Drug labeling

• US 8,639,525 B2
• Filed: 10/16/2009
• Issued: 01/28/2014
• Est. Priority Date: 10/16/2009
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: Codonics Incorporated
• Inventors: Levine, Wilton C., Davison, James Kenneth, Dempsey, Michael, Donovan, Kimberly, Driscoll, William D. III, Fishman, Gayle A., Sims, Nathaniel M.
• Primary Examiner(s): Le, Michelle L
• Application Number:
  US12/581,047
• Publication Number:
  US 20110093279A1
• Time in Patent Office: 1,565 Days
• Field of Search: 705 2- 3, 705/28, 235/375, 235/385, 235/562, 604/189
• US Class Current: 705/2
• CPC Class Codes: G06F 16/22 Indexing; Data structures therefor; Storage structures
• CPC Class Codes: G06F 16/24 Querying
• CPC Class Codes: G06K 7/10297 arrangements for handling protocols designed for non-contact record carriers such as RFIDs NFCs, e.g. ISO/IEC 14443 and 18092 cryptographic protocols H04L9/00; network security protocols H04L63/00; real-time communication protocols in data switching networks H04L65/00; network protocols for data switching network services H04L67/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

Disclosed are systems and methods for enabling transfer of a drug from a first drug container to a second drug container including a drug identification component that recognizes a first drug container to retrieve drug identifying data for the drug, a storage medium that stores a site-specific database comprising attributes and associated values for a set of drugs including the drug in the first drug container, a processor that obtains the drug identifying data and the attributes and associated values for the drug and produces information about the drug using the drug identifying data and the attributes and associated values, a rules engine that applies one or more rules to the information about the drug to generate drug handling information, and an output unit that outputs markings comprising the drug handling information in human-readable or machine-readable form, or both, to be associated with the second container.

Claims

1. A system for enabling transfer of a drug from a first drug container to a second drug container at a specific institution, comprising:

a drug identification component that retrieves drug identifying data for a drug in the first drug container by scanning machine-readable data on the first drug container, wherein the drug is included in a set of drugs;

a storage medium that stores a site-specific database comprising attributes and associated values for the set of drugs including the drug in the first drug container, wherein the attributes comprise patient-independent drug policies and patient-independent drug handling guidance specific for the institution;

a processor that obtains the drug identifying data and the attributes and associated values for the drug and produces information about the drug using the drug identifying data and the attributes and associated values;

a rules engine that applies one or more rules to the information about the drug to generate patient-independent drug handling information; and

an output unit that generates a label comprising the drug handling information in human-readable or machine-readable form, or both, to be affixed on the second container.

2. The system of claim 1, wherein the drug identifying data is based on a National Drug Code (NDC) number.

3. The system of claim 1, wherein the drug identifying data is based on one or more proprietary codes.

4. The system of claim 1, wherein the drug identifying data is derived from a barcode affixed to or on the first drug container.

5. The system of claim 1, wherein the drug identifying data is derived from an image of the first drug container.

6. The system of claim 1, wherein the drug identifying data is derived from a radio frequency identification (RFID) tag associated with the first drug container.

7. The system of claim 1, wherein the processor communicates with a memory and the storage medium storing the site-specific database, wherein one or both of the memory and the storage medium are local to the system.

8. The system of claim 1, wherein the processor communicates with a memory and the storage medium storing the site-specific database, wherein one or both of the memory and the storage medium are located remote from the system.

9. The system of claim 1, wherein the label is affixed on a syringe.

10. The system of claim 1, wherein the label is affixed on a vial.

11. The system of claim 1, wherein the label is affixed on an intravenous administration container.

12. The system of claim 1, wherein the label comprises information for controlling an intravenous pump or other drug delivery device.

13. The system of claim 1, wherein the rules comprise one or more of mixing rules, diluting rules, and reconstituting rules.

14. The system of claim 1, wherein the rules comprise rules for intercepting recalled, expired, or prohibited drugs.

15. The system of claim 1, wherein the rules comprise rules for drug interactions.

16. The system of claim 1, wherein the rules comprise rules for drug allergies.

17. The system of claim 1, wherein the label comprises information about pedigree of the drug.

18. The system of claim 1, wherein the label comprises one or more of a warning that the drug contains a paralyzing agent, a warning that the drug contains latex, a warning that the drug should be protected from light, and a warning that the drug should be administered directly into a muscle.

