Patent Application
20090319299
The disclosure generally relates to reporting systems, and more particularly to collecting and reporting adverse events.
Drug safety and pharmacovigilance are important issues throughout the world. The attention these issues generally receive, however, has been negative. In the United States, for instance, the U.S. Food and Drug Administration (FDA) has been criticized for allowing drugs perceived by many as unsafe to enter and remain on the market, taking delayed action, and requiring product withdrawal only after major health problems have occurred. For example, there have been over twenty (20) product withdrawals from the U.S. market since 1980.
Generally, the drug safety systems for marketed drugs in the U.S., E.U., Japan, Canada and most of the other major countries involve the voluntary reporting of adverse events (formerly called “side effects”) to the manufacturer or the national health agency. Typically, the manufacturer is required to report all serious adverse events (SAEs) and most non-serious ones to the appropriate health agencies in the countries where the drug is marketed. The techniques utilized by these systems typically rely on phone, e-mail and facsimile technology, resulting in a low percentage of all SAEs being reported. These systems also tend to require that all information be manually recorded, reviewed and be finally uploaded into one or more databases at the company and/or health agency for review by physicians responsible for food and drug safety.
As a result, companies and health agencies spend a considerable amount of time and resources to receive and analyze a sufficient number of cases with sufficient data and links between the drug or food and toxicity to make changes in the use of the drug or food (e.g. limit use to only certain patients or consumers, add warnings to the labeling, limit use to only certain diseases, limit doses in certain patients etc.) or to withdraw the product from the market. For example, the withdrawal of Baycol®, Vioxx® and Zelnorm® products required between four (4) and five (5) years of data gathering and analysis. In addition, the manual techniques used by these systems frequently result in backlogs in data entry by health agencies and companies.
Consumers and health care professionals (HCPs) are also discouraged from reporting SAEs because there is no easy and rapid way of doing so. For example, in the U.S., most cases are reported by consumers and HCPs by telephone to pharmaceutical companies or manufacturers which usually requires that the caller first identify the company and find its phone number in order to call. The contacts usually lead to one or more lengthy discussions. As HCPs and consumers generally have tight schedules and are not reimbursed for such reporting, there exists reluctance among some consumers and HCPs in reporting adverse events.
Accordingly, there exists a need for an improved system and technique for reporting adverse events relating to consumer products.
Techniques for collecting and reporting adverse events associated with a patient are disclosed. The techniques include providing a user interface to identify drug and medical conditions associated with the patient using standardized drug and medical terminology. The techniques also include generating and displaying a cumulative narrative of user selections on the interface. The cumulative narrative can be directly transmitted to one or more companies and/or and regulatory agencies.
For example, according to one aspect, a computer-based method of collecting and reporting adverse events associated with a patient includes providing a user interface capable of (i) prompting a user to identify information to be associated with a patient, the information including at least one of personal information, medical information, drug information, adverse event information, and (ii) associating the drug information and the medical information with the adverse event information in response to a request from the user.
The method also includes displaying iteratively a cumulative narrative on the user interface in response to the user identifying at least one of the personal information, medical information, drug information, adverse event information, and the association. Preferably for reporting to health authorities, the cumulative narrative describes the information in a standard format using a standardized nomenclature.
Preferably, the user of the system is a medical professional (e.g. a physician, nurse, pharmacist) or a patient. In one preferred embodiment, the method includes transmitting the cumulative narrative to a regulatory body. In another preferred embodiment, the method includes transmitting the cumulative narrative to a manufacturer or a data collection organization.
In one preferred embodiment, the method of prompting the user to identify information to be associated with the patient includes guiding the user using one or more display panels included in the user interface. Preferably, prompting the user to identify the information to be associated with the patient includes providing a user-selectable list on the user interface, the user-selectable list including entries conforming to the standardized nomenclature.
Prompting the user for the personal information can include providing a data entry area on the user interface for specifying a patient's initials, a patient-gender identifier, and a patient date-of-birth. The method can also include providing a user-selectable list including entries of a case outcome on the user interface. Preferably, the entries are selected from the group consisting of ‘congenital anomaly/birth defect’, ‘death’, ‘disabilities or permanent damage’, ‘hospitalization (initial or prolonged)’, ‘life-threatening’, ‘other serious/important medical event’ and combinations thereof (representing FDA approved categories and definitions).
