System and Method for Preparing a Pharmaceutical Compound
20230377141 · 2023-11-23
Inventors
- Christian Sandmann (Wayne, NJ, US)
- Matt Thomas (Philadelphia, PA, US)
- Chris Murray (Philadelphia, PA, US)
- Christian Hanke (Vienna, AT)
- Helmut Hoerner (Vienna, AT)
- Robert Tannen (Philadelphia, PA, US)
- Mathieu Turpault (Pennington, NJ, US)
- Erik Kurt Witt (Oakland, NJ, US)
Cpc classification
G01G19/00
PHYSICS
G06F3/04842
PHYSICS
G06V20/80
PHYSICS
H04N23/00
ELECTRICITY
G05B19/4155
PHYSICS
International classification
G06V20/80
PHYSICS
H04N23/00
ELECTRICITY
G05B19/4155
PHYSICS
Abstract
A system for preparing a pharmaceutical compound comprises: a computing device comprising a user interface providing an operator with instructions for preparing the pharmaceutical compound and at least one processor operatively connected to the user interface; a scale operatively connected to the at least one processor; and an image capture device operatively connected to the at least one processor and the scale and positioned to capture an image of at least one of a component used in preparing the pharmaceutical compound and the pharmaceutical compound.
Claims
1. A system for preparing a pharmaceutical compound, comprising: a computing device comprising a user interface providing an operator with instructions for preparing the pharmaceutical compound and at least one processor operatively connected to the user interface; a scale operatively connected to the at least one processor; and an enclosure comprising an image capture device having a field of view positioned to capture an image of an object positioned on the scale during the preparation of the pharmaceutical compound, the image capture device operatively connected to the at least one processor, wherein the scale transmits a signal to the at least one processor to verify a correct amount of at least one component of the pharmaceutical compound based on a weight of the at least one component, and wherein the image capture device captures an image of the object positioned on the scale when the at least one processor verifies the correct amount of the at least one component.
2. The system of claim 1, wherein the enclosure is positioned above the scale.
3. The system of claim 1, wherein the enclosure further comprises a barcode scanner.
4. The system of claim 3, wherein the barcode scanner is angled with respect to the scale.
5. The system of claim 3, wherein the barcode scanner has a sensor that is offset with respect to the scale.
6. The system of claim 1, wherein the enclosure has a streamlined shape to minimize flow disturbance within a flow hood.
7. A system for preparing a pharmaceutical compound comprising: a computing device comprising a user interface providing an operator with instructions for preparing the pharmaceutical compound and at least one processor operatively connected to the user interface; a scale operatively connected to the at least one processor; and an image capture device operatively connected to the at least one processor and the scale and positioned to capture an image of at least one of a component used in preparing the pharmaceutical compound and the pharmaceutical compound, wherein the scale transmits a signal to the at least one processor indicating that a weight detected thereby has changed when the at least one component is placed thereon and, based on the signal, the at least one processor triggers the image capture device to capture the image of the at least one component.
8. The system of claim 7, wherein the image of the at least one component is displayed on the user interface for review by the operator.
9. The system of claim 8, wherein a removal of the at least one component from the scale causes the at least one processor to accept the image, associate the image with a data record, and provide instruction on the user interface to allow the operator to move to a next step of the instructions for preparing the pharmaceutical compound.
10. The system of claim 9, wherein the data record and images are transmitted to a pharmacist workstation for verification.
11. The system of claim 8, wherein, if the image is deemed to be unacceptable by the operator, the user interface is configured to provide the operator with the capability to recapture the image.
12. The system of claim 7, wherein the image is saved to a database when the weight of the at least one component or the pharmaceutical compound on the scale has been verified by the at least one processor.
13. The system of claim 12, wherein the scanner is configured to scan a barcode provided on the at least one component and provide the at least one processor with information regarding the at least one component.
14. A system for preparing a pharmaceutical compound comprising: a computing device comprising a user interface, the user interface configured to display: instructions for preparing the pharmaceutical compound and at least one processor operatively connected to the user interface; and a listing of equipment and/or components used to prepare the pharmaceutical compound; a scale operatively connected to the at least one processor; and an image capture device operatively connected to the at least one processor and the scale and positioned to capture an image of at least one of a component used in preparing the pharmaceutical compound and the pharmaceutical compound.
15. The system of claim 14, wherein the image of the at least one component is displayed on the user interface for review by an operator.
16. The system of claim 15, wherein a removal of the at least one component from the scale causes the at least one processor to accept the image, associate the image with a data record, and provide instructions on the user interface to allow the operator to move to a next step of the instructions for preparing the pharmaceutical compound.
