MXPA01007901A - Method and apapratus for controlling the strategy of compounding pharmaceutical admixtures. - Google Patents

Abstract

A method and apparatus for controlling the compounding of pharmaceutical parenteral admixtures id disclosed. The apparatus preferably comprises a computer that contains a memory for storing instructions for operating the apparatus and for controlling compounders that prepare a prescription admixture, with the memory including data relating to a plurality of the pharmaceutical components that may be transferred to prepare the prescription admixture, and data concerning the operating characteristics of the compounders that the apparatus is adapted to control. The apparatus determines the order of admixing by general rules of admixing and by categorized compatibility groups of components, so that the number of rinses that must be done are minimized.

Description

METHOD AND APPARATUS TO CONTROL THE STRATEGY OF MAKING COMPOUNDS WITH PHARMACEUTICAL MIXTURES • The present invention relates in general to a method and apparatus for preparing and for pharmaceutical mixtures. More particularly, it is related to the strategies for preparing prescriptions for parenteral mixtures, to control the apparatuses that make the compositions and for the adequate elaboration of accounts of the prepared mixture with the strategies that are carried out in a 10 computer software. • BACKGROUND OF THE INVENTION 15 Pharmaceutical parenteral mixtures are a combination of sterile drugs that are mixed together under aseptic conditions and are intended for intravenous infusion. These mixtures can be relatively simple or extremely complex, increasing the complexity with the inclusion of 20 multiple active ingredients. Nutrition mixtures are an example of complex parenteral mixtures that are often prepared in a hospital pharmacy to treat hospital patients. . In general parenteral nutrition ("PN") mixtures refer to most types of nutritional solutions for intravenous feeding. The mixtures for total parenteral nutrition ("TPN") in general refer to those PN that do not contain lipids as a component, and the total nutritional mixtures (J TNA? I) refer to those PN 'that contain lipids. The pharmacy of a hospital, a center for making compositions - or a care facility prepares or elaborates the compounds of a prescription that • 5 typically has been determined by a doctor individually or in conjunction with a dietitian, pharmacist, or other caregiver. The pharmacy may * be required to make large PN compounds on a daily basis. The present processing of PN compositions is done primarily by an extremely sophisticated electromechanical mixing equipment called a composition processor that is adapted to mix many different components in different proportions as set forth in the pharmaceutical prescriptions.

Compositioners of compositions include developers of high volume compositions that are adapted to prepare PN by transferring those components that are normally found in relatively large volumes in a PN, for example, amino acids, sterile water, lipids and dextrose, and, to relatively high speed. Such compositors of compositions include a manufacturer of AUTOMIX 3 + 3 compositions made by Clintec Nutrition Division of Baxter 20 Healthcare Coforation.

The compositors of compositions also include processors of low volume compositions such as the developers of compositions of the same coiporation marketed as a compounder of compositions. 25 MICROMIX. The MICROMIX compounding processor is adapted to transfer exactly those components normally found in relatively small volumes in a PN. It is common in pharmacies to produce a prescribed PN by using both a MICROMIX and an AUTOMIX 5 compositor typically by adding the high volume components to the final container or final bag with the AUTOMIX Composer and then transferring the final bag. to the MICROMIX composition processor to transfer the smaller volume components. It should be understood that a simple composition processor may have the ability to transfer both high volume components 10 as low volume components either sequences or concurrently. fl) Alternatively, the simple composition processor could have either a high volume module or a low volume module that could transfer fluid to a common manifold, a common transfer tube connected to a final bag or container, or in separate ports in a final bag. 15 In order to prepare such NP with an acceptable cost it is important that the NP be prepared as compound as efficiently as possible. Efficiency is generally achieved by seeking to maximize the number of NPs prepared during a given period of time or "yield". However, the complexity of Adequate preparation of the PN tends to decrease such performance. You can find areas of complexity when determining the PN, appropriate for a prescription -given for a particular patient, prepare exactly the PN and prepare the accounts or bill the PN. However, the safety of the patient that is the capital and efficient of PN preparation must be met with little chance of 25 errors.

When preparing the appropriate prescription for a particular patient the pharmacist must perform many tasks that include the evaluation and determination of the appropriate components and their respective amounts. The • 5 patient-specific factors that include the type of patient ie neonatal, and the patient's weight will be considered. Improving the ability of the pharmacist to develop such evaluations and determinations will increase efficiency and reduce the possibility of errors. In order to maintain a record it is desirable and sometimes the pharmacist is required to enter a permanent record because the prescription differs from the generally desired quantities of source solutions.

As is well known in pharmacy practice, much of the complexity involved in the preparation of PN results from the compatibility issues related to the components that are located in the prescribed PN.

Compatibility is defined as the interaction between a drug and all the other components with which that drug comes into contact, which 20 include but are not limited to diluent, container and other drugs in the same PN. The compatibility is divided into two sub-categories that are physical as well as chemical compatibility. Physical compatibility is defined as an incompatibility that will alter the physical appearance of the drug, typically resulting in a visual change such as precipitation. 25 gas evolution or color change. Chemical incompatibilities are not observed visually but must be tested analytically. Chemical incompatibilities are presented as results of changes in the active drug such as oxidation or photo degradation. Factors that can - influence compatibility include, but are not limited to, volume of total diluent, concentration levels, order of mixing and pH. There are two stages in the evaluation of compatibility and parenteral mixtures. First, the compatibility of the complete PN during a period between the preparation of the mixture and the termination of the supply to the patient must be evaluated before the composition is prepared. Second, the process of comparing the compound should be planned in a way that allows for compatibility while ^ B the compounding process is in progress. For example, compatibility between a source solution that is added to the final mixing container or any intermediate mixing container and the solution present in that container must be evaluated. In many cases the solution is a source that is packaged 15 in concentrations that are incompatible with other solutions must be diluted before coming into contact with each other in such chambers.

As will be appreciated, the higher dilution will occur when the larger amount of diluent fluids are already present in the container within * of which the 20 solutions have been added. For example, amino acid or dextrose source solutions will form a large portion of a PN and are still typically compatible with most additives. In this way it will appear that these solutions will be transferred first to the final container or to any type of intermediate mixing chambers to dilute the added source solutions. 25 _ _t __ ^ ¡_ An additional complexity that must be considered is the prevention of contact between highly concentrated solutions that are incompatible with each other along with a common flow path in the compound processor. In representative instancesAlthough the source solutions may flow along 5 separate tubes during most of the transfer flow path, there may be a section along the transfer flow path that is common to the two incompatible source solutions. This common flow path can be found along any part of the flow path such as in an intermediate mixing chamber or after the intermediate mixing chamber or after a commutated valve.

• One method to reduce the possibility of a solution that is incompatible with the second solution along the common flow path is to flow the common flow path after each solution has been transferred. Such flow is achieved with a solution that is compatible both in the first solution and in the solution to be added after the flow. As you can see the frequent flow dilutes the incompatible solutions making them in this compatible way but also decreases the efficiency. • 20 There may also be a source of fluid for such a flow scheme. The source of such flow solutions could well be a compatible source solution that forms a part of the prescription or the solution present in a downstream chamber such as a mixture in the final mixing vessel. However, in current pharmacy practices, the prescribed amount of solutions Those which are used as flow solutions are typically transferred first to the final container for purposes of expense and dilution and are not available as flow solutions. In this case and by default the solution in the final bag must be compatible with the solution to be flowed and the flow solution will be removed to the final container. Directing the flow from the final bag and returning the flow to the • final bag decreases efficiency. On the other hand having a number of diluent source solutions for flow can lead to instances where two incompatible solutions come into contact with one another in the final mixing chamber without being properly diluted to a compatible concentration. 10 In an effort to increase efficiency, the pharmacist typically (H will group solution containers depending on the operating scheme of the compounding processor such that ingredients that are compatible with each other (at a concentration of the source solution) are sequentially added together between rinses that are established by the pharmacist. from To determine the compatibility of several solutions, the pharmacist can group a set of compatible solutions on station 1-4, a second set of compatible solutions on stations 5-8, etc. With rinses established after station 4, station 8, etc. However, a particular mixture may require five solutions that are compatible. Because the establishment 20 of rinses requires more time and effort, the pharmacist can loosen the fifth ingredient in a station that has before and after rinses instead of adjusting the station layout and the rinsing scheme. This, however, is not optimal.

