Patent Publication Number: US-6209921-B1

Title: System and method for quality assurance in animal medicine delivery

Description:
FIELD OF THE INVENTION 
     The present invention relates to systems and methods for quality control in the administration of medicines to animals. More particularly, families of medicines are associated with a selected corresponding color. Containers containing medicines from the families of medicines are then marked with their selected corresponding color for ease of identification. 
     BACKGROUND 
     Occasional errors in the administration of medicines to animals such as cattle and hogs have historically been considered by the agri-business industry to be an inevitability. Such errors (including variations) most often fall into one of two categories: (a) the administration of improper medicines; or (b) the administration of proper medicines in improper amounts. These errors and variations are almost always attributable to either human error or the mechanical failure of the devices used to deliver the medicines. For some errors and variations, the consequences to the health of the animal and the ultimate safety of the food products produced by the animal are minor. In other cases, the consequences can be costly and catastrophic. 
     Recently, numerous advances have been made in the mechanical devices used to deliver medicines to animals, with a view toward reducing such errors and variations. Notably, the Marking Syringe of U.S. Pat. No. 5,961,494 has revolutionized both the efficiency of the actual medicine delivery and the reliability of marking the occurrence and location of medicine delivery to the subject animal. While the failure to mark an injected animal (or marking a non-injected animal) has been recognized as a human-introduced “weak link” in the integrity of animal medicine delivery systems which results in administration of improper amounts of medicine, this problem is solved with implementation of the Marking Syringe taught in the &#39;494 patent. Nonetheless, other, more problematic human-introduced “weak links” in animal medicine delivery systems persist. 
     Specifically, overworked and often undertrained farmhands can be counted on to occasionally confuse the complex medical names for the numerous array of animal vaccines and medicines and, as a result, apply the wrong medicine to the wrong animal at the wrong time. Such confusion carries a high cost. 
     Animal medications, such as vaccines, are generally provided in clear or translucent plastic or glass bottles of a standard, generic shape. The contents of the bottles are noted on labels affixed to the outside of the bottle. The bottles are initially sealed by insertion of a rubber stopper in the opening (throat or neck) of the bottle. A metallic “cap” is then placed over the opening in the bottle to retain the stopper in place and provide a safety seal to indicate whether the bottle has been opened or otherwise tampered with after being filled by the manufacturer. As mentioned, the bottles all have basically the same shape and non-descriptive color. The rubber stoppers are usually a generic color such as orange-red (though they are occasionally black or grey), and the caps are usually silver. Because most medicines have no distinguishing coloration of their own, the labels on the bottle are normally the sole means of visual determination of bottle contents. As such, the person retrieving bottles of medicine from a storage cooler or a refrigerator must make an accurate reading of the name of the medicine indicated on the label in order for the proper medicine to be administered to the animals. 
     With most animals, basic medicines given the animals can be divided into a limited number of general groups. In the case of cattle, which will hereafter be used as an example, the major types of medicines given fall into the general families of upper respiratory, clostridial, venereal/reproductive, antibacterial and antibiotic. 
     The administration of a medicine from an improper medicine family may carry grave consequences for the animal, costly consequences for the producer, and unknown consequences for the consumer. For example, the RB-51 vaccine is designed to ameliorate the effects of infection by the brucellosis virus and, thereby prevent unwanted abortion in female animals. As with many animal vaccines, the RB-51 vaccine is a “modified live virus” vaccine, meaning that a small amount of the living virus (in a highly attenuated form) is contained in the vaccine. When the vaccine is administered to the animal, the animal&#39;s immune system attacks and destroys the attenuated living virus. During this process, the animal normally develops sufficient immunity to the virus to avoid contracting the virus from outside sources. 
     This particular vaccine (RB-51) is specifically designed for application to female animals. Because this vaccine is only applied to female animals, subsequent tests of these animals will often reveal low levels of the brucellosis virus. At that time, the cattleman can check the medical history of the animal to verify that RB-51 was administered. If so, and if the administration was within sufficiently close time proximity to explain the corresponding brucellosis level detected in the animal, the test result is “normal” and operations continue. 
