IES20060947A2 - An environmentally controlled delivery system - Google Patents

Abstract

An environmentally controlled delivery system for delivering a product sensitive to environmental parameters from a storage area 12 to an end user. The system comprises environmentally controlled storage means 12, 420, wherein products are stored and maintained at desired environmental parameters, means for monitoring environmental parameters of stored product, a central controller 20 for storing details of products, monitoring and recording the environmental parameters of the storage means and the stored product and processing orders for products, environmentally controlled transportation means 100 for transporting the product from the storage means to the end-user and means for updating the central controller 20 once the product has been delivered to the end-user. <Figure 1>

Description

AN ENVIRONMENTALLY CONTROLLED DELIVERY SYSTEM The present invention relates to a system and method for delivering products sensitive to environmental parameters between two points whilst maintaining the product in a controlled environment.

In recent years there has been growing concern surrounding the maintenance of quality in relation to cold-chain storage and distribution of pharmaceutical products especially specialist biological pharmaceutical products such as blood factor concentrates and vaccines. Deficiencies in this area comprised one-third of all critical deficiencies within the United Kingdom in 2001.

Validation is essential in pharmaceutical and biological industries. It is absolutely necessary to demonstrate accurately and reproducibly that the pharmaceutical products supplied to end users are of the highest standard and that the condition of said products have not deteriorated in any way from production through to use by end users. In order to ensure movement of the product is validated it is important to provide a detailed traceable account of each product from manufacture to end use.

This ensures that if an individual product within a batch is contaminated or has deteriorated in quality, that a record exists which will indicate where the fault may have occurred. Alternatively the record also provides a means of identifying the source and batch of the contaminated product and/or other batches of the contaminated product that may have emanated from the source. Once identified the other products and/or source can be tested for similar contamination/deterioration. Previous systems have failed to provide any such means or assurances.

Furthermore, it is of utmost importance to maintain accurate medical records to accompany the pharmaceutical products that enter into the cold-chain storage/distribution system. Currently there is a significant lack of quality standards concerning the best practice to validate movement of cold-chain pharmaceutical or biological products. The companies involved in the pharmaceutical or biological supply chain are constantly challenged to maintain good practices to ensure products are shipped to market in a controlled environment without deterioration of the product. fa θ 9 4 7 An object of the present invention is to overcome the problems associated with known systems for moving environmentally sensitive products from production to end-user.

According to the invention, there is provided an environmentally controlled delivery system 5 for delivering a product sensitive to environmental parameters from a storage area to an end user, the system comprising; (a) environmentally controlled storage means, wherein products are stored and maintained at desired environmental parameters; (b) means for monitoring environmental parameters of stored product; (c) a central controller for storing details of products, monitoring and recording the environmental parameters of the storage means and the stored product and processing orders for products; (d) environmentally controlled transportation means for transporting the product from the storage means to the end-user; and (e) means for updating the central controller once the product has been delivered to the end-user.

The advantage of this system lies in the fact that the products once generated immediately enter the system of the invention. Therein the various environmental parameters that affect the quality and contamination levels of the product are continuously monitored to ensure that the products are maintained to the highest standards whilst in storage and subsequently at distribution stage wherein the product is transported from storage to the end user. This is of particular relevance to blood factor concentrates and vaccines in order to avoid critical deficiencies wherein the biological products are no longer viable.

Furthermore the system of the present invention provides a means to provide a detailed traceable account of each product from manufacture to end use, thus validating the system.

The system of the invention also provides means to recall products should a problem with a particular product be detected.

Preferably products are generated by either the pharmaceutical companies or issued by the Central Authority responsible for issuing pharmaceutical products. Once the product ΙΕΰίο 947 is generated it is immediately placed in environmentally controlled storage means. Preferably environmental parameters which adversely affect the quality of the stored product are set to the desired levels prior to the product being placed therein. The parameters are subsequently controlled and monitored within the storage means. It is of course understood that the environmental parameters controlled include temperature and/or humidity. The environmental parameters are not limited these parameters, any environmental parameter in which a change in the value of said parameter would adversely affect the quality of the stored product will be controlled.

Preferably the storage means comprise a refrigerated area. Preferably the refrigerated area operates with a plurality of paired refrigeration units. The refrigeration units are powered by mains electricity and are also backed up by alternate power sources such as a generator which will start immediately should the mains electricity supply fail.

Optionally the storage means can be either a fixed or mobile refrigerated area.

Preferably the mobile refrigerated area comprises a refrigerated vehicle wherein the first refrigeration unit in the pair of refrigeration units is operable by the vehicle’s power supply and a second refrigeration unit in the pair of refrigeration units is operable by either a battery or mains electrical supply.

Optionally the storage means also comprise a Global Positioning System (GPS) and/or a General Packet Radio Service Device (GRPS) which is in communication with the central controller.

Preferably the refrigerated area is operated in the temperature range of between 2°C 8°C. The system of the invention is easily adapted to any temperature range required by a person skilled in the art.

Preferably the system of the invention operates a coding mechanism which allows each product once generated to have one or more identifying codes. Ideally the coding mechanism uses the internationally recognised barcode system for encoding relevant data. 0^0947 Preferably each product is identified primarily by a barcode which includes a Global Trade Item Number (GTIN) which identifies the product name, strength and at least one of the following pieces of information, quantity information (for example 10 x 10mls vials), batch information, and expiration information, Global Location Number (GLN) or Global Relationship Service Number (GRSN). Each product is assigned this primary identifying barcode when generated. Once the product is placed in the environmentally controlled storage means the barcode is entered into the central controller.

In a further embodiment of the invention the central controller generates a second barcode to identify the serial number of a product within a batch of same product items for example: if there are a number of same product items within the batch and they all have the same GTIN, then the central controller assigns a serial number for each product within a batch.

Preferably the environmental parameters are monitored using means such as temperature probes, temperature sensors, humidity sensors and so forth. Conveniently each of the monitoring means is connected to an alarm system and the central controller. The alarm system is set such that the preferred humidity and temperature range are entered into the system. In the event that either or both of these environmental parameters enter into a danger zone wherein the danger zone is defined as being plus or minus a defined amount below and above the upper and lower range limits respectively an alarm is activated. If the environmental conditions deteriorate further such that the upper and lower range limits are reached a second alarm is activated. It is of course understood that the delivery system of the present invention is not limited to two alarms, any number of alarms required by the skilled person is facilitated by the system of the invention.

