FIELD OF THE INVENTION

The present invention relates to a method and a system for tracking pharmaceutical products to end-users and up to the point of consumption.

BACKGROUND OF THE INVENTION

With the expansion and growth of global sourcing in the supply chain, more prevalent interest has been placed on the automatic monitoring of time and environmental related parameters to increase food and drugs safety and improve the food defense systems throughout all areas of production, processing, storage, transportation and operations. Food and drugs require proper handling of environmental related parameters such as temperature during the transport to assure shelf quality, longevity, and safety.

Logger devices are electronic monitoring devices commonly used for these purposes, and namely, to be associated to assets such as food, beverages or drugs to automatically monitor and record various environmental related parameters of the assets throughout a supply chain, such as temperature, humidity, acceleration, and air pressure, over time. A recent example of importance of such logger devices is the temperature monitoring of the COVID-19 vaccines, which is a critical monitoring parameter.

A supply chain contains different transport legs, such as a primary transport leg where a primary distribution from the manufacturing facility to regional distribution site takes place, a secondary transport leg where a secondary distribution from the regional distribution site to e.g. local market distribution takes place, and a last mile transport leg where the last mile distribution from the regional distribution to pharmacies, hospitals or even directly to a patient takes place.

Serialization of pharmaceutical products has been forced on the pharmaceutical industry. However, despite that the pharmaceutical industry does not have full tracking from manufacturing to patient or pharmacy /hospitals (end-to-end) on a unit level in their supply chain. Furthermore, even though serialization is somewhat solving possible counterfeit within the supply chain (wholesale to pharmacy) it is not solving any other issues e.g. end-to-end tracking issues. As an example, patients having access to pharmaceutical product data such as the stability budget of the product, the overall patient protection would improve, however this is currently not available. Therefore, giving the pharmaceutical industry more access to product data during the transport within the supply chain would better protect against counterfeiting, illegal parallel importing and give more visibility to the end patient.

Currently, visibility of pharmaceutical products during transport within the supply chain is limited beyond the primary distribution. Today, there is approximately 40% forecasting accuracy in the supply chain tracking industry leading to higher safety stocks and write offs, higher costs, suboptimal production capacity, and higher CO2 footprint. Getting more data points in the supply chain and until a point of consumption would thus significantly improve said forecast accuracy.

Wholesalers are reluctant to provide data to the pharmaceutical industry as they don’t see the benefit in doing so, but hypothetically the pharmaceutical industry could know stock levels and inventory needs in each market but doesn’t due to the lack of data communication on the wholesalers' side.

Moreover, more and more products are being sent directly to patients but proof that the correct patient got the correct products is not being verified. It is to be expected that auditors will put more pressure on pharmaceutical industry to prove that the chain of custody of the pharmaceutical products is accurate and robust. It would thus be desirable to have simple authentication and unit level tracking that works globally where the pharma industry can prove that the right patient has custody of the right product.

Moreover, there is a lot of paper waste world-wide caused by all the paper leaflets that follow medicine and especially because they must be replaced in different countries due to different languages. E-Leaflets are the future, however there are currently no plans to utilize the valuable engagement that pharma can gain with it.

There is thus an urgent need to provide full end-to-end visibility of pharmaceutical products being transported throughout the supply chain.

This is partly solved in WO2014126654 which relates to a track and trace solution for pharmaceutical products where data is received from numerous supply-chain participants such as the manufacturer, distribution center and pharmacy. A unique Quick Response (QR) is printed on the packaging material containing the product, where the QR code has a one-to-one mapping of the individual items of the biomedical product. The data received from the supply-chain participants is received when the QR code is scanned by e.g. the manufacturer, the distribution center(s) or the pharmacy etc.. Upon scanning the QR code at the different locations, information like the product usability is received, what entity within the supply chain did the scanning, and the location and time of the scanning. This data may be utilized for tracking and tracing, and also for anticounterfeiting purposes.