Another consideration of the pharmacist when making compositions with multiple prescriptions comprises a mixture of TNA and TPN which is a lipid mist in which a trace of lipids is present in the final solution that will not contain lipids. Mist can be produced with lipids that are • 5 present in quantities as low as one to 3 parts per million. Such a haze will typically occur when a prescription containing lipids is prepared as a compound immediately before a prescription that will not contain lipids. The mist with lipids is not generally believed to create a health risk, however the mist with lipids in a PN that is going to be infused 10 can be mistaken later with a PN with an unacceptable precipitation that w? arises from an error in the formulation of a compatible TN solution, and the mist solution can be ruled out by mistake.

If the lipid mist is a subject that the pharmacist can foresee to avoid such problems by flowing the compound maker after each lipid-containing prescription is elaborated. However, such a flow will decrease efficiency and will not be fully effective. To increase efficiency, / the pharmacist should decrease such flow by grouping the prescriptions with lipids; without • However, such groupings have a negative impact on flexibility. If the lipid mist is not a concern, the possibility of the lipid mist should be communicated to the people who are preparing the compounds of the solution and who are administering the PN to the patient to avoid that the administrator mistakenly believes that the mixture It has become unstable. 25 Other methods to seek to avoid lipid mist is the use of a completely separate flow path for lipids to the container in this end. However, once the lipids are present in the final container, making them fluid by rinsing them using solution from the final container will introduce lipids inside. 5 of the flow path and will originate a lipid mist in a subsequent PN.

In addition to the complexity of compounding the pharmacist should consider the limits of the precision of the compounding processors in such a way that the prescriptions that have ingredients at lower volume levels 10 to the precision limit of the compound developer is probably added by hand using a syringe. Such manual addition decreases the efficiency. Also inefficiencies inherent in the administration of PN to the patient such as residual volumes in administration sets should also be considered. Evaluating the complexities has proven to be a time-consuming element that leads to 15 activities and inefficient practices.

For the purpose of reimbursement and record keeping, the prepared mixture must be accounted for, which is generally achieved by either manually or electronically reporting information transfer within the facility's accounting system. The stages that the pharmacist must develop to ensure that a mixture is properly accounted for should be minimized to increase efficiency.

Thus, it is a primary object of the present invention to provide an improved method and apparatus for preparing and accounting for parenteral nutrition solutions. It is a further object of the present invention to provide a method and apparatus for preparing a parenteral mixture to reduce instances of incompatibility, which preferably include on-going proposal of a software method that will accommodate many known active ingredients and other components that are established in various prescription mixtures. More particularly, it is a related object to provide strategies for the preparation of prescriptions for parenteral mixing, to control the apparatus for making compounds, and to properly account for the mixture prepared with the strategies that are implemented with the computer software.

It is another primary object of the present invention to provide such an improved method and apparatus for preparing a parenteral mixture to increase the efficiency of a compounding agent, primarily to minimize the number of rinses that have to be developed.

A related object of the present invention is based on the condition of selectively determining the order or rearrangement of a plurality of mixing solutions or compatibility groups that may reside in a prescription, to more efficiently prepare the prescriptions, such as by maximizing the number of prescriptions that can be prepared during an estimated period of time.

A more detailed object of the present invention is to provide such improved apparatus and method for controlling a compounding processor of the type using an intermediate mixing chamber such as a funnel to mix components before transferring the contents of the chamber to the mixing chamber. final such as a final bag.

Another, object of the present invention is based on the condition of the data • 5 patient-specific to improve the ability of the pharmacist to efficiently and safely formulate the compound mixtures of the prescriptions.

Yet another object of the present invention is to provide an improved method and apparatus to enable the pharmacist to efficiently compensate for 10 Precision limits of the compounding agent in the inefficiencies in B nistering the PN to the patient such as the fluid that is lost in the nistration sets.

Another object of the present invention is to provide a method and apparatus 15 which includes a formulation of higher concentration of an ingredient when substituted for a prescribed formulation but which determines whether the diluent fluid can be provided by compatibilizing other ingredients such that the volume of the resulting mixture is minimized.

Another object of the present invention is to provide such an improved method and apparatus that controls the manufacture of compounds to alert users when the recommended limits have not been adhered and such alerts are accidentally ignored. A related object is to provide input and record the fundamental reason for ignoring a warning. Another object of the present invention is to provide a method and apparatus that reduces instances or alerting users to the possibility of lipid mist and the possibility that such lipid mist is accidentally mistaken as an unacceptable precipitate. These and other objects will be apparent to those skilled in the art upon reading the following detailed description which refer to the accompanying drawings, in which: Figure 1 is a block diagram illustrating the apparatus of the present invention shown in the context of a hospital having a central computer for accounts and patients that is networked with the apparatuses of the present invention and with the apparatus as well. Operationally connected to compound manufacturers and printers; Figure 2 is a perspective view of a representative composition processor that can be controlled by the method and apparatus of the present invention, and particularly showing the compound maker having an intermediate funnel or container in which the source components they are well 20 be sequences or concurrently before being transferred to the final bag; Figure 3 is a perspective view of a second representative compound processor that can be controlled by the method and apparatus of the display. Figures 4a-4h together comprise a flow diagram for controlling the making of compounds of a prescribed mixture according to the present invention.

• DETAILED DESCRIPTION Broadly stated, the present invention is directed to a method and apparatus for controlling the manufacture of compounds of pharmaceutical mixtures, where the elaboration of compounds is done by one or more processors of 10 compounds that can be remotely located in relation to the computer (H) control or processing means that are interconnected with the compound processors. With reference to Figure 1, the controlling computer or controller 10 has sufficient memory to store the pharmaceutical data in the form of a database as well as operating software for use in the 15 control of composites and other peripheral equipment. The computer 10 is preferably a multi-user, multi-tasking computer having a communication / interfaces for interconnecting the composite processors 12, 14, and 16 and other peripheral equipment such as printers 18 and 20 for communication connections 22 that can be wired or wireless, can be part of 20 a local area network or a wide area network or the Internet or a combination of the above. The computer 10 may have a screen 23 and a keyboard 25 as well as other accessories and features common to commercially available computers at this time.

Other peripheral equipment may include a non-intelligent terminal 24 having a keyboard and display or other input device such as a "laptop" 26 computer or other handheld device that is adapted to enter the prescriptions and enter the instructions to operate the software. of the controlling computer. 5 Compound developers can be located in different areas in the health facility such as a hospital, or different floors of a hospital or even in different hospitals. The processors of compounds 12 and 14 as well as printer 18 and terminal 24 are located in hospital B in figure 1, while the rest of the equipment is located in hospital A.

Preferably a printer located near each compounding processor or combination of compounding agents, as shown, for printing labels that are applied to the prescribed mixtures that are made. The controlling computer 10 is preferably interconnected by a general computer of the hospital 28 that can be used to prepare and record the accounts among others 15 functions.

