Systems and methods for facilitating medicament administration

Abstract

A non-transitory computer readable storage medium comprising instructions that, when executed by a computer, cause the computer to execute a program for managing a user's medical condition or treatment; monitor a current dosing schedule set within the program; determine whether a scheduled dose is due; determine an experience level of a user; in response to determining that the scheduled dose is due, generate a first notification alerting the user to the scheduled dose; and in response to detecting user interaction with the first notification, provide a user interface displaying content relating to the scheduled dose. At least part of the content displayed is based on the experience level of the user.

Description

[0001] Systems and Methods for Facilitating Medicament Administration

[0002] Field

[0003] The present specification relates to systems, methods and a device for medication and disease management and, in particular, to a computer implemented system, method, and device for assisting a user in medicament administration.

[0004] Background

[0005] A significant barrier to high quality therapeutic outcomes is patient engagement and adherence with a prescribed medicament regimen. The prescribed medicament regimen can often involve the use of a medicament delivery device to dispense one or more medicaments for managing or treating one or more diseases. Patient engagement and adherence with a prescribed medicament regimen may be linked to their familiarity with, and ability to use, the means of medicament delivery for treating or managing one or more conditions of the user.

[0006] Current systems do not effectively allow patients with complex morbidities to manage multiple health conditions in a convenient way. Current systems also do not effectively facilitate access to information and guidance relating to these conditions and how to use a medicament delivery device for managing or treating these conditions. Where users lack confidence or experience in administering their medicaments, they may be more likely to make an error when taking the medicament or experience discomfort during administration of the medicament. This, in turn, may reduce user adherence to a medicament regimen.

[0007] Therefore, there is a need for systems, methods, and devices to provide effective and informative assistance to patients in managing their health conditions, which improve patient engagement and adherence, and ultimately lead to improved therapeutic outcomes for the patient.

[0008] Summary

[0009] A first aspect of this specification provides a non-transitory computer readable storage medium comprising instructions that, when executed by a computer, cause the computer to: execute a program for managing a user’s medical condition or treatment; monitor a current dosing schedule set within the program; determine whether a scheduled dose is due; determine an experience level of a user; in response to determining that the scheduled dose is due, generate a first notification alerting the user to the scheduled dose; and in response to detecting user interaction with the first notification, provide a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

[0010] The experience level of the user may correspond to the user’s ability to independently administer a scheduled dose of medicament.

[0011] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to determining that the experience level of the user is less than a threshold level, provide a user interface including a guide providing step-by-step instructions for performing the scheduled dose.

[0012] The threshold may be a predetermined number of doses taken and / or logged by the user.

[0013] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to detecting user selection of the guide, provide a series of user interfaces corresponding to each step of the guide.

[0014] The step-by-step instructions may comprise one or more of: a document, an audio file, a video, and a link to a webpage on the Internet.

[0015] The step-by-step instructions may include a preparation guide comprising steps to guide the user to prepare a medicament delivery device for administering the scheduled dose.

[0016] The step-by-step instructions ,ay include a set of instructions for actuating a medicament delivery device to administer the scheduled dose.

[0017] The medicament delivery device may comprise medicament used in the management or treatment of the user’s medical condition.

[0018] The step-by-step instructions may include at least one of instructions for: preparing a medicament delivery device comprising a medicament for managing or treating the user’s medical condition for administering the scheduled dose of medicament; setting a timer to notify the user when the medicament delivery device is ready for administering the scheduled dose of medicament; requesting and / or receiving a call from a health care provider; preparing a site on the user’s body for receiving the scheduled dose; and use and / or disposal of the medicament delivery device. The instructions may be further configured, when executed by the computing device, to cause the computing device to: provide a user interface including user selectable options for a user to

[0019] (i) start a timer to notify the user when the scheduled dose is ready to be administered, and / or

[0020] (ii) confirm that the scheduled dose is ready to be administered.

[0021] The scheduled dose may be ready to be administered when it has reached ambient room temperature.

[0022] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to detecting user interaction indicating that the user has taken the scheduled dose, record a log of the scheduled dose taken by the user.

[0023] The log may include information relating to the scheduled dose. The information may comprises one or more of: an amount of medicament administered, a time, day and / or date, an injection site location, and a user survey.

[0024] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to determining that the experience level of the user is equal to or more than a threshold level, provide a user interface including an option to confirm that the user is ready to proceed with the scheduled dose.

[0025] The instructions may be further configured, when executed by the computing device, to cause the computing device to: determine a time remaining before a scheduled dose is due; and in response to determining that the time remaining before the scheduled dose is due is less than a threshold time, display the first notification alerting the user that the schedule dose is due.

[0026] The threshold time may be measured in minutes, hours or days. The threshold time may be pre-set by the instructions, set by a health care professional or set by a user.

[0027] The threshold time may be measured in minutes, hours or days. The threshold time may be pre-set in the application or set by a user.

