REMS MANAGEMENT TOOL

The various technologies presented herein relate to assisting a prescriber in obtaining and maintaining Risk Evaluation and Mitigation Strategy (REMS) compliance. A centralized approach is presented for obtaining REMS compliance data from a drug manufacturer, federal regulator, etc., and based on identifying one or more REMS medications associated with a prescriber, compliance of the prescriber with regard to the REMS compliance data for the one or more REMS medications can be determined. Interaction and notifications, etc., can be performed utilizing internet access. In the event of a prescriber failing a compliance requirement, one or more actions can be identified to facilitate bringing the prescriber into REMS compliance. REMS compliance data can be shared with the drug manufacturer, regulatory body, etc., to facilitate understanding of success of REMS compliance. Stored REMS compliance data can be forwarded to a third party.

DETAILED DESCRIPTION

The various, exemplary, non-limiting embodiments presented herein relate to generation and compliance with various regulations, etc., relating to REMS requirements for an identified REMS medication(s). Various embodiments are disclosed herein to facilitate prescribers or prescriber-affiliated organizations to investigate and manage medication safety requirements such as a REMs requirement(s). In an embodiment, a single source certification management system is provided to enable a prescriber to manage a REMS requirement(s) for at least one medication having an ETASU certification/educational training requirement. Single sourcing enables a plurality of REMS information to be accessed from one location. Rather than having to look up FDA publications and/or manufacturer publications for each medication (many of which may not be easily accessible) from a plurality of sources, the embodiments presented herein facilitate consolidation of REMS information into a single location. Further, rather than having to review a wealth of REMS information (much of which may not pertain to the prescriber), information only of interest to the prescriber can be presented. Interaction with the centralized system, and access of data stored thereon, can be by a graphical user interface (GUI) such as a webpage(s), dashboard(s), accessible via the internet.

While ensuring compliance of a prescriber with a REMS requirement, the various embodiments can further benefit a drug manufacturer by providing an opportunity for prescribers to have easier access to a REMS medication(s), increasing prescriber exposure to the drugs offered by the manufacturer, and decreasing risk and harm events associated with use of their medications by improving adherence with REMS elements of compliance and certification. Further, the various embodiments can serve as a national medication safety database data repository and output system to support efforts aimed at decreasing preventable harm and death related to the subset of drugs identified and proven to be more dangerous (e.g. REMS drugs) compared to other nationally prescribed medications.

A prescriber can create a profile and select a medication(s) they prescribe from a pre-defined list. Further, based upon user selection, a prescriber can be paired with a REMS requirement and element of compliance for each medication they selected. Also, in an embodiment, a work-list can be generated to guide a prescriber down a path to compliance along with selection of notification preferences for keeping up-to-date with REMS program changes. The work-list can be prioritized to facilitate effective compliance with one or more REMS regulation.

In another embodiment, a drug manufacturer may use the tool to verify that a prescriber has met the certification requirements for a REMS medication. In another embodiment, a data-feed organization may utilize the centralized REMS information system to export REMS data stored thereon to another party, such as a medical publisher, an associated electronic medical system, and the like.

The various, exemplary, non-limiting embodiments are now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. It is to be appreciated that while the various exemplary, non-limiting embodiments presented herein relate to REMS compliance, the various embodiments are not so limited and are applicable to any application regarding medical/medication compliance. It is also to be appreciated that for the sake of brevity and comprehension the abbreviation REMS is utilized throughout the application however the abbreviation ETASU (as previously described) is equally applicable. Furthermore, it is to be appreciated that the terms “compliance”, “regulation”, “requirement”, and the like, can be used interchangeably. Further, while the various embodiments are directed towards regulation(s) associated with a Federal entity (e.g., FDA, FDAAA), the various embodiments are not so limited and can be directed to any entity such as governmental, international, health authority, and the like.

FIG. 1illustrates an exemplary, non-limiting embodiment of system100to facilitate compliance with a REMS requirement. System100comprises a central component, REMS system110, which can be utilized to receive information from a medication manufacturer, a drug company120, a regulation generated by a government entity or other organization associated with REMS compliance, a federal/health regulator130, and any other entity140associated with REMS compliance. A prescriber150can be associated with the REMS system110, whereby a REMS compliance information125can be received at the REMS system110to facilitate various interactive tasks with the REMS compliance information125by the prescriber150.