In one preferred embodiment, prompting the user for the medical information includes providing a user-selectable list including entries of a current relevant medical condition on the user interface, the entries defined by the standardized nomenclature. Prompting the user for the medical information can include providing a user-selectable list including entries of a relevant surgery procedure name on the user interface, the entries defined by the standardized nomenclature. Prompting the user for the drug information can include providing a data selection area on the user interface for specifying a drug name, suspect identifier, start date and end date. Preferably, prompting the user for the adverse event information includes providing a data selection area on the user interface for identifying a drug name, a severity identifier, a start date and an end date.
In one preferred embodiment, describing the information using the standardized nomenclature includes selecting and displaying a drug term from a WHO Drug Dictionary. Describing the information using the standardized nomenclature can also include selecting and displaying a medical term from a Medical Dictionary for Regulatory Activities (MedDRA) database.
Preferably, describing the information in the standard format includes formatting the cumulative narrative and data into an E2B data format. The method can also include transmitting the E2B data format to at least one of a regulatory database and company safety database. In one embodiment, the method also includes providing an electronic acknowledgement to said user upon transmission of said E2B data format.
In yet another embodiment, the method includes storing the cumulative narrative in a database.
Preferably, providing the user interface includes transmitting the user interface over a network to a display device. In one embodiment, associating the drug information and the medical information with the adverse event information includes dragging one or more drug information and medical information onto the adverse event information displayed on the user interface.
A system, as well as articles that include a machine-readable medium storing machine-readable instructions for implementing the various techniques, are disclosed. Details of various embodiments are discussed in greater detail below.
In some embodiments, one or more of the following advantages may be present. For example, the disclosed techniques can facilitate the process by which consumers and HCPs report adverse events by prompting and guiding them through the reporting process.
An additional advantage may relate to increased accuracy of reporting adverse events. For example, by providing user-selectable lists of drug and medical terms that are pre-defined using a standardized nomenclature, data entry can be minimized and drug and medical conditions can be accurately described.
Another advantage may relate to timeliness of reporting adverse events. For example, by directly transmitting information to companies and heath agency databases, time spent manually entering adverse event information into these databases can be minimized. Direct upload into a health agency database without the need for manual entry decreases agency workload and data entry errors as well as making the data available immediately in real time.
Additional features and advantages will be readily apparent from the following detailed description, the accompanying drawings and the claims.
Like reference symbols in the various drawings indicate like elements.
Preferably, the system 10 is configured to include an access device 12 that is in communication with a server 22 over a network 20. The access device 12 can include a personal computer, laptop computer, or other type of electronic device, such as a cellular phone or Personal Digital Assistant (PDA). Preferably, the access device 12 is configured to include a browser 12A that is used to request and send information to the server 22. Although only one access device is shown in
The network 20 can include various devices such as routers, server, and switching elements connected in an Intranet, Extranet or Internet configuration. In some embodiments, the network 20 uses wired communications to transfer information to and from the access device 12 and the server 22. In another embodiment, the network 20 employs wireless communication protocols. In yet other embodiments, the network 20 employs a combination of wired and wireless technologies.
As shown in
The computer server 22 preferably includes a central processing unit (‘CPU’) 24, random access memory (‘RAM’) 26, non-volatile memory 30 and an input-output device 28, all of which are preferably interconnected via a common bus 32 and controlled by the CPU 24. In one preferred embodiment, the non-volatile memory 30 is configured to include a web server 34.