[0028] The instructions may be further configured, when executed by the computing device, to cause the computing device to: in response to (i) determining that the scheduled dose is ready for administration and / or (ii) detecting a user input confirming that the user is ready to administer the scheduled dose, initiate a telephone call with a health care professional. A second aspect of this specification provides a user device comprising processing circuitry configured to: execute a program for managing a user’s medical condition or treatment; monitor a current dosing schedule set within the program; determine an experience level of a user; determine whether a scheduled dose is due; in response to determining that the scheduled dose is due, generate a first notification alerting the user to prepare for the scheduled dose; and in response to detecting user interaction with the first notification, provide a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

[0029] A third aspect of this specification provides a computer implemented method, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current dosing schedule set within the program; determining an experience level of a user; determining whether a scheduled dose is due; in response to determining that the scheduled dose is due, generating a first notification alerting the user to prepare for the scheduled dose; and in response to detecting user interaction with the first notification, providing a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

[0030] Brief Description of the Figures

[0031] So that the general concepts set out in the foregoing sections can be more fully understood, embodiments thereof will be described with reference to the accompanying drawings, in which:

[0032] Figure 1 shows an overall architecture of a system for disease management and medication regimen management;

[0033] Figures 2a to 2d show exemplary screenshots illustrating content facilitating user preparations for administering a scheduled dose;

[0034] Figures 3a to 3e show exemplary screenshots illustrating content (steps) included in a step-by- step guide;

[0035] Figure 4a to 4g show exemplary screenshots illustrating the use of a timer for preparing the scheduled dose for administration;

[0036] Figures 5a to 5d show exemplary screenshots illustrating notifications indicating that the scheduled dose is ready for administration;

[0037] Figures 6a to 6d show exemplary screenshots illustrating a telephone call between the user and a health care professional;

[0038] Figures 7a to 7i show exemplary screenshots illustrating further content (steps) included in the step-by-step guide; Figures 8a to 8c show exemplary screenshots illustrating prompts to the user to indicate where on the user’s body the scheduled dose was administered;

[0039] Figures 9 shows an exemplary screenshot illustrating prompts to the user to complete a survey associated with the administration of the scheduled dose;

[0040] Figures 10a and 10b show exemplary screenshots illustrating a notification confirming that the scheduled treatment is complete;

[0041] Figures 11 a to 11c show exemplary screenshots illustrating a timer for preparing a medicament delivery device for administration of a scheduled dose;

[0042] Figures 12a to 12d show exemplary screenshots illustrating a notification associated with a timer for preparing the scheduled dose for administration;

[0043] Figure 13 shows a flow chart illustrating the steps of a computer implemented method for assisting a user to administer a scheduled dose; and

[0044] Figure 14 illustrates schematically a user device for running the computer program for disease management and medication regimen management.

[0045] Detailed Description

[0046] The present disclosure relates to an application which can be run on a user device and which assists a user with the management and treatment of one or more medical conditions. In particular, the application facilitates access to information and guidance relating to these conditions and how to use a medicament delivery device for managing or treating these conditions. Particularly, the application provides a simple and convenient way of assisting a user in administering, recording and adhering to their prescribed medicament regimen.

[0047] The application can be used to manage a broad range of diseases which are treated by a range of different medicaments. Although some of the specific embodiments below are described in relation to the treatment of atopic dermatitis and / or asthma using a single medicament, the application is not so limited. Various other immunology or other indications may also be managed by the application, where one or more of these immunology or other indications may be treated by using a single medicament approved for use in treating the one or more immunology or other indications. Such a single medicament can include, for example, different dosages containing the same API, different volumes or concentrations of the same API, or different formulations containing the same API. In some embodiments, a single medicament can include an anti IL-4R mAb (e.g., Dupilumab). Further, a broad range of immunological conditions may be managed by the application. The user may be prescribed one or more drugs and the application provides personalized support for users depending on their particular drug prescription(s) and health profile. For example, the application may be configured to provide support for a number of diseases caused by Type 2 inflammation. In the context of dermatology this may include Atopic Dermatitis, Prurigo Nodularis, Bullous Pemphigoid, an Urticaria (e.g., chronic spontaneous urticaria, or cold inducible urticaria), Hand and Foot Disease, or Pruritis, each of which may be treated by injections of Dupixent® or other injectable drugs, but also by some oral and topical medications. In the context of respiratory diseases, this may include Asthma, Nasal Polyps, Sinusitis (e.g., chronic (rhino)sinusitis with or without nasal polyps), Allergic Bronchopulmonary Aspergillosis (ABPA), or Allergic Fungal Rhinosinusitis (AFRS) (which may be treated by injections of Dupixent® or other injectable drugs but also by some oral medications and Chronic Obstructive Pulmonary Disease (COPD, which may be treated by injections of Dupixent® or other injectable drugs). In the context of Gastroenterology this may include Inflammatory Bowel Disease (IBD) and Eosinophilic Esophagitis (EoE), Eosinophilic Gastroenteritis (EGE), or Ulcerative Colitis, which may be treated by injections of Dupixent® or other injectable drugs but also by some oral medications.

[0048] Referring to Figure 1 , schematic overview of an overall architecture 100 for a disease management and medication regimen management system is shown. The system architecture 100 illustrates a number of functional modules and the data links between these. The system architecture 100 comprises a user device 104 running an application with a number of functional modules, illustrated in the central box. The architecture 100 also illustrates how the application run by the user device 104 can interact with other service providers to enhance the information which can be provided to the user through the application. For instance, by communicating with insurance / benefit provider systems and pharmacies.

[0049] One of these functional modules is a journal module 102. The journal module 102 is configured to allow a user to maintain a journal relating to one or more medical conditions of the user. The journal may comprise a plurality of journal entries that detail episodes of the one or medical conditions, such as symptoms, user specific health data, contextual information, or the like. The journal may be used to monitor the one or more medical conditions for patterns, and to identify potential triggers for episodes of the one or more medical conditions. The journal module 102 may communicate with an external service, Adverse Events. The journal module may transmit patient information associated with episodes of the one or more medical conditions to the adverse events service.

[0050] The journal may further maintain a record of the adherence of the user to a treatment regimen, such as a medicament regime. For instance, the journal entry can include a record logging a dose of medicament (e.g. a scheduled dose) that has been taken by the user, such as an injection log. The record can form a dose record including a variety of information associated with the dose administered by the user. The record can be stored as part of the journal entry or independently from the journal entry.