17. The system of claim 16, wherein the data record and the images are provided to a pharmacist for verification.
18. The system of claim 14, further comprising a scanner operatively coupled to the user interface.
19. The system of claim 18, wherein the scanner is configured to scan a barcode provided on the at least one component and provide the at least one processor with information regarding the at least one component.
20. The system of claim 19, wherein the scanner is arranged in a housing positioned above the scale.
21. The system of claim 20, wherein the housing has a streamlined shape to minimize flow when the system is arranged within a flow hood.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018]
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[0027]
DESCRIPTION OF THE INVENTION
[0028] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof, shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
[0029] With reference to
[0030] A. CPOE Module
[0031] The CPOE module 100 enables physicians to input prescribed treatment orders for patients that include prescribed pharmaceuticals associated with particular patients. In particular, the physician enters prescription information for a patient into a computer, and the data is transmitted over an intra-hospital network and stored for retrieval and use by the subsequent modules described herein. The prescription information can include one or more pharmaceuticals and the corresponding dosage/quantities for those pharmaceuticals. The CPOE module 100 is an optional component and may not be utilized in every instance in which the overall system is implemented.
[0032] B. Pharmacist Verification Module
[0033] The pharmacist verification module 200 of the system enables pharmacists to view the prescription information data input by the physician in the CPOE module 100 or from some other source in circumstances when the CPOE module 100 is not utilized, and manually verify the prescribed treatment for a particular patient. As discussed above, the pharmacist verification module 200 may be implemented on the same computing device as the CPOE module 100. Alternatively, the pharmacist verification module 200 may be implemented on a computing device that is remote from the computing device that implements the CPOE module 100.
[0034] C. Pharmacy Preparation Module
[0035] With reference to
[0036] In one embodiment, a barcode scanner 13 may be operatively connected to at least one of the user interface 3 and the scale 9, such that the barcode scanner 13 may scan a medication vial having a barcode that is placed onto a portion of the scale 9. In another embodiment, an image capture device 15 may be operatively connected to at least one of the user interface 3 and the scale 9, such that the image capture device 15 may take a picture of an item, such as a medication vial, IV bag, or syringe placed onto a portion of the scale 9. In one embodiment, the image capture device 15 may capture a plurality of still images or running video of items placed onto a portion of the scale 9 throughout the medication compounding process for documentation and/or subsequent review of the medication compounding process.
[0037] In still another embodiment, at least one of the barcode scanner 13 and the image capture device 15 may be at least partially enclosed within an enclosure housing 17. In certain configurations, the housing 17 may fully enclose the barcode scanner 13 and the image capture device 15. Optionally, the housing 17 may include only one of the barcode scanner 13 and the image capture device 15.
[0038] The housing 17 may be positioned above a portion of the scale 9, such as supported by a supporting arm 19. As shown in
[0039] This aerodynamically streamlined housing 17 as shown in
[0040] The smaller and/or more streamlined housing 17 results in a smaller flow disturbance and therefore a higher likelihood of meeting accuracy and stability requirements. The streamlined housing 17 has a form that minimizes flow disruption and drag, allowing for stable and accurate gravimetric readings that are required for medication preparation purposes. In addition, housing 17 allows for required gravimetric scale accuracy and stability, while placing the input devices (i.e., image capture device 15 and barcode scanner 13) in the upstream airflow vicinity relative to the scale 9. Placing these objects within the scale 9 vicinity is typically the ideal area for a number of reasons. A secondary advantage to the streamlined housing 17 is to provide and maintain a clean working environment for the sterile preparation of medications. In use, the purpose of the air stream in a flow hood is to create a clean zone for sanitary reasons. A turbulent zone created by objects near, or upstream of the airflow, may result in a potential contamination hazard during medication preparation. As a result, having an aerodynamically shaped housing for input devices minimizes the amount of laminar airflow disruption and decreases the chances of any type of contamination.
[0041] With continued reference to
[0042] The plurality of recessed grooves 39 and/or protrusions extending from a surface of the platen 31 may be configured to restrain any liquid material that is accidentally spilled on the upper surface 41 of the platen 31 during a drug compounding procedure. The plurality of recessed grooves 39 may define a receiving well 47 which serves to collect and restrain accidentally spilled material in a confined area within the platen 31 until proper disposal techniques may be employed. The surface of the platen 31 may be coated with a durable composition that resists degradation caused by exposure to caustic agents, such as chemotherapy compounds and drugs, as well as cleaning agents, such as bleach, isopropyl alcohol, and the like. In certain configurations, the durable composition may be an epoxy or epoxy-based paint or coating.
