JP2016148878A - Risk management of medical treatment based on device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a device-based risk management method in medical treatment having contraindication and/or side effects.SOLUTION: A request to register a prescriber in an RMS host device is received 210, educational information/teaching materials are provided to the prescriber in response to the request reception 220, authentication information including access to an authentication examination relating to the teaching materials is provided to the prescriber 230, the prescriber takes the authentication examination in a calculation device or the like of the prescriber, a host device receives an identifier of results of the prescriber about the examination 240, and when the prescriber's results satisfy criterion of results for the examination, the prescriber is registered in an RMS in a host device 250.SELECTED DRAWING: Figure 2

Description

[Priority of related applications]
This application claims the priority of Japanese Patent Application No. 2014-018583 filed on February 3, 2014, entitled “SYSTEMS, APPARATUSES, AND METHODS FOR RISK MANAGEMENT OF A THERAPEUTIC”. The disclosure of this Japanese application is incorporated herein by reference in its entirety.

  While treatments such as medications have the potential to significantly improve patient health and well-being, the use of medications is not without risk, especially in outpatient settings that are not monitored. Despite enhanced risk mitigation activities and risk communication from regulatory agencies such as the Food and Drug Administration (FDA), some medications with known preventable risks are monitored by appropriate patients. In order not to be violated, it is collected from the market or distribution is limited. In other cases, drug treatment continues to be inappropriately prescribed to patients with contraindications to the use of the drug treatment that appears when the patient begins to use the drug treatment.

  Thus, there is a need for effective device-based risk management of treatments with known contraindications and / or side effects.

  A risk management system (RMS) device comprises an RMS database and an RMS processor. The RMS processor comprises a prescriber module that receives a request to enroll a patient in an RMS program of therapeutics associated with a plurality of indications. This requirement includes the specification of at least one indication and confirmation of diagnostic tests performed on the patient. The RMS processor also includes a patient module configured to generate a patient profile. The RMS processor also includes a database module configured to store the patient profile in an RMS database. The RMS processor also includes an authorization module configured to generate an authorization code that indicates whether the patient is authorized to receive the therapeutic agent. The RMS processor also includes a communication module configured to send an authorization code to the pharmacy or prescriber.

1 is a schematic explanatory diagram of a system including an RMS host device according to an embodiment. FIG. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. 3 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to another embodiment. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. FIG. 2 is a diagram illustrating an example of an information flow between various entities illustrated in FIG. 1. FIG. 2 is a diagram illustrating an example of an information flow between various entities illustrated in FIG. 1. FIG. 2 is a diagram illustrating an example of an information flow between various entities illustrated in FIG. 1. FIG. 2 is a diagram illustrating an example of an information flow between various entities illustrated in FIG. 1. FIG. 2 is a diagram illustrating an example of an information flow between various entities illustrated in FIG. 1. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment. 2 is a flowchart illustrating a method of the RMS host device of FIG. 1 according to one embodiment.

  Described herein are systems, devices, and methods that enable management of the risk of using one or more therapeutic agents, such as prescription drugs (ie, restricted items) and potential side effects (risks) associated therewith. The Aspects of the present disclosure reduce known and unknown safety risks associated with therapeutic agents, as well as pharmaceutical manufacturers, prescribers (eg, medical professionals), patients, and dispensing entities (eg, hospitals, outpatient pharmacies, etc.), etc. Enables various entities involved in risk management to interact to allow the safe and informed use of restricted pharmaceuticals / therapeutics.

  In some embodiments, a risk management system (RMS) device comprises an RMS database and an RMS processor. The term “RMS” or “risk management system” can refer to any system that implements management and / or distribution strategies for the treatment of pharmaceuticals and / or biologicals, etc. May include scenarios ordered and / or desired by entities (eg, manufacturers) and / or regulatory agencies (eg, US Food and Drug Administration (FDA)) in a therapeutic supply / distribution chain. For example, one such RMS is needed if the FDA determines that a risk assessment mitigation strategy (REMS) is needed to ensure that the benefit of treatment is more important than the risk. Can be used to implement REMS. As another example, RMS can include risk management tasks required by the European Medicines Agency regarding the effectiveness of advanced medical products and post-authorization follow-up of adverse reactions. As yet another example, RMS can include risk management guidelines from the Ministry of Health, Labor and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In other embodiments, the RMS device can be initiated and / or implemented without being requested by a regulatory body (eg, by a manufacturer and / or a distributor based on risk autonomy).

  The RMS processor includes a prescriber module configured to receive, via a communication network, a request from a computing device associated with a prescriber to register a patient in an RMS program of therapeutics associated with a plurality of indications. Prepare. This requirement includes the specification of at least one indication and confirmation of diagnostic tests performed on the patient. This diagnostic test is associated with a therapeutic agent and with an indication. The RMS processor also includes a patient module that communicates with the prescriber module. In response to this request, the patient module is configured to generate a patient profile by identifying a predetermined enrollment period based on the indication. This predetermined registration period may have a first duration when the indication is the first indication. This predetermined enrollment period may have a second duration different from the first duration when the indication is a second indication. The RMS processor also includes a database module that communicates with the RMS database. The database module is configured to store patient profiles in an RMS database. The RMS processor also includes an authorization module configured to generate an authorization code that indicates whether the patient is authorized to receive the therapeutic agent based on a predetermined registration period. The RMS processor also includes a communication module configured to send an authorization code over a communication network to at least one of a computing device associated with the pharmacy or a computing device associated with the prescriber.

  In some embodiments, the RMS device comprises an RMS database that stores a dispenser profile, a patient profile, and a prescriber profile. The RMS device also includes an RMS processor. The RMS processor is configured to receive a request from a computing device associated with a pharmacy for a therapeutic agent associated with at least one indication to dispense a first amount of the therapeutic agent to a patient. A person module can be provided. The RMS database can include a pharmacy dispenser profile, and the RMS database can include a patient profile of a patient. The RMS processor may also include a prescriber module configured to receive confirmation of an appropriate diagnostic test for the patient from a computing device associated with the prescriber. The RMS database can include a prescriber profile of the prescriber. The RMS processor may also include an authorization module configured to generate a first authorization code if a confirmation of an appropriate diagnostic test for the patient is received within a first predetermined time period. The authorization module includes the following: (1) Confirmation of an appropriate diagnostic test for the patient is not received within a first predetermined period and a request from a computing device associated with the pharmacy is a second predetermined Or (2) a request is received from a computing device associated with the prescriber to dispense a second amount, different from the first amount, of the therapeutic agent to the patient. , Can be further configured to generate a second authorization code if at least one of them is true. The RMS processor may also comprise a communication module for transmitting the first authorization code or the second authorization code to a computing device associated with the pharmacy.

  Aspects of the systems, devices, and methods described herein are further operable to ensure that the prescriber receives authorization to prescribe a therapeutic agent through testing. In some embodiments, the method includes receiving a request from the prescriber to register the prescriber with the RMS at a host device of the RMS system for the therapeutic agent associated with the at least one indication. . The method further includes providing the prescriber with educational material associated with the RMS and associated with the therapeutic agent. The method additionally includes providing the prescriber with access to the exam for the teaching material and receiving at the host device an identifier of the prescriber's performance for the exam. The method also includes registering the prescriber with RMS at the host device if the prescriber's performance meets the test performance criteria.

  Aspects of the systems, devices, and methods described herein are further operable to ensure that a dispenser, such as a pharmacy, receives authorization to dispense a therapeutic agent through a test. In some embodiments, the method includes receiving a request from the pharmacy to register the pharmacy with the RMS at the RMS host device for the therapeutic agent associated with the at least one indication. The method also includes providing educational material associated with the RMS and therapeutic agent to the pharmacist associated with the pharmacy, and further includes providing the pharmacist with access to exams relating to the educational material. An identifier of the pharmacist's performance for the test can be received at the host device, and if the pharmacist's performance meets the test performance criteria, the pharmacy can be registered with the RMS at the host device.

  Aspects of the systems, devices, and methods described herein allow a patient to be treated when the patient undergoing a diagnostic test required to receive the therapeutic agent and / or re-supplement of the therapeutic agent is confirmed. It is further operable to ensure that a restocking of the drug and / or therapeutic agent is received. In some embodiments, the method confirms a diagnostic test of a patient enrolled in RMS by a prescriber enrolled in RMS at an RMS host device for a therapeutic associated with at least one indication Receiving. The method also includes generating an authorization code indicating whether a pharmacy registered in the RMS is authorized to dispense a therapeutic drug to the patient based on receipt of the confirmation by the prescriber. A request to dispense a therapeutic agent for the patient is received at the host device from a computing device associated with the pharmacy. The authorization code can be provided to a computing device associated with the pharmacy.

  Aspects of the systems, devices, and methods described herein are limited in scope and / or if a confirmation of a diagnostic test is not received when the patient provides a prescription for a therapeutic agent to a dispenser / pharmacy. Or, under certain circumstances, it is still operable to ensure that the patient can take advantage of the therapeutic agent. In some embodiments, the method is performed at a RMS host device for a therapeutic agent associated with at least one indication, from a computing device associated with a pharmacy registered with RMS, to a patient registered with RMS. Receiving a request to dispense a first amount of the therapeutic agent. The method includes generating a first authorization code if a confirmation of an appropriate diagnostic test for a patient is received within a first predetermined period from a prescriber registered with the RMS. The second authorization code is the following: (1) Confirmation of the appropriate diagnostic test of the patient is not received within the first predetermined time period and the request from the computing device associated with the pharmacy is the second Or (2) a request is received from the computing device associated with the prescriber for the patient to dispense a second amount of the therapeutic agent that is different from the first amount. Generated if at least one of the things done is true. The method does not receive confirmation of an appropriate diagnostic test for the patient within a first predetermined time period and receives a request to dispense a second amount of the therapeutic agent from a computing device associated with the prescriber. If not, further includes generating a third authorization code. The first authorization code, the second authorization code, or the third authorization code is provided to a computing device associated with the pharmacy.

  The aspects of the systems, devices, and methods described herein can be further used for multiple indications. At least some of these multiple indications can be associated with different patient enrollment periods. In some embodiments, the method includes receiving a request from the prescriber to register the patient with the RMS at the RMS host device for the therapeutic agent associated with the plurality of indications. This request can include indication details and can further include confirmation of a diagnostic test performed on the patient. This diagnostic test is associated with a therapeutic agent and with an indication. The method also includes registering the patient with the RMS at the host device in response to the request. This registration may include identifying a predetermined registration period based on the indication. This predetermined enrollment period may have a first duration when the indication is a first indication among a plurality of indications. This predetermined enrollment period may have a second duration different from the first duration when the indication is a second indication from among a plurality of indications. The method also includes generating an authorization code that indicates whether the patient is authorized to receive the therapeutic agent based on a predetermined registration period.

  Embodiments of the systems, devices, and methods described herein allow a patient to treat a therapeutic for that indication for the correct indication and duration (among multiple indications associated with the therapeutic). It is further operable to ensure that it is registered with the RMS before dispensing to the patient. In some embodiments, the method is a non-RMS registered patient from a computing device associated with an RMS registered pharmacy at an RMS host device for a therapeutic associated with multiple indications. Receiving a request to dispense a certain amount of the therapeutic agent. This requirement may include indication details. If the request meets patient registration criteria associated with the indication, a first authorization code can be generated at the host device in response to the request and the patient is RMS for a first duration. Can be registered. If the indication is a second indication and the request meets patient registration criteria associated with the second indication, in response to the request, generating a second authorization code at the host device The patient can be enrolled in the RMS for a second duration that is different from the first duration. The method can also include providing a first authorization code or a second authorization code to a computing device associated with the pharmacy.

  In some embodiments, the method includes receiving a request from the prescriber to register the patient with the RMS at the RMS host device for the therapeutic agent associated with the plurality of indications. This request can include indication details and can further include confirmation of a diagnostic test performed on the patient. Diagnostic tests can be associated with therapeutic agents and indications. The method can also include registering the patient with the RMS at the host device in response to the request. This registration may include identifying a predetermined registration period based on the indication. This predetermined enrollment period can have a first duration when the indication is the first indication. This predetermined registration period may have a second duration different from the first duration when the indication is a second indication. The method may also include generating an authorization code indicating whether the patient is authorized to receive the therapeutic agent based on a predetermined registration period.

  Aspects of the systems, devices, and methods described herein are for patients enrolled in RMS for one of several indications associated with a therapeutic agent, in some embodiments, indications You may continue to receive treatment if you do not meet the criteria for dispensing the disease / therapeutic (eg, confirming the diagnostic test) if you meet the dispensing criteria for another of the indications It is further operable to ensure that it can. In some embodiments, a method is provided for an RMS host device for a therapeutic agent associated with a plurality of indications from a computing device associated with an RMS registered pharmacy to an RMS registered patient. Receiving a request to dispense a therapeutic agent. This request may include an identifier for the first indication. In the host device, if (1) the request does not meet the dispensing criteria associated with the first indication and (2) the request meets the dispensing criteria associated with the second indication, It may also include generating an authorization code associated with the patient. The method can also include providing an authorization code to a computing device associated with the pharmacy so that the pharmacy can dispense the therapeutic agent to the patient using the authorization code.

  The aspects of the systems, devices, and methods described herein ensure that the patient is registered with the RMS for the correct indication and that the patient is in the correct form of the therapeutic agent (eg, correct amount, dosage, It is further operable to ensure that it is requesting (and receiving) frequency, titer, number of tablets, type of drug (tablet, liquid, capsule, etc.). In some embodiments, the method is a non-RMS registered patient from a computing device associated with an RMS registered pharmacy at an RMS host device for a therapeutic associated with multiple indications. Receiving a request to dispense a certain amount of the therapeutic agent. This requirement may include indication details. (1) the indication is the first indication, (2) the requirement meets the patient registration criteria associated with the first indication, and (3) the amount is a therapeutic agent for the first indication If the associated dispensing criteria are met, the host device can generate a first authorization code and respond to this request to register the patient with the RMS for a first duration. Can do. (1) the indication is a second indication, (2) the request meets patient registration criteria associated with the second indication, and (3) the amount is a therapeutic agent for the second indication If the associated dispensing criteria is met, the host device can generate a second authorization code and, in response to this request, for a second duration that is different from the first duration. Patients can be enrolled in RMS. The method can further include providing a first authorization code or a second authorization code to a computing device associated with the pharmacy. In some embodiments, registering a patient with RMS can, for example, activate pre-registration, re-register the patient with RMS, extend the duration of the patient's registration period with RMS. Etc. can be included.

  What is not specified for a quantity, as used herein, includes a plurality of referents in addition to the singular unless the context clearly dictates otherwise. Thus, for example, the term “network” is intended to mean a single network or a combination of networks.

  FIG. 1 is a schematic illustration of a system that can implement aspects of the RMS host device 100 (hereinafter “host device”) and can be used for one or more therapeutic agents and one or more indications. . Host device 100 is an entity (such as one or more prescribers 112, one or more patients 114, and one or more dispensers 116 for risk management of one or more therapeutic agents (in FIG. To be used by (indicated by the singular). In some embodiments, the host device 100 may include one or more manufacturers and / or distributors of one or more therapeutic agents, in other words, one or more therapeutic agent companies versus a patient. Owned, managed and / or otherwise associated with any entity in the business-to-business distribution chain that does not include the last entity involved in dispensing.

