SYSTEM, DEVICE, AND AUTOMATED METHOD FOR VERIFICATION OF MEDICATION INTEGRITY AND CHAIN OF CUSTODY

• US 20170076065A1
• Filed: 09/09/2016
• Published: 03/16/2017
• Est. Priority Date: 09/10/2015
• Status: Abandoned Application

• Current Assignee: LYNX Rx Incorporated
• Original Assignee: LYNX Rx Incorporated
• Inventors: Darr, David B., Agouridis, Athanasios D.
• Application Number:
  US15/260,792
• Publication Number:
  US 20170076065A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: H04W 4/02 Services making use of location information
• CPC Class Codes: H04W 4/029 Location-based management or tracking services

Abstract

Systems, devices, apparatuses and automated methods are described for tracking and verification of medications and chain of custody. The described technology enables prescription medications and samples to be tracked across supply chains during which the medications and samples may be verified for integrity and proper chain of custody. The described technology also enables prescription medications and samples to be identified by verified location and by unique alphanumeric codes, as well as by secure custodian identifiers, to verify proper tracking and transparent chain of custody. The described technology further provides for secure custody transfers and pedigree assurance for prescription medications and samples.

Claims

1. A method for tracking of prescription pharmaceuticals, comprising:

receiving, over a network, data that includes unique alphanumeric codes of two or more tracking tags affixed to a container of the prescription pharmaceuticals;

tracking a current location or one or more traversed locations of the prescription pharmaceuticals using tracking information in the data, the tracking information being associated with the unique alphanumeric codes of the two or more tracking tags;

determining a location validity of the current location or at least one of the one or more traversed locations for the prescription pharmaceuticals;

retrieving pedigree information for the prescription pharmaceuticals based on the unique alphanumeric codes; and

determining a pedigree validity by validating at least a portion of the data against the pedigree information.

2. The method of claim 1, wherein tracking the current location or the one or more traversed locations includes using at least one of global positioning system (GPS) coordinates or other geospatial data associated with the prescription pharmaceuticals;

or

wherein determining the location validity includes using at least one of a custodian identification, a recipient identification, or one or more custody-transfer locations of the prescription pharmaceuticals.

3. The method of claim 1, wherein the pedigree information includes one or more of a manufacturer name, a branded prescription pharmaceutical name, a generic prescription pharmaceutical name, a dosage, a national drug code (NDC), a lot number, an expiration date, a quantity per unit, one or more storage requirements, or a data input operator identifier.

4. The method of claim 1, wherein the unique alphanumeric codes are obtained as at least one of optical data, near-field communication (NFC) data, or radio frequency identifier (RFID) data from one or more labels affixed to packaging of the prescription pharmaceuticals.

5. The method of claim 1, wherein the current location or the one or more traversed locations of the prescription pharmaceuticals are one or more of a manufacturer, a wholesaler, a distributor, a hospital, a clinic, a transportation provider, a pharmacy, a specialty pharmacy, a pharmacy benefit manager (PBM), a group purchasing organization (GPO), and a patient location.

6. The method of claim 1, wherein determining a pedigree validity by validating at least a portion of the data against the pedigree information comprises at least one of:

determining the absence of diversion or theft of the prescription pharmaceuticals;

determining the absence of a recall notification for the prescription pharmaceuticals;

or

determining that the prescription pharmaceuticals are not expired.

7. The method of claim 6, wherein determining the absence of diversion or theft comprises verifying a continuous chain of custody link for the prescription pharmaceuticals using custodial transparency for the current location and the one or more traversed locations.

8. The method of claim 1, wherein the prescription pharmaceuticals comprise a plurality of identical prescription medication samples;

and

wherein the method further comprises one or more of;

conforming to a pharmaceutical law, a health insurance law, or a patient care quality standard,

adding individual prescription medication sample units to an inventory,

removing individual prescription medication sample units from the inventory, and

performing a real-time audit of the inventory.

9. The method of claim 8, wherein each prescription medication sample is associated with a first code of the unique alphanumeric codes that is obtained as optical data from a label of packaging for each prescription medication sample, and wherein each prescription medication sample is associated with a second code of the unique alphanumeric codes that is obtained as radio frequency data from a label of packaging that encapsulates the packaging for each prescription medication sample.

