Device and system for remote regulation and monitoring of drug delivery and method of same

Abstract

Aspects and embodiments of the present invention generally include a device for patient self-administration of a prescribed medication. The total quantity of doses to be contained in the device, the quantity of prescribed medication comprising each individual dose, and the dosing schedule, collectively referred to as prescription parameters, are determined and controlled solely by a health care provider (HCP) such as the patient's physician. In accordance with a prescribed dosing schedule, the device makes available for administration the precise quantity of prescribed medication constituting an individual dose. Patient access to the medication as well as patient control of the device is limited solely to the aspects of the device necessary to administer the available dose; that is, the patient has no control over the prescription parameters utilized by the device; that is, the quantity of a dose, the availability of individual doses, the schedule at which the doses are made available to the patient, nor the prescribed medication itself which is contained in the device. Preferably, the device also has a monitored subassembly which detects and transmits relevant device information to a remote management system accessible to the HCP, including detected attempts to alter, access, control or otherwise tamper with the device beyond its prescribed use. Advantageously, HCPs may render sufficient oversight and control over the device and its use to mitigate the risks associated with patients self-administering potentially dangerous or abusable medication without direct, in-person supervision.