Modular pharmacy system and pharmacy process

• US 5,511,594 A
• Filed: 06/23/1992
• Issued: 04/30/1996
• Est. Priority Date: 06/23/1992
• Status: Expired due to Fees

• Current Assignee: Central Admixture Pharmacy Services, Inc. (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Central Admixture Pharmacy Services, Inc. (B. Braun Holding GmbH & Co. KG)
• Inventors: Snider, Robert R., Pfeiffer, Jean, Brennan, Eric L., Bohn, William S., Rivero, Arnold E.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Douglas, Steven O.
• Application Number:
  US07/903,235
• Time in Patent Office: 1,407 Days
• Field of Search: 364/413.01, 364/413.02, 364/468, 364/479, 53/415, 53/436.1, 53/174, 53/167, 53/132, 53/510, 53/425, 53/428, 141/1, 141/2, 141/9, 141/100, 141/95, 141/98, 141/85, 600/21, 600/22, 454/187
• US Class Current: 141/98
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C

Abstract

A modular pharmacy and a modular pharmacy system and process for the admixture of intravenous drugs and total parenteral nutrition solution which includes automatic daily computer download of hospital prescriptions and the daily compounding under controlled systematic aseptic conditions including individually controlled environments at each work station and following systematically controlled process steps.

Claims

1. A pharmaceutical system

for the admixture of ultra-high purity intravenous solutions and drugs, said system comprising:

a plurality of work stations for completion of successive process flow steps in the admixture of intravenous solutions and drugs and comprising;

at least one work station for reception of patient prescriptions and generation of prescription labels comprising computer means for accessing and receiving a hospital'"'"'s prescription data files for prescription orders;

at least one work station for raw materials receiving and storage;

at least one work station for compounding of solutions, for sterile microfiltration of said solutions, and for unit filling of IV bags or syringes;

at least one work station for cleaning or sterilization of work station equipment;

at least one work station for analysis, control and testing of solutions and equipment;

at least one work station for double checking labeled product for release thereof; and

,

environment control means comprising air filtration means to supply air in ultra-high purity form, at controlled pressure and temperature, to said plurality of work stations.

2. A pharmaceutical system according to claim 1 further comprising:

means for automatic computer download of prescription orders,

means for accessing ASCII text files;

means for translating text and ASCII text files to said computer means process flow system computer files;

means for formatting ASCII text files in ANSI standard data format; and

,

means for computer analysis of a patient specific prescription as to at least one of height, weight, allergies, number of ingredients, concentration, and dosage.

3. A pharmaceutical system according to claim 2 further comprising:

means for including in a patient specific prescription the information as to at least one of the following information;

prescription name;

type of order as to parenteral nutrition, chemical, antibiotic, chemotherapy;

a hospital defined patient ID number;

patient name;

ordering physician'"'"'s name;

hospital defined prescription number for order;

sex of patient;

height of patient;

weight of patient;

room where patient is residing at time of order;

area or ward of hospital where patient is residing;

known allergies of patient;

diagnosis of patient;

special instructions for prescription;

number of units requested;

rate of delivery for solution;

total kilocalories required;

total prescription volume in milliliters;

duration of delivery;

start prescription date;

end prescription date;

separate identification of each solution, additives, drug name;

quantity or concentration including a unit of measure for each solution additive or drug name;

frequency of inclusion by day, week, or month; and

a total solution and additives count.

4. A pharmaceutical system according to claim 3 further comprising an order file summary comprising computer means for registering at least one of the following information:

a record header, a type of order, a total count of orders, a total count of solutions and additives for said file, a sum of all unit quantities, a date said file was created, and a time of day said file was created.

5. A pharmaceutical system according to claim 1 wherein said raw materials receiving and storage station comprises computer means for communication with said prescription reception computer work station for inventorying raw materials, for computer communication of said inventory to said prescription reception work station, and for computer reception of a pick list of raw materials based upon prescription orders.

6. A pharmaceutical system according to claim 1 wherein:

said system includes at least one work station for compounding of intravenous total parenteral nutrition and extemporaneous solutions, at least one work station for compounding of intravenous general pharmacy and intravenous chemotherapy prescriptions, and at least one work station for compounding of intravenous antibiotic solutions.

7. A pharmaceutical system according to claim 6 wherein said general pharmacy compounding and chemotherapy work stations further comprise means for such compounding under a laminar flow class 100 biohazard hood to avoid contamination of the air with such compounds.

8. A pharmaceutical system according to claim 6 wherein said antibiotic work station further comprises means for compounding under a laminar flow class 100 biohazard hood.

9. A pharmaceutical system according to claim 6 wherein said work station for compounding TPN and extemporaneous solutions comprises a work station for extemporaneous compounding of solutions and a work station for microcompounding and filling, said extemporaneous compounding work station comprises means for weighing raw materials, means for introducing raw materials into a solution tank to form a solution, means for heating said solutions, means for mixing said solutions, and means for transporting said solutions from said macrocompounding of solutions work station to said work station for microcompounding and filling.

