BR102016024325A2 - TRACEABILITY, IDENTIFICATION AND MONITORING METHOD OF PSYCHOTROPIC AND HIGH-SURVEILLANCE DRUGS BASED ON THE REAL-TIME AND RFID LOCATION SYSTEM OPERATING IN UHF - Google Patents

Abstract

traceability, identification and monitoring method for psychotropic and high surveillance drugs based on the real-time tracking and rfid system operating in uhfa The present invention relates to the traceability, identification, authentication and monitoring system of physically psychotropic items, persons and drugs similar and high-surveillance, based on real-time location system, monitoring, dispensing and verification units, operating with uhf rfid and item and container guarding operation method. Alternative use of this technology is foreseen in the monitoring and tracing of high value-added small items such as jewelry, electronic circuits, slide bank, bone and tissue.

Description

(54) Title: METHOD OF TRACEABILITY, IDENTIFICATION AND MONITORING OF PSYCHOTROPIC AND HIGH SURVEILLANCE DRUGS BASED ON THE REAL TIME AND RFID LOCATION SYSTEM OPERATING IN UHF (51) Int. Cl .: G06Q 50/22; G06F 19/00; A61J 7/04 (52) CPC: G06Q 50/22, G06F 19/3456, G06F 19/323, G06F 19/326, A61M 2205/6054, A61J 7/0463, A61J 2205/60 (73) Holder (s) : SYNERGY TECNOLOGIA EM SISTEMAS LTDA.

(72) Inventor (s): MAURÍCIO STRASBURG; PAULINO GOMES DE SOUZA NETO (74) Attorney (s): RENATO DE QUEIROZ (57) Summary: METHOD OF

TRACEABILITY, IDENTIFICATION AND MONITORING OF PSYCHOTROPIC AND HIGH SURVEILLANCE MEDICINES BASED ON THE REAL TIME AND RFID LOCATION SYSTEM OPERATING AT UHFA This invention refers to a system for traceability, identification, authentication and monitoring of psychotropic items, people and drugs, physically similar and high surveillance, based on a real-time location system, monitoring, dispensing and verification units, operating with UHF RFID and operating method based on item and container protection. The alternative use of this technology is foreseen in the monitoring and tracking of small items of great added value such as jewelry, electronic circuits, bank of slides, bones and tissues.

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METHOD OF TRACEABILITY, IDENTIFICATION AND MONITORING OF PSYCHOTROPIC AND HIGH SURVEILLANCE MEDICINES BASED ON THE LOCALIZATION SYSTEM IN REAL TIME AND RFID OPERATING IN UHF

FIELD OF USE

01. The present invention refers to equipment and method that together provide the identification, authentication, monitoring and assistance in dispensing psychotropics, physically similar drugs and highly surveillance drugs. For this purpose, equipment was developed, radio frequency tags that operate in contact with ampoules, radio frequency tags with seals, dispensing table and dispensing monitoring unit that, together with the present method, characterize the present invention.

02. Alternative use of this technology is foreseen in the use of tracking small items such as jewelry or electronic circuits, for example, in closed installations and with the same purpose. Also for use outside the medical field, monitoring the flow in critical or complex sectors and automatically setting the status of the operation.

TECHNICAL STATUS

03. The law determines the total traceability of psychotropics due to the nature of their effects. The loss of psychotropic drugs incurs criminal liability characterized as drug trafficking. Faced with such responsibility, the health services put great effort in the control and

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Page 2 of 10 monitoring of these medications from their arrival at the hospital until their final dispensation. Such control takes place through signed and stamped forms and forms where each professional is responsible for the medication in their possession. Such control is determined by law and must remain, however it is not effective in the problem observed in daily use.

04. The Joint Commission, an independent body responsible for quality certification of healthcare companies, reports in its event list preventable adverse drug that the error is the 8th (eighth) most common complication, followed by anesthesia related event in 17th (seventeenth) place and overdose of medication in 18th (eighteenth) place. Despite the strict control, these events together account for 680 (six hundred and eighty) events notified to this institution since 2004. The adverse events together determine a mortality of 57% (fifty-seven percent), reflecting the need for greater control over this flow, which is highly regulated and monitored.

05. When considering medication errors, we have to deal with the physical similarity of drugs and the context of their use. Great difficulty occurs when it comes to injectable medicine ampoules. Due to their established design, they differ very little, basically in size and transparency of the glass. Amber glass provides protection for photosensitive drugs, while transparent glass allows the content to be identified also by the aspect of the content.

06. The amber vial of 1 (one) or 2 (two) ml has reduced dimensions, making the letters printed on the glass or on the label small. Many use medications

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Page 3 of 10 during urgencies or emergencies are packaged in these ampoules causing a great risk of changing medications. Such a scenario favors errors and exchanges of medicines.

