GB2568166A - A system and method for distributing, monitoring and managing inventory - Google Patents

A system and method for distributing, monitoring and managing inventory Download PDF

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Publication number
GB2568166A
GB2568166A GB1817488.8A GB201817488A GB2568166A GB 2568166 A GB2568166 A GB 2568166A GB 201817488 A GB201817488 A GB 201817488A GB 2568166 A GB2568166 A GB 2568166A
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United Kingdom
Prior art keywords
rfid
pharmaceutical
storage unit
tagged
pharmaceutical storage
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Pending
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GB1817488.8A
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GB201817488D0 (en
Inventor
Michael Condon Richard
Edward Priestley Graham
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Bayer PLC
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Bayer PLC
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Priority to GB1715201.8A priority Critical patent/GB2566938A/en
Priority to GB1817488.8A priority patent/GB2568166A/en
Publication of GB201817488D0 publication Critical patent/GB201817488D0/en
Publication of GB2568166A publication Critical patent/GB2568166A/en
Application status is Pending legal-status Critical

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Classifications

    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F17/00Coin-freed apparatus for hiring articles; Coin-freed facilities or services
    • G07F17/0092Coin-freed apparatus for hiring articles; Coin-freed facilities or services for assembling and dispensing of pharmaceutical articles
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/08Logistics, e.g. warehousing, loading, distribution or shipping; Inventory or stock management, e.g. order filling, procurement or balancing against orders
    • G06Q10/083Shipping
    • G06Q10/0833Tracking
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/08Logistics, e.g. warehousing, loading, distribution or shipping; Inventory or stock management, e.g. order filling, procurement or balancing against orders
    • G06Q10/087Inventory or stock management, e.g. order filling, procurement, balancing against orders
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Systems or methods specially adapted for specific business sectors, e.g. utilities or tourism
    • G06Q50/10Services
    • G06Q50/22Social work
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Systems or methods specially adapted for specific business sectors, e.g. utilities or tourism
    • G06Q50/28Logistics, e.g. warehousing, loading, distribution or shipping
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07CTIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
    • G07C9/00Individual entry or exit registers
    • G07C9/00007Access-control involving the use of a pass
    • G07C9/00031Access-control involving the use of a pass in combination with an identity-check of the pass-holder
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F11/00Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/002Coin-freed apparatus for dispensing, or the like, discrete articles where the dispenser is part of a centrally controlled network of dispensers
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F9/00Details other than those peculiar to special kinds or types of apparatus
    • G07F9/02Devices for alarm or indication, e.g. when empty; Advertising arrangements in coin-freed apparatus
    • G07F9/026Devices for alarm or indication, e.g. when empty; Advertising arrangements in coin-freed apparatus for alarm, monitoring and auditing in vending machines or means for indication, e.g. when empty
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F9/00Details other than those peculiar to special kinds or types of apparatus
    • G07F9/10Casings or parts thereof, e.g. with means for heating or cooling
    • G07F9/105Heating or cooling means, for temperature and humidity control, for the conditioning of articles and their storage
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • AHUMAN NECESSITIES
    • A47FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47BTABLES; DESKS; OFFICE FURNITURE; CABINETS; DRAWERS; GENERAL DETAILS OF FURNITURE
    • A47B67/00Chests; Dressing-tables; Medicine cabinets or the like; Cabinets characterised by the arrangement of drawers
    • A47B67/02Cabinets for shaving tackle, medicines, or the like
    • A47B2067/025Cabinets for shaving tackle, medicines, or the like having safety means
    • AHUMAN NECESSITIES
    • A47FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47FSPECIAL FURNITURE, FITTINGS, OR ACCESSORIES FOR SHOPS, STOREHOUSES, BARS, RESTAURANTS OR THE LIKE; PAYING COUNTERS
    • A47F10/00Furniture or installations specially adapted to particular types of service systems, not otherwise provided for
    • A47F2010/005Furniture or installations specially adapted to particular types of service systems, not otherwise provided for using RFID elements
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07CTIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
    • G07C2209/00Indexing scheme relating to groups G07C9/00 - G07C9/02
    • G07C2209/04Access control involving a hierarchy in access rights

Abstract

A system for securing inventory at patient points of care in the event of a recall comprises a pharmaceutical storage unit located at a patient point of care and a data processing system. The pharmaceutical storage unit comprising at least one RFID reader configured to scan at least one RFID-tagged pharmaceutical product, namely vascular endothelial growth factor (VEGF) antagonist for ophthalmological purposes, and update stock data. The data processing system is configured to: a) update a global inventory database to reflect that at least one RFID tagged pharmaceutical product is to be recalled 2000; and b) for each patient point of care, check stock data of the at least one pharmaceutical storage unit to determine if said pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled 2200 and, if so: i) issue an alert to a user of the pharmaceutical storage unit 2220; and/or ii) prevent access to the pharmaceutical storage unit by all users except appropriately authorised users 2210. Authorisation may involve reading an RFID user ID card and/or biometric.

Description

A System and Method for Distributing, Monitoring and Managing Inventory

Field

The present invention relates to systems and methods for distributing, monitoring and managing inventory, in particular for pharmaceutical products and especially those requiring temperature controlled conditions such as any anti-vascular endothelium growth factor (anti-VEGF) for ophthalmological purposes, for example Aflibercept. In particular embodiments, the systems and methods relate to the use of RFID in the distributing, monitoring and managing of inventory, and control of the inventory at a location such as a patient point of care.

Background

The accurate monitoring of inventory levels and tracking inventory movement is essential to efficiently deliver inventory, maintain inventory levels at all points along the distribution chain, and prevent inventory leakage (for example, theft or loss of inventory).

The accurate tracking of inventory movement is of particular concern in distribution chains for high-value pharmaceutical products as high-value pharmaceutical products are at significant risk for inventory leakage. Inventory leakage can occur at any point during the distribution chain, including during transit from pharmaceutical product distribution centre to patient point of care, and at the patient point of care.

One cause of inventory leakage is the antiquated distribution methods and systems, particularly at healthcare facilities. For example, a typical distribution of a pharmaceutical product from a distribution hub of a pharmaceutical company would involve boxing and packing a plurality of pharmaceutical products onto an unsecured delivery vehicle and delivering the packaged products to the pharmacy of a healthcare facility such as a hospital. From here, the product may be taken to an on-site storage location by a nominated person responsible for handling inventory (in particular, high value inventory). From the on-site storage location, another person may be responsible for unpacking the products and delivering a certain number to one or more specific clinics, depending on the product. There may be yet another person involved at the clinic to take receipt of said products and store them away at a point of care. It will be appreciated that this process is not only burdensome in terms of the personnel responsible for the product, but is also prone to theft or loss of inventory.

Furthermore, in some distribution chains for products such as pharmaceutical products, there may only be a few units of the pharmaceutical product kept at any patient point of care. This may be because, for example, the product must be stored in particular conditions, or the product is only occasionally administered to patients. In these distribution chains, it is essential that inventory levels of the pharmaceutical product are accurately tracked so that orders for restocking to patient points of care can be made in good time ahead of when the products expire, or will be needed for administration to patients so as not place unnecessary strain on the manufacturing, packaging and distribution centres and/or incur extra expense.

Moreover, in distribution chains where product is delivered to a patient point of care and a particular product is recalled or expires, it can be time-consuming and costly to accurately recall products since the usual practice is that a nurse or practitioner must manually check all stock and remove products to be recalled from the patient point of care. It is also possible that pharmaceutical products that are to be recalled or have expired may be missed during this manual removal process, and so unsafe drugs may be administered to patients.

Hence, there is a need for a system and method for securely distributing pharmaceutical products from pharmaceutical distribution centres to patient points of care. Furthermore, there is a need for a system and method for securely dispensing pharmaceutical products for administration to patients at patient points of care.

Furthermore, there is a need for a system and method for improving the accountability of inventory of pharmaceutical products throughout the entire distribution chain so the inventory can be replaced and/or reordered when necessary, and areas of inventory leakage can be identified. US20090160646A, US20130159135A and US20100213086A are concerned with the use of RFID tags in the first stages of a distribution chain, from manufacturer to warehouse, retail unit, or laboratory. However, these documents do not explain how RFID tags could be used to continue the monitoring and tracking process to a patient point of care, or beyond to administration for patient. Therefore, the systems these documents describe leave opportunities for inventory leakage at the patient points of care. Furthermore, since there is no continued inventory management at the patient points of care, these documents do not describe how to improve accountability of inventory throughout the entire distribution chain, and so improve inventory management processes such as restocking and recall. US20090160646A - System & Method for Monitoring and Tracking Inventories - describes a system for monitoring and tracking inventories including a monitoring station for monitoring and tracking one or more assets. The assets may be mobile assets that are employed to deliver inventory from one place to another. The assets include a plurality of sensors (including RFID readers) to monitor the inventory and sense various parameters related to the assets and inventory. Each of the assets further includes a hub that is in contact with a remote monitoring station and with the sensors on the asset. An electronic association is made between the tagged inventories being shipped and the RFID readers and the result is transmitted in an automated fashion to the remote monitoring station either directly or via the hub. As the inventories are transported from the location of shipment to the destination in the asset, updates along the travel route may be recorded automatically and remotely through the interrogation of RFID readers. The integrity of the asset (no door openings or other integrity faults) is also monitored so that no unauthorised access to the asset is provided. The asset can also be another place where inventory is temporarily stationed (e.g. warehouse, retail store). US20130159135A- System and Method for Automated Laboratory Inventory Management Using RFID Technology - describes a system and method for automated laboratory inventory management using RFID technology. In practice, a site uses items tagged with RFID tags and tracks the total number of items at a site. Whenever an item is used, the laboratory personnel scan the item, indicating that the item is being disposed of. If the inventory falls below a threshold, the system generates a purchase order. A vendor tags the items with RFID tags (or an RFID tag may be placed on the item at the site). Upon receipt of the item at the site, the item enters a receiving room which includes RFID portals. The portals scan the RFID tag whereby inventory is updated by the computer program. Upon receiving the item at the receiving room, tagging the item and communicating item information to the computer program, the item remains in the receiving room or is transferred to another area such as a storage room. US20100213086A - Method and Apparatus for Tracking Transported Items Using RFID Tags -describes a method and apparatus for tracking transported items using RFID tags. The apparatus comprises a tote for the shipment of items, such as pharmaceutical products tagged with RFID tags. Using materials that are reflective and/or absorbent to RF signals on one or more of the six walls of the tote, it is possible to increase the readability of RFID tags inside the tote.

There is some discussion in the state of the art as to how to provide secure dispensing systems at patient points of care, and in some cases, how to track dispensing of pharmaceutical products. Examples of such documents are discussed in more detail below.

However, none of these documents describe how to use RFID tags to manage inventory throughout the entire distribution chain, from manufacturer to patient point of care. Furthermore, in some systems, RFID tags are used in conjunction with other systems such as cameras. Using multiple systems increases the chances for inventory leakage and also leads to reduced accountability of stock levels throughout the dispensing chain. US20090043253A - Smart Medical Compliance Method and System - describes a smart medical compliance method and system. The document describes a process where a pharmacist is required to correctly identify himself via an RFID tag and fill a prescription with the appropriate medication or supply for the corresponding patient, as well as identify the care provider who is responsible for the actual act of prescription and administration. The document also describes a smart container for medical applications comprising an RFID enabled electromechanical lockable latch enabling the opening and/or closing of an access gateway to the contents of the container. At a pharmacological preparation point, medical content can be identified and placed in an RFID enabled portable or mobile container, the RFID enabled container and content could be registered for subsequent tracking (this includes identifying and locking the container or content). The container (along with the content) is then transported to the patient point of care. The point of care can interrogate the RFID tag of a patient, and corroborate this with the RFID tag of the container. Upon corroboration, the container is unlocked and the medical content retrieved. This document teaches certain solutions useful for preventing inventory leakage in a clinical setting and ensuring that the correct medical content is administered to the correct patient. However, this document is not concerned with ensuring security of medical content at the initial stages of the distribution chain - from pharmaceutical distribution centre through to delivery to the patient point of care. US20150347712A - System & Method for Product Distribution and Tracking - describes a product tracking system for managing and sharing product information with one or more vested entities. The vested entities may include: a healthcare professional, a pharmacy and a manufacturer or distributor of the pharmaceutical product. The system comprises a smart package, a smart package reader, a network and a server. The smart package includes one or more products in one or more cells where each cell is associated with an RFID tag. The smart package reader includes a designated storage location, and an RFID reader to wirelessly and automatically detect and identify the contents of the smart package associated with the storage location. The storage location may be a cabinet including a locking mechanism. The locking mechanism can be opened remotely if the data processing system receives such a command from a particular node of the product tracking system.

Two methods are described in US20150347712A. Method 1 occurs as follows. Firstly, products are received from manufacturer or distributor and an inventory of blister cards and RFID films are received for assembly. Then, pharmaceutical products are placed in the blister cards and RFID films are placed on the filled blister cards to produce a ‘smart package’. Information about each product in a smart package is then associated with information about its corresponding RFID tag. The smart package is associated with patient or user, and then distributed to that patient. The patient can place the smart package in contact with a smart package reader, and when they do so information is distributed to one or more vested entities.

Method 2 described by US20150347712A occurs as follows. Firstly, a patient or user receives an RFID-enabled smart package which they place in contact with a smart package reader. The package reader obtains information about the smart package and its contents. The patient or user then removes smart package from its designated slot, dispenses a dose of the pharmaceutical product and returns the package to reader. When the package is returned to reader, the reader obtains information about the smart package and its contents and the information is transmitted to vested entities. Product usage information can include aging, expiration, recall data. US20140266581A - Modular Smart Label Data Transmission Systems for Applied End-User Optimisation - describes a modular smart label data transmission system for applied end user optimisation comprising individual medicine bottles with embedded RFID transponders, together with infrastructure sites such as Wi-Fi hotspots. When a smart medical label is in an environment in which communication is possible, the label checks with a network to find out if there are any updates available. If updates are available, the label checks to make sure that the update is cryptographically assured to be authorised and, if so, the label will update itself.