A drug company120can include any medication manufacturer, or associated entity, and can, in an embodiment, utilize the REMS system110to issue compliance regulations, etc., and based thereon, certify that a prescriber150has met the certification requirements for a REMS medication (e.g., to facilitate supplying one or more medications to a prescriber).

In this embodiment, a prescriber150can include any entity utilizing REMS system110and can include an individual prescriber(s), a physician, a nurse practitioner, a medical resident, a medical professional, a health care organization(s) (e.g., a hospital), a pharmacy, etc. In an embodiment, a healthcare facility has access to the REMS system110to facilitate overseeing or aiding an affiliated prescriber (e.g., a physician at a medical facility) in keeping track of their compliance with a REMS requirement(s). In another embodiment, a pharmacy, which may have responsibility or liability for only dispensing REMS medications when a certified prescriber has prescribed the medications, may use the REMS system110to verify compliance with the REMS requirements prior to dispensing the REMS medication.

Based upon compliance regulations (e.g., as effected by federal regulator130) a drug company120can generate information regarding a medication, a REMS compliance information125, which is forwarded to the REMS system110. The REMS information125can comprise of any information regarding one or more medications, where such information can include information regarding a medication, medication dosage, drug interaction, training requirement, handling requirement, certification requirement, re-certification requirement, removal of REMS regulations for the medication, addition of the medication to REMS compliance, and other information related to REMS compliance and regulation.

The REMS information125can be received at the REMS system110. The REMS system110can comprise of any components, applications, software, etc., to facilitate receipt, interpretation, analysis, information generation, information dissemination, etc., where such components, applications, etc., can include a medication component112, a prescriber component113, a compliance component114, a graphical user interface (GUI) component116, and any associated processor(s)118and data store(s)119. The data store119can store any information associated with operation of the REMS system110to facilitate effective utilization of the REMS system110by a drug company120, a federal/health regulator130, an other entity140, a prescriber150, a patient160, an insurance provider170, a third party data feed195, etc. In an embodiment, a data store119can store a list of medications121, a compliance information122, a prescriber information123, and the like.

In an exemplary scenario, REMS information125can be received at a REMS system110and acted upon by a medication component112, whereby the medication component112can review (e.g., by performing an analyzing operation, a parsing operation, and the like) the content of the REMS information125to determine which medication(s) is associated with the REMS information125. A list of medications121can be stored in a data store119, where a medication list121can comprise of the entirety of medications available for prescription, or a subset, where the subset can be based on a medication having a REMS requirement (either current or previous), a medication relating to a particular physician/prescriber specialty, etc. In an embodiment, the list of medications121(and associated compliance information122) can be updated in collaboration with a drug company120to facilitate accurate and shareable data regarding a medication(s) manufactured by a drug company120and accordingly ensuring compliance for dispensing particular REMS drugs.

Based upon identification of a medication, a compliance component114can be utilized to retrieve any existing compliance information122relating to the medication, e.g., as stored on a data store119. A compliance component114can identify the status of any existing compliance information122with reference to any compliance information received in a REMS information125, and in the event of new compliance information being received, the existing compliance information122can be updated accordingly. Further, if the REMS information125is directed towards a medication not in the medication list121, the medication can be added to the medication list121and compliance information added to the compliance information122.

A REMS system110, e.g., in accordance with a medication component112and/or a compliance component114, can notify a prescriber150of the newly received compliance information. Notification can be by any suitable means such as email, a notice directed to a prescriber150on a GUI190of the REMS system110, a text message, or other electronic means. As further described herein, in an embodiment, a GUI190can be utilized to facilitate interaction between a prescriber150, the REMS system110, and ultimately any of a drug company120, a federal/health regulator130, or an other entity140, etc. Utilization of a GUI190enables an interface (e.g., a website, a webpage, an interactive webpage, etc.) to be generated either of a general nature, or specific to the requirements of a particular prescriber150. Hence, rather than REMS related information being distributed across a plurality of individual websites on the internet (e.g., at each drug manufacturers website), all available REMS related information can be presented on a GUI190or as a direct download hosted thereon. In another embodiment, the GUI190provides links to REMS related information on third party internet websites.