[0051] The functional module may further comprise a memory module, or database 106. The memory module 106 is configured to store journal entries made by the user via the journal module 102 for later retrieval and / or analysis. The memory module 106 may, in some embodiments, be linked to the cloud, and store journal entries remotely.

[0052] In some embodiments, the functional modules may further comprise a weather module 108. The weather module 108 is configured to determine and / or record weather conditions at the location of the user. The user location can be determined, for example, by a GPS capability of the user device. The weather module 108 may, for example, access an online weather forecasting system to obtain current weather conditions, previous weather conditions and / or predicted future weather conditions. The weather module 108 may provide weather conditions to the journal module 102 for inclusion in journal entries. As well as weather conditions such as general weather condition, temperature, humidity, air pressure and UV index, the weather module may additionally obtain air quality information such as pollen count, pollution index, NO2count and / or an air quality index.

[0053] Another of the functional modules is a user management module 110. The user management module 110 is responsible for obtaining user preferences and for generating notifications for output on the user device 104. Necessary data for the notification scheme may be stored on the memory module 106. The user management module 110 may also update the information held in the memory module 106 as the application is used.

[0054] The user management module 110 may define and help implement a notification scheme which determines when a notification should be generated and how it should be output on the user device 104. The notification scheme may have three main notification types; (i) a silent notification; (ii) a batched summary notification; and (iii) a push notification.

[0055] In some embodiments, the silent notification may be pushed into the application silently and viewable only within the application. The user may be presented with the silent notification within the application, for example on an application home screen. In some embodiments, the silent notifications are surfaced to the user when certain requirements are met and do not require any action on user’s part. The batched summary notification may relate to several different reminders and other notifications. The user can interact with the batched summary notification to expand and show the individual notifications. The batch summary notification may indicate the number of notifications which are present for the user to review. The push notification may relate to a single notification and is pushed to the lock screen or home screen of the user device 104. In some embodiments, the push notifications are time-sensitive and actionable items that require the user’s immediate attention. They are reserved for actions related to the user’s treatment routine or as a follow up to actions that can impact the user’s access to the treatment / drug.

[0056] Notifications can escalate, i.e. move up the notification types, depending on the user’s action (or lack thereof). For example: a. When the user is 5 days away from their next medicament dose, their next dosing reminder will show up as a silent notification in the application, for example underneath the carousel on the App homepage. b. In the days leading up to the dosing, the application will push batch notifications to the user to either review instructional videos, book a call with a nurse, or review the instructions for self-administration. c. On the day of the dosing and an hour prior to the scheduled time, the application will push a notification to the user to take their dose. If the user’s medication is kept in the fridge, the notification will instruct the user to take their medicament out of the fridge. Interacting with this notification will trigger a warm-up timer, set to their medication dose.

[0057] Another of the functional modules is a Health / Assessment Module 112. The Health / Assessment Module 112 is responsible for onboarding the user and obtaining details regarding the user’s medical conditions and medicaments being used to treat these. The Health / Assessment Module 112 may also gather information about the user’s prescriptions and manage delivery of medicaments.

[0058] Another of the functional modules is a Health Care Professional (HCP) Services Module 114. The HCP Services Module 114 is responsible for facilitating contact with a nurse, doctor or other health care professional, including scheduling reminders relating to appointments and calls, prompting the user to create reports or otherwise prepare for an upcoming appointment or call, initiating voice or video calls, providing follow-up notifications after calls or appointments and initiating a journal entry after calls or appointments. The HCP Services Module 114 interacts with an internet-based Patient Support Program 116. Health care professionals may also have access to certain aspects and information held by the Patient Support Program 116, in order to facilitate contact with the user and monitor the user’s treatment and / or disease progression.

[0059] Another of these functional modules is a Consent Module, which, in conjunction with other aspects of the system, is responsible for managing consents and permissions for accessing patient specific information, such as health related data for the user. The Memory Module 106 may be configured to store user ID and role information as well as consent templates for use by the Consent Module. The Memory Module 106 may also store consent and permission information input by the user via the Consent Module, including any time limits set on the consents and permissions.

[0060] The Consent Module may communicate with an external service called Consent Management service. The consent and permission information generated by the Consent Module may be stored or copied to the Consent Management 120 service. The Consent Management service may also be responsible for sending the patient specific information to third parties when the associated consents indicate that this is permitted.

[0061] Another of the functions modules is a Content Module. The Content Module is responsible for receiving and recording personalised content and / or preferences set by the user. The Content Module may communicate with an external service called Content Management. The Content Management service responsible for providing patient specific content or settings from an external user, such as a healthcare professional. The Content Module may interact with the memory module 106 to store the personalised content and / or settings.

[0062] Another of the functional modules is a Benefits Module, which, in conjunction with other aspects of the system, is responsible for managing patient access to health care. The Benefits Module may include a pharmacy integration service and / or a benefits integration service. The information generated by the Benefits Module may be responsible for sending patient specific information to third parties to indicate patient access to health care services. The Benefits Module may interact with external services, such as benefit provider systems and pharmacy services.

[0063] Another of the functional modules is an Analytics Module. The Analytics Module may, in conjunction with the Journal Module 102 and User Management Module 110, be responsible for analysing the patient information associated with the status and / or treatment of the user’s medical conditions. Another of the functional modules is a Messaging System. The Messaging System may communicate with the Analytics Module. For instance, if the Analytics Module identifies an episode or a trigger to an episode of the one or more medical conditioners of the user, the Messaging System outputs a message communicating this result. The Messaging System may communicate with an external service called an Information Hub. The Information Hub may store the data received from the messaging system. The Information Hub may also interact with other service providers to enhance the information which can be stored in respect of the user through the application. For instance, by communicating with the Patient Support Program, insurance / benefit provider systems and pharmacies, Adverse Events service, and so on.