  The prescriber 112, the patient 114, and / or the dispenser 116 represents a human entity, a hardware / software interface that interacts with the host device 100 (eg, computing device, landline or mobile phone, web interface, etc.), etc. It is understood that you can. For example, the prescriber 112 may use a web browser-based interface and / or a cloud-based application to manage and administer a certification test (described below) for the prescriber, a prescriber's internal phone call to request diagnostic test confirmation (described below) Etc. can be included. In another example, the dispenser 116 can include a web browser-based interface for providing the dispenser with code (described below) for dispensing the therapeutic agent (s) to the patient 114. . Thus, the distinction between these entities, in particular the distinction between the prescriber 112 and the dispenser 116, can be merely functional. In other words, the same entity can both prescribe and dispense pharmaceuticals, but will interact with the host device 100 via different interfaces.

  The host device 100 can communicate with the prescriber 112, the patient 114, and / or the dispenser 116, for example, via one or more networks, as shown by the solid lines in FIG. Each of these networks can be any type such as, for example, a local area network (LAN), a wide area network (WAN), a virtual network, a telecommunications network, and / or the Internet implemented as a wired network and / or a wireless network. Network. Any or all communications can be secure (eg, encrypted) or non-secure, as is known in the art. The host device 100 can be a personal computer, server, workstation, tablet, mobile device, cloud computing environment, application or module running on any of these platforms, and the like. Dotted lines indicate communication and / or other interactions between the prescriber 112, the patient 114, and / or the dispenser 116. These interactions are not necessarily performed via the host device 100. For example, the prescriber 112 may request the prescription medicine of the patient 114 from the dispenser 116 by telephone.

  The host device 100 includes at least a processor 110 (sometimes referred to as an “RMS processor”) and a memory 160. Although FIG. 1 also shows a database 170 (sometimes referred to as an “RMS database”), it will be understood that in some embodiments, the database 170 and memory 160 may be a common data store. Will. In some embodiments, the database 170 comprises one or more databases. Furthermore, in other embodiments (not shown), the at least one database may reside external to the host device 100. FIG. 1 also shows an input / output (I / O) component 180. This component is one implemented in software and / or hardware for the prescriber 112, patient 114, dispenser 116, and / or other entity to interact directly or indirectly with the host device 100. Or multiple input / output interfaces can be shown.

  The memory 160 and / or database 170 may be individually, for example, random access memory (RAM), memory buffer, hard drive, database, erasable programmable read only memory (EPROM), electrically erasable read only memory (EEPROM), A read-only memory (ROM), a flash memory, or the like can be used. Memory 160 and / or database 170 may store instructions that cause processor 110 to perform modules, processes, and / or functions associated with host device 100.

  The processor 110 includes a business module 122, a prescriber module 124, a patient module 126, a dispenser module 128, an authorization module 130, a database module 136, and a communication module 140. In some embodiments, processor 110 may include additional modules (not shown). Each module may be individually a hardware module and / or a software module (implemented in hardware such as processor 110).

  In some embodiments, the functions of one or more of these modules can be combined and / or superimposed. For example, the communication module 140 and the database module 136 can be a single module. In some embodiments, the functionality of one or more modules and / or the interaction between those modules can be based on legal regulations for data processing, storage, integrity, security, etc.

  The processor 110 can be, for example, a general purpose processor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a digital signal processor (DSP), or the like. The processor 110 may be configured to operate and / or execute application processes and / or other modules, processes and / or functions associated with the device 100 and / or the network. Any of prescriber 112, patient 114, dispenser 116 may also include a memory and processor (not shown in FIG. 1).

  Communication module 140 may be operable to facilitate network connectivity for host device 100, as is known in the art. For example, the communication module 140 can include and / or operate a network interface controller (NIC), a wireless connection, a wired port, and the like. Accordingly, the communication module 140 can establish and / or maintain a communication session with the prescriber 112, the patient 114, and / or the dispenser 116. In other words, the communication module 140 may allow the RMS host device 110 to send and receive data to the prescriber 112, the patient 114, and / or the dispenser 116.

  Database module 136 is operable to interface with memory 160 and / or database 170 for data manipulation (including storage, modification, and / or deletion). For example, the database module 136 may be operable to store the prescriber profile of the prescriber 112 in the memory 160, store the patient profile of the patient 114 in the database 170, and the like. In another example, the database module 136 is operable to store the patient profile in the database 170 and / or change the patient profile stored in the database 170 to change the patient status from active to inactive. (Described in more detail herein). In yet another example, the database module 136 may determine the dispenser profile associated with the dispenser 116 and stored in the database 170 when the dispenser cannot re-register with the host device 100 before the expiration of the dispenser registration period. May be operable to delete or update (eg, set an inactive flag).

  The office module 122 is operable to facilitate control of the host device 100 including browsing and manipulation of the memory 160 and / or the database 170. In some embodiments, as described in more detail herein, the office module 122 can be used by a user (not shown), such as a telephone operator, third party computing device, etc., associated with the host device 100. 112, patient 114, and / or dispenser 116 may be further operable to facilitate information input by the user when interacting with one another.

  In some embodiments, the prescriber module 124 is operable to register the prescriber 112 with the host device 100 for one or more of the therapeutic agents. In some embodiments, these one or more therapeutic agents include N- (4-{[(5R) -7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-. 1-Benzazepin-1-yl] carbonyl-3-methylphenyl) -2-methylbenzamide, ie tolvaptan (hereinafter “tolvaptan”). In some embodiments, these one or more therapeutic agents include different formulations and / or amounts of tolvaptan. In some embodiments, different formulations and / or amounts of tolvaptan are intended for different indications. In some embodiments, at least one of these indications is hyponatremia. In some embodiments, at least one of these indications is autosomal dominant polycystic kidney disease (ADPKD).

  In some embodiments, the prescriber module 124 is operable to receive directly from the prescriber 112 a request to register the prescriber via any suitable means such as, for example, the web interface of the prescriber module 124. It is. In other embodiments, the prescriber module 124 indirectly receives a request to register the prescriber 112. For example, in some embodiments, the prescriber 112 provides the registration request via a mail form, a facsimile form, or a telephone call. In such embodiments, the registration request can be entered into the host device 100 via the office module 122 (eg, by a user interacting directly with the host device) and then and / or indirectly the prescriber module. 124 can receive.

  In some embodiments, the registration request includes prescriber registration information. In some embodiments, prescriber registration information is received as part of a registration form that is reviewed and completed by the prescriber 112. In some embodiments, in response to the registration request, a blank prescriber registration form is provided to the prescriber 112, and in response to providing the blank registration form, the registration information / completed registration form is Received. In some embodiments, the registration request is specific to one or more therapeutic agents and / or indications, and subsequent registration operations may include the specific therapeutic agent (s) and / or Alternatively, it is intended to register the prescriber 112 with the host device 100 for the indication (s).

  For simplicity, now described with respect to one specific therapeutic agent, in some embodiments, in response to a registration request for a therapeutic agent, the prescriber module 124 may be configured via a web interface, email, etc. And is operable to provide education information and authentication information to the prescriber 112. In other embodiments, the user of the device 100 is instructed (via the office module 122) to provide printed prescription information and authentication information to the prescriber 112, for example, via mail or facsimile. .

  In some embodiments, the educational information includes: prescription information for a therapeutic agent, prescriber compliance requirements for registration, one or more indications associated with the therapeutic agent, therapeutic agent One or more side effects associated with the drug, adverse event reporting information for the treatment (whether or not associated with one or more indications), a list of additional educational resources, and registration with the RMS system Including one or more of the diagnosed patient diagnostic test requirements and the like. Prescription information can include patient registration / interruption information, patient counseling information, diagnostic test instruction information, diagnostic test review information, diagnostic test report / confirmation information, patient re-registration information, etc. Absent. In some embodiments, the educational information is in the form of letters, online forms, email messages, interactive (online or directly met) question answering sessions, and the like. In embodiments where the registration request specifies more than one therapeutic agent, the educational information can include the specified therapeutic agent.

  The authentication information may include access information for an authentication test related to educational information. In some embodiments, the access information includes a unique link and / or identifier for accessing a web-based authentication test conducted by the prescriber module 122. In some embodiments, a third party may administer a prescriber authentication test directly (not shown) directly from the server and / or host device associated with the third party via the host device 100. it can. In other embodiments, the third party can manually administer the test (eg, at a test center, prescriber's office, etc.).

  In other embodiments, the access information includes a phone number that the prescriber 112 can call and can perform an automated authentication test by phone or a manually managed authentication test. In some embodiments, the access information is a hardcopy fillable request (eg, a prepaid postcard) of the certification test that is mailed to the prescriber 112. In some embodiments, the authentication information can include a certification test. In some embodiments, the registration duration of the prescriber 112 is based on the prescriber's performance (e.g., a higher score results in a longer registration duration than a lower score, and vice versa) ). For example, if the prescriber's score is above a first threshold but below a second threshold, the prescriber may be authorized to prescribe a therapeutic agent for a first period. On the other hand, if the prescriber's score is above both the first threshold and the second threshold, the prescriber authorizes to prescribe the therapeutic agent for a second period that is longer than the first period. Can receive.

  Certification tests can include questions in any suitable format that test the prescriber's ability to understand educational information (eg, multi-choice questions, short answers, etc.). In some embodiments, the prescriber module 122 operates to comprehensively analyze the prescriber's 112 performance (eg, answers to multi-choice questions via automated text analysis, etc.) regarding the certification test. Is possible. In other embodiments, the prescriber module 124 analyzes a portion of the authentication test and receives an analysis of the remaining portion of the authentication test from another entity (eg, an external test entity, a user of the device 100, etc.). In yet another embodiment, the prescriber module 124 communicates prescriber responses to the certification test to another entity (not shown) that parses those responses.

  In some embodiments, the analysis of the certification test generates an identifier of the prescriber 112 performance. In some embodiments, this identifier is a sliding scale (eg, 43% correct answer, 56/100 correct answer, etc.) or discrete scale (eg, 30% -40% correct answer, 50-60 correct answer, etc.) prescription. This is a measure of the performance of the person 112. In some embodiments, this identifier is a binary identifier of the prescriber's 112 performance, such as, for example, whether the prescriber has achieved a threshold score (“pass”) or not (“fail”). In some embodiments, the threshold score may be a perfect score (ie 100% correct). In some embodiments, the authentication test includes several sections, and the identifier can be a combination of identifiers per section or a single identifier across multiple sections.

  In some embodiments, the prescriber module 124 is operable to register the prescriber 112 with the host device 100 when the prescriber's performance meets the certification test performance criteria. The performance criteria for this certification test or section thereof must achieve the following: a threshold scale (eg, at least 60%), a binary scale (eg, a “pass” score as discussed above) ), And the like.

  In some embodiments, registering the prescriber provides the prescriber registration form to the prescriber 112 via the prescriber module 124 and / or the completed registration form directly from the prescriber or the prescriber. Receiving indirectly via module 124. The registration form consists of the following: the prescriber's name, the prescriber's registration identifier, such as the National Provider Identifier (NPI), contact information, qualifications, specialties, and the contractual provisions specified in the registration form. One or more fields of agreement agreement etc. may be included.

  In some embodiments, the prescriber module 124 is further operable to generate an authentication identifier for the prescriber 112 in response to receiving the registration form. The prescriber module 124 is further operable to generate a prescriber profile for the prescriber 112 and store the prescriber profile in the memory 160 and / or the database 170 (eg, via the database module 136). The prescriber profile includes prescriber registration information, authentication identifiers, treatment (s) and / or indication (s) for which the prescriber 112 has been registered, prescriber for each treatment It can include, but is not limited to, the registration duration, the date of the most recently passed certification test, and the like.

  Although described herein with respect to embodiments in which the prescriber 112 requires registration, in other embodiments, the prescriber module 124 may provide education information and authentication information without input from the prescriber. Is operable to prompt the prescriber to register. The prescriber 112 can then undergo a certification test and register in a manner similar to that described above.

  In some embodiments, the enrollment of the prescriber 112 to the RMS does not expire within a certain period. In some embodiments, the registration of the prescriber 112 with the RMS expires at the end of the prescriber registration period, and the prescriber module 124 re-registers with the prescriber when the prescriber registration period is about to expire. It is operable to recall. The prescriber 112 can then choose to re-register before expiration. In some embodiments, the prescriber 112 may need to re-take the certification test for re-registration and / or take a different certification test, while in other embodiments the pre-registrant's re-registration is Does not require the assessment to be completed.

  In some embodiments, the patient module 126 sends a request to enroll a patient in a therapeutic RMS program associated with multiple indications from the prescriber 112 or a computing device associated with the prescriber 112 to a communication network. Is operable to receive via. This requirement may include at least one indication of indication. In some embodiments, the request can also include confirmation of the diagnostic test performed on the patient if the diagnostic test is associated with a therapeutic agent and an indication. In some embodiments, the patient module 126 is operable to register the patient 114 with the host device 100 for one or more of the therapeutic agents and / or one or more indications. In some embodiments, the patient module 126 is operable to provide a patient registration form to the patient 114 and / or the prescriber 112 and receive patient registration information from the patient 114 and / or the prescriber 112.

  In some embodiments, the patient module 126 is operable to provide a patient registration form to the prescriber 112. In other words, in such an embodiment, the prescriber 112 registers the patient 114 after counseling the patient and obtaining the patient's consent for treatment by the prescriber. In such embodiments, patient module 126 is operable to provide patient education information and patient registration forms to prescriber 112 directly or through prescriber module 124. The prescriber 112 then communicates patient education information to the patient, verbally, electronically, via a printout, etc., according to the prescriber registration form described above, etc. be able to. Although the case of patient registration is described herein, the patient registration form can also be used for patient re-registration (eg, every time patient registration expires).

  In some embodiments, a patient registration form is performed on patient 114 to monitor the potential and / or actual occurrence of adverse side effects related to / not related to the therapeutic agent (s). Authentication of the diagnostic test to be performed may be required by the prescriber 112. In such embodiments, the prescriber 112 can obtain diagnostic test results in any suitable manner. Any suitable method may include, but is not limited to, performing a diagnostic test by the prescriber himself, instructing the diagnostic test to be performed at the laboratory, and then reviewing the results. Absent. In some embodiments (not detailed herein), the prescriber 112 can direct a diagnostic test via the host device 100, such as via an instruction module (not shown). In some embodiments, the patient 114 can select the location to be tested and prepare the prescriber 112 to receive the diagnostic test results. In some embodiments, the diagnostic test is a liver function test (LFT). In some embodiments, the LFT measures plasma levels of one or more of total bilirubin, alanine aminotransferase, and aspartate aminotransferase.

  Patient registration form includes patient identification information, patient contact information, indication of whether the patient is registered for the first time or re-registration, one or more indications that the patient is undergoing treatment, procedures such as diagnostic tests And patient consent for treatment related issues, one or more diagnostic test results for the patient, authentication from the prescriber that the diagnostic test results are good, and the like. The patient module 126 sends the completed patient registration form directly or via the prescriber module 124 or through the office module 122 (eg, when the prescriber 112 sends the completed form via mail or facsimile). This is then further operable to receive (entered into device 100).