Preferably the core temperature of each product is tested after generation prior to entry to the storage area using appropriate testing means such as, for example, a temperature probe or temperature sensor. Conveniently the core temperature of the product can be checked at regular intervals once in the storage area. The testing means are also connected to the central controller.

Preferably the means for monitoring the environmental parameters and/or testing the core temperatures are also in communication with the refrigeration units and one or more of the various power supply means. ®°^0947 Preferably the central controller further comprises a dial-out unit that can dial one or more telephone numbers to alert personnel in the event of alarm activation and/or power supply failure. Advantageously the dial-out unit also facilitates personnel accessing monitoring and/or testing equipment for real-time external monitoring.

In a further embodiment of the invention the central controller is operated in a network using a telecommunication system that facilitates a secure environment which enables data to be transmitted securely. This provides a means by which the monitored parameters can be recorded and stored for validation purposes.

Preferably, an order can be placed for one or more of the environmentally sensitive products on the central controller. Conveniently the order can be placed directly on the central controller or communicated to the central controller using the telecommunication system. Preferably the central controller processes the orders by assigning a further barcode to the ordered product which is subsequently attached to each individual dosage amount of the product. The further barcode is known as a patient barcode and contains the Global Relationship Service Number (GRSN) which identifies the relationship between two separate entities such as the patient and either the hospital or doctor and/or the patient and the product. Any other appropriate information deemed necessary may also be included in this barcode. Once the patient barcode is attached to each individual dosage of the product the product is transferred from the environmentally controlled storage means to the environmentally controlled transportation means and dispatched to, for example, a hospital for the end user.

Preferably transportation means comprises a mobile refrigerated area. Conveniently if the product is to be transported over a distance which requires a vehicle, the refrigerated vehicle described above is used to transport the product. Alternate mobile refrigerated areas for use over relatively small distances, for example, when moving a product from one controlled storage area to another controlled storage area within a hospital comprise means such as, for example, thermos packs, liquid nitrogen and so forth as appropriate. Preferably the core temperature and other environmental parameters are monitored throughout the transportation process. 0&o g47 In a further embodiment of the invention, when transporting the product the delivery location can be reassigned and relocated at any stage during the delivery process. If the end-user has to change location, for example transfer to a different ward within a hospital or indeed to another hospital, the new location is relayed electronically to the central controller which in tum relays the information to the person transporting the product, for example, via a mobile telephone or the GPS or the GRPS system within the refrigerated vehicle. The person can react accordingly and the product can be delivered to the correct location.

Preferably once the product has been delivered the central controller is updated. The central controller then electronically advises the appropriate authorities that the delivery cycle has been completed. For example, the central controller may alert the doctor or hospital that initially issued the prescription that the patient or pharmacist had received the order. Alternatively the central controller may inform the Central Authority that the delivery had been successfully completed to aid validation and quality control.

There is also provided a method for delivering a product sensitive to environmental parameters from a storage area to an end user, the method comprising the steps of; (a) storing products in an environmentally controller storage means; (b) storing details of stored products on a central controller; (c) monitoring the environmental parameters of the stored products and recording the environmental parameters of the stored products and the storage means on the central controller; (d) processing one or more orders for stored product on the central controller; (e) transporting the ordered product to the end user; and (f) updating the central controller once the product has been delivered.

In another embodiment of the invention, the method comprises steps (a) to (f) above and also the further steps of: (c1) producing patient prescriptions from a doctor or a hospital electronic format; (c2) forwarding the electronic prescriptions to a pharmacist for dispensing; and (c3) the pharmacist forwarding the electronic prescription as an order to the temperature controlled system. /f0^0947 The invention will now hereinafter be more particularly described with reference to the accompanying drawings, which illustrate by way of example only, the structure and operation of an embodiment of the environmentally controlled delivery system in accordance with the invention.

In the drawings: Figure 1 is a schematic flow chart showing the elements of the environmentally controlled delivery system of the present invention; Figure 2 is a flow chart indicating the information flow between the elements of the environmentally controlled delivery system; Figure 3 is a flow chart illustrating the components of the transfer part of the 15 environmentally controlled delivery system; Figure 4 is a flow chart illustrating the components of the transfer and receipt part of the environmentally controlled delivery system; Figures 5 and 6 are flow charts of the in-hospital environmentally controlled delivery system; Figure 7 is a flow chart of the steps involved in generating a stock re-order report; Figure 8 is a flow chart of the steps involved in generating a stock replenishment order; Figure 9 is a flow chart of the steps involved in generating stock receipts; Figure 10 is a flow chart of the steps involved in generating the standing (Call Off) orders patient prescription (GSRN); Figure 11 is a flow chart of the steps involved in generating delivery orders; Figure 12 is a flow chart of the steps involved in contacting the patient/hospital; Ιε O£o 947 Figure 13 is a flow chart of the steps involved in generating patients orders report; Figure 14 is a flow chart of the steps involved in product allocation; Figure 15 is a flow chart of the steps involved in picking the order; Figure 16 is a flow chart of the steps involved in packing the order; Figure 17 is a flow chart of the steps involved in delivery van loading; Figure 18 is a flow chart of the steps involved in confirming the delivery; Figure 19 is a schematic diagram indicating the nature of the steps e.g. decision 15 making in each of the flow charts shown in Figures 1-18; Figure 20 is a side view of a refrigerated vehicle; Figure 21 is an end view of a refrigerated vehicle with the rear doors of the vehicle 20 and the door of the refrigerator in an open position; Figure 22 is a side cross-sectional view of the vehicle.

The elements of the environmentally controlled delivery system of the invention will now 25 be described with particular reference to Figure 1 of the accompanying drawings.

Systems Outline: The following description details the elements of the system flow for the environmentally controlled delivery system also known as the Central Distribution, Tracking and Control System (CDTCS).

Master Record Files Patient Records Including: Patient Master GSRN (PMGSRN).

,E 0^0947 GSRN (Global Service Relationship Number).

GLN (Global Location Number): A main GLN is included as well as one additional alternative GLN per patient.