US20140165614A - Smart Storage of Temperature Sensitive Pharmaceuticals - describes a refrigerator and/or freezer unit and system for storing, monitoring, and maintaining a supply of temperature sensitive pharmaceutical products in compliance with regulatory requirements. The system comprises a refrigerator unit including a user interface device (UID) and a reader (which may be an RFID reader), and an ASP (Application Service Provider) inventory management system. The refrigerator has one or more compartments, each compartment may have at least one temperature sensor and a camera to capture an image of the compartment content. In use, an on-site user logs into the unit via the UID and scans the product using a reader on the unit. The reader is in communication with the UID and sends an image of the product to the ASP, the ASP analyses the image and generates a product descriptor. The ASP will check the product descriptor against other product in the refrigerator and assign the product a compartment. The product descriptor and instructions for placement are delivered to the on-site user via the UID. The user can also manually enter information. The product is placed in the appropriate compartment and the user logs out. To dispense the product, the user selects the product, enters the reasons for dispensing the product and removes the product. The camera takes an image of the compartment, sends the image to the ASP, and the unit information is updated. US20080184719A - Intelligent Refrigerator for Storing Pharmaceutical Product Containers -describes an intelligent refrigerator for storing pharmaceutical product containers. The refrigerator comprises a cold storage compartment including shelves adapted to hold one or more containers. Positioned on or near the shelves are RFID antennas which are configured to read any tagged containers placed on the shelves. The refrigerator further comprises a temperature sensor and a processor compartment including a reader, event monitor, event manager and local database. The event monitor will generate an event identifying code in response to the reader detecting that a tagged pharmaceutical product container has been added to or removed from cold storage. While event monitor determines what kind of event has occurred, event manager selects the course of action to take and carries out the selected course of action. If a product has expired or been recalled by the manufacturer, the system will display a warning message. US20080004908A - RFID Medical Supply Monitoring and Tracking System - describes a medicine and medical consumables monitoring and tracking system. The system comprises unique RFID enabled identification cards for the doctor, pharmacist, nurse, etc. and a medicine trolley with RFID controller. In use, a doctor will scan an RFID tag on a patient with a portable RFID reader connected to a doctor’s communication device. Once the doctor’s communication device has been verified, the patient information stored in the central database is sent to the doctor’s communication device. The doctor can then prescribe medication and the prescription is sent to the pharmacist. The pharmacist scans the drug supply RFID tag and sends it to the database for processing. Once the database has been updated, a new RFID tag is produced and the pharmacist affixes it to the drugs. The pharmacist then scans the RFID tag with their own communication device and sends a validation signal to the central database. Once the central database has verified the pharmacist’s identity and the drug, the pharmacist puts the drugs into a medical drawer on a medicine trolley. A nurse then scans the patient’s RFID tag, checks the prescription for the patient and picks up the prescription from the drawer. RFID readers on the medicine trolley detect that the medicine container has been removed from the drawer and either affirms the nurse’s decision or alerts the nurse to an error. The central database is then updated. US20060006999A - Monitoring People, Objects and Information Using Radio Frequency Identification - describes a monitoring system for people, objects, and information using radio frequency identification. In one embodiment, drugs are tagged for specific patients. The patient room is tagged with an RFID reader. If the RFID reader detects tagged medication that does not correspond to the patient location, an alarm is set off. US20130006415A - Medication Dispensing Cabinet Systems and Methods - describes a medication dispensing cabinet including a plurality of drawers, a controller that may control the drawers and a RFID reader. A user requesting access to the cabinet may carry a RFID-tagged token, and the RFID code from the token may be automatically scanned when the token comes into proximity with the cabinet. The code is compared with a list of codes for which access is authorised and access is granted if a match is found. The controller may include remote administration capability. US20100185458A - Method for Retrieving Prescriptions with RFID Detection - describes a method for retrieving prescriptions with RFID detection. A vial is provided with RFID tag and once the vial is filled with a prescription for a particular patient, stored in a storage area. The RFID tag is specific for the prescription. The RFID tag is detected with an RFID detector associated with a controller. The vial is removed from the storage area and the removal of the RFID tag is detected. The removal of the vial and tag is then recorded in the controller. US20110298587A - Safety System for Avoiding Wrong Use of Medicine - describes a safety system for avoiding the wrong use of a medicine which is administered by means of an applicator device. The system includes a transponder associated with the medicine, and a reader assigned to an applicator device. The medicine must cooperate with the applicator device in order to be applied or taken. US20060124655A - Smart Medical Container - describes a medicine dispensing system comprising a smart medicine container having an inbuilt pill dispensing assembly. The smart medicine container is covered by a cap having a universal safety lock that can be coupled with an RFID reader. The smart medicine container is connected to the pharmacy, the pharmacist enters the medicine data including dosage and time. At the specified time, the pill dispensing assembly dispenses the pill. The patient or authorised user can open the cap once it is unlocked and retrieve the medicine. The smart medicine container can receive instructions remotely and the smart medicine container can be instructed to stop dispensing medicament in the event of a recall. TMW424947Y - Can Lock Container - describes a lockable container comprising a cover body and a body, at least one movable lock member and a control unit, the control unit controls the movement of the lock member and the control unit may be an RFID identification unit. US20140155827A - Medicament Information System and Method - describes a medicament information system and method comprising an electronic medicament device including an RFID tag, a sensor, a display and a speaker. The electronic medicament device is for use with a network environment, such as a mobile device. The mobile device may interact with the electronic medicament device for example, by determining proximity of medicament device and issuing an alarm if necessary, ordering replacement upon expiry of medicament, location tracking of the medicament device, or notifying emergency contacts.

Summary of Invention

The invention is defined in the present claims.

In a first aspect, there is provided a method for distributing and monitoring inventory.

Distributing inventory involves transporting the inventory from one location to another. In the case of the invention, distribution involves transporting the inventory from a distribution centre, which might be a local or regional hub, to a patient point of care. There might be many patient points of care to which inventory is distributed from a single distribution centre. A patient point of care is preferably a clinic in a healthcare setting such as a hospital, where a patient will receive treatment. Of course, clinics need not only exist at hospitals and may be ‘stand-alone’. Another example of a patient point of care is a general practitioner’s (GP’s) surgery. Another example of a patient point of care is the patient’s home. Not every environment in a healthcare setting is a patient point of care. For example, no treatment is given to patients in waiting rooms or stock rooms, including pharmacies. Whilst these parts of a hospital are of course vital to its smooth operation, they are not considered patient points of care.

Monitoring inventory involves keeping a record of where the distributed inventory is located. Monitoring need not be perpetual - it may only take place for a particular duration such as between certain locations or until a particular destination or point in time is reached.

The method according to the first aspect of the invention involves: a) detecting at least one RFID-tagged pharmaceutical product using an RFID reader at a pharmaceutical product distribution centre; b) updating the status of a global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer at the pharmaceutical product distribution centre; c) detecting the at least one RFID-tagged pharmaceutical product using a pharmaceutical storage unit comprising at least one RFID reader, wherein the pharmaceutical storage unit is located at a patient point of care; and d) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product has been delivered to the pharmaceutical storage unit at the patient point of care.

Thus, it is possible to ascertain by reference to a global inventory database (which may be operated as part of a network) that a product has left the distribution centre (hub) and arrived at the patient point of care.

According to the invention, no further steps of detecting the at least one RFID-tagged pharmaceutical products take place between steps a) and c). This minimises the opportunity for products to be lost in transit by minimising the different transit steps or people involved in the distribution process. It is an advantage of the invention (and deemed within its scope to be claimed) that the same operator (a first operator) may handle the RFID-tagged pharmaceutical product to facilitate performance of steps a) and c). In this context, an ‘operator’ may be a handler such as a delivery driver, or may be a group of people belonging to the same distribution company. In other words, for example, a delivery driver may handle the product(s) to facilitate product detection at the distribution centre, and the same delivery driver may handle the product(s) to facilitate product detection at the patient point of care.

The pharmaceutical storage unit may comprise more than one compartment. Alternatively (or in addition), there may be provided more than one pharmaceutical storage unit. Each of the multiple compartments and/or multiple pharmaceutical storage units may be independently lockable. The pharmaceutical storage unit may be a temperature controlled pharmaceutical storage unit.

Preferably, to keep track of how many products are located in the pharmaceutical storage unit, step d) further comprises increasing a stock level of the RFID-tagged pharmaceutical product at the pharmaceutical storage unit. The stock level may be a parameter stored locally at the pharmaceutical storage unit and/or on the global inventory database. Of course, a stock level is optional; the pharmaceutical storage unit and/or the global inventory database may simply maintain a list of RFID identifiers located in the pharmaceutical storage unit.

The pharmaceutical product distribution centre need not be the first place the RFID-tagged pharmaceutical product is detected. A distribution chain may include, for example, multiple distribution centres such as continental, national, regional and local. Alternatively, a distribution chain may include other locations such as a pharmaceutical product packaging plant. For example, prior to the commencement of step a), above, the method may comprise: i) detecting the at least one RFID-tagged pharmaceutical product using an RFID reader at a pharmaceutical product packaging plant; ii) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer at the pharmaceutical product packaging plant; iii) detecting the RFID-tagged pharmaceutical product using an RFID reader at the pharmaceutical product distribution centre; and iv) updating the status of the global inventory database to reflect that the at least one RFID-pharmaceutical product has been delivered to the pharmaceutical product distribution centre.

In some methods according to the invention, the RFID-tagged pharmaceutical product is not scanned at any location other than: the pharmaceutical product distribution centre and/or the pharmaceutical product packaging plant, and the pharmaceutical storage unit.

Because stock level is monitored, it is further advantageous to place orders automatically (i.e. by processing means associated with one or more of the global inventory database, pharmaceutical product distribution centre, pharmaceutical storage unit). For instance, preferably the method includes monitoring the stock level of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre and/or pharmaceutical storage unit; and generating an order of the RFID-tagged pharmaceutical product to be delivered to the pharmaceutical product distribution centre and/or pharmaceutical storage unit when the stock level of the RFID-tagged pharmaceutical product in the respective location falls below a predetermined threshold level. The order may be sent to the manufacturer of the pharmaceutical product, to the pharmaceutical product packaging plant (especially in the case where the order is generated at the pharmaceutical product distribution centre) or to the pharmaceutical product distribution centre (especially in the case where the order is generated at the patient point of care or by the pharmaceutical storage unit itself).

The size of the order generated may be based on usage data of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre and/or patient point of care. This usage data may be stored in the global inventory database and/or locally, such as at the pharmaceutical product distribution centre and/or pharmaceutical storage unit. The predetermined threshold level may be determined in any one of a number of ways, including based on one or more data sets. The threshold could be an absolute number. Alternatively, it could take into account factors such as unfulfilled prescriptions of the RFID-tagged pharmaceutical product issued from the patient point of care; usage data at the patient point of care, such as number of fulfilled prescriptions per day, week or month; and even seasonal information, such as time of year or weather conditions. For example, if usage of a particular product is known to increase during the months October to March, the size of the orders during that time could be increased compared with other months. Similarly, if more patients are treated when the weather is cold, a corresponding adjustment to the size of orders could be made depending on the weather forecast.

It is conventional to keep pharmaceutical storage units locked. Preferably, therefore, prior to step c) the pharmaceutical storage unit is locked, and the method further comprises an authorisation step wherein the identity of a first authorised user is verified in order to unlock the pharmaceutical storage unit and to allow the first authorised user access to the pharmaceutical storage unit.

In certain situations (for example, where the pharmaceutical storage unit is refrigerated) it is preferable to grant access (e.g. open the door) for as short a period of time as possible. Moreover, long periods of a door being left open could, in certain situations, be indicative of suspicious activity such as theft. Thus, the present invention contemplates a plurality of user authorisation levels (also referred to herein as user types). Three are specifically contemplated - a first type of user, such as a nurse, who may take a single product from the unit for delivering a treatment; a second type of user, such as a delivery driver, who may restock the unit with a plurality of products; and a third type of user, such as a pharmaceuticals controller, who may be responsible for checking stock, for example in the event of a product recall.

Accordingly, methods according to the invention may provide that a first authorised user has a first predetermined user authorisation level, a second authorised user has a second predetermined user authorisation level, and a third authorised user has a third predetermined user authorisation level. According to the method, after the authorisation step is completed to unlock the pharmaceutical storage unit, the unit is locked again after a predetermined amount of time, wherein the predetermined amount of time is based upon the predetermined user authorisation level. For instance, a first predetermined amount of time corresponds to the first authorisation level; a second predetermined amount of time corresponds to the second authorisation level; and a third predetermined amount of time corresponds to the third authorisation level.

Preferably, the pharmaceutical storage unit and/or global inventory database is configured to issue an alert if the pharmaceutical storage unit is not locked after the predetermined amount of time.

The predetermined amount of time is preferably between 5 seconds and 15 minutes. More preferably, the first predetermined period of time (relating to the first user) is preferably between 30 and 90 seconds, preferably 60 seconds. More preferably, the second predetermined period of time (relating to the second user) is preferably between 3 and 7 minutes, preferably 4 or 5 minutes. More preferably, the third predetermined period of time (relating to the third user) is preferably between 8 and 12 minutes, preferably 10 minutes.

Because inventory is monitored, the invention may be utilised to detect when an ‘order’ is not fulfilled or only partially fulfilled. For example, when at least one RFID-tagged product is part of an order of more than one RFID-tagged products to be delivered to the patient point of care, the method may further comprise checking the status of each of the more than one RFID-tagged products on the global inventory database; and if the statuses of each of the more than one RFI D-tagged products has been updated to reflect that it has been delivered to a pharmaceutical storage unit at the patient point of care, updating the global inventory database to reflect that the order has been delivered. Alternatively, if any one status of the more than one RFID-tagged products has not been updated to reflect that it has been delivered to the patient point of care, the method may comprise updating the global inventory database to reflect that the order has not been delivered or has been partially delivered.

Optionally, the method includes issuing an alert to an authorised user of the pharmaceutical storage unit. In some embodiments, an alert is issued only if a predetermined threshold amount of time has elapsed since the status of any one of the more than one RFID-tagged products has been updated to reflect that the RFID-tagged pharmaceutical product has been delivered to the pharmaceutical storage unit.

Once a pharmaceutical storage unit has been stocked (at least partially) with product, a product may be taken out for treatment. Methods of the invention do not include any steps of treatment by surgery or therapy and specifically exclude and disclaim such method steps.

According to the invention, the method may comprise e) removing the at least one RFID-tagged pharmaceutical product from the pharmaceutical storage unit; f) detecting the removal of the at least one RFID-tagged pharmaceutical product from the pharmaceutical storage unit using the pharmaceutical storage unit comprising the at least one RFID reader; and g) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer located in the pharmaceutical storage unit.