[0064] Referring now to Figures 2a to 2d, screenshots illustrating screens displaying content facilitating user preparations for administering (delivering) a scheduled dose are shown. In the following, a screen may represent a user interface.

[0065] The application can be arranged to display a notification in response to one or more different triggers. For instance, the application can be arranged to monitor a current dosing schedule set within the application. From this, the application can determine whether a scheduled dose is due. For instance, the application may determine that the scheduled dose is due based on a calendar entry. The calendar entry may relate to one or more of a date, a day, or a time of a scheduled dose. Alternatively, the notification may be displayed in response to a scheduled reminder. The reminder can be associated with or independent from the calendar. The reminder may be set in advance by the user.

[0066] The application may also determine a time remaining before a scheduled dose is due. The time may be measured in minutes, hours or days. In response to determining that the time remaining before the scheduled dose is due is less than a threshold time, the application may display the notification alerting the user to the scheduled dose. The threshold time may be measured in minutes, hours or days. The threshold time may be pre-set in the application or set by a user.

[0067] In response to determining that the scheduled dose is due, the application generates a notification alerting the user to the scheduled dose, such as the notifications shown in Figures 2a and 2b. The notification provided is to alert or notify a user that a scheduled dose is due. This can be done in a variety of ways. In one example, the notification may prompt a user to prepare for taking the scheduled dose. For instance, if the medication for managing or treating the user’s medical condition is kept in the fridge, the notification can prompt the user to take the medication out of the fridge, as shown in Figure 2a. Alternatively or additionally, the notification may prompt the user to consult a guide for assisting the user in treatment and management of their medical condition(s). In another example, as shown in Figure 2b, the notification may simply indicate that the next scheduled dose is due and / or indicate a day and / or time when the scheduled dose is due. In general, the notification acts as a prompt for the user to interact with the notification. It will be readily envisaged that one or more of these examples can be combined or omitted.

[0068] In the first screenshot 200 shown in Figure 2a, a lock screen of a user device 1400 is shown. The lock screen has a notification area 202 where a notification relating to a scheduled dose is shown. The notification may be a silent notification or an audible notification and / or a haptic notification. The push notification may relate to a single notification and is pushed to the lock screen or a home screen of the user device. In this example, the notification is a push notification pushed to the lock screen of the user device. The notification is to alert or notify the user that a scheduled dose is due.

[0069] Interacting with the notification shown in Figure 2a may cause the application to display the screen shown in Figure 2b. Alternatively, the screen shown in Figure 2b may be displayed independently from the notification displayed on the lock screen of the user device 1400 as shown in Figure 2a. The screen may be displayed when the user device is unlocked and may be in response to a user interaction with the user device when the user device is unlocked.

[0070] In the second screenshot 204, shown in Figure 2b, a screen is displayed in which a Home tab 206 is selected. The application shows a number of user selectable tabs at the bottom of the screen, the tabs including at least two of Home Screen, Treatment, Journal, Learning and Settings. In the top portion of the home screen, a first silent notification or a graphic with a suggested action is displayed. The content of the suggested action may change. For instance, the suggested action changes depending on the proximity of a user’s next scheduled dose, doctor’s appointment, prescription renewal / delivery date, etc. In the example of the second screenshot 204 of Figure 2b, the suggested action is to learn more about how to prepare for and / or administer a scheduled dose of medicament. In this example, the suggested action includes how to inject a medicament correctly, but other forms of medicament delivery may equally apply. A user selectable option 208 with a suggested action is provided prompting the user to learn more about administering a medicament. Interacting with the option 208 may open a learning centre providing information to support and / or educate the user in administering the scheduled dose and / or in relation to managing the one or more medical conditions of the user. The home screen has a notification area where silent notifications are shown. A first silent notification 210 is shown reminding the user that their next dose (scheduled dose) is due today. Alternatively, the notification may remind the user that they have an upcoming appointment with an HCP. Interacting with the first silent notification 210 may open a notification centre, where any further details relating to the notification can be seen as well as any other notifications which are awaiting the user’s review.

[0071] In one example, interacting with the first silent notification 210 may open a screen displaying content relating to the scheduled dose, such as the exemplary screens shown in the third screenshot 214 of Figure 2c and the fourth screenshot 220 of Figure 2d. The third and fourth screenshots show summary screens which display a number of areas providing a variety of information relating to the scheduled dose. For instance, the areas may include information detailing one or more of: a day, a date, a time and an amount (quantity) of the scheduled dose, patient information, prescribing information, and the means of dose delivery. In Figures 2c and 2d, the means of dose delivery is shown as being via a pre-filled injection pen, but other means may equally well apply. The means of dose delivery may be via an intramuscular or an intravenous method. For instance, the dose delivery may also be via a syringe or infusion.

[0072] One or more of the areas may be implemented as user selectable options. For instance, an area 216 relating to patient information may be implemented as a user selectable option for the user to view further information associated with the patient (i.e., the user). For instance, the patient information may include one or more of the patient name, date of birth, address, registered HCP for the patient, and the like. Alternatively or additionally, an area 218 relating to prescribing information may be implemented as a user selectable option for the user to view further information associated with the user’s prescriptions. The prescribing information may include information detailing one or more medical conditions of the user, medicament regimens prescribed for treating each medical condition of the user, the regimen including a dose, a means of administration, a periodicity of administration, and the like.