The fact that the tracking is based on the scanning of the QR code from numerous supplychain participants makes the tracking far from being complete throughout the supply chain. As an example, the data resolution in a supply chain consists of e.g. three supply-chain participants, but where the transport time may take several weeks, and be based on said three data points, meaning that the end-to-end visibility is still very limited.

Moreover, the utilization of this method as an anti-counterfeiting measure is based on the monitoring of whether the QR code has been scanned or not, where the scanning is used to authenticate whether the product is in the package. The system records that the code has been scanned, what entity along the supply chain has scanned it, and where the device that scanned it was located at the time of the scanning. If the code has never been scanned before, it is an indication that this package has never been opened by a consumer and that no duplicates of this code exist. If on the other hand the QR code has previously been scanned, the consumer might be informed that this product might be a counterfeit, along with the date and the location of the previous scanning.

If the date and the location of the scanning match a previous scan that the consumer performed, then the product is still safe to use.

Based thereon, the location of the scanning and the information of the scanning history is used to determine whether the product might be a counterfeit or not.

This method does not ensure that the products are sent directly to the patients and surely does not provide proof that the correct patient got the correct products. The step of scanning the QR code for the first time may occur anywhere during the supply chain.

SUMMARY OF THE INVENTION

It is an object of the invention to overcome the above-mentioned drawbacks by providing an end-to-end visibility for pharmaceutical products while being transported within the supply chain, irrespective of the number of transport legs. Moreover, the object of the present invention is to provide a reliable solution verifying that the correct patient consumed the product, i.e. correct Point Of Consumption (POC).

In general, the invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-mentioned disadvantages of the prior art singly or in any combination. In particular, it may be seen as an object of the embodiments of the present invention to enhance the data visibility for the products which may typically be pharmaceutical products, during the transport in a supply chain and provide a method and a system that solves the above- mentioned problems, or other problems.

To better address one or more of these concerns, in a first aspect of the invention a method is provided of tracking products to end-users and up to the point of consumption (POC), where the products originate from a larger product entity having a pre-defined transport order, where the transport order includes product serial numbers and the final destinations for the products are transported throughout a supply chain, and where each product has an associated unique identifier (ID) for uniquely identifying the product, where the unique product ID comprises a plurality of application identifiers including a serial number identifier, wherein the method comprises:

• scanning a unique product ID of a given product selected from the larger products entity,

• providing location information of the scanning,

• accessing a manufacturer Uniform Resource Locator (URL) portal address where the data from the unique product ID of the scanned product is compared with data in the predefined transport order, the step of comparing includes: o comparing the serial number of the unique product ID with the serial number in the shipment order, and o comparing the location information of the scanning with the final destination associated with the serial number in the shipment order, where in case of a match between the serial numbers and between the location of the scanning and the final destination,

• confirming POC and providing data access related to the product via the manufacturer URL portal address.

The product may be any sensitive product that is to be consumed by a patient. In the following, it is assumed that the product is a pharmaceutical product. In one embodiment, prior to providing the access to the manufacturer URL portal address, the method further comprises an intermediate step of accessing a general URL portal where at least some of the application identifiers in the unique product ID are utilized in identifying the manufacturer URL portal address. In another embodiment, the step of providing the access to the manufacturer URL portal address comprises incorporating the manufacturer URL portal address preferably with the serial number into the unique product ID as additional application identifier. The umbrella term for these identifiers is a so-called GS1 standard where the code may be presented in a barcode form or as a data matrix (QR code).

The term manufacturer URL may in one embodiment be understood as a specific URL that is intended to guide the person performing the scanning, e.g. end-user, to a web portal to get further information on the pharmaceutical product. Thus, by adding a new application identifier identical to a so-called GS1 Resolver in the digital link version it is possible to use the information in the barcode or the QR code to guide the person to a web portal that is linked to said pharmaceutical product.

