System and method for data access in the distribution of limited distribution drugs

• US 10,303,853 B2
• Filed: 04/25/2014
• Issued: 05/28/2019
• Est. Priority Date: 01/10/2014
• Status: Active Grant

• Current Assignee: IQVIA, Inc. (IQVIA Holdings, Inc.)
• Original Assignee: IQVIA, Inc. (IQVIA Holdings, Inc.)
• Inventors: Johnson, Kjel
• Primary Examiner(s): Burgess, Joseph D
• Application Number:
  US14/261,856
• Publication Number:
  US 20150199492A1
• Time in Patent Office: 1,859 Days
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A computer-assisted method that includes: receiving a first list of data entries set forth by a first pharmaceutical manufacturer for a first limited distribution drug for a target condition; receiving first prescription data from a server at a first specialty pharmacy authorized to distribute the first limited distribution drug, the first prescription data initiated by a patient, at the first specialty pharmacy, for whom a healthcare provider of the patient had prescribed the limited distribution drug; automatically generating first report data entries based on the first prescription data and according to the first list set forth by the first pharmaceutical manufacturer, the first report data entries devoid of information identifying the patient or the prescribing healthcare provider; transmitting the generated first report data entries to the first pharmaceutical manufacturer; and receiving a response from the first pharmaceutical manufacturer.

Claims

1. A computer-assisted method, comprising:

receiving, by a computer system, a set of data entries for a drug from a pharmaceutical manufacturer;

receiving, by the computer system, a first prescription data submission from a first specialty pharmacy, wherein;

the first specialty pharmacy and the pharmaceutical manufacturer are not communicatively linked,

the first prescription data submission corresponds to a first prescription for the drug presented to the first specialty pharmacy, and

the first prescription data submission encodes a first set of de-identified fields associated with the first prescription and a medical record;

generating, by the computer system, a first set of report data entries based on the first prescription data submission, wherein the first set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

receiving, by the computer system, a second prescription data submission from a second specialty pharmacy, wherein;

the pharmaceutical manufacturer and the second specialty pharmacy are not communicatively linked,

the second prescription data submission corresponds to a second prescription for the drug presented to the second specialty pharmacy, and

the second prescription data submission encodes a second set of de-identified fields associated with the second prescription and the medical record;

generating, by the computer system, a second set of report data entries based on the second prescription data submission, wherein the second set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

determining, by the computer system, a set of links between the first set of report data entries and the second set of report data entries based on the first set of de-identified fields and the second set of de-identified fields being associated with the same medical record;

determining, by the computer system, a cumulative dose of the drug received by the patient of the medical record is within a safety limit associated with the drug based on the set of links;

providing, by the computer system and to the pharmaceutical manufacturer, an indication that shows the cumulative dose of the drug received by the patient of the medical record is within the safety limit;

receiving, by the computer system and from the pharmaceutical manufacturer, an authorization that permits the second specialty pharmacy to dispense the drug to the patient of the medical record based on the cumulative dose of the drug being within the safety limit; and

providing, by the computer system, an instruction to the second specialty pharmacy to dispense the drug.

2. The method of claim 1, wherein:

the first specialty pharmacy is authorized by a first healthcare insurance carrier to distribute the drug,

the second specialty pharmacy is authorized by a second healthcare insurance carrier to distribute the drug, and

the second healthcare insurance carrier is different from the first healthcare insurance carrier.

3. The method of claim 1, further comprising:

receiving, by the computer system, a second set of data entries for a second drug from a second pharmaceutical manufacturer.

4. The method of claim 3, further comprising:

receiving, by the computer system, a third prescription data submission from the first specialty pharmacy, wherein;

the third prescription data submission corresponds to a third prescription for a second drug presented to the first specialty pharmacy, and

the third prescription data submission encodes a third set of de-identified fields associated with the third prescription and the medical record;

generating, by the computer system, a third set of report data entries based on the third prescription data submission, wherein the third set of report data entries are anonymized with respect to a patient that presents the third prescription to the first specialty pharmacy.

5. The method of claim 4, further comprising:

determining, by the computer system, that the first set of report data entries and the third set of report data entries are associated with the same medical record;

determining, by the computer system, a second set of links between the first set of report data entries and the third set of report data entries based on the first set of de-identified fields and the third set of de-identified fields being associated with the same medical record; and

adjusting, by the computer system, the cumulative dose of the drug based on the second set of links.

6. The method of claim 3, wherein the second pharmaceutical manufacturer is different from the pharmaceutical manufacturer.

7. The method of claim 3, wherein the second pharmaceutical manufacturer is identical to the first pharmaceutical manufacturer.

8. The method of claim 1, wherein receiving the first prescription data submission comprises receiving a request originally from the patient that presents the first prescription to the first specialty pharmacy to participate in a patient-assistance-program (PAP) offered by the first pharmaceutical manufacturer.

