Abstract:
A system and method for orchestrating electronic execution of acknowledgment of content includes a service engine that generates at least a first type of data and a second type of data in response to at least one sample request order that is processed and validated. The system and method include a compliance engine that receives and stores the first type of data and the second type of data from the service engine. The system and method include an orchestration engine that verifies the first type of data and forwards an electronic proof of acknowledgement through an interface to the compliance engine such that the electronic proof is appended to both the first type of data and the second type of data.

Description:
PRIORITY INFORMATION 
       [0001]    This application claims priority from provisional application Ser. No. 61/778,780 filed Mar. 13, 2013, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to architecture for orchestrating the electronic execution of acknowledgement of content of drug sample distributions, and more particularly, to the design of software related to acknowledgement of content execution incorporating protocols and means for expansion and interfacing with other systems. 
       BACKGROUND OF THE INVENTION 
       [0003]    Once the Food and Drug Administration (FDA) has approved a drug, a pharmaceutical company promotes the drug in a number of ways, including the use of sales representatives and non-personal or self-service methods. In either case, it is often the practice of the pharmaceutical company to provide prescribers access to drug samples in the hope that the prescribers will prescribe these drugs to their patients. 
         [0004]    In response to the Prescription Drug Marketing Act of 1987, and in an attempt to identify potential diversion of drug samples, pharmaceutical companies employ a method of verification, most commonly, but not exclusively, known as “Acknowledgement of Content” (AOC) to ensure that drug samples shipped directly to a prescriber are received, in their entirety, as stated on the packing slip or manifest which accompanies the sample shipment. Traditionally, a paper-based AOC form is provided with each shipment of samples to the prescriber. The form contains a detailed breakdown of itemized product information which can be matched to each item in the shipment. Upon unpacking of the shipment, the prescriber (or a designee of the prescriber) must verify that the drug sample items contained in the shipment match all items listed on the AOC form, sign the form, then return the form to the pharmaceutical company or their distributer to maintain a compliance record of the sample shipment. The form is then scanned or keyed into a system which stores the compliance data for a period of time designated by the pharmaceutical company. 
         [0005]    It is a common practice of most pharmaceutical companies to restrict samples to prescribers who have not provided all acknowledgements of content forms for a specified period of time as this creates compliance risk for the pharmaceutical company. Ensuring compliance by prescribers is often difficult and expensive due to the inconvenience of traditional paper-based mail and fax processes and the time-consuming nature of forms entry by the pharmaceutical company or distributer&#39;s personnel. In addition to process cost and inefficiency, non-compliance (or the inherent delay in paper-based cycle times) which result in the pharmaceutical company&#39;s inability to provide additional samples, significantly reduces the returns which are associated with subsequent scripts generated after successful patient titration through the drug sample process. Thus, there exists the need for an architecture which orchestrates acknowledgement of content while avoiding or reducing the foregoing and other problems. 
       SUMMARY OF THE INVENTION 
       [0006]    According to one aspect of the invention, there is provided a system for orchestrating electronic execution of acknowledgment of content. The system includes a service engine that generates at least a first type of data and a second type of data in response to at least one sample request order that is processed and validated. The system includes a compliance engine that receives and stores the first type of data and the second type of data from the service engine. The system includes an orchestration engine that verifies the first type of data and forwards an electronic proof of acknowledgement through an interface to the compliance engine such that the electronic proof is appended to both the first type of data and the second type of data. 
