Drug Monitoring and Regulation Systems and Methods

• US 20140114676A1
• Filed: 10/21/2013
• Published: 04/24/2014
• Est. Priority Date: 10/23/2012
• Status: Abandoned Application

• Current Assignee: Theranos Incorporated
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth
• Application Number:
  US14/059,173
• Publication Number:
  US 20140114676A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

Systems and methods for monitoring and regulating the concentration of a drug in a subject are provided. A method may include administering to a subject a first dose of a pharmaceutical composition at a first time point. Next, a concentration of an active ingredient of the pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of the pharmaceutical composition in the subject, may be determined from a biological sample of the subject with the aid of a point of care system. A second dose of the pharmaceutical composition may be administered to the subject at a second time point. The second dose and/or the interval between the first and second time points may be determined based on the concentration of the pharmaceutical composition in the subject.

Claims

1. A method for administering a pharmaceutical composition to a subject, comprising:

(a) administering to a subject a first dose of a pharmaceutical composition at a first time point;

(b) obtaining a biological sample of said subject with the aid of a point of care system;

(c) measuring, with the aid of the point of care system and the use of said biological sample, concentration of an active ingredient of said pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition present in said subject;

(d) calculating, with the aid of a computer processor, dosage and/or time interval between dosages based on said concentration measured in step (c); and

(e) administering to said subject a second dose of said pharmaceutical composition at a second time point according to said calculated dosage and/or time interval of step (d).

2. The method of claim 1, wherein one or more of step (a), step (c), and step (e) is carried out with the aid of the point of care system and without the involvement of any human other than the subject.

5. A The method of claim 1, wherein said measuring step (c) comprises measuring at a measuring time point, and wherein said calculating step:

(d) comprises calculating, with the aid of a computer processor, dosage and/or time interval between dosages based on said concentration measured in step (c), thereby determining said second dose and/or the interval between said measuring time point and said second time point.

6. The method of claim 1, further comprising:

comparing said concentration to one or more set-point concentrations; and

calculating the second dose based on the difference between said concentration and the one or more set-point concentrations.

7. The method of claim 6, wherein comparing the concentration to one or more set-point concentrations comprises comparing the concentration to a subject-specific maximum drug concentration and a subject-specific minimum drug concentration.

8. The method of claim 6, wherein:

a) the one or more set-point concentrations are subject-specific set-point concentrations;

b) comparing the drug concentration to one or more set-point concentrations comprises comparing the drug concentration to an average set point concentration;

or comparing the concentration to one or more set-point concentrations comprises comparing the concentration to a subject-specific maximum drug concentration and a subject-specific minimum drug concentration, wherein the subject-specific maximum drug and subject-specific minimum drug concentrations are determined based on maximum concentrations and minimum concentrations of a plurality of subject-specific drug concentration profiles.

12. The method of claim 1, wherein step (c) comprises measuring the blood concentration of said active ingredient of said pharmaceutical composition or a metabolite thereof, wherein said blood concentration is measured in real-time, or at pre-determined intervals, or both.

14. The method of claim 12, wherein the point of care system is operatively coupled to the blood or tissue of the subject.

15. The method of claim 1, further comprising monitoring, with the aid of a computer processor, the progression of a health condition of said subject in response to administering said first dose and/or said second dose.

16. The method of claim 15, further comprising adjusting said first dose, said second dose and/or said interval based on said monitoring.

29. The method of claim 1, wherein said biological sample is blood.

3. (canceled)

4. (canceled)

9. (canceled)

10. (canceled)

11. (canceled)

13. (canceled)

17. A method for monitoring the concentration of a pharmaceutical composition in a subject, comprising:

(a) prescribing to a subject a first dose of a pharmaceutical composition at a first time;

(b) obtaining a biological sample of said subject with the aid of a point of care system;

(c) measuring, with the aid of the point of care system and the user of the said biological sample, concentration of an active ingredient of said pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition present in said subject; and

(d) calculating, with the aid of a computer processor, dosage and/or time interval between dosages based on said concentration measured in step (c); and

(e) prescribing to the subject a second dose of the pharmaceutical composition at a second time according to said calculated dosage and/or time interval of step (d).