  In other embodiments, the patient module 126 is based on a patient registration form or otherwise, the patient is a new patient (ie no patient profile exists) or is a currently registered patient (ie , Associated with an active patient profile) or a previously registered patient (ie, associated with an inactive patient profile). In some cases, patient 114 is a new patient and patient module 126 is operable to generate a new patient profile for that patient based on the completed registration form. It is operable to store in memory 160 and / or database 170 (eg, via database module 136). In some embodiments, the patient module 126 generates a patient profile by identifying a predetermined enrollment period / duration of enrollment based on the indication. This predetermined enrollment period can have different durations for different indications. For example, in some embodiments, the predetermined enrollment period has a first duration for the first indication and a second duration that is different from the first duration for the second indication. The same applies to other indications.

  The patient profile includes patient registration information, the treatment (s) for which the patient 114 has been registered, patient prescription information, patient registration duration, one or more prescribers associated with the patient profile , Current status of the patient profile (active / inactive), one or more indications associated with the patient, etc., but are not limited to these. In some embodiments, prescribing information such as dosage, quantity, duration, number of refills, etc. is predetermined and cannot be specified by the prescriber 112.

  In some cases, the patient is a currently registered patient with an existing (active) patient profile, and the patient module 126 uses the information from the received patient registration form to Operate to update the profile. Such cases can occur, for example, when the patient is re-registered before the expiration of the previous registration period, or when the patient switches to a different prescriber for the same treatment.

  In some cases, the patient was previously registered, but the procedure was interrupted, so the patient has an inactive patient profile associated with the patient, and the patient module 126 has an existing patient profile. Is updated with information from the received patient registration form and is operable to actively change the status of the updated patient profile. In such cases, for example, when the patient continues treatment again, when switching from one therapeutic agent to another therapeutic agent also managed by the host device 100, when receiving treatment for a different indication, etc. Could happen.

  In some embodiments, the patient module 126 is further operable to receive a periodic confirmation from the prescriber 112 of appropriate diagnostic test results for the patient 114 for continued dispensing of the therapeutic agent. In some embodiments, confirmation of appropriate diagnostic test results is required each time a therapeutic agent is dispensed to patient 114. In other embodiments, confirmation of appropriate diagnostic test results is not required each time a therapeutic agent is dispensed to patient 114. For example, confirmation of appropriate diagnostic test results can be required when the therapeutic agent is first dispensed, then can be required after every two refills, and the patient can re-register If needed / sometimes it can be needed again. In some embodiments, the frequency with which an appropriate diagnostic result needs to be provided can be based on the indication associated with the therapeutic agent. In some embodiments, patient module 126 is operable to store diagnostic test result confirmation (s) in memory 160 and / or database 170 as part of or associated with a patient profile. It is. In other embodiments, the patient module 126 is operable to store diagnostic test result values in the memory 160 and / or database 170 as part of or associated with the patient profile.

  In some embodiments, confirmation of the appropriate diagnostic test result is received as a test confirmation form completed by the prescriber 112. This examination confirmation form can include fields for patient information, prescriber information, examination information, and the like. The test information may include the date of the test, authentication of the test results by the prescriber 112, authentication by the prescriber whether the patient should continue to receive the treatment, etc. In some embodiments, the test information can also include a value of a test result, such as, for example, a blood concentration of the analyte. The test confirmation form can be received electronically by the host device 100 from the prescriber 112 or can be entered indirectly (eg, manual entry of the test confirmation form received via mail or facsimile). ).

  Thus, it is understood that the prescriber 112 can provide confirmation of the diagnostic test results to the host device 100 via a patient registration form, or via a separate test confirmation form, or both. When the duration of patient registration is substantially similar to the periodicity of diagnostic tests and / or dispensing, the prescriber 112 can report test results through a single form during re-registration. . When the duration of patient registration is significantly longer (eg, one year) compared to the periodicity of diagnostic tests and / or dispensing (eg, every 30 days), prescriber 112 is once a year. , And personally meet with patient 114 to complete the patient registration / re-registration form (which can include the patient's signature / consent), and then review the patient's diagnostic test results, Can be submitted. This submission need not include the presence / consent of the patient.

  In some embodiments, the duration of patient enrollment, the periodicity of diagnostic tests, the periodicity of dispensing therapeutics, and / or the duration for which prescriptions (including restocking) are provided can vary. . As an example, the prescriber 112 may provide confirmation of diagnostic test results via a patient registration form upon registration of the patient 114 with the RMS for one year (or other suitable time frame). In such an example, the patient may receive a monthly replenishment of therapeutic agent after undergoing a monthly diagnostic test. In some embodiments, the duration for which the prescription is provided is 3 months (eg, 1 month supply with 2 refills). In this example, the prescriber 112 can fill in a prescription for a one month supply with two refills, and when enrolling the patient 114 or (eg, for one year or other suitable time frame) Confirmation of diagnostic test results can be provided when re-registering). Patient 114 can receive a supply for the first month after being enrolled in RMS. The patient 114 can receive each of the two refills without visiting the prescriber 112 by taking a diagnostic test and having the prescriber 112 confirm the diagnostic test results. In such an example, the patient 114 can visit the prescriber 112 every three months and receive a new prescription for three months (one month supply with two refills). Since the duration of patient registration is one year in this example, patient 114 can first meet with prescriber 112 to receive registration and / or re-registration, and three more times during the registration period. You can meet.

  As another example, the prescriber 112 can provide confirmation of diagnostic test results via a patient registration form during enrollment of the patient 114 for one year. In such an example, the patient receives a therapeutic drug restocking (ie, 11 restocking) every month, and a diagnostic test is performed every three months. In this example, the prescriber 112 can direct and review the diagnostic test results every three months without necessarily interacting with the patient, and the patient 114 is given three times after providing the appropriate diagnostic test results. You can receive a one-time refill. For other refills, no action is taken by the prescriber. If the prescriber decides to re-register the patient for another year, the prescriber can meet the patient again, direct and review the diagnostic tests, and complete the patient re-registration form.

  In some embodiments, the patient module 126 issues periodic reminders to the prescriber 112 associated with the patient 114 if the test confirmation form is not received within a specified period of time since the previous event. Further operation is possible. This previous event may be when the patient 114 last received the therapeutic agent, when the patient's test confirmation form was last received from the prescriber 112, and so on. These reminders can be issued automatically (eg, by the host device 100) or manually (eg, by the dispenser 116). In some embodiments, the reminder is sent by the prescriber 112 when creating the prescriber profile, such as email, text message, automatic phone call, automatic facsimile, notification via cloud-based application on the prescriber's smartphone. Communicate via any suitable means specified. In some embodiments, the periodicity of the reminder and / or whether to issue the reminder may be the duration of the patient's registration, the remaining duration of the patient's registration, the remaining duration of the specified period Based on time, therapeutic agent, one or more indications associated with the therapeutic agent, and the like. For example, if the prescriber is supposed to submit a test confirmation form once a month, the reminder will be 1 per week for the first two weeks after the last time the test confirmation form was submitted. Times, twice in the third week, and every other day in the fourth week. In another example using a similar scenario, the prescriber receives an email reminder during the first two weeks, a text message reminder during the third week, and an automatic telephone call during the fourth week.

  In some embodiments, the patient module 126 is further operable to receive a therapeutic dispensing request for the patient 114 from the prescriber 112 without receiving a test confirmation form. In some embodiments, this dispensing request indicates an authorization from the prescriber 112 for the dispenser 116 to dispense a limited amount of therapeutic agent to the patient 114. In this way, the prescriber 112 may be informed of multiple cases, for example, when the patient notifies the provider of delay in providing diagnostic test results, and when the provider does not have an opportunity to fully review the received diagnostic test results. Under circumstances, the dispenser 116 may be authorized to provide the patient 114 with a therapeutic agent. In some embodiments, the prescriber 112 may provide a dispensing request in response to a reminder from the patient module 126 that submits a test confirmation form. In some embodiments, the prescriber 112 is allowed to issue a limited number of dispensing requests per patient enrollment period. In some embodiments, the prescriber is not allowed to issue successive dispensing requests without submitting a test confirmation form in between.

  The prescriber 112 can provide the dispensing request in any suitable form, such as via a web interface, reply to an email or text message, a telephone call, via facsimile. In some embodiments, patient module 126 may associate a dispensing request for patient 114 with a patient profile for that patient.

  In some embodiments, patient module 126 is further operable to receive one or more adverse event reports for patient 114 from prescriber 112, patient 114, and / or dispenser 116. . In some embodiments, patient module 126 is operable to store adverse event reports in memory 160 and / or database 170 as part of the patient profile or associated with the patient profile. In some embodiments, the patient module 126 is operable to change the status of the patient profile from active to inactive based on the adverse event report.

  In some embodiments, the adverse event report is received as a completed adverse event report form. The adverse event report form may include columns for patient information, information about the reporting entity, and the like. These adverse event reporting forms and / or information can be received electronically directly by the host device 100 from the prescriber 112 or can be entered indirectly (eg, manually entered). Adverse event report (s) may be stored in memory 160 and / or database 170. In some embodiments, certain types of adverse events, such as poor diagnostic test results, are written to an adverse event report form and stored in memory 160 and / or database 170. In some embodiments, other types of adverse events can be reported directly to the manufacturer (s) of the therapeutic agent (s).

  In some embodiments, the stored adverse event report may include a prescriber 112, a patient 114, a dispenser 116, and / or other prescriber / patient / not associated with a researcher, regulatory agency, host device 100. It can be searched by other entities (not shown) such as a dispenser. In some embodiments, the host device 100 may be operable to combine, edit, interconnect, and / or otherwise manipulate stored adverse event reports. In some embodiments, the result of such an operation may be searchable as described above. In some embodiments, these operations can be performed by an adverse event reporting module (not shown) of processor 110.

  In some embodiments, the patient module 126 is further operable to remind the prescriber 112 and / or the patient 114 to re-register the patient when the patient enrollment period is about to expire. The prescriber 112 can then communicate with the patient 114 to complete a new patient registration form and re-register the patient before expiration. As described above for the reminder for the confirmation form, the reminder can be issued automatically (eg, by the host device 100) or manually (eg, by a telephone operator associated with the host device 100). You can also. In some embodiments, the reminder is sent by the prescriber 112 when creating the prescriber profile, such as email, text message, automatic phone call, automatic facsimile, notification via cloud-based application on the prescriber's smartphone. Communicate via any suitable means specified. In some embodiments, the periodicity of the reminder and / or the decision whether to issue the reminder is the following: the elapsed duration of patient registration, the remaining duration of patient registration, ( One of the specific amount of therapeutic drug that the patient receives until the date (for example, after the patient has received his last refill), the therapeutic drug, one or more indications associated with the therapeutic drug, etc. Or it can be based on multiple.

  In some embodiments, dispenser module 128 is operable to register dispenser 116 with host device 100 for one or more of the therapeutic agents. In some embodiments, the dispenser 116 works in an outpatient setting such as a retail pharmacy and / or dispenses directly to the patient. In some embodiments, the dispenser 116 works in a hospital setting such as a hospital, care facility, psychological facility, prison, and the like.

  In some embodiments, the dispenser module 128 may receive a request to register the dispenser directly from the dispenser 116 via any suitable means such as, for example, a web interface of the dispenser module 128 or a telephone call. It is possible to operate. In other embodiments, dispenser module 128 indirectly receives a request to register dispenser 116. For example, in some embodiments, the dispenser 116 provides a registration request via mail, facsimile, or telephone call. In such embodiments, the registration request can be entered into the host device 100 via the office module 122 (eg, by a user interacting directly with the host device) and then (eg, indirectly) the dispenser. Module 128 can receive. Thus, the dispenser can choose to register on demand, such as when the patient 114 is presented with a prescription for the therapeutic agent (s) to the dispenser 116, etc. .

  In some embodiments, the registration request includes dispenser registration information. In some embodiments, dispenser registration information is received as part of a registration form that is reviewed and completed by dispenser 116. In some embodiments, in response to the registration request, an incomplete dispenser registration form is provided to the dispenser 116 and the dispenser (eg, pharmacist) has completed the provided dispenser registration form. Then, the dispenser registration information / completed dispenser registration form is received. In some embodiments, the registration request is specific to one or more therapeutic agents and / or indications, and all subsequent registration operations are performed for that specific therapeutic agent (s). And / or registering the dispenser 116 with the host device 100 for the indication (s).

  For simplicity, now described with respect to one specific therapeutic agent, in some embodiments, in response to a registration request for a therapeutic agent, the dispenser module may be configured via a web interface, email, etc. It is operable to provide educational information and authentication information to the dispenser 116. In other embodiments, the user of the device 100 is instructed (via the office module 122) to provide printed educational information and authentication information to the dispenser 116, such as via postal mail or facsimile. .

  In some embodiments, the educational information includes prescription information for the therapeutic agent, prescriber compliance requirements for registration, one or more indications associated with the therapeutic agent, one or more associated with the therapeutic agent. Side effects, therapeutic drug adverse event reporting information (whether or not associated with one or more indications), a list of additional educational resources, etc. In some embodiments, the educational information is in the form of a letter. In some embodiments, if the registration request specifies more than one therapeutic agent, the educational information can include those specified therapeutic agents.

  The authentication information may include access information for a dispenser authentication test related to educational information. In some embodiments, the access information includes a unique link and / or identifier for accessing a web-based dispenser authentication test performed by the dispenser module 128. In other embodiments, the access information includes a telephone number that a representative of a dispenser 114, such as a pharmacist employed by the dispenser, can call to complete an automated test by telephone. In some embodiments, a third party may administer a dispenser authentication test directly (not shown) directly from the server and / or host device associated with the third party via the host device 100. it can. In other embodiments, the third party can manually administer the test (eg, at a test center, prescriber's office, etc.). In some embodiments, the access information is a hard copy fillable request (e.g., prepaid postcard) of the certification test that is mailed to the dispenser 114. In some embodiments, the authentication information can include a dispenser authentication test.

  The dispenser authentication test can include questions in any suitable format that test the representative's ability to understand educational information (eg, multi-choice questions, short answers, etc.). In some embodiments, the dispenser module 128 comprehensively analyzes the performance of the representative of the dispenser on the dispenser authentication test (eg, answers to multi-choice questions via automated text analysis). It is possible to operate. In other embodiments, the dispenser module 128 analyzes a portion of the authentication test and receives an analysis of the remaining portion of the authentication test from another entity (eg, an external test entity, a user of the device 100, etc.). In yet another embodiment, dispenser module 128 communicates with another entity that comprehensively analyzes the certification test.

  In some embodiments, the analysis of the certification test generates a performance identifier for the representative of the dispenser. In some embodiments, this identifier is a dispensing scale (eg, 43% correct answer, 56/100 correct answer, etc.) or discrete scale (eg, 30% -40% correct answer, 50-60 correct answer, etc.) Is a measure of the performance of the representative of the person. In some embodiments, this identifier is a binary value of the performance of the dispenser's representative, eg, whether the dispenser's representative has achieved a threshold score (“pass”) or not (“fail”). It is an identifier. In some embodiments, the authentication test includes several sections, and the identifier can be a combination of identifiers for each section, or a single identifier across all sections.