     If this vaccine is given to a male animal by mistake, detection of the brucellosis virus in the animal will cause deep concern and drastic measures on the part of the cattleman. There is presently no easy way to determine that the brucellosis was introduced by an accidental injection of the RB-51 vaccine. Instead, the cattleman must assume the possibility of an outbreak of brucellosis among the herd and take immediate remedial measures, at a significant cost in terms of dollars and time. Furthermore, if a group of male animals mistakenly received the RB-51 vaccine instead of a different scheduled medication, the animals have not received all of the medications they were expected to receive, possibly exposing them to other risks. Even if the mistake is detected after injection, the animals will then likely be injected with the originally intended medication, resulting in increased (and highly undesirable) levels of pharmacological residue is the derivative food products. 
     It is entirely possible that a male animal improperly injected with RB-51 may be destroyed, as a consequence of the above-referenced issues. Losing one animal to such a mistake is not good, but the reality of farm operations is such that any such mistake would be multiplied many times over. Specifically, one bottle of RB-51 vaccine, like most other vaccines and medicines, provides a sufficient quantity to inject at least 50, and maybe as many as 150 animals. Thus, a single error in setting up an injection system with an improper vaccine could mean necessary destruction of many dozens of head of cattle. The economic impact of such an error could be catastrophic in both the short term and long term. 
     Accordingly, there is an acute need for a system and method which will reduce or eliminate accidental administration of improper medicines to animals. 
     SUMMARY OF THE INVENTION 
     A system and corresponding method for quality control in the administration of medicines to animals satisfies the foregoing need by identifying a particular group of animals for application of the principles of the present invention. Thereafter, families of medicines which are commonly given to the group of animals are identified. A plurality of different colors are selected for association with the families of medicines, then each family of medicines is associated with a single selected color from among the plurality of colors. The system and corresponding method of the present invention are completed when the containers containing medicines belonging to a particular family of medicines are marked in such a way as to make visually conspicuous the color coordinated association between the contents of the medicine bottle and to the family of medicines to which the medicine belongs. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 depicts an exemplary system for grouping and marking animal medications in accordance with a preferred embodiment of the present invention. 
     FIGS. 2 a  and  2   b  depict the implementation of an exemplary embodiment of the system of the present invention. 
    
    
     DETAILED DESCRIPTION 
     FIG. 1 depicts an exemplary system for grouping and marking animal medications in accordance with a preferred embodiment of the present invention. 
     At the outset, it will be understood and appreciated that the objectives satisfied by the present invention are equally applicable to a wide variety of animal species, including cattle, hogs, and even humans. Furthermore, the principles of the present invention may apply to groups of animals such as combined multiple species or defined subsets of a single species. For simplicity of illustration and avoidance of unnecessary redundancy, illustrative representations made hereafter will relate to cattle only. 
     Referring now to FIG. 1, medicine families such as medicine family A  10  and medicine family B  50  are identified from among the vast numbers of different medicines available for administration to cattle. Importantly, medicine families such as medicine family A  10  and medicine family B  50  comprise different families of medicines. Examples of possible different medicine families relating to the cattle industry include upper respiratory, clostridial, venereal/reproductive, antibacterial, and antibiotic. In the depicted scheme, all medicines fitting within one of the medicine families identified for a species, such as clostridials, for example, are categorized in a single medicine family such as medicine family A  10  or medicine family B  50 . 
     In the depiction of FIG. 1, medicine family A  10  comprises three different medicines, medicine A 1   12 , medicine A 2   14 , and medicine A 3   16 . For simplicity of illustration, only three medicines are shown in medicine family A  10 , though it is understood and appreciated that any particular medicine family may include a much greater number of currently existing and later developed medicines which meet the criteria for inclusion in a particular medicine family. 
     When grouping medicines into a medicine family such as medicine family A  10 , medicines included in a given medicine family may be the same medicines manufactured by different manufacturers and, thus, having slightly different characteristics. Other medicines which may be included in the same medicine group include different medicines formulated to resolve similar medical problems. In the example of medicines in the clostridial medicine family, for example, a variety of medicines currently exist which would be included in such a medicine family, to include 4-way black leg, 7-way black leg, 8-way black leg, and others. Even though each of these medicines are different, they all may be included in the so-called “clostridial” medicine group. 