[0073] In Figures 2c and 2d, at least some of the areas shown are based on an experience level of the user. They correspond to or are associated with the experience level of the user. The experience level of the user corresponds to the user’s ability to administer a scheduled dose of medicament. In one example, the experience level corresponds to the user’s ability to administer a dose of medicament independently, for instance without supervision from an HCP. The application determines an experience level of a user and the areas displayed are determined by the experience level of the user. In other words, the application varies the areas (content) displayed according to the experience level determined for the user of the application. The application may determine the experience level of the user with respect to a threshold level (otherwise termed, threshold, experience threshold, or the like). To determine the experience level of the user, the application compares the experience level of the user with the threshold level. The threshold level may correspond to a variety of different values. The threshold level may be predetermined. In one example, the threshold corresponds to a predetermined number of doses taken and / or logged by the user. In another example, the threshold corresponds to a predetermined number of medicament delivery devices used by the user. For instance, the application may identify or pair with each new medicament delivery device used and / or log the number of medicament delivery devices identified. The user could also indicate that a new medicament delivery device is in use. The application could also determine that a new medicament delivery device is in use based on a comparison between the amount of medicament administered in previous doses and the volume of medicament stored in the device. For instance, the medicament delivery device may be a disposable injection pen or syringe. In yet another example, the threshold may correspond to a score associated with the user’s medicament administration experience. The score may be logged in a record that is stored by the application or stored remotely and accessed by the application. Alternatively, in a different example, the experience level of the user may be pre-set in the application by the user or a health care professional.

[0074] The application can determine whether the experience level of the user is less than a threshold level. In response to determining that the experience level of the user is less than a threshold level, the application can display a screen including a user selectable area to a guide providing step-by-step instructions for performing the scheduled dose. In the exemplary screenshot 214 shown in Figure 2c, the screen includes user selectable option 222 for the user to access a guide providing step-by-step instructions for performing the scheduled dose when it is determined that the experience level of the user is less than a threshold level. In this instance, the user selectable option is a button with a qualitative description indicating the option to start a step-by-step guide providing step-by-step instructions for performing the scheduled dose. However, any other suitable indication method may be used, such as pictorial indications (e.g. a book, emojis, etc.).

[0075] Alternatively or additionally, the application can determine that the experience level of the user is equal to or more than a threshold level. In response to determining that the experience level of the user is equal to or more than a threshold level, the application can display a screen including a user selectable option for the user to confirm that they are ready to proceed with the scheduled dose. In the exemplary screenshot 220 shown in Figure 2d, the screen includes a user selectable option 224 allowing the user to elect to proceed with the scheduled dose. The user selectable option shown in Figure 2d is a button with a qualitative description “continue”, indicating the option for the user to progress with the process of administering the scheduled dose. However, any other suitable indication method may be used, such as pictorial indications (e.g. a book, emojis, etc.). The configuration of the application with respect to an experienced user will be discussed in more detail further below.

[0076] Referring now to Figures 3a to 3e, screenshots illustrating content of the step-by-step guide are shown. The guide includes step-by-step instructions (or a step-by-step guide, for instance a Home Access Guide Card) for assisting and educating the user in preparing for and / or administering a scheduled dose.

[0077] The step-by-step guide may include instructions for at least one of: preparing a medicament delivery device comprising a medicament for managing or treating the user’s medical condition for delivering the scheduled dose of medicament; setting a timer to notify the user when the medicament delivery device is ready to deliver the scheduled dose of medicament; requesting and / or receiving a call from a HCP; use of the medicament delivery device; and preparing a site on the user’s body for receiving the scheduled dose.

[0078] In one example, the step-by-step instructions include a preparation guide comprising steps to guide the user to prepare a medicament delivery device for administering the scheduled dose. Additionally or alternatively, the step-by-step instructions include a set of instructions for use of a medicament delivery device to administer the scheduled dose. The medicament delivery device includes the medicament used in the management or treatment of the user’s medical condition.

[0079] The content of the step-by-step guide may be provided in a variety of different formats. For instance, the instructions may include one or more of: a qualitative description (text), a document, an audio file, an image, and a video. Through the provision of a step-by-step guide the application facilitates access to information and guidance that can assist and educate the user in how to administer the scheduled dose effectively and safely. The application thereby provides a simple and convenient way enabling the user to administer a scheduled dose with more confidence, such that they are more likely to adhere to the medicament regimen for treating their one or more medical conditions.

[0080] In response to detecting user interaction with the user selectable option 222 shown in Figure 2c, the application may display the screen shown in the first screenshot 300 of Figure 3a. Here, the screen displays a home page or initial / start screen of the step-by-step guide. The start screen shows content of the step-by-step guide in the form of a series of menu options 302, such as drop-down menu options. However, any other suitable indication method may be used, such as user selectable thumbnails, pictorial indications (e.g. a book, emojis, etc), pages, tabs, and the like. The menu options 302 represent one or more steps included in the guide for assisting the user with taking the scheduled dose. The menu options are user selectable options. Interacting with the menu option may cause the menu to display the content of the step associated with that menu option.

[0081] The start screen may include a variety of menu options 302 providing instructions relating to steps of the medicament administration process. These steps are provided to ensure that the medicament is safe to administer and that the dosage to be delivered is correct in terms of quantity and / or type. These steps may include one or more of gathering the medicament delivery device, checking the medicament delivery device; checking the type of medicament and / or the dose of medicament provided in the medicament delivery device (e.g., looking at the pen / medicament label); checking the quality of the medicament (e.g., the colour and / or consistency of the medicament). The above examples are not exhaustive and various other instructions may equally well be provided or omitted.