Route Code: each patient is associated with a Particular Delivery Route/Journey.

Treatment Centre (Hospital) Code: This code designates the Treatment Centre (Hospital) normally attended by a particular patient. (GLN Code).

Prescriber Code: A code is designated for each clinician and the prescribed code on the patient records identifies the Clinician normally attended. (GLN Code).

Indicative Usage (Shelf Life): Indicates the normal expiration (use by) date.

Product Records Including: GTIN (Global Trade Item Number).

A method of FIFO (First In First Out) stock control is used based on the Batch 15 Number/Expiry Date. Product is allocated by stock Batch/Expiry date. Based on the indicated usage of the patient, the system will provide the patient with the optimum product shelf life.

Cold Store Warehouse/Locations Stock is maintained in the Cold Store Warehouse.

The Warehouse has distinct Location areas. These are for example: Goods Inward Cold Store (Main Warehouse Area) Goods Outward Pending Quarantine There is a Global Location Number (GLN) for each location.

Each Hospital is treated as a location, and there may be sub-locations in each Hospital, There is a GLN for each location and sub-location. Barcode Labels are used in each location for the GLN. θ#0947 Each Patient has at least one GLN. Barcode Swipe Cards are used in the location.

Patient’s home fridges are stock locations.

Barcodes and Data Messaging The Barcodes and Data Messaging requirements have been developed to EAN Standards for Global Identification using EAN Symbology Standards and Data Messaging to EAN Standards.

Barcodes The system uses the EAN.UCC System Data Messaging and Transfer Methods CDTCS facilitates the use of the Messaging Carrier System incorporating Encryption to AS2 or similar. Messages received are translated and mapped to the CDTCS system. CDTCS maps and translates outgoing messages for onward transmission.

The steps of the method of the invention are now described hereinbelow in relation to temperature with particular reference to Figures 2 to 4. It is of course understood that steps of the method apply to other environmental parameters such as humidity.

Patient records 10 and approved product information 11 is sent electronically from the Central Issuing Authority to the central controller 20 at steps 101 and 102 respectively. The product information 11 is stored in a stock file and details new products and possible substitute products together with the Global Trade Item Number (GTIN) of both the product and the substitute product. Any other appropriate information is also included.

The product is delivered to the storage area 12 from either the Central Issuing Authority or the pharmaceutical companies. When the delivery is accepted at the storage area, the details of the delivery are electronically input by scanning the manufacturer’s barcode of the product. All of the required information will be on the manufacturer’s barcode. Once each barcode is scanned, the information is relayed electronically to the stock file on the central controller 20 at step 103. Any barcode information not included can be entered manually onto the central controller 20. The stock file is updated using the Global Trade Item Number (GTIN) as an identification number and the quantity, batch and expiration information is added to the relevant product information. The central controller 20 automatically allocates a serial number for each vial of product thereby creating a unique ,£OZo947 vial box serial barcode label. The vial box serial barcode label is put onto the product, scanned in the storage area, thus becoming available for allocation.

The storage area 12 is divided into two areas, a processing area and a storage 5 refrigerator. The product is initially accepted into the processing area, where scanning occurs. In the processing area, the product is checked for quantity and quality, including a check of the temperature of the product. After checking, if the product is found to be at a temperature outside within the requisite temperature range i.e. outside the range, 2°C to 8°C, the product is rejected and placed in a quarantine area. Accepted product is transferred into the storage refrigerator. The storage area 12 operates with four refrigerator units, which operate alternatively as pairs with the second pair providing a backup in the event of failure of the first pair. The electricity supply to the storage area 12 is backed up by a generator which will start immediately if the electricity supply from the national grid fails.

The temperature of the storage area 12 is maintained between 4°C and 6°C and is monitored constantly to ensure that the temperature remains within the range 2°C - 8°C. Monitoring equipment is used for both pairs of storage refrigerators, temperature probes are positioned on the two storage refrigerators between the processing area and the storage refrigerators. These probes are supported by two probes located outside the storage area 12 for measuring ambient temperature and also two probes located outside the building also for measuring ambient temperature. There are also connections to the power generator to indicate if the power has failed. As a final precautionary measure there is also a temperature probe that is packaged as a product and is placed in a product container and placed in the storage refrigerator thereby mimicking the conditions in which an actual product is stored. The alarm system is set to activate in the case of temperatures reaching either 3°C or 7°C. This allows time for reaction before the lower and upper temperature limits of 2°C and 8°C respectively are reached.

A computerised control unit is connected to the monitoring equipment and the generator. The control unit has a dial-out unit with a series of telephone numbers, which can be called in the event of alarm activation and/or electricity supply failure. The control unit also enables the refrigeration engineers to access the system so that real-time external monitoring can take place. All temperature data is recorded to allow a continuous audit of the system. 47 Patient prescriptions 14 are generated by the prescribing physician and are sent electronically to the pharmacist 13 at step 105. The pharmacist 13 sends the prescription or order to the central controller 20 at step 106. Alternatively, the prescription may be forwarded directly from the prescribing physician to the central controller 20 at step 109. The prescription information is correlated with the information held in the stock file on the central controller 20 and the relevant product is assigned to that prescription at step 21.

A picking list 22 relating the prescription or order to the product containing all the relevant 10 product information is generated by the central controller 20 and is forwarded electronically to the storage area 12 at step 107. At the storage area 12, the product is selected at step 23 and verified by the barcode. A dispensing label 24 is then generated for each of the GTINs within a package. A Serial Shipping Container Code (SSCC) barcode label 24 is generated and placed on the outer box reflecting the product contained within. The SSCC barcode label contains the Global Trade Item Number (GTIN), Patient Master Global Service Relationship Number (PMGSRN), GLN and other relevant data.

A delivery order notice 25 is generated in conjunction with the dispensing label and the SSCC barcode label 24 and is dispatched with the product. The product is issued from the storage area 12 into the refrigerated van at step 26. The SSCC barcode label 24 is scanned electronically as the product leaves the storage area 12. Each refrigerated van is assigned a Global Location Number (GLN). The Global Location Number (GLN), together with the date and time of each dispatchment of product is input into the General Packet Radio Service (GPRS) system of the van, this is then communicated to the central controller 20 at step 27. The location of the refrigerated van can be monitored at all times using the Global Positioning System (GPS) system.

