Abstract:
A device and method is provided for converting product-specific identification numbers associated with bar code indicia on pharmaceutical products to an industry standard identification number. The process involves reading a bar code indicia, converting the indicia into an input string and standardizing the input string by means of adding or subtracting characters in accordance with rules based on the bar code type and length of the input string. By means of the invention pharmaceutical products of two different sources may be compared to determine if they contain the same drug as determined by the standard identification number. The device can include a removable member for interchanging and updating bar code indicia information rather than reprogramming the device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 09/085,279, filed May 27, 1998, which claims priority on U.S. application Ser. No. 60/048,124, filed May 30, 1997. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to a system and method for accurately dispensing prescriptions in a pharmacy including a conversion of at least one piece of data into a pharmaceutical standard NDC number. 
     2. Description of Related Art 
     Universal Product Code (UPC) symbols arc displayed on a myriad of products throughout the country. Often, the UPC symbol is displayed in a “bar code” format, whereby an intermittent pattern of alternating black and white vertical lines of varying widths signifies a string of alphanumeric characters. Bar codes serve as a language which functions to place the string of characters into a machine-readable form. In addition, bar codes have a number of formats which typically must be determined before a machine can read a bar code. FIG. 1 shows examples of different types of bar codes with the generally-accepted name of the type of bar code shown directly above the bar code. 
     UPC symbols, in the form of bar codes, are commonly displayed on all kinds of products, including those in the pharmaceutical industry such as medicine containers. FIGS. 2-5 show examples of medicine containers which have been provided with UPC symbols by a product source, such as a manufacturer or distributor. FIG. 2 shows a bottle  10  having a label  12  provided with bar code indicia  14  thereon. FIG. 3 shows a box  16  having a sidewall  18  provided with bar code indicia  20  thereon. FIG. 4 shows a shrink wrapped package  22  of multiple bottles  10  having an upper surface  24  on which a label  26  provided with bar code indicia  28  thereon has been affixed. FIG. 5 shows a carton  30  having a label  32  provided with bar code indicia  34  thereon. 
     Bar codes are typically read by a device called a “scanner.” An example of a system which includes a scanner is shown in FIG.  6 . The system, shown generally by reference numeral  36 , comprises a computer  38  and a scanner  40  interconnected by a conduit  42 . The computer  38  generally comprises a processing unit  44 , a keyboard  46  and a monitor  48 . It will be understood that the monitor  48  and the processing unit  44  are interconnected in a manner well known in the art. The conduit  42  comprises a Y-shaped cable having first, second and third portions  50 ,  52  and  54 , respectively, each provided with a suitable connector  56  at a distal end. 
     The scanner  40  is typically interconnected intermediate the keyboard  46  and the processing unit  44  by the conduit  42 . For example, the connector  56  on the first portion  50  is interconnected to a suitable socket (not shown) on the scanner  40 . The connector  56  on the second portion  52  is interconnected to a suitable socket  58  on the keyboard  46 . The connector  56  of the third portion  54  is interconnected to a suitable socket (not shown) on the processing unit  44 . 
     Thus, signals can be provided to the processing unit  44  by either the keyboard  46  through the portions  50 - 54  or by the scanner  40  through the portions  50  and  54 . FIG. 7 shows the operation of the scanner  40 . The scanner  40  typically includes an illumination emitting device therein, such as a laser or intense light, which is actuatable by a trigger (not shown). When the trigger is depressed, a beam  60  is oscillated across a bar code  62 . desired to be read. The bar code  62  is converted to an alphanumeric signal by the scanner  40  and sent through the conduit  42  to the processing unit  44 . Because the scanner  40  is interconnected intermediate the keyboard  46  and the processing unit  44  and is able to generate alphanumeric characters, the scanner  40  acts as a “second keyboard,” providing alphanumeric input to the processing unit  44 . 
     As shown in FIGS. 2-5, bar codes in the form of UPC symbols are marked on packaging for medicine and other pharmaceuticals. With continuing pressure to reduce health care costs there is a need to use technology to improve the quality and accuracy of pharmaceutical distribution. The National Drug Code (NDC) was developed as a universal identification system for pharmaceutical products distributed in the U.S. Since 1969, the Food and Drug Administration (FDA) has required that all drug products be identified clearly with the NDC, which provides pharmaceutical products with a unique all-numeric system identifying the pharmaceutical source, product and package size. Because the industry uses the NDC to order, track and report on pharmaceutical products, bar coding of this number has provided a faster and more accurate way to move both products and information. 