         [0007]    According to another aspect of the invention, there is provided a method for orchestrating electronic execution of acknowledgment of content. The method includes the step of generating at least a first type of data and a second type of data by a service engine in response to at least one sample request order that is processed and validated. The method includes the step of receiving and storing the first type of data and the second type of data from the service engine in a compliance engine. The method includes the step of verifying the first type of data by an orchestration engine and forwarding an electronic proof of acknowledgement through an interface to the compliance engine such that the electronic proof is appended to both the first type of data and the second type of data. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a block diagram that illustrates different components and data flow directions of the electronic AOC management process life cycle; 
           [0009]      FIG. 2  is a process diagram that illustrates relationships between system components; 
           [0010]      FIG. 3  is a block diagram that illustrates different components of the system for interacting with the orchestration engine; 
           [0011]      FIG. 4  is a process diagram that illustrates the electronic orchestration of AOC; and 
           [0012]      FIG. 5  is a process diagram that illustrates a method for orchestrating electronic AOCs. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0013]    The invention involves a services engine that provides transactional responses to a user&#39;s requests, directly correlated to unique key data generated by the service engine that corresponds to the acknowledgement of content (AOC) compliance record of a specific shipment, with resulting compliance information being returned to the user&#39;s computer or electronic device for verification by the user and subsequent return of proof of acknowledgement of the compliance information&#39;s legitimacy and accuracy. The compliance engine stores key data previously generated by the service engine and maintains compliance detail information with respect to matching shipments and, upon receipt of the unique key from the orchestration engine, provides the matching compliance detail information to the orchestration engine for electronic delivery to the user interface. Upon receipt of proof of acknowledgement via the orchestration engine, the compliance engine appends the acknowledgement of content (AOC) compliance record with the proof of acknowledgment data received. 
         [0014]      FIG. 1  illustrates different components and the data flow directions of the electronic AOC management process life cycle. As later described in further detail, a service engine  101  comprises an order processing system (OPS)  105  and a warehouse management system (WMS)  106 . The OPS  105  processes any and all sample request orders received based on the order validation rules which are set uniquely at the customer job level. For every order that is received, the OPS  105  generates a unique key data and transfers this data to a compliance engine  102 . After successful completion of validation, the OPS  105  transfers the order data to the WMS  106  for shipping. The shipment details are sent by the WMS  106  to the OPS  105 , which again get transferred to the compliance engine  102 . 
         [0015]    As later described in further detail, the compliance engine  102  comprises a compliance data processing system (CDPS)  109  and AOC master  110 . The compliance engine  102  stores AOC information received from the service engine  101 , and upon receiving the unique key data from the orchestration engine  103 , provides matching compliant AOC information to the orchestration engine  103 . The CDPS  109  is the part of compliance engine  102  which interacts with the service engine  101 , whereas the AOC master  110  interacts with the orchestration engine  103 . Upon receiving the proof of receipt from the user via the orchestration engine  103 , the AOC master  110  appends the proof of acknowledgement (POA) to the original compliance information. 
         [0016]    The orchestration engine  103  provides user interface  112  functionality such as receiving the AOC information requests (unique key data) from the user and displaying the requested compliance AOC information through the user interface  112 , upon gathering the information from the compliance engine  102 . The proof of acknowledgement that the user returns after verifying the AOC information is forwarded by the orchestration engine  103  to the compliance engine  102 . The orchestration engine  103  acts as a bridge between the user and the compliance engine  102 , where all the compliance AOC information is stored. 
         [0017]    As shown in  FIG. 2 , the architecture for orchestrating the electronic execution of acknowledgement of content (AOC) consists of a service engine  101 , compliance engine  102  and an orchestration engine  103 . The service engine  101  comprises an order processing system (OPS)  105  which manages order processing/validation, and a warehouse management system (WMS)  106  which manages order fulfillment. Upon receiving a sample request order  104 , the order  104  is transferred to the OPS  105  for processing/validation of the order. The order  104  is validated using a set of order validation rules, which are configurable per client requirements and compliance laws. The order  104  is processed by the OPS  105  and is then transferred to the WMS  106  for verification of the inventory followed by pick/pack/ship for order fulfillment. For each shipment  107  that is processed by the WMS  106 , associated shipment data is sent back to the OPS  105  which is transferred to the compliance data processing system (CDPS)  109 , in the compliance engine  102 , along with a unique key data related to that particular order generated by the OPS  105 . This shipment data and the unique key data of that particular order are transferred from CDPS  109  to the AOC master  110 , in the compliance engine  102 , where the AOC record is stored. 
