Method and system for point-of-dispensing management of anticoagulation agent therapy

• US 20090265182A1
• Filed: 04/22/2008
• Published: 10/22/2009
• Est. Priority Date: 04/22/2008
• Status: Abandoned Application

• Current Assignee: Allen M. Day, Brent W. Peterson, Charles E. Nunn
• Original Assignee: Allen M. Day, Brent W. Peterson, Charles E. Nunn
• Inventors: Day, Allen M., Peterson, Brent W., Nunn, Charles E.
• Application Number:
  US12/081,794
• Publication Number:
  US 20090265182A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets

Abstract

A method and system for point-of-dispensing, point-of-sale, or retail pharmacy management of an anticoagulation agent therapy for a subject, includes reviewing an anticoagulation regimen and obtaining data for a subject relating to anticoagulation therapy, determining an International Normalized Ratio (INR) level for the subject, determining any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents that the subject intends to take or is taking, evaluating in real time any need to adjust the anticoagulation regimen, and adjusting in real time, if needed, the anticoagulation regimen based on one or both INR level and any interaction determinations, to maintain the subject'"'"'s INR level within a desired range.

Claims

1. A method for point-of-dispensing management of an anticoagulation agent therapy for a subject, comprising the steps of:

a) reviewing an anticoagulation regimen and obtaining data for a subject relating to anticoagulation therapy;

b) determining an International Normalized Ratio (INR) level for the subject;

c) determining any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents that the subject intends to take or is taking;

d) evaluating in real time any need to adjust the anticoagulation regimen based on a determination made in one or both steps b) and c); and

e) adjusting in real time, if needed, the anticoagulation regimen to maintain the subject'"'"'s INR level within a desired range.

2. The method of claim 1, wherein:

the step a) of obtaining data comprises compiling a list of one or more non-anticoagulation agents that the subject intends to take or is taking.

3. The method of claim 2, wherein:

the step a) of obtaining data further comprises assessing one or more of the following;

i) sign or symptom of hemorrhage, bleeding, and/or bruising;

ii) sign or symptom of thromboembolism;

iii) change in a condition requiring anticoagulation therapy;

iv) alteration in diet, medication, and/or alcohol intake;

v) recent alteration in a medical condition or illness;

vi) any complication relating to the anticoagulation agent; and

vii) compliance with anticoagulation therapy.

4. The method of claim 2, wherein:

the non-anticoagulation agent comprises at least one member selected from the group consisting of prescription medication, over-the-counter (OTC) medication, dietary supplement, herbal medication, herbal supplement, vitamin, mineral, food item, and a combination thereof.

5. The method of claim 1, further comprising the step of:

f) obtaining from, or on behalf of, the subject an assent to acquire any and all one or more non-anticoagulation agents that the subject intends to take or is taking.

6. The method of claim 4, wherein:

the step b) of determining an INR level comprises conducting a blood test to determine whether the INR level is sub-therapeutic, therapeutic, or supra-therapeutic.

7. The method of claim 6, wherein:

the step e) of adjusting the anticoagulation regimen comprises providing a supplemental anticoagulation agent, if the INR level is sub-therapeutic.

8. The method of claim 6, wherein:

the step e) of adjusting the anticoagulation regimen comprises reversing anticoagulation therapy, if the INR level is supra-therapeutic.

9. The method of claim 1, wherein:

at least one of steps d) and e) is performed by or at the direction of a person or entity other than the prescribing health care practitioner.

10. The method of claim 9, wherein:

the person or entity is a pharmacist or pharmacy.

11. The method of claim 10, wherein:

the step e) is performed by or at the direction of the pharmacist.

12. In a point-of-sale establishment, a method of managing an anticoagulation agent therapy for a subject, comprising the steps of:

a) reviewing an anticoagulation regimen prescribed by a health care practitioner for a subject;

b) enrolling the subject into an anticoagulation therapy program, the program including dispensing of an anticoagulation agent, as well as one or more non-anticoagulation agents that the subject intends to take or is taking;

c) assessing any sign or symptom of anticoagulation therapy-related complication in the subject;

d) determining any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents;

e) evaluating in real time any need to adjust the anticoagulation regimen prescribed by the health care practitioner based on a determination made in one or both steps c) and d); and

f) adjusting in real time, if needed, the anticoagulation regimen to maintain the subject'"'"'s International Normalized Ratio (INR) level within a desired range.

13. The method of claim 12, further comprising the step of:

g) obtaining from, or on behalf of, the subject an assent to acquire any and all one or more non-anticoagulation agents that the subject intends to take or is taking.

14. The method of claim 12, further comprising the step of:

g) conducting, prior to step e), a blood test to determine whether the INR level for the subject is sub-therapeutic, therapeutic, or supra-therapeutic.

15. The method of claim 14, wherein:

the step f) of adjusting the anticoagulation regimen comprises providing a supplemental anticoagulation agent, if the INR level is sub-therapeutic.

