Pharmacy based method and algorithm for handling of radioactive pharmaceuticals and generating of reports therefor

• US 20090023974A9
• Filed: 05/28/2003
• Published: 01/22/2009
• Est. Priority Date: 10/30/2001
• Status: Active Grant

• Current Assignee: ec2 Software Solutions LLC
• Original Assignee: Biodose LLC
• Inventors: Whittacre, Bretten, Curnutt, Troy
• Granted Patent: US 8,175,890 B2
• Time in Patent Office: Days
• US Class Current: 600/1
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

An algorithm for generating of a program, as well as an associated method for handling of radioactive pharmaceuticals by a pharmacy so that data may be maintained on the acquisition, dispensing and handling of the radioactive pharmaceuticals and the disposition thereof. The algorithm and method allow for data to be electronically introduced in generally temporal relationship to the performance of physical activities. In addition, the algorithm and the method allow for computerized generation of required governmental reports, which thereby reduces the amount of manual operator attention which would otherwise be required. In addition, the algorithm and method allows for periodic information to be sent to quality control assurance personnel for generation of reports and information by such personnel.

Claims

1. A process for acquiring and distributing radioactive pharmaceuticals by a pharmacy and simultaneously collecting necessary data in connection with the acquisition and delivery of the radioactive pharmaceuticals, said method comprising:

a) electronically examining a previously recorded database to determine if a bulk quantity of a desired radioactive pharmaceutical exists in inventory;

b) physically extracting a selected amount of that radioactive pharmaceutical if same exists in bulk form and meets certain criteria and electronically identifying and recording information about the extracted amount;

c) subjecting a selected pharmaceutical to radioactivity in an elution process if not in bulk form or if it does not meet the certain criteria and recording information about the elution;

d) preparing the desired amount of the radioactive pharmaceutical for delivery to a user;

e) electronically recording information about quality control associated with the acquisition and distribution of the radioactive pharmaceuticals; and

f) electronically recording information about delivery of the radioactive pharmaceutical.

2. The process for acquiring and distributing radioactive pharmaceuticals of claim 1 further characterized in that the process further comprises:

a) simultaneously with performing of steps (b) and (d) in the process of claim 1, the process comprises conducting quality control procedures in connection with the performance of said steps; and

b) the information recorded in step (e) is that required in the performance of step (f).

3. The process for acquiring and distributing radioactive pharmaceuticals of claim 2 further characterized in that the quality control procedures are conducted late with regard to the radioactive pharmaceuticals and with regard to implements used in the acquisition of the radioactive pharmaceuticals.

4. The process for acquiring and distributing radioactive pharmaceuticals of claim 2 further characterized in that the process comprises electronically generating reports to a governmental agency controlling the use of radioactivity based on data introduced during preparation and distribution of the radioactive pharmaceuticals.

5. The process for acquiring and distributing radioactive pharmaceuticals of claim 2 further characterized in that the process also involves the automatically electronically generating reports to quality control personnel when conducting quality control procedures.

6. The process for acquiring and distributing radioactive pharmaceuticals of claim 2 further characterized in that the process further comprises:

a) disposing of radioactive pharmaceuticals or implements used in the generation of such pharmaceuticals in accordance with governmentally approved disposal procedures; and

b) electronically recording information relating to such disposals.

7. The process for acquiring and distributing radioactive pharmaceuticals of claim 2 further characterized in that prior to processing of an order for a radioactive pharmaceutical the process automatically instructs personnel to conduct quality control procedure on equipment and instruments used in producing radioactive pharmaceuticals.

22. The electronic data processing algorithm for performing method activities of claim 20 further characterized in that the algorithm further comprises:

performing those steps set forth in claim 1 for a plurality of different authorized users who may receive different radioactive pharmaceuticals and different amounts thereof.

8. A process for acquiring and distributing radioactive pharmaceuticals by a pharmacy and simultaneously collecting necessary data in connection with the acquisition and delivery of the radioactive pharmaceuticals, said method comprising:

a) receiving an order for a radioactive pharmaceutical;

b) processing that order by acquiring the radioactive pharmaceutical and electronically recording data about the order and the processing of the radioactive pharmaceutical;

c) performing quality control procedures with regard to the radioactive pharmaceutical and any implements used in connection therewith and which may have been contaminated by radioactivity;

d) recording data about the quality control procedures with respect to the radioactive pharmaceutical and implements used in connection therewith;

e) automatically segregating the data recorded according to requirements for reporting information on the pharmaceuticals and the implements used in connection therewith; and

f) printing reports in accordance with governmental requirements with the segregated data such that the data for the reports is automatically gathered and presented in the report formats required by such governmental requirements, thereby minimizing the time required for personnel to generate the required reports.

