Cold storage system for storing pharmaceutical product containers

• US 10,134,099 B2
• Filed: 04/10/2014
• Issued: 11/20/2018
• Est. Priority Date: 01/18/2006
• Status: Active Grant

• Current Assignee: Merck Sharp & Dohme LLC (Merck & Co., Inc.)
• Original Assignee: Merck Sharp & Dohme Corporation (Merck & Co., Inc.)
• Inventors: Lowenstein, Alan J.
• Primary Examiner(s): Hayles, Ashford S
• Application Number:
  US14/250,015
• Publication Number:
  US 20140244289A1
• Time in Patent Office: 1,685 Days
• Field of Search: 62126, 62127, 62129, 235375, 235382, 235385, 705 22, 705 28
• CPC Class Codes: F25D 2400/36 Visual displays
• CPC Class Codes: F25D 2700/08 Sensors using Radio Frequency Identification [RFID]
• CPC Class Codes: F25D 2700/12 Sensors measuring the inside temperature
• CPC Class Codes: F25D 29/00 Arrangement or mounting of control or safety devices
• CPC Class Codes: G06Q 10/087 Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G07F 9/026 for alarm, monitoring and auditing in vending machines or means for indication, e.g. when empty
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Intelligent cold storage system for storing pharmaceutical product containers, such as vials, ampules, syringes, bottles, medication tubes, blister packs and cartons, at the point of dispensing. Embodiments of the invention use product identification technology, such as radio-frequency identification (RFID) tags and barcode readers, to uniquely identify containers as they are added to or removed from the cold storage compartment, and automatically retrieve from a local or remote database a variety of details associated with the containers and their contents, such as manufacturing data, expiration dates, time out of refrigeration, inventory levels, safety information, usage statistics, known contraindications and warnings, etc. If the details indicate that there is a problem with a particular pharmaceutical (e.g., that it is counterfeit, expired, suspect, spoiled, recalled or almost depleted), then a message or warning is automatically delivered to a human operator via an attached output device, such as a display screen, speaker or printer. Embodiments of the invention may also be configured to monitor and report temperature faults, power failures and other anomalies associated with the cold storage system or cold storage compartment.

Claims

1. A cold storage system for pharmaceutical product containers, comprising:

a refrigeration unit housing a cold storage compartment configured to hold a plurality of pharmaceutical product containers;

a local database for storing a set of details for each pharmaceutical product container in the plurality of pharmaceutical product containers located in the cold storage compartment, the set of details including a specified temperature level for said each pharmaceutical product container;

a network interface to a remote pharmaceutical database;

a barcode reader configured to determine and relay a unique identifier for a pharmaceutical product container added to the cold storage compartment;

a processor configured to receive the unique identifier from the barcode reader and determine, based on the set of details in the local database and the unique identifier, (i) whether the added pharmaceutical product container was previously removed from the cold storage compartment, (ii) a length of time that the added pharmaceutical product container was most recently removed from the cold storage compartment, and (iii) an updated total time out of refrigeration value for the added pharmaceutical product container, wherein the processor calculates the updated total time out of refrigeration value by retrieving a prior total time out of refrigeration value from the local database and adding thereto said most recently removed length of time; and

a temperature sensor that periodically measures a current temperature inside the cold storage compartment and communicates the current temperature to the processor;

wherein the processor is further configured to

modify the set of details in the local database to include the length of time that the added pharmaceutical product container was most recently removed and the updated total time out of refrigeration value;

wherein the processor is further configured to

modify the set of details in the local database to include the length of time that the added pharmaceutical product container was most recently removed and the updated total time out of refrigeration value;

if the unique identifier is already included in the local database when the added pharmaceutical product container is added to the cold storage compartment, cause a message concerning the added pharmaceutical product container to be delivered to a human operator, the message including at least one of;

the unique identifier, the length of time elapsed since the added pharmaceutical product container was previously removed from the cold storage compartment, and the updated total length of time that the added pharmaceutical product container has been removed from the cold storage compartment,

if the unique identifier is not already included in the local database when the added pharmaceutical product container is added to the cold storage compartment, cause the unique identifier and the time that the added pharmaceutical product container was added to the cold storage compartment to be recorded in the set of details for the added pharmaceutical product container in the local database, and access the remote pharmaceutical database through the network interface to copy information associated with the unique identifier from the remote pharmaceutical database to the set of details in the local database, the copied information including the specified temperature level for the added pharmaceutical product container,