[0082] In the screenshots of Figures 3a to 3e (see also, Figure 4a and Figures 7a to 7i), the top of the screen may also include a progress area showing a number, a graphic, a pictorial indication, or the like (e.g. a progress bar), showing the progress of the user through the step-by-step guide. Here, the number represents a page of the guide showing one or more steps. However, it may equally well represent the individual steps of the guide or the like. The number may be implemented as a user selectable option that the user to toggle backwards and forward through each step or page of the guide.

[0083] In the screenshot 300 shown in Figure 3a, the start screen includes a user selectable option 304 allowing the user to elect to proceed with the first step of the step-by-step guide. In this example, the option is a continue button. Alternatively or additionally, the user selectable option 304 may also allow the user to toggle backwards and forward through each step or page of the guide (e.g., Figures 7a to 7i). Although only a continue button is shown in Figure 3a, in other examples, the user selectable option may include another mechanism, such as a back button to allow the user to return to the previous step or page of the guide. In one example, the guide is configured such that the user is required to progress through each menu option or step of the guide. The guide may require that the user selects each step sequentially. The guide may also require that the user confirms that they have read and / or actioned each step of the guide in order to progress to the next step of the guide. However, the start screen may further allow the user to select the step (menu option) directly and / or select the step (menu option) with which they require assistance.

[0084] If the user is an inexperienced user, the guide may be configured so that the user is required to confirm that they have progressed through each step of the guide. In this way, the application assists and educates the user in how to administer the scheduled dose effectively and safely. The application thereby enables the user to gain confidence in administering a scheduled dose, such that they are more likely to adhere to the medicament regimen for treating their one or more medical conditions.

[0085] Following the steps of the guide may be essential for an inexperienced user but may not be necessary once the user is an experienced user. If the user is an experienced user, they may not have the need to consult with each step of the guide. The experienced user may be able to effectively administer the scheduled dose independently. In this case, the guide may be configured so that the experienced user does not need to interact with the step-by-step guide. For example, they can skip the guide or they can select the particular step(s) with which they wish to consult or require assistance. In this case, the experienced user does not need to progress through each step or confirm that they have read and / or actioned each step of the guide.

[0086] Figures 3b to 3e show exemplary screenshots illustrating instructions included in steps of the guide. As discussed above, the instructions may include one or more of: qualitative description (text), document(s), image(s), audio file(s), video(s), thumbnails, Internet links, and the like. It will be appreciated that any suitable combination of indication methods to convey information may be provided. Here, the steps are directed to a pre-filled injection pen for administering a scheduled dose. However, as discussed above, it will be appreciated that other means may equally well apply. For instance, the steps may be directed to the use of an intramuscular syringe for administering the schedule dose.

[0087] In the second screenshot 306 shown in Figure 3b, the step 308 to “Gather Supplies” is shown. Here, the step-by-step guide provides instructions on the components / equipment that are needed for, or to assist with, administering the scheduled dose. In this example, the instructions include text and an area providing a user selectable link to a video 310 for assisting the user in gathering the required supplies for administering the scheduled dose. In the third screenshot 312 shown in Figure 3c, the step 314 to “Check the Pen” is shown. Here, the step-by-step guide provides instructions on how to check that the medicament delivery device is safe to use. The safety of the medicament delivery device may relate to the condition of the device. In this example, the instructions include text. The instructions may include a warning to the user not to use the medicament delivery device based on the outcome of the checks. For instance, if the device is damaged or has been tampered with prior to use.

[0088] In the fourth screenshot 316 shown in Figure 3d, the step 318 to “Look at the Label” is shown. Here, the step-by-step guide provides instructions on how to check that the medicament delivery device is suitable for use by the user. This may include checking the medicament type, expiration date and dose amount. In this example, the instructions include text and an area providing a user selectable link to a video 320 for assisting the user checking the medicament label. The instructions may include a warning to the user not to use the medicament delivery device based on the outcome of the checks (e.g. the expiration date has passed).

[0089] In the fifth screenshot 322 shown in Figure 3e, the step 324 to “Check the Medicine” is shown. Here, the step-by-step guide provides instructions on how to check that the medicament is suitable for use by the user. This may include a visual inspection of the medicament. In this example, the instructions include text and an area providing a user selectable link to a video 326 for assisting the user checking the medicament. The instructions may include a warning to the user not to use the medicament based on the outcome of the checks (e.g. the medicament contains flakes or particles).

[0090] Referring now to Figures 4a to 4g, screenshots illustrating the use of a timer for preparing the scheduled dose for administration are shown.

[0091] Medicaments (medicament containers) and medicament delivery devices containing medicaments are often stored in a refrigerator, or the like, to preserve the longevity and efficacy of the medicament. The user removes the medicament or medicament delivery device from the refrigerator to take a scheduled dose. When administering the dose, the temperature of the medicament can affect the delivery of the medicament to the patient (e.g., efficiency, quality, ease of use and user experience of delivery can be affected). If the medicament is too cold, the user may feel discomfort or pain during administration. To alleviate this problem, the application provides a timer to instruct and / or prompt the user to remove the medicament and / or the medicament delivery device containing the medicament from storage. The timer is set to a duration that allows sufficient time for the medicament to reach an ambient temperature prior to taking the dose, to eliminate or reduce any potential adverse effects or discomfort during administration. For example, the timer may be set to 45 minutes for a pre-filled injection pen containing 300mg of medicament. In another example, the timer may be set to 30 minutes for a pre-filled syringe containing 200mg of medicament. However, these are merely examples and the duration of the timer may vary depending on one or more of the amount of the dose or medicament, the type of medicament, or the type of medicament delivery device.

