IP Library Granted Patent US 12,561,781
Granted Patent B2
US 12,561,781 · App. 17/932,861 · Granted Feb 24, 2026

Methods, systems, and computer program product for validating drug product package content using tiered evaluation factors

Inventors: Russell F. Lewis (Dallas, TX); Arthur F. Swanson (Cary, NC); Todd Martin Jenkins (Raleigh, NC)
Assignee: PARATA SYSTEMS, LLC
G06T7/0004G06T11/00G06V10/776G16H20/10G16H50/30G06T2207/30108
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Quick Facts
Patent No.
US 12,561,781
App. No.
17/932,861
Granted
Feb 24, 2026
Kind
B2
Abstract

A method includes receiving a drug product package containing one or more drug products therein; evaluating the one or more drug products contained in the drug product package based on a plurality of drug product evaluation factors, the plurality of drug product evaluation factors including an enhanced scrutiny factor; assigning a validation score to the drug product package based on evaluating the one or more drug products contained in the drug product package, a magnitude of the validation score being greater with decreasing patient risk; and validating the drug product package. Validating the drug product package comprises: validating the drug product package based on a first comparison of the magnitude of the validation score with a first threshold responsive to a presence of the enhanced scrutiny factor and a second comparison of the magnitude of the validation score with a second threshold responsive to an absence of the enhanced scrutiny factor, the first threshold being greater than the second threshold; or identifying the drug product package as requiring manual validation responsive to the presence of the enhanced scrutiny factor.

Claims (99)

1 . A method comprising:

receiving a drug product package containing one or more drug products therein;

evaluating the one or more drug products contained in the drug product package based on a plurality of drug product evaluation factors, the plurality of drug product evaluation factors including an enhanced scrutiny factor;

assigning a validation score to the drug product package based on evaluating the one or more drug products contained in the drug product package, a magnitude of the validation score being greater with decreasing patient risk; and

validating the drug product package;

wherein validating the drug product package comprises:

generating, using an artificial intelligence engine, a modified image of the drug product package;

detecting, using the artificial intelligence engine, the one or more drug products contained in the drug product package based on the modified image; and

validating the drug product package based on the modified image and a first comparison of the magnitude of the validation score with a first threshold responsive to a presence of the enhanced scrutiny factor and a second comparison of the magnitude of the validation score with a second threshold responsive to an absence of the enhanced scrutiny factor, the first threshold being greater than the second threshold.

2 . The method of claim 1 , wherein the drug product package is part of a fulfillment of a packaging order; and

wherein the method further comprises:

defining the enhanced scrutiny factor for the packaging order.

3 . The method of claim 1 , wherein the drug product package is part of a fulfillment of a packaging order;

wherein the method further comprises:

defining the first threshold and the second threshold for the packaging order.

4 . The method of claim 1 , wherein the plurality of drug product evaluation factors include a plurality of enhanced scrutiny factors, the plurality of enhanced scrutiny factors comprising a first subset of enhanced scrutiny factors and a second subset of enhanced scrutiny factors.

5 . The method of claim 4 , wherein validating the drug product package comprises:

validating the drug product package based on the first comparison of the magnitude of the validation score with the first threshold responsive to a presence of at least one enhanced scrutiny factor of the first subset of enhanced scrutiny factors and absent a presence of at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors; and

validating the drug product package based on a second comparison of the magnitude of the validation score with the second threshold responsive to an absence of any of the plurality of enhanced scrutiny factors.

6 . The method of claim 5 , wherein validating the drug product package further comprises:

identifying the drug product package as requiring manual validation responsive to the presence of the at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors.

7 . The method of claim 4 , wherein the plurality of enhanced scrutiny factors comprises one or more of:

an age of a patient to whom the one or more drug products is prescribed;

a gender of the patient to whom the one or more drug products is prescribed;

a pharmacogenomic profile of the patient to whom the one or more drug products is prescribed;

a financial cost of the one or more drug products;

an interaction between the one or more drug products;

a side effect of the one or more drug products;

a propensity of the one or more drug products to create debris in the drug product package;

packaging order history information for the patient to whom the one or more drug products is prescribed;

recall information for the one or more drug products;

a potential for exceeding a safe dosing for the one or more drug products; and

an indication that the one or more drug products includes a substituted drug product that differs from a packaging order.

8 . The method of claim 1 , wherein generating, using the artificial intelligence engine, the modified image of the drug product package comprises:

generating, using the artificial intelligence engine, the modified image of the drug product package that has selected content removed from a surface thereof.

9 . The method of claim 1 , wherein generating, using the artificial intelligence engine, the modified image of the drug product package comprises:

detecting, using the artificial intelligence engine, characteristics of an image of the drug product package that are associated with a drug product packaging system; and

generating, using the artificial intelligence engine, the modified image of the drug product package based on characteristics of the drug product packaging system.