9. The process for acquiring and distributing radioactive pharmaceuticals of claim 8 further characterized in that the step of performing quality control procedures comprises:

a) conducting an area survey for radioactivity levels after acquiring the radioactive pharmaceutical; and

b) conducting a wipe survey for surface radioactivity levels after acquiring the radioactive pharmaceutical.

10. The process for acquiring and distributing radioactive pharmaceuticals of claim 9 further characterized in that the step of acquiring the radioactive pharmaceutical comprises:

a) physically extracting a selected amount of that radioactive pharmaceutical if same exists in bulk form and meets certain criteria and electronically identifying and recording information about the extracted amount; and

b) subjecting a selected pharmaceutical to radioactivity in an elution process if not in bulk form or if it does not meet the certain criteria and recording information about the elution;

11. The process for acquiring and distributing radioactive pharmaceuticals of claim 8 further characterized in that the step of generating quality control comprises conducting quality control with respect to implements used in acquisition of the radioactive pharmaceutical.

12. The process for acquiring and distributing radioactive pharmaceuticals of claim 10 further characterized in that data is maintained and generated with regard to extracting the radioactive pharmaceutical in bulk storage or using the elution process if not in bulk form and segregating the data according to requirements for generating reports.

13. Electronic data processing program based algorithm for aiding in the acquiring, supplying and deliver of radioactive pharmaceuticals to a plurality of patient facilities, said algorithm comprising:

a) a group of transaction generating activities for generating instructions to an operator about patient facilities and the dates certain radioactive pharmaceuticals are to be acquired and delivered to a patient facility;

b) provisions for introducing into a first data bank data about radioactive pharmaceutical products to be supplied to a patient facility and introducing into a second bank data about the radioactive pharmaceuticals to be supplied and introducing into a third data bank data about the amount of radioactivity in the radioactive pharmaceuticals and introducing into a fourth data bank data about the dates of delivery to the facilities to which such radioactive pharmaceuticals can be delivered;

c) steps in said algorithm for automatically assigning to the data introduced a separate one of first codes about each of the patient facilities who are to receive a radioactive pharmaceutical, a separate one of second codes about each of the radioactive pharmaceutical products, a separate one of third codes about the amount of radioactivity in each of the radioactive pharmaceuticals which are to be delivered and a separate one of fourth codes about dates in which radioactive pharmaceuticals are to be delivered; and

d) additional steps in said algorithm for automatically accumulating and presenting information about the patient facilities, information about the radioactive pharmaceutical products, information about the amounts of radioactivity and information about the dates of deliveries to determine the proper facility and the proper product to which the radioactive pharmaceuticals are to be delivered by locating the first, second, third, and fourth codes, and generating a display thereof.

14. The electronic data processing program based algorithm of claim 13 further characterized in that said algorithm comprises:

a routine for automatically correlating the codes to the information sought so that the patient facilities and the radioactive pharmaceutical products and the dates of delivery are in individual data banks and can be automatically retrieved from said data banks by codes assigned thereto, thereby reducing the redundancy of information recorded.

15. The electronic data processing program based algorithm of claim 13 further characterized in that each of the said codes are introduced into a code database before use in the algorithm and in use these codes are automatically assigned to the data which is introduced, by the electronic data processing system, such that the codes do not have to be manually introduced by a user thereof at the time of introduction of the data.

16. The electronic data processing program based algorithm of claim 13 further characterized in that the code assigned to a patient facility will always remain the same for that patient facility, the code assigned to the radioactive pharmaceutical product will always remain the same for that radioactive pharmaceutical product regardless fo the patient facility to which it is delivered and the code assigned to the radioactivity dose will always remain the same regardless of the radioactive pharmaceutical in which it exists and codes for such date or dates delivered will always remain the same regardless of the patient facility, dose and radioactive pharmaceutical product.

17. The electronic data processing program based algorithm of claim 16 further characterized in that the provision for introducing data provides for data into a fifth data bank about quality control tests to be performed and a separate one of information codes will be assigned to each of those quality control tests and will always remain the same for such tests regardless of the products of implements on which the tests are to be performed.

18. The electronic data processing program based algorithm of claim 17 further characterized in that the provision for introducing data provides for information into a sixth data bank about volume amount of the radioactive pharmaceutical products to be delivered and a separate one of sixth codes will be assigned to each of those volume amounts and will always remain the same for such volume amounts regardless of the radioactive pharmaceutical product.

19. The electronic data processing program based algorithm of claim 18 further characterized in that the provision for introducing data into a separate data bank about quality control testing for radioactivity levels and a separate one of seventh codes will be assigned to each of the tests for measuring radioactivity levels in such quality control tests and the same code will be applied to such quality control tests regardless of the radioactive pharmaceutical product with respect to which the tests are to be performed.