The scanning may in one embodiment be performed by a scanning device, such as a mobile device e.g. a mobile phone or any other portable or non-portable device, and where the step of providing the location information of the scanning is performed via the Internet Protocol (IP) address of the mobile device. The location information may as an example be the country where the scanning takes place, alternatively the location information may be obtained via a WiFi positioning system.

The term POC may be understood as the location where the patient consumes the pharmaceutical product. Another definition of the term POC is, as an example, a hospital, a pharmacy or any type of organization close to the patient, where it is only a matter of time when the pharmaceutical product will be consumed. This may be where the packing containing the pharmaceutical product is e.g. on a box level containing multiple packages on a consumer level (smallest packing level), where upon scanning and opening the packages, it is within a given short time frame that it will be consumed by a patient.

In an embodiment, the step of providing the end-user with data access related to the pharmaceutical product via the manufacturer URL portal address includes providing the end user with information selected from one or more of the following:

• An electronic pharmaceutical information leaflet (E-leaflet) related to the pharmaceutical product, • A status Data update of the pharmaceutical product obtained by a real time tracking device during the transport throughout the supply chain.

Accordingly, a tracking of the pharmaceutical product up to a POC is provided giving patients access to product data such as whether the pharmaceutical product is safe to be consumed via e.g. the stability budget information, thus the patient protection is ensured. Moreover, the pharmaceutical industry can be ensured that the POC is the correct POC and thus better protection against counterfeit and illegal parallel importing is provided.

Furthermore, world-wide paper waste is avoided due to E-leaflets replacing normal paper leaflets where the E-leaflets are preferably in the end-user’s language where the POC is.

In an embodiment, in case of a non-match between at least one of the serial numbers and/or between the location of the scanning and the final destination associated with the serial number in the shipment order a message indicator is triggered indicating that the pharmaceutical product is not to be used and that there may be a possible counterfeit, and optionally a contact information may be provided to the end-user.

In an embodiment, the method further comprises providing an end-user with an ID code such as a pin number code to enter after scanning for accessing the manufacturer URL portal address. Accordingly, a 100% verifying solution is provided to ensure that the POC is correct. The end user might as an example receive an email with e.g. a four-digit pin code.

In an embodiment, the pharmaceutical product is at a box level, where the step of comparing the serial number of the unique product ID with the serial number in the shipment order and comparing the location information of the scanning with the final destination associated with the serial number in the shipment order is performed with the unique product ID on the box. The unique product ID code may be a GS1 code having several identifiers such as a Product identifier (GTIN) which on such a box level is the same for different boxes (on the same level) having the same size, an expiration date identifier, a Batch/Lot number identifier and said serial number identifier, where such boxes are distinguished via different serial numbers (each box has a unique serial number). As an example, boxes having the same volume and same shape coming from a given manufacturer have the same GTIN number. The scanning might be done at a pharmacy or a hospital with any type of scanning device, where the box may contain 2 or more consumer packages.

In an embodiment, the pharmaceutical product is at a consumer package level, where the step of comparing the serial number of the unique product ID with the serial number in the shipment order and comparing location information of the scanning with the final destination associated with the serial number in the shipment order is performed with the unique product ID on the consumer package.

In an embodiment, scanning the unique product ID further triggers an inventory related signal informing the manufacturer of the pharmaceutical product that the pharmaceutical product has been consumed or will be consumed within a given time frame. Accordingly, the inventory may be updated in real time. Taking the box level scanning as an example, a predefined rule of e.g. 1 week as a POC estimate since it includes tens or hundreds of consumer packages, meaning that an estimate signal of 1 week indicates that the these tens or hundreds of the pharmaceutical products have been consumed by consumers in this 1 week.

The step of verifying the POC and providing the end-user with data access related to the pharmaceutical product via the manufacturer URL portal address may also be estimated by the time until consumption, meaning that if the pharmaceutical product is at a box level, the consumer packages will not be consumed immediately, but e.g. within the next 7 days. Thus, verifying of the POC may be at some time period later. If on the other hand the product is at a consumer level packaging, said scanning results in an immediate verification of the POC.