Once the records have been updated at step 27, delivery of the product to the end user is effected at step 28. This delivery might be at the hospital or pharmacy 14a or directly to the patient 14b. On arrival at the delivery point, the driver of the refrigerated van scans the SSCC barcode label 24 and the delivery date and time are also entered either manually or automatically. This data is transmitted to the central controller 20 from the GRPS system 30. 947 In the case of a delivery to the pharmacy or hospital 14a, a further barcode 15a is scanned which identifies the hospital or pharmacy 14a as the point of delivery. Once the delivery is made to the hospital or pharmacy 14a, responsibility for the delivery is transferred to either the hospital or pharmacy, respectively. However, in the case of a delivery directly to a patient 14b, the delivery is made to an appropriate designated point. This is very often a refrigerated unit with suitable identification means i.e. barcode and/or security tag 15b. Delivery is only completed in this case when the driver scans the appropriate identification means, namely, either barcode 15a or security tag 15b. Once delivery is completed at step 29, the central controller is again updated by the GRPS system 30.

There are a number of different options when delivering directly to a patient or a hospital/pharmacy. Swipe cards are provided for each patient location (GLN) and each hospital/pharmacy location (GLN).

In the case of directing delivery to the patient's home (Patient direct), the delivery is to the appropriate designated point, which has the patient’s GLN barcode swipe card available for validation. The driver scans the GLN Card, which is validated against the data in the driver’s hand held device. The SSCC and GLN labels on the tote boxes are scanned, confirmed and delivery complete. The confirmed product delivery is updated to the hand held device including time and date stamp. The patient signs electronically for the delivery. A signature is obtained for all deliveries irrespective of the delivery point.

Patient Mobile: This is a swipe card which the patient carries with them or leaves with, for example, a neighbour or office reception, for scanning on delivery. The swipe card is made available to confirm delivery and a signature is obtained.

In the event that the delivery instructions are changed by agreement prior to delivery, then the new destination is not a designated GLN on the patient’s master record, facility is provided within the method, apparatus and system of the invention to complete the delivery. This is considered an “Unregistered GLN” and the address is manually input to the hand held. A report of such deliveries is provided. £ θ£ΰ 947 The completed delivery information is transmitted via GPRS to the communications server in CDTCS.

Multiple deliveries to one location are possible. This means that the same delivery to GLN 5 could be used for more than one patient.

Delivery data is downloaded from the drivers’ hand held device on return to the CDTCS Warehouse. The confirmed deliveries are updated to CDTCS, which confirms the stock movement and records the delivery time and date. In the case of those deliveries not completed an exception status is recorded.

Delivery to the hospital is to a designated refrigerated area and is made in similar fashion to that for delivery to the Patient. There is an in house network made available in the hospital. Each location has a GLN. The GLN barcode is firmly attached or fixed.

The in hospital locations include; Blood Transfusion Laboratory Fridge (Server), Wards, Quarantine, ICU and Casualty. The hospital server application stores patient details including: Patient Master GSRN, GSRN, Name and Address and Date of Birth.

The hospital system has a facility to capture movements. Issues, returns etc. are scanned and recorded. A menu system is provided to cover all types of potential movements. A transaction code is provided to identify each type of movement. When a patient presents at the hospital, their details are selected from the file. This includes patient master GSRN and name and address. Date of birth can be used in the case of patients with the same name.

Using a keyboard wedge scanner, the vial boxes selected for the patients treatment are scanned and the details stored on the hospital server. The transactions are captured on the environmentally controlled delivery system of the present invention. The patient details file is updated on a regular basis from environmentally controlled delivery system.

The central controller 20 then electronically advises the hospital or pharmacy 14a at step 108 that delivery has been completed. The central controller also advises the central authority 20a and/or other relevant authorities 14d that the delivery has taken place. This in effect maintains quality control of the environmentally controlled delivery system. 11 0^0 947 A detailed description of particular aspects of the system of the invention will be described hereinbelow.

Stock Replenishment - Ordering and Receiving Product: With particular reference to Figures 7 and 8, the stock re-order steps of the system will now be described.

Stock Re-ordering Each product has a re-order stock level. A report highlights items at the re-order level. Initially, a suggested purchase order is raised for items when they reach their reorder level. The Responsible Person (RP) reviews this and a stock replenishment order is issued.

Stock Receipts With particular reference to Figure 9, the steps involved in stock receipt will now be described.

Product delivery is accepted into the goods-in area in the cold store warehouse. Each delivery is processed on a batch-by-batch basis. The appropriate quality control check-in procedure is carried out. This quality control check-in procedure includes validating that the product and quantity received are consistent with the supplier delivery docket.

Inputs into the CDTCS Supplier Reference (GLN) Warehouse Number (GLN) Stock Replenishment Order Number GTIN Code (Scanned) Batch Number Expiry Date Quantity of vial boxes Received The environmentally controlled delivery system of the invention validates that the correct stock replenishment order is being processed. The required stock Global Trade Item Number (GTIN) is selected and the batch processed by entering the batch number, expiry date and number of vial boxes received.

CDTCS automatically allocates the next available serial numbers in sequence to the vial 5 boxes in the batch. CDTCS allocates consecutive serial numbers within batch. These are stored and the system allows for separate receipt of deliveries of the same batch number.

The environmentally controlled delivery system prints a barcode label, called the vial box serial number label for each vial box in the batch. This label contains: GTIN Product Code Batch Number Expiry Date Unique Serial Number (Serial Number within Batch) A label is attached to each individual vial box in the batch.

In the event of a shortage or an over delivery, CDCTS provides the facility to “cancel” specified labels (with a reason code) or to produce additional labels.

At this point, the goods receipt for the batch is complete. The products are transferred directly into the cold store main warehouse area. The physical transferral of the products is accompanied by scanning each vial box in the batch out of the “Goods-ln” and into the “Cold Store zone” of the warehouse area. The products are placed “in stock” on CDTCS and therefore available for allocation.

Supply of Product: With particular reference to Figure 10, the steps involved in supplying product (according to orders prescribed) will now be described.