  In some embodiments, the dispenser module 128 is operable to register the dispenser 114 with the host device 100 when the performance of the dispenser representative meets the performance evaluation criteria of the certification test. The performance criteria for this certification test or section thereof must achieve the following: a threshold scale (eg, at least 60%), a binary scale (eg, a “pass” score as discussed above) ), And the like. In some embodiments, the registration duration of the dispenser 114 is based on the performance of the representative of the dispenser (e.g., a higher score results in a longer registration duration than a lower score, and vice versa). Result). For example, if the dispenser's score is above a first threshold but below a second threshold, the dispenser may be authorized to dispense a therapeutic agent for a first period. On the other hand, if the dispenser's score is above both the first threshold and the second threshold, the dispenser may approve the dispensing of the therapeutic agent for a second period that is longer than the first period. Can receive.

  In some embodiments, registering the dispenser 116 provides the dispenser registration form to the dispenser 116 via the dispenser module 128 and / or the completed registration form directly or indirectly from the dispenser. Receiving automatically. The Dispenser Registration Form includes an indication of whether the Dispenser is in the hospital and / or outpatient setting, the facility name of the Dispenser, the facility type of the Dispenser (eg, in-house pharmacy), the registration identifier for the Dispenser, and contact This may include prior information, qualifications, specialties, contact information for a designated representative of the dispenser, agreement to a contractual agreement as defined in the dispenser registration form, and the like. In some embodiments, contact information is included, and thus registering a dispensing facility that receives and dispenses the therapeutic agent (s) is at least one person associated with the dispensing facility. Virtually enrolling a pharmacist.

  The dispenser module 128 is further operable to generate an authentication identifier for the dispenser 116 in response to receiving the dispenser registration form. Dispenser module 128 is further operable to generate a dispenser profile for dispenser 116 and store the dispenser profile in memory 160 and / or database 170 (eg, via database module 136). The dispenser profile includes the dispenser registration information, the authentication identifier, the treatment drug (s) registered by the dispenser 116, the registration duration of the dispenser 116 for each treatment drug, and the dispenser 116 registered. Indications (in some cases) may be included, but are not limited thereto.

  Although described herein with respect to embodiments where the dispenser 116 requires registration, in other embodiments, the dispenser module 128 may provide the dispenser and / or the pharmacist associated with the dispenser to Even without input from those dispensers and / or pharmacists, it is operable to prompt the dispenser to register by providing educational information. The dispenser 116 can then choose to receive registration in a manner similar to that described above.

  The authorization module 130 receives the authorization request from the dispenser and, after verifying some of the dispensing requirements, as described in more detail herein, allows the dispenser to provide the therapeutic agent to the patient. Can be configured to generate code. In some embodiments, the authorization module 130 is configured to automatically generate a code that allows a dispenser to provide a therapeutic agent to a patient after verifying some dispensing requirements. Can do. In some embodiments, this authorization request is received from a prescriber and / or patient. Further operations of the authorization module 130 can be described, for example, with respect to the following non-limiting scenarios. Patient 114 visits prescriber 112. Here, prescriber 112 considers that patient 114 should receive a prescription for a therapeutic managed by host device 100. The prescriber 112 is registered or already registered with the host device 100 for the therapeutic agent, as described above, and then appropriately advises the patient 114 and the diagnostic tests (s) required. The patient registration form is completed and submitted to the host device 100, and a prescription for the therapeutic agent is issued to the patient 114. The prescriber 112 and / or patient 114 then presents the prescription to the dispenser 116. Here, the dispenser is registered in the host device 100 or has already been registered. In some embodiments, the prescription includes prescriber information (including prescriber authentication identifiers), dispensing information, restocking information, and the like. The dispenser 116 requests authorization from the host device 100 to dispense the therapeutic agent to the patient. In some embodiments, dispenser 116 requests authorization via web interface of dispenser module 128 and / or authorization module 130.

  The authorization module 130 is then operable to receive an authorization request from the dispenser. In some embodiments, the authorization module 130 may allow the patient 114 to receive a therapeutic agent based on whether the prescriber 112 is currently registered and / or authorized to prescribe the therapeutic agent. It is further operable to determine whether it can. For example, in such embodiments, the authorization module 130 can access the prescriber profile of the prescriber 112 in the database 170 via the database module 136. If such a prescriber profile does not exist, or if the prescriber profile does not contain the prescribed therapeutic agent, or if a predetermined period has elapsed since the date of the prescriber's last certification test, etc. The authorization module 130 determines that the prescriber 112 is not authorized. In some embodiments, the prescriber profile may include a flag that indicates the status of the prescriber 112 as authorized / unauthorized, active / inactive, etc. Based on this flag, it can be determined whether or not the prescriber is authorized.

  In some embodiments, the authorization module 130 is currently registered with the dispenser 116, such as by accessing the dispenser's dispenser profile in the database 170 via the database module 136, and / or Based on whether the patient is authorized to dispense the therapeutic agent, the patient 114 is further operable to determine whether the therapeutic agent can be received.

  In some embodiments, the authorization module 130 is further operable to determine whether the patient 114 is authorized to receive a therapeutic agent. In some embodiments, determining whether the patient is authorized includes determining whether the patient 114 is actively registered with the host device 100. In some embodiments, determining whether the patient is approved is whether confirmation of the appropriate diagnostic test results for the patient 114 is provided by the prescriber 112 as part of the patient registration form. Including judging. In some cases, such as when a patient has requested the dispenser 116 to re-supplement a prescription, determining whether the patient is authorized is a subsequent confirmation of the appropriate diagnostic test results of the patient 114. Determining whether or not is provided by the prescriber 112. In some embodiments, determining whether a patient is approved may be an appropriate diagnostic test result, for example, within the past 30 days or from the last date that a patient 114 was dispensed with a therapeutic agent. And determining whether or not it has been received within a first predetermined period, such as within days. In this way, if the patient has been properly tested in a timely manner, the patient can receive the prescribed amount.

  In some embodiments, if an appropriate diagnostic test result is not received within a first predetermined period of time, determining whether the patient is authorized may include an authorization request, eg, a first And determining whether or not it is received within a second predetermined period, such as within seven days from the end of the predetermined period. Thus, if patient 114 has failed to undergo a diagnostic test and / or prescriber 112 has not been able to provide a timely confirmation of the appropriate diagnostic test results, nevertheless The patient 114 may receive a limited amount of therapeutic agent to avoid interruption of treatment.

  In some embodiments, if an appropriate diagnostic test result is not received within the first predetermined period of time, determining whether the patient is approved is a dispensing request received from the prescriber 112; Determining whether the patient 114 is associated with a patient profile. In this way, the prescriber 112 can specify that the patient can receive a limited amount of the therapeutic agent in order to avoid interruption of the procedure that holds the diagnostic test results. In some embodiments, the dispensing request authorizes the patient 114 to receive the therapeutic agent, regardless of how much time has passed since the patient last received the therapeutic agent. In other embodiments, a dispensing request is received if the dispensing request is received within a specific time frame, such as after the expiration of the first predetermined period and / or before the expiration of the second predetermined period, for example. Authorize patient 114 to receive the therapeutic agent.

  In some embodiments, the authorization module 130 is operable to generate and / or update one or more codes (also referred to as “authorization codes” in some embodiments). In some embodiments, these one or more codes can be generated during creation of the patient profile and associated with the patient profile. For example, if a patient will be enrolled for one year and receives the first standard amount of therapeutics at enrollment plus 11 restockings, in some embodiments, 12 codes Can be associated with the patient profile when generating the patient profile. Each code can be set to a forbidden code and / or a warning code (discussed in more detail herein) by default. In other embodiments, the twelve codes can be associated with the patient profile when generating the patient profile when appropriate diagnostic test results are received when generating the patient profile. The first code is a standard authorization code (discussed in more detail herein) and the remaining codes are forbidden / warning codes. Each of these codes can then be changed based on one or more subsequent events. These events include, but are not limited to, receiving diagnostic test results, receiving adverse event reports, receiving dispensing requests, sending codes to dispensers, and the like. In other embodiments, these codes can be continuously generated and associated with a patient profile and updated based on one or more subsequent events.

  In more detail describing the generation and updating of these codes, in some embodiments, these one or more codes are in response to receipt of appropriate diagnostic test results or appropriate diagnosis by the prescriber. Generated and / or updated in response to confirmation of the inspection result. In some embodiments, the one or more codes are generated and / or updated in response to receiving an adverse event report. In some embodiments, the one or more codes are generated and / or updated in response to receiving a dispensing request from the prescriber. In some embodiments, one or more codes are generated and / or updated in response to an authorization request from a dispenser. In some embodiments, the one or more codes are updated upon transmission of the one or more codes to the dispenser. In some embodiments, the one or more codes are updated in response to confirmation of the dispensing of the therapeutic agent for the patient.

  In embodiments where appropriate diagnostic test results are received within the first predetermined time period, the authorization module 130 may be operable to send a standard authorization code to the dispenser 116. In some embodiments, this standard authorization code (e.g., first authorization code) conveys permission for dispenser 116 to dispense a first amount of therapeutic agent to patient 114. . In some embodiments, the first amount is a prescribed amount and / or a standard amount.

  If an appropriate diagnostic test result is not received within the first predetermined period and an authorization request is received within the second predetermined period, the authorization module 130 generates a temporary authorization code; It can be operable to transmit to dispenser 116. In some embodiments, this temporary authorization code (eg, a second authorization code) conveys permission for dispenser 116 to dispense a second amount of therapeutic agent to patient 114. It is. In some embodiments, this second amount is different from the first amount. In some embodiments, this second amount is less than the first amount.

  If the confirmation of the appropriate diagnostic test result is not received within the first predetermined period and the dispensing request from the prescriber 112 has not been received, the authorization module 130 generates a prohibition code and sends it to the dispenser 116. Can be made operable. In some embodiments, the prohibition code (also referred to as “third authorization code” in some embodiments and / or in some cases) is used by the dispenser 116 to dispense a therapeutic agent to the patient 114. It conveys prohibition and / or prohibition to do.

  In some embodiments, the standard authorization code, temporary authorization code, and forbidden code are different from each other. These codes can be of any suitable type as is known in the art and can include alphanumeric characters, symbolic characters, image / graphic elements, and the like. In some embodiments, the code generates prescriber registration information, patient registration information, dispenser registration information, therapeutic agent, time and / or date information (diagnostic tests, authorization requests, code (s)). And / or associated with transmission, etc.), generated based on random numbers, and / or can be specified.

  In some embodiments, the authorization module 130 is operable to associate the generated / transmitted code with the patient profile and / or update the patient profile with the generated / transmitted code. In some embodiments, the authorization module 130 receives confirmation that the therapeutic agent has been dispensed to the patient 114 and associates this dispensing event (eg, via the patient module 126) with the patient profile. It is possible to operate. This confirmation can include dispensing information. This dispensing information includes the time / date of dispensing, the lot number where the therapeutic agent was dispensed, and the like. In some embodiments, the authorization module 130 is operable to associate a dispensing event with a corresponding code that authorized the dispensing event. For example, in some embodiments, the authorization module 130 associates the lot number of the dispensed therapeutic with a standard authorization code or (eg, by appending the lot number to the end of the standard authorization code). Update the standard authorization code using. In another example, the authorization module 130 associates the dispensed lot number of the therapeutic agent with the temporary authorization code or updates the temporary authorization code with the lot number. In some embodiments, the lot number indicates a second amount of pharmaceutical product. For example, in some embodiments, aspects of the present disclosure can be used in scenarios where a therapeutic agent is provided to a dispenser for dispensing in two amounts, a first amount and a second amount. Thus, dispensing the first or second amount of the therapeutic agent to the patient via the code associated with the dispensing event, the lot number associated with the dispensing event, or both Can be tracked.

  Returning to the description of the office module 122, for the various modules, the office module 122 may interact with the user and / or the prescriber 112, the patient 114, and / or the dispenser 116 as described in the description of the various modules. The input of information in the host device 100 by the computing device to be executed can be facilitated. For example, a user receives a prescriber registration form via mail and then enters information from the prescriber registration form into the host device 100 or at the user's computing device associated with the host device. Thus, the prescriber 112 can be registered. As another example, the user may be a call center employee who communicates with the prescriber over the phone, entering prescriber registration information into the host device 100 and defining a prescriber profile. Thus, aspects of the present disclosure provide for any mode of interaction (electronic, verbal, telecommunications, postal, etc.) between the host device 100, prescriber 112, patient 114, and / or dispenser 116. Of combinations.

  In some embodiments, the office module 122 is further operable to periodically report adverse event reports stored in the memory 160 and / or database 170 to a third party, such as a regulatory agency. In some embodiments, the office module 122 is further configured to periodically synchronize one or more therapeutic agent and / or indication adverse event reports managed by the host device 100 with an external adverse event database. It is possible to operate.

  FIG. 2 illustrates a method 200 for registering a prescriber, such as prescriber 112, at the host device 100 for a therapeutic agent associated with at least one indication, according to one embodiment. This FIG. 2 will be described with reference to FIG. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the therapeutic agent is associated with multiple indications.

  At 210, a request to register the prescriber 112 with the RMS host device 100 is received. In response, at 220, educational information / teaching material is provided to the prescriber 112. In addition, at 230, authentication information is provided to the prescriber 112, including access to an authentication test related to the teaching material. The prescriber 112 undergoes an authentication test, such as at the prescriber's computing device, and at 240, the host device 100 receives an identifier of the prescriber's performance for the test. At 250, if the prescriber's performance meets the performance criteria for the test, the prescriber is registered with the RMS at the host device. In some embodiments, registering the prescriber 112 includes authorizing the prescriber to prescribe a therapeutic agent.

  In some embodiments, registering includes registering the prescriber 112 for a predetermined period, such as a prescriber registration period. In some embodiments, the method 200 further includes providing the prescriber with re-registration information associated with the RMS and the therapeutic agent after enrollment and prior to a predetermined period of time. In some embodiments, the method 200 may also receive consent from the prescriber in response to the re-registration information and re-register the prescriber with the RMS at the host device 100 in response to receiving this consent. Including.

  FIG. 3 illustrates a method 300 for registering a pharmacy, such as dispenser 116, at host device 100 for a therapeutic agent associated with at least one indication, according to one embodiment. This FIG. 3 will be described with reference to FIG. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the therapeutic agent is associated with multiple indications.

  At 310, a request to register the pharmacy with the RMS is received at the RMS host device 100. At 320, educational information / teaching material is provided to a pharmacist associated with the pharmacy. Further, at 330, the pharmacist / pharmacy is provided with access to a certification test related to the teaching material. The pharmacist takes this test and, at 340, an identifier of the pharmacist's performance for the test is received by the host device 100. If, at 350, the pharmacist's performance meets the performance evaluation criteria for the certification test, the pharmacy is registered with the RMS. In some embodiments, registering a pharmacy includes authorizing the pharmacy to dispense a therapeutic agent.