As previously, the method may further comprise decreasing the stock level of the RFID-tagged pharmaceutical product at the pharmaceutical storage unit. Again, the stock level may be a parameter stored locally at the pharmaceutical storage unit and/or on the global inventory database. Of course, a stock level is optional; the pharmaceutical storage unit and/or the global inventory database may simply maintain a list of RFID identifiers located in the pharmaceutical storage unit.

Access to the pharmaceutical storage unit to remove a product has already been described above in connection with depositing one or more products.

In some methods of the invention, the method further comprises providing input data of a pharmaceutical product to be removed from one or more pharmaceutical storage units at a patient point of care to a user interface associated with the said one or more pharmaceutical storage units. The input data may include one or more of the product name, a product ID (batch number, serial number) or patient name or ID, wherein the patient is linked (for example in the global inventory database) to a particular product. The user interface may be a computer, a tablet, or a touch screen or other input device on or communicatively coupled to the one or more pharmaceutical storage units.

The method may further comprise comparing the input data with stock data of the one or more pharmaceutical storage units. If at least one RFID-tagged pharmaceutical product stored in the one or more pharmaceutical storage units matches the input data, the method comprises allowing access to the or each of the one or more pharmaceutical storage units for which a match is detected. Preferably, the method comprises prohibiting access to the or each of the one or more pharmaceutical storage units for which a match is not detected.

In these methods described above, if the RFID reader of the pharmaceutical storage unit (or processing means associated therewith) detects removal of an RFID-tagged pharmaceutical product, and the product that is removed does not match the product associated with the input data provided to the user interface, the pharmaceutical storage unit may issue an alert.

In some methods of the invention, access to a pharmaceutical storage unit may be prohibited if the RFID-tagged pharmaceutical product fails to fulfil a safety criteria. In practice, access may be prohibited by allowing access only after verifying that the RFID-tagged pharmaceutical product fulfils a safety criteria. Alternatively, the method may include periodically polling the contents of the or each pharmaceutical storage unit in at least one patient point of care, wherein the polling comprises verifying that the RFID-tagged pharmaceutical product fulfils a safety criteria. If any pharmaceutical storage unit is found to contain one or more RFID-tagged pharmaceutical products that fail to fulfil the safety criteria, access may be prohibited to all users except an appropriately authorised user, for example a user of the third type.

Fulfilment of a safety criteria may take many forms, but examples include the following: that the batch number of the RFID-tagged pharmaceutical product has not been marked for recall on the global inventory database; that the serial number of the RFID-tagged pharmaceutical product has not been marked for recall on the global inventory database; that the expiration date ofthe RFID-tagged pharmaceutical product has not lapsed; and that the required storage conditions of the RFID-tagged pharmaceutical product are marked as fulfilled on the global inventory database.

It will be appreciated that to fulfil this purpose (and, in fact, for other purposes), an RFID tag of the RFID-tagged pharmaceutical product may comprise one or more of the following data: batch number of the RFID-tagged pharmaceutical product; serial number ofthe RFID-tagged pharmaceutical product; expiration date ofthe RFID-tagged pharmaceutical product; and required storage conditions of the RFID-tagged pharmaceutical product.

Storage conditions may comprise a minimum and/or maximum temperature at which the product must be stored.

In a related aspect, the invention provides a system for distributing and monitoring inventory comprising: an RFID reader located at a pharmaceutical product distribution centre and configured to scan at least one RFID-tagged pharmaceutical product; a pharmaceutical storage unit located at a patient point of care and comprising at least one RFID reader, the pharmaceutical storage unit RFID reader being configured to scan the at least one RFID-tagged pharmaceutical product; a data processing system configured to: update a global inventory database to reflect that the at least one RFID-tagged product is no longer at the pharmaceutical product distribution centre when the RFID reader located at the pharmaceutical product distribution centre scans the at least one RFID-tagged pharmaceutical product; and update a global inventory database to reflect that the at least one RFID-tagged product has been delivered to the pharmaceutical storage unit at the patient point of care when the pharmaceutical storage unit RFID reader scans the at least one RFID-tagged pharmaceutical product.

The system may comprise sub-systems or parts corresponding to the optional method steps described above.

In a second aspect, the present invention provides a method for securing inventory at a plurality of patient points of care in the event of a recall of at least a portion of said inventory. By ‘securing’ it is meant preventing access to a pharmaceutical storage unit in which the affected inventory is located by all users except one or more appropriately authorised users, for example a user of the third type described above. It would typically be the role of the appropriately authorised user to locate and remove the affected inventory, and confirm that remaining inventory had not been subject to a recall. The number of appropriately authorized users is usually lower than the number of users for which access is prevented. Usually, the number of appropriately authorized users is one, two, three, four or five; but can also be higher. Preferably, the users for which access is prevented are users of the first type and/or the second type.

It will be appreciated that steps of methods according to the second aspect may be combined with steps according to the first aspect described above, and vice versa.

The method according to the second aspect comprises: a) updating a global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled; b) for each patient point of care, checking stock data of at least one pharmaceutical storage unit to determine if said pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled and, if so, further comprising one or more of the following steps: i) issuing an alert to a user of the pharmaceutical storage unit; and ii) preventing access to the pharmaceutical storage unit to all users except one or more appropriately authorised users.

It will be appreciated that steps a) and b) are preferably implemented electronically and performed by processors associated with the global inventory database and/or at the patient point of care, such as at the pharmaceutical storage unit. In particular, step a) is likely to be performed by processors associated with the global inventory database or at least part of the same network. Whether step b) is carried out by processors associated with the global inventory database or locally at the patient point of care may depend on the sophistication of the patient point of care; whether the patient point of care operates its own processors and/or maintains its own databases storing stock data. Preferably storage of all stock data and all processing takes place in a networked environment including the global inventory database.

Issuing alert to a user of the pharmaceutical storage unit comprises sending an email to a user of the pharmaceutical storage unit, such as a user of the third type.

Conventionally in product recall situations, access to all inventory is completely prohibited for the purposes of delivering treatment until all inventory has been checked to ensure that recalled products have been removed. This is particularly frustrating because much of the inventory may be safe to use. Accordingly, in conventional methods there is potential for unnecessary delay in patient care whilst an administrative process is completed.

In an advantageous method of the invention, a patient point of care has a plurality of independently lockable pharmaceutical storage units (or independently lockable compartments in a single pharmaceutical storage unit) and step b) includes, checking stock data of the plurality of pharmaceutical storage units (or compartments). In this method, the step of preventing access comprises first checking the stock data of each of the plurality of pharmaceutical storage units (or compartments) to identify which of them contains the at least one RFID-tagged pharmaceutical product to be recalled.

For those pharmaceutical storage units (or compartments) which are found to contain one or more RFID-tagged pharmaceutical product to be recalled, access to the units (or compartments) is prohibited to all users except one or more appropriately authorised users, for example ofthe third type described above. For those pharmaceutical storage units (or compartments) which are found not to contain one or more RFID-tagged pharmaceutical product to be recalled, access to the units (or compartments) is not prohibited, except insofar as access to the unit is granted only to authorised users such as the first type described above.

Preferably, once access to the pharmaceutical storage unit that contains the RFID-tagged pharmaceutical product to be recalled has been prevented, the method further comprises an authorisation step wherein the identity of an authorised user is verified in order to provide access the pharmaceutical storage unit, and allowing the authorised user access to the pharmaceutical storage unit. The authorised user is preferably an appropriately authorised user, for example of the third type described above.

The method includes removing the RFID-tagged pharmaceutical product to be recalled from the pharmaceutical storage unit and verifying that the pharmaceutical storage unit no longer contains the RFID-tagged pharmaceutical product to be recalled using the at least one RFID reader associated with the pharmaceutical storage unit. Once the pharmaceutical storage unit is verified to no longer contain the RFID-tagged pharmaceutical product, the method includes allowing access to the pharmaceutical storage unit to authorised users such as the first type described above.

In an associated aspect, the invention provides a system for securing inventory at a plurality of patient points of care in the event of a recall of at least a portion of said inventory, comprising: a data processing system configured to: update a global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled; and a pharmaceutical storage unit located at each of the plurality of patient points of care, wherein each pharmaceutical storage unit is configured to prevent access to all authorised users except one or more appropriately authorised users if it is determined that the respective unit contains at least one RFID-tagged pharmaceutical product to be recalled.

The system may comprise sub-systems or parts corresponding to the optional method steps described above.

In a third aspect of the invention, there is provided a lockable cabinet for storing RFID-tagged pharmaceutical products, comprising a door and door sensor, an access system configured to enable the door to be opened upon detection of an identifier of one of a plurality of types of user, and an alert system for raising an alert if the door sensor indicates that the door has been opened for longer than a pre-determined time period, wherein the predetermined time period differs depending on the type of user associated with the identifier detected by the access system.

As described above, it is conventional to keep pharmaceutical storage units locked. Units may be unlocked (i.e. to enable the door to be opened) by using an access system to determine the identity of the user. The present invention contemplates a plurality of user authorisation levels (also referred to herein as user types). Three are specifically contemplated - a first type of user, such as a nurse, who may take a single product from the unit for delivering a treatment; a second type of user, such as a delivery driver, who may restock the unit with a plurality of products; and a third type of user, such as a pharmaceuticals controller, who may be responsible for checking stock, for example in the event of a product recall.

Accordingly, methods according to the invention may provide that a first authorised user has a first predetermined user authorisation level, a second authorised user has a second predetermined user authorisation level, and a third authorised user has a third predetermined user authorisation level. According to the method, after the authorisation step is completed to unlock the pharmaceutical storage unit, the unit is locked again after a predetermined amount of time, wherein the predetermined amount of time is based upon the predetermined user authorisation level. For instance, a first predetermined amount of time corresponds to the first authorisation level; a second predetermined amount of time corresponds to the second authorisation level; and a third predetermined amount of time corresponds to the third authorisation level.

Preferably, therefore, the access system is configured to identify at least three types of user, and operate with at least three corresponding time periods.

The first time period associated with the first user type is preferably between 5 and 120 seconds, preferably between 10 and 110 second, more preferably between 30 and 90 seconds, more preferably between 45 and 75 seconds, more preferably between 55 and 65 seconds, and most preferably one minute. These time periods are sufficient to enable a product to be selected for delivering a treatment.

The second time period associated with the second user type is preferably between 1 and 10 minutes, preferably between 2 and 8 minutes, more preferably between 3 and 6 minutes, more preferably between 4 and 5 minutes, and most preferably either 4 minutes or 5 minutes. These time periods are sufficient to enable a plurality of products to be deposited, such as when the unit is being restocked.

The third time period associated with the third user type is preferably between 5 and 15 minutes, preferably between 6 and 14 minutes, more preferably between 7 and 13 minutes, more preferably between 8 and 12 minutes, more preferably between 9 and 11 minutes, and most preferably 10 minutes. These time periods are sufficient to enable inventory to be assessed, for example in a product recall situation.

In an associated aspect, the invention provides a method of selecting an RFID-tagged pharmaceutical product for administration to a patient. The method comprises presenting an identifier of a first user type to the access system to enable the door to be opened, and opening the door; removing, by a user of the first user type, the at least one RFID-tagged pharmaceutical product from the lockable storage cabinet; and closing the door within the first time period, or else raising an alert.

In another associated aspect, the invention provides a method of delivering at least one RFID-tagged pharmaceutical product to a lockable cabinet. The method comprises presenting an identifier of a second user type to the access system to enable the door to be opened, and opening the door; depositing, by a user of the second type, the at least one RFID-tagged pharmaceutical product within the lockable cabinet; and closing the door within the second time period, or else raising an alert.

In yet another associated aspect, the invention provides a method of removing at least one RFID-tagged pharmaceutical product that has been recalled from a lockable cabinet, the method comprising: presenting an identifier of a third user type to the access system to enable the door to be opened, and opening the door; removing, by a user of the third type, the at least one RFID-tagged pharmaceutical product that has been recalled from the lockable cabinet; and closing the door within the third time period, or else raising an alert. Preferably, prior to the step of presenting an identifier of a third user type, the method comprises preventing access to the lockable cabinet by users of the first and/or second type even upon detection of an associated identifier.

It will be appreciated that steps of methods according to the third aspect may be combined with steps according to the first and second aspects described above, and vice versa.

In a fourth aspect, the present invention provides a method for registering a pharmaceutical product with an RFID tag comprising a user authorisation step wherein a user inputs login credentials into a user interface associated with an RFID reader; scanning an RFID tag with the RFID reader; a data processing step wherein the RFID reader connects to a global inventory database; presenting pharmaceutical product information data to the user; a user selection step wherein the user selects pharmaceutical product information data that are associated with a pharmaceutical product to be registered with the RFID tag; and updating the global inventory database to reflect that the RFID tag is now associated with the user-selected selected pharmaceutical product information data.

Preferably pharmaceutical product information data includes one or more of: batch numbers of pharmaceutical products; serial numbers of pharmaceutical products; expiration dates of pharmaceutical products; and required storage conditions of pharmaceutical products.

In some methods of the invention, the user manually inputs pharmaceutical product information data associated with a pharmaceutical product to be registered with the RFID tag into the user interface; and the user interface highlights a pharmaceutical product data that matches the input pharmaceutical product information data; and the user selects the pharmaceutical product information data that is associated with the pharmaceutical product to be registered with the RFID tag.

In another aspect, the present invention provides a system for distributing and monitoring inventory comprising: an RFID reader located at a pharmaceutical product distribution centre and configured to scan at least one RFID-tagged pharmaceutical product; a pharmaceutical storage unit located at a patient point of care and comprising at least one RFID reader, the pharmaceutical storage unit RFID reader being configured to scan the at least one RFID-tagged pharmaceutical product; a data processing system configured to: update a global inventory database to reflect that the at least one RFID-tagged product is no longer at the pharmaceutical product distribution centre when the RFID reader located at the pharmaceutical product distribution centre scans the at least one RFI D-tagged pharmaceutical product; and update a global inventory database to reflect that the at least one RFID-tagged product has been delivered to the pharmaceutical storage unit at the patient point of care when the pharmaceutical storage unit RFID reader scans the at least one RFID-tagged pharmaceutical product.

In another aspect, the present invention provides a lockable cabinet comprising a door and door sensor, an access system configured to enable the door to be opened upon detection of an identifier of one of a plurality of types of user, and an alert system for raising an alert if the door sensor indicates that the door has been opened for longer than a pre-determined time period, wherein the predetermined time period differs depending on the type of user associated with the identifier detected by the access system.

Preferably, the access system of the lockable cabinet is configured to identify at least three types of users, and operate with at least three corresponding time periods.