10. A pharmaceutical system according to claim 9 wherein said work station for microcompounding and filling of intravenous total parenteral solutions work station comprises:

a computer means in communication with said computer means in said prescription reception computer work station;

means for accommodating solutions produced in said extemporaneous compounding work station;

means for aseptic pumping of each solution through an aseptic 0.2 micron filter into a reservoir container;

means for dispensing metered amounts of selected solutions into an aseptic prescription container; and

,

computer means for control of the identity and amount of each solution which is introduced into each prescription container.

11. A pharmaceutical system according to claim 10 further comprising:

means for inline testing of filters, and means for the consistent, systematic introduction of small amounts of microadditive ingredients; and

,

computer control means for checking and dispensing the amount of said small amounts.

12. A pharmaceutical system according to claim 1 wherein said control and testing work station comprises:

means for individual testing of micron filters;

an incubator for incubating samples of filled prescriptions;

a refrigerator for cooling;

means for analysis of prescriptions and for verification of identity of prescription ingredients; and

,

means for testing the sterility of prescriptions as well as the sterility of equipment used in the preparation of the prescriptions.

13. A pharmaceutical system according to claim 1 wherein said cleaning and sterilizing work station includes means for washing, drying, and sterilizing of equipment and other items used in the preparation and testing of prescriptions.

14. A pharmaceutical system according to claim 1 wherein said product release work station comprises:

computer means in communication with said prescription reception computer work station for double checking of individual prescriptions prior to release;

means for packaging individual patient prescriptions together; and

,

means for maintaining prescriptions at prescribed temperatures.

15. A pharmaceutical system according to claim 1 further comprising at least one area for changing from street clothes into sterile clothing.

16. A pharmaceutical system according to claim 1 further comprising a work station for wipe down of all solutions and associated equipment prior to set up in said compounding and unit fill work station in order to remove particles and maintain sterility.

17. A pharmaceutical system according to claim 1 further comprising a work station for ultra purification of water and the storage thereof.

18. A pharmaceutical system according to claim 17 wherein said water purification system further comprises at least one means selected from reverse osmosis filters, carbon bed filters, ion exchange beds, chemicals to kill organisms, filters to remove particles, mixed bed polishing containing cation and anion exchange resins, sterilization means and distillation and evaporation operations for production of water to the pharmaceutical standard of Water For Injection, U.S.P..

19. A pharmacy comprised of at least one modular structure divided interiorly into separate rooms and areas for performing specific activities for the admixture of ultrapure intravenous solutions and drugs comprising:

at least one area for prescription order entry for receipt of prescriptions comprising computer means for accessing and receiving a hospital'"'"'s prescription data files for prescription orders;

at least one changing area for donning sterile work garments;

at least one control, analysis, and testing area for analysis of prescriptions and for testing for sterility of prescriptions and equipment;

at least one process preparation area for washing and sterilizing of equipment; and

for weighing out and measuring raw materials;

at least one area for extemporaneous compounding of prescription solutions;

at least one area for wipe down of exterior portions of equipment prior to use in compounding and unit filling of prescriptions;

at least one positive air pressure area for total parenteral nutrition compounding, sterile microfiltering and filling;

at least one negative air pressure biohazard hood for general pharmacy, antibiotic and chemotherapy compounding and filling; and

,

at least one area for product release.

20. A pharmacy according to claim 19 further comprising at least one area for raw materials receiving and storage and at least one area for water purification.

21. A pharmacy according to claim 19 further comprising means for controlling said general pharmacy compounding and said antibiotic compounding areas and maintaining the air therein to a class 1000 standard or better;

and,

means for maintaining said total parenteral nutrition compounding and filling enclosure to a positive air pressure of at least about +0.1 inch of water and maintaining air therein to a quality of class 1000 standard or better.

22. A pharmacy according to claim 19 further comprising means for maintaining said control and testing area, said process preparation and cleaning and sterilizing equipment area, and said area for water purification to a positive air pressure of at least about +0.02 inch of water and a class 10,000 or better standard.

23. A pharmacy comprising:

at least one structure divided interiorly into separate rooms for performing specific process flow activities for the production of ultrapure intravenous solutions and drugs comprising;

at least one ambient air pressure room for raw materials receiving and storage, for receiving prescriptions, and for changing into scrubs;

at least one positive air pressure room for control and testing of prescriptions, for process preparation, for cleaning and for sterilizing of equipment used in the preparation of prescriptions, for large scale compounding of solutions, for wipe down of equipment used in TPN compounding and filling, for changing into sterile gowns and related apparel, for TPN microcompounding, filtering and filling, for unit filling of antibiotic prescriptions, and for release of filled prescription products; and

,

at least one separate negative air pressure room for compounding of general pharmacy and chemotherapy drugs and at least one separate negative air pressure room for compounding of antibiotics; and

,

a biohazard hood disposed within each negative air pressure room for the compounding of the prescription drugs within each room.

