METHODS FOR DELIVERING A DRUG TO A HOSPITAL PATIENT FOR SHORT-TERM USE WHILE MINIMIZING LONG-TERM USE OF THE DRUG

• US 20090287501A1
• Filed: 05/15/2009
• Published: 11/19/2009
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Merck Sharp & Dohme LLC (Merck & Co., Inc.)
• Original Assignee: Adolor Corporation (Merck & Co., Inc.)
• Inventors: Maurer, George Raymond, Jones, Robert Barnett
• Granted Patent: US 8,112,290 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61K 31/451 having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

Novel methods for delivering a drug to hospital patients for short-term in-hospital use while minimizing long-term use of the drug. Embodiments are provided in which hospitals are identified which may be eligible to treat patients, for example, perform certain types of surgery, and which have measures in place to limit use of the drug to short-term use. The identified hospitals are preferably registered in a storage medium, including computer readable storage media, and may be authorized to receive the shipments of the drug. The received drug may then be dispensed to the patient.

Claims

1. A method for delivering a drug to hospital patients for short-term use while minimizing long-term use of the drug, wherein the method comprises:

(a) identifying hospitals which may be eligible to dispense the drug;

(b) providing said hospitals with literature regarding use of the drug;

(c) identifying a subpopulation of said hospitals which treat the patients and which have measures in place to limit use of the drug to short-term use;

(d) registering said subpopulation in a storage medium;

(e) authorizing said subpopulation to receive shipment of the drug; and

(f) dispensing the drug to the patients in said subpopulation for short-term use.

2. A method according to claim 1 wherein the patients are hospital inpatients and the delivery is limited to in-hospital administration.

3. A method according to claim 1 wherein long-term use of the drug is associated with the observation of an adverse event.

4. A method according to claim 3 which minimizes the occurrence of said observed adverse event.

5. A method according to claim 3 wherein said observed adverse event is an ischemic cardiovascular event.

6. A method according to claim 5 wherein said ischemic cardiovascular event is a myocardial infarction.

7. A method according to claim 1 wherein said subpopulation comprises acute care hospitals.

8. A method according to claim 7 wherein said acute care hospitals perform abdominal surgery.

9. A method according to claim 8 wherein said abdominal surgery is bowel resection surgery.

10. A method according to claim 1 wherein the patients are acute care patients.

11. A method according to claim 10 wherein said acute care patients are abdominal surgery patients.

12. A method according to claim 11 wherein said abdominal surgery is bowel resection surgery.

13. A method according to claim 11 wherein the delivery of the drug to said abdominal surgery patients is for the treatment or prevention of gastrointestinal dysfunction.

14. A method according to claim 13 wherein said gastrointestinal dysfunction is ileus.

15. A method according to claim 1 wherein said literature describes the observation of an adverse event associated with long-term use of the drug.

16. A method according to claim 15 wherein said observed adverse event is an ischemic cardiovascular event.

17. A method according to claim 16 wherein said ischemic cardiovascular event is a myocardial infarction.

18. A method according to claim 1 wherein said measures comprise systems, order sets or protocols to limit use of the drug to short-term use.

19. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of no more than about 20 doses of the drug.

20. A method according to claim 19 wherein no more than about 15 doses of the drug are delivered to each of the patients.

21. A method according to claim 20 wherein no more than about 10 doses of the drug are delivered to each of the patients.

22. A method according to claim 21 wherein no more than about 7 doses of the drug are delivered to each of the patients.

23. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of a total of from about 10 to about 20 doses of the drug.

24. A method according to claim 23 wherein a total of from about 14 to about 16 doses of the drug is delivered to each of the patients.

25. A method according to claim 24 wherein a total of about 15 doses of the drug is delivered to each of the patients.

26. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of a total of from about 4 to about 8 doses of the drug.

27. A method according to claim 26 wherein a total of from about 6 to about 7 doses of the drug is delivered to each of the patients.

28. A method according to claim 11 wherein the drug is delivered to said abdominal surgery patients prior to surgery, after surgery, or both prior to and after surgery.

29. A method according to claim 28 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for no more than about 10 days after surgery.