Patient Prescriptions (Orders) GSRN A “Standing Orders” file is created for patient prescriptions and maintained in CDTCS. This has the patients “standing” or usual requirement. Each patient standing order references a PMGSRN and GSRN. There are two types of change to a standing order. change orders (a new prescription for a patient), which is a permanent change, and 947 specific order requests (additional or special requirements for a patient), which is a temporary or one off change.

Each standing order has a maximum deliverable quantity per prescription. CDTCS provides an alert for those patients approaching this level within the time scale covered. Some form of emergency requirement or similar event could cause this, for example. CDTCS will not allow delivery of quantities beyond this level without the intervention of the responsible person (RP).

There may be more than one product type on a standing order. The original standing order may be amended as a result of a change order. This may only affect one item on the standing order. CDTCS will maintain reference to these changes.

There are two ways to maintain a standing order. There is the facility to receive an electronic message from the prescribing clinician via EAN messaging system and a facility to manually input a prescription direct.

The standing orders file allows facility for the input of dispensing details for incorporation onto a dispensing label. There is one dispensing label for each product type on an order.

Change orders and specific order requests are input to the standing orders file on CDTCS in similar fashion to the standing order.

Emergency Orders Emergency orders are given priority within the CDTCS distribution system. Emergency orders are processed as a route and follow the system flow through to delivery as a single route, single (or multiple if appropriate) order delivery. The distribution process is completed for emergency orders, but they have priority over the normal standing order deliveries.

Order Production, Picking and Dispensing Create Delivery Orders Referring now particularly to Figure 11, the steps involved in generating delivery orders will be described. 947 A delivery order is produced for a patient based on their standing order. Any changes either temporary or permanent are reflected on this delivery order. Delivery orders are produced for all patients allocated to a particular journey.

Patient Contact Referring now to Figure 12, the steps involved in contacting the patient will be described.

The responsible person (RP) will amend/delete/confirm the delivery orders as appropriate. All patients in a particular journey are contacted and their requirement is checked against the suggested delivery order. Any changes, along with confirming the patients’ required GLN, are made to the order. The responsible person (RP) can alter the route sequence or can change the GLN delivery point manually for a specific delivery.

The confirmed orders are the basis for instigating the delivery process.

Suggested Patient Orders Report Referring now to Figure 13, the steps involved in producing a suggested patient orders report will be described.

CDTCS produces a suggested patient orders report based on the route to be serviced. This report lists the patient, PMGSRN, GSRN and any changes made to the standing order.

The Responsible Person (RP) can review the suggested orders report.

Product Allocation Referring now to Figure 14, the steps involved in product allocation will be described.

CDTCS system allocates products to orders on a route journey. Orders are processed in patient/route order. Products are allocated by batch and expiry date. Certain patients have an indicative shelf life requirement. The system will provide these patients with products having a longer shelf life. When this is not possible an exception report will be produced.

The responsible person (RP) is allowed to manually allocate product to an order in specific circumstances.

Order Picking List Referring now to Figure 15, the steps involved in picking the order will be described. Picking lists are printed in the Warehouse. Each delivery order has a picking list. The picking list contains the order details including: Patient Master GSRN Warehouse Number Route Number Delivery Order Number Delivery Date GSRN Name Address GLN GLN Address Order Number Per Batch/Product: GTIN Product Identity Number Product Description Batch Number Expiry Date Quantity The data for the order is sent to the hand held device.

Order Picking The order is picked and placed in the appropriate container (basket) taking detail from the printed picking list.

The delivery number and warehouse GLN are scanned into the hand held terminal for validation and the product vial boxes are scanned individually. In this way the individual serial numbers for each vial box are input to the system.

The hand held terminal will contain the full stock list of vial boxes available for selection. As each vial box is selected CDTCS confirms/validates that it is available and is appropriate for the delivery order.

The scanned data is compared with the order data and confirmed on the hand held device. This ensures that the products picked match the products ordered. Any discrepancy is dealt with at this time. If there is a discrepancy, the whole order can be rejected and the process recommenced for that particular order. The order is confirmed as picked and awaiting packing.

Order Packing Referring now to Figure 16, the steps involved in packing the order will be described. The picked order is now validated and packed by scanning the individual vial boxes, comparing against the order, viewing the product, confirming the patient details and placing them in a tote box.

The quantity of tote box labels needed is calculated and CDTCS will print an individual SSCC (Serial Shipping Container Code) Barcode label for each tote box to be used for the delivery. These are fixed to the tote boxes. The SSCC number is created by CDTCS on a sequential basis. This label also shows the PMGSRN and GLN in barcode format and patient name and address in readable form.

Using the hand-held device the SSCC is scanned, as also are the vial boxes as they are placed into the tote box. When a box is full this is indicated to the system and the next box is packed in similar fashion. CDTCS now has a record of each SSCC and the vial boxes associated with it.

On completion of the delivery order CDTCS provides the following: printed delivery docket including printed barcode GLN, printed barcode PMGSRN, printed barcode delivery order number printed SSCC number and a dispensing label (one for each product on the order).

The order is confirmed as picked and awaiting dispensing.

Dispensing The responsible person (RP), who also attaches the dispensing labels, can now dispense 5 the order. The tote box is closed and sealed and placed in Goods-Out awaiting delivery.

Delivery Referring now to Figure 17 and Figure 18, the steps involved in delivery van loading and confirming the delivery will be described.

Route Summary Sheet A summary sheet is printed in route order. This includes the tote box SSCC numbers per patient.

Cold Chain Vehicle The tote boxes are issued from the Goods-Out in the warehouse and placed into the coldchain refrigerated vehicle. The delivery data is downloaded from CDTCS to the hand held device for the vehicle. This includes the GLN for patient delivery and SSCC. This data is in route order. The driver confirms that the correct tote Boxes have been loaded by means of scanning and comparison of the SSCC barcodes. Each refrigerated vehicle is assigned a Global Location Number (GLN).

Delivery Points There are a number of optional points of delivery: Patient Home GLN; Alternative Patient GLN; Hospital GLN; or Pharmacy GLN.

Delivery is validated by scan and comparison of GLN codes.

Patient Delivery There are 4 possible delivery situations: Delivery to Patient Home (GLN 1) “Mobile (GLN 2) (Patient Work or other address) Un-Registered GLN as outlined below Sign off by Delivery Person (GLN 1).