         [0018]    The order fulfillment shipment  107  is done by shipment carrier services and for each order  107  that is shipped; an acknowledgement of delivery is received from the shipping carrier upon delivery  108  of the sample fulfillment shipment/package. The AOD data of an order  108 , received from the shipment carrier services is transferred by the CDPS  109  to the AOC master  110 , where the AOD data gets appended to the unique key data and shipment data of the particular order, which are already stored in the AOC master  110 . At this stage of the process, CDPS  109  establishes the particular shipment data as an open AOC. It is noted that the unique key data (pick slip number), shipment data and AOD data are the mandatory pre-conditions for an “open” AOC, where “open” refers to the fact that no signed acknowledgement of content has been received corresponding to the shipment referenced in the AOD data. This process of mandatory pre-conditions helps to ensure that and AOC is not prematurely considered “open” and the open AOC period is accurately reflected within the system. 
         [0019]    Further shown in  FIG. 2 , the orchestration engine  103  comprises a user interface  112  and an AOC interface  111 , where the AOC interface  111  acts as a medium between users and the AOC master  110 , by allowing the transfer of compliant AOC information data. Once the user, through a user interface  112  (for example, a website, mobile device, etc.), requests the AOC (shipment) details regarding a particular order using the unique key data (pick slip number), the AOC interface  111  gathers the request/unique key data and transfers it to the AOC master  110 . The AOC master  110  sends back the compliant AOC data which is matching to the requested unique key data, to the AOC interface  111 . The compliant AOC information received from AOC master  110  is displayed to the user by the AOC interface  111 , through the user interface  112 . The user verifies the compliant AOC/shipment related details shown as part of AOC and sends back the proof of acknowledgement (electronically signed AOC) to the AOC interface  111 . The AOC interface  111  collects the proof of acknowledgement from the user and transfers it to the AOC master  110 , where the proof of acknowledgement is appended to the original AOC data (unique key data, shipment data and AOD of the particular order) and the AOC is closed. 
         [0020]      FIG. 3  illustrates the different components of the system by which the users are coupled to the AOC orchestration ecosystem. An orchestration ecosystem  207  is used by the pharma representatives  201  (who works for pharma  204  and distributes the sample pharmaceuticals manufactured by the pharma  204  to the prescribers/designees  202  hoping that they will prescribe the pharmaceutical samples to their patients), to manage the AOC information that is associated with his/her sample transactions. The pharma representatives  201  are entitled to solicit a proof of acknowledgement for all the promotional sample shipments received by their prescribers/designees  202 . The pharma representatives  201  use the orchestration ecosystem  207  to facilitate closing (providing the proof of acknowledgement) of the AOCs by the prescribers  202  or the prescriber&#39;s designee  202 . 
         [0021]    Prescribers  202  are the authorized personnel to provide drug samples to the patients/consumers. The prescribers and/or their designee  202  use the orchestration ecosystem  207  for managing the AOC information associated with their sample transactions. If the prescriber/designee  202  is directly receiving the drug samples from a distributor  203 , the prescriber/designee  202  is entitled to submit a proof of acknowledgement after receiving the drug sample shipment. The prescribers/designees  202  use the orchestration ecosystem  207  to view and/or close (providing the proof of acknowledgement) the AOCs. 
         [0022]    Pharma  204  is a company engaged in the manufacture and sales of pharmaceuticals, which are medical drugs used for therapeutic applications. Pharma  204  accesses the orchestration ecosystem  207  to view the status of AOCs. By viewing the current status of AOCs, pharma  204  analyzes the compliance of their pharma representatives  201  and prescribers/designees  202  and if necessary (number of open AOCs are above the allowed limit), pharma  204  will notify the pharma representative  201  and/or prescriber/designee  202  to close the open AOCs. If the pharma representative  201  and/or prescriber/designee  202  fails to do so, pharma  204  has the full authority to stop the prescriber/designee  202  from being sampled again. It is mandatory that all the products that are shipped/received/distributed should be accountable. 
         [0023]    The distributor  203  manages the distribution/fulfillment of the samples that a pharma  204  manufactures. The distributor  203  keeps track of the AOC details of each prescriber/designee  202  and notifies them if it seems the sampling transactions does not meet the compliance rules. The distributor  203  will make sure that, in a case of exceeding the allowed number of open AOCs, a prescriber/designee  202  is made non-sampleable until the pharma  204  authorizes them to be sampleable again. 
