Patient compliance and monitoring system

• US 20030036923A1
• Filed: 05/18/2001
• Published: 02/20/2003
• Est. Priority Date: 05/18/2001
• Status: Abandoned Application

• Current Assignee: Barr Laboratories Incorporated (Teva Pharmaceutical Industries Limited)
• Original Assignee: Barr Laboratories Incorporated (Teva Pharmaceutical Industries Limited)
• Inventors: Leonard, Thomas W., Waldon, R. Forrest
• Application Number:
  US09/861,005
• Publication Number:
  US 20030036923A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

This invention is directed to methods and systems for monitoring compliance with or effectiveness of hormone replacement therapy. The methods and systems of the invention provide an efficient means of communication between medical professionals and patients for between visit monitoring of patient compliance with a prescribed hormone therapy and the effectiveness of the treatment recommended.

Claims

1. A method for monitoring compliance with or effectiveness of hormone replacement therapy comprising:

(a) initiating a patient account with an automated, interactive information system comprising an information database;

(b) posing one or more queries comprising symptoms of menopause during hormone replacement therapy, side effects of hormone replacement therapy, or compliance in patient administration of hormone replacement therapy, said queries to be answered by the patient on a regular basis;

(c) inputting responses to the queries into the information database;

(d) compiling the responses to the queries in the information database;

(e) automatically converting the responses into digital data using the information system;

(f) automatically analyzing the digital data to generate a hormone replacement patient acceptability score for hormone replacement therapy;

(g) automatically generating patient information and medical professional information using the information system;

(h) automatically providing the patient information to the patient; and

(i) automatically providing the medical professional information to a medical professional.

2. The method of claim 1, wherein a visit to a medical professional is used to initiate a patient account with the information system.

3. The method of claim 1, comprising an additional step of activating the patient account with the information system by having a pharmacist fill a prescription for hormone replacement agents and the pharmacist sending a rebate to the information system.

4. The method of claim 1, wherein the queries are directed to one or more of vasomotor symptoms, osteoporosis markers, declining libido, sexual dysfunction, vaginal dryness, vaginal atrophy, reddening of the skin on the face, neck and chest, joint pain, urinary incontinence, skin dryness, dizziness, headache, weakness, mental anguish, depression, inability to concentrate, memory loss, insomnia, nervousness, irritability, abrupt mood swings, breakthrough bleeding, migraines, weight gain, breast tenderness, bloating, hypertension, nausea, vomiting, diarrhea, or leg cramps.

5. The method of claim 1, wherein the queries are directed to dosing compliance by the patient to a prescribed hormone replacement agent.

6. The method of claim 4, wherein the queries are directed to side effects to a prescribed hormone replacement agent experienced by the patient.

7. The method of claim 4, wherein the queries are directed to symptoms of menopause suffered by the patient.

8. The method of claim 1, wherein the patient information is selected from the group consisting of summaries, educational quarterly newsletters, educational monthly newsletters, educational materials relating to a specific a area of concern, a notification to consult medical professionals, a notification that the symptoms or side effects are abnormal, and a notification to discontinue medication.

9. The method of claim 1, wherein the medical professional information is selected from the group consisting of monthly summaries of patient side effects, symptoms, and dosing compliance;

weekly summaries of patient side effects, symptoms, and dosing compliance;

a notification that the patient is suffering from a particular side effect;

a notification that the patient is suffering from a particular symptom; and

a notification to contact the patient to schedule an appointment.

10. The method of claim 1 further comprising as steps:

automatically analyzing the digital data to generate pharmacist information; and

automatically providing the pharmacist information to the pharmacist.

11. The method of claim 1 wherein both compliance with and effectiveness of hormone replacement therapy is monitored.

12. The method of claim 1, further comprising screening the analyzed data against one or more predetermined treatment paradigms.

13. The method of claim 12, further comprising performing a statistical analysis on the analyzed data and modifying the predetermined treatment paradigms based on the statistical analysis.

