Apparatus and method for transferring data to a pharmaceutical compounding system

• US 7,317,967 B2
• Filed: 12/03/2004
• Issued: 01/08/2008
• Est. Priority Date: 12/31/2001
• Status: Expired due to Term

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Golebiowski, Michael, Pierce, Richard S., DiGianfilippo, Aleandro
• Primary Examiner(s): KOSOWSKI, ALEXANDER J
• Application Number:
  US11/003,232
• Publication Number:
  US 20050086008A1
• Time in Patent Office: 1,131 Days
• Field of Search: 700/215, 700/216, 700/265, 700/266, 700/268, 221/1, 221/2, 141/10, 141/104
• US Class Current: 700/265
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 2205/70 Audible labels, e.g. for pre-recorded info or messages
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: G07F 11/70 in which the articles are formed in the apparatus from components, blanks, or material constituents
• CPC Class Codes: G07F 13/06 with selective dispensing of different fluids or materials or mixtures thereof
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions is provided. A first label comprising first indicia defining a desired pharmaceutical compound is generated. The first indicia is then provided to the pharmaceutical compounding device as an input. The pharmaceutical compounding device then prepares a pharmaceutical compound based on the first indicia and generates a second label comprising second indicia indicative of at least the contents of pharmaceutical compound. The first indicia and second indicia are provided to a comparison device where the contents of the actual pharmaceutical compound as indicated by the second indicia are compared to the desired pharmaceutical compound as indicated by the first indicia.

Claims

1. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

a) generating a first label comprising first indicia defining an allocation of said plurality of source solutions;

b) providing said first indicia to said pharmaceutical compounding device as an input;

c) generating a pharmaceutical compound based on said first indicia input into said pharmaceutical compounding device;

d) generating a second label comprising second indicia indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

e) providing said second indicia to said data entry system as an input; and

f) comparing said allocation of said plurality of source solutions to said second indicia with said data entry device to determine if said generated compound conforms to said first indicia.

2. The method according to claim 1, further comprising the step of generating a first output if a mismatch of said allocation of said plurality of source solutions and said generated pharmaceutical compound is determined based on said step f).

3. The method according to claim 1, further comprising the step of generating a second output if a match of said allocation of said plurality of source solutions and said generated pharmaceutical compound is determined based on said step f).

4. The method according to claim 1, wherein said second indicia further compromises information relating to a patient for which the pharmaceutical compound is intended.

5. The method according to claim 1, wherein at least one of said first indicia and/or said second indicia comprises a bar code.

6. The method according to claim 1, wherein at least one of said first indicia and/or said second indicia comprises a two dimensional bar code.

7. The method according to claim 1, wherein said first indicia and said second indicia each comprises a two dimensional bar code.

8. The method according to claim 1, wherein at least one of said first label and/or said second label is an electronic label.

9. The method according to claim 8, wherein said electronic label is a Radio Frequency Identification label.

10. The method according to claim 9, wherein at least one of the providing step (b) and/or the providing step (e) comprise the steps of:

activating said electronic label with an RF signal; and

transmitting said indicia responsive to said RF signal.

11. The method according to claim 1, wherein the pharmaceutical compounding device generates said second label.

12. The method according to claim 1, wherein said first indicia further compromises information relating to a patient for which the pharmaceutical compound is intended.

13. The method according to claim 1, wherein said first indicia comprises a bar code.

14. The method according to claim 1, wherein said first indicia comprises a two dimensional bar code.

15. The method according to claim 1, wherein said first label is an electronic label.

16. The method according to claim 15, wherein said electronic label is a Radio Frequency Identification label.

17. The method according to claim 16, wherein the providing step (b) comprises the steps of:

activating said electronic label with an RF signal; and

transmitting said indicia responsive to said RF signal.

18. The method according to claim 1, wherein said data entry system generates said first label.

19. The method according to claim 1, wherein at least one of the first indicia or second indicia includes information for instructing an infusion pump regarding delivery of the generated pharmaceutical compound to a patient.

20. The method according to claim 1, wherein the first indicia includes information for instructing an operator of the pharmaceutical compounding device at which pumping stations to install respective ones of said plurality of source solutions.

21. The method according to claim 20, further comprising the steps of:

scanning a bar code of said installed plurality of source solutions; and

scanning a bar code of respective ones of transfer tubing coupled to said plurality of source solutions and said pump station;

comparing the scanned information of the installed plurality of source solutions and transfer tubing with an expected configuration; and

either permitting the operator to commence compounding if the comparison is valid or preventing the operator from compounding if the comparison is invalid.

22. The method according to claim 1, wherein Step d) comprises the steps of:

d1) pumping a first portion of at least one of the source solutions at a first flow rate with a first pump element until a predetermined threshold of the source solution is reached, and

d2) pumping a remaining portion of the at least one source solution at a second flow rate with the first pump element until a target volume of the source solution is reached, the second flow rate being less than the first flow rate.

23. The method according to claim 1, wherein the pharmaceutical compound is a Total Parenteral Nutrition (TPN) compound.

24. The method according to claim 1, wherein Step d) comprises the steps of:

d1) pumping a first portion of one of the source solutions at a first flow rate, and

d2) pumping a remaining portion of the source solution at a second flow rate, the second flow rate being less than the first flow rate.

25. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

a) generating a first label comprising first indicia defining an allocation of said plurality of source solutions;

b) providing said first indicia to said pharmaceutical compounding device as an input;

c) generating a pharmaceutical compound based on said first indicia input into said pharmaceutical compounding device;

d) generating a second label comprising second indicia indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

e) providing said first indicia to a comparison device as an input;

f) providing said second indicia into said comparison device as a further input;

g) comparing at least a portion of said first indicia with at least a portion of said second indicia with said comparison device; and

h) determining if said generated pharmaceutical compound matches said allocation based on said comparison.