In an embodiment, during initial engagement between a prescriber150and a REMS system110, a questionnaire155can be transmitted from the REMS system110to the prescriber150. Such questionnaire155may comprise questions, regarding the prescriber's150practice, such as their function or title, field of practice, specialty within the field, medications typically prescribed/of interest, and conditions typically treated or of interest. Further, questions may include contact information, employer, hospital or medical facility affiliations or “rights,” and a unique identifier such as the prescribers150national provider information (NPI)/Drug Enforcement Administration (DEA) number/state licensure (e.g., to facilitate unique identification between each of the prescribers150engaged with the REMS system150). In response to receiving the questionnaire155, the prescriber150can self-complete and forward a completed response158providing their pertinent details.

Upon receipt of the response158comprising information about the prescriber150, a prescriber component113can be utilized to generate a prescriber profile123which comprises information pertinent to the prescriber150, where such information can be utilized by a GUI component116to generate/update an interface(s) (e.g., GUI190) to facilitate interaction between the REMS system110and the prescriber150. For example, the prescriber profile123can contain information regarding how a webpage associated with the GUI190is to be formatted with regard to font, color, content. In an embodiment, a prescriber150can be a healthcare organization, such as a hospital, whereby the healthcare organization enables its logo to be displayed on a webpage associated with their data thereby indicating that the healthcare organization supports REMS compliance of the facility and anyone associated with the organization (e.g., a physician at an affiliated medical center).

Based on information provided in the response158(and any supplemental information) the GUI190can be configured in accordance with utilization requirements of the prescriber150. For example, based upon a list of medications identified as being prescribed by/of interest to prescriber150, the GUI190can be configured to present information regarding those medications. For example, if new information is received in the REMS information125, the GUI190can be configured to present the new information, and/or provide notification that new information regarding a particular medication is available. Thus, the prescriber150can view the new information directly on the GUI190, follow a link on the GUI190to the information, and/or request the new information (e.g., via checkbox or other interactive means) be displayed or emailed. As indicated by the broken lines between the prescriber150, the GUI190and the REMS system110, any information can be conveyed, viewed, responded to, etc., at any time on the GUI190to facilitate timely generation, interaction, and review of REMS related information between the prescriber150and the REMS system110. The GUI190can be configured to display one or more tasks, which when completed by the prescriber150, enable the prescriber150to complete the task(s) and progress toward completing any necessary REMS requirements to facilitate achieving certification/compliance. Further, owing to a prescriber150self-completing compliance-related information (e.g., via feedback158and/or GUI190) it is considered that the information provided will have a high level of veracity owing to the prescriber150providing the information themselves and taking the time to go through a step-by-step approach. Further, any information provided or accessed by prescriber150, via REMS system110, can be date-time stamped to facilitate auditing, if necessary. Further, review of the prescriber information158and the various REMS regulations125can be performed at any time, such as at a pre-defined time interval (e.g., hourly, daily, weekly, or monthly), or at any other time to facilitate timely compliance with one or more REMS regulations. Tasks presented on GUI190can include providing a medication guide, a patient informed consent requirement, provision of a patient counseling document, an appropriate use checklist, obtaining one or more certifications, enrolling a patient in a program such as a course of medication or monitoring, enrolling a facility into a required course, provisioning clinical information, and the like.

Along with the prescriber150, other entities can be further associated with REMS system110such as a patient160, an insurance provider170, or a third party data feed195, who can view or retrieve various REMS information stored at REMS system110as necessary. Furthermore, it is to be appreciated that a requestor of information from the REMS system110can be any of a prescriber150, a drug company120, a federal/health regulator130, an other entity140, a patient160, an insurance provider170, or other third party195. In the various embodiments, information (e.g., a REMS regulation125, a response158, and any other supplemental information) can be provided to the REMS system110, e.g., by a drug company120, and a federal/health regulator130, an other entity140, a prescriber150a patient160, an insurance provider170, or other third party195, and similarly, information (e.g., operational information128, webpages presented on GUI190, etc.) can be requested and viewed by a drug company120, and a federal/health regulator130, an other entity140, a prescriber150a patient160, an insurance provider170, or other third party195.