The present invention is adapted to control the processors of compounds such as the processors of compounds 12, 14 and 16. The presence of two machines in hospital B indicates that two different types of compounds are 20 may be used in combination to prepare prescription mixtures such as, for example, the aforementioned AUTOMIX and MICROMIX compositors. In this way, the processors of compounds 12 can be a compounding agent adapted to transfer high volume additives and the compounding agent 14 can be a compounding agent. 25 adapted for low volume additives. Moreover, the compound maker 16 can be adapted to transfer both high volume and low volume amounts of the ingredients.

Referring to Figure 2, a perspective view of a low flow module compound processor is illustrated and adapted to transfer small volumes of components such as micro-nutrients and other drugs from the individual source containers 30. However , the prescription mixtures can be prepared by a simple compound processor 16 adapted to transfer a high volume and a low volume of additives or multiply compound processors attached to a single final bag 46.

In an embodiment where high accuracy is desired such as when low volume additives are being added to a PN the fluids from the containers 30 are transferred through a separate single fluid conduit 32 to a simple intermediate container or funnel 34 which is suspended from a load cell assembly 36. The load cell assembly 36 weighs the total weight of the funnel 34 to develop an output signal, which indicates the amount of fluid in the funnel 36 at any time. The funnel 34 is closed and connected to a pressure conduit 38 which is connected to a pressure means and occlusion means such as a valve 40 for example. The pressure means is preferably a simple peristaltic pump that can selectively create positive and negative pressures in the funnel 34 to control the direction and flow of the fluid in and out of the funnel 34. The funnel 34 is also connected to an outlet conduit 42 that it extends to a second occlusion means 44 which is interposed between the funnel 34 and the final bag or container 46.

By selectively operating the occlusion means 40 and 44, and the pressure means, the fluid can be directed into the funnel and transferred out of it. These same portions of the machine can also control the flow direction, so that the fluid can be transferred into the final bag 46 and can be removed from the final bag for the purpose of rinsing the funnel 34.

A detailed operation of an example of a compounding processor adapted to transfer low volume components, at least as approximately as in April 1990, describes US Patent No. 5,228,485 which is transferred to the same assignee of the present invention, and is incorporated by specific reference here.

The current commercial MICROMIX compound processor can cover certain improved ones compared to the 485 patent, but is considered similar to that described in the patent.

The compound maker 12 may also include an assembly that transfers additives using other methods of operation, such as one or more pumping mechanisms and switching mechanisms alone or in combination with volumetric delivery methods, possibly including calibration such as devices of making compounds commercially available from BAXA Corporation of Englewood, Colorado.

Referring to Figure 3, an additional embodiment of a compound maker 50 is shown, which is particularly suitable for transferring large volumes of additives. The compound maker 50 includes a number of individual pump stations 52 that cooperate with a disposable transfer set 54 for pumping fluid from individual source vessels 56 to a final container 58. A detailed operation of an example • 5 of a compound maker adapted to transfer components in low volume, at least as approximately in 1999 is described in US Patent 4,712,590 and 5,927,349 which is transferred to the same assignee of the present invention, and is incorporated by specific reference herein. The current commercial AUTOMIX compound processor may comprise certain improvements compared to that of patents 485 and 349 but is believed similar to mk, that described in the patent.

PREPARATION OF THE PRESCRIPTION In one example of a process for using the preferred embodiment of the present invention, a physician or other health care provider or group of providers determines what the parental nutritional requirements of a patient are and arrives at a prescription. A pharmacist will need ^^ then convert the prescription into particular amounts or concentrations of 20 additives in the PN that will be administered to the patient. These amounts would vary depending on the particular patient. For example, the patient may not be able to accept a large amount of fluid parenterally, and the nutritional requirements will need to be achieved within a minimum amount of fluid. An example of 'a patient with restricted fluid is a neonatal patient. For By administering the desired amount of an additive in a smaller total volume, the level of concentration of the additive in the final bag 46 may be higher in the PN than without more than one volume of diluent could be used. This higher concentration can lead to a greater possibility of compatibility problems with other additives in the PN and may exceed acceptable limits for the patient. • Referring to Figure 3a in the preferred embodiment, the pharmacist enters the patient identification data such as the patient identification code within the controller using the keypad 25 (block 70). The controller 10 then requests and accepts the specific data of the patient 10 (block 72) of the data storage site such as a computer system f? 28 of the installation and displays such information on the screen 23. A type of patient-specific data that is preferably used by the controller 10 in the preferred embodiment is the type of patient such as premature, neonatal, pediatric, or adult etc. . In an alternative mode, the supplier 15 enters the patient-specific data directly into the controller 10 or to a storage site there.

The controller 10 also retains in a storage site preferred ranges for the acceptable concentration levels of the different mixtures. 20 of a final bag 46. In one embodiment, the controller 10 may also retain in the data storage site, the concentration ranges for the ingredients for various types of patients and establish the preferred concentration range with a dependent type range. for the particular patient. In additional modalities the ranges corresponding to such patient attributes 25 as various patient ages and weights can be retained at the data storage site and the controller 10 can establish the preferred concentration range with the specific attribute ranges.

In an additional mode, the controller may also contain a • 5 algorithm to adjust the concentration range depending on the specific predetermined factors of the patient such as the age of the patient.

In this way, depending on the patient-specific data, the controller 10 can evaluate whether the preferred ranges are suitable for the specific patient type 10 and can be adjusted to the range (block 74). ^ The health care provider will then enter the prescription (block 76) when using, for example, the keyboard 25. When entering the prescription, the supplier will adjust the concentration levels of the solutions of the 15 ingredients in such a way that when preparing the composition the PN will correspond to the prescription. The controller 10 will allow the prescription to be introduced in several different formats. By way of example, the controller 10 can accept inputs of the ingredients as a percentage of the final solution, concentration by • unit of volume or an amount corresponding to the weight per unit of the 20 patient.

As the supplier introduces the prescription, the controller 10 reviews the entered concentrations against determined ranges (block 78). If the concentration that is outside the range is entered, a message of 25 error on screen 23. In addition, if the supplier introduces an ingredient with an inappropriate format, an error or alarm message is displayed on the screen to alert the health care provider. An example of an inadequate format is one where the concentration is entered into units of measurement by the weight of the patient but the patient's weight has not been entered as part of the patient's specific data.

In an alternative embodiment, after all concentrations have been entered, the controller 10 can then review the various ingredients and highlight with error messages those ingredients that fall outside the range that has been established for that ingredient.

In an additional mode, prototypes of various prescriptions corresponding to various types of patient can be retained at the storage site. The pharmacist or controller 10 can then call the prototype and accept or adjust the prototype. In an additional mode, a prior prescription of the patient can be retained in a storage site. The pharmacist or controller 10 can then call the previous prescription and adjust or accept the previous prescription to be used as the present prescription.

When an alarm is displayed, even when the concentration is outside the range, the concentration can still be, according to the medical judgment of a supplier, the desired one. The controller 10 may then in certain predetermined cases allow the supplier to bypass the alarm (block 82). The controller 10 will allow the omission after the occurrence of one or a combination of certain factors. A factor is whether the supplier introduced the prescription has the accreditation to omit the particular alarm. Each alarm may require a different level of accreditation before the omission is accepted. Some alarms may not be omitted. • 5 The identity and level of accreditation of the supplier can be established through a unique key that is requested by the controller 10 and that is introduced at an appropriate time such as at the beginning of / the entry of the prescription or the occurrence of an alarm ( block 84). Other methods for establishing the identity of the provider are also contemplated such as key cards, retinal scanners or the like.

• In addition to establishing the supplier's accreditation to verify that the supplier is recognizing and appreciating the error message and for recording maintenance purposes. The controller 10 may require that the fundamental reason for the omission be entered into the note screen shown on the screen 23. For certain alarm situations, the controller 10 can not allow any omission to a with a fundamental reason (block 86). ).