19. The system of claim 1, wherein the label comprises information enabling documentation of drug administration.

20. The system of claim 1, further comprising an audio-visual unit for producing one or more of an audible and visual indication of information about the drug.

21. The system of claim 1, wherein the label comprises information enabling a safety system to, based on the information, provide feedback to a clinician regarding one or more of a drug name, an allergic reaction to the drug, a drug amount, and an expiration date.

22. The system of claim 1, wherein the label comprises information enabling a documentation system to, based on the information, document administration of the drug.

23. The system of claim 1, further comprising a user interface to receive instructions from an authorized individual for updating the site-specific database.

24. The system of claim 23, wherein the user interface is configured to receive dose information associated with drugs in the site-specific database.

25. The system of claim 23, wherein the instructions include updates to one or more of the patient-independent drug policies and patient-independent drug handling guidance.

26. A system to record a utilization of a drug transferred from a first drug container to a second drug container at a specific institution, comprising:

a drug identification component that scans machine-readable data on a first drug container to retrieve drug identifying data for the drug, wherein the drug is included in a set of drugs;

a storage medium that stores a site-specific database comprising attributes and associated values for the set of drugs including the drug in the first drug container, wherein the attributes comprise patient-independent drug policies and patient-independent drug handling guidance specific for the institution; and

a processor configured to obtain the drug identifying data, the attributes, and the associated values for the drug, and record information regarding transfer of the drug and administration of the drug into an information management system using the drug identifying data, the attributes, and the associated values.

27. The system of claim 26, wherein the information management system is an anesthesia information management system.

28. The system of claim 26, wherein one or more of the information regarding the transfer of the drug and the information regarding administration of the drug includes a name of the drug.

29. The system of claim 26, wherein one or more of the information regarding the transfer of the drug and the information regarding administration of the drug includes a concentration of the drug.

30. The system of claim 26, wherein one or more of the information regarding the transfer of the drug and the information regarding administration of the drug includes NDC number of the drug.

31. The system of claim 26, wherein one or more of the information regarding the transfer of the drug and the information regarding administration of the drug includes drug lot number of the drug.

32. The system of claim 26, wherein one or more of the information regarding the transfer of the drug and the information regarding administration of the drug includes identity of an entity that transferred the drug.

33. The system of claim 26, wherein information regarding drug utilization documentation is used to track one or more of the utilization and waste of the drug by clinicians.

36. The system of claim 26, further comprising a user interface to receive instructions from an authorized individual for updating the site-specific database.

37. The system of claim 36, wherein the user interface is configured to receive dose information associated with drugs in the site-specific database.

38. The system of claim 36, wherein the instructions include updates to one or more of the patient-independent drug policies and patient independent drug handling guidance.

34. A method for enabling transfer of a drug from a first drug container to a second drug container at a specific institution, the method comprising:

retrieving drug identifying data for a drug in the first drug container by scanning machine-readable data on the first drug container;

retrieving from a storage medium that stores a site-specific database one or more attributes and associated values for the identified drug, wherein the attributes comprise patient-independent drug policies and patient-independent drug handling guidance specific for the institution;

based on the drug identifying data and the attributes and associated values for the drug, producing, by a processor, information about the drug;

applying, by a processor, one or more rules to the information about the drug to generate patient independent drug handling information; and

generating a label comprising the drug handling information in human-readable or machine-readable form, or both, to be affixed on the second container.

35. A computer program product stored on a computer readable storage device for enabling transfer of a drug from a first drug container to a second drug container at a specific institution, the computer program product comprising instructions to cause a computer to:

retrieve drug identifying data for a drug in the first drug container by scanning machine-readable data on the first drug container;

retrieve from a storage medium that stores a site-specific database one or more attributes and associated values for the drug, wherein the attributes comprise patient-independent drug policies and patient-independent drug handling guidance specific for the institution;

obtain the drug identifying data and the attributes and associated values for the drug and produce information about the drug using the drug identifying data and the attributes and associated values;

apply one or more rules to the information about the drug to generate patient-independent drug handling information; and

generate a label comprising the drug handling information in human-readable or machine-readable form, or both, to be affixed on the second container.