18. The method of claim 17, further comprising:

comparing, with the aid of a processor, said measured concentration of step (c) to the one or more set-point concentrations; and

calculating the second dose based on the difference between said measured concentration and the one or more set-point concentrations.

19. The method of claim 18, wherein comparing said concentration to the one or more set-point concentrations comprises:

a) comparing said concentration to said subject-specific maximum concentration and a subject specific minimum concentration;

b) comparing the drug concentration to one or more set-point concentrations comprises comparing the drug concentration to an average set point concentration;

or

c) comparing the concentration to a subject-specific maximum drug concentration and a subject-specific minimum drug concentration, wherein said subject-specific maximum minimum drug concentrations are determined based on maximum concentrations and minimum concentrations of a plurality of subject-specific blood concentration profiles.

22. The method of claim 17, wherein said biological sample is blood.

23. The method of claim 18, wherein the one or more set-point concentrations are subject specific set-point concentrations.

24. The method of claim 17, wherein said concentration is measured in real-time, or is measured at predetermined intervals, or both.

26. The method of claim 17, wherein the point of care system is operatively coupled to the blood or tissue of the subject.

27. The method of claim 17, further comprising monitoring, with the aid of a computer processor, the progression of a health condition of said subject in response to prescribing said first dose and/or said second dose.

28. The method of claim 27, further comprising determining said first dose, said second dose and/or said predetermined interval based on said monitoring.

20. (canceled)

21. (canceled)

25. (canceled)

30. A system for monitoring a concentration of a drug in a subject, comprising:

a point of care module for monitoring, with the aid of a computer processor, a concentration of an active ingredient of a pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition in said subject;

a drug monitoring module in communication with the point of care module, the drug monitoring module for providing one or more set point concentrations of an active ingredient of a pharmaceutical composition or a metabolite thereof in the subject; and

a medical record module comprising records of doses in time, the medical record module for storing and providing a medical record of the subject.

31. The system of claim 30, wherein the drug monitoring module provides the one or more set point concentrations with the aid of i) a predetermined table, ii) a learning engine, or iii) both a predetermined table and a learning engine.

33. The system of claim 30, further comprising an output module for providing one or more instructions to the subject.

35. The system of claim 30, further comprising a server in communication with the point of care module and the medical records module.

36. The system of claim 35, wherein the server includes one or more of a learning engine, protocols and calibration protocols.

32. (canceled)

34. (canceled)

37. A method for recommending a dose of a pharmaceutical composition to a subject, comprising:

administering to the subject at a first point in time a dose of the pharmaceutical composition;

using a point of care system to determine concentration data for an active ingredient of said pharmaceutical composition, a metabolite of an active ingredient of said pharmaceutical composition, or a biological marker indicative of the concentration of said pharmaceutical composition in said subject;

comparing, by a computing device, a) the concentration data and b) at least one set point value, wherein the set point value is stored in computer memory, retrieved from a data structure, or calculated by the computing device;

in response to comparing the concentration data and the at least one set point value, directing the computing device to determine if at least one change in a dosing regimen for the pharmaceutical composition is desired in order to have the concentration of said pharmaceutical composition be in a desired range, said computing device utilizing a predictive model based at least in part on pharmacokinetic data of the pharmaceutical composition; and

generating a recommendation for at least a next dose of said pharmaceutical composition,

wherein the recommendation sets forth at least one of;

a) an amount of the next dose or b) a time for applying the next dose.

38. The method of claim 37, further comprising directing a processor to modify a patient history data structure to store concentration data related to the pharmaceutical composition administered at the first point in time, wherein the patient history data structure is configured to store longitudinal data regarding concentration from other points in time.