26. The method according to claim 25, wherein said data entry system comprises said comparison device.

27. The method according to claim 25, wherein said pharmaceutical compounder comprises said comparison device.

28. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

a) generating a first output comprising first bar coded information defining at least an allocation of said plurality of source solutions conforming to a predetermined configuration;

b) transferring said first bar coded information to said pharmaceutical compounding device;

c) generating a pharmaceutical compound in a predetermined order based on said first bar coded information;

d) generating a second output comprising second bar coded information indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

e) providing first bar coded information to a comparison device as an input;

f) providing said second bar coded information to said comparison device as a further input; and

g) comparing said second bar coded information with said first bar coded information with said comparison device to determine if said generated pharmaceutical compound matches said predetermined configuration.

29. The method according to claim 28, wherein the first output is generated by said data entry system.

30. A system for providing input data to a pharmaceutical compounding device for generating a pharmaceutical compound based on an associated plurality of source solutions, the system comprising:

means for generating a first output comprising first information defining at least an allocation of said plurality of source solutions conforming to a predetermined configuration;

means for transferring said first information into said pharmaceutical compounding device;

means for generating said pharmaceutical compound based on said first information;

means for generating a second output comprising second information indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

means for comparing said second information with said first information; and

means for determining if said generated pharmaceutical compound matches said predetermined configuration.

31. The system according to claim 30, wherein said second output is a label.

32. The system according to claim 30, wherein said second information is bar-coded information.

33. The system according to claim 30, wherein said second output is an RFID tag.

34. The system according to claim 33, wherein said second information is stored in said RFID tag.

35. The system according to claim 34, wherein said first information is stored in said RFID tag.

36. The system according to claim 30, wherein said first output is a label.

37. The system according to claim 30, wherein said first information is bar-coded information.

38. The system according to claim 30, wherein said first output is an RFID tag.

39. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

generating a first label comprising first indicia defining at least one solution identification and respective volume information conforming to a desired compound;

providing said first indicia to said pharmaceutical compounding device as an input;

generating a pharmaceutical compound in a predetermined order based on said indicia input into said pharmaceutical compounding device;

generating a second label comprising second indicia indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

providing said second indicia to said data entry system as an input; and

comparing said allocation of said plurality of source solutions to said second indicia with said data entry system to determine if said generated compound conforms to said first indicia.

40. The method according to claim 39, further comprising the step of determining a placement of said at least one solution on said compounding device based on at least one of an existing solution placement and/or available solution placement stations on said compounding device.

41. The method according to claim 39, wherein the first label is generated by said data entry system.

42. A system for providing input data to a pharmaceutical compounding device for generating a pharmaceutical compound based on an associated plurality of source solutions, the system comprising:

means for generating a first output comprising first information defining at least one solution identification and respective volume information conforming to a desired compound;

means for transferring said first information into said pharmaceutical compounding device;

means for generating a pharmaceutical compound in a predetermined order based on said first information;

means for generating a second output comprising second information indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

means for comparing said second information with said first information; and

means for determining if said pharmaceutical compound matches said predetermined configuration.

43. The system according to claim 42, further comprising means for determining an allocation of at least one source solutions based on at least one of an existing solution placement and/or available solution placement stations on said compounding device.

44. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

a) generating a first label comprising first indicia defining an allocation of said plurality of source solutions conforming to a predetermined configuration;

b) providing said first indicia to said pharmaceutical compounding device as an input; and

c) generating a pharmaceutical compound based on said indicia input into said pharmaceutical compounding device, by;

c1) pumping a first portion of one of the source solutions at a first flow rate, and

c2) pumping a remaining portion of the source solution at a second flow rate;

d) generating a second label comprising second indicia indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device;

e) providing said second indicia to said data entry system as an input; and

f) comparing said allocation of said plurality of source solutions to said second indicia in said data entry system to determine if said generated compound conforms to said first indicia.

45. The method according to claim 44, wherein the second flow rate is less than the first flow rate.

46. The method according to claim 44, wherein a transition between the first flow rate and the second flow rate is based on a linear profile.

47. The method according to claim 44, wherein a transition between the first flow rate and the second flow rate is based on a non-linear profile selected from the group consisting of concave, convex, or any combination thereof.

48. The method according to claim 44, wherein the pumping comprises stepping or pulsing the first pump element in increments of about 0.72 degrees of rotation for each step or pulse as the target volume is approached.

49. A method for use with a data entry system for providing input data to a pharmaceutical compounding device having an associated plurality of source solutions, the method comprising the steps of:

a) generating a first label comprising first indicia defining an allocation of said plurality of source solutions conforming to a predetermined configuration;

b) providing said first indicia to said pharmaceutical compounding device as an input; and

c) generating a pharmaceutical compound based on said indicia input into said pharmaceutical compounding device, by;

c1) pumping a first portion of at least one of the source solutions at a first flow rate with a first pump element until a predetermined difference between a volume of the source solution delivered to a designated receptacle and a target volume is reached, and

c2) pumping a remaining portion of the at least one source solution at a second flow rate with the first pump element until the target volume of the source solution is reached;

d) generating a second label comprising second indicia indicative of at least said pharmaceutical compound as generated by said pharmaceutical compounding device; and

e) providing said second indicia to said data entry system as an input; and

f) comparing said allocation of said plurality of source solutions to said second indicia with said data entry system to determine if said generated compound conforms to said first indicia.