     The NDC for prescription pharmaceuticals is the single basic identifier for all forms of pharmaceutical products in the health industry. Pharmacy computer systems, third-party prescription claims processing, and sale tracking, reporting and industry support services typically use the NDC to identify, describe and pay for pharmaceutical services. For pharmacy providers, legislation now mandates the use of the NDC for all Medicaid claims. The Department of Justice and the Drug Enforcement Administration require monthly reporting of all incoming and outgoing controlled substance transactions and inventories on a system which mandates use of NDC numbers. From drug manufacturer to wholesaler to drug provider, computer systems are often required to depend on NDC numbers for identifying what is being ordered, paid, returned and credited. It is a proven method of enhancing the efficiency and accuracy of pharmaceutical distribution. 
     The NDC, by federal regulation, is a 10-digit numeric code preceded with the letter N or letters NDC. It consists of three numeric fields of information: a source identification field, a product identification field, and a trade package field. The FDA assigns the labeler portion of the code, while the labeler assigns the product identification and trade package portions according to format standards. 
     The FDA originally assigned the source identification field as four digits, starting at 0002. The system was designed not to exceed a source identification field of 0999. When it became apparent to the FDA that the number of product sources applying for labeler codes would exceed 0999, they reformatted the source I.D. field to comprise a five-digit numeric field beginning with 10000. 
     The product identification and trade package fields together comprise five digits, with the product identification field being three or four digits and the trade package field being two or one. 
     The NDC is presented in one of three formats: 4-4-2, 5-3-2 or 5-4-1 referred to in order of the above-identified three fields. The first field of four or five numbers corresponds to the source identification field. The next field of three or four numbers corresponds to the product identification field. The final field of one or two numbers corresponds to the trade package field. 
     Whenever an NDC is printed, all leading, imbedded and trailing zeros must be included. Each of the three fields are typically separated by a hyphen when printed in a human readable fonn, for example, 51999-432-10 for a 5-3-2 NDC number. 
     In their catalogs and on price lists, manufacturers and labelers are encouraged to include NDC numbers for each listed item. Labelers are typically urged to discontinue use of internal or traditional list, order or product numbers, as these identifiers are not generic to the pharmaceutical industry. 
     Because the NDC is the single basic means of product identification for all pharmaceutical products, it is desirable to have the NDC numbers encoded into a bar code and labeled onto products. Therefor, drug manufacturers and labelers are urged to identify their drug products with an NDC and to encode this number in bar code formats. However, there are many different bar code types as shown by example in FIG. 1 and a growing number of applications for each. Problems have arisen in that the various bar code types have different character lengths which do not correspond to the ten-digit NDC number. 
     SUMMARY OF THE INVENTION 
     In one aspect, the invention relates to a system for accurately dispensing prescriptions in a pharmacy comprising a computer, a reader operably interconnected to the computer, at least one of the reader and the computer adapted to detect and read indicia, and a converter operably interconnected to at least one of the computer and the reader for converting read indicia into an NDC number. The reader preferably reads the indicia from at least one of a package containing pharmaceutical products and a prescription. The read indicia is thereby standardized to an NDC number to ensure accuracy during the dispensation of a prescriptions in the pharmacy. 
     In various embodiments, the reader can comprise a scanner. The indicia can comprise a bar code. The converter can further comprise a database containing at least one table for converting the read indicia into an NDC number. Means for storing a first indicia and a second indicia can be provided as well as means for comparing the first indicia and the second indicia after both have been converted to NDC numbers by the converter. An alarm device for alerting an operator of the system can be employed if the an NDC number representing the first indicia does not match an NDC number representing the second indicia. The computer, reader and converter can be contained in a single housing. 
     In another aspect, the invention relates to a method of accurately dispensing prescriptions in a pharmacy having a computerized prescription dispensing system including a scanner and having an inventory of pharmaceutical products including the steps of: receiving a prescription for a patient identifying a desired pharmaceutical product and a desired dosage of the desired pharmaceutical product; entering first data representative of the prescription into the dispensing system; converting the first data into a first NDC number; retrieving the desired pharmaceutical product from the inventory; scanning a bar code on the desired pharmaceutical product with the scanner to convert the bar code into second data representative of the bar code; converting the second data into a second NDC number; and comparing the first NDC number with the second NDC number. 
