important to the Divert-X strategy, and Vatex is committed to maintaining the long-term credibility of its system. As a counter example, abuse-deterrent drug formulations are highly regulated and, hence, are evolved slowly if at all. As a result, these products lose their credibility when internet cooks share their recipes widely.
Divert-X Medication Packaging
- Divert-X medication dispensers will contain up to one months’ supply of each controlled medication and are assembled at a pharmacy with medications already stocked by the pharmacy.
- The Divert-X system is an alternate to the traditional bottle-and-sticker approach to filling a prescription. The addresses where the patient would normally take their medication are entered into the pharmacy by the pharmacist along with the prescribed dosing schedule. In many cases, all this information already resides in pharmacy and insurer databases. The Divert-X system does not contain address information.
- The dispensing units are integrated into a fully functional compliance network. Software, databases, and machine-to-machine communication protocols to capture the wireless data use the same security technologies employed in the banking industry. The Divert-X data system will not transmit or house personal information that can be used to identify or locate a patient.
- To maintain medical confidentiality during wireless transmittal, the Divert-X data system will not transmit or house personal information that can be used to identify or locate a patient.
- The Divert-X system wireless device uses location awareness technology. The wireless system transmits the time of dose access in real-time, along with concurrent transmission of approximate location and other measures. The data transmittal portion of the device remains in standby unless the printed circuitry is disrupted by dosing, enabling battery life to exceed one month.
- The Divert-X medication-use risk algorithm monitors each prescription in real time.
- The Divert-X system features software integrating secure data transmission with remote system servers. Proprietary medication-use risk algorithms link the data to an interpretation of patient behavior and are a key Vatex asset.
- The Divert-X medication-use risk scoring algorithm will be kept secret so that it can maintain its effectiveness. As an analogy, the debt-repayment risk scoring algorithms (credit scoring systems) commonly used by banking and finance industries are secret so that they are not gamed.
- The data, graphs and charts, and the medication-use risk score can be accessed via a web portal and reviewed by the patient’s doctor or pharmacist.
- Secure, web-based access will be available for review of the base and trending data. The medication-use risk score will be automatically available to the majority of users without the need to log into the web portal.
- If compliant behavior is found, refill requests are approved.
- If aberrant behavior is found, the insurer, physician, or pharmacist can refer the patient for counseling or law enforcement.
- The patient must return the Divert-X device to the pharmacy to be eligible for a good score.
- The unit is inspected for tampering. If no tampering is found, the prescription is refilled if clinically indicated.
- If the pharmacist finds the unit has been tampered with, the patient can be referred for intervention.
- Because the Divert-X device must be returned to a pharmacy – even for single prescriptions with no refills – the system is an important mechanism to rid households of unused medications.
- Each insurer will formulate inducements to ensure that the devices are returned for device recovery, score determination, and unused medication disposal.
- If unexpected behavior is found in any of the review stages, the patient is referred for intervention.
- Patients may be referred to the prescribing physician, a counselor, or law enforcement.
- Early intervention is key to preventing dependency, addiction, and drug trafficking.