receive the periodic measurements of the current temperature inside the cold storage compartment from the temperature sensor,

while the added pharmaceutical product container remains in the cold storage compartment, periodically compare the current temperature in the cold storage compartment to the specified temperature level for the added pharmaceutical product container to determine a duration of time that the current temperature in the cold storage compartment falls outside the specified temperature level for the added pharmaceutical product container,

produce a revised updated total time out of refrigeration value for the added pharmaceutical product container by adding to the updated total time out of refrigeration value for the added pharmaceutical product container the duration of time that the current temperature in the cold storage compartment falls outside the specified temperature level for the added pharmaceutical product container, and

in the set of details for the added pharmaceutical product container in the local database, replace the updated total time out of refrigeration value with the revised updated total time out of refrigeration value.

2. The cold storage system of claim 1, wherein the processor causes the message to be delivered to the human operator via at least one of:

an information store, a log file, an attached output device, an email communication program, a web page server, and an online information publication service.

3. The cold storage system of claim 1, wherein:

the processor is electronically coupled to a clock configured to provide a current date;

the set of details in the local database includes a record specifying an expiration date for the added pharmaceutical product container; and

the processor is further configured to (i) determine an expiration status for the added pharmaceutical product container by comparing the current date to the expiration date, and (ii) cause a warning to be delivered to the human operator concerning the expiration status of the added pharmaceutical product container.

4. The cold storage system of claim 1, wherein:

the set of details in the local database includes a record specifying a maximum time out of refrigeration value for the added pharmaceutical product container; and

the processor is further configured to (i) determine a spoliation status for the added pharmaceutical product container by comparing the updated total length of time to the maximum time out of refrigeration value, and (ii) cause a warning to be delivered to the human operator concerning the spoliation status of the added pharmaceutical product container.

5. The cold storage system of claim 1, wherein:

the processor is electronically coupled to a clock configured to provide a current time;

the set of details in the local database comprises a record for storing (i) a removal time indicating a time that the added pharmaceutical product container was previously removed from the cold storage compartment, and (ii) a prior total length of time that the added pharmaceutical product container has been removed from the cold storage compartment; and

the processor determines the updated total length of time that the added pharmaceutical product container has been removed from the cold storage compartment by retrieving the current time from the clock, retrieving the removal time and the prior total length of time from the local database, subtracting the removal time from the current time to obtain a removal duration, and adding the removal duration to the prior total length of time.

6. The cold storage system of claim 1, wherein if the processor determines that the remote pharmaceutical product database does not contain the information associated with the unique identifier, then the processor will (i) create a record in the local database indicating that the authenticity of the added pharmaceutical product container is suspect, and (ii) cause a warning to be delivered to the human operator concerning the suspect authenticity of the added pharmaceutical product container.

7. The cold storage system of claim 1, wherein the cold storage compartment is a freezer.

8. The cold storage system of claim 1, wherein the cold storage compartment is a refrigerator.

9. The cold storage system of claim 1, wherein:

the processor is electronically coupled to a clock configured to provide a current time, and calculates the duration by determining each of a start time and an end time of the current temperature falling outside the specified temperature level, and subtracting the end time from the start time.

10. A cold storage system for pharmaceutical product containers, comprising:

a refrigeration unit housing a cold storage compartment configured to hold a plurality of pharmaceutical product containers;

a barcode reader configured to determine a unique identifier for a pharmaceutical product container added to the cold storage compartment by decoding a light energy signal reflected from a barcode label affixed to the added pharmaceutical product container;

a local database for storing the unique identifier and a set of details for the added pharmaceutical product container, the set of details including a specified temperature level for the added pharmaceutical product container;

an output device for delivering messages to a human operator;

a processor configured to record the unique identifier and the set of details in the local database; and

a temperature sensor configured to periodically determine a current temperature inside the cold storage compartment;

wherein the processor is further configured to (i) periodically compare the current temperature inside the cold storage compartment with the specified temperature level for the added pharmaceutical product container, (ii) generate a temperature alert for the added pharmaceutical product container if the current temperature in the cold storage compartment falls outside the specified temperature level for the added pharmaceutical container, and (iii) transmit a message concerning the added pharmaceutical product container and the temperature alert to the output device.