In an embodiment, the REMS system110can be configured such that different entities associated with the REMS system110can have different levels of access and information accordingly provided. For example, a prescriber150can be provided with a high level of access enabling full querying/viewing of any information associated with the prescriber150. Alternatively, a patient160may be accorded low level access and is thus only able to query/view a limited amount of information regarding a particular prescriber150. For example, a patient160(e.g., via a website or similar interface) may only be able to query/view information regarding the compliance of the prescriber150with regard to a particular medication as a means for answering a question such as “Is my doctor in REMS compliance regarding drug x? and if not, who in my locality is?” In another aspect, an insurance provider170may have sufficient level of access to facilitate querying the REMS system110to determine a level of REMS compliance of a prescriber150for a particular medication. Such a query can be of use when reviewing an incident of medical malpractice (e.g., by a lawyer), determining insurance coverage and cost for a prescriber150, whereby, for example, a lower premium can be charged for a prescriber150being in compliance rather than one that is not.

Further, a drug company120, a federal/health regulator130, or an other entity140can obtain operational information128from a REMS system110. In an embodiment, the operational information128can be utilized to indicate how successfully the REMS system110is operating in terms of degree of REMS compliance by one or more prescribers150, a success of implementation of a given REMS regulation (e.g., in a REMS regulation125submitted by a drug company120), and the like. For example, there may be reluctance or lack of perception in the benefit of applying a REMS regulation by a prescriber. However, the reluctance to expend time and/or money on complying with a REMS regulation may be a function of the difficulties encountered with current approaches to obtaining REMS regulation information. Operational information128can be obtained to identify REMS compliance by one or more prescribers150, for example, increase in REMS compliance based on utilization of the REMS system110, REMS compliance based on a new regulation (e.g., regulation125) being initiated by a drug company120, a federal/health regulator130, or other entity140, or REMS compliance based on a new training regimen initiated by drug company120.

FIGS. 2-12illustrate exemplary methodologies relating to provisioning REMS compliance. While the methodologies are shown and described as being a series of acts that are performed in a sequence, it is to be understood and appreciated that the methodologies are not limited by the order of the sequence. For example, some acts can occur in a different order than what is described herein. In addition, an act can occur concurrently with another act. Further, in some instances, not all acts may be required to implement the methodologies described herein.

FIG. 2illustrates a methodology200for gathering, compiling and disseminating REMS compliance information. At210REMS compliance information is received at a centralized system configured to store and provide REMS compliance information and actions. As previously mentioned, a large number of medications have one or more REMS requirements associated therewith, whereby the number of medications requiring REMS compliance can change at any time, the content of the REMS requirements can change at any time, and further, REMS compliance information can be provided by a plurality of sources, rather than a single source. A centralized system enables all of the REMS compliance regulations and information that a prescriber may have to comply with to be provided from a single source rather than the prescriber having to track down the REMS compliance information themselves.

At220, the various REMS compliance regulations and information can be compiled, e.g., for each medication requiring REMS compliance, in accord with ETASU or other requirement/regulation. For each medication with REMS elements of compliance, a REMS compliance questionnaire can be generated to facilitate evaluation of a prescribing entity's ability to meet a requirement(s) for REMS compliance for the medication.

At230, the REMS compliance questionnaire can be provided to the prescriber. The questionnaire can be provided in the form of an interactive webpage(s) comprising various data fields which the prescriber can accordingly complete.

At240, the completed REMS compliance questionnaire can be received at the centralized system from the prescriber.

At250, based on the completed REMS compliance questionnaire in conjunction with the requirement(s)/regulation(s) pertaining to a medication, the REMS compliance of the prescriber can be evaluated. As described herein, if a prescriber fails to satisfy a particular REMS requirement, the prescriber can be tasked with one or more actions to facilitate compliance, whereby the REMS system can monitor adherence and prescriber activity as they are directed towards being compliant.

FIG. 3illustrates a methodology300for receiving REMS compliance information and based thereon, maintaining a centralized REMS information system. At310, a REMS compliance system can be initialized. As previously mentioned, the REMS system can act as a centralized repository for any information regarding REMS compliance, e.g., REMS compliance regulations received from a drug manufacturer, addition of a medication to REMS compliance, removal of a medication from REMS compliance, or a federal mandate.

At320, information is received at the REMS system regarding REMS compliance for a medication.

At330, the received information can be analyzed and a file generated for the medication, where the generated file can store any information pertinent to the medication, such as one or more REMS regulations associated with the medication and any activities required to facilitate compliance with the REMS regulation(s).

