Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug
First Claim
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1. A method for delivering a drug to hospital patients for short-term use while minimizing long-term use of the drug, wherein the drug requires compliance with a risk evaluation and mitigation strategy approved by the Food and Drug Administration (FDA) which is designed to minimize the occurrence of an observed adverse event;
- and wherein the method comprises;
identifying hospitals that may be eligible to dispense the drug, said eligibility requiring that said hospitals;
perform abdominal surgery or are acute care hospitals; and
treat patients who are inpatients;
providing said identified hospitals with literature regarding use of the drug including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of the drug;
wherein the drug is a peripherally acting mu-opioid receptor antagonist selected from the group consisting of alvimopan and N-methylnaltrexone;
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 the drug to short-term use;
wherein said measures comprise order sets, protocols or guidelines, residing on an integrated information system, including a data processing machine, to limit use of the drug to short-term use;
registering said subpopulation in a computer readable storage medium;
authorizing said subpopulation to receive shipment of the drug; and
dispensing the drug 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.
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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.
46 Citations
54 Claims
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1. A method for delivering a drug to hospital patients for short-term use while minimizing long-term use of the drug, wherein the drug requires compliance with a risk evaluation and mitigation strategy approved by the Food and Drug Administration (FDA) which is designed to minimize the occurrence of an observed adverse event;
- and wherein the method comprises;
identifying hospitals that may be eligible to dispense the drug, said eligibility requiring that said hospitals; perform abdominal surgery or are acute care hospitals; and treat patients who are inpatients; providing said identified hospitals with literature regarding use of the drug including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of the drug; wherein the drug is a peripherally acting mu-opioid receptor antagonist selected from the group consisting of alvimopan and N-methylnaltrexone; 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 the drug to short-term use; wherein said measures comprise order sets, protocols or guidelines, residing on an integrated information system, including a data processing machine, to limit use of the drug to short-term use; registering said subpopulation in a computer readable storage medium; authorizing said subpopulation to receive shipment of the drug; and dispensing the drug 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)
- and wherein the method comprises;
Specification
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Current AssigneeMerck Sharp & Dohme LLC (Merck & Co., Inc.)
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Original AssigneeAdolor Corporation (Merck & Co., Inc.)
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InventorsMaurer, George Raymond, Jones, Robert Barnett
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Primary Examiner(s)O'Connor, Gerald J.
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Assistant Examiner(s)PAULS, JOHN A
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Application NumberUS12/467,016Publication NumberTime in Patent Office998 DaysField of Search705/2US Class Current705/2CPC Class CodesA61K 31/451 having a carbocyclic group ...A61P 1/00 Drugs for disorders of the ...G16H 20/17 delivered via infusion or i...G16H 40/20 for the management or admin...