     After a group of medicines has been grouped into a particular medicine family such as medicine family A  10 , a distinguishing color is identified and associated with medicine family A  10 . In the depicted example, the color blue is pseudo-arbitrarily selected. The selection of a color is pseudo-arbitrary in that the color should be a color not already selected for association with another medicine family, and the color should not be the reddish-orange (or occasionally black or grey) colors historically used for sealing containers of all different medicine varieties. Apart from these considerations, the color selection is arbitrary. 
     Importantly, after selection of a color for association with a family of medicines such as the color blue with medicine family A  10 , a colored sealing stopper  20  of the color associated with medicine family A  10  is produced in a well known manner. In the present example, colored sealing stopper  20  is blue. 
     Before distribution of medicines through various distribution channels, medicines A 1   12 , A 2   14 , and A 3   16  are transferred to corresponding medicine bottles A 1 ′  22 , A 2 ′  24 , and A 3 ′  26  for distribution and ultimate sale to end users. By “corresponding” medicine bottles, it will be appreciated that medicine A 1   12  is transferred to medicine bottles such as A 1 ′  22 , and the like. This correspondence is significant because each of the medicines A 1   12 , A 2   14 , and A 3   16  belonging to medicine family A  10  may be different. Differences between medicines within the same medicine family such as medicine family A  10  are denoted by distinguishing labels affixed to each medicine bottle such as medicine bottles A 1 ′  22 , A 2 ′  24 , and A 3 ′  26 , as has been the standard for many years. In an optional embodiment of the present invention, a medicine bottle label such as medicine bottle label  23  may be color coded to correspond to the color associated with the medicine family to which the contents of the medicine bottle  22  correspond. In the depicted example, medicine bottle label  23  would be coded with a blue color, thereby corresponding to the color of the container sealing stopper  20  which, itself corresponds to the color chosen for association with medicine family A  10 . Optional embodiments of the present invention include marking the medicine bottles A 1 ′  22 , A 2 ′  24 , and A 3 ′  26  in any manner so as to associate the respective medicine bottle with the corresponding color chosen for association with the medicine family A  10 , including forming the bottle itself of a material capable of carrying the corresponding color. 
     The same grouping and association principles apply to other medicine families, such as medicine family B  50  which may be a medicine family comprising upper respiratory medicines, for example. In the same fashion as with medicine family A  10 , medicine family B  50  comprises three different medicines, medicine B 1   52 , medicine B 2   54 , and medicine B 3   56 . For simplicity of illustration, only three medicines are shown in medicine family B  50 , though it is understood and appreciated that any particular medicine family may include an unlimited number of currently existing and later developed medicines which meet the criteria for inclusion in a particular medicine family. 
     After a group of medicines has been grouped into a particular medicine family such as medicine family B  50 , a distinguishing color is identified and associated with medicine family B  50 . In the depicted example, the color blue has already been selected for association with medicine family A  10 , so a different color, yellow, is selected. 
     Importantly, after selection the color yellow for association with medicine family B  50 , a colored sealing stopper  60  of the color associated with medicine family B  50  is produced in a well known manner. In the present example, colored sealing stopper  60  is yellow. 
     Before distribution of medicines through various distribution channels, medicines B 1   52 , B 2   54 , and B 3   56  are transferred to corresponding medicine bottles B 1 ′  62 , B 2 ′  64 , and B 3 ′  66 . By “corresponding” medicine bottles, it will be appreciated that medicine B 1   52  is transferred to medicine bottles such as B 1 ′  62 , and the like. As with the medicines of medicine family A  10 , medicine bottles such as medicine bottle B 1 ′  62  may carry or have otherwise affixed a medicine bottle label  63  which corresponds in color to the container sealing stopper  60 . In the depicted example, medicine bottle label  63  would be coded with a yellow color. 