[0092] In response to detecting the user accessing a predetermined step of the guide, the application may display the screen shown in the first screenshot 400 of Figure 4a. The predetermined step represents the step in the process of preparing for a scheduled dose in which the medicament and / or medicament delivery device is to be removed from storage. In Figure 4a, the top half of the screen has an information area including a user selectable link to a video 402 providing information to assist the user in preparing the scheduled dose for administration according to a predetermined waiting time. The notification area may also include a qualitative description (text) warning the user not to put the medicament in a microwave, hot water or direct sunlight, in order to reach a certain temperature.

[0093] In the bottom half of the screen of Figure 4a, the application shows a number of user selectable options, which may represent a suggested action or prompt for the user. A first user selectable option 404 is shown suggesting that the user starts the timer to prepare the scheduled dose for administration. Here, the first option 404 includes a qualitative description (“Start my timer”). However, any other suitable description or indication method may be used, such as numbers or pictorial indications (e.g. emojis).

[0094] In another example, the application may also display a second user selectable option 406, prompting the user to confirm that the scheduled dose is ready for administration. Here, the second option 406 includes a qualitative description (“My dose has been out for at least 45 min. Confirm”). However, any other suitable description or indication method may be used, such as numbers or pictorial indications (e.g. emojis). The second option 406 allows the user to confirm that the scheduled dose has already been removed from storage for a sufficient period of time, for instance at least the duration of time set by the timer, and / or confirm that the scheduled dose has reached the required ambient temperature for administration.

[0095] In response to detecting an input from the user selecting the second option 406 confirming that the scheduled dose is ready, the application may display the screen shown in the second screenshot 408 of Figure 4b. Here, the screen includes a notification 410 prompting the user to confirm again that the scheduled dose is ready. The notification may be a pop-up notification. The notification may be a silent notification or it may be accompanied by an audible, visual or haptic alert. The notification may also include a warning informing the user to wait the required amount of time set by the timer before administering the dose, otherwise they may experience discomfort during administration.

[0096] The two-step confirmation process shown in Figure 4b is provided to allow the user to confirm that the second option 406 has not been selected in error. The notification 410 provides two options for response, namely a positive response and a negative response. In Figure 4b, the two options include a qualitative description, “Yes, I confirm” and “Cancel”. However, other qualitative descriptions may equally well apply, such as “yes / no”, “confirm / cancel”, “confirm / back”. Any other suitable indication method may also be used, such as numbers, pictorial indications (e.g. emojis), or the like. The options for response are provided to allow the user to confirm whether or not the scheduled dose is ready, and / or, in the event that the dose is not yet ready, whether the user has selected the second option 406 in error. In response to detecting an input indicating that the scheduled dose is ready, the application displays another screen, such as the next screen in the step-by-step guide. The application may display a screen such as the screen shown in Figure 5c, as described below. In response to detecting an input indicating that the dose is not ready, the application displays another screen or reverts to the previous screen in the step-by-step guide, such as the screen shown in Figure 4a.

[0097] Referring back to Figure 4a, in response to detecting an input from the user selecting the first option 404 shown in Figure 4a to start the timer, the application displays the screen shown in the third screenshot 412 of Figure 4c, showing or confirming that the timer is started. The top portion of the screen has a notification area 414, which may include an indication showing the time remaining on the timer. The indication method may include a graphic, an icon, a thumbnail, a widget, or the like. Additionally or alternatively, the notification area may further include a qualitative description of the time remaining on the timer and / or a suggested action for the user whilst the timer is active. The screen shown in Figure 4c may also include a user selectable option 416 to allow the user to confirm that they have understood that the timer has started. The user selectable option 416 may be implemented as a button. Interacting with the button may cause the application to close the screen shown in Figure 4c.

[0098] Figures 4d to 4f show screenshots illustrating exemplary screens that may be displayed once the timer has started and / or in response to detecting interaction with the user selectable option 416 shown in Figure 4c. The screens shown in Figures 4d to 4f include different areas providing information or content associated with the scheduled dose and the management of the user’s medical condition more generally, in addition to the time remaining on the timer. It will be understood that a variety of content associated with the scheduled dose can be displayed and that content, such as that shown in the screens of Figures 4d to 4f, can be combined or omitted in different ways.

[0099] In the fourth screenshot 418 of Figure 4d, the application displays a screen, similar to Figure 2b, where the Home tab is selected. The home screen may include an area including a user selectable option with a suggested action for the user to learn more about administering a medicament correctly. Here, the top area of the home screen includes an indication 420 of the time remaining on the timer. The indication 420 may include one or more of a qualitative description, a number, a pictorial graphic, or the like.

[0100] In the fifth screenshot 422 of Figure 4e, the application displays a screen including information such as the day, date, and amount of the scheduled dose. The screen may include an area displaying an indication of the location on the user’s body at which the previous dose of medicament was administered. This is beneficial as it enables the user to vary the area of the body at which the dose in administered. This can help to prevent any potential discomfort or harm that might occur from repeatedly selecting the same administration site. The screen may also include areas, such as the areas 216, 218 shown in Figure 2d, in which the user can access patient information and / or prescribing information. It is beneficial for the user to be able to access such information whilst preparing to administer the scheduled dose. This information can verify that the user is preparing to administer the correct treatment for the medical condition

[0101] In the bottom half of the screen of Figure 4e, the application shows a number of user selectable options, which may represent a suggested action or prompt for the user. A first user selectable option 424 is shown suggesting that the user confirms that the scheduled dose has already been administered. Here, the first option 424 includes a qualitative description (“I have already made this injection”). However, any other suitable wording or indication method may be used, such as pictorial indications (e.g. emojis).