     In various embodiments of the invention, the method can further comprise the step of alerting an operator of the pharmacy if the first NDC number does not equal the second NDC number. The method can also further comprise the step of dispensing the prescription to the patient if the first NDC number equals the second NDC number. A label can be printed describing the prescription for application to a container containing the dispensed prescription. The steps of scanning and converting to the first and second NDC numbers and the step of comparing the first and second NDC numbers can be performed internally of at least one of the computerized prescription dispensing system and the scanner. The method can further comprise the step of verifying the correct amount of the desired pharmaceutical product has been dispensed to the patient in accordance with the desired dosage. The first data can be used from a previously-dispensed prescription a refill label on a previously-dispensed patient refill bottle. The first data can be scanned from a bar code used for a previously-dispensed prescription. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will now be described with reference to the drawings wherein: 
     FIG. 1 is a view of several different types of bar codes shown with the name of the type of bar code shown therewith; 
     FIG. 2 is a perspective view of a medicine bottle having a bar code thereon; 
     FIG. 3 is a perspective view of a small box having a bar code thereon; 
     FIG. 4 is a perspective view of a shrink wrapped package of multiple medicine bottles having a bar code thereon; 
     FIG. 5 is a perspective view of a large carton having a bar code thereon; 
     FIG. 6 is a perspective view of a typical computer system incorporating a scanner therein; 
     FIG. 7 is a perspective view of a prior art scanning device shown reading a typical bar code; 
     FIG. 8 is a perspective view of an improved scanning device according to the invention; 
     FIG. 9 is a flow chart illustrating the method of converting a bar code to a standardized NDC number, 
     FIG. 10 is a flow chart illustrating the process of standardizing an input string into a first string; 
     FIG. 11 is a flow chart illustrating the process for eliminating non-standard characters from the input string; 
     FIG. 12 is a flow chart illustrating the process of standardizing a bar code of UPC format; 
     FIG. 13 is a flow chart illustrating the process of standardizing a bar code of Code  128  format; 
     FIG. 14 is a flow chart illustrating the process of standardizing a bar code of Code  39 , Interleaved 2 of 5, and other bar code formats; and 
     FIG. 15 illustrates a second method of comparing two bar code indicia. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention comprises the converting of a bar code of any of the formats shown in FIG. 1 to a standardized 11-digit NDC number while simultaneously ensuring accurate entry of data relating to the pharmaceutical product into a computer system. As shown in FIG. 9, the first basic step  100  involves reading a bar code in the form of machine-readable data Such a bar code is typically found on the source&#39;s medication container. Bar codes on a source&#39;s bulk medication container can contain a bar code in a UPC symbol format or any of the other formats shown in FIG.  1 . The manipulating of the data contained in the bar code into an NDC output format  101 , comprises a step  102  of converting a bar code indicia into an input string, a step  104  of setting the first string to null, and a step  106  of standardizing the input string into a first string. Finally, as shown in step  108 , the NDC output format  101  of the manipulated bar code is sent to a processing unit on a computer  38 , as illustrated in FIG.  6 . It will be understood that, although a particular scanning unit  40  and computer system  38  is disclosed in the drawings, any type of scanning unit having an internal or external connection to a processor can be used without departing from the scope of this invention. This includes a scanning device having all processing and memory elements contained in a unitary configuration or separate components, as shown in FIG.  6 . 
     The step  106  of standardizing an input string into a first string may be broken down into a number of additional steps illustrated in FIG.  10 . First, as shown by step  110 , the type of bar code must be identified. Second, as shown by step  112 , any check digits present in the alphanumeric string read by the bar code must be eliminated. Third, any other digits not contained in an 11-digit NDC number must be eliminated as shown by step  114 . 
     The following paragraphs outline the rules for converting a bar code into an NDC number depending upon the type of bar code read by a scanning device in accordance with a further breakdown of steps  110 ,  112 , and  114 . FIG. 11 in an expansion of step  110 , wherein it will be understood that the scanning device has the ability to recognize a particular type of bar code. 
     At step  116 , the device determines if the bar code indicia is equal to UPC format. If it is, then the formatting rules for the UPC format are followed at block  118  as illustrated in greater detail in FIG.  12 . Alternatively, at step  120 , if the bar code indicia is Code  128  format then the formatting rules for the Code  128  format are followed at block  122  as illustrated in greater detail in FIG.  13 . If the bar code indicia is instead of Code  39  format as determined at step  124 , then the formatting rules for the Code  39  format are followed at block  126  as shown in greater detail in FIG.  14 . At step  128 , the device determines if the bar code Indicia is of Interleaved 2 of 5 format. If so, then the formatting rules of block  130  are followed as also shown in FIG.  14 . Finally, at step  132  the device determines if the bar code indicia are of any other recognized format. If so, then the formatting rules represented by block  134  are followed. Thus, the device calls upon one of the following format rules represented by blocks  118 ,  122 ,  126 ,  130 , or  134 , respectively, depending upon the type of bar code read. If the particular type of bar code cannot be recognized, the system returns an error at point  136  and the process ends. 
