PRESCRIPTION COMPLIANCE DEVICE AND METHOD OF USING DEVICE

• US 20080215289A1
• Filed: 12/14/2007
• Published: 09/04/2008
• Est. Priority Date: 06/22/2001
• Status: Active Grant

• Current Assignee: Bareholdtech LLC (IP Edge LLC)
• Original Assignee: Ronald D. Sekura
• Inventors: Sekura, Ronald D.
• Granted Patent: US 7,639,120 B2
• Time in Patent Office: Days
• US Class Current: 702/177
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/04 Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0454 for dispensing of multiple drugs
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A prescription compliance device which aids patients in complying with instructions given by a physician for taking prescription medication. The device reminds a patient when the next dose of medication is to be taken and indicates whether a specified dose has been taken. The device includes a microcontroller, a display, a program memory for storing pre-programmed medication-taking regimens for single and multiple medications, a real time clock, a selector for selecting one of the regimens and for programming the device as to the time and day on which a first dose of medication is to be taken, a display which alternately displays the current time and a time at which a next dose of medication is to be taken and an alarm which alerts the patient at times when a dose of medication is to be taken. The selector includes an event switch which is activated by the patient after taking a dose of medication so as to record the taking of medication and to cause the microcontroller to effect the display of the next time at which a dose of medication is to be taken. A memory may also be included to record the times at which a patient takes doses of medication. The device also includes a remote programming feature via a wireless link.

Claims

1. A method for monitoring patient compliance to medical therapy, comprising:

repeatedly measuring therapy compliance of a patient and storing such information on a device;

uploading the therapy compliance measurements stored on the device to a computing unit;

evaluating patient compliance based on the received therapy compliance measurements;

identifying instances where patient compliance fails to meet predetermined compliance requirements; and

sending a notification, about one or more instances, to a party based on patient compliance whereby action can be taken by that party.

2. The method according to claim 1, further comprising:

using a computer to conduct the evaluating.

3. The method according to claim 1, the sending comprising:

sending the notification over a network.

4. The method according to claim 1, further comprising:

scheduling and uploading therapy regimens into the device over a network.

5. The method according to claim 4, comprising:

scheduling and uploading therapy regimens into the device over a network from a health care provider or health care professional.

6. The method according to claim 5, wherein the therapy regimens include using medication with food within a time range of approximately 15 minutes before food intake to 60 minutes after food intake.

7. The method according to claim 6, wherein the therapy regimens include using medication without food within a time range of at least 30-60 minutes before food intake and 120-180 minutes after food intake.

8. The method according to claim 7, wherein the therapy regimens include a requirements that there be a minimum of 4 hours between first food intake of a day and second food intake of the day, that there be a minimum of 5 hours between second food intake of the day and third food intake of the day and the first, second and third food intakes must be completed within 14 hours.

9. The method according to claim 5, wherein the therapy regimens include monthly cycle, fixed cycle or As-need cycle type regimens.

10. The method according to claim 9, wherein the monthly cycle is based on a perpetual calendar and is calculated using a time of day for a “

take” and

a start and stop data in a month in which medication is to be used.

11. The method according to claim 9, wherein the fixed cycle is a regimen in which a duration of a cycle is set and is counted from a first day of the cycle.

12. The method according to claim 9, wherein the As-needed cycle requires that medication only be taken after a minimum interval has passed, the minimum interval until a next dose is calculated at a time of medication use.

13. The method according to claim 1, further comprising:

scheduling and uploading therapy regimens into the device locally at the device.

14. The method according to claim 4, wherein calculations needed for therapy regimens are performed locally at the device.

15. The method according to claim 4, wherein calculations needed for therapy regimens are executed prior to uploading the therapy regimens into the device.

16. The method according to claim 4, wherein the device is able to perform calculations needed for therapy regimens locally or receive therapy regimens which have been previously calculated.

17. The method according to claim 1, wherein the device includes a skip function enabling a user to decline therapy in response to a local device alert, the execution of the skip function resulting in a recordation in the device.

18. The method according to claim 1, wherein the device includes a take function enabling a user to accept therapy in response to a local device alert, the execution of the take function resulting in a recordation in the device.

19. The method according to claim 1, wherein the device generates a missed therapy event when no skip or take function is entered in response to a local device alert, the generation of the missed therapy event resulting in a recordation in the device.

20. The method according to claim 1, wherein a number of doses required for a trip is calculated by a trip algorithm within the device that requires entry of a start and stop date for the trip and on this basis a need for refill during the trip is calculated.

21. The method according to claim 4, wherein the device includes a time change means that adjusts the therapy regimens based on a time change.

22. The method according to claim 20, wherein the device includes an early takes means for dealing with early execution of a take function using information regarding the trip.

23. The method according to claim 1, wherein the device includes a cellular phone.

24. The method according to claim 1, wherein the device is a PDA.

25. The method according to claim 1, wherein the device includes a personal music player.

26. The method according to claim 1, wherein the device includes a personal music player and a cellular phone.

27. The method according to claim 1, wherein the device is configured to receive SMS, WIFI or wireless communications.

28. The method according to claim 1, wherein the device is a gaming device.

29. The method according to claim 1, wherein the device is a pager.

30. A prescription compliance device comprising:

microcontroller;

a program memory storing data representing a plurality of pre-programmed commonly prescribed medication-taking regimens;

a selector selecting one of said regimens and programming said device in accordance therewith; and

a display, said selector including an event switch which is activated in conjunction with a patient taking a dose of a medication corresponding to a respective medication-taking regimen to record the taking of said medication, said event switch causing said microcontroller to effect the display of the time at which a next dose of medication is scheduled to be taken, in accordance with the regimen selected by said selector,

wherein the microcontroller recalculates the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

31. A prescription compliance device comprising:

control means;

program memory means for storing data representing a plurality of pre-programmed commonly prescribed medication-taking regimens;

select means for selecting one of said regimens and programming said device in accordance therewith; and

display means, said select means including an event switch which is activated in conjunction with a patient taking a dose of a medication corresponding to a respective medication-taking regimen for recording the taking of said medication, said event switch causing said control means to effect the display of the time at which a next dose of medication is scheduled to be taken, in accordance with the regimen selected by said select means,

wherein the control means recalculates the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.

32. A method of operating a prescription compliance device, comprising the steps of:

(a) switching said device to a setup state;

(b) programming the current time into said device;

(c) selecting one of a plurality of pre-programmed commonly prescribed medication-taking regimens;

(d) programming a time of day a first dose of medication is to be taken in accordance with the selected regimen;

(e) switching said device from a setup state to an operation state;

(f) indicating to said device that a dose of medication has been taken; and

(g) recalculating the time the next dose is to be taken based on a last time the dose of medication was taken in conjunction with a time change of the prescription compliance device to ensure a medically acceptable minimum time interval is maintained between doses of the medication.