COMPATIBILITY GROUPS 20 The preferred embodiment of the present invention evaluates the compatibilities of the ingredients and solutions within which the ingredients come into contact during the process of making the composition and also the solution in the final solution bag 46 after that the elaboration of the 25 composition.

In the present practice the evaluation of the final NP prepared is a process that is routinely developed by a pharmacist. Pharmacists compare the components of the final mixture prepared with the literature, which has information • related to compatibility. Many times, the literature is not specific enough with the exact type of ingredients in the mixture that are being prepared, which requires the pharmacist to use their professional judgment in deciding whether the resulting mixture will be compatible.

In accordance with the present invention, the total evaluation of the (B compatibility for complex mixtures is primarily focused on the preparation of parenteral nutrition compounds, which broadly includes determination of PN and determination of calcium phosphate solubility.

The process preferably involved a first step of determination when comparing all PN additives with the limits set by the controller 10 which may include the steps of establishing ranges of preferred concentration limits as described above. One, second stage • I involve comparing the final concentration of amino acids, dextrose and 20 lipid-based components with the database of the mixtures tested. The amino acid comparisons are specific to the brands. The databases of the mixtures have been compiled through the trials of the mixtures and also by using published literature. The database of the mixtures preferably comprises concentrations for both stable and unstable mixtures with 25 an annotation of the study conditions' such as time and temperature. Preferably the database includes mixtures having such identified source components, for example amino acids with brand name.

In the second stage, the prescribed mixture is compared with the databases of the mixtures. Preferably the comparison is first carried out against mixtures having identified source components. If the prescribed mixture falls within some range of a stable mixture the present invention proceeds to the next step without generating a note to the pharmacist. The range can be established by some amount of variation, for example by setting a percentage of the concentration level amounts of the corresponding basic components fl in a stable mixture.

However, the mixtures that marry (with stable and unstable houses mixed) with the unstable formulation contained in the database (with 15 preferably more or less at the established variation of the amounts of the base components) and have still passed the first stage of determination can be designated as potentially unstable.

• In one embodiment of the present invention, if the described mixture hunts with the unstable mixture, an additional step such as determining whether the married study conditions of the mixture are equivalent to the present conditions can be developed. The following invention provides a warning to pharmacists that the mixture is equivalent to a potentially unstable mixture under study conditions of that mixture. 25 23 In a further embodiment, mixtures that do not match any of the stable and unstable mixtures contained in the database are re-evaluated. When this is done, the amino acid mark is ignored and the mixture is then compared to the entire database. The results of this comparison are • 5 handle following the same stages that have been previously described. Preferably, the pharmacist will provide a warning about the ignorance of the amino acid label of the database mixture. If the mixture does not marry the database after the re-evaluation of the entire database, the present invention will provide a warning to the pharmacist that a similar PN has not been previously tested.

• With regard to the determination of the solubility of calcium phosphate, the solubility of calcium salts and phosphate salts in the same solution depends on many variables including but not limited to concentration, temperature, form of the salt, mixing order, pH, concentration of amino acids, other additives and time. It has been practiced in the prior art that pharmacists compare the final concentration of both the calcium salt and the phosphate salt with a solubility curve that is specific to a brand of • given amino acids and the final concentration. In the present invention the solubility of calcium phosphate which is determined in a complex compound manufacturing process is achieved by the controller 10 which compares the final concentration of both the calcium salt and the phosphate salt with a matrix of known compatibility. The matrix can be 25 enter within the storage site by the pharmacist or be entered 24 _t_j _ ^ _ ¡li_¡_mmmm_ previously to the database. The present invention uses the matrix to classify the compatibility by means of the amino acid labels and the final concentration. For example, a calcium phosphate solubility matrix for specific amino acid labels can have compatible concentrations of calcium salts and phosphate salts for 1%, 2% and 4% final amino acid concentration. The present invention determines the solubility limits that have been exceeded and will generate a warning to the pharmacist if he has one.

In a further embodiment, the controller 10 can generate and display over 10 the screen 25 a graph of a form representing the solubility of fl) calcium phosphate for a particular amino acid and may also present a prescribed mixture designation in relation to the form of solubility to assist the pharmacist in achieving the prescription that it's compatible. 15 However, in addition to the determination of whether the prescription present in the final bag is compatible. The compatibility during the process of the elaboration of composition must be evaluated. For example, the compatibilities of a solution with a second solution at the time of contact must be evaluated. The second fluid can be found as a common conduit, a 20 intermediate mixing chamber or final bag.

To solve this potential problem, the pharmacist can adapt general rules for compounding processes. For example it is common practice that all diluent volumes are added to the final bag first 25 in such a way that all the additives that are present in the final bag are diluted as much as possible at the time of the addition of an additional ingredient to the final bag. However, such a practice reduces the rinsing capacity of such diluent during the process of compounding.

• In accordance with an important aspect of the present invention, the controller computer 10 can utilize the known compatibilities of the components to enable the manufacture of concurrent compounds of such compatible components within the final bag or an intermediate mixing chamber. In addition, rinsing can be achieved with a source solution that is compatible with both 10 solutions that flow through the rinsed portion before and after f) rinsing. In this way, large volumes of additives can be transferred to the final container or bag or transferred to an intermediate mixing chamber while small volumes of additives are used as rinsing fluids. Such a determination of compatibility and elaboration of concurrent compounds gives the It is possible for the present invention to maximize the speed at which the mixtures are made which result in more efficient use of the compound developers, as well as the controller computer.

• In accordance with an important aspect of the present invention, the tests 20 of the components for the compatibility characteristics are used to construct a database that includes a plurality of groups, which represent concentration-dependent compatibility on the basis of tests of the components. For example, there are seven groups of components identified in Table 1 established below, based on current knowledge. It should be understood that many more groups of components can be defined to the extent that greater knowledge of the characteristics of the various ingredients is acquired, even to the point of having a group 1 for each individual component or even separate groups for them. components in different concentrations.

TABLE 1 Group Compatibility • fifteen • Compatibility groups can be known based on the 20 results and are contained in the databases of the controlling computer so that the compounding process can be carried out with the information in the database. It is preferred that the database is located only in the controlling computer, instead of being distributed in several places in such a way that it can be reliably controlled, managed and modified as knowledge and additional information that is gained during the history, continuous tests. , and the addition of other drugs and components to the database. In a preferred embodiment of the present invention, based on the database, the controller will logically group the fluids in source vessels 30 (Figure 2) into compatibility groups regardless of their physical location on one of • 5 the compound developers 12, 14, 16.

In a further embodiment of the present invention, the controller will calculate a particular prescription, the number of grams present and the choice of the groups in sets of compatibility groups between which rinsing is required in such a way as to minimize the total number of rinses.

• In yet another embodiment of the present invention the controller uses other inputs such as physical constraints of the system to determine the sequence of elaboration of suitable composition to use more efficiently the 15 source solutions while rinsing unlike the final bag rinses.

Examples of a physical restriction may include the volume of an intermediate chamber or funnel 34 and the volume of rinse for such a chamber. • In one example, the intermediate chamber has a funnel with a volume of 60 ml and a 30 ml rinse volume requirement. If the prescription requires 5 ml of, group 1, 20 ml of group 2; 20 ml of group 3; 55 ml of group 4 and 40 ml of group 6, controller 10 can adopt an order of elaboration of composition of group 1, group 2, group 3, group 6 and group 4 instead of a sequence 25 ascending.

By partially filling funnel 34 with groups 1, group 2, group 3, and 10 ml of group 6, then draining the partially filled funnel before the addition of the remainder of group 6, at least 30 ml of group 6 fluid are left. after the funnel 34 is filled first and the fluid of the group 6 can serve as a rinse • 5 removing in this way the need to rinse the final bag.