  In some embodiments, registering a pharmacy includes registering the pharmacy for a predetermined period, such as a dispenser registration period. In some embodiments, the method 300 further includes providing the pharmacist with re-registration information associated with the RMS and the therapeutic agent after enrollment and before a predetermined period of time. The method also includes receiving consent from the pharmacist in response to the re-registration information and re-registering the pharmacist with the RMS in response to receiving the consent.

  FIG. 4 illustrates a method 400 for authorizing a pharmacy (eg, dispenser 116) to dispense a therapeutic agent associated with at least one indication to a patient, such as patient 114, according to one embodiment. . This FIG. 4 will be described with reference to FIG. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the therapeutic agent is associated with multiple indications.

  At 410, confirmation of a diagnostic test for a patient registered with the RMS is received by the prescriber 112 at the host device 100. Here, the prescriber is already registered in the RMS. At 420, based on receipt of confirmation from the prescriber 112, an authorization code is generated indicating whether the pharmacy registered in the RMS is authorized to dispense the therapeutic agent to the patient 114. At 430, a request to dispense a therapeutic agent to patient 114 is received from the pharmacy, and at 440, an authorization code is provided to the pharmacy.

  In some embodiments, the confirmation includes an identifier of the date on which the diagnostic test was performed on the patient, and the code is generated if the request is received within a predetermined period from this date. . In some embodiments, the confirmation includes an identifier of the date on which the diagnostic test was performed on the patient, and the code is valid for a predetermined period from this date.

  In some embodiments, the method 400 further includes transmitting a request for confirmation of the diagnostic test from the host device 100 to the prescriber 114. This confirmation can be received in response to a request for confirmation. In some embodiments, the method 400 further includes verifying that at least one of the pharmacy or the pharmacist associated with the pharmacy is registered with the RMS before providing the authorization code. In some embodiments, the method 400 further includes verifying the prescriber's registration status prior to generating the code.

  In some embodiments, the confirmation includes confirmation of an appropriate diagnostic test, and the authorization code authorizes the pharmacy to dispense the therapeutic agent to the patient. In some embodiments, the confirmation includes confirmation of an inappropriate diagnostic test and / or confirmation of an adverse event associated with the patient using the therapeutic agent, and the authorization code indicates that the pharmacy has issued the therapeutic agent to the patient. Dispensing is prohibited. In some embodiments, the adverse event is associated with one or more side effects associated with at least one indication. In other embodiments, the adverse event is associated with one or more side effects that are not associated with at least one indication.

  FIG. 5 illustrates a method 500 for authorizing a pharmacy (eg, dispenser 116) to dispense a therapeutic agent associated with at least one indication to a patient, such as patient 114, according to one embodiment. . This FIG. 5 will be described with reference to FIG. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the therapeutic agent is associated with multiple indications.

  At 510, a request to dispense a first amount of therapeutic agent (eg, a prescribed amount and / or a standard amount) to a patient already registered with the host device (eg, by dispenser module 128). Is received at the RMS host device 100 from a pharmacy already registered in the host device.

  At 520, the host device 100 determines that the confirmation of an appropriate diagnostic test for the patient within a first predetermined period (eg, such as can be received by the prescriber module 124) (eg, the prescriber 112). ) Is received or not. If this confirmation is received, a first authorization code is generated at 530 and the generated first authorization code is transmitted to the pharmacy at 570a. In some embodiments, this first authorization code allows the pharmacy to dispense a first amount of the therapeutic agent to the patient.

  If a confirmation is not received (as determined at step 520), at 540A, the host device 100 determines whether a request from the pharmacy has been received within a second predetermined time period. If received, a second authorization code is generated at 550 (eg, by authorization module 130) and the generated second authorization code is transmitted to the pharmacy at 570b.

  If the request from the pharmacy is not received within the second predetermined time period (as determined at step 540A), at 540B, the host device 100 requests the second amount of the therapeutic agent to be dispensed to the patient. It is determined whether (for example, a dispensing request as described above) has been received from the prescriber. If received, a second authorization code is generated at 550 (eg, by authorization module 130) and the generated second authorization code is transmitted to the pharmacy at 570b. If not, a third authorization code is generated at 560 and the generated third authorization code is transmitted to the pharmacy at 570c. In some embodiments, the second authorization code allows the pharmacy to dispense a second amount of the therapeutic agent to the patient without confirmation of an appropriate diagnostic test. In some embodiments, the second amount is less than the first amount. In some embodiments, the third authorization code prohibits the pharmacy from dispensing the therapeutic agent to the patient.

  Although FIG. 5 shows that step 540A is performed before step 540B, in other embodiments, steps 540A and 540B can be performed substantially in parallel, and in other embodiments It will be appreciated that step 540B may be performed before 540A. Regardless of the order in which steps 540A and 540B are performed (as in the illustrated embodiment of FIG. 5), if the second authorization code is found to be true for either step 540A or step 540B It is further understood that the third authorization code is generated when both step 540A and step 540B are found to be false. In yet another embodiment, one of step 540A or step 540B is performed, a second authorization code is generated if the performed step is found to be true, and a third authorization code is Generated when the executed step turns out to be false.

  In yet another embodiment, steps 540A and 540B are performed sequentially or substantially in parallel, and a second authorization code is generated if both steps 540A, 540B are found to be true, This authorization code is generated when any of steps 540A and 540B is found to be false. Thus, if the prescriber sends a dispensing request and the pharmacy makes an authorization request within the second predetermined time period, the patient receives a second amount of the therapeutic agent, otherwise it receives it. Absent.

  FIG. 6 illustrates a method 600 of whether a patient, such as patient 114, is authorized to receive a treatment for a first indication of a plurality of indications associated with a treatment, according to one embodiment. Is shown. This FIG. 6 will be described with reference to FIG. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the indication comprises hyponatremia. In some embodiments, the indication comprises autosomal dominant polycystic kidney disease (ADPKD).

  At 610, a request from a prescriber to register a patient with RMS is received at the RMS host device (eg, by patient module 126 and / or prescriber module 124) for a treatment associated with multiple indications. The In some embodiments, the request may include a description of an indication from a plurality of indications, such as a first indication or a second indication, and a diagnosis made to the patient. Including inspection confirmation. Diagnostic tests can be associated with therapeutic agents and specified indications. At 620, the patient is registered with the RMS at the host device (eg, by the patient module 126) in response to this request. In some embodiments, registering the patient includes identifying a predetermined registration period based on the indication. This predetermined enrollment period may have a first duration when the indication is a first indication among a plurality of indications. The predetermined enrollment period may have a second duration different from the first duration when the indication is a second indication from among a plurality of indications. Thus, in some embodiments, at least two indications, such as a first indication and a second indication, are associated with different enrollment durations. In other embodiments, each indication can be associated with a different enrollment duration. At 630, a first authorization code is generated based on a predetermined registration period (eg, by authorization module 130). The first authorization code can indicate whether the patient is authorized to receive the therapeutic agent.

  In some embodiments, the method 600 further includes receiving a request from the pharmacy to dispense a refill of the therapeutic agent to the patient. The method 600 may additionally include generating a new authorization code that indicates whether the patient is authorized to receive a refill of the therapeutic agent. In some embodiments, generating this new authorization code for the first indication is different from generating this new authorization code for the second indication. In other words, different techniques, algorithms, processes, etc. can be used depending on the indication that the patient is receiving the therapeutic agent. In some embodiments, the same techniques, algorithms, processes, etc. can be used to generate new authorization codes for two or more indications.

  In some embodiments, the confirmation of the diagnostic test is the first confirmation. In some embodiments, when the indication is the first indication, the method 600 is responsive to receiving confirmation of the second diagnostic test from the prescriber within a predetermined enrollment period at the host device. Generating a new authorization code. For example, if a patient is enrolled for one year and the patient needs to be examined monthly to obtain a monthly re-supplement of therapeutics, the first duration may be about one month or less than one month it can. The second diagnostic test can be related to, for example, a refill request or a re-registration request. In some embodiments, when the indication is a second indication, the method 600 is responsive to receiving the request within a predetermined enrollment period without receiving confirmation of the second diagnostic test. Generating a new authorization code. For example, if the patient has been enrolled for one month, the second duration can be one month, and the second confirmation can be made without the need for subsequent diagnostic test confirmation. Received properly at any time during the duration.

  In some embodiments, the method 600 includes: (1) an RMS, (2) a therapeutic agent, and (3) a first indication after enrollment and before the first predetermined enrollment period. Further comprising providing associated pre-registration information to the prescriber. In some embodiments, the method 600 additionally receives consent from the prescriber and the patient in response to the patient re-registration information and re-sends the patient to the RMS in response to receiving the consent at the host device. Including registering.

  In some embodiments, the method 600 further includes receiving a request from the prescriber at the host device to register the prescriber with the RMS for the therapeutic agent. The method 600 may additionally include providing the prescriber with educational material associated with the RMS, therapeutic agent, and / or indication. The method 600 may also include providing the prescriber with access to the exam for the teaching material and receiving at the host device an identifier of the prescriber's performance for the exam. Method 600 may further include registering the prescriber with RMS at the host device if the prescriber's performance meets the test performance criteria.

  In some embodiments, the method 600 further includes receiving a request from the pharmacy at the host device to register the pharmacy with the RMS for the therapeutic agent. Method 600 may additionally include providing educational material associated with the RMS, therapeutic agent, and / or indication to a pharmacist associated with the pharmacy. The method 600 may further include providing the pharmacist with access to the exam relating to the teaching material and receiving an identifier of the pharmacist's grades relating to the exam at the host device. The method 600 can also include registering the pharmacy with the RMS at the host device if the pharmacist's performance meets the test performance criteria.

  7A-7E are illustrations of interactions between the various entities of FIG. 1 in a scenario where the RMS device 100 is a REMS host compliant with FDA REMS requirements, according to one embodiment. 7A-7E show an RMS host 700 (similar to host device 100), prescriber 712 (similar to prescriber 112), patient 714 (similar to patient 114), and pharmacy 716 (dispenser). 116).

  FIG. 7A is an explanatory diagram of prescriber registration and patient registration according to one embodiment. At 720, the prescriber 712 receives a package that includes education information and authentication information that encourages the prescriber 712 to register with the REMS program at the REMS host 700. At 722, the prescriber 712 uses this package information to contact the REMS host 700 to obtain a training program and then undergo a prescriber authentication test. These training programs and prescriber certification tests are provided / managed by the REMS host 700 (or third party) at 724. Assuming that the prescriber 712 meets the performance criteria for the certification test, at 726, the prescriber completes the prescriber registration form and any suitable, such as email, online, fax, etc. Submit to the REMS host 700 via any other means. The REMS host 700 confirms receipt of the prescriber registration form at 728 and registers the prescriber 712 with the REMS program (eg, creates a prescriber profile and stores it in the database). The REMS host 700 also sends the password to the prescriber 712 for future access to the REMS program / website.

  After registration, the prescriber 712 can prescribe the therapeutic agent according to the terms agreed during prescriber registration. Thus, if the prescriber 712 determines during patient 714 counseling that the patient should receive a therapeutic or medication, the prescriber directs the patient's liver function test (LFT) at 730. Patient 714 receives this test at 732 and at 734 prescriber 712 determines whether the LFT meets certain baseline parameters for markers such as total bilirubin, alanine aminotransferase, aspartate aminotransferase, etc. Judging. If this baseline parameter is not met, no further action is taken. If the baseline parameters are met, the prescriber 712 can counsel the patient 714 at 738. This counseling includes explaining the risk of the drug at 736, educating the patient about the drug and the need for regular LFT, and the patient prescriber consent form (similar to the patient registration form) to patient 714 To submit to. Patient 714 receives this counseling / education at 736 and signs the patient prescriber consent form. At 740, the prescriber 712 submits the signed patient prescriber agreement to the REMS host 700, which then registers the patient 714 with the REMS program. The prescriber 712 can then indicate the patient's 714 monthly LFT at 744. At this time, the prescriber can provide the patient with an LFT instruction form for the patient's convenience / recording and a useful starter kit for the pharmaceutical including usage, importance of monthly testing, etc.

  FIG. 7B is an explanatory diagram of pharmacy registration according to an embodiment. At 746, the pharmacy 716 can designate a representative (at 746) to receive a training / authentication program for enrollment in the REMS program hosted by the REMS host 700. At 748, the representative reviews the registration information in the received package. At 750, the representative accesses a training program on the REMS host 700 and takes a certification test. At 752, the REMS host 700 provides a training program and manages a prescriber authentication test. If the representative's performance meets the performance evaluation criteria for the prescriber certification test, at 754, the representative or another pharmacy constituent uses the pharmacy registration form (similar to the prescriber registration form) to the REMS host 700. The REMS host then registers (among other things) the pharmacy 716 with the REMS program.

  FIG. 7C is an illustration of dispensing a first prescription for patient 714, according to one embodiment. At 758, the prescriber 712 sends the therapeutic / pharmaceutical prescription to the pharmacy 716 as part of or separately from the patient prescriber consent form. The prescriber 712 can also send other patient information, such as insurance information, to the REMS host 700 (see step 760). The REMS host 700 can register this information, for example, by associating the received information with the patient profile of the patient 714. The pharmacy will determine whether the prescriber is registered in the REMS program (see step 766) and whether the patient is registered in the REMS program (see step 768) before dispensing the drug based on the prescriber. Check. The pharmacy 716 can then contact the patient 714 at 770 to confirm delivery options (eg, the patient's postal address). The patient confirms the delivery information at 772 and pharmacy 716 responds to delivering the medication to the patient at 774 and the patient receives it at 776. The pharmacy 716 also sends the delivery information to the REMS program at 778 and the REMS host registers this delivery at 780, for example by associating this delivery with the patient profile of the patient 714.

  FIG. 7D is an illustration of dispensing a subsequent prescription (eg, refill) for a patient according to one embodiment. Assuming that the patient receives restocking every 28 days during enrollment, at 782, the REMS host 700 sends an LFT reminder to the patient 714 at 782 when no LFT confirmation has been received (patient , 784, receive this reminder), and at 786, send a reminder to confirm the LFT to the prescriber 712 (the prescriber receives this reminder at 788). Both of these reminders will be sent and received 20 days before the next refill date. At 790, approximately 10 days before the date of the next refill, the REMS host 700 determines whether a test confirmation form (here, a liver function monitoring confirmation form, or HMCF) has been received (correct: determines). . If not, a telephone call reminder is made to the prescriber 712 at 792 and received by the prescriber at 794.

  At some point, the patient 714 completes the LFT at 796 and the LFT results are received by the prescriber 712 (step 798) and reviewed (step 800). If the prescriber 712 thinks that the LFT result is not suitable for continuing the prescription of the therapeutic agent, the prescriber reports an unfavorable result at D (described in more detail in FIG. 7E). If the prescriber 712 thinks that the LFT results are appropriate, the prescriber can instruct refill for the patient 714 and send the HMCF to the REMS host 700. The pharmacy 716 can receive the refill prescription at 806 and the REMS host 700 can receive the HMCF at 808 and update the patient status (eg, patient profile) based on the HMCF.

