Pharmaceutical compounding systems and methods and information management system for same

• US 20040087888A1
• Filed: 12/05/2003
• Published: 05/06/2004
• Est. Priority Date: 12/31/2001
• Status: Active Grant

• 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: DiGianfilippo, Aleandro, Pierce, Richard S.
• Granted Patent: US 7,343,224 B2
• Time in Patent Office: Days
• US Class Current: 604/19
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A compounding control method to prepare a compounded mixture for use with at least one pharmaceutical compounding device having an associated plurality of source solutions and a mixture receptacle. The method comprises determining whether the plurality of source solutions conform to a predetermined configuration; providing an alert to an operator and preventing compounding if the source solutions are not as expected; determining respective expiration dates of the source solutions; warning/preventing use of any of the source solutions if any have the source solutions have expired; accepting mixture inputs for the source solutions; and urging at least a portion of at least one of the source solutions into the mixture receptacle based on the mixture inputs to form the compounded mixture.

Claims

1. A compounding control method to prepare a compounded mixture for use with at least one pharmaceutical compounding device having an associated plurality of source solutions and a mixture receptacle, the method comprising the steps of:

a) determining whether said plurality of source solutions conform to a predetermined configuration;

b) at least one of providing an alert to an operator and preventing compounding based on said determining step a);

c) determining respective expiration dates of said plurality of source solutions;

d) at least one of providing a warning and preventing use of any of said plurality of source solutions based on said determination step c);

e) accepting mixture inputs for one or more of said plurality of source solutions; and

f) urging at least a portion of at least one of said plurality of source solutions into said mixture receptacle based on said mixture inputs to form said compounded mixture.

2. The method according to claim 1, further comprising the steps of:

determining a nutritional assessment of a patient;

comparing said mixture inputs with said nutritional assessment; and

providing an output to a user based on said comparison.

3. The method according to claim 1, further comprising the steps of:

determining if a lipid source solution and a dextrose source solution one of immediately follow or immediately precede one another;

generating an alert to a user based on said determination; and

preventing further processing of the compounded mixture until at least one buffer source solution is selected to be provided between said lipid source solution and said dextrose source solution.

4. The method according to claim 1, further comprising the step of generating a bar coded label based at least in part on a composition of the compounded mixture in the mixture receptacle.

5. The method according to claim 1, further comprising the step of selecting an infusion pump type for dispensing the compounded mixture prior to beginning compounding the compounded mixture.

6. The method according to claim 5, further comprising the step of selecting at least one of a ramp-up time and a ramp-down time for said infusion pump.

7. The method according to claim 1, wherein said determining step c) is based at least in part on a bar code scan of said source solution.

8. The method according to claim 1, wherein said urging step f) is based at least in part on a proportional-integral-derivative (PID) control of a pump element of said compounding device.

9. The method according to claim 1, further comprising the steps of:

receiving an input signal from a pump element of the compounding device indicative of pump motor speed error; and

sending an output correction signal to said pump element to compensate for said motor speed error.

10. The method according to claim 9, further comprising the steps of:

determining a direction of rotation of at least a portion of said pump element;

comparing said direction to a desired direction of rotation; and

setting an alarm condition based on said comparison.

11. The method according to claim 1, further comprising the steps of:

determining a state of motion of a plurality of pump elements of said compounding device;

generating a first alert signal if any of said plurality of pump elements are in a state of motion that should otherwise be stationary, said alert advising of a defective compounded mixture; and

generating a second alert signal if any of said plurality of pump elements are in a stationary state that should otherwise be in motion.

12. The method according to claim 1, further comprising the steps of:

determining if selection of said source solutions may form an insoluble precipitate; and

generating an alert signal based on said comparison.

13. The method according to claim 1, further comprising the step of:

generating a label comprising indicia indicative of attributes of said compounded mixture.

14. The method according to claim 1, wherein said mixture inputs are received via a touch screen display.

15. The method according to claim 14, further comprising the step of selectively deactivating a tactile input of said touch screen display for a predetermined period to allow for cleaning of a surface of said touch screen display.

16. The method according to claim 1, further comprising the steps of:

advising a user of at least one of maintenance procedures and replacement of component parts of the compounder device;

receiving input from said user responsive to said advising step; and

preventing further processing of said compounded mixture until said input from said user indicates compliance with said advising step.

17. The method according to claim 1, further comprising the steps of:

providing the user with an inventory of mixture receptacles for selection;

receiving a input from the user for selecting a desired mixture receptacle;

comparing said selection with a volume of said desired compounded mixture based on said mixture inputs of step e); and

generating an alert to said user if said volume of said desired compounded mixture exceeds a volume of said selected mixture receptacle and preventing further processing until an alternate selection of a mixture receptacle is made that will accommodate said compounded mixture.

18. The method according to claim 1, further comprising the steps of:

determining if a plurality of said compounded mixture are to be prepared;

determining if any of a plurality of additive solutions are to be part of said compounded mixture;

determining if any of said plurality of additive solutions may be pooled into a pooled additive solution;

urging at least one of said plurality of additive solutions into a pooled additive solution container; and

designating said pooled additive solution as a further source solution for preparation of said compounded mixture.

19. The method according to claim 1, wherein the urging step further comprising the steps of:

determining if a container of any of said source solutions dictate a low flow rate; and

setting said urging for said source solution to have a reduced upper speed limit based on said determining step in order to prevent a false flow rate alarm condition.

20. A compounding control method to prepare a compounded mixture for use with at least one pharmaceutical compounding device having an associated plurality of source solutions and a mixture receptacle, the method comprising the steps of:

a) determining whether said plurality of source solutions conform to a predetermined configuration;

b) at least one of providing an alert to an operator and preventing compounding based on said determining step a);

c) determining respective expiration dates of said plurality of source solutions;

d) preventing use of any of said plurality of source solutions based on said determination step c);

e) determining if a plurality of compounded mixtures are to be prepared;

f) determining if any of a plurality of additive solutions are to be part of said compounded mixture;

g) determining if any of said plurality of additive solutions may be pooled into a pooled additive solution;

h) urging at least one of said plurality of additive solutions into a pooled additive solution container based on said determining step g);

i) designating said pooled additive solution as a further source solution;

j) accepting mixture inputs for one or more of said plurality of source solutions; and

k) urging at least a portion of at least one of said plurality of source solutions into said mixture receptacle based on said mixture inputs to form said compounded mixture.

21. A compounding control system for preparing a compounded mixture for use with at least one pharmaceutical compounding device having an associated plurality of source solutions and a mixture receptacle, the system comprising:

first determining means for determining whether said plurality of source solutions conform to a predetermined configuration;

means for generating at least one of an alert to an operator and preventing compounding based on an output of said first determining means;

second determining means for determining respective expiration dates of said plurality of source solutions;

means for preventing use of any of said plurality of source solutions 12 based on an output of said second determining means;

input means accepting mixture inputs for one or more of said plurality 14 of source solutions; and

pumping-means for pumping at least a portion of at least one of said plurality of source solutions into said mixture receptacle based on said mixture inputs to form said compounded mixture.