At340, new information can be received, whereby the new information can potentially include REMS compliance information for the medication, or other medication stored in the REMS compliance repository.

At350, upon receipt of the new information, the information can be analyzed, e.g., parsed, to determine whether the information includes REMS information pertinent to any of the medication(s) stored in the REMS compliance repository. If a determination is made that the information does not contain any information pertinent to the medication, flow returns to340to await receipt of the next information.

At360, if a determination is made that the information contains information pertinent to the medication the REMS compliance information for the medication is updated in accord with the newly received information. Further, the newly received information can contain information regarding a medication that is not currently stored in the REMS compliance repository (e.g., the medication is newly available, has recently been indicated as requiring REMS compliance, etc.), whereupon a file for the new medication can be added to the REMS compliance repository. Flow returns to340for new information to be received.

FIG. 4illustrates a methodology400for providing a prescriber with REMS compliance information. At410, a request from a prescriber to join the REMS compliance system can be initialized. The request can include any information pertinent to the prescriber as required to facilitate generation of a prescriber file and also to facilitate monitoring of the prescribers compliance with any pertinent REMS regulations. At420, based on the received information, a prescriber profile can be generated.

At430, as part of the subscribing operation the prescriber can select/submit which medications they prescribe. Further, as described herein, one or more medications can be associated with a specialty of a prescriber.

At440, the list of selected/submitted medications can be reviewed and any REMS compliance information for each medication can be presented/forwarded to the prescriber (e.g., by email, GUI, text message).

At450, new information regarding REMS compliance for one or more medications can be received.

At460, a determination can be made regarding whether the new information affects the status of a medication identified as being of interest to the prescriber. If no new information pertains to the medication(s) of interest to the prescriber, the flow returns to450.

At470, based on the new information comprising REMS compliance information pertaining to a medication of interest to the prescriber, the prescriber can be informed of the new REMS compliance information being available. In an embodiment, the prescriber can be accessing the REMS system via a GUI, and in such an event, a notification can be placed on the GUI indicating that new REMS information is available, the information can be provided in its entirety, a link with an address to a page comprising the new information can be provided or an email sent.

FIG. 5illustrates a methodology500for assisting a prescriber in establishing and/or maintaining compliance with at least one REMS requirement or regulation. At510, REMS compliance information is compiled, where such information can include a requirement for compliance as generated by a manufacturer of a medication, as previously mentioned.

At520, based on the REMS compliance information, a questionnaire can be forwarded to a prescriber (e.g., based on the medication(s) identified as being of interest/prescribed by the prescriber). The questionnaire can be presented in the form of a webpage in a GUI.

At530, the completed questionnaire is received from the prescriber.

At540, the response(s) entered in the questionnaire can be compared with the REMS compliance information for each medication identified as being prescribed/of interest to the prescriber. Based thereon, a determination can be made with regard to whether the prescriber is in compliance with one or more regulations relating to one or more medications.

At550, in the event of being in compliance, the prescriber can be informed of compliance satisfaction. It is to be appreciated that the prescriber may be in compliance with regard to a regulation(s) pertaining to particular medication and out of compliance with regard to another regulation(s). Hence, a report can be compiled and comprise of information directed to each of the medication(s)/regulation(s), and can indicate compliance with one regulation and out of compliance with another.

At560, a new REMS compliance regulation can be received, e.g., a new medication has been added to the REMS compliance list, there has been an update to a REMS compliance regulation, etc. Flow returns to540for determination of whether the prescriber is in compliance based on the newly received compliance.

At570, in the event of the prescriber being determined to not be in compliance with at least one REMS compliance regulation, at least one means for satisfying the out of compliance REMS regulation can be determined. Any suitable means can be determined, for example, forwarding medical information (for example, a medical guide) to the prescriber regarding a particular medication to enable the prescriber's information base to be brought into conformity with the regulation (e.g., information base comprises of required information), a physician or other entity associated with the prescriber can undergo training to obtain specific experience/knowledge required for a medication(s), indicate they can diagnose a condition for which the medication is directed towards, they understand the risks and benefits of a medication, they have read educational materials associated with the medication, they can diagnose and treat a potential adverse reaction to the medication, they periodically recertify and re-enroll in an ETASU/REMS program, they agree to terms of a prescription (e.g., required to receive prior-authorization, check ‘qualification stickers’, dispense within a pre-determined amount of time, complete prescriptions only from an enrolled physician, conduct patient monitoring, etc.), and the like.