     The principal improvement provided by the preferred embodiment of the present invention relates to the use of colored sealing stoppers  20 ,  60  of a single, distinguishable color for all different medicines within the same medicine family. With reference to the depicted example, even though the medicines contained in medicine bottles A 1 ′  22 , A 2 ′  24 , and A 3 ′  26  are different, they will each be sealed with a blue colored sealing stopper such as colored sealing stopper  20  because blue was the color chosen for association with all medicines included in medicine family A  10 . Similarly, even though the medicines contained in medicine bottles B 1 ′  62 , B 2 ′  64 , and B 3 ′  66  are different, they will each be sealed with a yellow colored sealing stopper such as colored sealing stopper  60  because blue was the color chosen for association with all medicines included in medicine family B  50 . 
     FIGS. 2 a  and  2   b  depict the implementation of an exemplary embodiment of the system of the present invention. More specifically, FIG. 2 a  depicts medicine bottle A 1 ′  22  filled with medicine A 1 , with medicine bottle label  23  affixed to the medicine bottle A 1 ′  22 , and with various medicine bottle sealing components illustrated in exploded view. 
     In particular, it is well known in the art to seal medicine bottles such as medicine bottle A 1 ′  22  with a sealing stopper. In an embodiment of the present invention, the sealing stopper is a colored sealing stopper  20 . The colored sealing stopper  20  is sized to fit within an opening  110  defined within the neck  120  of the medicine bottle A 1 ′  22  in a leak-proof fashion. Additionally, it is preferred that a metal cap  130  be sized to securely fit over a bottle lip  140  at the top edge of the medicine bottle A 1 ′  22  to prevent tampering with the medicine A 1   12  within the medicine bottle A 1 ′  22 . Regarding the metal cap  130 , a satiation cover  150  is often removably incorporated therein to allow access to the container sealing stopper  20  and, ultimately, to the medicine A 1  within the bottle. Optionally, the metal cap  130  may be color coded in the same fashion as the colored sealing stopper  20 . 
     FIG. 2 b  depicts the various medicine bottle sealing components in an installed configuration. The colored sealing stopper  20  has been inserted into the opening  110  defined by the neck  120  of the medicine bottle A 1 ′  22 . The metal cap  130  has been placed over the bottle lip  140  and secured thereon in a manner well known to those skilled in the art. In an initial configuration (not shown), satiation cover  150  would remain integral to the metal cap  130  until the medicine bottle A 1 ′  22  was being prepared for use. FIG. 2 b  depicts, however, the metal cap  130  after removal of the satiation cap  150 , thereby revealing satiation access  155 . Importantly, satiation access  155  exposes the colored sealing stopper  20  for both visual inspection and insertion of a “draw off” through the colored sealing stopper  20  and into the interior of medicine bottle A 1 ′  22  for removal of the medicine A 1   12 . 
     An advantage of the system of the preferred embodiment of the present invention becomes clear when considering the illustration of FIG. 2 b . After insertion of the colored sealing stopper  20  into the bottle, a technician or other individual preparing to administer the medicine can visually identify the color of the stopper through the clear or translucent neck  120  of the medicine bottle A 1 ′  22 . The color of the colored sealing stopper  20  should correspond to the color of the medicine bottle label  23 . Furthermore, as the technician removes the satiation cover  150  from the metal cap  130  and prepares to insert a draw-off (typically comprising a long needle or sharpened pipette) through the colored sealing stopper, there is not choice but to notice the color of the colored sealing stopper  20 . Again, if the color seen by the technician does not correspond to either the instructions given the technician by a supervisor or the color of the medicine bottle label  23 , the technician is alerted of a potential problem. 
     Although specific attention has been directed to the preferred embodiments of the present invention, it will be understood and appreciated that other equivalent embodiments are easily achieved within the spirit and scope of the present invention. Particularly, yet another alternate embodiment may include a medicine bottle such as medicine bottle A 1 ′  22  being formed of a material colored the color associated with its contents. In the present example, the medicine bottle A 1 ′  22  could be formed of blue plastic, blue glass, or simply painted or otherwise all or partially covered to as to indicate the family of medicines from which its contents derive. 
     As such, it is specifically intended that the scope of the present invention not be limited to the embodiments described hereinabove, but by the claims appended hereto.