System and method for early identification of safety concerns of new drugs

• US 20060241981A1
• Filed: 03/16/2006
• Published: 10/26/2006
• Est. Priority Date: 04/25/2005
• Status: Active Grant

• Current Assignee: Optuminsight, Inc. (UnitedHealth Group Incorporated)
• Original Assignee: Ingenix Incorporated (UnitedHealth Group Incorporated)
• Inventors: Walker, Alexander M.
• Granted Patent: US 7,917,374 B2
• Time in Patent Office: Days
• US Class Current: 705/4
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 40/08 Insurance
• 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 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

Method and system for identifying safety concerns regarding a new drug. In one example, a database of healthcare claims is utilized and the method may include identifying from the database a first group of patients that have received the drug; extracting one or more medical events that the first group of patients have experienced; identifying a second group of patients that have received a comparator drug; extracting one or more medical events that the second group of patients have experienced; and comparing the one or more medical events of the first group to the one or more medical events of the second group to determine one or more common occurrences therebetween. The method may also include computing a probability value for each of the one or more common occurrences. In this way, embodiments of the present invention may be used to identify and quantify the probability that certain medical events will occur to patients taking the new drug.

Claims

1. A method for identifying safety concerns regarding a drug, comprising:

from a database of healthcare claims, identifying a first group of patients that have received the drug;

from the database of healthcare claims, extracting one or more medical events that the first group of patients have experienced;

from the database of healthcare claims, identifying a second group of patients that have received a comparator drug;

from the database of healthcare claims, extracting one or more medical events that the second group of patients have experienced; and

comparing the one or more medical events of the first group to the one or more medical events of the second group to determine one or more common occurrences therebetween.

2. The method of claim 1, further comprising:

computing a probability value for each of the one or more common occurrences.

3. The method of claim 1, further comprising:

filtering the one or more common occurrences based on ages of the first and second group of patients.

4. The method of claim 1, further comprising:

filtering the one or more common occurrences based on genders of the first and second group of patients.

5. The method of claim 1, further comprising:

filtering the one or more common occurrences based on one or more diagnosis codes of the healthcare claims of the first and second group of patients.

6. The method of claim 1, further comprising:

filtering out pre-existing conditions from the one or more common occurrences of the healthcare claims of the first and second group of patients.

7. The method of claim 1, further comprising:

determining whether the drug has been prescribed in an amount exceeding a minimum threshold.

8. The method of claim 7, wherein the minimum threshold is 1,000 patients.

9. The method of claim 1, wherein the comparator drug has a similar pharmacological purpose as the drug.

10. The method of claim 1, wherein the comparator drug has been commercially available for a greater period of time than the drug.

11. A system, comprising:

a database of healthcare claims;

an engine for identifying safety concerns regarding a drug, the engine comprising;

a module for identifying from the database a first group of patients that have received the drug;

a module for extracting from the database one or more medical events that the first group of patients have experienced;

a module for identifying from the database a second group of patients that have received a comparator drug;

a module for extracting from the database one or more medical events that the second group of patients have experienced; and

a module for comparing the one or more medical events of the first group to the one or more medical events of the second group to determine one or more common occurrences therebetween.

12. The system of claim 11, wherein the engine computes a probability value for each 20 of the one or more common occurrences.

13. The system of claim 11, wherein the engine filters the one or more common occurrences based on ages of the first and second group of patients.

14. The system of claim 11, wherein the engine filters the one or more common occurrences based on genders of the first and second group of patients.

15. The system of claim 11, wherein the engine filters the one or more common occurrences based on one or more diagnosis codes of the healthcare claims of the first and second group of patients.

16. The system of claim 11, wherein the engine filters out pre-existing conditions from the one or more common occurrences of the healthcare claims of the first and second group of patients.

17. The system of claim 11, wherein the engine determines whether the drug has been prescribed in an amount exceeding a minimum threshold.

18. The system of claim 11, wherein the comparator drug has a similar pharmacological purpose as the drug.

19. The system of claim 11, wherein the comparator drug has been commercially available for a greater period of time than the drug.

20. A system for identifying safety concerns regarding a drug, comprising:

means for storing a plurality of healthcare claims;

means for identifying from the plurality of healthcare claims a first group of patients that have received the drug;

means for extracting from the plurality of healthcare claims one or more medical events that the first group of patients have experienced;

means for identifying from the plurality of healthcare claims a second group of patients that have received a comparator drug;

means for extracting from the plurality of healthcare claims one or more medical events that the second group of patients have experienced; and

means for comparing the one or more medical events of the first group to the one or more medical events of the second group to determine one or more common occurrences therebetween.