At580, at least one means for satisfying the out of compliance REMS regulation can be forwarded to the prescriber, e.g., by email or notification via an interactive GUI.

At590, while the various REMS compliance information can be directed towards the prescriber, REMS compliance information pertinent to the prescriber can be made available to other entities. For example, a summary can be provided on a webpage associated with the prescriber whereby a patient (or other member of the public) can view the webpage to identify whether the prescriber is in REMS compliance regarding at least one medication.

FIG. 6illustrates a methodology600for disseminating REMS compliance information. At610, as previously mentioned, a REMS compliance system can act as a centralized repository of REMS compliance regulations and information. Accordingly, the REMS compliance regulations/information can be provided to any interested party. A request can be received for REMS information, for example, from a third party (e.g., a data-feed organization) associated with generation of medical literature.

At620, based upon the received request, REMS information pertinent to the request can be identified. For example, a request may be for REMS information associated with a particular medication, whereby a data store associated with the REMS compliance system can be queried and any information relating to the medication of interest can be retrieved.

At630, the requested information can be forwarded to other parties having an interest in the medication (e.g., a medical publisher).

FIG. 7illustrates a methodology700for generating a REMS compliance report. At710, a request can be received from a prescriber regarding their REMS compliance. For example, as part of an internal audit, a prescriber pharmacy is required to provide REMS compliance information regulations and information. Accordingly, the prescriber can generate a request for their compliance information (e.g., for the various physicians and other medical personnel) associated with the prescriber.

At720, in response to the request, the REMS compliance information for the prescriber can be retrieved, e.g., from a data store associated with the REMS compliance system.

At730, a report can be compiled for the REMS compliance information for the prescriber. For example, information can be provided regarding which REMS regulations are satisfied, which REMS regulations are not, what is being done to remedy a lack of compliance, etc. As previously mentioned, the prescriber can indicate how their report is to be formatted with regard to content, color, graphics (e.g. prescriber logo), etc.

At740, the REMS compliance report can be provided to the prescriber.

FIG. 8illustrates a methodology800for provisioning a REMS compliance system to an individual practitioner, e.g., a physician with a solo practice, an individual operating in association with a prescriber organization such as physician at a hospital, etc. At810, a request can be received from an individual regarding their REMS compliance. Similarly, the request can be generated by a prescriber organization on behalf of the individual, e.g., on behalf of the physician.

At820, at least one practitioner associated with the request is identified.

At830, REMS compliance information for each practitioner is generated, whereby information can be generated based on unique identification of the practitioner, e.g., based on their DEA number, NPI number, state licensure.

At840, a REMS compliance report is compiled for the practitioner. The report can be of an interactive nature (e.g., as a webpage supported by the REMS system, a webpage generated by an application local to the prescriber/physician, etc.), which enables the practitioner to enter information regarding their REMS compliance activities.

At850, a task-list regarding the various REMS compliance regulations can be generated.

At860, based on the task list, a determination can be made regarding whether the practitioner is in compliance, e.g., has the practitioner received certain training such as does the practitioner have specific experience/knowledge required to prescribe a medication(s), can they diagnose a condition for which the medication is directed towards, do they understand the risks and benefits of a medication, have they read the educational materials associated with the medication, can they diagnose and treat a potential adverse reaction to the medication, they communicate with a patient the risks and benefits regarding a particular medication, they periodically recertify and re-enroll in an ETASU/REMS program, they agree to terms of a prescription (e.g., required to receive prior-authorization, check ‘qualification stickers’, authorize the dispensing of a medication within a pre-determined amount of time), conduct patient monitoring, does the practitioner's operation meet REMS regulations?, and the like.

At870, based on a determination that the practitioner is not in compliance with at least one regulation, an associated task can be identified, and based upon completion of the task the flow returns to860to re-evaluate the practitioner's REMS compliance status.

At880, based upon a determination that the practitioner is in compliance with the at least one regulation, an indication can be presented/forwarded to the practitioner indicating their compliance.