The web server 34 is provided and sends requested web pages to the browser 12A of the access device 12 in response to a web page request. The web server 30 communicates with the web browser 20 using one or more communication protocols, such as HTTP (Hyper Text Markup Language). In one embodiment, the web server 30 is configured to include the Java 2 Platform, Enterprise Edition (‘J2EE’) for providing a plurality of panels included in a user interface displayed on the browser. Details of the user interface are discussed in connections with
As shown in
Preferably, the control module 36 iteratively generates a narrative representing information identified and/or selected by the user using one or more of the display panels included in the user interface. As the control module 36 guides the user in selecting and identifying information, user selections are appended to the narrative resulting in a cumulative narrative being generated and displayed iteratively based upon selections made by the user in the interface. The cumulative narrative that is generated uses a standardized nomenclature. An example of the iterative generation and display of the cumulative narrative is discussed in connection with the example shown in
The display module 38 of the web server 34 provides the user interface to the browser 12A in response to requests from tbe webs server 34 and control module 36. In one embodiment, the display module 38 uses eXtensible Markup Language (XML) to define and display the user interface on the browser 12A. In another preferred embodiment, the display module 38 is formed from one or more enterprise java beans (EJBs) that execute on the browser. An example of the user interface provided by the display module 38 is discussed in connection with
As shown in
An event data store 44 is provided that is used to access and store information identified by users of the system. In one preferred embodiment, the event data store 44 is a relational database. In another embodiment, the event data store 44 is a directory server, such as a Lightweight Directory Access Protocol (‘LDAP’) server. In other embodiments, the event data store 44 is a configured area in the non-volatile memory 30 of the server 22.
Although the drug data store 42, medical term data store 40, and event data store 44 are not shown in
Turning now to
Preferably, the user interface 300 also includes a login ID area 305 for entering a user ID and password area 307 for entering a user password. Upon selection of an enter button 307A, the display module 38 retrieves the user ID and user password entered 52 and transmits the same to the control module 36 for authorization. The control module 36 then compares the retrieved user ID and password entered to valid user IDs and passwords 54 that are stored in the event data store 44. If the control module 36 determines that a valid user ID and password was not entered 56, the control module 36 directs the display module 38 to display an error message 58 and to prompt the user for a new user ID and password 60. Otherwise, if a valid user ID and password were entered 56, the control module 36 directs the display module 38 to populate a user selectable gender list 62 and calendar entries for identifying a patient date of birth 64. Next, the control module 36 directs the display module 38 to display a patient information panel 310 in the adverse event area 302.
An example of the patient information display panel 310 and options are shown in
Referring back to
Referring now to
If the next button 308 is selected, the control module 36 determines whether an outcome type has been selected 86. If an outcome type has been selected, the control module 36 compares the selected outcome type to a ranked scale of outcome types and generates a narrative representing the outcome type selected using a standardized nomenclature representing a severity level of the outcome. The control module 36 then directs the display module 38 to append the generated narrative onto the case narrative 88 resulting in a cumulative narrative representing information entered and/or selected in the patient information panel 310 and case outcome panels 400. The control module 36 then directs the display module 38 to display an adverse event description panel 500 in the adverse event area 302.
Turning now to FIGS. 2C and 9-13, an example of the adverse event description panel 500 and example method for providing the same are disclosed. The adverse event description panel 500 allows the user to specify medical events that are to be associated with the patient. As shown in
Preferably, each of the data entry areas 506, 508 are in communication with calendar selection boxes 506A, 508A that include calendar entries for selection by the user. In one preferred embodiment, as shown in
In one preferred embodiment, referring to
Upon the next button 308 being selected by the user, the control module 36 determines whether a selection is made 100 from the pull-down severity menu 504. As shown in
Next, the control module 36 determines whether the duration indicator 510 has been set by the user 106. Preferably, as shown in
The control module 36 then generates a narrative representing the identified adverse event descriptions and directs the display module 38 to append the generated narrative onto the case narrative 114, resulting in a cumulative narrative 304 representing information entered and/or selected from the patient information panel 310, case outcome panel 400 and adverse event panel 500. If the user does not select the add another description link 514, the control module 36 directs the display module 38 to display a drug description panel 600 in the adverse event area 302.
