1. Field of the Invention
This invention relates in general to certain new and useful improvements in algorithm and methods for enabling the preparation, handling and delivery of radioactive pharmaceuticals by a radioactive pharmaceutical supplier to a user, and more particularly, to an algorithm, and a software program used therein, and an associated method which allows for the production of radioactive pharmaceuticals and control over these pharmaceuticals and the areas in which they are used and for a system and method for maintaining records and generating reports, relating to the handling and the delivery of such radioactive pharmaceuticals.
2. Brief Description of Related Art
In recent years, the field of nuclear medicine has relied more heavily upon the use of radioactive pharmaceuticals, primarily for diagnostic purposes, but for other purposes, such as treatment purposes, as well. Generally, radioactive pharmaceuticals are introduced into a patient's blood stream, and allowed to be carried to one or more organs of the body which are to be examined. In this way, it is possible to specifically locate tumors or other dysfunction causing conditions.
Also, in the recent past, it has been found that certain tumors, and other dysfunction causing conditions, will not become visually apparent from presently available diagnosing techniques, such as magnetic resonance imaging and computer tomography. However, it has been found that these conditions will become visually apparent when radioactive dies are lodged or introduced into the tumors and other tissue in which observation may be necessary. Due to the greater widespread use of radioactive pharmaceuticals, and the potential for radioactive hazard, both in the handling and in the disposition of waste materials, there has been a need for careful control over the use of such materials. In fact, in the United States, both the federal government and the various state governments have levied numerous regulations controlling the use and disposition of these radioactive materials.
Inasmuch as the pharmacies are essentially the suppliers of the radioactive pharmaceuticals they are inherently in a position to provide data regarding the actual use and, to some extent, the disposition of these radioactive pharmaceuticals. Hence, the various governmental agencies responsible for the control of radioactive pharmaceuticals rely upon this data and are demanding of fairly accurate data regarding these radioactive pharmaceuticals.
It can be understood that there are numerous details involved in the handling and the use of radioactive materials and for that matter in the handling of these materials. As a result, the reporting requirements can be and frequently are extensive and involve the preparation of time consuming, labor intensive, and hence expensive reports. Not only have the users and pharmacies become involved in these myriads of reporting requirements, but the pharmacies themselves have had to report ever increasing amounts of information to the various governmental agencies. Hence, many pharmacies have had to hire full time personnel to do nothing more than generate reports.
The pharmaceutical houses which dispense these radioactive materials, are required to account for complete use of the radioactive materials, including the handling of the waste resulting therefrom. These pharmaceutical houses are also required to generate reports to those government agencies which are involved in the regulation thereof. The same holds true, to some extent, for the end users of these radioactive pharmaceuticals, as for example, the hospitals and the physicians and medical centers which are involved in the administration of these radioactive pharmaceuticals.
The pharmacies are typically involved in the business of acquiring or producing a pharmaceutical product and then imparting the desired amount of radiation to that product. They do not provide medical care or administer radioactive pharmaceuticals and do not keep data regarding the administration. However, the pharmacies are required to generate governmental reports which becomes a very time consuming and, therefore, an expensive task.
This increasing widespread use of radioactive pharmaceutical materials has given rise to a number of radioactive pharmaceutical supply facilities which supply the end users, e.g., medical institutions, hospitals and physicians with these radioactive materials. These organizations which primarily deal only in the generation and distribution of radioactive pharmaceuticals, are referred to as “pharmacies.” Therefore, as used here, the term “pharmacy” shall mean and refer to only those organizations who deal in the generation and distribution of radioactive pharmaceuticals and who are or may be subject to governmental control in the production and/or distribution of such radioactive pharmaceuticals.
Initially, some of the pharmacies, and for that matter, even the end users, such as hospitals, etc., were originally quite lax in control of the radioactive materials, and in the maintenance of data for generation of reports. Consequently, the U.S. government and the various state governments, have enacted, and even tightened, regulations which require very accurate reporting on a periodic basis.