  The pharmacy 716 confirms the prescriber registration (step 810) and confirms the patient registration (step 812). The pharmacy 716 also ensures that the HMCF has been received by contacting the REMS host 700 at 814. Steps 810, 812, 814 generally include an authorization request from the pharmacy 716 to the REMS host 700 and the response (s) received from the REMS host prior to dispensing the drug as discussed above. Can be included. The REMS host 700 verifies, at 816, that at least one HMCF associated with the patient profile has been reliably received within 30 days from the last time the therapeutic agent was dispensed. Otherwise, no further action is taken by the REMS host 700 or the pharmacy 716. If the conditions at 816 are met, the pharmacy 716 can move on to dispensing the drug in a manner similar to that described above and confirm the delivery operation at 818 (patient 714 confirms at 820). And sending the medication at 822 (the patient receives the medication at 824). The pharmacy 716 also sends delivery information to the REMS host 700 at 826, and the REMS host registers this delivery information at 828.

  FIG. 7E is an illustration of a prescriber 712 reporting an unfavorable LFT report according to one embodiment. At 830, the prescriber 712 completes a hepatotoxicity reporting form (HRF) that can be provided to the REMS host via a web interface, email, fax, or the like. At 832, the REMS host 700 receives the HRF, and in this embodiment, shares the HRF with, for example, a pharmaceutical manufacturer. At 834, the REMS host 700 further ensures that the patient does not receive an additional amount of medication by changing the patient's status to inactive, thereby effectively “unregistering” the patient 714. To.

  FIG. 8 illustrates a method 800 for authorizing a patient, such as patient 114, to receive a therapeutic associated with multiple indications if some registration criteria are met. This FIG. 8 will be described with reference to FIG. In some embodiments, the patient may be the first person registered with RMS. In other embodiments, the patient may be one who is re-registered with RMS and / or who gets a re-supplement of a therapeutic agent. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the indication comprises hyponatremia. In some embodiments, the indication comprises autosomal dominant polycystic kidney disease (ADPKD).

  At 810, a request to dispense a certain amount of therapeutic agent to a patient is received from a computing device associated with a pharmacy registered with the RMS, such as dispenser 116. In some embodiments, the request may include a description and / or identifier of an indication from among multiple indications. In other embodiments, the request may include an identifier associated with the indication and / or patient, and the RMS is identified by an identifier associated with the indication and / or patient within the RMS. Indications can be identified based on analyzing the profile of the patient being treated.

  At 820A, whether the indication is a first indication among multiple indications and whether the request meets patient registration criteria associated with the first indication (e.g., Determined by the patient module 126). If the first indication is found to meet patient registration criteria, a first authorization code is generated at 830 (eg, by authorization module 130) and the patient is first continuation at 840. Register (or re-register) with RMS for a period of time. This registration criteria can be any suitable requirement (s) that the request must / must meet for patient registration, and these requirements include the requirement (eg, harmful Specify the diagnostic test results associated with the therapeutic agent (to monitor the possibility of and / or the actual occurrence of any adverse side effects), the request includes the requested patient identification information, and the request is the first indication However, it is not limited to these. At 850, the first authorization code is provided to the pharmacy, eg, by the authorization module 130 (eg, transmitted to the pharmacy computing device via a network, telephone communication, etc.).

  In some embodiments, the first indication is autosomal dominant polycystic kidney disease (ADPKD), and patient registration criteria associated with the first indication include confirmation of a diagnostic test, and ADPKD It further includes a diagnostic indication. In some embodiments, the diagnostic test can be a liver function test (LFT).

  Substantially simultaneously with step 820A, before step 820A, or after step 820A, at 820B, the indication is a second indication among a plurality of indications and the request is for a second indication. It is determined (eg, by the patient module 126) whether the associated patient registration criteria are met. If the second indication is found to meet patient registration criteria, a second authorization code is generated at 860 and the patient registers with RMS at 870 for a second duration ( (Or re-register). In some embodiments, the second indication is hyponatremia, and the second patient enrollment criteria includes an indication of the diagnosis of hyponatremia, the date of patient admission, (eg, hospital environment) The date of commencement of treatment with the therapeutic agent, the name and location associated with the location of the treatment (eg, the name and address of the hospital where the patient is being treated), the daily dose of treatment with the therapeutic agent Including at least one of an indication or an indication of a patient's serum sodium concentration. At 880, the first authorization code or the second authorization code is provided to the pharmacy by, for example, the authorization module 130 (eg, transmitted to the pharmacy computing device via a network, telephone communication, etc.). In some embodiments, if the condition of step 820A is met, step 820B is not performed and vice versa. That is, if step 820B is satisfied, step 820A is not executed.

  In other embodiments, instead of performing steps 820A and 820B, after step 810, the RMS identifies the indication with which the request is associated. If the request is associated with the first indication, the RMS determines whether the request meets the first patient registration criteria and if so, proceeds to step 830. If the request is associated with the second indication, the RMS determines whether the request meets the second patient registration criteria and if so, proceeds to step 860. In such embodiments, RMS identifies the indication before analyzing enrollment criteria. In such embodiments, registration criteria for identified indications are analyzed, but registration criteria for unspecified indications are not analyzed.

  In some embodiments, if the request does not meet any indication patient registration criteria in step 890, the patient is not registered (or re-registered) and the pharmacy dispenses the therapeutic agent to the patient. Not authorized to do so. This can be communicated to the pharmacy and / or patient in any suitable manner including, for example, not responding to the request, generating a code indicating that the request does not meet the dispensing criteria, etc. In some embodiments, the first indication is autosomal dominant polycystic kidney disease (ADPKD) and the second indication is hyponatremia. In other embodiments, the first indication and / or the second indication may be any other suitable indication associated with the therapeutic agent.

  FIG. 9 illustrates that if a certain dispensing criteria associated with either a patient indication such as patient 114 or another indication associated with a therapeutic agent is met, that patient is indicated for that patient's indication. FIG. 9 illustrates a method 900 for authorizing receipt of a therapeutic agent associated with a. This FIG. 9 will be described with reference to FIG. In some embodiments, the patient may be the first person registered with RMS. In other embodiments, the patient may be one who is re-registered with RMS and / or who gets a re-supplement of a therapeutic agent. For example, the method 900 can be used for patients who are already registered with the RMS but do not require replenishment of therapeutic agents. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the plurality of indications includes hyponatremia. In some embodiments, the plurality of indications includes autosomal dominant polycystic kidney disease (ADPKD). In other embodiments, the therapeutic agent can be any other suitable therapeutic agent, and / or the first indication and / or the second indication is other associated with the therapeutic agent. Can be any suitable indication.

  At 910, a request to dispense a therapeutic agent to a patient is received (eg, by dispenser module 128) from a computing device associated with a pharmacy (eg, dispenser 116) registered with the RMS. In some embodiments, the request includes a first indication identifier associated with the therapeutic agent. In other embodiments, the request may include an identifier associated with the patient, and the RMS is based on analyzing a patient profile within the RMS identified by the identifier associated with the patient. The first indication can be identified.

  At 920A, it is determined whether the request meets the dispensing criteria for the first indication. If it is found that it is satisfied, a first authorization code is generated at 930. At 940, a first authorization code is provided to dispenser 116 so that the pharmacy / dispenser can dispense the therapeutic agent to the patient using the authorization code (eg, network, telephone communication, etc.). To be sent to the pharmacy computing device via).

  At 920A, if the request does not meet the first indication dispensing criteria, at 920B whether the request meets the dispensing criteria associated with the second indication (eg, by the authorization module 130). To be judged. A second authorization code is generated at 950 if found to be satisfied. At 960, a second authorization code is provided to dispenser 116 so that the pharmacy / dispenser can dispense the therapeutic agent for the patient for the first indication using the authorization code (eg, , Sent to the pharmacy computing device via network, telephone communication, etc.). In some embodiments, at 920B, if the request does not meet the dispensing criteria associated with the second indication, at 990, the pharmacy is not authorized to dispense the therapeutic agent to the patient. This can be communicated to the pharmacy and / or patient in any suitable manner including, for example, not responding to the request, generating a code indicating that the request does not meet the dispensing criteria, etc. In some embodiments, if the condition of step 920A is met, step 920B and its subsequent steps are not executed, and vice versa. That is, when the condition of step 920B is satisfied, step 920A and the subsequent steps are not executed.

  In some embodiments, the dispensing criteria associated with the second indication includes confirmation of a diagnostic test performed on the patient and associated with the therapeutic agent. In some embodiments, for example, the diagnostic test is LFT. In some embodiments, for example, the first indication is hyponatremia and the second indication is autosomal dominant polycystic kidney disease (ADPKD). The dispensing criteria can include any suitable requirement (s) that the request must meet in order to authorize the patient to receive the therapeutic agent. These requirements include whether the patient has undergone a diagnostic test, whether the request is for the dose / dose titer quantity / number appropriate to the patient's indication, etc. However, it is not limited to these. As described above, when the requirement for dispensing the pharmaceutical agent for the second indication is satisfied, the therapeutic agent for the first indication can be dispensed. In some embodiments, the second indication dispensing criteria can be more stringent than the first indication dispensing criteria, and in cases where the patient indication dispensing criteria are not met, the patient is treated Ask patients more if they want to get the drug.

  FIG. 10 illustrates a method 1000 for authorizing a patient, such as patient 114, to receive a treatment for an indication if a certain dispensing and / or enrollment criteria are met for that indication. . This FIG. 10 will be described with reference to FIG. In some embodiments, the patient may be the first person registered with RMS. In other embodiments, the patient may be one who is re-registered with RMS and / or who gets a re-supplement of a therapeutic agent. In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the indication is one of a plurality of indications associated with the therapeutic agent. In some embodiments, the plurality of indications includes hyponatremia. In some embodiments, the plurality of indications includes autosomal dominant polycystic kidney disease (ADPKD).

  At 1010, a request to dispense a certain amount of therapeutic agent to the patient is received (eg, by dispenser module 128) from a computing device associated with a pharmacy (eg, dispenser 116) registered with the RMS. The This request may include details and / or identifiers associated with an indication from among multiple indications. This requirement can also include an indication of the amount / form of the therapeutic agent to be dispensed (eg, dosage, tablet / capsule / liquid, number of units, etc.). In other embodiments, the request may include an identifier associated with the patient, and the RMS is based on analyzing a patient profile identified by the identifier associated with the patient within the RMS. Indications and / or amounts / forms can be identified.

  In 1020A, (1) whether the requested indication is a first indication among a plurality of indications, and (2) the amount is associated with a therapeutic agent for the first indication. It is determined (e.g., by the RMS device 100) whether the dispensing criteria are met. If the first indication is found to meet the dispensing criteria, a first authorization code is generated at 1030. At 1040, a first authorization code is provided to a computing device associated with the pharmacy (eg, transmitted to the pharmacy computing device via a network, telephone communication, etc.).

  In some embodiments, the first indication is hyponatremia and the dispensing criteria associated with the first indication include a diagnosis indication of hyponatremia, a date of patient admission, treatment It includes at least one of a date of initiation of treatment with the drug, a daily dose of treatment with the therapeutic agent, or an indication of the patient's serum sodium concentration. In some embodiments, the first indication is hyponatremia, the therapeutic agent is tolvaptan, and the dispensing criteria associated with the therapeutic agent of the first indication is, for example, 15 mg per day ~ 60 mg per day. For example, the formulation criteria may include about 15 mg / day, about 20 mg / day, about 30 mg / day, about 40 mg / day, about 50 mg / day, about 55 mg / day, about 55 mg / day, including intermediate values and / or subranges. Or from about 60 mg per day. In other embodiments, the dispensing criteria associated with the first indication may be any other suitable dose, such as less than 15 mg per day or greater than 60 mg per day. In some embodiments, the dispensing criteria associated with the first indication treatment can be, for example, a dose of 5 mg to a dose of 45 mg. For example, the first indication of dispensing criteria is about 5 mg dose of therapeutic agent, about 10 mg dose, about 15 mg dose, about 20 mg dose, about 25 mg dose, about 30 mg dose. A dose of about 35 mg, a dose of about 40 mg, and / or a dose of about 45 mg, combinations thereof, and / or intermediate values. In other embodiments, the dispensing criteria associated with the first indication can be any other suitable dose, such as, for example, a dose less than 5 mg or a dose greater than 45 mg.

  If the condition of step 1020A is not met, in 1020B, (1) the requested indication is a second indication among a plurality of indications, and (2) the amount is equal to the second indication It is determined whether the dispensing criteria associated with the indication treatment are met. If the second indication is found to meet the dispensing criteria, a second authorization code is generated at 1060. In some embodiments, if the condition of step 1020A is met, step 1020B and the subsequent steps are not performed, and vice versa. That is, when the condition of step 1020B is satisfied, step 1020A and the subsequent steps are not executed.

  In some embodiments, at 1090, if the request does not meet the 1020A or 1020B criteria, the pharmacy is not authorized to dispense the therapeutic agent to the patient. This can be communicated to the pharmacy and / or patient in any suitable manner including, for example, not responding to the request, generating a code indicating that the request does not meet the dispensing criteria, etc.

  In some embodiments (not shown), step 1020A may further include determining whether the request meets patient registration criteria associated with the first indication. If this is met and the other aspects of step 1020A are also met, the patient can be enrolled in RMS for a first duration associated with the first indication.

  In some embodiments (not shown), step 1020B may further include determining whether the request meets patient registration criteria associated with the second indication. If this is met and other aspects of step 1020B are also met, the patient is RMS for a second duration associated with the second indication (which may be different from the first indication). Can be registered.

  In some embodiments, the second indication is autosomal dominant polycystic kidney disease (ADPKD), and the dispensing criteria associated with the second indication is an indication of the diagnosis of ADPKD and the patient Confirmation of diagnostic tests associated with the therapeutic agent performed. In some embodiments, the diagnostic test is LFT. In some embodiments, the second indication is autosomal dominant polycystic kidney disease (ADPKD), the therapeutic agent is tolvaptan, and the dispensing criteria associated with the therapeutic agent for the second indication is For example, a dose of 15 mg to a dose of 120 mg. For example, the formulation criteria include 15 mg dose, 20 mg dose, 30 mg dose, 40 mg dose, 50 mg dose, 60 mg dose, 70 mg dose, 80 mg, including all sub-values. , 90 mg dose, 100 mg dose, and / or 120 mg dose, combinations thereof. In other embodiments, the dose can be any other suitable dose, eg, less than 15 mg or greater than 120 mg. At 1070, a second authorization code is provided to the computing device associated with the pharmacy (eg, transmitted to the pharmacy computing device via a network, telephone communication, etc.).

  In some embodiments, (1) the indication is a first indication among a plurality of indications, and (2) a dosage criterion whose amount is associated with a therapeutic agent for the first indication And (3) the method 1000 generates a warning code, eg, at step 1090, etc., if the amount meets the dispensing criteria associated with the second indication treatment. Can further be included. In this way, the pharmacy / dispenser can be warned that the patient is requesting a prescribable amount for different indications.