[0043] With reference to
[0044] Next, the technician scans a second barcode of a fluid container of fluid that is to be mixed with the drug to be reconstituted (block 308) as shown in
[0045] Thereafter, the user mixes the drug to be reconstituted with the fluid in the fluid container by injecting the fluid from the fluid container into the medication container (block 316) as shown in
[0046] Once the drug preparation is complete, the system prints a barcode label for placement on the reconstituted drug preparation.
[0047] With reference to
[0048] Next, the technician is instructed to withdraw a predetermined amount from the reconstituted drug preparation with the syringe (block 342) as shown in
[0049] Once the additional amount of the reconstituted drug preparation is withdrawn into the syringe, the syringe is placed back on the scale 9 (block 354) as shown in
[0050] The technician then scans a barcode of a fluid container having a saline solution therein, such as an IV bag (block 362). The fluid container is then placed on the scale 9 (block 364) and, once the weight stabilizes, the image capture device 15 takes an image of the fluid container and displays it to the user on the display 5 of the user interface 3 (block 366). If the technician decides the image was not meeting certain requirements, there is the option to request a new or additional image (block 368). Requesting another picture will automatically switch the camera into a “live video mode” displayed at the user interface 3 (block 370). The technician can now move the medication container on the scale 9 to a preferred position and trigger the image capture through the user interface 3 (block 372). As before, the captured image will be shown at the user interface 3 and by removing the item from the scale 9, the technician accepts the image (block 374) and the system automatically awaits authorization from a pharmacist to precede (block 376). The screen shots in
[0051] Once pharmacist authorization has been provided (block 378), the user injects the contents of the syringe into the fluid container (block 380) as shown in
[0052] The pharmacy preparation module 300 also includes software instructions that cause the processor of the computing device 4 to perform the following actions during the drug preparation: (i) retrieve the prescription information data input by the physician in the CPOE module 100 from the intra-hospital network; (ii) verify that the scanned barcode corresponds with the prescription information; (iii) determine if the weight of the syringe and/or IV bag is within a predetermined threshold accuracy level for the amount of the pharmaceutical to be administered; (iv) determine what adjustments must be made if the weight is not accurate; and (v) transmit data relating to the weight of the syringe and/or IV bag back to the intra-hospital network.
[0053] D. Pharmacy Final Verification Module
[0054] Subsequent to preparing the prescribed pharmaceutical, the pharmacy final verification module 400 allows the pharmacist to review the data and/or documentation created by the pharmacy preparation module 300 including the images taken by the image capture device 15 and either approve or disapprove the preparation for the release to the patient. As described hereinabove, the pharmacist final verification module 400 may be implemented on the same computing device as the pharmacy preparation module 300. Alternatively, the pharmacist final verification module 400 may be implemented on a computing device that is remote from the computing device of the pharmacy preparation module 300. Such a remote configuration is illustrated schematically in
[0055] An exemplary screen shot provided at the pharmacy final verification module 400 is provided in
[0056] As illustrated in
[0057] With continued reference to
[0058] Additionally, the icon 430 in the thumbnail indicates if the tolerance requirements of the particular compounding step were met, giving the pharmacist a quick guidance to where in the compounding procedure problems occurred. A gray box (not shown) around multiple thumbnails provides an indication to the pharmacist that the image representing this compounding step was retaken.
[0059] The overlay of a captured image with verification information generated by a mathematical methodology from gravimetric data allows the pharmacist to quickly review very different types of information. The visual information content of the image allows the pharmacist to check very apparent information such as, but not limited to, the drug color, the syringe type, or whether the system was used improperly (e.g., the user used an additional object to generate the necessary weight to pass the tolerance requirements of the methodology). The icon 430 in the thumbnail representing the methodology check outcome is binary information telling the pharmacist that the amount of drug was either inside or outside of the tolerance requirements for the particular compounding step. An accumulation of icons 430 on thumbnails in the form of red exclamation marks provides a quick indication to the pharmacist that the technician needed several iterations to meet tolerance requirements and may trigger additional scrutiny when reviewing such a drug preparation.
[0060] E. Bedside Module
[0061] Prior to administering the prescribed pharmaceutical to a patient, the bedside module 500 allows for a final verification. A barcode scanner located proximate to a patient is used by a nurse or other technician to scan the barcode label on the syringe and/or IV bag. The barcode scanner is in communication with a computer, which verifies the information encoded on the second barcode with patient information and/or prescription information retrieved from the intra-hospital network.
[0062] While specific embodiments of the invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives to those details could be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are meant to be illustrative only and not limiting as to the scope of invention which is to be given the full breadth of the claims appended and any and all equivalents thereof.