There have been attempts to use data processing techniques for storage of information. However, and heretofore, these data processing techniques generally rely upon the pure storage of information, without much attention being given to segregation of data for report preparation and auditing, and even for information purposes by the user thereof.
There has been, at least, a few attempts to provide a software program for these pharmacies to be used in the gathering of data and generating reports for the handling and delivery of radioactive materials. However, these attempts were somewhat rudimentary and did not take into consideration all of the numerous reporting requirements by the governmental agencies involved. Even more frequently, they did not have means for calculating data to be presented and hence, the user of the program had to necessarily do calculations by hand or through another program and then introduce that data into the particular software program for generating a report. In addition to the foregoing, the few software programs developed for pharmacies were not capable of universal use and did not take into consideration a large number of potential pharmaceutical materials which could be used and a variety of other conditions relevant to radioactive pharmaceuticals. In generally all cases, the software programs were lacking and required a substantial amount of personnel time in manually gathering information in order to generate the necessary reports.
One of the primary problems with the prior art software programs which have been generated for handling and delivery of radioactive materials by a pharmacy, is the fact that they were not particularly user-friendly. The operator of the system had to be fairly well experienced in dealing with computers in general, and in switching back and forth between subroutines in complex algorithms. As a simple example, if there were a menu page presented on the screen of a monitor, the operator would have to track the particular page involved, in order to examine details of a routine on that menu page. In many cases, the operator even had to go to additional menu screens in order to find the routine which was needed. Moreover, when the operator finished with one routine, the algorithm did not allow the operator to immediately return to the main screen, with a mere click of a pushbutton switch.
Another one of the problems inherent in the prior art systems is that they were not readily adaptable to changing requirements. Thus, if a governmental agency required a new type of report or an altered report to be generated, this almost necessitated the need for a skilled programmer to input that instruction base necessary for an operator to use. Consequently, the prior art programs were severely lacking in many respects.
There has therefore been a need for a system which will allow for the automatic retention of data, segregation of data according to specific functions and materials, and which will also generate reports based on the collected data, all on an automated basis. There has also been a need for systems of this type which could be universally applicable to the collection and segregation of data and generation of reports, based on the activities employed and the functions which are necessary by a pharmacy using such system.
In addition to the foregoing, there has been a need for these pharmacies to maintain internal controls over the use and dispensing of radioactive pharmaceuticals, in order to insure for the health and the safety of those users to whom they deliver these pharmaceuticals. This need for control over the radioactive pharmaceuticals also involves an intended need for careful control and monitoring of the areas in which the pharmaceuticals are used, inasmuch as these areas can also become contaminated from the radioactive pharmaceuticals.
Furthermore, there has also been a need for an orderly and regulated manner in which a radioactive pharmaceutical company could maintain appropriate record keeping in order to insure the delivery of radioactive pharmaceuticals which may be ordered. It may be appreciated that in many cases, the pharmaceutical activity of a radioactive pharmaceutical can decrease rapidly, depending upon the half life of the radioactive material. Consequently, careful control over the preparation of the radioactive materials and delivery must also be maintained.
3. Related Subject Matter
In my co-pending U.S. Utility patent application Ser. No. 10/283,480, filed Oct. 29, 2002, there is provided a method and algorithm for handling radioactive pharmaceuticals and which was designed for use by the ultimate user of the radioactive materials. Those users included for example clinics, hospitals, physicians and the like, who had need to use the radioactive pharmaceuticals with patients. That method and algorithm in the aforesaid copending application allows for the maintenance of records and acquisition of data relating to the use of the radioactive materials.
The data which is gathered can be used by the user, such as the clinic, etc. to govern its operations and to monitor quality control. The algorithm and method will allow for organization of the data so that such evaluation and monitoring can readily take place. That aforesaid algorithm and method also enables the generation to required governmental reports without substantial manual attention. There has been a need for an algorithm and a method for use by a pharmaceutical organization or so-called “pharmacy” to maintain similar data and generate reports therefrom. This present invention thereby provides an algorithm and a method which are suitable for use by a pharmacy.
USPTO Backgrounds
USPTO Backgrounds