  While various embodiments have been described herein, it is to be understood that these embodiments have been presented by way of example and not limitation. Although the method described above shows some events occurring in a certain order, the ordering of some events can be changed. In addition, some of the events can be performed simultaneously in parallel processes if possible, and can also be performed sequentially as described herein.

  Some of the modules are described as providing an interface for interacting with the prescriber 112, patient 114, dispenser 116, and / or other users of the RMS host device 100. In this embodiment, it will be appreciated that some or all such interactions can be enabled via an integrated portal that each of these entities can use. In such an embodiment, each entity that interacts with the portal may have an account and / or register with the host device 100 in another manner. In some embodiments, this registration can be linked to and / or included in the entity's profile information. For example, the prescriber 112 registration can be linked to a prescriber profile for that particular prescriber. As another example, the registration of a pharmacy (ie, pharmacist) and / or one or more pharmacists at the pharmacy can be linked to the pharmacy profile for that pharmacy.

  Although not described in detail herein, the host device 100 may include additional modules and / or functions for interacting with other entities such as insurance providers, diagnostic laboratories, distribution vendors, etc. . For example, the insurance provider may require confirmation of an appropriate diagnostic test before reimbursing the patient and / or dispenser for the cost of the therapeutic agent. As another example, a prescriber can direct a diagnostic test for a patient in a diagnostic test laboratory directly through the host device 100. As yet another example, a distribution vendor in charge of delivery of a therapeutic agent to a vendor checks with the host device 100 whether the vendor is registered and always notifies when the dispenser is registered / deregistered. Can be received by the host device.

  While the prescription of the therapeutic agent has been described as being provided to the patient by the prescriber, in other embodiments, in addition or alternatively, the prescription information is included in the patient registration form by the prescriber. In such embodiments, the host device 100 can perform additional checks to ensure that the patient receives the prescribed dose. For example, in the embodiment of FIG. 5, the first authorization code or the second authorization code is generated only when the host device determines that the patient has not run out of the prescription. If the prescription allows five refills, the patient will be re-applied for the sixth time, even if the appropriate diagnostic test is confirmed by the prescriber in a timely manner (eg, within the first predetermined period). Unable to get replenishment. This is because the host device generates a third authorization code that prohibits the pharmacy from dispensing the therapeutic drug to the patient. Skilled pharmacists and modern pharmacy systems typically capture such oversights, but such aspects of the host device 100 can provide an additional layer of security against oversight and / or potential misuse. .

  In some embodiments, the patient visits the dispenser for the first time, the therapeutic agent is dispensed to this patient, and the prescribed refill is then dispensed without further action on the part of the patient. Can be provided to the patient. For example, the dispenser submits an authorization request to the host device 100 as described above before the patient is expected to use up the last dispensed amount of the therapeutic agent. In this way, the dispenser can verify that the patient is authorized to continue to receive the therapeutic agent and mail a re-replenishment of the therapeutic agent to the patient in a timely manner.

  In some embodiments, the method requests from a prescriber to register the prescriber with the RMS at a host device of a risk management system (RMS) for a therapeutic agent associated with at least one indication. Including receiving. The method also includes providing the prescriber with educational materials associated with the RMS and associated with the therapeutic agent. The method further includes providing the prescriber with access to a test relating to the teaching material and receiving at the host device an identifier of the prescriber's performance relating to the test. The method also includes registering the prescriber with the RMS at the host device when the prescriber's performance meets the test performance criteria.

  In some embodiments, the therapeutic agent is tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the enrollment includes authorizing the prescriber to prescribe the therapeutic agent.

  In some embodiments, registering the prescriber can include registering the prescriber for a predetermined period of time. In some embodiments, the method further includes providing the prescriber with re-registration information associated with the RMS and the therapeutic agent after the registration and before the predetermined period of time. be able to. The method includes receiving consent from the prescriber in response to the re-registration information and re-registering the prescriber with the RMS in response to receiving the consent at the host device. You can also.

  In some embodiments, the therapeutic agent is associated with multiple indications.

  In some embodiments, another method sends a request from a pharmacy to register the pharmacy with the RMS at a host device of a risk management system (RMS) for a therapeutic associated with at least one indication. Including receiving. The method also includes providing educational material associated with the RMS and the therapeutic agent to a pharmacist associated with the pharmacy. The method also includes providing the pharmacist with access to exams related to the teaching material. The method further includes receiving, at the host device, an identifier of the pharmacist's performance for the test. The method also includes registering the pharmacy with the RMS in the host device when the performance of the pharmacist satisfies the performance evaluation criteria of the test.

  In some embodiments, the therapeutic agent comprises tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD). In some embodiments, the registration includes authorizing the pharmacy to dispense the therapeutic agent.

  In some embodiments, the registering includes registering the pharmacy for a predetermined period of time. In some embodiments, the method further includes providing the pharmacist with re-registration information associated with the RMS and the therapeutic agent after the registration and before the predetermined period of time has elapsed. The method may also include receiving consent from the prescriber in response to the re-registration information and re-registering the pharmacist with the RMS in response to receiving the consent at the host device. it can.

  In some embodiments, another method is provided for the RMS by a prescriber registered with the RMS at a host device of a risk management system (RMS) for a therapeutic associated with at least one indication. Receiving confirmation of a diagnostic test of a registered patient. Based on the receipt of the confirmation from the prescriber, the method generates a code indicating whether a pharmacy registered in the RMS is authorized to dispense the therapeutic agent to the patient. Including. The method also includes receiving at the host device a request to dispense the therapeutic agent to the patient from a computing device associated with the pharmacy. The method also includes providing the authorization code to the computing device associated with the pharmacy.

  In some embodiments, the confirmation includes an identifier of the date on which the diagnostic test was performed on the patient. In some embodiments, generating the code includes generating the code when the request is received within a predetermined period from the date.

  In some embodiments, the method may further include transmitting the request for confirmation of the diagnostic test from the host device to the prescriber. The confirmation can be received in response to the request for the confirmation.

  In some embodiments, the therapeutic agent comprises tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).

  In some embodiments, the method further comprises verifying that at least one of the pharmacy or a pharmacist associated with the pharmacy is registered with the RMS before providing the authorization code. Can be included. In some embodiments, the confirmation can include confirmation of an appropriate diagnostic test. In such embodiments, the code authorizes the pharmacy to dispense the therapeutic agent to the patient.

  In some embodiments, the method can further include re-registering the patient with the RMS based on the appropriate diagnostic test.

  In some embodiments, the confirmation includes confirmation of at least one of an inappropriate diagnostic test or an adverse event associated with the patient using the therapeutic agent. In such an embodiment, the authorization code prohibits the pharmacy from dispensing the therapeutic agent to the patient. In some embodiments, the adverse event is associated with one or more side effects associated with the at least one indication. In some embodiments, the method may further include verifying the prescriber's enrollment status prior to the generation.

  In some embodiments, another method registers at the RMS from a pharmacy registered at the RMS at a host device of a risk management system (RMS) for a therapeutic associated with at least one indication. Receiving a request to dispense a first amount of the therapeutic agent to the treated patient. The method further includes generating a first authorization code if confirmation of an appropriate diagnostic test for the patient is received within a first predetermined period from a prescriber registered with the RMS. . The method is such that the confirmation of the appropriate diagnostic test of the patient is not received within the first predetermined period and the request from the computing device associated with the pharmacy is within a second predetermined period. Or a request is received from the computing device associated with the prescriber for the patient to dispense a second amount of the therapeutic agent that is different from the first amount, Or generating a second authorization code in both cases. The method includes the second confirmation of the therapeutic agent from the computing device that the confirmation of the appropriate diagnostic test of the patient is not received within the first predetermined period and is associated with the prescriber. Generating a third authorization code if the request to dispense the amount is not received. The method also includes providing the first authorization code, the second authorization code, or the third authorization code to the computing device associated with the pharmacy.

  In some embodiments, the therapeutic agent comprises tolvaptan. In some embodiments, the at least one indication comprises hyponatremia. In some embodiments, the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).

  In some embodiments, the first authorization code authorizes the pharmacy to dispense the first amount of the therapeutic agent to the patient, wherein the first amount is a standard amount. It is. In some embodiments, the second authorization code allows the pharmacy to dispense the second amount of the therapeutic agent to the patient without the confirmation of the appropriate diagnostic test. Is authorized. In some embodiments, the third authorization code prohibits the pharmacy from dispensing the therapeutic agent to the patient.

  In some embodiments, the method may further include transmitting the request for confirmation of the appropriate diagnostic test from the host device to the prescriber. In such embodiments, the confirmation is received in response to the request for the confirmation.

  In some embodiments, another method receives a request from a prescriber to register a patient with the RMS at a risk management system (RMS) host device for a treatment associated with multiple indications. Including doing. The request includes a specification of at least one indication and confirmation of a diagnostic test performed on the patient. The diagnostic test is associated with the therapeutic agent and the indication. The method may also include registering the patient with the RMS in response to the request at the host device. Registering the patient includes identifying a predetermined registration period based on the indication. The predetermined registration period has a first duration when the indication is a first indication and is different from the first duration when the indication is a second indication. Has a second duration. The registering also includes generating an authorization code indicating whether the patient is authorized to receive the therapeutic agent based on the predetermined registration period.

  In some embodiments, the method can further include receiving a request to dispense a restocking of the therapeutic agent to the patient. The method uses (1) the first process when the at least one indication is the first indication, and (2) the at least one indication is the second indication. In some cases, using a second process different from the first process, including generating a new authorization code that indicates whether the patient is authorized to receive a restocking of the therapeutic agent Can do.

  In some embodiments, the diagnostic test is a first diagnostic test. In some embodiments, the at least one indication is the first indication and the method confirms a second diagnostic test within the predetermined enrollment period from the prescriber at the host device. Can further include generating the new authorization code in response to receiving. In some embodiments, the at least one indication is the second indication, and the method does not receive the confirmation of the second diagnostic test within the predetermined enrollment period. In response to receiving the request, the method may further include generating the new authorization code.

  In some embodiments, the method includes (1) the RMS, (2) the therapeutic agent, and (3) the first indication after the registration and before the predetermined registration period has elapsed. The method may further include providing patient re-registration information associated with the condition to the prescriber. In response to receiving the consent from the prescriber and the patient in response to the patient re-registration information, and in response to receiving the consent, the method retransmits the patient to the RMS at the host device. Registration can also be included.

  In some embodiments, the method may further include receiving a request from the prescriber for the therapeutic agent at the host device to register the prescriber with the RMS. The method can also include providing the prescriber with educational materials associated with the RMS and associated with the therapeutic agent. The method may also include providing the prescriber with access to a test relating to the teaching material and receiving at the host device an identifier of the prescriber's performance relating to the test. The method may also include registering the prescriber in the RMS at the host device when the prescriber's grade meets the test grade criteria.

  In some embodiments, the method can also include, at the host device, receiving a request from the pharmacy to register the pharmacy with the RMS for the therapeutic agent. The method may further include providing educational material associated with the RMS and the therapeutic agent to a pharmacist associated with the pharmacy. The method may also include providing the pharmacist with access to a test relating to the teaching material and receiving at the host device an identifier of the pharmacist's performance relating to the test. The method may also include registering the pharmacy with the RMS at the host device when the pharmacist's performance meets the test performance criteria.

  Some embodiments described herein are non-transitory computer-readable media (also referred to as non-transitory processor-readable media) having instructions or computer code for performing various computer-implemented operations. Relates to a computer storage product. This computer readable medium (or processor readable medium) is itself non-transitory in the sense that it does not contain transitory propagation signals (eg, propagating electromagnetic waves that carry information on a transmission medium such as space or cable). . The medium and computer code (also referred to as code) may be designed and constructed for a particular purpose or purposes. Examples of non-transitory computer readable media include magnetic storage media such as hard disks, floppy disks, and magnetic tapes; compact disks / digital video disks (CD / DVD), compact disk read-only memory (CD-ROM), and holograms. Optical storage media such as graphic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and application specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memories (ROMs), and random access memories ( RAM devices and the like include hardware devices specially configured to store and execute program code, such as but not limited to. Other embodiments described herein relate to computer program products that can include, for example, the instructions and / or computer code discussed herein.

  Examples of computer code include microcode or microinstructions as generated by a compiler, machine instructions, code used to generate web services, and higher level instructions executed by a computer using an interpreter. Including files, but not limited to. For example, the embodiment includes an instruction type programming language (for example, C, Fortran, etc.), a functional type programming language (for example, Haskell, Erlang, etc.), a logical type programming language (for example, Prolog), an object-oriented programming language (for example, Java, C ++, etc.), or other suitable programming language and / or development tools. Additional examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

  While various embodiments have been described above, it is to be understood that these embodiments have been presented by way of example and not limitation. Although the method described above shows some events occurring in a certain order, the ordering of some events can be changed. In addition, some of the events can be performed simultaneously in parallel processes if possible, and can also be performed sequentially as described above.

Claims (65)