07. Considering this scenario, the present invention was developed.

SOLUTION OF THE PROBLEM

08. In order to track, monitor, authenticate and control the dispensing of critical medications, and the performance of the surgical unit, the method advocated here was created, in which the medication that needs to be monitored arrives at the central pharmacy, where it is identified with TAG specially designed for this function. Its origin, batch and validity are associated with TAG's EPC number, creating a serialized GTIN (SGTIN). The properly identified drugs are sent to the dispensing units. There, the medicines are placed in boxes according to their destination. These boxes are sealed with TAGs of greater reach, which are monitored by tracking units (Arrays).

09. At the destination, the seal is opened and the medications are validated, ensuring that they have reached the correct patient.

10. In the case of anesthetics and emergency medications, the box containing them is placed on the dispensing monitoring unit. This identifies the date, time and place that each component was removed from the box, generating automatic registration of the medication schedule. Text-to-speech feature identifies each item removed from the box in real time, avoiding medication changes or errors.

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11. With this technology it was possible to accurately determine the time at which each medication was used, without the need for a human interface. Thus, the system described here allows full automatic monitoring of the dispensing of critical drugs. Still, with reliable information determined by the intelligence of the items and processes, it becomes a reliable electronic management tool, in addition to automatic science of those responsible for the transportation of critical medicines and their itinerary.

12. High cost items can also be monitored individually as well as their container. Low cost items can be monitored together through the monitorable box and its tamper-evident seal. Orthotics, prostheses and special materials are expensive items and can be individually monitored using this technology.

13. The connection with an intelligent video system allows you to follow the path of this item by images in real time or through the automatic recovery of recorded images.

DESCRIPTION OF THE FIGURES

14. Figure 1: Radio frequency label operating in UHF, specially tuned to be coupled to glass ampoules with liquid content inside.

15. Figure 2: Unit for monitoring medication dispensing in a box operating in UHF.

16. Figure 3: Psychotropic box seal label operating in UHF to monitor the path and integrity of the seal.

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17. Figure 4: Internal item distribution box.

18. Figure 5: Box of low cost items.

19. Figure 6: Box of high cost items.

20. Figure 7: Example of a prescription dispensing table for surgery.

21. Figure 8: Example of a psychotropic monitorable box on the unit described in figure 2.

22. Figure 9: Example of Array operating on WiFi, Bluetooth and UHF RFID.

23. Figure 10: Example of equipment monitorable by the method and technology described in it.

24. Figure 11: Example of a monitoring unit for monitorable items and a box inside.

DETAILED DESCRIPTION OF THE INVENTION

25. The invention described here deals with a method of continuous monitoring of drugs in a closed complex unit, exemplified by the operating room, but not exclusively aimed at this unit.

26. In this invention, items of interest are identified with the radio frequency tag (TAG), preferably in their origin by the pharmaceutical industry, if not when admitted to the hospital's central pharmacy. This is best characterized in figure 1. After that, they are placed on a

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Page 6 of 10 verification (figure 7), where they are counted, identified and serialized according to the GS1 standard. The information contained in the chips is exemplified, but not restricted, to medicine, manufacturer, batch, validity and serialization (unitarization). Along with the system, these serials are associated with invoice number, unit cost price, supplier, date of purchase, date of delivery and date of serialization with RFID. These items, now identified by this technology, go to the identified stock, where they are distributed in dispensing boxes, according to prescription or industry standards such as anesthesia box, sedation box, blue code emergency box, among others.

27. Low-cost items are treated differently. When admitted, they are serialized according to the GS1 standard using a two-dimensional QRCode code. This can be printed on the packaging or on a label added to the item. For the surgical environment, standard kits are assembled according to the size of the surgery. These items have their SGTIN identified through barcode scanners and are added to the box equipped with UHF RFID tags and which at the end are sealed with a UHF RFID traceable tag with tampering sensor. In this way, low cost items are monitored together, ensuring good cost-benefit ratio, full traceability and real-time audit including low cost items.

28. These boxes, currently standardized for each hospital, are sealed to ensure safety. In our model, the box is sealed with the RFID tag, shown in figure 3. This seal has 2 (two) versions, in which one loss of the radio frequency signal occurs and in the other, a warning indicates the seal is broken .

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29. This has a longer reach than the drug labels, allowing the box to be tracked along its path to the destination. Log records are created, saving information about the path taken by the box. Combined with a commercially available video surveillance system, we can monitor the box's path in real time or consult the archived video about the entire path where there is video monitoring. If there is a detection of the rupture of the seal, institutional alarm occurs automatically, and the video of the path traveled from the last detection of the intact seal until the moment of detection of the broken seal is automatically made available. This is particularly interesting for tracking high-cost equipment, OPMEs and psychotropic drugs. The entire route or strategic points from the origin to the destination are monitored by the Arrays, shown in figure 9, which verify the identity of the box and its seal.