Other examples of choice of relationships and algorithms can be defined and implemented by the controller to achieve the wishes of users, such as locating the volume of a group to other compatible groups. 10 to reduce the drainage number of the chamber or funnel 34 that can be minimized.

In this respect and reiterating what was established above, by means of which seven separate groups are continued in table 1, it is expected that additional groups will be defined, which are based on more sophisticated knowledge and trials. The precise number of groups will eventually be a function of the sophistication of the compatibility knowledge vis-a-vis of all the components that are used, and it is contemplated that a significant number • Large of groups will be defined. This will lead the controlling computer to be able to more precisely control the stages of compounding which will result in an efficiency which is an increasing efficiency and speed of compounding. Additionally, the database can be considered as 25 owner to the extent that its sophistication was increased and the control of the database in the single site is a significant protection that would not be present if the database were distributed to a processor in each compound processor, for example . 5 COMPOSITE ELABORATION STRATEGIES In a further embodiment of the present invention the mixing strategy or method which recognizes the possibility of lipid mist and preferably uses minimal rinsings of the final bag is shown in Figures 4b-10 4h, which illustrates the preferred embodiment of a method of defining operation f) of at least one compounding agent to provide a mixture of nutritional formula. The start (block 100) of the method or process is shown in Figure 4b and occurs after the precipitations are introduced into the controlling computer. In an alternative embodiment of the present invention the prescription is initially determined by the controller 10 in one or more of the methods described above.

The next stage is to decide the strategy of elaboration of the compound (block 102) which is partly dependent on the class of the equipment for the elaboration of the compound which is present.

In this regard, and as previously mentioned, a hospital, another health care facility or pharmacy may have only one high flow module compound 12 processor (Figure 1) that is adapted to transfer high volume fluids. at a relatively high flow rate. However, in the event that the facility only has a low flow modulus composite processor, then it can transfer solutions at a low flow rate, which generally allows very small volumes or quantities of a component to be added. to a bag. Therefore, in instances where particularly high bound volume and compound volume down processors are used, the controller decides the strategy for making compounds (block 2) determining which strategy to use. The program is adapted to control either an index of High flow (block 104) which would control a high flow modulus composite processor eg a low lux index (block 106) and would control a low flow modulus composite processor, for example, or an index of high-flow downstream (block 108) which would result in both machines being used or for a simple compound processor 16 suitable for high-throughput transfers 15 volume and low volume, for example.

In relation initially to the high volume flow only, the controller develops calculations for the initial compound processor to assemble a processor of • high flow compounds only (block 104) comprising several calculations 20 that the program will execute for each large volume component that will be part of the final bag. This includes the calculation based on the specific gravity to convert the measurement of volume to weight measurement, if the transfer is carried out using the weight of a component that is transferred instead of the volume that is transferred. In this regard, a prescription can be described using 25 measures that are entered in grams or milliliters or a percentage of the final solution the program may be required to convert the measurements to weight if the 'compound' processors transfer in dependence on the captured weight of the transferred component. For example, a high-flux modulus 14 and low-flux modulus composite processors 12 make a compound that uses the weight or • 5 the weight change of an intermediate or final container.

After the calculations are made line 110 extends to Figure 4c where the determination is made as to whether the lipid-containing prescription should have the lipids transferred to the final bag first (block 112), which is the 10 conclusion of a user. In this regard, users may wish to have the lipids be the first or the last in the final bag, which is strictly an opinion that the user can specify. Such a specification is preferably based on the criteria that is initially constructed before the composite processor works in a facility. 15 This involves the choice of all additives within the compatibility groups such as the compatibility groups and this is done by grouping common compatibility components as shown in Table 1 above. Yes • the lipids are first transferred into the final bag, a determination is made of the number of 20 compatibility meta-groups, and the number of rinsings N that will be required (block 1 14) and then the program specifies a sequence of large transfers. volume with lipids first. Once the sequence is determined, then line 1 18 is extended to figure 4 from where the instructions for the operation of the compound maker are transferred to the compound processor (block 120).

Alternatively, the controller 10 can transfer the fluids using other user conclusions that include conclusions that reflect the general rule of the TPN mix (block 116,124). In relation to the general rules of the total parenteral nutrient mixture, they include the following: • 5 1. Phosphate salts are added before the calcium salts. 2. The determination of calcium phosphate solubility should be made based on the volume of the solution in the TPN bag at the time the calcium is added. 3. Unless lipids are required as the final additive, calcium should always be the last additive in the TPN bag. Keeping fl out a rinse if possible. 4. Compatibility groups are listed sequentially to match the mix order unless specific exceptions are identified. If the compound processor 14 has separate conduits for the final bag for each of the source solutions of the controller 10, it establishes the pumping order to ensure that the fluid added to the final bag, the determination • Primary of the order of pumping is the compatibility of the fluid that enters the bag 20 with the fluid present in the bag.

Returning to FIG. 4c, if the lipids are not first in the final bag, the number of compatibility groups is also determined, such as the number of rinses required (block 122) and the sequence of transfers and rinses with Lipids at the end are determined using one or more of the methods of making compounds that are run and the final step shown by line 126 extending to Figure 4d results in the transfer of instructions that is sent to the compound processor (block 120). • 5 Switching now to the low flow only path that starts with the calculations for the preparation of low flow start compounds (block 106), this would be used for compounding compounding prescriptions that would be made with a flow module with a low flow modulus composite processor, for example. Even so, it is likely that a high-flow compound 10 manufacturing apparatus would exist in the same area, it is common to choose the low flow compound processor if the volume to be added to the final bag is relatively low, as would be the case. for a neonatal prescription or for a very small infusion.

An initial determination is made of whether the final bag already contains lipids (block 130). The reason why this determination is made is that there may be a precipitation that is generated in two stages with high volume flow components that have already been transferred to a bag and the bag is then placed in a • low flow module to transfer micro nutrients to it. If the lipids are already 20 in the bag, which will make a difference in how the final bag rinses are made inside the funnel or intermediate mixing chamber which may be present in a low flow module composite processor.

The program determines from the description whether there are lipids contained in the bag 25 and if so, the complete mixture prescription is checked to determine if the lipids are or will be in the final bag. If they are, a question is asked whether the user cares if there are traces of lipids in the next mixing prescription (block 132). This is due to the fact that if any rinse is developed using fluid in the final bag some of the lipids will be back in the funnel. • 5 These lipids can be transferred to a number of the following bags and in an amount sufficient to produce a visible trace in the solution. If the present bag is made with lipids and the next bag has no lipids and there are no rinses on the surfaces that will come into contact with the contents of both bags, then there is a possibility that the lipids contaminate the bag 10 below, particularly if the previous bag uses a final rinse of the bag. In the event that the installation does not want correlation with lipids, then the compound will not be prepared at that time but will remain in the queue to be elaborated at another time (block 134). If the hospital accepts traces of lipids, then a warning is printed by the printer or by an item Visual that indicates that there is a possibility that there is contamination with lipid in the funnel (block 136).

If the final bag does not contain lipids (block 130), or if they do not contain 20 lipids but lipid contamination is not of interest (block 136), then the solubility and compatibility tables are used and the compound is calculated with the mind in mind that the rinse will be from the final bag (block 138) The stage attempts to develop calculations that are designed to minimize the number of rinses to maximize efficiency and could use one of the methods described above. When this is done, line 140 extends to Figure 4d and transfer instructions to the compound processor are then sent to the composite processor (block 142).