     For a UPC formatted bar code represented by block  118 , the scanner reads the bar code at step  100  and converts it into an input string of the ten digits contained in a UPC bar code at step  102 . Then to standardize the input string into a first string in a break down of steps  112  and  114 , the specific approach illustrated in FIG. 12 is utilized. The first or lead character of the inputted string is identified at decision point  140 . If the first character is a zero, then a zero is inserted at the beginning of the bar code at  142  and the ten characters of the alphanumeric string are appended thereto at  144  and sent to the process unit as shown by step  108 . If the lead character is not a zero, then at decision point  146  the device determines if the first five characters of the input string are a replacement group. If the answer is no, then the device determines at decision point  150  if the first five characters in the alphanumeric string read by the scanning device are a predetermined group of, such as, but not limited to, 59911, 51875, 59930, 59762, 58634, 51672, 59366, or 59772. If the answer is yes, then the device sends the first eight digits of the inputted alphanumeric string from the bar code as shown by point  152 , then a zero as shown by point  154 , and then the remaining two characters of the alphanumeric string as shown by point  156  to create the first string. Then the first string is sent to the processing unit as shown by point  108 . 
     If the first five characters of the input string comprise a replacement group at decision point  146 , then the first five digits must be replaced with a substitute string as shown at point  148 . For example, it has been found that if the first five digits are in the group of, but not limited to, 28176, 12899 and 47228, then the device must substitute the strings 51285, 55953 and 55053, respectively. This substitution is made for the purpose of converting a particular source&#39;s bar code to that source&#39;s NDC number. It will be understood that additional substitute NDC numbers can be provided in a database or other look-up table as required. Then, the process continues to decision step  150  as discussed above. 
     For UPC symbols wherein the first five characters of the input string are not a predetermined group at decision point  150 , the scanning device will send the first five characters of the inputted string as shown at point  160 , then a zero as shown at point  162 , and then the remaining five characters of the UPC string as shown at point  164 . Then the first string is sent to the processing unit as shown by point  108 . Thus, in all cases, an 11-digit NDC number is produced and transmitted to the processing unit. For a code  128  formatted bar code represented by block  122 , the scanner reads the bar code at step  100  and converts it into an input string. As shown in FIG. 13, for bar codes in Code  128  format, the bar codes typically produce either 10 or 15 alphanumeric characters when read by a scanning device. For a Code  128  bar code with 10 characters, the scanning device transmits a zero shown at step  166  followed by the ten digits of the inputted string. At decision point  168  the device confirms that the input string has 10 characters and then appends the ten characters of the input string to the first string at step  170 . The first string is then sent to the processing unit as shown by step  108 . 
     For bar codes in Code  128  format with 15 characters, the scanning device transmits a zero as shown at step  166 , confirms that the input string has 15 characters at decision point  168  and then appends ten sequential characters of the input string beginning with the fourth character and ending with the thirteenth character as shown at step  172 . The first string is then sent to the processing unit as shown by step  108 . 
     For bar codes in Code  39  format represented by block  126 , the scanner reads the bar code at step  100  and converts it into an input string. For bar codes in Code  39  format, the inputted alphanumeric string typically produces fifteen characters. As shown in FIG. 14, the scanning device transmits a zero as shown at point  176  in FIG. 14, followed by ten characters selected from the input alphanumeric string comprising the fourth through thirteenth characters therefrom as shown at point  178 . The first string is then sent to the processing unit as shown by step  108 . 
     For bar codes in Interleaved 2 of 5 format, represented by block  130 , the bar codes typically produce a 14-character alphanumeric string. For these types of bar codes, the scanner reads the bar code at step  100  and converts it into an input string. The scanning device transmits a zero as shown at step  176 , followed by the fourth through thirteenth characters in the inputted alphanumeric string as shown at point  178 . The first string is then sent to the processing unit as shown by step  108 . 