Swipe cards are provided for each patient location (GLN) and each hospital location (GLN). These are used to validate deliveries to the patient.

A. In the case of directing delivery to the patient’s home (Patient direct), the delivery is to the appropriate designated point, which has the patient’s GLN barcode swipe card available for validation.

The driver scans the GLN Card, which is validated against the data in the driver’s hand held device. The SSCC and GLN labels on the tote boxes are scanned, confirmed and delivery complete. The confirmed product delivery is updated to the hand held device including time and date stamp. The patient signs electronically for the delivery. A signature is obtained for all deliveries irrespective of the delivery point.

B. Patient Mobile: This is a swipe card which the patient carries with them or leaves with, for example, a neighbour or office reception, for scanning on delivery. The swipe card is made available to confirm delivery and a signature is obtained.

C. In the event that the delivery instructions are changed by agreement prior to delivery, then the new destination is not a designated GLN on the patient’s master record, facility is provided within the method, apparatus and system of the invention to complete the delivery. This is considered an “Unregistered GLN” and the address is manually input to the hand held. A report of such deliveries is provided.

D. Sign-off by Delivery Person: To be used if the patient GLN barcode is not available for whatever reason. This facility allows the driver to scan the GLN number from the delivery docket. A transaction code is allocated to allow the driver to indicate that this is what has happened.

In the event that a delivery fails or, for a legitimate reason, the patient requests a part delivery only, the goods are returned to the pending area (GLN) and a decision is then made on these items. If the delivery is cancelled, the goods are returned to the cold store.

The returned items are entered into pending on CDTCS and are further processed when a decision is taken as to the appropriate course of action. The completed delivery information is transmitted via GPRS to the communications server in CDTCS.

Multiple deliveries to one location are possible. This means that the same deliver to GLN could be used for more than one patient.

Delivery data is downloaded from the drivers hand held device on return to the CDTCS warehouse. The confirmed deliveries are updated to CDTCS, which confirms the stock movement and records the delivery time and date. In the case of those deliveries not completed an exception status is recorded. A flash card is used for the hand held device as an additional security measure.

Patient Usage Each patient is provided with a hand held device, either smart phone or PDA, for use in the home environment. This is either a Java enabled camera phone, with or without bar code reader orXDA II Smartphone with external SDIO bar code scanner. Area coverage is a dictator of the type of device. The patient scans vial boxes out of the fridge and inputs a transaction type code to indicate the reason for the movement. The data captured is transmitted to CDTCS and captured on the CDTCS communications server. The transaction data is updated to the patient stock file on CDTCS.

Hospital/Pharmacy Delivery Referring now to Figures 5 and 6, the in-hospital CDTCS will now be described.

Delivery to the hospital is to the designated Blood Transfusion (BT) laboratory refrigerated area and is made in similar fashion to that for delivery to the patient. Orders for the hospital are input to CDTCS in similar fashion to the patients order input other than that these are stock orders for the hospital and as such are delivered “into stock” in the hospital location. In addition, there is an in house network made available in the hospital. Each location has a GLN. The GLN barcode is firmly attached or fixed.

The In Hospital Locations include; BT Laboratory Fridge (Server) Wards Mo 947 Quarantine ICU Casualty The server application stores patient details including: Patient Master GSRN GRSN Name and Address Date of Birth The hospital system has a facility to capture movements. Issues, returns etc. are scanned and recorded. A menu system is provided to cover all types of potential movements. A transaction code is provided to identify each type of movement.

When a patient presents at the hospital, their details are selected from the file. This includes patient master GSRN and name and address. Date of birth can be used in the case of patients with the same name. Using a keyboard wedge scanner, the vial boxes selected for the patients treatment are scanned and the details stored on the hospital server. The transactions are captured on the central distribution, tracking and control system (CDTCS) of the present invention.

The patient details file is updated on a regular basis from CDTCS.

Returns from Patient/Hospital Product can be handed back to the driver from either patients or hospitals. These items are brought back by the driver and placed in quarantine. A decision is taken as to the course of action to follow for each return. CDTCS provides the facility to log the return against the initial recipient and to indicate the action taken with the returned product.

Stock Control Product Stock Rotation The CDTCS system maintains a FIFO/Expiry Date basis of stock so that it is always delivering in the correct manner from the warehouse. CDTCS provides a report detailing the list of products approaching expiry date (based on date range entry, re-order level and «47 minimum stock level) in respect of each patient, warehouse and the hospital locations. The report is provided to the hospital for action.

Stock can be transferred between depots and locations. This is carried out by scanning 5 the product vial box out of the current location and into the location to which it is to be moved. There is a facility for a transaction code to describe the movement. The transaction types include wastage, returns etc. There is also a facility to handle lost or unaccounted for vial boxes.

Quarantine Stock An area is allocated in the cold store warehouse and hospital for quarantined stock. This is treated as a stock location and has a GLN. This area holds products returned by recall, instruction etc. It also holds products for other reasons such as damage, return by hospital or patient etc. The system provides a manual entry facility to record final movement of the product once that decision has been made.

Pending Stock An area is allocated in the cold store warehouse for pending stock. This is treated as a stock location and has a GLN. This area is used to hold failed deliveries pending action.

Product Stock Check CDTCS maintains stock items by product, batch and serial number for the cold store warehouse locations and the hospital BT and other patient locations. The system provides details of its stock holdings in respect of a specific location for stock check purposes.

In Hospital Patients: Product issued to in-hospital patients is processed through the in hospital stock system. The patient master GSRN is captured via swipe or entry and is stored along with the transaction code, reason code and product vial box details. The data is forwarded to CDTCS. Provision is provided to handle visitors from other countries etc. who are not members of the main database.

Updates The issuing authority is notified by electronic means following the completion of the delivery cycle. This report provides all delivery and patient details for the route and, in the case of the hospital, the stock delivery details. ιιιί»„ Replenishment Stock Orders CDTCS provides a suggested replenishment order report based on usage and minimum stock level. This is reviewed by the RP and a replenishment stock order issued for each stock holding. The replenishment order number is used to validate stock receipts.

Daily Delivery Report At the end of each day a report is prepared and sent to the issuing authority detailing the hospital deliveries carried out for that day. The report in respect of the cold store warehouse covers all patient and hospital deliveries managed by the cold store.