14. A method for monitoring compliance with or effectiveness of hormone replacement therapy comprising:

(a) initiating a patient account with an automated, interactive information system comprising an information database;

(b) providing a patient code to allow patient access to the system;

(c) establishing patient access to the system;

(d) posing one or more queries comprising symptoms of menopause during hormone replacement therapy, side effects of hormone replacement therapy, or compliance in patient administration of hormone replacement therapy, said queries to be answered by the patient on a regular basis;

(e) inputting responses to the queries into the information database;

(f) compiling the responses to the queries in the information database;

(g) automatically converting the responses into digital data using the information system;

(h) automatically analyzing the digital data to generate patient information and medical professional information using the information system;

(i) automatically providing the patient information to the patient; and

(j) automatically providing the medical professional information to the medical professional.

15. The method of claim 14, wherein the information system is further comprised of a primary computer on which the information system is maintained and one or more remote terminals or computers interactively integrated with the information system.

16. The method of claim 14, further comprising a step of issuing a pharmacist rebate payable to the pharmacist who fills a prescription of hormone replacement agents for the patient.

17. The method of claim 14, wherein the patient access to the system is established by a pharmacist who fills a prescription for hormone replacement agents.

18. The method of claim 14, further comprising screening the analyzed data against one or more predetermined treatment paradigms.

19. The method of claim 14, wherein the queries are directed to one or more of vasomotor symptoms, osteoporosis markers, declining libido, sexual dysfunction, vaginal dryness, vaginal atrophy, reddening of the skin on the face, neck and chest, joint pain, urinary incontinence, skin dryness, dizziness, headache, weakness, mental anguish, depression, inability to concentrate, memory loss, insomnia, nervousness, irritability, abrupt mood swings, breakthrough bleeding, migraines, weight gain, breast tenderness, bloating, hypertension, nausea, vomiting, diarrhea, or leg cramps.

20. A method for monitoring compliance with or effectiveness of hormone replacement therapy comprising:

(a) initiating a patient account with an automated, interactive information system comprising an information database;

(b) posing one or more queries to be answered by the patient on a regular basis;

(c) inputting responses to the queries into the information database;

(d) compiling the responses to the queries in the information database;

(e) automatically converting the responses into digital data using the information system;

(f) automatically analyzing the digital data to generate a hormone replacement therapy patient acceptability score;

(g) automatically generating patient information and medical professional information using the information system;

(h) automatically providing the patient information to the patient; and

(i) automatically providing the medical professional information to a medical professional.

21. The method of claim 20, wherein the queries are directed to dosing compliance by the patient to a prescribed hormone replacement agent;

side effects to a prescribed hormone replacement agent experienced by the patient;

or symptoms of menopause suffered by the patient.

22. The method of claim 20, wherein the hormone replacement therapy patient acceptability score is used to permit relative assessment of one patient'"'"'s symptoms, side effects of hormone replacement therapy and compliance with therapy against hormone replacement patient acceptability scores of other patients as collected by the information system or provided by known treatment paradigms.

23. An automated, interactive system for monitoring compliance with or effectiveness of hormone replacement therapy comprising:

(a) a means for posing one or more queries relevant to hormone replacement therapy to a patient;

(b) a means for inputting responses to the queries into an information database;

(c) a means for storing the responses;

(d) a means for manipulating the responses to obtain an assessment of the patient relevant to hormone replacement therapy; and

(e) a means for providing information based on the assessment to medical professionals and to the patient.

24. An automated, interactive system for monitoring compliance with or the effectiveness of hormone replacement therapy comprising:

(a) a primary computer system;

(b) an information database stored on the primary computer;

(c) an input device for receiving and transferring information from a patient to the information database;

(d) a computer program for manipulating the information to generate an assessment of the information resulting in a hormone replacement patient acceptability score; and

(e) an output device for providing information based on the assessment to a patient and a medical professional monitoring the patient'"'"'s care.

25. The automated, interactive information system of claim 24, further comprising one or more remote terminals or computers interactively integrated with the primary computer and the information database stored on the primary computer.

26. The automated, interactive information system of claim 24, wherein the information from the patient is obtained from responses provided by the patient to queries posed by the information system.

27. The automated, interactive information system of claim 24, wherein the input device is a computer.

28. The automated, interactive information system of claim 24, wherein the output device is a printer.