30. Upon reaching its destination, or in the case of a psychotropic, when the box is placed on the monitoring unit best described in figure 4, the security seal can be breached without activating institutional alarms. This unit and the Array automatically recognize the enabled user and record the time and place when the seal was opened and who broke it. On this the security seal is breached. This unit automatically recognizes a qualified user and records the moment when the seal was opened and who broke it.

31. Medicines are automatically identified when they are removed from the box. Your name appears on the equipment screen, as well as your name and dose are converted into a voice message, guaranteeing assistance during emergency care and interpretation of the miniaturized text due to the tiny dimensions of the ampoules.

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32. The box also contains a reservoir dedicated to the deposit of empty medicine hulls. TAGs still transmit, but a difference observed in the signal can allow us to infer that such an ampoule is empty. At the end of the medication use, the box is closed and sealed with a new seal, previously located inside the box. This seal is also monitored along its path, back to the pharmacy, where the box is deposited on a reading unit and checked. Any reading divergence is checked manually whenever it has been observed.

33. Upon returning from the pharmacy, the seal is opened again and the reservoir containing the empty hulls is read over the monitoring unit and checked manually. The result of the reading, with the endorsement of the pharmacist, authenticates the use of the medication and generates a charge from the paying source. The box is filled with the missing drugs and is made available for the next procedure.

34. Alternatively, the seal can be reusable, with magnetic locks that can be opened only at destinations.

35. In the case of surgical boxes, they are followed up to their destinations, ensuring arrival at the correct destination. If the seal has been breached before reaching the room, institutional alarms occur and the contents of the box must be reconciled. In the room, items inside the box are consumed. At the end of the surgery, the box continues with the unused items for the pharmacy. In the case of the box with high cost items, the reconciliation is done in a specific station, exemplified in figure 11. It is the Faraday Cage specially developed to accommodate the box with items in its

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Page 9 of 10 interior. Its technical design, dimensions and RF sealing techniques are detailed in another patent. If the reading coincides with the consumption form, the box is received by the pharmacy. In case of divergence, the divergent content is reconciled. The returned items are returned to the internal distribution boxes and the box is available for the next cycle of use.

36. The concept of guardianship, defended in another patent, also applies to this scenario, where at all times there is a person responsible for the box and its contents. Guardianship is carried out through identification with the identification badge of the individual qualified for this function.

37. From the point of view of software logic (SW) every time the box is identified by the tracking system, a record is created with a local time and tutor date. In combination with a video camera system, you can monitor an item, person or organs and tissues throughout your journey in real time or retrieving specific segments of recorded images.

38. As a result of the information in real time, we can map the real times that the events take place, creating, consequently, a real-time electronic governance tool that identifies and authenticates the drugs, their containers and tutors.

39. By mapping these items, an adequate and reliable substrate is generated for corrective administrative actions, in addition to optimizing the unit's performance.

40. The alternative use of this technology is provided for monitoring and tracking small items of great value

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Page 10 of 10 aggregate such as jewelry, electronic circuits, bank of slides, bones and tissues.

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Claims (11)

1. Method of traceability, identification, authentication and monitoring of psychotropic drugs, physically similar and of high surveillance, characterized by tracking, identifying, authenticating and monitoring psychotropic drugs, physically similar and of high surveillance, based on a real-time location system and RFID operating in UHF. 2. Radio frequency tag (TAG), characterized by operating in passive UHF, tuned to act on a glass ampoule filled with isotonic liquid in relation to the blood. 3. Radio frequency tag (TAG), characterized by operating in passive UHF with a seal to identify the violation of the contents of the box containing monitored items, in the signal loss and violated seal sensor versions. 4. Radio frequency tag (TAG) characterized by operating in passive UHF to identify the container of intra-hospital transit items. 5. Psychotropic box monitoring unit, characterized by operating in UHF to identify psychotropic drugs, physically similar and of high surveillance. 6. Process flow logic, characterized by monitoring fractionation and composing the decomposition of boxes during their cycle of use in the hospital environment. 22/29 Page 2 of 2 7. Monitoring of low-cost items, characterized by their aggregated form in containers and with a monitorable seal. 8. RFID seal, with electronic tamper, characterized by identifying its violation in real time. 9. Guardianship concept, characterized by identifying the person responsible for the items in real time. 10. Electronic dispensing table for items monitored by RFID tag, configuring electronic Kanban system, characterized by being able to reconcile and monitor real time. 11. Monitored box system, characterized by capacity of internally distribute items in the environment hospital. 12. Unit characterized by the ability to check the box contents with items monitored with UHF RFID TAG 23/29 Page 1 of 5 TRACEABILITY METHOD, IDENTIFICATION AND MONITORING OF PSYCHOTROPIC AND HIGH SURVEILLANCE MEDICINES BASED ON REAL TIME AND RFID LOCATION SYSTEM OPERATING IN UHF - FIGURES