Preferably, the first time period associated with the first user type is between 5 and 120 seconds, more preferably between 10 and 110 second, more preferably between 30 and 90 seconds, more preferably between 45 and 75 seconds, more preferably between 55 and 65 seconds, and most preferably one minute.

Preferably, the second time period associated with the second user type is between 1 and 10 minutes, Preferably, ore preferably between 2 and 8 minutes, more preferably between 3 and 6 minutes, more preferably between 4 and 5 minutes, and most preferably either 4 minutes or 5 minutes.

Preferably, the third time period associated with the third user type is between 5 and 15 minutes, more preferably between 6 and 14 minutes, more preferably between 7 and 13 minutes, more preferably between 8 and 12 minutes, more preferably between 9 and 11 minutes, and most preferably 10 minutes.

In other aspects associated with aspects of the invention, the RFID-tagged pharmaceutical product, or pharmaceutical product comprises an anti-vascular endothelium growth factor (anti-VEGF) for ophthalmological purposes, preferably wherein the RFID tagged pharmaceutical product or pharmaceutical product comprises Aflibercept.

Preferred embodiments of the invention or aspects thereof, will now be described in detail with reference to the drawings, in which:

Figure 1 shows an exemplary distribution chain for an RFID-tagged pharmaceutical product from a pharmaceutical product manufacturing plant to a patient point of care.

Figure 2 shows an exemplary RFID-tagged pharmaceutical product.

Figure 3a shows an example of a closed pharmaceutical storage unit in accordance with the present invention. Figure 3b shows an open pharmaceutical storage unit. Figure 3c shows a high-level block diagram illustrating the main components of the pharmaceutical storage unit.

Figure 4a shows an example of a handheld RFID reader and Figure 4b shows a high-level block diagram illustrating the main components of the handheld RFID reader, along with a pharmaceutical storage unit.

Figures 5a-5c show high level block diagrams displaying alternative configurations of more than one pharmaceutical storage units at a patient point of care and pharmaceutical product distribution centre.

Figure 6 shows an exemplary network by which the distribution chain of Figure 1 may be implemented.

Figure 7 shows an example of the method for monitoring inventory during a distribution process from pharmaceutical product distribution centre to a pharmaceutical storage unit at a patient point of care.

Figure 8 shows an alternative method of Figure 7 in which the at least one RFID-tagged product is part of an order of more than one RFID-tagged products to be delivered to the patient point of care.

Figure 9 shows a secure method for monitoring the removal of the RFID-tagged pharmaceutical product from the pharmaceutical storage unit.

Figure 10 shows an alternative example ofthe method of Figure 9 comprising providing input data of a pharmaceutical product to be removed from the pharmaceutical storage unit to a user interface associated with the pharmaceutical storage unit.

Figure 11 shows a method for reordering RFID-tagged pharmaceutical product to a pharmaceutical storage unit located at a patient point of care.

Figure 12 shows an example ofthe method for recalling at least one RFID-tagged pharmaceutical product from a pharmaceutical storage unit.

Detailed Description ofthe Invention

Exemplary components of the system and methods

Figure 1 shows an exemplary distribution chain for an RFID-tagged pharmaceutical product from a pharmaceutical product manufacturing plant 1 to a patient point of care 4, 5, 6.

The distribution chain begins at pharmaceutical product manufacturing plant 1, where pharmaceutical products are manufactured. The pharmaceutical products are then transported to pharmaceutical product packaging plant 2 where an RFID tag is applied to at least one pharmaceutical product. RFID tags are described further elsewhere herein. From the pharmaceutical product packaging plant 2, the at least one RFID-tagged pharmaceutical product 10 is transported to pharmaceutical product distribution centre 3. The at least one RFID-tagged pharmaceutical product 10 is then transported from the pharmaceutical product distribution centre 3 to a pharmaceutical storage unit 10 at a patient point of care 4, 5, 6.

Pharmaceutical Product Manufacturing Plant

The pharmaceutical product manufacturing plant 1 manufactures at least one pharmaceutical product. In one embodiment of the invention, the pharmaceutical product manufacturing plant 1 manufactures a pharmaceutical product for the treatment of eye disorders or eye diseases. In a preferred embodiment of this invention, the pharmaceutical product manufacturing plant 1 manufactures an anti-vascular endothelium growth factor (anti-VEGF) for ophthalmological purposes. In a further preferred embodiment of this invention, the pharmaceutical product manufacturing plant 1 manufactures a pharmaceutical product for the treatment of wet-macular degeneration. In a further preferred embodiment of this invention, the pharmaceutical product manufacturing plant 1 manufactures Aflibercept (trade name Eylea®).

As used herein, the expression "VEGF antagonist" or “anti-VEGF” means any molecule that blocks, reduces, neutralizes, inhibits, abrogates, or interferes with the normal biological activity of VEGF including its binding to one or more VEGF receptors (VEGFR1 and VEGFR2). VEGF antagonists (or anti-VEGF) include for example molecules which interfere with the interaction between VEGF and a natural VEGF receptor, e.g. molecules which bind to VEGF or a VEGF receptor and prevent or otherwise hinder the interaction between VEGF and a VEGF receptor. VEGF antagonists (or anti-VEGF) include (i) antibody VEGF antagonists such as but not limited to - anti-VEGF antibodies such as bevacizumab (Avastin®; WO9845331) and antigenbinding fragments thereof such as ranibizumab (Lucentis® WO9845331), brolucizumab (RTH258, EP2307454) - anti-VEGFR1 or anti-VEGFR2 antibodies or and antigen-binding fragments thereof (ii) non-antibody VEGF antagonist such as but not limited to - small molecule inhibitors of the VEGFR tyrosine kinases (e.g. sunitinib), - RNA aptamers specific to VEGF, - Antibody-Mimetika against VEGF or VEGF receptors (e.g. Affibody®-molecules (e.g. DARPin® MP0112 (WO2010/060748)), Affiline, Affitine, Anticaline, Avimere), and - VEGF receptor-based chimeric molecules also known as VEGF fusion proteins or VEGF-Traps such as Aflibercept (Eylea®; W02000/75319) or conbercept (Langmu®, W02005/121176). VEGF receptor-based chimeric molecules include chimeric polypeptides which comprise two or more immunoglobulin (Ig)-like domains of a VEGF receptor such as VEGFR1 (also referred to as Flt1) and/or VEGFR2 (also referred to as Flk1 or KDR), and may also contain a multimerizing domain, e.g. a Fc domain which facilitates the multimerization, e.g. dimerization of two or more chimeric polypeptides. Exemplary VEGF receptor-based chimeric molecules are Aflibercept or conbercept.

Pharmaceutical Product Packaging Plant

The pharmaceutical product packaging plant 2 receives at least one pharmaceutical product, packages the pharmaceutical product and/or applies an RFID tag to the packaging of the pharmaceutical product. In this way, the at least one pharmaceutical product is packaged as an RFID-tagged pharmaceutical product 10.

The RFID tags applied to the pharmaceutical products are registered with the pharmaceutical product on the global inventory database. This registration process can occur before or after the RFID tag is applied to the pharmaceutical product and at the pharmaceutical product packaging plant 2 or the pharmaceutical product distribution centre 3. The global inventory database and registration process is described further elsewhere herein.

Pharmaceutical Product Distribution Centre

The least one RFID-tagged pharmaceutical product 10 is delivered from the pharmaceutical product distribution centre 3 to a pharmaceutical storage unit 20 comprising an RFID reader 22, wherein the pharmaceutical storage unit 20 is located at a patient point of care.

Also according to an embodiment of the present invention, the at least one RFID-tagged pharmaceutical product 10 is detected using an RFID reader at a pharmaceutical product distribution centre. In one embodiment of the invention, this RFID reader may be handheld RFID reader 40, for example, the MC55 from Zebra Technologies (3 Overlook Point, Lincolnshire, Illinois, 60069. UNITED STATES OF AMERICA). In another embodiment of the invention, this RFID reader 22 may be included in a pharmaceutical storage unit 20. RFID reader 40 is further described elsewhere herein, with reference to Figures 4a-4c.

Patient Point of Care

In the present invention, patient points of care 4, 5 and 6 are locations at which the RFID-tagged pharmaceutical product is administered to a patient. Administering the RFID-tagged pharmaceutical product to the patient is the process by which the pharmaceutical product is delivered into or applied onto the patient’s body. Methods of administering the product can be for example topical, parenteral or enteral.

For example, in the present invention, administering an RFID-tagged pharmaceutical product to a patient includes injecting an injectable RFID-tagged pharmaceutical product into a patient or applying a topical RFID-tagged pharmaceutical product topically to the area of concern of a patient.

In the present invention, administration of an RFID-tagged pharmaceutical product to a patient does not include dispensing the RFID-tagged pharmaceutical product to a patient for later administration. For example, in the present invention, a patient point of care would not be a pharmacy, where an RFID-tagged product is dispensed for administering to the patient at another location. Furthermore, in the present invention, a patient point of care would not be a manufacturing facility, a warehouse, a distribution centre, a retail store or delivery vehicle.

In the example shown in figure 1, a patient point of care is a part of a hospital 4, a clinic 5, or a patient’s home 6.

Figure 2 shows an exemplary pharmaceutical product 10 packaged in a box. In this example, the box contains vials of the liquid pharmaceutical Aflibercept, but it will be appreciated that other products may be packaged in the box, and also in many different forms (e.g. pills, capsules, prefilled syringes, and so on). The box has attached thereto an RFID tag 11 comprising a microchip and a tag antenna. The microchip includes memory for storing a unique identification code. The tag antenna collects radio-frequency electromagnetic energy and provides it to the microchip in order to power the microchip. In the present system and method, the memory can also include one or more of the following data: batch number of a pharmaceutical product, serial number of a pharmaceutical product, expiration date of a pharmaceutical product, required storage conditions of a pharmaceutical product. RFID tags

The RFID tag 11 on the box in figure 2 is a passive tag, however this need not be the case. RFID tags can be passive or active. Active RFID tags contain their own power source (such as a battery) and can transmit their own unique identification code periodically. Passive RFID tags RFID tags do not contain their own power source and are powered by the radio-frequency electromagnetic energy transmitted from an RFID reader.

In the present system and method, pharmaceutical products are labelled with an RFID tag 11 so that they can be monitored during the distribution chain, from the pharmaceutical product distribution centre 3 or pharmaceutical product packaging plant 2 to a pharmaceutical storage unit at a patient point of care 4, 5, 6, and, in some embodiments of the invention, to administration to a patient at a patient point of care 4, 5, 6. Also in some embodiments of the present invention, RFID identification cards or token or the like (RFID ID cards) comprising an RFID tag are used in conjunction with an RFID scanner to complete a user authorisation step.

Figure 2 shows an RFID tag applied to the box of a pharmaceutical product. As will be appreciated, in other examples of an RFID-tagged pharmaceutical product, the RFID tag can be embedded into the packaging, or put inside the packaging. In some examples of an RFID-tagged pharmaceutical product, there may be more than one RFID tag 11. For example, in the case of a blister pack with multiple pills inside each blister, there may be an RFID tag 11 on each blister. Alternatively, where an RFID-tagged pharmaceutical product 10 comprises inner and outer packaging, for example an inner tube and a box, there may be distinct RFID tags 11 on both the inner and outer packaging.

In other examples of the RFID-tagged pharmaceutical product 10, the RFID tag is applied to the outside of the product itself, for example, onto a tube, or vial, as opposed to a box.

Figure 3a shows an example of a closed pharmaceutical storage unit 20 in accordance with the present invention. Figure 3b shows an open pharmaceutical storage unit 20. Figure 3c shows a high-level block diagram illustrating the main components of pharmaceutical storage unit 20.

As illustrated in Figure 3a, pharmaceutical storage unit 20 is a cabinet with door 26. As illustrated in Figure 3b, pharmaceutical storage unit 20 includes shelves 27. Of course, it will be appreciated that pharmaceutical storage unit 20 can also be a cabinet with more than one door, a cabinet with one or more drawers, a cabinet with one or more compartments, or any combination thereof. The pharmaceutical storage unit 20 can be portable or stationary within the patient point of care.

As illustrated in Figure 3a, pharmaceutical storage unit 20 further includes user interface 23 including temperature controls. Pharmaceutical storage unit 20 also includes an LCD screen 25 to display the temperature inside the pharmaceutical storage unit. It will be appreciated that in other embodiments of pharmaceutical storage unit 20, the user interface 23 can be configured such that a user can enter information into the user interface, such as information of a pharmaceutical product they wish to retrieve, or login data.

As illustrated in Figure 3c, pharmaceutical storage unit 20 includes control unit 21, RFID reader 22, and sensor 24.

Control unit 21 is configured to communicate with a cloud-storage based global inventory database via inventory management software in order to provide information to the global inventory database. The cloud-storage based global inventory database and inventory management software is described in more detail elsewhere herein, and with respect to Figure 6. Control unit 21 is internet enabled to allow this communication with cloud-based storage. The internet enablement may be one or more of Ethernet, cellular, and WiFi connections.

In one example of pharmaceutical storage unit, the temperature of temperature controlled pharmaceutical storage unit 20 can be controlled remotely via the control unit 21 running the inventory management software. In embodiments of the invention where the pharmaceutical storage unit includes more than one compartment, the temperature of each compartment can be independently set via the control unit 21.

Pharmaceutical storage unit 20 includes sensor 24. In the example of pharmaceutical storage unit 20 where the temperature can be controlled, sensor 24 is a temperature sensor. However, it will be appreciated that sensor 24 could also be/include a humidity sensor and/or a pressure sensor and/or a sensor to sense whether or not the pharmaceutical storage unit is open or closed.

The pharmaceutical storage unit can be electrically powered via mains electricity and/or by battery. RFID reader 22 of pharmaceutical storage unit 20 is configured to detect RFID-tagged pharmaceutical products that are within the pharmaceutical storage unit. In the present invention, RFID reader 22 is further configured to provide information to a global inventory database 82 via control unit 21 to update the global inventory database. RFID reader 22 comprises a reader antenna which transmits radio-frequency electromagnetic energy (interrogation signals) to the RFID tag antenna in order to bi-directionally communicate with the RFID tag antennas and deliver RFID tag data to a data processing unit running inventory management software. This bi-directional communication can include continuous inventorying -continuously sending out interrogation signals from the RFID readers in order to detect RFID tags within the range of the RFID reader and/or filtering - sending out interrogation signals from the RFID readers to search for RFID tags that meet certain criteria. In the present invention, these certain criteria can be one or more of the following: batch number, serial number, expiration date and storage requirement data.