Now changing to the high and low flow branch shown in Figure 4b, the • Initial step 5 is to start the composite processing assembly (block 108) which requires the conversion of calculations to be carried out that have been described with respect to the high flow only routine (block 104) and line 144 extends to Figure 4c, where the number of compatibility and rinsing groups is determined (block 146). Basically, it is a determination of whether there is a problem with the prescription if it is elaborated in the way it is written.

• The determination is made as if lipids were included in the final bag (block 152). If lipids are required, a determination is made whether lipids should be transferred first, at the end or otherwise optimized (block 154). If they are required 15 the first, end or optimized lipids is the preference of the user that is programmed in the sense that the user defines this once and is not, therefore, dependent on the prescription. Optimization usually means always that the lipids would be located first. In this way, the criteria for preparing • compounds that are established by the user will initially determine the path 20 of the stages followed. If they are first optimized, then line 156 extends to Figure 4d and Figure 4c to the stage that will be described later. If the lipids are not included in the final bag, then line 158 extends to Figures 4d and 4e for steps that will be described later. If lipids are required at the end, then line 160 extends to Figure 4 and determination is made of whether the prescription is stable without the lipid volume (block 162).

If the prescription is not stable without the volume of lipids then the program alerts the user that the prescription can not be elaborated if the lipids are at the end and that a pharmacist's review may be required (block 164). The program then determines whether lipids can be transferred first within the final bag (block 166), which does not result in the compound not being prepared (block 168). If the lipids can be transferred first, then line 170 extends to Figure 3b where the number of rinses including the volume of lipids and lipids will be transferred to the final bag first (block 172). 10 fl Returning to block 162 if the prescription is stable without including the volume of lipids, then the program calculates all the solubilities that include the volume of lipids and the lipids will be transferred to the final bag of last (block 174) (figure 4d) . The calculation of the solubilities does not include the volume of lipids 15 (block 174) which is made to calculate the solubility of calcium phosphate based on a volume possibly lower than that which was included in the original determination. Therefore, for example, if there were 50 milliliters of lipids in a PN of total volume of 200 milliliters, then the evaluation of the phosphate solubility • Calcium would be made over 150 milliliters. After the compatibility and rinsing groupings have been calculated (blocks 172 and 174) the program then determines whether the total volume excluding lipids is more than the volume of the funnel (block 176), if so, line 178 is extends to figure 4f where the program determines whether the lipids are 25 first (block 180) which if true, results in the program determining whether the number of rinsings of a base source rinse can be maintained for a rinse in an acceptable sequence (block 182). If you can, the program breaks into accounting groups and proceeds with the elaboration of compounds with the required rinses coming from the source container. • 5 selected (block 184) and the instructions are transferred to the compound processor (block 186). As described above, the steps described in blocks 182 and 184, while being identified as separate steps in the flowchart, are actually interrelated. This is because the number of rinses is a function of the compatibility groups and the compatibility groups must be determined in order to identify which rinses should occur as described above.

If the total volume excluding the lipids is not greater than the volume of the funnel, then the completion of the elaboration of the compound is done using the low flow module and can be done in the funnel of the compound processor of the low flow module .

• The program determines whether a source rinsing volume of a component solution 20 can be retained for final rinsing (block 188) if so, this results in retention when the rinsing volume source of a base component and all the ingredients are made in the funnel and transferred to the final bag in the funnel which is then rinsed with a reserve base (block 190) with the rinse transferred to the final bag and the transfer instructions are sent to the compound processor ( block 192).

In order to determine if the source rinse volume can be retained, it is necessary to determine the fluid present during mixing in the funnel without the dilution effect of the rinse to see if it is permissible to remove something, ie if the resulting mixture will be stable. Also, the capacity of the funnel is important in relation to the volume that can be removed to make a complete rinse. For example, if the capacity of the funnel is 50 milliliters and only 30 milliliters can be retained, then there will not be a full funnel rinse and the decision of whether this is appropriate or not should be done by the user. It is also contemplated that the rinsing method will have to see the final rinse originated from a source component such as sterile water dextrose or amino acids and that fl | Intermediate rinses can be made using a solution of the final bag with the front rinsing of a component volume that is retained for final rinsing in such a way that the funnel can be cleaned as much as possible. 15 If there is not a sufficient source rinse volume program, the program determines whether the amount of source rinse volume can be retained for the final rinse (block 194) if so, that is done and all the ingredients are processed in the funnel and rinse with the reserve base (block 196). The • Transfer instructions are then sent to the compound processor 20 (block 198).

If there is not a quantity of source that can be retained for the final report, all the ingredients are then processed in the funnel without any rinsing (block 200) and the instructions are sent to the compound processor (block 25 202). 39 _ _i_M _? _ _? It should be appreciated that block 152 and the answer is that there are no lipids in the final bag, then the path through the flow chart assumes that the total volume is in excess of the volume of the funnel that results from the determination of whether the lipids they are first in block 180 which is not really applicable because • Lipids are not present. In this case, steps 182 and 184 can be carried out with the source rinse of the source container and / or the final bag. As described above the controller will preferably use rinsing and composition sequence which eliminates the need for rinsing of the final bag. 10 Returning to block 204, if the answer is no, or if the mixture contains lipids, the lipids must be transferred first and a final bag rinse is required (block 182) the program determines whether the lipids can be transferred from last (block 206) which if not, the program will ask if lipid traces are acceptable (block 208), which if not, results in the The preparation of the compound should not continue (block 210). If it is acceptable, the program produces a warning about the lipid counter-relationship (block 212).

If the lipids can be transferred last, then the program 20 determines whether the source rinse number can be maintained for a rinse and an acceptable sequence can be carried out with a rinse that originates from the final bag (block 214). If it is possible, then the prescription is analyzed for the compatibility groups and the elaboration of the compound will continue with the rinses presenting itself at the appropriate moments with preferably the 25 following the last rinse making the final bag with all the others 40 _? _ ^ _ t_ _t_4_m from the source components (block 216). In this way when rinsing with the contents of the final bag, the ingredients present in the final bag will be diluted as much as possible while allowing a rinse of the final source container. The instructions are transferred to the compounding processor (block 218).

If the answer of block 214 is no, idea 220 extending to Figure 4 will result in the program determining whether the number of rinses minus 2 (N2) times the rinsing of the source component can be maintained for 10 a rinse in an acceptable sequence with two rinsings from the final bag fl) being determined (block 222). If so, then the compatibility group stage is executed again (block 224) if the instructions to the computer are issued (block 226). If not, another determination is made of the number of rinses minus 3 (N-3) (block 228), with compatibility analysis if so. 15 (block 230) and transfer instructions are sent to the compound processor (block 232). If not, the determination is made in relation to N-4 (block 234). If the determination of block 234 is yes, the compatibility analysis is again conducted (block 236) and the instructions are transferred to the processor. • compound (block 238). If the determination is not on line 240, the program 20 then determines if the source rinse can be maintained for the final rinse (block 242) if so, this results in the once again carried out compatibility analysis (block 244) and compounding instructions they are issued (block 246). If not, the program determines if any quantity of source solution can be extracted to achieve the required volume excluding the lipids below the volume of the funnel (block 248). If the answer is yes, then the appropriate volume is retained and the ingredients are processed in the funnel and the maintained base component is used to rinse the funnel (block 250) and the transfer instuctions are emitted to the compound processor (block 252) . If not, the program determines if the lipids are in the prescription (block 254), otherwise, it results in the program making the compound with all the rinses that originate from the final bag (block 256) and the instmctions are issued for the compound processor (block 258) but if the lipids are present, the program determines whether care should be taken with lipid contamination (block 258). If not, a warning is issued (block 260) and if so the compound will not be prepared (block 262). After issuing the warning, the compounding is generated with all the rinses from the final bag (block 256) which results in transfers of instructions being sent to the compound processor (block 258).