Access Between Clinical/PAS Systems and CDTCS System An “icon” is provided to allow access to the CDTCS stock system from the Clinical/PAS system desktop to allow user access from clinical/PAS systems to CDTCS stock system.

This is provided to allow stock level enquiry which is limited to certain operations subject to password validation and also request and generate certain reports remotely. This is most particularly a recall report. The user is allowed input parameters such as GTIN, batch number and expiry date whereupon the system will generate the report. The report lay out is designed and available to the users. The ability to generate reports is limited to certain reports and is subject to Password validation.

User Access Systems Standards and QC.

Access is available in similar fashion to that outlined above. This is read only system and a number of stock reports are pre designed to allow input of variable parameters. The reports are produced in the hospital to facilitate the daily quality control routines.

The reports include: Daily stock reconciliation per in hospital location.

Report detailing in-hospital quarantine Items.

Daily stock check.

Connectivity with Clinical/PAS System from CDTCS.

The main areas of connectivity are as follows: Clinical/PAS system provides CDTCS in agreed format via encrypted message: to 947 Data incorporating new patients (PMGSRN), name and address, GLN’s and the other static details. Data in respect of changed static data circumstance for existing patients. New standing orders, change orders and emergency orders (including GSRN).

CDTCS provides Clinical/PAS system in agreed format via encrypted message: Data reporting the daily deliveries. Reports including recall. Messages have acknowledgements of receipt.

Reports The system records product deliveries per patient and is therefore able to report delivery patterns. In the case of the hospital, re-order levels are implemented and warnings issued if this limit is being approached.

In addition reports provided include: Standard Stock Reports.

Stock Valuation Stock Levels Stock Re-Order Journey Reports Patient Reports Rotating Stock Report Product Utilisation Report Customised Reports Hospital and/or Patient Reports - No of Deliveries - Batch Number Usage - By Product/Serial Number - By Patient/Hospital Product Reports.

- By Batch/Serial Number - By Month - By Patient/Hospital - Products Returned to Supplier ,ε0&> 947 Batch Report - By Expiry Date - By Patient/Hospital - By Serial Number 5 Region / County Analysis Product Report Deliveries Report Batch Recall Report CDTCS provides product cost prices at vial box level. The cost price is used to provide valuations as an average cost on reports taking the quantity delivered and the cost price per vial box. It is possible to provide previous year comparative data when the system has been implemented over a sufficient period to gather this data. This includes year to date and last year to date comparisons.

Stock reports are provided by stock location. It is also possible to provide special reports, which are based on the available data in the CDTCS database. Data for reports is also provided from CDTCS to the Clinical/PAS systems to allow them to incorporate these details into the clinical reports they will be providing from their system.

Recall The system provides a recall report to two levels.

A. An overall Report showing: Per Product, Batch Number, Location and also Quantity.

B. Where appropriate to a detail level including Serial Number.

A mail merge facility is provided so that a notice may be sent as well via email, post or other appropriate methods.

Audit Trail There is a full verifiable audit trail provided to cover the steps in the distribution system sequence. This provides the facility to carry out a visual check at key points in the distribution process. The audit trail includes: Stock Replenishment Orders Suggested Orders 947 Delivery Orders Picking Lists Delivery Dockets Route Summary Sheets Each document has facility for authorised signatures.

Locations CDTCS caters for multiple treatment centres (hospitals), where the data captured is collated and reported to the issuing authority.

Refrigeration Vehicle Referring to Figures 20, 21 and 22, the refrigeration vehicle 100 comprises two refrigerating units 120 (Main Unit) and 140 (Back-up Unit) mounted on the roof of the vehicle. Each refrigeration unit comprises an evaporator 120a and 140a, a condenser 120b and 140c. The main refrigerating unit 120 is connected and powered by the engine 100. The back-up refrigerating unit 140 is powered by the auxiliary battery 200 and can also be powered from a mains electricity supply 600. The auxiliary battery 200 is linked to the engine battery 10 and is recharged via an alternator 40 when the vehicle 100 is in motion.

The back-up refrigeration unit 140 is switched on by the driver when the engine is switched off. Alternatively the back up refrigeration unit 140 can be switched on while the main refrigeration unit 120 is in operation. Generally, this will only occur when the external ambient temperature is very high and auxiliary cooling is required.

An isolation relay switch 500 is activated when the vehicle 100 is not in use to prevent power being drained from the main battery unit ofthe engine 100.

Audio and visual alarms are built into the dashboard 200 of the vehicle. A global positioning system 230 is built into the vehicle 100, the aerial 220 of the GPS being positioned on the roof of the vehicle 100. The GPS 230 is linked to a temperature monitoring unit 210 which enables the driver of the vehicle to monitor the temperature at all times. The vehicle is tracked by a remote computer using the GPS 230 and Global Positioning System tracking technology which is linked to a data communication unit such /£OZo947 as a GSM modem. Furthermore, the temperature data generated during a vehicles journey can be downloaded through a Data Carrier Unit (DCU) device and loaded to a remote computer for analysis and storage. Both systems allow interrogation of the vehicle positioning and temperature data in real-time or historic or a combination of both.

This is performed on the GPS 230 by means of a GSM communication from the remote computer to the host unit in the vehicle. Any untoward event relating to temperature is signalled through the data communication unit back to base. The remote computer is then capable of SMS messaging to alert an on-call staff member such as the driver of the vehicle or a technical engineer.

The refrigeration area 420 has a number of probes 110, 150, 160 and 170 positioned within it. There are three air probes, 150, 160 and 170 respectively and one product probe 110. The product probe 110 is packaged as if a real product and placed in a product container within the refrigeration area 420, thereby mimicking a real product.

Each of the probes 110,150,160 and 170 are connected to the monitoring unit 230 within the cab of the vehicle 100.

The door 400 of the refrigeration unit is also connected to the monitoring unit 210, thus providing an indication every time the door 400 is opened and closed via switch 180.

As can be seen in Figure 21, when the rear doors 300 of the vehicle are opened, another door 400 of the refrigeration area 420 has to be opened to gain access to the area. The fridge door 400 is purpose built for extra insulation and extra insulation 440, approximately, double the normal, is provided for the refrigeration area 420.