Since RFID tag 11 antenna and RFID reader 22 antenna communicate via radio-frequency electromagnetic energy, the RFID reader 22 can detect RFID tag 11 without the RFID tag 11 being in line-of-sight of the RFID reader 22. The range of the RFID reader 22 can be as long as 100m. RFID reader 22 can detect thousands of RFID tags simultaneously.

It will be appreciated that in other examples of pharmaceutical storage unit 20, there may be more than one RFID reader 22. In the example of pharmaceutical storage unit 20 shown in Figures 3a-3c, the pharmaceutical storage unit RFID reader 22 is a low-frequency proximity RFID reader, wherein it operates at RFID frequencies of 902 to 928 MHz.

In general, RFID readers can be stationary or mobile. In the present invention, pharmaceutical storage unit 20 includes a built in RFID reader 22. It is well known how to set up an RFID reader into a storage unit (for example, see US20080184719A1, described in more detail in the Background section).

Figure 4a shows an example of a handheld RFID reader 40 and Figure 4b shows a high-level block diagram illustrating the main components of RFID reader 40, along with pharmaceutical storage unit 30.

In contrast to pharmaceutical storage unit 20, pharmaceutical storage unit 30 does not include an inbuilt RFID reader. Instead, pharmaceutical storage unit 30 is configured to interact with handheld RFID reader 40.

As shown in Figure 4b, pharmaceutical storage unit 30 includes control unit 31, user interface 33 and sensor 34. These components are configured to work in the same way as respective control unit 21, user interface 23 and sensor 24, as described above. Handheld RFID reader includes a control unit 41, RFID reader 42 and user interface 43. These components are configured to work in the same way as respective control unit 21, RFID reader 22 and user interface 23, as described above.

In the present invention, pharmaceutical products are stored at the pharmaceutical product distribution centre 3 in pharmaceutical storage unit 30. It will be understood that, in some examples, pharmaceutical storage unit 30 is not temperature-controlled. In yet a further example of the invention, the pharmaceutical storage unit 30 is not temperature-controlled but is kept in a temperature controlled environment.

In some examples of the invention, pharmaceutical storage unit 30 is a lockable pharmaceutical storage unit and requires a user authorisation step in order to allow access to the pharmaceutical storage unit 30. In an alternative embodiment of the invention, pharmaceutical storage unit 30 does not require a user authorisation step in order to allow access to the pharmaceutical storage unit.

Figures 5a-5c show high level block diagrams displaying alternative configurations of more than one pharmaceutical storage units. Figure 5a shows a patient point of care 4, 5, 6 including four pharmaceutical storage units 20, each pharmaceutical unit configured to communicate with control unit 60, which in turn is configured to communicate with cloud storage network 70 (not shown in Figure 5a). Figure 5b shows a pharmaceutical product distribution centre 3 including four pharmaceutical storage units 20, each pharmaceutical unit configured to communicate with control unit 60, which in turn is configured to communicate with cloud storage network 70 (not shown in Figure 5b). Figure 5c shows a pharmaceutical storage unit 3 including three pharmaceutical storage units 20 and a handheld RFID reader 40, each pharmaceutical unit configured to communicate with control unit 60, which in turn is configured to communicate with cloud storage network 70 (not shown in Figure 5c). It will be appreciated that there are alternative embodiments ofthe invention including any configuration of one or more pharmaceutical storage units 20 and/or 30, RFID reader 40 and control unit 60.

Lockable pharmaceutical storage units and user authorisation:

In some examples of the invention, pharmaceutical storage unit 20 (as shown e.g. in Figures 3a-3c), and pharmaceutical storage unit 30 (as shown e.g. in Figure 4b can be lockable). In the example shown in Figures 3a-3c, pharmaceutical storage unit 20 can remotely lockable via control unit 21 running the inventory management software. In the example shown in Figures 4a-4b, pharmaceutical storage unit 30 can remotely lockable via control units 31 and 41 running the inventory management software. It will be understood that, in examples of the invention where pharmaceutical storage unit 20 has more than one compartment, the more than one compartment can be independently lockable and/or independently remotely lockable. In examples shown in Figures 5a-5c where there is more than one pharmaceutical storage units, each of the pharmaceutical storage units can be lockable and/or remotely lockable.

In examples of the invention in which pharmaceutical storage unit 20 and/or pharmaceutical storage unit 30 is lockable, pharmaceutical storage unit 20, 30 requires a user authorisation step wherein the identity of an authorised user is verified in order to unlock the pharmaceutical storage unit access to pharmaceutical storage unit 20, 30. It will be appreciated that this user authorisation step could be in one and/or more of the following forms: • pharmaceutical storage unit RFID reader 22, 42 detecting an RFID ID card that is registered with the global inventory database 82 and assigned to an authorised user; • an authorised user entering login details into user interface 23, 33, 43 registered with pharmaceutical storage unit 20, 30; • an authorised user providing biometric information to a biometric reader registered with the pharmaceutical storage unit 20, 30.

Figure 6 shows an exemplary network by which the distribution chain of Figure 1 may be implemented.

The network of Figure 6 includes a cloud storage network 70, which is a remote storage network that is accessed via the internet. Cloud storage network 70 is a network of one or more servers 80. Server 80 includes memory 81 to store global inventory database 82, and a processor 83 to perform computations required to complete methods of the present invention such as registering delivery of an RFID-tagged product; generating a reorder of an RFID-tagged product and completing a recall of an RFID-tagged product. These methods are described further elsewhere herein.

Server 80 is configured to communicate with pharmaceutical product manufacturing plant 1, pharmaceutical product packaging plant 2, pharmaceutical product distribution centre 3 and patient points of care 4, 5, 6.

Control unit 21, 31 and 41 (not shown in Figure 6) run inventory management software used to direct the communication between the RFID readers and the global inventory database 82. In the present invention, the RFID readers include the pharmaceutical storage unit 20 comprising an RFID reader 22 (not shown in Figure 6) and the handheld RFID reader 40 (not shown in Figure 6) for use at the pharmaceutical product distribution centre 3 and/or pharmaceutical product packaging plant 2.

The global inventory database 82 includes data relating to all of the RFID-tagged pharmaceutical products 10 that have been registered with the distribution, monitoring and managing system of the present invention. This data can include any or all of the following data: batch numbers of the RFID-tagged pharmaceutical products, serial numbers of the RFID-tagged pharmaceutical products, expiration dates of the RFID-tagged pharmaceutical products 10, location and required storage conditions of the RFID-tagged pharmaceutical products 10 (for example temperature requirements).

The global inventory database further includes data relating to all RFID readers 22, 42 that are registered with the system. In some embodiments, these RFID readers are mobile RFID readers 42 including handheld RFID reader 40 that is used at the pharmaceutical product distribution centre 3 and/or pharmaceutical product packaging plant 2. These RFID readers may also be stationary RFID readers 22, for example, stationary RFID reader 22 included in a pharmaceutical storage unit 20 located at patient point of care 4, 5, 6.

The global inventory database also includes data relating to pharmaceutical storage units 20, 30 that have been registered with the system - this data can include one or more of the following data: location data of the pharmaceutical storage unit 20, 30, current stock level data of the pharmaceutical storage unit 20, 30, past usage data of the pharmaceutical storage unit 20, 30 and authorised users of the pharmaceutical storage unit 20, 30.

In embodiments of the invention where there is more than one pharmaceutical storage unit 20, 30 at any one location, as shown in Figures 5a-5c, the global inventory database can include data for each patient point of care 4, 5, 6. This data can include location data, current stock level data, past stock level data, and authorised users for each patient point of care 4, 5, 6.

In embodiments of the invention which include an authorisation step (as described previously), the global inventory database 82 includes data relating to authorised users of the pharmaceutical storage unit 20, 30. This data can include: RFID ID card data of each authorised user; contact information of each authorised user (for example an email address); and user authorisation level.

The user authorisation level data further includes a predetermined amount of time each authorised user is allowed to a particular pharmaceutical storage unit before it is remotely locked. For example, the predetermined amount of time allowed to access a pharmaceutical storage unit for a nurse or doctor would be enough for the nurse or doctor to collect an RFID-tagged pharmaceutical product for a patient, in some embodiments, this predetermined amount of time is around 60 seconds, though more or less time could be provided. The predetermined amount of time for an authorised user who delivers RFID-tagged pharmaceutical products to the pharmaceutical storage unit would be longer than that for a nurse or doctor, in some embodiments this predetermined time is 4 to 5 minutes, though again more or less time could be provided. The predetermined time for a pharmaceuticals controller responsible for all aspects of pharmaceutical handling at a health care setting would be longer than for a nurse/doctor or delivery person, in some embodiments, this predetermined time is 10 minutes, though again more or less time could be provided. User authorisation levels are described in more detail elsewhere herein.

Figure 6 shows a cloud-based storage network to store a global inventory database 82. Of course, the system could be implemented across a local area network, for example in a healthcare facility such as a hospital, or a wide area network including multiple healthcare facilities in a district, for example.

For completeness, an exemplary embodiment of a system for distributing and monitoring inventory comprises an RFID reader 22,42 located at a pharmaceutical product distribution centre 3 and configured to scan at least one RFID-tagged pharmaceutical product 10. The system further comprises a pharmaceutical storage unit 20 located at a patient point of care 4, 5, 6 and comprising at least one RFID reader 22. The pharmaceutical storage unit RFID reader 22 is configured to scan the at least one RFID-tagged pharmaceutical product 10. The system further comprises a control unit 21 configured to update a global inventory database 82. It does this on at least two occasions: firstly to reflect that the at least one RFID-tagged product 10 is no longer at the pharmaceutical product distribution centre 3, which it does when the RFID reader 22, 32 located at the pharmaceutical product distribution centre 3 scans the at least one RFID-tagged pharmaceutical product 10, and secondly to reflect that the at least one RFID-tagged product 10 has been delivered to the pharmaceutical storage unit 20 at the patient point of care 30, which it does when the pharmaceutical storage unit RFID reader 22 scans the at least one RFID-tagged pharmaceutical product 10.

Exemplary methods according to the present invention

One method according to the invention, described in more detail below with reference to Figures 7 and 8, is a method for monitoring inventory during a distribution process from pharmaceutical product distribution centre to a pharmaceutical storage unit at a patient point of care. As described elsewhere herein, the invention does not require the starting point ofthe RFID-tagged pharmaceutical product to be the pharmaceutical product distribution centre, and also covers methods wherein the pharmaceutical product travels to pharmaceutical product distribution centre from a pharmaceutical product packaging plant, and even wherein a pharmaceutical product packaging plant is itself a pharmaceutical product distribution centre.

Another method according to the invention, described in more detail below with reference to Figures 9 and 10, involves a method for dispensing of RFID-tagged pharmaceutical product from the pharmaceutical storage unit at the patient point of care.

Another method according to the invention, described in more detail below with reference to Figures 9 and 11, involves a method for ordering RFID-tagged pharmaceutical products from a pharmaceutical product packaging plant to a pharmaceutical product distribution centre, and/or a method for ordering RFID-tagged pharmaceutical products from a pharmaceutical product distribution centre to the pharmaceutical storage unit at a patient point of care.

Another method according to the invention, described in more detail below with reference to Figure 12, is a method for managing a product-recall of at least one RFID-tagged pharmaceutical products from a pharmaceutical storage unit.

Another method according to the invention, described in more detail below, is a method for registering a pharmaceutical product with an RFID-tag.

An exemplary method for monitoring inventory during a distribution process from pharmaceutical product distribution centre to a pharmaceutical storage unit at a patient point of care:

Figure 7 shows an exemplary method for monitoring inventory during a distribution process from pharmaceutical product distribution centre 3 to a pharmaceutical storage unit 20 at a patient point of care 4, 5, 6.

The first step 100 of the method comprises detecting at least one RFID-tagged pharmaceutical product 10 using an RFID reader 40, 22 at a pharmaceutical product distribution centre 3. As previously described, this RFID reader can be a handheld RFID reader 40, for example, the MC55 from Zebra (3 Overlook Point, Lincolnshire, Illinois, 60069. UNITED STATES OF AMERICA) and as shown in Figures 4a and 4b. Alternatively, this RFI D reader can be an RFI D reader 22 included in a pharmaceutical storage unit 20, as shown in Figure 3c.

At step 200, the method comprises updating the status of a global inventory database 82 to reflect that the RFID-tagged pharmaceutical product 10 is no longer at the pharmaceutical product distribution centre 3. Updating the status of the global inventory database 82 comprises the control unit 41 of the handheld RFID reader 40 communicating to the global inventory database via the inventory management software, or the control unit 21 of the pharmaceutical storage unit 20 communicating to the global inventory database 82 via the inventory management software.

At step 300, the method comprises detecting the at least one RFID-tagged pharmaceutical product 10 using a pharmaceutical storage unit 20 comprising at least one RFID reader 22, wherein the pharmaceutical storage unit 20 is located at a patient point of care 4, 5, 6. This detecting step 300 can occur as the RFID-tagged pharmaceutical product 10 is placed into the pharmaceutical storage unit 20 or when the RFID-tagged pharmaceutical product 10 has been placed into the pharmaceutical storage unit 10.

At step 400, the method includes updating the status of the global inventory database 82 to reflect that the at least one RFID-tagged pharmaceutical product 10 has been delivered to the pharmaceutical storage unit 20 at the patient point of care 4, 5, 6. Updating the status of the global inventory database 82 to reflect that the RFID-tagged pharmaceutical product 10 has been delivered to the pharmaceutical storage unit 2 comprises the control unit 21 of the pharmaceutical storage unit 20 communicating with the global inventory database 82 via the inventory management software.

Once steps 100 to 400 have been completed, the delivery process is complete (step 500).

Since the global inventory database 82 is updated to reflect the location of the RFID-tagged pharmaceutical product 10 when it leaves the pharmaceutical product distribution centre 3, and also when it is delivered to the pharmaceutical storage unit 20 at the patient point of care 4, 5, 6, the present invention provides a method for monitoring and managing the RFID-tagged pharmaceutical product throughout the entire distribution chain, from pharmaceutical product distribution centre 3 to the patient point of care 4, 5, 6. Thus, the present invention: improves security of the distribution chain; improves accountability of the inventory throughout the distribution chain, for example, it is possible to obtain stock level data of RFID-tagged pharmaceutical products at all patient points of care; and prevents inventory leakage. Furthermore, the present invention can identify areas of inventory leakage - for example, RFID-tagged product can be stolen or lost during the delivery process to the pharmaceutical storage unit.

