Abstract:
A business model for facilitating the deployment of prescription validation systems into pharmacies is installed in pharmacies for little or no up-front cost to the pharmacy. Instead, the pharmacy is charged on a per use basis, that is, charged every time a prescription is validated in the system. In this way, the system vendor obtains payment on a subscription-like basis. Up-front costs at the pharmacy are avoided. Moreover, risks to a pharmacy concerning maintenance and slow productivity are avoided, or shifted onto the system owner, who is able to assess those risks.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    Improperly filled prescriptions represent a substantial risk of injury to customers at pharmacies. Filling prescriptions is a generally commoditized business where the objective is to maximize the number of prescriptions filled by each pharmacist per hour. It is inevitable that some prescriptions are filled with the incorrect drugs or medication. 
         [0002]    To address this problem, systems for the validation of prescriptions have been proposed. For example, U.S. Pat. No. 6,771,369 concerns a system and method for pharmacy validation and inspection. The disclosed system provides a combination of a bar code reader and a spectroscopy system. In operation, a container of pills is provided with a label containing prescription information for a specific patient. The label is read by the system&#39;s bar code reader. Contemporaneously, the spectral response of the pills contained within the container is also resolved. A data analysis system then compares the information from the bar code reader with the spectral response information to ensure that the chemical content of the pills within the container matches the prescription. Such systems provide a way of confirming the accuracy of a filled prescription. Specifically, they insure that the contents of the container match the container&#39;s label. In this way, errors in prescriptions could be reduced. 
       SUMMARY OF THE INVENTION 
       [0003]    The main impediment to the market penetration of prescription validation systems into the typical pharmacy is the cost of such systems. While there might be savings in terms of the pharmacy&#39;s liability insurance because of the decrease in the pharmacy&#39;s errors, the systems are comparatively expensive and represent an up-front cost to the typical pharmacy. Further, it is often unclear whether such systems will work accurately enough and at the speeds required in the pharmacy to justify investment. There are also risks to the pharmacy concerning costs of ownership including maintenance and equipment downtime. 
         [0004]    The present invention is directed to a business model for facilitating the deployment of prescription validation systems into pharmacies. Specifically, these systems are installed in pharmacies for little or no up-front cost to the pharmacy. Instead, the pharmacy is charged on a per use basis, i.e., charged every time a prescription is validated in the system or based on entirely or in part on the number of validations performed. In this way, the system vendor obtains payment on a subscription basis. At the same time, up-front costs at the pharmacy are avoided. Moreover, risks to a pharmacy concerning maintenance and slow productivity are avoided, or shifted onto the system owner, who is able to assess those risks. 
         [0005]    Payment per validation business model is similar to other business models used in the pharmacy industry. For example, currently, a process of “adjudication” is used whereby a pharmacist confirms the level of insurance of a given customer. Specifically, when a customer seeks to fill a prescription, the pharmacist will usually contact an insurance information clearing house, which provides the pharmacist with information concerning the level of coverage for that specific customer. In this way, the pharmacy can handle prescriptions from customers having different insurance and different coverage levels, while being assured that the insurance company will provide the expected level of reimbursement. 
         [0006]    The above and other features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention are shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    In the accompanying drawings, reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale; emphasis has instead been placed upon illustrating the principles of the invention. Of the drawings: 
           [0008]      FIG. 1  is a schematic diagram of a prescription validation system used in the present invention; and 
           [0009]      FIG. 2  is a flow diagram illustrating a method for prescription validation and charges to a pharmacy. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0010]      FIG. 1  shows a prescription validation system that is used in connection with the present invention, in one example. 
         [0011]    The validation system  100  is used to analyze the contents of a container, such as a pill container  50 . Specifically, in operation, a container  50 , typically representing a filled prescription, with a prescription specific label  52  on its outer surface, is placed within an analysis area  110  of the validation system  100 . 
         [0012]    In one embodiment, both a spectrometer  114  and vision system  116  are oriented to view the contents of the container  50 , usually near its mouth  54 . The vision system  116  is used to check the shape, color, and symbols found on pills, for example, within the container  50 . The spectrometer  114  is used to collect the spectroscopic response of those same drugs, such as pills, within the container  50 . 
         [0013]    Simultaneously or contemporaneously, in one embodiment, a label reader  112  reads the prescription information found on the label  52 . In one example, the label reader has an optical character recognition (OCR) system to decode the human-readable information encoded on the label  52 . In another example, the label reader alternatively, or in addition, comprises a machine code reading component such as a bar code reader that reads a machine-readable, e.g., bar code, found on the label  52 . 
         [0014]    The prescription information from the label reader  112 , the spectroscopic information from the spectrometer  114 , and the pill shape, color, and symbol information from the vision system  116  are analyzed by the prescription validation system controller  120 . The controller  120  confirms whether the prescription has been properly filled. Specifically, the prescription information found on the label  52  is compared to the pill shape, color, and/or symbols that were determined by the vision system  116  and the composition of those pills as determined by the spectrometer  114 . 
         [0015]    According to the invention, the prescription validation system controller  120  connects to a pharmacy management system  130 . This contains the pharmacy&#39;s database for the drugs and/or drugs held by the pharmacy and/or the existing customers serviced by the pharmacy. The prescription validation system controller  120  confirms the prescription information on the label  52  is consistent with this back office system, for example, based on scheduled prescriptions to be filled at the pharmacy. That is, in one embodiment, the pharmacy management system comprises customer information and pending prescriptions to be filled. These prescription orders are then assigned to pharmacists at each validation system  100 . As prescriptions are validated, the pharmacy management system  130  updates the queue of prescriptions to be filled and confirms the validated prescriptions were to be filled. 