     For all other bar codes, represented by block  134  in FIG. 14, the scanning device transmits a zero as shown at step  180 , followed by the first ten characters of the inputted alphanumeric string as shown by step  182  to form the 11-digit NDC number. Once again, the first string is then sent to the processing unit as shown by step  108 . 
     A second embodiment of a method according to this invention compares a bar code on a source&#39;s pharmaceutical container with a bar code on a patient&#39;s prescription bottle, receipt or prescription which was printed by a pharmacy or doctor&#39;s office to verify that a correct prescription was dispensed. 
     As illustrated in FIG. 15, the second embodiment of a method comprises the step  100  of reading a first bar code from a first label. The first bar code is manipulated into an NDC output format or number  101  by the first embodiment of the method outlined above. The NDC number  101  is transmitted to the processing unit as shown by step  108  described above. The number  101  is then stored therein as shown at point  200 . A second bar code is read from a label from a different container or prescription bottle or receipt by means of step  100 . The second bar code is also manipulated into an NDC number  101  and transmitted to the processing unit and stored therein as shown by the repetition of steps  108  and  200 . The first and second manipulated NDC numbers  101  are then compared at step  202  to determine whether they match. As shown at decision point  204 , if the first and second NDC numbers  101  match, a confirmation signal  206  is sent. Alternatively, an alert signal  208  is sent. 
     It will be understood that the processing unit can be located in a conventional computer workstation as described in the Background section or, alternatively, located in the scanning unit itself. For the latter option, greater convenience can be had by the operator because the scanning mechanism and processing unit are located in a single housing. 
     Thus, bar codes in varying formats from different sources can be converted into a standard NDC number and compared to determine whether the pharmaceutical products identified in each of the first and second bar codes are indeed the same product. It can thereby be verified that a patient has received a correct product and dosage. Otherwise, the pharmacist or pharmacy technician will receive an alarm before an incorrect product is dispensed. 
     It is contemplated that the scanner employed in connection with this invention be any type of suitable scanner capable of reading bar code indicia into a processing unit. Further, it is also contemplated that the scanner employed in connection with this invention be capable of reading all of, but not limited to, the bar code types displayed in FIG.  1 . These bar codes include typical one-dimensional bar codes such as code  39  and code  128 , two-dimensional bar codes such as PDF 417, and fill height and truncated UPC-A-EAN-13 symbols as shown in FIG.  1 . Further, it is also contemplated that the scanner can read new types of bar codes such as three-dimensional bar codes by means of an imaging mechanism incorporated into the scanner or other means currently known or developed. 
     This invention also addresses the problem of updating a scanner&#39;s memory to reflect recent changes or additions to frequently changing bar code conversion information or routines stored in the scanner. Scanning devices, such as that shown as  40  in FIGS. 6-7, are typically provided with a memory chip (not shown) therein having a bank of random access memory (RAM) therein. Critical information, such as bar code recognition software and alphanumeric output programs, is loaded into the RAM and stored. Pharmaceutical suppliers and vendors often load information pertaining to recognition of specific bar code content as well, such as software which recognizes particular bar codes or a data bank of common bar codes. 
     As new bar code information becomes available, it must be downloaded into the RAM of the scanner  40 . This process can be tedious, especially if a large volume or several smaller volumes of changes are required. 
     FIG. 8 shows an example of improved scanner  64  according to the invention which comprises a housing  66  having a laser port  68  and a handle  70 . The scanner  64  is shown emitting a beam  70  over a bar code  72  as is conventionally done in the art. A distal end  74  of the handle  70  is provided with a removable panel  76  thereon. The panel  76  includes a substrate  78  which mounts a orthogonally-extending removable circuit  80  having a connector  82  thereon. The panel  76  is adapted to be inserted into the handle  70  and interconnected to the internal circuitry of the scanner  64  via the connector  82 . The removable panel  76  can be positioned at any suitable location on the scanner  64  so that the panel  76  can be easily removed and does not interfere with any required connections to external components. 
     The circuit  80  is preferably a removable integrated circuit chip which can be removed and replaced with a new chip having any new bar code data stored thereon in addition to any older information to be retained. Thus, when new information becomes available, it can be mass produced in a new chip which thereby can be mounted to the panel  76  and inserted into the scanner  64 . Thus, the need for a complicated reprogramming procedure for the scanner is eliminated. 
     While particular embodiments of the invention have been shown, it will be understood, of course, that the invention is not limited thereto since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. Reasonable variation and modification are possible within the scope of the foregoing disclosure of the invention without departing from the spirit of the invention.