Unit dose compliance monitoring & reporting device & system

Abstract

A unit dose medication compliance monitoring and reporting apparatus and system that includes a dispenser shell formed with dose compartments. A retainer sheet affixed to the shell seals each compartment and partially bursts upon dispensing. A sensor network and monitoring and reporting circuitry records dispensing times and determines an average time interval, which can be reported with other data on an integral data display. The system can thereby monitor and report patient compliance with prescription regimens. Additional data can be recorded and displayed for augmented patient compliance assistance and analysis, which data can include customized informational messages, telephone and other patient support contact information, unit doses dispensed and remaining, reminder alarms, identification data, prescription regimens, among other data. In myriad variations and alternative preferred configurations, the devices and systems have demonstrated efficacy in minimalist to complex monitoring and reporting applications ranging from routine prescription monitoring to detailed clinical trial assessments.

Description

TECHNICAL FIELD [0001] This invention spans several technology areas but is most often viewed to be in the field of pharmaceutical prescription, and sometimes over-the-counter, medicament compliance monitoring and reporting. BACKGROUND OF THE INVENTION [0002] A substantial amount of the costs associated with the treatment and management of medical conditions are devoted to prescribing and procuring pharmaceutical medications for consumption by patients. Even though best of class physicians and pharmacists can mediate a wide variety of medical conditions with appropriate pharmacological prescription regimens, sans hospitalization and controlled environments, obtaining the cooperative compliance of the target patient remains a key challenge. [0003] Some experts seem to reason that de facto patient non-compliance with prescription regimens results in substantially increased burdens on medical professionals who must re-examine the patient, as well as unnecessarily increased pharmacologi...

AI Technical Summary

Benefits of technology

[0015] The retainer sheet is also preferably fabricated from any of a variety of materials that can enable dispensing of the unit dose by pressing the unit dose through the retainer sheet to thereby perforate or burst through the sheet. In many applications, it has been found to be effective to incorporate a score mark or partial scoring of an area of the retainer sheet that is about in the center of the container or compartment. Such scoring can reduce the pressure needed to dispense the unit dose as it is pressed through from the shell side of the assembled package. Thus, the perforation or bursting that is effected is more predictable in location and shape, and any pressure exerted on the unit dose to push it through the retainer sheet during dispensing is minimized.

[0026] While many possible energy sources are contemplated for use with the devices of the invention, one preferred energy source for use in the invention can be what is commonly referred to by those skilled in the art as button type batteries. The battery can be inserted into the configurations of the invention either permanently or in a replaceable adaptation and can also be replaced or used in conjunction with a photovoltaic cell or solar battery. While the power consumption of the various preferred embodiments of the invention is very low, it may be also more preferable in various alternative arrangements to incorporate a power switch or to include an insulating tab to preserve battery life until the monitoring and reporting device and apparatus is issued to a patient for use, which will maximize battery shelf life.

[0029] The preferred unit dose medication compliance monitoring and reporting devices and apparatus according to the principles of the invention may also further be directed to the retainer sheet being adapted with a one or more layers bound together or sandwiched against one another. The layers preferably include a sealing layer that is adapted to substantially prevent passage of liquids, gases, and solids to thereby protect the unit doses once the dispensing shell or blister pack is filled.

[0031] Even more preferably, any of the preceding preferred embodiments may also further include an insulative layer that can be incorporate between the metallic and conductor layers as may be needed for various operational configurations. In this latter alternative preferred arrangement, grounding bosses may be formed that establish electronic communication between, for illustrative example without limitation, the respective elements of the sensor network and the metallic layer, which can be used as a grounding conductor to eliminate the possible need for additional ground wires or traces or signal paths that may be required to complete the various circuits.

Problems solved by technology

A substantial amount of the costs associated with the treatment and management of medical conditions are devoted to prescribing and procuring pharmaceutical medications for consumption by patients.

Even though best of class physicians and pharmacists can mediate a wide variety of medical conditions with appropriate pharmacological prescription regimens, sans hospitalization and controlled environments, obtaining the cooperative compliance of the target patient remains a key challenge.

Some experts seem to reason that de facto patient non-compliance with prescription regimens results in substantially increased burdens on medical professionals who must re-examine the patient, as well as unnecessarily increased pharmacological costs due to unused or improperly used medicaments that must be re-prescribed.

Additionally, in the face of patient-asserted compliance, but apparent lack of clinical response due to de facto patient non-compliance with the originally prescribed regimen, such medicaments are most often replaced with alternative prescription regimens.

Many experts appear to agree that first-time patient compliance with prescription would unequivocally result in more effective amelioration of target medical conditions.

The latter circumstance is perhaps understandably undesirable when viewed from the paradigm of the developers, manufacturers, and distributors of pharmacological products.

No. 2004 / 0133305 A1, which is limited to a complex prescription drug compliance monitoring system that is restricted to use with wireless transmitters embedded into bottle-cap medicament containers.

While many attempts have been made, all such attempts are either expensive and cumbersome to implement and use, are limited in capability, or require doctor or pharmacist to patient interaction for purposes of monitoring or improving the prospects of patient compliance.

While in the past, the doctor-patient or pharmacist-patient relationships have been the primary sources of influence that could motivate a patient to comply with the indicated prescription regimen most likely to achieve the desired clinical result, in more recent times, this paradigm has been demonstrated time and again to have, less clinical effectiveness.

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