A risk management system (RMS) device,
An RMS database;
An RMS processor,
The RMS processor
A request to enroll a patient from a computing device associated with a prescriber to an RMS program of therapeutics associated with a plurality of indications via a communication network, wherein at least one of the plurality of indications A description of one indication and confirmation of a diagnostic test performed on the patient and associated with the therapeutic agent and associated with the at least one indication from the plurality of indications; A patient module configured to receive a request comprising: responding to the request by identifying a predetermined registration period based on the at least one indication from the plurality of indications And further configured to generate a patient profile, wherein the at least one indication is the plurality of indications during the predetermined enrollment period. The first indication has a first duration, and the predetermined enrollment period is a second indication from among the plurality of indications wherein the at least one indication is A patient module having a second duration different from the first duration;
A database module configured to communicate with the RMS database and to store the patient profile in the RMS database;
An authorization module configured to generate an authorization code indicating whether the patient is authorized to receive the therapeutic agent based on the predetermined registration period;
A risk management system device comprising: a communication module configured to transmit the authorization code via the communication network to at least one of a calculation device associated with a pharmacy or a calculation device associated with a prescriber . The RMS processor further comprises a dispenser module;
The dispenser module is
Receiving a request to register the pharmacy with the RMS program from the computing device associated with the pharmacy for the therapeutic agent;
Sending to the computing device associated with the pharmacy teaching material associated with the RMS and the therapeutic agent;
Sending to the computing device associated with the pharmacy access to exams relating to the teaching material for a user of the computing device associated with the pharmacy;
Receiving an identifier of the user's performance of the computing device associated with the pharmacy for the trial;
If the identifier of the grade meets the grade evaluation criteria of the trial, the pharmacy dispenser profile is configured to be generated,
The RMS device of claim 1, wherein the database module is further configured to store the dispenser profile as a new dispenser profile in the RMS database. The patient module of the RMS processor is
Patients associated with (1) the RMS program, (2) the therapeutic agent, and (3) the first indication before the predetermined registration period has elapsed and after the generation of the patient profile Generate re-registration information,
Sending the patient re-registration information to the computing device associated with the prescriber;
Responsive to the patient re-registration information, further configured to receive an indication of consent from the computing device associated with the prescriber;
The RMS device of claim 1, wherein the database module is further configured to update the patient profile in the RMS database in response to receiving the consent. A risk management system (RMS) device,
An RMS database for storing dispenser profiles, patient profiles and prescriber profiles;
An RMS processor;
The RMS processor
Receiving a request from a computing device associated with the pharmacy for a therapeutic agent associated with at least one of the plurality of indications to dispense a first amount of the therapeutic agent to the patient; A dispenser module, wherein the RMS database includes a dispenser profile of the pharmacy, and wherein the RMS database includes a patient profile of the patient;
A prescriber module configured to receive confirmation of an appropriate diagnostic test for the patient from a computing device associated with the prescriber, wherein the RMS database includes a prescriber profile of the prescriber; The module,
An authorization module configured to generate a first authorization code if the confirmation of the appropriate diagnostic test of the patient is received within a first predetermined period of time; (1) the The confirmation of the appropriate diagnostic test of the patient is not received within the first predetermined period and the request from the computing device associated with the pharmacy is received within a second predetermined period Or (2) if a request is received from the computing device associated with the prescriber for the patient to dispense a second amount of the therapeutic agent that is different from the first amount; An authorization module further configured to generate a second authorization code if at least one of the
A risk management system device comprising: a communication module for transmitting the first authorization code or the second authorization code to the computing device associated with the pharmacy. Receiving a request from a prescriber to register the prescriber with the RMS at a host device of a risk management system (RMS) for a therapeutic agent associated with at least one indication;
Providing the prescriber with educational materials associated with the RMS and associated with the therapeutic agent;
Providing the prescriber with access to exams relating to the material;
Receiving at the host device an identifier of the prescriber's performance for the test;
Registering the prescriber with the RMS at the host device when the grade of the prescriber meets the grade evaluation criteria of the test.   6. The method of claim 5, wherein the therapeutic agent is tolvaptan.   6. The method of claim 5, wherein the at least one indication comprises hyponatremia.   6. The method of claim 5, wherein the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).   6. The method of claim 5, wherein the registering comprises authorizing the prescriber to prescribe the therapeutic agent. Registering includes registering the prescriber for a predetermined period of time;
The method
Providing the prescriber with re-registration information associated with the RMS and the therapeutic agent after the registration and before the predetermined period of time;
Receiving consent from the prescriber in response to the re-registration information;
6. The method of claim 5, further comprising re-registering the prescriber with the RMS in response to receiving the consent at the host device.   6. The method of claim 5, wherein the therapeutic agent is associated with multiple indications. Receiving a request from a pharmacy to register the pharmacy with the RMS at a host device of a risk management system (RMS) for a therapeutic associated with at least one indication;
Providing a pharmacist associated with the pharmacy with educational materials associated with the RMS and associated with the therapeutic agent;
Providing the pharmacist with access to exams relating to the teaching materials;
Receiving at the host device an identifier of the pharmacist's grades for the test;
Registering the pharmacy with the RMS when the pharmacist's grades meet the grade assessment criteria of the trial.   The method of claim 12, wherein the therapeutic agent comprises tolvaptan.   The method of claim 12, wherein the at least one indication comprises hyponatremia.   13. The method of claim 12, wherein the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).   13. The method of claim 12, wherein the registering comprises authorizing the pharmacy to dispense the therapeutic agent. Registering includes registering the pharmacy for a predetermined period of time;
The method
Providing the pharmacist with re-registration information associated with the RMS and the therapeutic agent after the registration and before the predetermined period of time;
Receiving consent from the pharmacist in response to the re-registration information;
13. The method of claim 12, further comprising re-registering the pharmacist with the RMS in response to receiving the consent at the host device. At a risk management system (RMS) host device for a therapeutic agent associated with at least one indication, a confirmation of a diagnostic test of the patient registered with the RMS is received by the prescriber registered with the RMS And
Based on the receipt of the confirmation by the prescriber, generating an authorization code indicating whether a pharmacy registered in the RMS is authorized to dispense the therapeutic agent to the patient;
Receiving a request from the computing device associated with the pharmacy at the host device to dispense the therapeutic agent to the patient;
Providing the authorization code to the computing device associated with the pharmacy. The confirmation includes an identifier of the date on which the diagnostic test was performed on the patient;
The method of claim 18, wherein the generating includes generating the code if the request is received within a predetermined time period from the date. The confirmation includes an identifier of the date on which the diagnostic test was performed on the patient;
The method of claim 18, wherein the code is valid for a predetermined period from the date. Further comprising transmitting the request for confirmation of the diagnostic test from the host device to the prescriber;
The method of claim 18, wherein the receiving the confirmation is in response to the request for the confirmation.   The method of claim 18, wherein the therapeutic agent comprises tolvaptan.   The method of claim 18, wherein the at least one indication comprises hyponatremia.   19. The method of claim 18, wherein the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).   19. The method of claim 18, further comprising verifying that at least one of the pharmacy or a pharmacist associated with the pharmacy is registered with the RMS before providing the authorization code. The confirmation includes confirmation of an appropriate diagnostic test,
19. The method of claim 18, wherein the code authorizes the pharmacy to dispense the therapeutic agent to the patient.   27. The method of claim 26, further comprising re-registering the patient with the RMS based on the appropriate diagnostic test. The confirmation includes confirmation of at least one of an inappropriate diagnostic test or an adverse event associated with the patient using the therapeutic agent,
19. The method of claim 18, wherein the authorization code prohibits the pharmacy from dispensing the therapeutic agent to the patient.   30. The method of claim 28, wherein the adverse event is associated with one or more side effects associated with the at least one indication.   30. The method of claim 28, wherein the adverse event is associated with one or more side effects not associated with the at least one indication.   19. The method of claim 18, further comprising verifying the prescriber registration status prior to the generating. A request for dispensing a first amount of the therapeutic agent to a patient enrolled in the RMS at a host device of a risk management system (RMS) for the therapeutic agent associated with at least one indication, Receiving from a computing device associated with a pharmacy registered with the RMS;
Generating a first authorization code if a confirmation of an appropriate diagnostic test for the patient is received within a first predetermined period from a prescriber registered with the RMS;
(1) The confirmation of the appropriate diagnostic examination of the patient is not received within the first predetermined period and the request from the computing device associated with the pharmacy is within a second predetermined period If received, or (2) a request is received from the computing device associated with the prescriber for the patient to dispense a second amount of the therapeutic agent different from the first amount. Generating a second authorization code if at least one of the following:
Dispensing the second amount of the therapeutic agent from the computing device that is not received within the first predetermined period of time and wherein the confirmation of the appropriate diagnostic test of the patient is associated with the prescriber Generating a third authorization code if the request to be received is not received;
Providing the first authorization code, the second authorization code, or the third authorization code to the computing device associated with the pharmacy.   35. The method of claim 32, wherein the therapeutic agent comprises tolvaptan.   35. The method of claim 32, wherein the at least one indication comprises hyponatremia.   35. The method of claim 32, wherein the at least one indication comprises autosomal dominant polycystic kidney disease (ADPKD).   33. The first authorization code authorizes the pharmacy to dispense the first amount of the therapeutic agent to the patient, wherein the first amount is a standard amount. the method of.   The second authorization code allows the pharmacy to authorize the patient to dispense the second amount of the therapeutic agent without making the confirmation of the appropriate diagnostic test. The method described.   33. The method of claim 32, wherein the third authorization code prohibits the pharmacy from dispensing the therapeutic agent to the patient. Further comprising transmitting the request for confirmation of the appropriate diagnostic test from the host device to the prescriber;
The method of claim 32, wherein the confirmation is received in response to the request for the confirmation. In a risk management system (RMS) host device for a therapeutic agent associated with multiple indications, a request from a prescriber to register a patient with the RMS, comprising: (1) And (2) confirmation of a diagnostic test performed on the patient, wherein the diagnostic test is associated with the therapeutic agent and the indication. Receiving,
Registering the patient with the RMS in response to the request at the host device;
The registration is
Identifying a predetermined enrollment period based on the indication, wherein the predetermined enrollment period is a first when the indication is a first indication from among the plurality of indications. And the predetermined registration period has a second duration different from the first duration when the indication is a second indication from among the plurality of indications. To identify,
Generating an authorization code indicating whether the patient is authorized to receive the therapeutic agent based on the predetermined enrollment period. Receiving a request to dispense replenishment of the therapeutic to the patient;
(1) if the at least one indication is the first indication, use the first process; (2) if the at least one indication is the second indication Using a second process different from the first process to generate a new authorization code that indicates whether the patient is authorized to receive a refill of the therapeutic agent. 41. The method according to 40. The diagnostic test is a first diagnostic test;
The method
In response to receiving confirmation of a second diagnostic test within the predetermined enrollment period at the host device from the prescriber when the at least one indication is the first indication, the new indication Generating an authorization code;
In response to receiving a request within the predetermined registration period without receiving the confirmation of the second diagnostic test when the at least one indication is the second indication, 42. The method of claim 41, further comprising generating a new authorization code. After the registration and before the elapse of the predetermined registration period, (1) the RMS, (2) the therapeutic agent, and (3) patient re-registration information associated with the first indication To provide
Receiving consent from the prescriber and the patient in response to the patient re-registration information;
41. The method of claim 40, further comprising re-registering the patient with the RMS at the host device in response to receiving the consent. Receiving a request from the prescriber for the therapeutic agent at the host device to register the prescriber with the RMS;
Providing the prescriber with educational materials associated with the RMS and associated with the therapeutic agent;
Providing the prescriber with access to exams relating to the material;
Receiving at the host device an identifier of the prescriber's performance for the test;
41. The method of claim 40, further comprising: registering the prescriber with the RMS at the host device when the grade of the prescriber meets the test performance criteria. Receiving a request from the pharmacy to register the pharmacy in the RMS for the therapeutic agent at the host device;
Providing educational materials associated with the RMS and the therapeutic agent to a pharmacist associated with the pharmacy;
Providing the pharmacist with access to exams relating to the teaching materials;
Receiving at the host device an identifier of the pharmacist's grades for the test;
41. The method of claim 40, further comprising: registering the pharmacy with the RMS at the host device when the grade of the pharmacist meets the grade assessment criteria of the exam. In a risk management system (RMS) host device for a therapeutic agent associated with multiple indications, a request to dispense an amount of the therapeutic agent to a patient not registered in the RMS comprising: Receiving a request including an identifier associated with an indication from a plurality of indications from a computing device associated with a pharmacy registered with the RMS;
A first authorization code if the indication is a first indication of the plurality of indications and the request meets patient registration criteria associated with the first indication; Generating and registering the patient with the RMS for a first duration in response to the request at the host device;
A second authorization code if the indication is a second indication of the plurality of indications and the request meets patient registration criteria associated with the second indication; Generating and registering the patient with the RMS for a second duration different from the first duration in response to the request at the host device;
Providing the first authorization code or the second authorization code to the computing device associated with the pharmacy.   47. The method of claim 46, wherein the therapeutic agent is tolvaptan. Said first indication is autosomal dominant polycystic kidney disease (ADPKD);
47. The method of claim 46, wherein the second indication is hyponatremia. Said first indication is autosomal dominant polycystic kidney disease (ADPKD);
47. The method of claim 46, wherein the patient registration criteria associated with the first indication includes confirmation of a diagnostic test and further includes an indication of a diagnosis of ADPKD. The second indication is hyponatremia;
The second patient enrollment criteria includes an indication of a diagnosis of hyponatremia, a date of hospitalization of the patient, a date of commencement of treatment with the therapeutic agent, a daily dose of the treatment with the therapeutic agent, 47. The method of claim 46, comprising at least one of an indication of the patient's serum sodium concentration. In a risk assessment management system (RMS) host device for therapeutics associated with multiple indications, a request to dispense the therapeutics to a patient registered in the RMS, the multiple indications Receiving from a computing device associated with a pharmacy registered with the RMS a request including an identifier of a first indication from among the symptoms;
(1) the request does not meet the dispensing criteria associated with the first indication, and (2) the dispensing is associated with a second indication from among the plurality of indications. Generating an authorization code associated with the patient at the host device if criteria are met;
Providing the authorization code to the computing device associated with the pharmacy so that the pharmacy can dispense the therapeutic agent to the patient using the authorization code.   52. The method of claim 51, wherein the therapeutic agent is tolvaptan. Said first indication is hyponatremia;
52. The method of claim 51, wherein the second indication is autosomal dominant polycystic kidney disease (ADPKD). The authorization code is a first authorization code;
52. The method of claim 51, wherein the method further comprises generating a second authorization code if the request meets the dispensing criteria associated with the first indication.   52. The method of claim 51, wherein the dispensing criteria associated with the second indication includes confirmation of a diagnostic test performed on the patient and associated with the therapeutic agent.   56. The method of claim 55, wherein the diagnostic test is a liver function test (LFT). In a risk management system (RMS) host device for a therapeutic agent associated with multiple indications, a request to dispense a certain amount of the therapeutic agent to a patient, from among the multiple indications Receiving a request including an identifier associated with a certain indication from a computing device associated with a pharmacy registered with the RMS;
(1) the indication is a first indication among the plurality of indications; and (2) the amount is a dispensing criterion associated with the therapeutic agent of the first indication. If so, generating a first authorization code and activating the patient in the RMS for a first duration;
(1) the indication is a second indication among the plurality of indications, and (2) the amount is a dispensing criterion associated with the therapeutic agent of the second indication. If so, generating a second authorization code and activating the patient in the RMS for a second duration different from the first duration;
Providing the first authorization code or the second authorization code to the computing device associated with the pharmacy.   58. The method of claim 57, wherein the therapeutic agent is tolvaptan. Said first indication is hyponatremia;
58. The method of claim 57, wherein the second indication is autosomal dominant polycystic kidney disease (ADPKD). Said second indication is autosomal dominant polycystic kidney disease (ADPKD);
58. The method of claim 57, wherein the dispensing criteria associated with the second indication includes confirmation of a diagnostic test performed on the patient and associated with the therapeutic agent.   61. The method of claim 60, wherein the diagnostic test is a liver function test (LFT). Said first indication is hyponatremia;
The dispensing criteria associated with the first indication may include a duration from the date of registration of the patient, a daily dose of treatment with the therapeutic agent, or an indication of the patient's serum sodium concentration. 58. The method of claim 57, comprising at least one. Said second indication is autosomal dominant polycystic kidney disease (ADPKD);
The therapeutic agent is tolvaptan;
The formulation criteria associated with the therapeutic agent for the second indication include a combination of a 45 mg dose and a 15 mg dose, a combination of a 45 mg dose and a 90 mg dose, a 45 mg dose, 58. The method of claim 57, selected from the group consisting of a combination of a 60 mg dose, or a combination of a 45 mg dose and a 30 mg dose. Said first indication is hyponatremia;
The therapeutic agent is tolvaptan;
58. The formulation criteria associated with the therapeutic agent for the first indication is 15 mg to 60 mg per day based on either a 15 mg dose or a 30 mg dose. Method.   (1) the indication is a first indication of the plurality of indications; (2) the amount meets a dispensing criterion associated with the therapeutic agent of the first indication. 58. The method of claim 57, further comprising: and (3) generating an alert code if the amount meets a dispensing criteria associated with the therapeutic agent of the second indication.

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