Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug

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.

1 . A method for delivering alvimopan to hospital patients for short-term use wherein the method comprises:
 identifying hospitals that may be eligible to dispense alvimopan, said eligibility requiring that said hospitals:
 perform abdominal surgery or are acute care hospitals; and 
 treat patients who are inpatients undergoing bowel resection surgery involving anastomosis; 
   providing said identified hospitals with literature regarding use of alvimopan including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of alvimopan;
 wherein alvimopan is formulated for oral administration; 
   receiving registration information from said identified hospitals;   identifying a subpopulation of said identified hospitals which treat the patients and which have said measures in place to limit use of alvimopan to short-term use;
 wherein said measures comprise systems, order sets or protocols to limit use of alvimopan to short-term use; 
   registering said subpopulation in a computer readable storage medium;   authorizing said subpopulation to receive shipment of alvimopan; and   dispensing alvimopan to the patients in said subpopulation for short-term use;
 wherein the patients are hospital inpatients and the delivery is limited to in-hospital administration; and 
   monitoring the patients for said observed adverse event.   
     
     
         2 . A method according to  claim 1  wherein the short term use comprises the delivery to each of the patients of no more than about 15 doses of alvimopan. 
     
     
         3 . A method according to  claim 2  wherein the drug is delivered to said bowel resection surgery patients both prior to and after surgery. 
     
     
         4 . A method according to  claim 3  wherein the drug is delivered to said bowel resection surgery patients for no more than about 7 days after surgery. 
     
     
         5 . A method according to  claim 4  wherein about 1 dose of the drug is delivered to each of said bowel resection surgery patients prior to surgery. 
     
     
         6 . A method according to  claim 5  wherein each of said doses contains about 12 mg alvimopan. 
     
     
         7 . A method according to  claim 1  further comprising the step of:
 transferring alvimopan 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 are eligible to dispense alvimopan; and 
 (ii) said one or more additional hospitals have been provided with the literature regarding use of alvimopan; including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of alvimopan; 
 
 registering said one or more additional hospitals in the computer readable storage medium; and 
 authorizing said one or more additional hospitals to receive shipment of alvimopan. 
 
     
     
         8 . A method according to  claim 7  further comprising the step of dispensing the drug to said patients in said one or more additional hospitals for short-term use.