In a second aspect of the invention, a system is provided for tracking a product such as a pharmaceutical products to an end-users and up to the point of consumption (POC), where the pharmaceutical products originate from a larger pharmaceutical product entity having a predefined transport order where the transport order includes information like the product serial numbers and the final destinations for the pharmaceutical products which are transported throughout a supply chain, where each pharmaceutical product has an associated unique identifier (ID) for uniquely identifying the pharmaceutical product, where the unique product ID comprises a plurality of application identifiers including a serial number identifier, wherein the system comprises:

• a scanning device for scanning a unique product ID of a given pharmaceutical product selected from the pharmaceutical products,

• means for providing the location information of the scanning,

• a computer system for providing access to a manufacturer Uniform Resource Locator (URL) portal address, where the computer system compares the data from the unique product ID of the scanned pharmaceutical product with the data in the pre-defined transport order, the comparison includes: o comparing the serial number of the unique product ID with the serial number in the shipment order, and o comparing location information of the scanning with the final destination associated with the serial number in the shipment order, where in case of a match between the serial numbers and between the location of the scanning and the final destination, where the computer system is further configured to verify the POC and provide data access related to the pharmaceutical product via the manufacturer URL portal address.

In an embodiment, the system further comprises one or more tracking devices such as a bendable logger device e.g. a smart label (loT label) or a logger device associated with at least the larger product, e.g. pharmaceutical product, entity, where the tracking device comprises at least a sensor including a temperature sensor and a communication module to communicate through a communication network such as a cellular network with an external control computer, where the at least one tracking device tracks at least the temperature together with the position of the tracking device in real time, where the external control computer is configured to process the temperature data for determining if the pharmaceutical products fulfil a pre-defined temperature criteria and thus if the pharmaceutical products are safe to be consumed.

In general the various aspects of the invention may be combined and coupled in any way possible within the scope of the invention. These and other aspects, features and/or advantages of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will be described, by way of example only, with reference to the drawings, in which

Figure 1 shows a flowchart of an embodiment of a method according to the present invention,

Figure 2 illustrates graphically an example of transporting a pharmaceutical product in a supply chain having three transport legs, Figure 3 illustrates an embodiment of providing the access to the manufacturer URL portal address,

Figure 4 illustrates the same simplified supply chain as shown in figure 2 having said three transport leg,

Figure 5 depicts an embodiment according to the present invention showing a consumer package where said manufacturer URL code (URL + serial number of the product) is printed on an inner side of the consumer package, and

Figure 6 depicts graphically some QR codes.

DESCRIPTION OF EMBODIMENTS

Figure 1 shows a flowchart of an embodiment of a method of tracking products, which in the following text will be assumed to be pharmaceutical products, to end-users and up to the point of consumption (POC). The pharmaceutical products originate from a larger pharmaceutical product entity having a pre-defined transport order, where the transport order includes information like product serial numbers and final destinations for the pharmaceutical products. The pharmaceutical products are transported throughout a supply chain, where each pharmaceutical product has an associated unique identifier (ID) for uniquely identifying the pharmaceutical product, where the unique product ID comprises a plurality of application identifiers including a serial number identifier. The larger pharmaceutical product entity may be a pallet level entity containing x many boxes, or even be on a container level.

The unique product ID may be a GS1 identification key, which is a standardized technique used to concoct numbers and characters providing product consignments with a unique, difficult to replicate identity.

GS1 is an umbrella term for several identifiers such as the: Global Location Number Identifier (GLIN), Global Trade Item Number (GTIN), expiration date identifier, batch/Lot identifier, Serial number identifier, Serial Shipping Container Code (SSCC) identifier. GLIN is the GS1 code used to identify a location and identify locations uniquely where required, e.g. within a factory, GTIN is the code used to identify products (identical packages for the same product have the same GTIN code) and the SSCC code is used to identify a logistic unit. Accordingly, the unique product ID may as an example be a barcode or QR code consisting of a Product Identifier (GTIN), an Expiration date, a Batch/Lot number and a Serial number.