9. The method of claim 8, wherein generating first set of report data entries comprises generating a participation request to participate in the PAP offered by the first pharmaceutical manufacturer, the participation request comprising de-identified income characteristics of the patient that presents the first prescription to the first specialty pharmacy.

10. The method of claim 9, wherein the first set of report data entries includes the participation request.

11. The method of claim 10, wherein the authorization received from the pharmaceutical manufacturer comprises a determination result from the pharmaceutical manufacturer indicating the patient that presents the first prescription to the first specialty pharmacy is allowed to participate in the PAP.

12. The method of claim 11, further comprising:

in response to receiving the authorization that includes the determination result indicating the patient that presents the first prescription to the first specialty pharmacy is allowed to participate in the PAP, providing, by the computer system and to a healthcare insurance carrier of the patient that presents the first prescription to the first specialty pharmacy, an indication of the determination result.

13. The method of claim 9, wherein generating the participation request further comprises querying a government agency to confirm the income characteristics of the patient that presents the first prescription to the first specialty pharmacy.

14. The method of claim 1, further comprising:

forwarding, by the computer system, at least a portion of the first set of report data entries to a regulatory agency.

15. The method of claim 14, wherein forwarding at least a portion of the first set of report data entries comprises forwarding at least a portion of the first set of report data entries to comply with a risk mitigation strategy in consuming the drug.

16. A computer system, comprising one or more processors, configured to perform operations of:

receiving, by a computer system, a set of data entries for a drug from a pharmaceutical manufacturer;

receiving, by the computer system, a first prescription data submission from a first specialty pharmacy, wherein;

the first specialty pharmacy and the pharmaceutical manufacturer are not communicatively linked,

the first prescription data submission corresponds to a first prescription for the drug presented to the first specialty pharmacy, and

the first prescription data submission encodes a first set of de-identified fields associated with the first prescription and a medical record;

generating, by the computer system, a first set of report data entries based on the first prescription data submission, wherein the first set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

receiving, by the computer system, a second prescription data submission from a second specialty pharmacy, wherein;

the pharmaceutical manufacturer and the second specialty pharmacy are not communicatively linked,

the second prescription data submission corresponds to a second prescription for the drug presented to the second specialty pharmacy, and

the second prescription data submission encodes a second set of de-identified fields associated with the second prescription and the medical record;

generating, by the computer system, a second set of report data entries based on the second prescription data submission, wherein the second set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

determining, by the computer system, a set of links between the first set of report data entries and the second set of report data entries based on the first set of de-identified fields and the second set of de-identified fields being associated with the same medical record;

determining, by the computer system, a cumulative dose of the drug received by the patient of the medical record is within a safety limit associated with the drug based on the set of links;

providing, by the computer system and to the pharmaceutical manufacturer, an indication that shows the cumulative dose of the drug received by the patient of the medical record is within the safety limit;

receiving, by the computer system and from the pharmaceutical manufacturer, an authorization that permits the second specialty pharmacy to dispense the drug to the patient of the medical record based on the cumulative dose of the drug being within the safety limit; and

providing, by the computer system, an instruction to the second specialty pharmacy to dispense the drug.

17. A computer-readable medium, comprising software instructions, that when executed by a computer, cause the computer to execute operations of:

receiving, by a computer system, a set of data entries for a drug from a pharmaceutical manufacturer;

receiving, by the computer system, a first prescription data submission from a first specialty pharmacy, wherein;

the first specialty pharmacy and the pharmaceutical manufacturer are not communicatively linked,

the first prescription data submission corresponds to a first prescription for the drug presented to the first specialty pharmacy, and

the first prescription data submission encodes a first set of de-identified fields associated with the first prescription and a medical record;

generating, by the computer system, a first set of report data entries based on the first prescription data submission, wherein the first set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

receiving, by the computer system, a second prescription data submission from a second specialty pharmacy, wherein;

the pharmaceutical manufacturer and the second specialty pharmacy are not communicatively linked,

the second prescription data submission corresponds to a second prescription for the drug presented to the second specialty pharmacy, and

the second prescription data submission encodes a second set of de-identified fields associated with the second prescription and the medical record;

generating, by the computer system, a second set of report data entries based on the second prescription data submission, wherein the second set of report data entries are anonymized with respect to a patient that presents the first prescription to the first specialty pharmacy;

determining, by the computer system, a set of links between the first set of report data entries and the second set of report data entries based on the first set of de-identified fields and the second set of de-identified fields being associated with the same medical record;

determining, by the computer system, a cumulative dose of the drug received by the patient of the medical record is within a safety limit associated with the drug based on the set of links;

providing, by the computer system and to the pharmaceutical manufacturer, an indication that shows the cumulative dose of the drug received by the patient of the medical record is within the safety limit;

receiving, by the computer system and from the pharmaceutical manufacturer, an authorization that permits the second specialty pharmacy to dispense the drug to the patient of the medical record based on the cumulative dose of the drug being within the safety limit; and

providing, by the computer system, an instruction to the second specialty pharmacy to dispense the drug.