Example of Validation Testing of the Refrigeration Vehicle Performance & Operational Qualification Example Protocol Currently, the main refrigeration unit on the vehicle is a Carrier Transicold Xarios 200 unit 120, supported by a Carrier Transicold Basic 700 back up refrigeration unit 140. Any suitable refrigeration unit known to a person skilled in the art can be used. The equipment was designed to ensure operating temperatures can be maintained over pre-set ranges at all times e.g. 2°-8QC.

IE O&Q 947 The monitoring unit was a Tanscan 2 temperature recorder with four temperature probes (three air 150,160 and 170 and one product 110) in the refrigeration area.

The refrigeration vehicle 100 is tested under normal operating conditions. Each test 5 taking at least 4 hours, monitoring every 10mins. There are eight test locations in the refrigeration area 420. The position of the test probes are identified on Temperature Probe Location Forms. Each location is tested for 4 hours with the fridge empty (one test) and 4 hours with the fridge loaded (second test). Two operational 6 hour tests are then carried out, thereby testing the vehicle 100 under full operational conditions. The hot and cold spots are then analysed and the final position of the probes for general use decided. Alarm tests are also carried out at both high and low set points.

Example Acceptance Criteria The fridges should show operational temperatures of within the set range appropriate to 15 the product requirements at all times. In this example, the temperature range is 2°-8°C.

Any test that gives results outside the required limits is analysed and the reason for the deviation found. This is then corrected before further testing commences.

Example Report A cold chain service is offered to health boards, Hospitals and pharmaceutical companies. The service involves refrigerated storage of pharmaceutical products at an appropriate warehouse, and refrigerated nationwide transport to deliver direct to health authorities and/or hospitals.

All refrigerators used and the transport systems are subject to validation. Each refrigeration vehicle and transport procedures will are tested initially in both winter and summer conditions and then on an annual basis thereafter. Daily analysis occurs during normal operation of the vehicle 100.

Aims of Validation Most regulatory authorities require that validation and requalification processes should establish and provide documentary evidence as out lined below: 947 The premises, the facilities, the equipment and the processes have been designed in accordance with the requirements of current G.D.P. (Good Distribution Practice.) The equipment has been installed in compliance with their design specifications.

The aim of this validation process will be to show that the facilities and equipment operate in accordance with their design specifications. This Process Qualification (P.Q) will show that the equipment and processes operate to a consistent and reliable standard, maintaining the integrity of the product at all times.

Any aspect of, including significant changes to, the vehicle, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.

Requalification will occur annually or at another time where the changes outlined above require it. Appropriate documentary evidence will be carried out with each validation or requalification. Initial validation testing will be repeated during the winter to show testing through the two extremes of temperatures. The initial validation work will be carried during the summer.

The vehicle 100 used is a refrigerated vehicle.

It will or course be understood that the present invention is not limited to the specific details herein described which are given by way of example only, and that various alternations and modifications may be made without departing from the scope of the invention as defined in the appended claims. ,εοάο 947

Claims (5)

CLAIMS:

1. An environmentally controlled delivery system for delivering a product sensitive to environmental parameters from a storage area to an end user, the system 5 comprising; (a) environmentally controlled storage means, wherein products are stored and maintained at desired environmental parameters; (b) means for monitoring environmental parameters of stored product; (c) a central controller for storing details of products, monitoring and recording the 10 environmental parameters of the storage means and the stored product and processing orders for products; (d) environmentally controlled transportation means for transporting the product from the storage means to the end-user; and (e) means for updating the central controller once the product has been delivered 15 to the end-user.

2. An environmentally controlled delivery system as claimed in Claim 1, wherein the system further comprises monitoring means for monitoring and controlling environmental parameters which adversely affect the quality of the product within 20 the storage means and/or transportation means; the environmental parameters include temperature and/or humidity; the monitoring means include one or more of temperature probe, temperature sensor and humidity sensor wherein each of the monitoring means is connected to an alarm system and the central controller; and the storage means comprise a refrigerated area wherein the refrigerated area 25 operates with a plurality of paired refrigeration units and wherein the refrigeration units are powered by mains electricity and by alternate power sources such as a generator which will start immediately should the mains electricity supply fail; and optionally, the storage means comprises a mobile refrigerated area, wherein the 30 mobile refrigerated area comprises a refrigerated vehicle which operates with a plurality of paired refrigeration units wherein the first refrigeration unit in the pair of refrigeration units is operable by the vehicle’s power supply and a second refrigeration unit in the pair of refrigeration units is operable by either a battery or mains electrical supply. Ιε °&>947

3. An environmentally controlled delivery system as claimed in Claim 1 or Claim 2, wherein the system further comprises a coding mechanism which allows each product once generated to have one or more identifying codes wherein, each product is identified by a first barcode which includes a Global Trade Item Number 5 (GTIN) which identifies the product name, strength and at least one of the following pieces of information, quantity information, batch information, and expiration information, Global Location Number (GLN) or Global Relationship Service Number (GRSN); 10 optionally, the central controller generates a second barcode to identify the serial number of a product within a batch of same product items; and optionally the central controller generates a third barcode which contains the Global Relationship Service Number (GRSN) wherein the GRSN identifies the 15 relationship between two separate and is attached to each individual dosage of the product.

4. A method for delivering a product sensitive to environmental parameters from a storage area to an end user, the method comprising the steps of; 20 (a) storing products in an environmentally controller storage means; (b) storing details of stored products on a central controller; (c) monitoring the environmental parameters of the stored products and recording the environmental parameters of the stored products and the storage means on the central controller; 25 (d) processing one or more orders for stored product on the central controller; (e) transporting the ordered product to the end user; and (f) updating the central controller once the product has been delivered; optionally, the method also comprises the further steps of: 30 (c1) producing patient prescriptions from a doctor or a hospital electronic format; (c2) forwarding the electronic prescriptions to a pharmacist for dispensing; and (c3) the pharmacist forwarding the electronic prescription as an order to the temperature controlled system. IE Otfo 947

5. An environmentally controlled delivery system substantially as herein described with reference to and as shown in the accompanying drawings. 5 MACLACHLAN & DONALDSON, Applicants’ Agents, 47 Merrion Square, Dublin 2.