In a first step (SI) 101, the unique product ID on a given pharmaceutical product selected from the pharmaceutical products is scanned. The pharmaceutical product may in one embodiment be at a box level, where the step of scanning may e.g. be performed by a pharmacist in a pharmacy. In another embodiment, the pharmaceutical product is at a consumer package level, where the scanning may be performed by a patient using e.g. a mobile phone.

In a second step (S2) 102, the location information of the scanning is provided, where this may e.g. be done via an IP address of the scanning device, which may be a mobile phone, or via Wi-Fi addresses. The location information may as an example include the country where the scanning is performed.

In a third step (S3) a manufacturer Uniform Resource Locator (URL) portal address is accessed where the data from the unique product ID of the scanned pharmaceutical product is compared with data in the pre-defined transport order. In an embodiment, this may be done by, prior to providing the access to the manufacturer URL portal address, having an intermediate step of accessing a general URL portal where at least some of the application identifier in the unique product ID are utilized in identifying the manufacturer URL portal address. In another embodiment, the step of providing access to the manufacturer URL portal address may be done by incorporating the manufacturer URL portal address into the unique product ID as an additional application identifier.

Said step of comparing includes comparing the serial number of the unique product ID with the serial number in the shipment order, and comparing the location information of the scanning with the final destination associated with the serial number in the shipment order,

In a fourth step (S4) 104, in case of a match between the serial numbers and between the location of the scanning and the final destination, the POC is verified and the user performing the scanning is provided with data access related to the pharmaceutical product via the manufacturer URL portal address. Accordingly, data access may e.g. be provided to said pharmacist or said patient that is consuming the pharmaceutical product. The step of providing the end-user with data access related to the pharmaceutical product via the manufacturer URL portal address includes providing the end user with information selected from one or more of the following:

• An electronic pharmaceutical information leaflet (E-leaflet) related to the pharmaceutical product,

• A status Data update of the pharmaceutical product obtained by a real time tracking device during the transport throughout the supply chain.

In case of a non-match between least one of the serial numbers and/or between the location of the scanning and the final destination associated with the serial number in the shipment order a message indicator is triggered indicating that the pharmaceutical product is not to be used and that there may be a possible counterfeit, and optionally a contact information may be provided to the end-user.

To even further improve the security/reliability of the products at the POC, the method may further comprise providing the said pharmacist or said patient with an ID code such as a pin number code to enter after scanning for accessing the manufacturer URL portal address. In that way, it is 100% ensured that the right person is in possession of the products.

Figure 2 illustrates graphically an example of transporting a pharmaceutical product in a supply chain which in this simplified view has three transport legs, where the first transport leg 205 is considered the primary distribution and it starts at a manufacturing (or packaging) site 201, the second transport leg 206 is considered the secondary distribution and the last transport leg 207 is considered the last mile distribution, where the primary and secondary distributions are e.g. separated at a regional distribution site 202 (e.g. wholesaler), and the second and last mile distribution is separated at local market distribution 203 (e.g. retailer).

The product may in the primary distribution be associated with a logger device which on a regular basis, e.g. every hour, transmits data such as the temperature and the location to an external computer system together with the unique product ID of the product.

As shown here, the pharmaceutical products are transported in a container 210 having a unique product ID 211 in the primary transport leg, where at the regional distribution site 202 the pharmaceutical products are split into the two pallets 212, 213, where each pallet may be uniquely identified via e.g. a QR code or a serial code 220, and 221. At the local market distribution 203 the pharmaceutical products may further be divided into boxes 214-219, where each box has a unique product ID. Although not shown here, a further split up may be performed into consumer packages which would be the smallest entity.