Furthermore, since the pharmaceutical storage unit is located at the patient point of care, as opposed to a retail centre, warehouse or pharmacy, the opportunities for inventory leakage are reduced and the present invention provides a secure method of distribution of pharmaceutical products.

In some embodiments ofthe method of Figure 7 (not shown) the method further includes updating the status of the global inventory database 82 to reflect the stock level of the RFID-tagged pharmaceutical product 10 at the pharmaceutical storage unit 20.

In an alternative method of the method of Figure 7 in which the pharmaceutical storage unit 20 is initially locked the method comprises an authorisation step 250 (shown in dashed lines on Figure 7), wherein the identity of an authorised user is verified in order to unlock the pharmaceutical storage unit 20 and allow the authorised user access to the pharmaceutical storage unit. As previously described with reference to Figures 3a-3c and 5a-5c, this authorisation step can take the form of one or more of the following: the RFID reader 22 of the pharmaceutical storage unit 20 detecting an RFID ID card of an authorised user; an authorised user entering login details into a user interface 23 registered with the pharmaceutical storage unit 20; and an authorised user providing biometric information to a biometric reader registered with the pharmaceutical storage unit 20.

In some embodiments of the method of Figure 7 (not shown) the authorised user has a predetermined user authorisation level and the pharmaceutical storage unit 20 is locked after a predetermined amount of time, wherein the predetermined amount of time is based upon the user authorisation level.

In a further embodiment of the method of Figure 7 (not shown) the pharmaceutical storage unit 20 is configured to issue an alert if the pharmaceutical storage unit 20 is not locked after the predetermined amount of time. Issuing an alert can include one or more of the following: processor 83 sending a warning email, text, and/or phone call to one or more authorised users of the pharmaceutical storage unit 20; the user interface 23 of the pharmaceutical storage unit 20 displaying a warning message; a warning light on the pharmaceutical storage unit 20 turning on; a warning sound emanating from the pharmaceutical storage unit 20.

In a further embodiment of the above method of Figure 7 (not shown) the predetermined amount of time is one of the following: 20 to 30 seconds; 5 to 10 minutes; and 10 to 30 minutes. In one example of the method of Figure 7, a nurse or doctor may be allowed 20 to 30 seconds to retrieve an RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20; a delivery person may be allowed 5 to 10 minutes to deliver RFID-tagged pharmaceutical products 10 to the pharmaceutical storage unit 10 and/or rotate stock; and a pharmaceutical storage unit engineer may be allowed 10 to 30 minutes to access the pharmaceutical storage unit 10. These user authorisation levels are described in more detail elsewhere herein.

In an alternative method of Figure 7 (not shown) and as described with reference to Figures 3a-3c, the pharmaceutical storage unit 20 comprise can more than one compartment. In further embodiments of the invention, the more than one compartments are independently and/or remotely lockable.

In an alternative method of Figure 7 (not shown) and as described with reference to Figures 5a-5c, there can be more than one pharmaceutical storage unit 20. In further embodiments of the invention, the more than one pharmaceutical storage units 20 are independently lockable.

In some embodiments of the method of Figure 7, the pharmaceutical storage unit 20 is remotely lockable.

Figure 8 shows an alternative method of Figure 7 in which the at least one RFID-tagged product 10 is part of an order of more than one RFID-tagged products to be delivered to the patient point of care 4, 5, 6. At step 405, the method of Figure 8 comprises checking the status of each of the more than one RFID-tagged products on the global inventory database 10.

At step 415, a decision step is taken and the processor 83 checks if the statuses of each of the more than one RFID-tagged products has been updated to reflect that it has been delivered to a pharmaceutical storage unit at the patient point of care 4, 5, 6. If the answer is yes, step 455 comprises updating the global inventory database to reflect that the order has been delivered, followed by step 500. If the answer is no, step 425 comprises a decision step wherein the processor 83 checks if a predetermined threshold amount of time has elapsed since the status of any one of the more than one RFID-tagged products has been updated to reflect that the RFID-tagged pharmaceutical product 10 has been delivered to the pharmaceutical storage unit 20.

If the answer to decision step 425 is yes, the method of Figure 8 continues to step 435 which comprises issuing an alert to an authorised user of the pharmaceutical storage unit 20. Issuing an alert can include one or more of the following: processor 83 sending a warning email, text, and/or phone call to one or more authorised users of the pharmaceutical storage unit 20; the user interface 23 of the pharmaceutical storage unit 20 displaying a warning message; a warning light on the pharmaceutical storage unit 20 turning on; a warning sound emanating from the pharmaceutical storage unit 20. At step 445, the status of the global inventory database 82 is updated to reflect that the order has not been delivered. The method then continues to step 500.

If the answer to decision step 425 is no, the method of Figure 8 returns to step 405.

An exemplary method for the distribution of RFID-tagged pharmaceutical products from a pharmaceutical product packaging plant to a pharmaceutical product distribution centre:

In some embodiments of the methods of Figures 7 and 8 (not shown) the method further includes a method for the distribution of the RFID-tagged pharmaceutical products 10 from a pharmaceutical product packaging plant 2 to the pharmaceutical product distribution centre 3. The method comprises detecting the least one RFID-tagged pharmaceutical product 10 using an RFID reader 40 at a pharmaceutical product packaging plant 2; updating the status of the global inventory database 82 to reflect that the at least one RFID-tagged pharmaceutical product 10 is no longer at the pharmaceutical product packaging plant 2; detecting the RFID-tagged pharmaceutical product 10 using an RFID reader 40 at the pharmaceutical product distribution centre 3; and updating the status of a global inventory database 82 to reflect that the at least one RFID-pharmaceutical product 10 has been delivered to the pharmaceutical product distribution centre 3.

In this way, the present invention further improves the security of the distribution chain since the RFID-tagged product is monitored as it is moved from the pharmaceutical product packaging plant to the patient point of care, providing more accountability of the distribution chain and so minimising opportunities for inventory leakage and allowing identification of points of inventory leakage.

An exemplary method for monitoring the removal of RFID-tagged pharmaceutical product from the pharmaceutical storage unit at the patient point of care:

Figure 9 shows a secure method for monitoring the removal of the RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20. At step 800 of Figure 10, the method comprises removing the at least one RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20. At step 900 of Figure 10, the method comprises detecting the removal of the at least one RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20 using the pharmaceutical storage unit 20 comprising the RFID reader 22. At step 1000 ofthe method of Figure 10, the method comprises updating the status ofthe global inventory database 82 to reflect that the at least one RFID-tagged pharmaceutical product 10 is no longer located in the pharmaceutical storage unit 20.

As described with reference to Figures 3a-3c, detecting the removal of the at least one RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20 using the pharmaceutical storage unit 20 comprising the RFID reader 22 (step 900), can include the pharmaceutical storage unit RFID reader 22 sending out an interrogation signal to interrogate the RFID-tagged pharmaceutical products 10 within the pharmaceutical storage unit 22, detecting the RFID-tagged pharmaceutical products 10 that are within the pharmaceutical storage unit 20, and providing information to the global inventory database 82 to update the status of the global inventory database 82 to reflect that the at least one RFID-tagged pharmaceutical product 10 is no longer located in the pharmaceutical storage unit 20.

In some embodiments ofthe method of Figure 9, the pharmaceutical storage unit is initially locked and method 9 comprises user authorisation step 600 (shown in dashed lines in Figure 9) wherein the identity of an authorised user is verified in order to unlock the pharmaceutical storage unit 20 and allow the authorised user access to the pharmaceutical storage unit 20. In this way, the security of the dispensing process of the RFID-tagged pharmaceutical product 10 for administration to patient is improved, minimising opportunities for inventory leakage and allowing greater accountability of movement of inventory in order to identify areas of inventory leakage.

In further embodiments of the above method, the authorised user has a predetermined user authorisation level and the pharmaceutical storage unit 10 is locked after a predetermined amount of time, wherein the predetermined amount of time is based upon the user authorisation level.

In yet further embodiments of the above method, the pharmaceutical storage unit is configured to issue an alert if the pharmaceutical storage unit 20 is not locked after the predetermined amount of time. For example, in one example of the method, the predetermined amount of time is one of the following: 30 to 90, preferably 60 seconds; 2 to 8, preferably 4 or 5 minutes; and 5 to 15, preferably 10 minutes. For example, a nurse or doctor may be allowed 60 seconds to retrieve an RFID-tagged pharmaceutical product 10 from the pharmaceutical storage unit 20; a delivery person may be allowed 5 minutes to deliver RFID-tagged pharmaceutical products to the pharmaceutical storage unit and rotate stock; and a pharmaceuticals controller may be allowed 10 minutes to assess the stockof a pharmaceutical storage unit in a product-recall scenario. User authorisation levels are described further elsewhere herein.

Figure 10 shows an alternative example of the method of Figure 9 comprising step 700 comprising providing input data of a pharmaceutical product to be removed from the pharmaceutical storage unit 20 to a user interface 23 associated with the pharmaceutical storage unit 20. Step 710 comprises checking the input data of the pharmaceutical product against the stock data of the pharmaceutical storage unit 20. Step 720 is a decision step where the processor 83 queries if pharmaceutical storage unit 20 contains the pharmaceutical product to be removed. If the answer to step 720 is no, access to the pharmaceutical storage is prevented at step 740. If the answer to step 720 is yes, access to the pharmaceutical storage unit is allowed at step 730, and the method returns to step 800.

In alternative examples of the method of Figure 10, wherein the pharmaceutical storage unit 20 comprises more than one compartment and wherein more than one compartment of the pharmaceutical storage unit 20 contains an RFID-tagged pharmaceutical product matching the RFID data, access (at step 730) is allowed only to the number of compartments that contain the RFID-tagged pharmaceutical product necessary to fulfil the input data. For example, if an authorised user inputs data for 5 units of RFID-tagged pharmaceutical product 10 and one compartment in the pharmaceutical storage unit 20 contains 3 units of the RFID-tagged pharmaceutical product 10, and the two remaining compartments in the pharmaceutical storage 20 unit contain 2 units of the RFID-tagged pharmaceutical product 10, the pharmaceutical storage unit 20 will allow access to the compartment containing 3 units of the RFID-tagged pharmaceutical product 10, and one of the compartments containing 2 units of the RFID-tagged pharmaceutical product 10, and prevent access to the other compartment containing 2 units of the RFID-tagged pharmaceutical product 10.

In a further example of the method of Figure 10 (not shown), if the removal of an RFID tagged pharmaceutical product 10 is detected (step 900) and the RFID-tagged product 10 that is detected does not match the input data provided to the user interface 23, the pharmaceutical storage unit 20 issues an alert. Issuing an alert can include one or more of the following: processor 83 sending a warning email, text, and/or phone call to one or more authorised users of the pharmaceutical storage unit 20; the user interface 23 of the pharmaceutical storage unit 20 showing a warning; a warning light on the pharmaceutical storage unit 20 turning on; a warning sound emanating from the pharmaceutical storage unit 20.

In the above example, the RFID tag ofthe RFID-tagged pharmaceutical product 20 relates to one or more of the following data: batch number of the RFID-tagged pharmaceutical product; serial number of the RFID-tagged pharmaceutical product; expiration date of the RFID-tagged pharmaceutical product; required storage conditions ofthe RFID-tagged pharmaceutical product.

In another example of the method of Figure 10, the method further comprises decision step 910 in which processor 83 queries if RFID-tagged pharmaceutical product 10 fulfils a safety criteria. In this example of the method of Figure 10, step 910 comprises querying if one or more of the following: the batch number ofthe RFID-tagged pharmaceutical product 10 has not been marked for recall on the global inventory database 82; the serial number of the RFID-tagged pharmaceutical product 10 has not been marked for recall on the global inventory database 82; the expiration date of the RFI D-tagged pharmaceutical product 10 is not after the date of removing drugs from the pharmaceutical storage unit 20; and the required storage conditions of the RFID-tagged pharmaceutical product 10 are marked as fulfilled on the global inventory database 82.

In the above example ofthe method of Figure 10, if the answer to step 910 is no, an alert is issued to an authorised user at step 920. As described previously, issuing an alert can include one or more of the following: processor 83 sending a warning email, text, and/or phone call to one or more authorised users of the pharmaceutical storage unit 20; the user interface 23 of the pharmaceutical storage unit 20 showing a warning; a warning light on the pharmaceutical storage unit 20 turning on; a warning sound emanating from the pharmaceutical storage unit 20.

If the answer to step 910 is yes, the method returns to step 1000.

An exemplary method for ordering RFID-tagged pharmaceutical products from a pharmaceutical product packaging plant to a pharmaceutical product distribution centre, and/or a method for ordering RFID-tagged pharmaceutical products from a pharmaceutical product distribution centre to the pharmaceutical storage unit at a patient point of care:

Figure 11 shows a method for reordering RFID-tagged pharmaceutical product 10 to a pharmaceutical storage unit 20 located at a patient point of care 4, 5, 6.

At step 410 of the method, the method includes monitoring the stock level of the RFID-tagged pharmaceutical product 10 in the pharmaceutical storage unit 20. Step 420 of the method of

Figure 11 includes a decision step in which processor 83 queries whether the stock level of the RFID-tagged pharmaceutical product 10 has fallen below a predetermined threshold level. If the answer to step 420 is yes, step 430 comprises generating an order of the RFID-tagged pharmaceutical product 10 for delivery to the pharmaceutical storage unit 20. In further embodiments of the method of Figure 11, the size of the order generated is based on usage data of the RFID-tagged pharmaceutical product at the patient point of care, wherein the usage data is stored in the global inventory database 82.

Similarly to the method of Figure 11, there is provided a method for reordering RFID-tagged pharmaceutical product to a pharmaceutical product distribution centre. The method includes monitoring the stock level of the RFID-tagged pharmaceutical product 10 at the pharmaceutical product distribution centre 3; and generating an order ofthe RFID-tagged pharmaceutical product 10 for delivery to the pharmaceutical product distribution centre 3 when the stock level of the RFID-tagged pharmaceutical product 10 falls below a predetermined thresheld level. In further examples of this method, the size of the order generated is based on usage data of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre 3; wherein the usage data is stored in the global inventory database 82.

An exemplary method for recalling at least one RFID-tagged pharmaceutical products from a pharmaceutical storage unit:

Figure 12 shows a method for recalling at least one RFID-tagged pharmaceutical product from a pharmaceutical storage unit. At step 2000, the global inventory database 82 is updated to reflect that at least one RFID-tagged pharmaceutical product 10 is to be recalled. Step 2100 comprises checking the stock data of a pharmaceutical storage unit 20 at a patient point of care 4, 5, 6. Step 2200 comprises decision step wherein processor 83 queries if the pharmaceutical storage unit 20 contains the at least one RFID-tagged pharmaceutical product 10 to be recalled.