10 . A system, comprising:

a processor; and

a memory coupled to the processor and comprising computer readable program code embodied in the memory that is executable by the processor to perform operations comprising:

receiving a drug product package containing one or more drug products therein;

evaluating the one or more drug products contained in the drug product package based on a plurality of drug product evaluation factors, the plurality of drug product evaluation factors including an enhanced scrutiny factor;

assigning a validation score to the drug product package based on evaluating the one or more drug products contained in the drug product package, a magnitude of the validation score being greater with decreasing patient risk; and

validating the drug product package;

wherein validating the drug product package comprises:

generating, using an artificial intelligence engine, a modified image of the drug product package;

detecting, using the artificial intelligence engine, the one or more drug products contained in the drug product package based on the modified image; and

validating the drug product package based on the modified image and a first comparison of the magnitude of the validation score with a first threshold responsive to a presence of the enhanced scrutiny factor and a second comparison of the magnitude of the validation score with a second threshold responsive to an absence of the enhanced scrutiny factor, the first threshold being greater than the second threshold.

11 . The system of claim 10 , wherein the plurality of drug product evaluation factors include a plurality of enhanced scrutiny factors, the plurality of enhanced scrutiny factors comprising a first subset of enhanced scrutiny factors and a second subset of enhanced scrutiny factors.

12 . The system of claim 11 , wherein validating the drug product package comprises:

validating the drug product package based on the first comparison of the magnitude of the validation score with the first threshold responsive to a presence of at least one enhanced scrutiny factor of the first subset of enhanced scrutiny factors and absent a presence of at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors; and

validating the drug product package based on a second comparison of the magnitude of the validation score with the second threshold responsive to an absence of any of the plurality of enhanced scrutiny factors.

13 . The system of claim 12 , wherein validating the drug product package further comprises:

identifying the drug product package as requiring manual validation responsive to the presence of the at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors.

14 . The system of claim 11 , wherein the plurality of enhanced scrutiny factors comprises one or more of:

an age of a patient to whom the one or more drug products is prescribed;

a gender of the patient to whom the one or more drug products is prescribed;

a pharmacogenomic profile of the patient to whom the one or more drug products is prescribed;

a financial cost of the one or more drug products;

an interaction between the one or more drug products;

a side effect of the one or more drug products;

a propensity of the one or more drug products to create debris in the drug product package;

packaging order history information for the patient to whom the one or more drug products is prescribed;

recall information for the one or more drug products;

a potential for exceeding a safe dosing for the one or more drug products; and

an indication that the one or more drug products includes a substituted drug product that differs from a packaging order.

15 . A computer program product, comprising:

a non-transitory computer readable storage medium comprising computer readable program code embodied in the medium that is executable by a processor to perform operations comprising:

receiving a drug product package containing one or more drug products therein;

evaluating the one or more drug products contained in the drug product package based on a plurality of drug product evaluation factors, the plurality of drug product evaluation factors including an enhanced scrutiny factor;

assigning a validation score to the drug product package based on evaluating the one or more drug products contained in the drug product package, a magnitude of the validation score being greater with decreasing patient risk; and

validating the drug product package;

wherein validating the drug product package comprises:

generating, using an artificial intelligence engine, a modified image of the drug product package;

detecting, using the artificial intelligence engine, the one or more drug products contained in the drug product package based on the modified image; and

validating the drug product package based on the modified image and a first comparison of the magnitude of the validation score with a first threshold responsive to a presence of the enhanced scrutiny factor and a second comparison of the magnitude of the validation score with a second threshold responsive to an absence of the enhanced scrutiny factor, the first threshold being greater than the second threshold.

16 . The computer program product of claim 15 , wherein the plurality of drug product evaluation factors include a plurality of enhanced scrutiny factors, the plurality of enhanced scrutiny factors comprising a first subset of enhanced scrutiny factors and a second subset of enhanced scrutiny factors.

17 . The computer program product of claim 16 , wherein validating the drug product package comprises:

validating the drug product package based on the first comparison of the magnitude of the validation score with the first threshold responsive to a presence of at least one enhanced scrutiny factor of the first subset of enhanced scrutiny factors and absent a presence of at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors;

validating the drug product package based on a second comparison of the magnitude of the validation score with the second threshold responsive to an absence of any of the plurality of enhanced scrutiny factors; and

identifying the drug product package as requiring manual validation responsive to the presence of the at least one enhanced scrutiny factor of the second subset of enhanced scrutiny factors.

18 . The system of claim 10 , wherein generating, using the artificial intelligence engine, the modified image of the drug product package comprises:

generating, using the artificial intelligence engine, the modified image of the drug product package that has selected content removed from a surface thereof.

19 . The system of claim 10 , wherein generating, using the artificial intelligence engine, the modified image of the drug product package comprises:

detecting, using the artificial intelligence engine, characteristics of an image of the drug product package that are associated with a drug product packaging system; and

generating, using the artificial intelligence engine, the modified image of the drug product package based on characteristics of the drug product packaging system.

20 . The computer program product of claim 16 , wherein the plurality of enhanced scrutiny factors comprises one or more of:

an age of a patient to whom the one or more drug products is prescribed;

a gender of the patient to whom the one or more drug products is prescribed;

a pharmacogenomic profile of the patient to whom the one or more drug products is prescribed;

a financial cost of the one or more drug products;

an interaction between the one or more drug products;

a side effect of the one or more drug products;

a propensity of the one or more drug products to create debris in the drug product package;

packaging order history information for the patient to whom the one or more drug products is prescribed;

recall information for the one or more drug products;

a potential for exceeding a safe dosing for the one or more drug products; and

an indication that the one or more drug products includes a substituted drug product that differs from a packaging order.

Continuity (2)
Provisional Application 63249304 · Sep 28, 2021
Related Publication 20230098966A1 · Mar 30, 2023
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