         [0024]    The pharma representatives  201 , prescribers/designees  202 , distributor  203  and pharma  204  access the orchestration ecosystem  207  via a plurality of input/output devices  205 . These input/output devices  205  include wired/wireless workstations such as desktop computers, laptop computers, notebook computers, servers and similar hardware. Other input/output devices include personal digital assistants; personal digital assistant proxies; telephones; printers and facsimile communication machines. The input/output devices  205  are coupled to the AOC orchestration ecosystem  207  via a network  206 . 
         [0025]    The network  206  comprises a group of computers and associated devices that are connected by communication facilities. The network  206  may involve permanent connections, such as coaxial or other cables, or temporary connections made through telephone or other communication links. The network  206  may be as small as LAN (Local Area Network) consisting of a few computers, printers and other devices, or many small and large computers distributed over a vast geographical area (WAN or Wide Area Network). The Internet is a very good example of WAN, which is a worldwide connection of networks and gateways. 
         [0026]    The orchestration ecosystem  207  collects the requests (unique key data) from the users (pharma representatives  201 , prescribers/designees  202 , distributor  203  and pharma  204 ) and displays the matching compliance information through the input/output devices  205 . 
         [0027]    Referring now to  FIG. 4 , this illustrates a method for orchestration of a drug sample shipment with acknowledgement of content. For purposes of clarity, the following description of this method  400  makes references to various elements illustrated in connection of electronic AOC management orchestration of  FIG. 2 . From a start block  400 , the method proceeds to a step  401 , defined between a continuation terminal (“terminal A”) and an exit terminal (“terminal B”), and that initially, a user requests to start a method of orchestration, such as acknowledging a closure of the order. From terminal A, the method proceeds to step  401  where the user requests to receive compliance detail information regarding a unique shipment of samples using a previously generated unique key as a quick response code generated by the service engine  101  and scanned by a user&#39;s mobile device. The method then enters the exit terminal B. 
         [0028]    From exit terminal B, the method proceeds to another step  402 , defined between a continuation terminal (“terminal C”) and an exit terminal (“terminal D”), where communication between the orchestration engine  103  and compliance engine  102  is referenced. From terminal C, the unique key data is passed on to the compliance engine  102  for matching a corresponding acknowledgement of content (AOC) compliance record, and returns the corresponding AOC compliance information provided by the compliance engine  102  to the user. The method then exits proceeds to exit terminal D. 
         [0029]    Once the device receives this information, it is displayed on the screen for the user to verify. From exit terminal D, the method proceeds to a step  403 , defined between a continuation terminal (“terminal E”) and an exit terminal (“terminal F”) where communication between the orchestration engine  103  and the compliance engine  102  for the closure of AOC is referenced. From terminal E, upon verification of legitimacy and accuracy of the compliance information, the user provides proof of acknowledgement (for example, a digital signature, mouse signature, etc.) captured on the user&#39;s device, and is transferred by the orchestration engine  103  to the compliance engine  102  which appends the referenced AOC record with the AOC compliance data received. The method then exits from terminal F, where it terminates execution  404 . 
         [0030]      FIG. 5  defines the steps involved in the electronic AOC management process life cycle and orchestration method. The user, through the user interface  112  and starting from  500 , makes a call  501  requesting the AOC information using the unique key data. This unique key data is transmitted to the AOC interface  111 . The AOC interface  111  receives  502  the unique key data and transfers  503  it to the AOC master  110 . The AOC master  110  receives  504  the unique data and collects  505  the compliance AOC information associated/matching to the unique key data. The compliance AOC information associated information is transferred  506  from the AOC master  110  to the AOC interface  111 . The AOC interface  111  receives  507  and transfers  508  the same to the user interface  112  where it is displayed  509  to the user. 
         [0031]    The user, upon verification  510  of the compliance AOC information being displayed through the user interface  112 , acknowledges  511  the AOC information and sends back a proof of acknowledgement (POA) to the AOC interface  111  through the user interface  112 . The AOC interface  111  receives  512  and transfers  513  the POA to the AOC master  110 . Upon receiving  514  the POA, the AOC master  110  appends  515  the POA to the original AOC information and the AOC is closed  516  and saved and then terminated  517 . 
         [0032]    Although the present invention has been shown and described with respect to several preferred embodiments thereof, various changes, omissions and additions to the form and detail thereof, may be made therein, without departing from the spirit and scope of the invention.