10. A system for tracking of prescription pharmaceuticals, comprising:

at least one storage device configured to store computer-readable instructions;

at least one processing device configured to execute the computer-readable instructions, the computer-readable instructions comprising;

network instructions executable to receive, over a network from a client device, data that includes unique alphanumeric codes of two or more tracking tags affixed to a container of the prescription pharmaceuticals;

track instructions executable to;

track a current location or one or more traversed locations of the prescription pharmaceuticals using tracking information in the data, the tracking information being associated with the unique alphanumeric codes of the two or more tracking tags; and

determine a location validity of the current location or at least one of the one or more traversed locations for the prescription pharmaceuticals; and

pedigree instructions executable to;

retrieve pedigree information for the prescription pharmaceuticals based on the unique alphanumeric codes; and

determine a pedigree validity by validating at least a portion of the data against the pedigree information.

11. The system of claim 10, wherein the track instructions are further executable to:

track the current location or the one or more traversed locations using at least one of GPS coordinates or other geospatial data associated with the prescription pharmaceuticals; and

determine the location validity using at least one of a custodian identification, a recipient identification, or one or more custody-transfer locations of the prescription pharmaceuticals; and

wherein the network instructions are further configured to transmit, over the network to the client device, information associated with the location validity and the pedigree validity.

12. The system of claim 10, wherein the pedigree information includes one or more of a name of a manufacturer, a branded prescription pharmaceutical name, a generic prescription pharmaceutical name, a dosage, a national drug code (NDC), a lot number, an expiration date, a quantity per unit, one or more storage requirements, and a data input operator identifier;

and

wherein the unique alphanumeric codes are obtained as optical data or radio frequency data from one or more labels affixed to packaging of the prescription pharmaceuticals.

13. The system of claim 12, wherein the system further comprises the one or more labels, and

wherein the one or more labels are affixed to the packaging by the manufacturer of the prescription pharmaceuticals or by a packaging or warehousing vendor of the manufacturer.

14. The system of claim 10, wherein the pedigree instructions are further executable to validate the at least a portion of the data against the pedigree information by at least one of:

determining the absence of diversion or theft of the prescription pharmaceuticals by verifying a continuous chain of custody link for the prescription pharmaceuticals using custodial transparency for the current location and the one or more traversed locations;

determining the absence of a recall notification for the prescription pharmaceuticals;

or

determining that the prescription pharmaceuticals are not expired.

15. The system of claim 10, wherein the prescription pharmaceuticals comprise a plurality of identical prescription medication samples;

and

wherein the computer-readable instructions further comprise inventory instructions executable to;

add individual prescription medication sample units to an inventory,

remove individual prescription medication sample units from the inventory, and

perform a real-time audit of the inventory.

16. The system of claim 15, wherein each prescription medication sample is associated with a first code of the unique alphanumeric codes that is obtained as optical data from a label of packaging for each prescription medication sample, and wherein each prescription medication sample is associated with a second code of the unique alphanumeric codes that is obtained as radio frequency data from a label of packaging that encapsulates the packaging for each prescription medication sample.

17. A method for transferring custody of prescription pharmaceuticals from a first custodian to a second custodian using a third-party tracking service over a network, the method comprising:

(a) scanning optical information including a first unique alphanumeric code from a first label affixed to a package containing prescription pharmaceuticals using a camera or scanner;

(b) scanning optical, or reading radio frequency (RF), information including a second unique alphanumeric code from a second label physically associated with the package using the camera or scanner, or using an RF reader;

(c) determining geospatial information related to the location of the custody transfer;

(d) generating indicia of identity for the second custodian;

(e) subsequent to generating the indicia of identity, transmitting over the network, by the first custodian, data that includes the first and second unique alphanumeric codes, the generated indicia, and the geospatial information to the third-party tracking service;

(f) receiving a validation of pedigree information for the prescription pharmaceuticals; and

(g) adding the prescription pharmaceuticals to an inventory of the second custodian.

18. The method of claim 17, further comprising repeating one or more of (a) through (g) for additional individual units of prescription pharmaceuticals or for additional packages of prescription pharmaceuticals.

19. The method of claim 17, further comprising at least one of:

scanning a thermal sensor affixed to the package, and wherein the validation of pedigree information includes an integrity determination that the prescription pharmaceuticals have not been subjected to a temperature outside of a required storage temperature range;

or

receiving the validation of pedigree information that includes a determination that the prescription pharmaceuticals are not expired.

20. The method of claim 17, wherein the prescription pharmaceuticals comprise prescription medication samples;

and

wherein the method further comprises;

providing an indication of approval for distribution of the prescription medication samples based on the geospatial information.