By sending the instruments to the compound developer (block 192, 186 etc.) the compound developer and the controller can use various methods and adaptations to develop the preparation of compounds. For example, the controller 10 may send instructions to the included controller as a part of the compound processor 12, 14, 16 or the controller may directly operate the compound processor or any combination or similar method.

In addition to the strategies of the compound maker that are carried out in the manner described in relation to the flowcharts of Figures 4a to 4h, there are other functionalities that are carried out by the present invention. In this regard, the computer controller 10 is adapted to examine the composition of each prescription mixture that is present in a queue of such prescription mixture for which the instructions are sent to the computer that will prepare the mixture. By examining the components of each mixture of • prescription in the queue for, determining those mixtures that contain lipids, for example, those mixtures that do not contain lipids can be grouped together so that the contamination of lipids is not a concern until the last mixture containing lipid 10 As described in U.S. Patent No. 4,653,010 the mixtures of ^ P prescription residing in the queues can be chosen and grouped around common components. In one embodiment of the invention other desired groupings of the mixtures such as by type of patient can be determined in a similar manner. Such rearrangement of the prescription mixtures in the glue 15 can have the effect of increasing the efficiency due to the needs and requirements of the installation.

• Another important aspect of the present invention involves the ability of the computer 10 to adjust to a defined user the volume of overfill by increasing the volume of each of the components is layers to be added to the prescription mixture by a predetermined amount to achieve an equal prescription mix but a slightly larger volume, and thus compensate for the volume that is required to initiate an administrator game or address precision concerns.

When the prescription requires extremely small concentrations of a mixture in such a way that the correct amount of the component in the desired concentration will in fact be supplied to the patient.

• Still another important aspect of the present invention involves the ability of the ordinate 10 to receive a switchable user option, which when activated, enables a higher diluted concentration ingredient to be substituted for an ingredient of lower prescribed concentration. In many instances where the patient is not constrained by the fluid that dilutes a concentration solution The larger one with a compatible rinse solution such as sterile water will produce the prescribed mixture with the minimum amount of potential instability. In a further embodiment of the present invention, particularly when the patient is constrained by fluid, the stability of the mixture by eliminating or minimizing the dilution solution when considering other ingredients as diluting fluids is 15 determines by the controller 10 that he can employ one of the methods described above to determine the stability during and after processing of the composition.

In a further embodiment of the method of the present invention, a compounding strategy for the overfill of the final bag 46 must be developed. As previously described, overfilling may be desired to compensate for the amount of mixture, which is not to be administered due to the delivery system. For example, some portion of the solution can be retained in the 25 final bag even after administration. 44 __ ^ _ _j¡_i _i__ By maintaining with an aspect of the present invention, the desired overfill setup method can be particularly configured. By way of example of volume of overfill can be set in absolute quantities, by a percentage or so that the final bag has a desired volume • 5 specific. In preparing such a prescription, the method calculates the new quantities of ingredients required to achieve a mixture substantially equivalent to the prescribed mixture but at a slightly higher volume.

By determining the appropriate ingredient amounts of the ingredients, the controller 10 can review the resulting mixture against the various criteria to determine whether the resulting mixture can be administered. For example, for a patient with fluid restriction, overfilling can generate a mixture with an amount of fluid in excess of the allowable amount. An alarm can be generated and an error message can be displayed to the user. fifteen In a further embodiment, the controller 10 can adjust or suggest adjusting the volume of the mixture to avoid having one or more of the ingredients in the mixture. • an amount less than the predetermined level such as that corresponding to a The minimum suggested amount of precision for the compound processor 12, 14, 16. By way of example, the amount of a component can be 90% of the suggested minimum amount. The controller can then increase the total volume of the mixture in such a way that the amount of component reaches the minimum suggested amount and indicate to the user that only a portion of the resulting mixture is going to 25 administer to the patient.

It should be understood that the arrangement of the stages in the various preferred embodiments of the present invention can be altered. For example, the stability of the final mixture can be determined before or after the determination of the strategy for the preparation of the own compound. • REPORT The compound processor 12, 14 and 16 can communicate with the controller 10 during and after the compounding process. By For example, if a pick-up device such as that described in U.S. Patent No. 5,927,349, which is incorporated by reference herein, detects an incorrect source solution flowing through one of the ducts 32, an alarm may be reported. Similarly, during and after the evaluation of the compound the exact amounts of the ingredients transferred to 15 the final bag 46 can be transmitted to the controller 10.

Upon receipt of the quantities of the ingredients transferred during compounding, the controller 10 can present cost data to the • Pharmacist or communicate such data to the hospital's computer system 28. The 20 controller 10 can adjust the cost data to reflect the current costs of providing the mix. By way of example, some ingredients can measure in containers that can only be accessed once before discarding. Thus if such an ingredient is used in a smaller quantity than that found in the container, the controller 10 will indicate the costs of the complete container in 25 opposite that portion of the ingredient used in the mixture. 46 _é_ii -? ^^ ^? U_ From the foregoing, it should be appreciated that an improved method and apparatus for controlling the preparation of parenteral mixtures has been described, which resulted in a more rapid and efficient preparation thereof without sacrificing security in any way. Moreover, several of the features provide added security elements. The present invention employs extensive analysis of the blending components and utilizes known features of the components in a novel way to control the compound developers such that the prescription blends can be reliably and safely prepared without violating known rules of preparation, but also in a manner consistent with certain preferences defined by the user.

While various embodiments of the present invention have been shown and written, it should be understood that other modifications, substitutions and alternatives will be apparent to the skilled person.

Claims (30)