30. A method according to claim 29 wherein the drug is delivered to said abdominal surgery patients for no more than about 7 days after surgery.

31. A method according to claim 30 wherein the drug is delivered to said abdominal surgery patients for no more than about 5 days after surgery.

32. A method according to claim 31 wherein the drug is delivered to said abdominal surgery patients for no more than about 3 days after surgery.

33. A method according to claim 28 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for about 5 to about 10 days after surgery.

34. A method according to claim 33 wherein the drug is delivered to said abdominal surgery patients for about 6 to about 8 days after surgery.

35. A method according to claim 34 wherein the drug is delivered to said abdominal surgery patients for about 7 days after surgery.

36. A method according to claim 28 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for more than about 1 to about 4 days after surgery.

37. A method according to claim 36 wherein the drug is delivered to said abdominal surgery patients for about 2 to about 3 days after surgery.

38. A method according to claim 28 wherein the drug is delivered to said abdominal surgery patients about twice a day after surgery.

39. A method according to claim 28 wherein short-term use comprises the delivery to each of said abdominal surgery patients of a total of from about 10 to about 20 doses of the drug after surgery.

40. A method according to claim 39 wherein a total of from about 12 to about 15 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

41. A method according to claim 40 wherein a total of about 14 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

42. A method according to claim 28 wherein short-term use comprises the delivery to each of said abdominal surgery patients of a total of from about 5 to about 8 doses of the drug after surgery.

43. A method according to claim 42 wherein a total of from about 6 to about 7 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

44. A method according to claim 28 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 5 days prior to surgery.

45. A method according to claim 44 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 2 days prior to surgery.

46. A method according to claim 45 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 1 day prior to surgery.

47. A method according to claim 28 wherein about 0 to about 5 doses of the drug are delivered to each of said abdominal surgery patients prior to surgery.

48. A method according to claim 47 wherein about 1 to about 3 doses of the drug are delivered to each of said abdominal surgery patients prior to surgery.

49. A method according to claim 48 wherein about 1 dose of the drug is delivered to each of said abdominal surgery patients prior to surgery.

50. A method according to claim 1 wherein said storage medium is a computer readable storage medium.

51. A method according to claim 1 wherein the drug is a mu opioid antagonist compound.

52. A method according to claim 51 wherein the drug is a peripherally-acting mu opioid antagonist compound.

53. A method according to claim 52 wherein the drug is selected from the group consisting of alvimopan and N-methylnaltrexone.

54. A method according to claim 53 wherein the drug is alvimopan.

55. A method according to claim 54 wherein said alvimopan is formulated for oral administration.

56. A method according to claim 55 wherein said alvimopan is in the form of a hot-melt gelatin capsule.

57. A method according to claim 56 wherein said hot-melt gelatin capsule comprises alvimopan suspended in water-soluble polyethylene glycol.

58. A method according to claim 55 wherein each dose delivered to each of the patients contains from about 5 to about 20 mg alvimopan.

59. A method according to claim 58 wherein each of said doses contains from about 10 to about 15 mg alvimopan.

60. A method according to claim 59 wherein each of said doses contains about 12 mg alvimopan.

61. A method according to claim 54 wherein said alvimopan is formulated for intravenous administration.

62. A method according to claim 61 wherein each dose delivered to each of the patients contains from about 0.5 to about 5 mg alvimopan.

63. A method according to claim 62 wherein each of said doses contains from about 1 to about 3 mg alvimopan.

64. A method according to claim 4 further comprising the step of:

(g) monitoring the patients for an observed adverse event.

65. A method according to claim 4 which avoids the occurrence of said observed adverse event.

66. A method according to claim 1 further comprising the step of:

(g′

) transferring said drug from a hospital in said subpopulation to one or more additional hospitals for delivery to a patient within said one or more additional hospitals, provided that;

(i) said one or more additional hospitals have been provided with literature regarding use of the drug; and

(ii) said one or more additional hospitals treat said patients and have measures in place to limit use of the drug to short-term use.

67. A method according to claim 66 further comprising the step of:

(h) dispensing the drug to said patients in said one or more additional hospitals for short-term use.