If the answer to step 2200 is yes, step 2210 comprises preventing access to the pharmaceutical storage unit 20. At step 2220, the method of Figure 12 comprises issuing an alert to a user of the pharmaceutical storage unit. At step 2230, the method of Figure 12 comprises a user authorisation step wherein an identity of an authorised user is verified in order to unlock the pharmaceutical storage unit 20. At step 2240, the method comprises removing the RFID-tagged pharmaceutical product 10 to be recalled from the pharmaceutical storage unit 20. The method then returns to step 2100.

If the answer to step 2200 is no, the method continues to step 2300 in which access to the pharmaceutical storage unit 20 is allowed.

Step 2200 can comprise sending an email to an authorised user of the pharmaceutical storage unit.

In some examples of the method of claim 12, wherein the pharmaceutical storage unit 10 comprises more than one independently lockable compartment (as described in reference to Figures 3a-3c), method step 2100 comprises checking the stock data of the pharmaceutical storage unit 20 to identify which of the more than one independently lockable compartments contain the RFID-tagged pharmaceutical product to be recalled and; step 2210 comprises preventing access to the compartments containing the RFID-tagged pharmaceutical product to be recalled 10 and permitting access to the compartments which do not contain the RFID-tagged pharmaceutical product to be recalled 10.

In another example of the method of Figure 12, where there is more than one pharmaceutical storage unit (as described in reference to Figures 5a) the step 2100 comprises checking the stock data of each of the more than one pharmaceutical storage units 20 to identify which of the pharmaceutical storage units 20 contain the RFID-tagged pharmaceutical product to be recalled 10 and; step 2210 comprise preventing access to the pharmaceutical storage units 20 containing the RFID-tagged pharmaceutical product to be recalled and permitting access to the pharmaceutical storage units 20 which do not contain the RFID-tagged pharmaceutical product to be recalled 10.

The method for registering a pharmaceutical product with an RFID tag:

The method for registering a pharmaceutical product with an RFID tag comprises: a user authorisation step wherein a user inputs login credentials into a user interface associated with an RFID reader and/or scans an RFID tag with the RFID reader; a data processing step wherein the RFID reader connects to a global inventory database; presenting pharmaceutical product information data to the user; a user selection step wherein the user selects pharmaceutical product information data that are associated with a pharmaceutical product to be registered with the RFID tag; updating the global inventory database to reflect that the RFID tag is now associated with the user-selected selected pharmaceutical product information data.

In some embodiments ofthe above method, the pharmaceutical product information data includes one or more of: batch numbers of pharmaceutical products; serial numbers of pharmaceutical products; expiration dates of pharmaceutical products; and required storage conditions of pharmaceutical products.

In some embodiments of the invention, wherein the user manually inputs pharmaceutical product information data associated with a pharmaceutical product to be registered with the RFID tag into the user interface; the user interface highlights a pharmaceutical product data that matches the input pharmaceutical product information data; and the user selects the pharmaceutical product information data that is associated with the pharmaceutical product to be registered with the RFID tag.

An exemplary method for registering a pharmaceutical product with an RFID tag: A method for registering a pharmaceutical product with an RFID tag 11 comprises: a user authorisation step wherein a user inputs login credentials into a user interface 43 associated with an RFI D reader 40 and/or scans an RFI D tag 11 with the RFI D reader 40; a data processing step wherein the RFID reader 40 connects to a global inventory database 82; presenting pharmaceutical product information data to the user; a user selection step wherein the user selects pharmaceutical product information data that are associated with a pharmaceutical product to be registered with the RFID tag 11; updating the global inventory database 82 to reflect that the RFID tag is now associated with the user-selected selected pharmaceutical product information data.

In some embodiments of the above method, the pharmaceutical product information data includes one or more of: batch numbers of pharmaceutical products; serial numbers of pharmaceutical products; expiration dates of pharmaceutical products; and required storage conditions of pharmaceutical products.

In some embodiments of the invention, wherein the user manually inputs pharmaceutical product information data associated with a pharmaceutical product to be registered with the RFID tag 11 into the user interface 43; the user interface highlights a pharmaceutical product data that matches the input pharmaceutical product information data; and the user selects the pharmaceutical product information data that is associated with the pharmaceutical product to be registered with the RFID tag 11.

User authorisation level and access controls:

As described previously, in some embodiments of the invention, in which there is a user authorisation step, the authorised user may be allowed access to the pharmaceutical storage unit for a predetermined amount of time, the length of the predetermined amount of time being based on a user authorisation level. Specifically, this user authorisation level is described with reference to Figures 7 and 9. Furthermore, with reference to Figure 12, step 2230 comprises a user authorisation step in which an authorised user is verified in order to unlock the pharmaceutical storage unit. In some embodiments of the method of Figure 12, a user may or may not be able to unlock the pharmaceutical storage unit at step 2230 based on their user authorisation level. Examples of these user authorisation levels and are summarised in Table 1 below. As will be understood, this Table is only one example of the user authorisation levels and there may be additional access levels with other access restrictions.

Table 1:

It will be appreciated that the invention has been described with reference to exemplary situations only and these should not be taken as restricting the scope of the invention which is defined by the claims that follow. Features described herein in conjunction with a particular aspect or example of the disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. As used herein, the words “a” or “an” are not limited to the singular but are understood to include a plurality, unless the context requires otherwise.

Aspects of the Invention: 1. A method for distributing and monitoring inventory, comprising: a) detecting at least one RFID-tagged pharmaceutical product using an RFID reader at a pharmaceutical product distribution centre; b) updating the status of a global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer at the pharmaceutical product distribution centre; c) detecting the at least one RFID-tagged pharmaceutical product using a pharmaceutical storage unit comprising at least one RFID reader, wherein the pharmaceutical storage unit is located at a patient point of care; and d) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product has been delivered to the pharmaceutical storage unit at the patient point of care; wherein no further steps of detecting the at least one RFID-tagged pharmaceutical products take place between steps a) and c). 2. The method of aspect 1 wherein step d) further comprises increasing a stock level of the RFID-tagged pharmaceutical product at the pharmaceutical storage unit. 3. The method of aspects 1 or 2, wherein the following steps are carried out prior to the commencement of step a): i) detecting the at least one RFID-tagged pharmaceutical product using an RFID reader at a pharmaceutical product packaging plant; ii) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer at the pharmaceutical product packaging plant; iii) detecting the RFID-tagged pharmaceutical product using an RFID reader at the pharmaceutical product distribution centre; and iv) updating the status of the global inventory database to reflect that the at least one RFID-pharmaceutical product has been delivered to the pharmaceutical product distribution centre. 4. The method of any of the preceding aspects comprising: monitoring the stock level of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre; and generating an order of the RFID-tagged pharmaceutical product for delivery to the pharmaceutical product distribution centre when the stock level of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre falls below a predetermined threshold level. 5. The method of aspect 4 wherein the size of the order generated is based on usage data of the RFID-tagged pharmaceutical product at the pharmaceutical product distribution centre; wherein the usage data is preferably stored in the global inventory database. 6. The method of any preceding aspect, comprising monitoring the stock level of the RFID-tagged pharmaceutical product at the pharmaceutical storage unit and generating an order of the RFID-tagged pharmaceutical product for delivery to the pharmaceutical storage unit when the stock level of the RFID-tagged pharmaceutical at the pharmaceutical storage unit product falls below a predetermined threshold level. 7. The method of aspect 6, wherein the predetermined threshold level is determined based on one or more data sets, including: unfulfilled prescriptions of the RFID-tagged pharmaceutical product issued from the patient point of care; usage data at the patient point of care, such as number of fulfilled prescriptions per day, week or month; seasonal information, such as time of year or weather conditions. 8. The method of any of the preceding aspects wherein the pharmaceutical storage unit comprises more than one compartments, and/or wherein there is more than one pharmaceutical storage unit. 9. The method of any of the preceding aspects wherein prior to step c) the pharmaceutical storage unit is locked, and the method further comprising an authorisation step wherein the identity of a first authorised user is verified in order to unlock the pharmaceutical storage unit and allow the first authorised user access to the pharmaceutical storage unit. 10. The method of aspect 9 wherein the first authorised user has a first predetermined user authorisation level and wherein after the authorisation step is completed to unlock the pharmaceutical storage unit, the unit is locked again after a first predetermined amount of time, wherein the first predetermined amount of time is based upon the first predetermined user authorisation level. 11. The method of aspect 10 wherein the pharmaceutical storage unit is configured to issue an alert if the pharmaceutical storage unit is not locked after the first predetermined amount of time. 12. The method of aspect 10 or aspect 11 wherein the first predetermined amount of time is between 5 seconds and 15 minutes, preferably one of: I. between 30 and 90 seconds, preferably 60 seconds; II. between 3 and 7 minutes, preferably 4 or 5 minutes; III. between 8 and 12 minutes, preferably 10 minutes. 13. The method of any of aspects 9 to 12 when dependent on aspect 8, wherein each of the multiple compartments and/or multiple pharmaceutical storage units is independently lockable. 14. The method of any of the preceding aspects wherein the at least one RFID-tagged product is part of an order of more than one RFID-tagged products to be delivered to the patient point of care, the method further comprising: checking the status of each of the more than one RFID-tagged products on the global inventory database; and if the statuses of each of the more than one RFID-tagged products has been updated to reflect that it has been delivered to a pharmaceutical storage unit at the patient point of care, updating the global inventory database to reflect that the order has been delivered; and if any one status of the more than one RFID-tagged products has not been updated to reflect that it has been delivered to the patient point of care, updating the global inventory database to reflect that the order has not been delivered or has been partially delivered and, optionally, issuing an alert to an authorised user of the pharmaceutical storage unit. 15. The method of aspect 14 wherein if the global inventory database has been updated to reflect that the order has not been delivered or has been partially delivered; and a predetermined threshold amount of time has elapsed since the status of any one of the more than one RFID-tagged products has been updated to reflect that the RFID-tagged pharmaceutical product has been delivered to the pharmaceutical storage unit, issuing an alert to an authorised user of the pharmaceutical storage unit. 16. The method of any of the preceding aspects further comprising: e) removing the at least one RFID-tagged pharmaceutical product from the pharmaceutical storage unit; f) detecting the removal of the at least one RFID-tagged pharmaceutical product from the pharmaceutical storage unit using the pharmaceutical storage unit comprising the RFID reader; and g) updating the status of the global inventory database to reflect that the at least one RFID-tagged pharmaceutical product is no longer located in the pharmaceutical storage unit. 17. The method of aspect 16 wherein step g) further comprises decreasing the stock level ofthe RFID-tagged pharmaceutical product at the pharmaceutical storage unit. 18. The method of aspect 16 or aspect 17 wherein prior to step e) the pharmaceutical storage unit is locked, and the method further comprising an authorisation step wherein the identity of a second authorised user is verified in order to unlock the pharmaceutical storage unit and allow the second authorised user access to the pharmaceutical storage unit. 19. The method of aspect 18 wherein the second authorised user has a second predetermined user authorisation level and wherein after the authorisation step is completed to unlock the pharmaceutical storage unit, the unit is locked again after a second predetermined amount of time, wherein the second predetermined amount of time is based upon the second predetermined user authorisation level. 20. The method of aspect 19 wherein the pharmaceutical storage unit is configured to issue an alert if the pharmaceutical storage unit is not locked after the second predetermined amount of time. 21. The method of aspect 19 or aspect 20 wherein the second predetermined amount of time is between 5 seconds and 15 minutes, preferably one of: I. between 30 and 90 seconds, preferably 60 seconds; II. between 3 and 7 minutes, preferably 4 or 5 minutes; III. between 8 and 12 minutes, preferably 10 minutes. 22. The method of aspect 21, wherein the second predetermined amount of time is shorter than the first predetermined amount of time, and preferably wherein the first predetermined amount of time is selected from Group III, and the second predetermined period of time is selected from Group I. 23. The method of any preceding aspect, further comprising: providing input data of a pharmaceutical product to be removed from one or more pharmaceutical storage units at a patient point of care to a user interface associated with the said one or more pharmaceutical storage units; and comparing the input data of the pharmaceutical product to be removed with stock data of the one or more pharmaceutical storage units and, if at least one RFID-tagged pharmaceutical product stored in the one or more pharmaceutical storage units matches the input data, allowing access to the or each of the one or more pharmaceutical storage units for which a match is detected. 24. The method of aspect 23, further comprising prohibiting access to the or each of the one or more pharmaceutical storage units for which a match is not detected. 25. The method of aspect 23 or 24, wherein, if the RFID reader of the pharmaceutical storage unit detects removal of an RFID-tagged pharmaceutical product that does not match the input data provided to the user interface, the pharmaceutical storage unit issues an alert. 26. The method of any of aspects 23 to 25 wherein allowing access to the RFID-tagged pharmaceutical product further comprises verifying that the RFID-tagged pharmaceutical product fulfils a safety criteria. 27. The method of any preceding aspect, further comprising the step of periodically polling the contents of the or each pharmaceutical storage unit at at least one patient point of care, wherein the polling comprises verifying that the RFID-tagged pharmaceutical product fulfils a safety criteria. 28. The method of any of the preceding aspects wherein an RFID tag of the RFID-tagged pharmaceutical product comprises one or more of the following data: batch number ofthe RFID-tagged pharmaceutical product; serial number of the RFID-tagged pharmaceutical product; expiration date ofthe RFID-tagged pharmaceutical product; and required storage conditions ofthe RFID-tagged pharmaceutical product. 29. The method of aspect 28 when dependent on aspect 26 or 27, wherein verifying that the RFID-tagged pharmaceutical product fulfils a safety criteria comprises verifying one or more of the following: that the batch number ofthe RFID-tagged pharmaceutical product has not been marked for recall on the global inventory database; that the serial number ofthe RFID-tagged pharmaceutical product has not been marked for recall on the global inventory database; that the expiration date of the RFID-tagged pharmaceutical product has not lapsed; and that the required storage conditions of the RFID-tagged pharmaceutical product are marked as fulfilled on the global inventory database. 30. The method of any of the preceding aspects comprising: updating the global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled; and checking the stock data of the pharmaceutical storage unit to determine if the pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled; and, if so, further comprising one or more of the following steps: issuing an alert to a user of the pharmaceutical storage unit; and preventing access to the pharmaceutical storage unit by all users except one or more appropriately authorised users. 31. The method of aspect 30 wherein issuing alert to a user of the pharmaceutical storage unit comprises sending an email to a user of the pharmaceutical storage unit. 32. The method of any of the preceding aspects wherein the RFID-tagged pharmaceutical product is not scanned at any location other than: the pharmaceutical product distribution centre and/or the pharmaceutical product packaging plant, and the pharmaceutical storage unit. 33. The method of any of the preceding aspects wherein the pharmaceutical storage unit is a temperature controlled pharmaceutical storage unit. 34. A system for distributing and monitoring inventory comprising: an RFID reader located at a pharmaceutical product distribution centre and configured to scan at least one RFID-tagged pharmaceutical product; a pharmaceutical storage unit located at a patient point of care and comprising at least one RFID reader, the pharmaceutical storage unit RFID reader being configured to scan the at least one RFID-tagged pharmaceutical product; a data processing system configured to: update a global inventory database to reflect that the at least one RFID- tagged product is no longer at the pharmaceutical product distribution centre when the RFID reader located at the pharmaceutical product distribution centre scans the at least one RFID-tagged pharmaceutical product; and update a global inventory database to reflect that the at least one RFID-tagged product has been delivered to the pharmaceutical storage unit at the patient point of care when the pharmaceutical storage unit RFID reader scans the at least one RFID-tagged pharmaceutical product. 35. A method for securing inventory at a plurality of patient points of care in the event of a recall of at least a portion of said inventory, comprising: a) updating a global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled; and b) for each patient point of care, checking stock data of at least one pharmaceutical storage unit to determine if said pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled and, if so, further comprising one or more of the following steps: i) issuing an alert to a user of the pharmaceutical storage unit; ii) preventing access to the pharmaceutical storage unit by all users except one or more appropriately authorised users. 36. The method of aspect 35 wherein issuing alert to a user of the pharmaceutical storage unit comprises sending an email to a user of the pharmaceutical storage unit. 37. The method of aspect 35 or aspect 36, wherein step b) includes, at each of one or more of the plurality of patient points of care, checking stock data of a plurality of pharmaceutical storage units and wherein preventing access to the pharmaceutical storage unit comprises first checking the stock data of each of the plurality of pharmaceutical storage units at said respective one or more patient points of care to identify which of the pharmaceutical storage units contains the at least one RFID-tagged pharmaceutical product to be recalled; and preventing access, by one or more users of a first and/or a second type, to the pharmaceutical storage units at said respective one or more patient points of care containing the RFID-tagged pharmaceutical product to be recalled and permitting access, by the one or more users of the first and/or the second type, to the pharmaceutical storage units at said respective one or more patient points of care which do not contain the RFID-tagged pharmaceutical product to be recalled. 38. The method of any of aspects 35 to 37, wherein once access to the pharmaceutical storage unit that contains the RFID-tagged pharmaceutical product to be recalled has been prevented to said one or more users, the method further comprises: an authorisation step wherein the identity of a user of a third type is verified in order to provide access the pharmaceutical storage unit, and allowing the user of the third type access to the pharmaceutical storage unit; removing the RFID-tagged pharmaceutical product to be recalled from the pharmaceutical storage unit; verifying that the pharmaceutical storage unit no longer contains the RFID-tagged pharmaceutical product to be recalled using at least one RFID reader associated with the pharmaceutical storage unit; and allowing access to the pharmaceutical storage unit by one or more users of a first and/or a second type. 39. A lockable cabinet for storing RFID-tagged pharmaceutical products, comprising a door and door sensor, an access system configured to enable the door to be opened upon detection of an identifier of one of a plurality of types of user, and an alert system for raising an alert if the door sensor indicates that the door has been opened for longer than a pre-determined time period, wherein the predetermined time period differs depending on the type of user associated with the identifier detected by the access system. 40. The lockable cabinet of aspect 39, wherein the access system is configured to identify at least three types of users, and operate with at least three corresponding time periods. 41. The lockable cabinet of aspect 40, wherein the first time period associated with the first user type is between 5 and 120 seconds, preferably between 10 and 110 second, more preferably between 30 and 90 seconds, more preferably between 45 and 75 seconds, more preferably between 55 and 65 seconds, and most preferably one minute. 42. The lockable cabinet of aspect 40 or aspect 41, wherein the second time period associated with the second user type is between 1 and 10 minutes, preferably between 2 and 8 minutes, more preferably between 3 and 6 minutes, more preferably between 4 and 5 minutes, and most preferably either 4 minutes or 5 minutes. 43. The lockable cabinet of any of aspects 40 to 42, wherein the third time period associated with the third user type is between 5 and 15 minutes, preferably between 6 and 14 minutes, more preferably between 7 and 13 minutes, more preferably between 8 and 12 minutes, more preferably between 9 and 11 minutes, and most preferably 10 minutes. 44. A method of selecting an RFID-tagged pharmaceutical product for administration to a patient from a lockable cabinet according to aspect 41, the method comprising: presenting an identifier of a first user type to the access system to enable the door to be opened, and opening the door; removing, by a user of the first user type, the at least one RFID-tagged pharmaceutical product from the lockable storage cabinet; and closing the door within the first time period, or else raising an alert. 45. The method of aspect 44, further comprising: detecting the removal of the at least one RFID-tagged pharmaceutical product from the lockable storage cabinet using at least one RFID reader associated with the lockable storage cabinet; and updating the status of a global inventory database to reflect that the at least one RFI D-tagged pharmaceutical product is no longer located in the lockable storage cabinet. 46. A method of delivering at least one RFID-tagged pharmaceutical product to a lockable cabinet according to aspect 42, the method comprising: presenting an identifier of a second user type to the access system to enable the door to be opened, and opening the door; depositing, by a user of the second type, the at least one RFID-tagged pharmaceutical product within the lockable cabinet; and closing the door within the second time period, or else raising an alert. 47. The method of aspect 46, further comprising: detecting the at least one RFID-tagged pharmaceutical product using at least one RFID reader associated with the lockable cabinet; and updating the status of a global inventory database to reflect that the at least one RFID-tagged pharmaceutical product has been deposited in the lockable cabinet. 48. A method of removing at least one RFID-tagged pharmaceutical product that has been recalled from a lockable cabinet according to aspect 43, the method comprising: presenting an identifier of a third user type to the access system to enable the door to be opened, and opening the door; removing, by a user of the third type, the at least one RFID-tagged pharmaceutical product that has been recalled from the lockable cabinet; and closing the door within the third time period, or else raising an alert. 49. The method of aspect 48, further comprising, prior to the step of presenting an identifier of a third user type: preventing access to the lockable cabinet by users of the first and/or second type even upon detection of an associated identifier. 50. The method of aspect 49, further comprising, subsequent to the step of removing the RFID-tagged pharmaceutical product that has been recalled: detecting the removal of the at least one RFID-tagged pharmaceutical product that has been recalled from the lockable cabinet using at least one RFID reader associated with the lockable cabinet; updating the status of a global inventory database to reflect that the at least one RFID-tagged pharmaceutical product that has been recalled is no longer located in the lockable cabinet; and allowing access to the lockable cabinet by users of the first and/or second type- 51. A method for registering a pharmaceutical product with an RFID tag comprising: a user authorisation step wherein a user inputs login credentials into a user interface associated with an RFID reader; scanning an RFID tag with the RFID reader; a data processing step wherein the RFID reader connects to a global inventory database; presenting pharmaceutical product information data to the user; a user selection step wherein the user selects pharmaceutical product information data that are associated with a pharmaceutical product to be registered with the RFID tag; updating the global inventory database to reflect that the RFID tag is now associated with the user-selected selected pharmaceutical product information data. 52. The method of aspect 51 wherein pharmaceutical product information data includes one or more of: batch numbers of pharmaceutical products; serial numbers of pharmaceutical products; expiration dates of pharmaceutical products; and required storage conditions of pharmaceutical products. 53. The method of any of aspects 51 or 52 wherein the user manually inputs pharmaceutical product information data associated with a pharmaceutical product to be registered with the RFID tag into the user interface; and the user interface highlights a pharmaceutical product data that matches the input pharmaceutical product information data; and the user selects the pharmaceutical product information data that is associated with the pharmaceutical product to be registered with the RFID tag. 54. The method, system or lockable cabinet of any of the preceding aspects wherein the RFID-tagged pharmaceutical product or pharmaceutical product comprises an anti-vascular endothelium growth factor (anti-VEGF) for ophthalmological purposes, preferably wherein the RFID-tagged pharmaceutical product or pharmaceutical product comprises Aflibercept.