16. The method of claim 14, wherein:

the step f) of adjusting the anticoagulation regimen comprises reversing anticoagulation therapy, if the INR level is supra-therapeutic.

17. The method of claim 12, wherein:

the step c) of assessing any sign or symptom comprises assessing one or more of the following;

i) sign or symptom of hemorrhage, bleeding, and/or bruising;

ii) sign or symptom of thromboembolism;

iii) change in a condition requiring anticoagulation therapy;

iv) alteration in diet, medication, and/or alcohol intake;

v) recent alteration in a medical condition or illness;

vi) any complication relating to the anticoagulation agent; and

vii) compliance with anticoagulation therapy.

18. The method of claim 13, wherein:

the non-anticoagulation agent comprises at least one member selected from the group consisting of prescription medication, over-the-counter (OTC) medication, dietary supplement, herbal medication, herbal supplement, vitamin, mineral, food item, and a combination thereof.

19. The method of claim 12, wherein:

the step f) of adjusting the anticoagulation regimen is carried out at the discretion of the point-of-sale establishment.

20. The method of claim 12, wherein:

the point-of-sale establishment comprises a retail pharmacy.

21. A retail pharmacist-managed, anticoagulation agent therapy method for a subject, the method comprising the steps of:

a) reviewing an anticoagulation regimen prescribed by a health care practitioner for a subject;

b) enrolling the subject into an anticoagulation therapy program, the program including dispensing of an anticoagulation agent, as well as one or more non-anticoagulation agents that the subject intends to take or is taking while in the program;

c) conducting a test to determine whether an International Normalized Ratio (INR) level for the subject is sub-therapeutic, therapeutic, or supra-therapeutic;

d) assessing any sign or symptom of anticoagulation therapy-related complication in the subject;

e) determining any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents;

f) evaluating in real time any need to adjust the anticoagulation regimen prescribed by the health care practitioner based on a determination made in one or more steps c), d) and e); and

g) adjusting in real time, if needed, at the discretion of the pharmacist, the anticoagulation regimen to maintain the subject'"'"'s INR level within a desired range.

22. The method of claim 21, further comprising the step of:

h) obtaining from, or on behalf of, the subject an assent to acquire any and all one or more non-anticoagulation agents that the subject intends to take or is taking.

23. The method of claim 22, wherein:

the anticoagulation agent comprises at least one member selected from the group consisting of warfarin, Factor Xa inhibitor, antiplatelet drug, Aspirin®

, and a combination thereof.

24. The method of claim 23, wherein:

the step g) of adjusting the anticoagulation regimen comprises providing a supplemental anticoagulation agent, if the INR level is sub-therapeutic.

25. The method of claim 24, wherein:

the supplemental agent comprises at least one member selected from the group consisting of heparin, low molecular weight heparin, and a combination thereof.

26. The method of claim 25, wherein:

the low molecular weight heparin comprises at least one member selected from the group consisting of enoxaparin, dalteparin, fondaparinux, and a combination thereof.

27. The method of claim 23, wherein:

the step g) of adjusting the anticoagulation regimen comprises reversing anticoagulation therapy, if the INR level is supra-therapeutic.

28. The method of claim 27, wherein:

reversing of anticoagulation therapy is achieved by administering one or more suitable doses of Vitamin K, or holding one or more anticoagulation agent doses.

29. The method of claim 21, wherein:

the step d) of assessing anticoagulation therapy-related complication comprises determining any complication relating to the anticoagulation agent.

30. A method for point-of-dispensing management of an anticoagulation agent therapy for a subject, the subject having already been enrolled in a therapy program, the method comprising the steps of:

a) determining an International Normalized Ratio (INR) level for the subject;

b) determining any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents that the subject intends to take or is taking;

c) evaluating in real time any need to adjust the anticoagulation therapy based on a determination made in one or both steps a) and b); and

d) adjusting in real time, if needed, the anticoagulation therapy to maintain the subject'"'"'s INR level within a desired range.

31. The method of claim 30, wherein:

the point-of-dispensing comprises a retail pharmacy.

32. In a point-of-sale establishment, a method of managing an anticoagulation agent therapy for a subject, the subject having already been enrolled in a therapy program, the method comprising the steps of:

a) assessing any sign or symptom of anticoagulation therapy-related complication in the subject;

b) determining in real time any potential interaction of the anticoagulation agent with one or more non-anticoagulation agents that the subject intends to take or is taking;

c) evaluating in real time any need to adjust the anticoagulation therapy based on a determination made in one or both steps a) and b); and

d) adjusting in real time, if needed, the anticoagulation therapy to maintain the subject'"'"'s International Normalized Ratio (INR) level within a desired range.

33. The method of claim 32, wherein:

the step a) of assessing anticoagulation therapy-related complication comprises determining any complication relating to the anticoagulation agent.

34. The method of claim 32, wherein:

the point-of-sale establishment comprises a retail pharmacy.

35. The method of claim 32, wherein:

the step d) of adjusting the anticoagulation therapy is carried out at the discretion of the point-of-sale establishment.