1. CLAIMS 1. Apparatus for use in the control of operation of at least one pharmaceutical compound processor adapted to transfer • selectively select prescribed amounts of pharmaceutical components from individual source containers through hollow, elongated transfer media to a final container for the purpose of preparing a prescription mixture, said apparatus comprising: 10 Computing means having memory means for storing instructions for operating the apparatuses and for controlling the compound processors for preparing a prescribed mixture, said memory means include data related to a plurality of pharmaceutical components that can be transferred 15 for preparing the prescription mixture, and data related to the operating characteristics of at least one of the compound developers that the apparatus is adapted to control; • Said computing means include at least one communication port to establish a communication link with each elaborate of the compound to be controlled; Said computing means are adapted to receive a prescription mixture, to identify the pharmaceutical components of these, Determine the compatibility of the pharmaceutical components with respect to each other, determine the order in which the components are transferred when preparing the prescription mixture, and communicate the instructions for preparing the prescription mixture to the component developers who will be used in the • 5 preparation of the prescription mixture. 2. Apparatus defined according to claim 1 wherein said counting means is adapted to convert the amount of component to a measure in which the compounding agent that 10 going to prepare the prescription mix is able to transfer. • Apparatus defined in claim 2 wherein said computing means is adapted to convert quantities of volume of component established in a prescription mixture to a measure of weight to 15 multiply the specific gravity of the component by the volume established in the prescription mixture. 4. Apparatus as defined in claim 1 wherein said Data relating a plurality of pharmaceutical components comprises a database having a plurality of compatibility groups, having with each group at least one of said pharmaceutical components, said database also having data specifying compatibility and / or incompatibility. of every 25 group with respect to other groups. Apparatus as defined in claim 4 wherein at least a first of said compatibility clips comprises components that include lipids, and a second of said compatibility groups comprises a component that is sterile water. Apparatus as defined in claim 4 wherein said computing means determine the order in which the components are transferred in such a way that the order is in accordance with a set of general mixing order rules, whose general rules comprise: Phosphate salts are added before calcium salts; The solubility of calcium phosphate is made based on the volume of the solution in the prescription mixture at the time the calcium is added; and Calcium is the ultimate additive to the prescription mix. Apparatus as defined in claim 6 wherein said computing means determines the number and sites of rinsings to be during the order of transferring the components, with a rinse a cleaning of at least a portion of the means of Transfer elongated hollows to the final container with a solution that is compatible with the next achieved component that will be transferred to the final container. 8. Apparatus as set forth in claim 6 wherein said cleaning solution is taken from one of the individual source containers or the final container. 9. Apparatus as defined in claim 4 wherein said computing means includes at least one port for receiving input data to select whether a pharmaceutical component including lipids will determine the order of transfer in such a way that the component containing the Lipid is transferred either any one first or last in relation to all the other pharmaceutical components. 10. Apparatus as defined in claim 1 wherein said communication link may be comprised of at least one of an Internet connection, a local area network connection and a wireless connection. 11. Apparatus as defined in claim 1 wherein said apparatus is adapted to be used by users in at least two sites, wherein each site may have at least one composite processor, and a printer to print labels, a terminal with screen and an input device for inputting selectable prescription and set mixtures that are related to the operation of the apparatus and the composite processors. 51 - * - ** - - * 12. Apparatus as defined in claim 11 wherein said counting means is adapted to control two compound developers at each site, with a compound processor being adapted to transfer components at a flow rate that is • 5 significantly greater than the other compound processor. 13. Apparatus as defined in claim 9 wherein said computing means is adapted to examine the prescription mixture and determine whether the lipid components are part of 10 these, determine if the user objects to the prescription mix • Subsequent to be prepared having a probable bmmosa appearance due to the presence of a lipid component in the prescription mixture that is currently being prepared, finish the preparation of the prescription mixture in the event of 15 that the user indicates an objection avoids a warning of such probable bmma in the event that the user does not indicate objection. • 14. An apparatus as defined in claim 9 wherein said counting means is adapted to receive a plurality of prescription mixtures and arranged in a preparation queue, many computing means are adapted to examine each prescription mixture that is in the queue and determine the common part of the predetermined components there, and to reorder the prescription mixtures in said queue to group together said prescription mixtures having such common elements of the predetermined components. 15. Apparatus as defined in claim 1 wherein said • 5 means of computation are adapted to receive data that relate to a profile of the patient for whom the prescription mixture is being prepared in which the patient's profile data include at least the patient's name, age, and weight, said computing means are adapted to receive data that are related 10 with a plurality of categories of patients, with each category • containing predetermined mixing limits of components that are specific to each category, said computing means are adapted to compare the amounts of components in a prescription mixture for a patient in one of said categories and 15 provide a signal when a component is outside the predetermined limits for said components in the prescription mixture. 16. Apparatus as defined in claim 15 wherein said 20 categories of patients comprise adult, pediatric, neonatal, and preterm patients. 17. Apparatus as defined in claim 15 wherein said signal is adapted to prevent the mixture from being prepared 25 prescription. 53 - "* A Apparatus as defined in claim 15 wherein said patient profile data further includes a history of the patient's weight and mixing prescriptions over a period of time, said processing means being adapted to prepare a related report with the patient, which includes a prediction of the patient's weight at some time in the future. Apparatus as defined in claim 1 wherein said counting means is adapted to receive data related to a patient profile for which the prescription mixture is to be prepared wherein the patient profile data includes at least the patient's name , age, and weight, said computing means are adapted to receive data related to the limits of the amounts of, the mixing components -which can be added to a particular prescription mixture of a patient, said computing means are adapted for compare the amounts of components in a prescription mixture for a patient and require an authoritative entry of data that explains the fundamental reasons for exceeding one or more of such limits. Apparatus as defined in claim 19 wherein the authorized entry of data is the entry of data for at least one physician or a pharmacist. 21. Apparatus as defined in claim 19 wherein an absence of required data that explains the rationale for exceeding one or more of such limits results in said computing means completing the preparation of said prescription of • 5 mixture. 22. Apparatus as defined in claim 1 wherein said memory means includes data relating the amount of fluid required to initiate, the compounding from 10 a container source through the transfer means • elongated holes to the final container, said processing means are adapted to increase the amount of a component by the amount that is required to start the compound processor. 23. Apparatus as defined in claim 1 wherein said processing means is adapted to receive a switchable input that is related to the preparation of a mixing prescription that requires a first component in an amount 20, a quantity of diluent for said first component and one or more additional components in relatively small amounts, wherein the total mixing prescription is to be a total predetermined amount, said computing means being adapted to utilize the volume of said one or more components Additional 25 in relatively small amounts as a substitute for the same volume of diluent such that the total predetermined amount is not exceeded. 24. A method for contracting the operation of at least one pharmaceutical compounding processor adapted to selectively transfer prescribed amounts of pharmaceutical components from containers from individual sources through hollow and elongated transfer means to a final container for the purpose of. prepare a prescription mixture the method uses a computer means that have 10 a means of memories, to store instructions to operate • the apparatus and for controlling the processors of compounds for preparing a prescribed mixture, with the memory means including data relating a plurality of pharmaceutical components that can be transferred to prepare the mixture of 15 prescription, and data that relate to the operating characteristics of at least one of the compounding processors to which the apparatus is adapted to control, the means of computation include at least one communication port to establish a • Communication link with each compounding processor that goes To be controlled, the method comprises the steps of: Receive a prescription mix in the computer media; Identify and determine the quantities of pharmaceutical components of the prescription mixture; 25 56 - "- * -" - ^ - ^^ ** Determine the compatibility of the pharmaceutical components with respect to each other; Determine the order in which the components will be transferred during the preparation of the prescription mixture; • Communicate the instructions for the preparation of the prescription mixture at least one compounding agent to be used in the preparation of the prescription mixture. 25. A method as defined in claim 24 wherein the 10 stage of identifying and determining the quantities includes the stage of ^ ß convert the quantity of each component to a measure in which the compounding agent who is going to prepare the mixing prescription is able to transfer. 26. A method as defined in claim 24 wherein the data relating to a plurality of pharmaceutical components comprises a database of pharmaceutical components that are characterized in a plurality of groups, % with the components of each group having a characteristic of In the case of common compatibility, said database has data that specify the compatibility and / or incompatibility of each group with respect to other groups, said compatibility determines the additional stage that comprises: 25 Examine the mixture prescription to identify the particular groups of components that are present there, and the compatibility characteristics of each group in relation to the other groups identified. • 27. A method as defined in claim 24 wherein said order determining the additional step comprises: Determine the order of mixing in such a way that the components within the groups that are compatible with each other are added concurrently or sequentially to the final container consistent with known general rules of 10 mix. 28. A method as defined in claim 27 wherein said general mixing rules comprise: Adding phosphate salts before the calcium salts; 15 Base the solubility of calcium phosphate on the volume of solution in the prescription mixture at the time the calcium is added; and Add the calcium at the end to the mixture, of prescription. 28. A method as defined in claim 26 wherein said order determining step further comprises determining the order of the mixture by means of which the components within the groups that are compatible with each other are added sequentially to the final container, in such a way that the rinse number is minimized, the rinses are made to clean the hollow transfer media near the container-end due to 58 ßSaii BÍÍiaaaÉka the incompatibility of a component of a group in relation to a component in another group that is then in order to be transferred. • 29. A method as defined in claim 24 wherein said step of identifying and determining the amounts of the pharmaceutical components further comprises identifying lipids as a component of the prescription mixture, and providing the user with the option to complete the preparation. of the prescription mixture if the user so chooses it. 30. A method as defined in claim 30 wherein an element warning is issued that the prescription mixture containing lipids is not finished, whose warning is that 15 that the next prescription mixture when prepared may exhibit a hazy appearance due to the presence of lipids. • twenty 25 59 Al ^ rttflÉH