FIG. 9illustrates a methodology900for prioritizing a task-list of activities to facilitate effective REMS compliance. As previously mentioned, based on feedback from a prescriber, a level of compliance with one or more REMS regulations can be determined for the prescriber. At910, a plurality of REMS compliance regulations can be identified that the prescriber has failed to satisfy. Identification of REMS compliance regulations for which an activity is to be conducted by a prescriber can be performed at any time. For example, upon initial registration with the REMS system, the prescriber information provided at registration can be reviewed and REMS compliance activity identified. Alternatively, as a new REMS regulation is received, e.g., from a drug manufacturer, the supplied prescriber information can be reviewed to identify whether the newly received REMS regulation places the prescriber out of compliance. Further, review of the prescriber information and the various REMS regulations can be performed at any time, such as at a pre-defined time interval (e.g., hourly, daily, weekly, monthly), or at any other time.

At920, a work-list of activities can be generated to be performed by the prescriber to facilitate satisfying the one or more regulations to bring the prescriber into compliance with the one or more REMS regulations.

At930, the work-list of activities can be prioritized. Prioritization can be based on one or more factors, for example, whether the medication is an ETASU/non-ETASU medication, a severity of risk associated with the medication (e.g., risk to a patient), risk of audit by a drug manufacturer, a federal organization (e.g., the FDA), or other entity associated with effecting REMS compliance, and whether performing an activity can facilitate meeting a plurality of REMS requirements simultaneously.

At940, the work-list can be provided to the prescriber, whereupon the prescriber can perform the various activities to facilitate their complying with the plurality of the REMS requirements, as previously described. As the one or more activities are performed and the associated REMS requirement satisfied, notification of the activity being performed can be forwarded to the REMS system to update the prescriber REMS compliance file at the REMS system.

FIG. 10illustrates a methodology1000for provisioning REMS compliance information to a plurality of entities based upon access level. For the various entities that may require information regarding at least one REMS compliance regulation, different access levels can be established based upon, for example, the level of interaction or information source. For example, a prescriber can be assigned a high level of access owing the sensitivity of information they are likely to provide to a REMS compliance system and according interaction with the REMS compliance system, information provided/stored by the REMS compliance system, etc. Alternatively, a member of the public may require information regarding the REMS compliance status of a prescriber, e.g., a prescriber affiliated medical facility, an employer of a prescriber, or a pharmacy, and hence may only be given low level access, such as being able to only view information regarding compliance of a prescriber, whereby the information may be viewable by a rudimentary search based on keywords such as prescriber, location, and the like. At1010, a request can be received from an individual regarding their REMS compliance. Similarly, the request can be generated by an organization (e.g. hospital) on behalf of the prescriber/individual, e.g., on behalf of the physician.

At1020, an access level associated with the request is determined (e.g., by an authentication and authorization process). As mentioned, if the request has a high level of access (e.g., the requesting entity is a prescriber) then the requesting entity is provisioned greater access than another entity, such as an attorney, accessing the REMS system for an issue associated with an incident of medical malpractice. In a further example, a member of the public who is interacting with the REMS system (e.g., via an online application) may not have to provide any authentication and interacts with the REMS as a visitor.

At1030, a response to the request is generated based on the access level with all of the information made available (e.g., for a high level access) or a subset thereof (e.g., for visitor access, low-mid level access).

FIG. 11illustrates a methodology1100for provisioning REMS compliance information based on prescriber specialty. At1110, as previously described, during registration with a REMS system (or at any other time), a prescriber can provide information regarding their specialty.

At1120, the prescriber specialty can be identified, for example, one prescriber could be an ophthalmologist, while another prescriber can be involved with sports medicine.

At1130, based at least on the prescriber specialty, one or more medications can be identified as being of possible interest to the prescriber. For example, a specific type of analgesic may be of potential interest to the sports medicine prescriber, where the potential interest can be determined based on number of other sports medicine prescribers also prescribing the specific analgesic. The medications that may be presented to a prescriber of a designated specialty may be determined by data gathered by the REMS system from the questionnaire responses of prescribers of the same speciality, and the medications that they list as being typically prescribed or of interest. At1140, REMS regulations pertaining to the one or more medications can be identified, e.g., for the specific analgesic.

At1150, the identified REMS regulations can be forwarded to the prescriber.

FIG. 12illustrates a methodology1200for provisioning REMS compliance information. At1210, a request can be received at a REMS system for operational information regarding compliance of one or more prescribers with a REMS regulation(s). The request can be generated by any entity such as a drug company, a federal regulator, or a health regulator. The operational information can be utilized to facilitate a determination of how successfully the REMS system is operating with regard to REMS compliance by one or more prescribers, success of implementation of a given REMS regulation (e.g., a REMS regulation submitted by a drug company), or to ensure compliance with REMS regulations.