24. A pharmacy according to claim 23 further comprising a positive air pressure of at least about +0.2 inch of water and a class 10,000 or better standard for said positive air pressure rooms including said at least one room for control and testing of prescriptions, for process preparation and cleaning and sterilizing of equipment, and for large scale compounding of solutions;

a positive air pressure of at least about +0.05 inch of water and a class 1000 or better standard for said at least one room for changing into scrubs, a positive pressure of at least about +0.1 inch of water and a class 1000 or better standard for said at least one room for TPN compounding and for antibiotic filling, and a positive pressure of at least about +0.01 inch of water for said at least one room for product release; and

,

a negative air pressure of at least about -0.1 inch of water and a class 1000 or better standard in said general pharmacy compounding and chemotherapy compounding room and for said antibiotic compounding room.

25. A pharmacy according to claim 23 further comprising a room for water purification which is maintained at a positive air pressure of at least about +0.02 inch of water and a class 10,000 or better standard for said air.

26. A process for admixture of ultrapure intravenous solutions and drugs comprising:

receiving prescription orders;

analyzing each prescription order at least with respect to identity of ingredients and amounts thereof;

preparing a list of needed materials, equipment and sterile prepared solutions;

wiping down the exterior of each container of materials and prepared solutions, and equipment, attached equipment and transport equipment;

transferring said wiped down containers, materials and equipment to form individual TPN prescriptions and extemporaneous solutions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with positive air pressure and provided with a class 1000 or better standard;

admixing at least one of the extemporaneous solutions and large scale batch TPN compounding solutions extemporaneously as needed wherein the steps comprise;

analyzing each prescription order at least with respect to identity of ingredients and amounts thereof;

preparing a list of needed raw materials and prepared solutions;

transferring raw materials on said list to a process preparation area for weighing and measuring of said materials;

mixing together needed raw materials and prepared solutions to form said extemporaneous and large scale batch solutions;

sampling each solution batch;

testing and analyzing each batch solution for quality;

releasing each extemporaneous and batch solution for use in filling prescriptions;

wiping down the exterior of each extemporaneous and large scale solution container, attached equipment and transport equipment;

transferring each container of extemporaneous and large scale batch solutions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with positive air pressure and a class 100 or better standard;

checking each prescription at least as to identity of ingredients and amounts thereof;

filtering each said extemporaneous and large scale batch solutions through a sterile micropore filter sized to exclude pathogenic organisms;

metering prescription amounts of each said sterile prepared solutions and each filtered extemporaneous and large scale batch solution according to the prescription amounts into individual unit bags;

checking for any prescription changes;

adding individual sterile microadditives to each unit bag according to each individual prescription;

rechecking for each prescription ingredient; and

,

releasing the filled prescription product.

27. A process according to claim 26 further comprising receiving prescription orders by means of a computer:

analyzing each prescription order as to ingredients and amounts by means of computer analysis;

preparing a label identifying individual ingredients, strengths, and amounts; and

,

controlling the metering of large scale solutions by computer.

28. A process according to claim 26 further comprising:

adding microadditives by verifying the prescription ingredients and dosages separately;

drawing a syringe with the required amount of the additive;

reverifying the ingredient, the amount, and the concentration as required by the prescription; and

,

adding to a unit bag; and

,

repeating the above procedure for each individual microadditive required.

29. A process according to claim 26 further comprising verifying the integrity of the filter inline periodically and at the end of a prescribed amount of use.

30. A process according to claim 29 further comprising arranging each microadditive solution in a sequential order corresponding to the same order in which such micro ingredients are listed on a prescription label;

adding each microadditive in the same order as found on the prescription label and double checking prior to the addition of each subsequent microadditive;

drawing additives into syringes in the sequence stated on the prescription label;

keeping the syringe attached to the drug solution for checking;

verifying check of drawn syringes prior to adding; and

,

adding according to setup sequence.

31. A process for admixture of ultrapure intravenous solutions and drugs comprising:

receiving and accessing a hospital'"'"'s prescription data files for prescription orders by computer means;

analyzing each prescription order at least with respect to identity of ingredients and amounts thereof by computer means;

preparing a list of needed materials, equipment and sterile prepared solutions;

wiping down the exterior of each container of materials and prepared solutions, and equipment, attached equipment and transport equipment;

transferring said wiped down containers, materials and equipment to form said prescriptions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with negative air pressure and provided with a class 1000 or better standard;

checking each prescription at least as to identity of ingredients and amounts thereof;

metering prescription amounts of each presterilized solution according to the prescription amounts into individual unit containers;

checking for any prescription changes;

rechecking for each prescription ingredient; and

,

releasing the filled prescription product.