SYSTEM AND TECHNIQUES FOR REPORTING ADVERSE EFFECTS

• US 20090319299A1
• Filed: 06/20/2008
• Published: 12/24/2009
• Est. Priority Date: 06/20/2008
• Status: Abandoned Application

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Inventors: De Vries, Glen Michael, Cobert, Barton Lewis, Bergtraum, Jordan
• Application Number:
  US12/143,386
• Publication Number:
  US 20090319299A1
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies.

Claims

1. A computer-based method of collecting and reporting adverse events associated with a patient comprising:

providing a user interface capable of (i) prompting a user to identify information to be associated with a patient, said information including at least one of personal information, medical information, drug information, adverse event information, and (ii) associating said drug information and said medical information with said adverse event information in response to a request from said user; and

displaying iteratively a cumulative narrative on said user interface in response to said user identifying at least one of said personal information, medical information, drug information, adverse event information, and said association, said cumulative narrative describing said information in a standard format using a standardized nomenclature.

2. The method of claim 1, wherein said user is selected from at least one of a medical professional, a pharmacist and said patient.

3. The method of claim 1, further comprising transmitting said cumulative narrative to a regulatory body.

4. The method of claim 1, further comprising transmitting said cumulative narrative to a manufacturer or data collection organization.

5. The method of claim 1, wherein prompting said user to identify said information to be associated with said patient comprises guiding said user using a plurality of display panels included in said user interface.

6. The method of claim 1, wherein prompting said user to identify said information to be associated with said patient comprises providing a user-selectable list on said user interface, said user-selectable list including entries conforming to said standardized nomenclature.

7. The method of claim 1, wherein prompting said user for said personal information comprises providing a data entry area on said user interface for specifying a patient'"'"'s initials, a patient-gender identifier, and a patient date-of-birth.

8. The method of claim 1, wherein prompting said user for said medical information comprises providing a user-selectable list including entries of a case outcome on said user interface, said entries selected from the group consisting of ‘

congenital anomaly/birth defect’

, ‘

death’

, ‘

disabilities or permanent damage’

, ‘

hospitalization (initial or prolonged)’

, ‘

life-threatening’

, ‘

other serious/important medical event’ and

combinations thereof.

9. The method of claim 1, wherein prompting said user for said medical information comprises providing a user-selectable list including entries of a current relevant medical condition on said user interface, said entries defined by said standardized nomenclature.

10. The method of claim 1, wherein prompting said user for said medical information comprises providing a user-selectable list including entries of a relevant surgery procedure name on said user interface, said entries defined by said standardized nomenclature.

11. The method of claim 1, wherein prompting said user for said drug information comprises providing a data selection area on said user interface for specifying a drug name, suspect identifier, start date and end date.

12. The method of claim 1, wherein prompting said user for said adverse event information comprises providing a data selection area on said user interface for identifying a drug name, a severity identifier, a start date and an end date.

13. The method of claim 1, wherein describing said information using said standardized nomenclature comprises selecting and displaying a drug term from a WHO Drug Dictionary.

14. The method of claim 1, wherein describing said information using said standardized nomenclature comprises selecting and displaying a medical term from a Medical Dictionary for Regulatory Activities (MedDRA) database.

15. The method of claim 1, wherein describing said information in said standard format comprises formatting said cumulative narrative into an E2B data format.

16. The method of claim 15, further comprising transmitting said E2B data format to at least one of a regulatory database and company safety database.

17. The method of claim 16, comprising providing an electronic acknowledgement to said user upon transmission of said E2B data format.

18. The method of claim 1, further comprising storing said cumulative narrative in a database.

19. The method of claim 1, wherein providing said user interface comprises transmitting said user interface over a network to a display device.

20. The method of claim 1, wherein associating said drug information and said medical information with said adverse event information comprises dragging at least one of said drug information and said medical information onto said adverse event information displayed on said user interface

21. A system for collecting and reporting adverse events associated with a patient comprising:

a network;

a user device coupled to said network, said user device configured to include a display;

a service delivery device coupled to the network, the service delivery device including a processor and memory storing instructions that, in response to receiving a first type of request for access to a service, cause the processor to;

provide a user interface on said display capable of (i) prompting a user to identify information to be associated with a patient, said information including at least one of personal information, medical information, drug information, adverse event information, and (ii) associating said drug information and said medical information with said adverse event information; and

display iteratively a cumulative narrative on said user interface in response to said user identifying at least one of said personal information, medical information, drug information, adverse event information, and said association, said cumulative narrative describing said information in a standard format using a standardized nomenclature.

22. The system of claim 21, wherein said user is selected from the group consisting essentially of a medical professional, pharmacist and said patient.

23. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to transmit said cumulative narrative to a regulatory body.

24. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to transmit said cumulative narrative to a manufacturer.

25. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to guide said user in specifying at least one of personal information, medical information, drug information, adverse event information using a plurality of display panels included in said user interface.

26. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a user-selectable list on said user interface, said user-selectable list including entries conforming to said standardized nomenclature.

27. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a data entry area on said user interface for specifying a patient'"'"'s initials, a patient-gender identifier, and a patient date-of-birth.

28. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a user-selectable list including entries of a case outcome on said user interface, said entries selected from the group consisting of ‘

congenital anomaly/birth defect’

, ‘

death’

, ‘

disabilities or permanent damage’

, ‘

hospitalization (initial or prolonged)’

, ‘

life-threatening’

, ‘

other serious/important medical event’ and

combinations thereof.

29. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a user-selectable list including entries of a current relevant medical condition on said user interface, said entries defined by said standardized nomenclature.

30. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a user-selectable list including entries of a relevant surgery procedure name on said user interface, said entries defined by said standardized nomenclature.

31. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a data selection area on said user interface for specifying a drug name, suspect identifier, start date and end date.

32. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to provide a data selection area on said user interface for identifying a drug name, a severity identifier, a start date and an end date.

33. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to select and display a drug term from a WHO Drug Dictionary.

34. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to select and display a medical term from a Medical Dictionary for Regulatory Activities (MedDRA) database.

35. The system of claim 21 wherein the memory stores instructions that, in response to receiving said first type of request over said network, cause the processor to associate said drug information and said medical information with said adverse event information in response to said user dragging at least one of said drug information and said medical information onto said adverse event information.

36. The system of claim 21 wherein the memory stores instructions that, in response to receiving a second type of request over said network, cause the processor to format said cumulative narrative into an E2B data format.

37. The system of claim 36 wherein the memory stores instructions that, in response to receiving the second type of request over said network, cause the processor to transmit said E2B data format to at least one of a regulatory database and company safety database over said network.

38. The system of claim 36 wherein the memory stores instructions that, in response to receiving the second type of request over said network, cause the processor to provide an electronic acknowledgement to said user upon transmission of said E2B data format.

39. The system of claim 36 wherein the memory stores instructions that, in response to receiving the second type of request over said network, cause the processor to store said cumulative narrative in a database.

40. The system of claim 21, wherein said network is an Internet-based network.

41. An article comprising a machine-readable medium storing machine-readable instructions that, when applied to a machine, cause the machine to:

provide a user interface on said display capable of (i) prompting a user to identify information to be associated with a patient, said information including at least one of personal information, medical information, drug information, adverse event information, and (ii) associating said drug information and said medical information with said adverse event information in response to a first type of request from said user; and

display iteratively a cumulative narrative on said user interface in response to said user identifying at least one of said personal information, medical information, drug information, adverse event information, and said association, said cumulative narrative describing said information in a standard format using a standardized nomenclature.

42. The article of claim 41 including instructions that, when applied to the machine, cause the machine to transmit said cumulative narrative to a regulatory body.

43. The article of claim 41 including instructions that, when applied to the machine, cause the machine to transmit said cumulative narrative to a manufacturer.

44. The article of claim 41 including instructions that, when applied to the machine, cause the machine to guide said user in specifying at least one of personal information, medical information, drug information, adverse event information using a plurality of display panels included in said user interface.

45. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a user-selectable list on said user interface, said user-selectable list including entries conforming to said standardized nomenclature.

46. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a data entry area on said user interface for specifying a patient initial, a patient-gender identifier, and a patient date-of-birth.

47. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a user-selectable list including entries of a case outcome on said user interface, said entries selected from the group consisting of ‘

congenital anomaly/birth defect’

, ‘

death’

, ‘

disabilities or permanent damage’

, ‘

hospitalization (initial or prolonged)’

, ‘

life-threatening’

, ‘

other serious/important medical event’ and

combinations thereof.

48. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a user-selectable list including entries of a current relevant medical condition on said user interface, said entries defined by said standardized nomenclature.

49. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a user-selectable list including entries of a relevant surgery procedure name on said user interface, said entries defined by said standardized nomenclature.

50. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a data selection area on said user interface for specifying a drug name, suspect identifier, start date and end date.

51. The article of claim 41 including instructions that, when applied to the machine, cause the machine to provide a data selection area on said user interface for identifying a drug name, a severity identifier, a start date and an end date.

52. The article of claim 41 including instructions that, when applied to the machine, cause the machine to select and display a drug term from a WHO Drug Dictionary.

53. The article of claim 41 including instructions that, when applied to the machine, cause the machine to select and display a medical term from a Medical Dictionary for Regulatory Activities (MedDRA) database.

54. The article of claim 41 including instructions that, when applied to the machine, cause the machine to format said cumulative narrative into an E2B data format.

55. The article of claim 54 including instructions that, when applied to the machine, cause the machine to transmit said E2B data format to at least one of a regulatory database and company safety database over said network.

56. The article of claim 55 including instructions that, when applied to the machine, cause the machine to provide an electronic acknowledgement to said user upon transmission of said E2B data format.

57. The article of claim 54 including instructions that, when applied to the machine, cause the machine to store said cumulative narrative in a database.

58. The article of claim 41 including instructions that, when applied to the machine, cause the machine to associate said drug information and said medical information with said adverse event information in response to said user dragging at least one of said drug information and said medical information onto said adverse event information.