         [0016]    The prescription validation system controller  120  is also connected to a drug information center database  140 . In one example, connection is a data connection across a public network, such as the internet. In other examples, the connection is supported by a dial-up connection or other direct point-to-point data communication. This drug information center includes databases of spectroscopic pill information and pill shape, color and symbol information. 
         [0017]      FIG. 2  shows the method of operation for the present invention. 
         [0018]    As is common, in step  210 , a prescription is received and entered into the billing/back office pharmacy management system  130  of the pharmacy. Most pharmacies have such a database system that stores previous prescriptions by a patient, the number of refills left on those prescriptions, insurance information for patients, billing information, and other account information. The system also controls pharmacy workflow in some examples so that prescriptions to be filled are distributed among the working pharmacists. 
         [0019]    Then, the billing/back office pharmacy management system  130  contacts an insurance coverage clearing house. This step is often referred to as adjudication where the pharmacy determines whether the patient is covered, the insurance company, and the level of coverage to determine the level of reimbursement that the pharmacy will be receive from the customers&#39; insurance. 
         [0020]    Then in step  214 , the drug is dispensed. Often, this filling is performed manually by pharmacist who puts a prescribed number of pills, for example, into the container  50 . In step  216 , pharmacist affixes the label  52  to the container  50 . Often this label  52  is printed directly by the billing/back office system  130  for the pharmacy. 
         [0021]    In other examples, the steps of filling the container and/or printing and affixing the prescription label  52  to the container  50  are performed by an automated system. Especially in large pharmacies, there are machines that take entered prescription information and then automatically dispense the drugs into the containers  50 , including the required labels  52 . In step  218 , the container  50  is placed in the analysis area  110  (see  FIG. 1 ). 
         [0022]    In step  220 , the validation system  100  acquires a spectroscopic data of the drug. Specifically the spectrometer  114  determines the spectral response of the pills contained in the container  50 . 
         [0023]    In step  222 , the validation system  100  also preferably acquires image information for the pills using the vision system  116 . Preferably this image recognition information includes the shape, color and any symbols contained on the pills. 
         [0024]    Based on the spectroscopic and image information, the validation system controller  120  searches for a match in an internal database  122  in step  224 . The system then determines whether or not there is a match for the pills based on the color, shape, symbols on the pills and/or the spectroscopic data on the pills in step  226 . If no match is found, then in step  228 , the validation system sends the spectroscopic, shape, color data, to the drug information center  140 . 
         [0025]    In step  230  the drug information center  140  receives this spectroscopic and/or image recognition information from the validation system in step  230 . It searches in the center&#39;s database for a match. The drug center  140  then sends match information to the validation system  100  in step  232  or signals an error condition with no match being found. 
         [0026]    In the event of a non-match at the center&#39;s database, the center  140  signals for a recalibration of the validation system  100 , usually including a recalibration of the spectroscopy system  114 . 
         [0027]    Based upon the match information from the drug center  140  or determined internally by reference to the database  122  of the validation system controller  120 , in step  224 , the validation system  100  reads the label  52  and/or receives intended prescription information from the billing/back office system  130 . Specifically, the validation system  100  or management system  130  validates that a request for this prescription exists, that the drugs in the container match both the label  52  on the container  50  and the intended prescription in the back office system  130 . 
         [0028]    Then in step  236 , the validation system  100  notifies the pharmacist of a match or an invalid condition. That is, if there is a detected error in the data, the system signals that the particular prescription has not been properly filled. 
         [0029]    In step  238 , the drug center  140  also sends an update with the spectroscopic, shape, and color symbol data for the internal database  122  of the validation system controller  120 . Specifically, the drug center  140  updates the internal database  122 , in one embodiment, of the validation system controller  120  based upon the requests that the validation sent in  228 . In this way, the validation system controller will signal a match if a similar drug is presented to the validation system in the future. In step  240 , the validation system controller  120  then updates its internal database  122  with the new spectroscopic, shape, color and symbol data from the drug center  140 . 
         [0030]    According to the step  242 , the validation system controller  120  notifies the drug information center  140  of the validation. In step  224 , the drug information center updates the pharmacy&#39;s billing information with this validation. In one embodiment, the center  140  periodically sends a bill to the pharmacy. The charges are based on the number of validations that were performed over the billing period. In other examples the bill also includes rental or lease changes for the validation system  100  for the billing period. 
         [0031]    Often, the validations will cost only a few cents. Also, in one embodiment, the pharmacy system notifies the center with accuracy information concerning the accuracy with which prescriptions are being filled at the pharmacy and any errors originating from the validation system  100  in step  246 . 
         [0032]    In step  248 , the drug center further updates its record information with this information from the local validation system at their pharmacy. 
         [0033]    In step  250 , the drug information center  140  periodically sends general updates for the internal database of the validation system. These internal updates are used, in one embodiment, to increase the probability of a match when the validation system  100  interrogates its internal database. For example, as the composition of pills, specifically pill coatings change, and/or with changes in color and introduction of instruction of new and generic pills, this information is continually sent by the drug information center  140  to update the internal database  122  of each validation system  100  at each pharmacy. Then, finally, in step  252 , the pharmacy validation system updates its internal database with the new data for its validation system. 
         [0034]    While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.