Claims (16)

1. A system for securing inventory at a plurality of patient points of care in the event of a recall of at least a portion of said inventory, the system comprising: at least one pharmaceutical storage unit located at a patient point of care, the pharmaceutical storage unit comprising at least one RFID reader, the pharmaceutical storage unit RFID being configured to scan at least one RFID-tagged pharmaceutical product, wherein the RFID-tagged pharmaceutical product comprises a vascular endothelial growth factor (VEGF) antagonist for ophthalmological purposes; a data processing system configured to: a) update a global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled; and b) for each patient point of care, check stock data of the at least one pharmaceutical storage unit to determine if said pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled and, if so: i) issue an alert to a user of the pharmaceutical storage unit; and/or ii) prevent access to the pharmaceutical storage unit by all users except one or more appropriately authorised users.
2. The system of claim 1 wherein, the data processing system is configured to send an email to a user of the pharmaceutical storage unit in order to issue an alert to a user of the pharmaceutical storage unit comprises.
3. The system of claim 1 or claim 2 wherein the data processing system is configured to prevent access, by one or more users of a first and/or a second type, to the pharmaceutical storage units at said respective one or more patient points of care containing the RFID-tagged pharmaceutical product to be recalled; and permit access, by the one or more users of the first and/or the second type, to the pharmaceutical storage units at said respective one or more patient points of care which do not contain the RFID-tagged pharmaceutical product to be recalled.
4. The system of any of claims 1 to 3, wherein the pharmaceutical storage unit requires a user authorisation step in order to provide access the pharmaceutical storage unit wherein the identity of a user of a third type is verified, and allow the user of the third type access to the pharmaceutical storage unit once the data processing system has prevented access to said one or more users to the pharmaceutical storage unit that contains the RFID-tagged pharmaceutical product to be recalled; and the pharmaceutical storage unit and data processing system are configured to verify that the pharmaceutical storage unit no longer contains the RFID-tagged pharmaceutical product to be recalled using at least one RFID reader associated with the pharmaceutical storage unit; and allow access to the pharmaceutical storage unit by one or more users of a first and/or a second type.
5. The systems of any of one of the preceding claims wherein the at least one pharmaceutical storage unit comprises more than independently lockable compartments and wherein the data processing system is configured to prevent access to the prevent access to the compartments containing the RFID-tagged pharmaceutical product to be recalled and permit access to the compartments which do not contain the RFID-tagged pharmaceutical product to be recalled.
6. The system of claim 4 or claim 5 wherein the RFID reader of the at least one pharmaceutical storage unit is configured to detect an RFID ID card that is that is registered with the global inventory database and assigned to an authorised user to complete the user authorisation step.
7. The system of claim 4 or claim 5 wherein the at least one pharmaceutical storage unit comprises a user interface, the user interface being configured to allow a user to enter information into the user interface to complete the user authorisation step.
8. The system of claim 4 or claim 5 wherein the at least one pharmaceutical storage unit comprises a biometric reader configured to allow a user to provide biometric information to the biometric reader to complete the user authorisation step.
9. The system of any of the preceding claims wherein the RFID reader is configured to search for RFID tags that meet certain criteria including batch number, serial number, expiration date and storage requirement data of RFID-tagged pharmaceutical products.
10. A method for securing inventory at a plurality of patient points of care in the event of a recall of at least a portion of said inventory, comprising: a) updating a global inventory database to reflect that at least one RFID-tagged pharmaceutical product is to be recalled, wherein the RFID-tagged pharmaceutical product comprises a vascular endothelial growth factor (VEGF) antagonist for ophthalmological purposes; and b) for each patient point of care, checking stock data of at least one pharmaceutical storage unit to determine if said pharmaceutical storage unit contains the at least one RFID-tagged pharmaceutical product to be recalled and, if so, further comprising one or more of the following steps: i) issuing an alert to a user of the pharmaceutical storage unit; ii) preventing access to the pharmaceutical storage unit by all users except one or more appropriately authorised users.
11. The method of claim 10 wherein issuing alert to a user of the pharmaceutical storage unit comprises sending an email to a user of the pharmaceutical storage unit.
12. The method of claim 10 or claim 11, wherein step b) includes, at each of one or more of the plurality of patient points of care, checking stock data of a plurality of pharmaceutical storage units and wherein preventing access to the pharmaceutical storage unit comprises first checking the stock data of each of the plurality of pharmaceutical storage units at said respective one or more patient points of care to identify which of the pharmaceutical storage units contains the at least one RFID-tagged pharmaceutical product to be recalled; and preventing access, by one or more users of a first and/or a second type, to the pharmaceutical storage units at said respective one or more patient points of care containing the RFID-tagged pharmaceutical product to be recalled and permitting access, by the one or more users of the first and/or the second type, to the pharmaceutical storage units at said respective one or more patient points of care which do not contain the RFID-tagged pharmaceutical product to be recalled.
13. The method of any of claims 10 to 12, wherein once access to the pharmaceutical storage unit that contains the RFID-tagged pharmaceutical product to be recalled has been prevented to said one or more users, the method further comprises: an authorisation step wherein the identity of a user of a third type is verified in order to provide access the pharmaceutical storage unit, and allowing the user of the third type access to the pharmaceutical storage unit; removing the RFID-tagged pharmaceutical product to be recalled from the pharmaceutical storage unit; verifying that the pharmaceutical storage unit no longer contains the RFID-tagged pharmaceutical product to be recalled using at least one RFID reader associated with the pharmaceutical storage unit; and allowing access to the pharmaceutical storage unit by one or more users of a first and/or a second type.
14. The method or system of any of the preceding claims wherein the VEGF antagonist comprises a VEGF fusion protein or an anti-VEGF antibody or an antigen-binding fragment of such antibody.
15. The method or system of any of the preceding claims wherein the VEGF antagonist comprises a VEGF fusion protein comprising two or more immunoglobulin-like domains of VEGF receptor 1 (VEGFR1) and/or VEGF receptor 2 (VEGFR2).
16. The method or system of any of the preceding claims wherein the VEGF antagonist comprises Aflibercept.
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