As shown, a unique product ID tree 230 is shown starting with the unique product ID of the container ID123, where the next level is the ID456 and ID789 of the pallets 212, 213, and the lowest level shown here is the unique product ID of the boxes ID100-ID103.

At the end, said step of scanning of the IDs discussed in relation to figure 1 is performed, where the scanning may e.g. be done by a pharmaci st/doctor or an end-consumer using e.g. a portable device 204 by scanning e.g. the QR code 231, where the scanning guides the pharmaci st/doctor or the end-consumer to a manufacturer URL address.

In the embodiment shown here, the manufacturer URL address may be incorporated into the QR code 231 where the URL 240 is uniquely identified with data such as the serial number 241 and/or a GTIN and/or a batch number.

The matching process is performed by a computer engine 233 where information such as the IP address of the scanning device, the GTIN and serial number is compared 234 with the ones included in the shipment order, where in case of a match the user receives information 236 that the pharmaceutical product is safe to be consumed 235, E-leaflets etc..

In case of a non-match the user is notified that the pharmaceutical product is not safe to consume, and that there is a possible counterfeit 232, and contact information of whom to contact may be provided.

Figure 3 illustrates another embodiment of providing access to the manufacturer URL portal address, where the method further comprises an intermediate step 302 of accessing a general URL portal where at least some of the application identifiers in the unique product ID 301 such as a GTIN, Serial number, Batch number are utilized in identifying the manufacturer URL portal address with the serial number 241.

Figure 4 illustrates the same simplified supply chain as shown in figure 2 having said three transport legs 205-207, and how a full traceability of the pharmaceutical products is achieved.

It also illustrates, the two pallets 212 - 213 already mentioned that are transported in said container 401 which is uniquely identified as ID123 e.g. via a serial number of any type or a QR code. When generating the shipment order, an ID tree 230 is generated for all units down to consumer packages, where the highest level of this ID tree is ID123. Accordingly, in the primary distribution 205 a logger device arranged in the container 401 may regularly transmit temperature data, the unique product ID 123 and the position of the container to a central control computer 404, where information such as the stability time budget for the pharmaceutical products is monitored.

When container 401 arrives at regional distribution site 202, it is opened and the two pallets 212 and 213 are removed from the container. At this moment, the logger device is removed and returned. The two pallets may be uniquely identified via ID456 and ID789 and each pallet may be transported by a transport means, e.g. a vehicle, where the e.g. QR code on the pallet is commonly scanned via e.g. a mobile device and placed into the vehicle. At this moment, it is the vehicle that communicates with control computer 404 about the products having IDs 456 and 789, which are obviously directly linked to the initial shipment order via ID tree 230.

At the local market distribution 203 the boxes are removed from the pallets, where each individual box is uniquely identified via ID100-ID105.

A similar process is now taking place, but on the box level, where the ID (e.g. QR code) is scanned, placed into a vehicle and transported to e.g. a hospital, a pharmacy or directly to a patient 204. Again, the temperature of each individual box is transmitted by the vehicles and the stability time budget profile is monitored for each unique product ID in real time.

Accordingly, said scanning discussed in relation to figure 3 enables the end-consumer to obtain immediate information about whether the pharmaceutical product is safe to be consumed, e.g. that the stability time budget is within a given limit, i.e. temperature excursions where within a given time limits.

Figure 5 depicts an embodiment according to the present invention showing a consumer package, where said manufacturer URL code (URL + serial number of the product) is printed on the inner side of the consumer package so that after opening it and scanning it, said information discussed in relation to figure 3 may be obtained.

Figure 6 depict graphically QR codes, where on a left side a conventional QR code is shown with four identifiers including a: GTIN, Serial number (SN), expiry data (EXP) and lot number (LOT), whereas the right side shows the same QR code with an additional URL address, which might be said general URL address, or more detailed manufacturer URL address as discussed in relation to figure 2 that is uniquely identified with the serial number of the product. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.