At1220, REMS compliance for at least one prescriber can be determined. For example, quantification can be obtained indicating how many prescribers are in compliance with a REMS regulation(s) (e.g., total number, percentage, etc.). By quantifying compliance with one or more REMS regulations a determination can be made regarding the effectiveness of a particular regulation, ease with which the regulation can be complied with, a change in REMS compliance based on availability of a REMS system, REMS compliance based on a new regulation being initiated (e.g., by a drug company, a federal regulator, a health regulator, or other entity), change in REMS compliance based on a new training regimen being initiated by a drug company, and the like. For example, a requestor may use compliance information and reports to compare against medication error and harm data in order to make determinations, assumptions and/or correlations between level/percent compliance and level/percent harm events associated with a REMS medication(s).

At1230, a feedback report can be generated presenting the various REMS compliance data and subsequently provided to the requesting entity.

FIG. 13illustrates a methodology1300for monitoring and provisioning REMS compliance information. At1310, information can be received at a REMS system from a prescriber. In an embodiment, where the prescriber is a health organization (e.g., a hospital), the information can include a list of all of the medical personnel associated with the health organization who may be involved with the prescribing/utilization of one or more medications having some form of REMS compliance.

At1320, the various medical personnel presented in the list can be identified.

At1330, the various medical personnel can be informed, e.g., by email, online notification, and the like, of a requirement to engage in a REMS compliance program.

At1340, enrollment information can be received from the various medical personnel, thereby enabling an individual approach to monitoring/enabling REMS compliance for one or more medical personnel associated with a health organization. Hence, while the health organization may initiate engagement with a REMS system, any activity including enrollment, monitoring, and facilitating REMS compliance can be conducted at an individual level.

At1350, as the various individuals engagement in the REMS compliance system, one or more REMS compliance activity can be determined for each individual (for example, based on the individual's specialty, list of medications indicated that the individual may prescribe, etc.).

At1360, ongoing monitoring of the individual's REMS compliance activity can be performed to facilitate the individual satisfying the REMS compliance, as well as enabling information gathered from a plurality of individuals to enable determination of REMS compliance at the health organization, at a county level, state level, national level, global level, etc., as previously mentioned with reference toFIG. 12. For example, the utilization activity of an enrolled prescriber, such as a download activity of one or more individuals can be monitored, whereby the total number of downloads from a REMS system by individual and also by prescriber, health organization, nationally, etc., can be monitored and used as a measure of REMS compliance. While not limited to, the downloads can include downloading of any of a medication guide, an informed consent, and appropriate use checklist, etc.

Referring now toFIG. 14, a high-level illustration of an exemplary computing device1400that can be used in accordance with the systems and methodologies disclosed herein is illustrated. For instance, the computing device1400may be used in a system to facilitate assisting a prescriber in obtaining and maintaining REMS compliance. The computing device1400includes at least one processor1402that executes instructions that are stored in a memory1404. The instructions may be, for instance, instructions for implementing functionality described as being carried out by one or more components discussed above or instructions for implementing one or more of the methods described above. The processor1402may access the memory1404by way of a system bus1406. In addition to storing executable instructions, the memory1404may also store operating parameters, required operating parameters, and so forth.

The computing device1400additionally includes a data store1408that is accessible by the processor1402by way of the system bus1406. The data store1408may include executable instructions, operating parameters, required operating parameters, etc. The computing device1400also includes an input interface1410that allows external devices to communicate with the computing device1400. For instance, the input interface1410may be used to receive instructions from an external computer device, from a user, etc. The computing device1400also includes an output interface1412that interfaces the computing device1400with one or more external devices. For example, the computing device1400may display text, images, etc. by way of the output interface1412.

The term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless specified otherwise, or clear from the context, the phrase “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, the phrase “X employs A or B” is satisfied by any of the following instances: X employs A; X employs B; or X employs both A and B.

Further, as used herein, the term “exemplary” is intended to mean “serving as an illustration or example of something”.

The articles “a”, “an”, and “the” should be interpreted to mean “one or more” unless the context clearly indicates the contrary.