20. An electronic data processing algorithm for electronically performing a plurality of activities associated with the preparation and delivery of radioactive pharmaceuticals, and maintaining records of radioactivity associated therewith, said method comprising:

a) scheduling the delivery of a radioactive pharmaceutical in accordance with an order of an authorized user;

b) electronically determining in advance but in reasonably close relation to the required data and time of delivery of the required radioactive pharmaceutical for that particular authorized user;

c) preparing a dose of the ordered radioactive pharmaceutical for that authorized user taking into consideration the decay of the radioactivity in that radioactive pharmaceutical and the date and time of delivery;

d) actually delivering the radioactive pharmaceutical to the selected user; and

e) maintaining data relating to the use and disposition of all radioactivity imparted to the radioactive pharmaceutical and instrumentalities used in connection therewith and organizing that data into individual data banks for accessing and correlating elements of that data for reports.

21. The electronic data processing algorithm for performing method activities of claim 20 further characterized in that the algorithm further comprises the step of:

disposing of certain instrumentalities used in the administration of the radioactive pharmaceutical to the patient and electronically tracking information related thereto.

23. The electronic data processing algorithm for performing method activities of claim 20 further characterized in that said method comprises the step of:

electronically organizing the data and sorting the data used in the performance of the method in such manner that the data can be easily electronically re-accessed and electronically organized into individual sections in accordance with certain governmental requirements.

24. The electronic data processing algorithm for performing method activities of claim 21 further characterized in that the step of disposing of certain of the instrumentalities comprises the steps of:

a) packaging of certain of the instrumentalities for delivery to locations having the facilities to handle radioactive contaminated instrumentalities;

b) measuring the amount of radioactive contamination in such instrumentalities and areas in which the instrumentalities having the radioactivity have been used; and

c) sorting such instrumentalities according to residual decay times.

25. The electronic data processing algorithm for performing method activities of claim 20 further characterized in that the step of preparing the dose of the radioactive pharmaceutical comprises:

a) determining if the dose of the required radioactive pharmaceutical is available in a bulk storage;

b) calculating the amount of the radioactivity to be in the dose; and

c) preparing an instrumentality of the proper amount of the dose for delivery to a user.

26. The electronic processing algorithm for performing method activities of claim 25 further characterized in that the step of acquiring the dose of the radioactive pharmaceutical comprises physically preparing that dose.

27. The electronic data processing algorithm for performing method activities of claim 20 further characterized in that all of steps (a), (b), (c), and (d) are performed with electronic intervention such that the algorithm allows the method to be performed with scheduling deliveries to the users electronically in step (a) the availability of the radioactive pharmaceuticals in step (b) with electronic intervention so that the ordering occurs in timed relation to the scheduling, the appointment, and preparing a dose of the pharmaceutical in step (c) by display of information relating to a particular user and electronically recording about the radioactivity in step (d).

28. An electronic data processing algorithm for electronically performing a plurality of method activities associated with the preparation and delivery of radioactive pharmaceuticals to a plurality of users of such radioactive pharmaceuticals, said algorithm comprising:

a) electronically recording orders for a plurality of users who are to receive radioactive pharmaceuticals for ultimate administration to patients;

b) scheduling the delivery of each radioactive pharmaceutical to each of a plurality of users with electronic intervention in accordance with anticipated administration dates and potential radiation decay rates;

c) electronically displaying based on previously input data the available radioactive pharmaceuticals of the type to be delivered;

d) preparing in reasonably close relation to the given time periods, the required radioactive pharmaceuticals for the actual delivery of those required radioactive pharmaceuticals;

e) electronically displaying on the screen of a monitor based on previously input data a schedule of users who are to be delivered radioactive pharmaceuticals in a given time period;

f) actually delivering the radioactive pharmaceutical to the users in the given time periods for each of those users; and

g) disposing of the instrumentalities used in the preparation of the radioactive pharmaceutical to the patient and electronically tracking information related thereto.

29. The electronic data processing algorithm for performing method activities of claim 28 further characterized in that the algorithm comprises:

a routine for electronically correlating the users to the required radioactive pharmaceutical and preparing a dose of the selected radioactive pharmaceutical for delivery to each user and also correlating pharmaceuticals to the respective users in those given time periods.

30. The electronic data processing algorithm for performing method activities of claim 28 further characterized in that the algorithm comprises taking the steps set forth in claim 28 for the plurality of users and certain of which users may receive different radioactive pharmaceuticals and different amounts of the same radioactive pharmaceuticals.

31. The electronic data processing algorithm for performing method activities of claim 28 further characterized in that said algorithm comprises the step of electronically organizing the data and sorting the data used in the performance of the method in such manner that all data is organized and returned for producing reports therefrom, and that a governmental report can be automatically generated electronically.

32. The electronic data processing algorithm for performing method activities of claim 28 further characterized in that the step of preparing of the radioactive pharmaceuticals comprises:

a) ordering the dose of the required radioactive pharmaceutical;

b) calculating the amount of the dose; and

c) preparing an instrumentality of the proper amount of the does of radioactive pharmaceutical for administration.