Referring now to FIGS. 2D and 14-17, an example of the drug description panel 600 and example method for providing the same are disclosed. The drug description panel 600 allows the user to specify any drugs that previously or currently are being administered to the patient. As shown in step 102 of
As shown in
As shown in
Referring back to
Next, the control module 36 determines whether the duration indicator 610 has been set by the user 134. Preferably, as shown in
The control module 36 then generates a narrative representing the identified drug descriptions and directs the display module 38 to append the generated narrative onto the case narrative 142, resulting in a cumulative narrative 304 representing information entered and/or selected from the patient information panel 310, case outcome panel 400, adverse event panel 500 and drug description panel 600. If the user does not select the add-another drug link 614, the control module 36 then directs the display module 38 to display a medical condition panel 700 in the adverse event area 302.
Turning now to FIGS. 2E and 18-20, an example of the medical condition panel 700 and example method for providing the same are disclosed. The medical condition panel 700 allows the user to specify any current relevant medical conditions associated with the patient. As shown in step 150 of
Similar to the start and end date data entry areas 506, 508 described in connection with
In one preferred embodiment, as shown in step 152 of
Referring back to
As shown in
Referring now to FIGS. 2F and 21-23, an example of the surgery panel 800 and example method for providing the same are disclosed. The surgery panel 800 allows the user to specify any relevant surgeries that the patient may have undergone. As shown in
In one preferred embodiment, as shown in
Turning back to
The control module 36 then generates a narrative representing the identified surgeries and directs the display module 38 to append the generated narrative 198 onto the case narrative, resulting in a cumulative narrative 304 representing information entered and/or selected from the patient information panel 310, case outcome panel 400, adverse event panel 500, drug description panel 600, medical condition panel 700, and surgery panel 800. If the user does not select the add-another surgery link 808, the control module 36 directs the display module 38 to display an association panel 900 in the adverse event area 302.
The association panel 900 allows the user to associate identified drugs and medical conditions with adverse events in an efficient and timely manner. For example, referring now to FIGS. 2G and 24-25, in one preferred embodiment, the control module 36 directs the display module 38 to display the association panel 900 on the user interface 300. Next, the control module 36 retrieves adverse event descriptions associated with the patient 204, any identified drug information associated with the patient 206, and any identified medical conditions for the patient 208 from the event data store 44.
Next, the control module 36 directs the display module 38 to display the retrieved drug and medical condition information associated with the patient 210 in the association panel 900. Next the control module 36 directs the display module 38 to display any adverse events associated with the patient 212 on the association panel 900. For example, as shown in
Once the selectable drugs 902, medical conditions 904 and adverse event descriptions 906 are displayed on the association panel 900 by the display module 38, the control module 36 associates the retrieved drug information and medical information with the adverse event information in response to a request from the user 214. In one preferred embodiment, the user using an input/output device of the access device 12, such as a mouse, can drag and drop one or more drug information and/or medical information onto one or more adverse events to create an association.
For example, as shown in the
In one preferred embodiment, once an association is performed, the control module 36 generates a narrative representing the association and directs the display module 38 to append the generated narrative onto the case narrative 220, resulting in an cumulative narrative 304 representing information entered and/or selected from the patient information panel 310, case outcome panel 400, adverse event panel 500, drug description panel 600, medical condition panel 700, surgery panel 800 and association panel 900.
Preferably, as shown at step 222 in
Furthermore, in some preferred embodiment, upon selection of the next button 308, the control module 36 formats the cumulative narrative into a E2B data format and then transmits the E2B formatted data directly to a regulatory agency database and/or company safety database. Preferably, upon transmission, the control module 36 provides an electronic acknowledgement to the user upon transmission of the E2B data format.
Of course, it will be appreciated by one skilled in the art that the present invention is not limited to immediately transmitting the cumulative narrative or to the E2B data format. For example, the cumulative narrative can be transmitted in ASCII format using batch processing.
It will be appreciated that various of the above-disclosed and other features and functions, or alternative thereof, may be desirably combined into many other different systems or applications. Any and all such modifications as would be obvious to those skilled in the art are intended to be covered within the scope of the following claims.
Although preferred embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments and that various other changes and modifications may be affected herein by one skilled in the art without departing from the scope or spirit of the invention, and that it is intended to claim all such changes and modifications that fall within the scope of the invention.