[0102] In Figure 4e, a second user selectable option 426 is shown suggesting that the user continues with the step-by-step guide. Here, the second option 424 includes a qualitative description (“Continue step-by-step guide”). However, any other suitable wording or indication method may be used, such as pictorial indications (e.g. emojis). In this example, the application is configured to prevent the user from continuing with the next step of the guide until the time set by the timer has elapsed. As shown in the screen of Figure 4e, the application is configured to deactivate the second option 426 for the user to continue with the step-by-step guide. In this example, the application disables the option to select or continue the step-by-step guide until the timer is completed (i.e., the time set by the timer has elapsed). The user is unable to progress with the next step of the guide until the scheduled dose is determined to be ready for administration. In response to determining that the time set by the timer has elapsed, the application is configured to activate the second option 426 to allow the user to continue with the step-by-step guide.

[0103] Alternatively, in a further example, such as the sixth screenshot 428 of Figure 4f, the screen displays a second user selectable option 430 to continue the step-by-step guide that is selectable (i.e. it is not deactivated) before the time set by the timer has elapsed. Here, in response to detecting an input from the user to select the second option 430 to continue the guide, the application may display a screen, such as the screen shown in seventh screenshot 432 of Figure 4g. Here, the screen includes a notification 434 prompting the user to confirm that they understand that the dose is not yet ready for administration. For instance, the notification 434 provides a qualitative description asking the user to confirm they understand that the dose is not yet ready for administration because the time set by the timer has not yet elapsed. The notification 434 may be a pop-up notification. Similar to Figure 4b, the notification 434 may provide two options for response, namely a positive response option and a negative response option. In Figure 4b, the two options include a qualitative description, “Continue” and “Cancel”. However, other qualitative descriptions may equally well apply, such as “yes / no”, “confirm / cancel”, “confirm / back”. Any other suitable indication method may also be used, such as numbers, pictorial indications (e.g. emojis), or the like. The notification 434 provides a two- step process to allow the user to proceed or to cancel the preceding user input, which may have been selected in error.

[0104] In response to detecting a negative response from the user to cancel the previous input, the application may display the previous screen, such as the screen shown in Figure 4d or 4f. The notification 434 may additionally inform the user that they can review the guide without administering the scheduled dose.

[0105] In response to detecting a positive response from the user to continue, the application may be configured to provide the user with an overview of the step-by-step guide. Once the time set by the timer has elapsed, the application is configured to allow the user to continue with the step- by-step guide.

[0106] Referring now to Figures 5a to 5d, screenshots illustrating notifications indicating that the scheduled dose is ready are shown. In response to determining that the time set by the timer has elapsed, the application is configured to display a notification indicating that the time set by the timer has elapsed and / or the scheduled dose is ready for administration. In the first screenshot 500 shown in Figure 5a, the lock screen of the user device 1400 is shown. The lock screen has a notification area 502 and the application pushes a push notification to the lock screen. The notification alerts the user that the predetermined time set by the timer has elapsed. The push notification indicates that the scheduled dose is ready for administration and / or the user can continue with the step- by-step guide to complete their treatment by taking the scheduled dose.

[0107] In the second screenshot 504 shown in Figure 5b, a screen is displayed, such as the screen shown in Figure 2b, in which a Home tab 206 is selected. The home screen has a notification area 506 where silent notifications are shown. In this example, a notification is shown indicating that the scheduled dose is ready for administration and / or the user can continue with the step- by-step guide.

[0108] Interacting with the notification shown in Figure 5a may cause the application to display the screen shown in Figure 5b. Alternatively, the screen of Figure 5b may be displayed independently from the notification displayed on the lock screen of the user device 1400 as shown in Figure 5a. The screen of Figure 5b may be displayed automatically when the user device is unlocked or in response to a user interaction with the user device when the user device is unlocked.

[0109] In the third screenshot 508 shown in Figure 5c, a screen is displayed including different areas providing information or content associated with the scheduled dose and the management of the user’s medical condition more generally. Similar to Figures 4e and 4f, the screen of Figure 5c may provide information such as the day, date, and amount of the scheduled dose, patient information, prescribing information and an area displaying an indication of the location on the user’s body at which the previous dose of medicament was administered. The screen of Figure 5c also has a notification area 510 where a silent notification indicating that the predetermined time set by the timer has elapsed, such that the scheduled dose is ready for administration.

[0110] In the bottom of the screen of Figure 5c, a number of user selectable options representing a suggested action or prompt for the user may be displayed. Similar to the screen of Figure 4e, in this example, the application shows a first user selectable option 512 suggesting that the user confirms that they have already taken the scheduled dose. Here, the first option 512 includes a qualitative description (“I have already made this injection”). A second user selectable option 514 suggesting that the user continues with the step-by-step guide is also shown in Figure 5c. Here, the second option 514 includes a qualitative description (“Continue step-by-step guide”). Although a qualitative description is shown in Figure 5c, any other suitable wording or indication method may be used, such as pictorial indications (e.g. emojis).

[0111] The screen of Figure 5c may be displayed in response to a user interaction with the notification shown in the notification area 506 of Figure 5b. The interaction may be to confirm that the user is ready to take the scheduled dose. However, this is not essential and the user interface shown in Figure 5c may be displayed independently.

[0112] Interacting with the first user selectable option 512 shown in Figure 5c may open the screen shown in the fourth screenshot 516 of Figure 5d. Here, the screen includes a notification 518 prompting the user to confirm that they have successfully completed treatment. That is, to confirm that the user has administered the scheduled dose. Similar to Figures 4b and 4g, the notification 518 may provide a positive response option and a negative response option. In Figure 5d, the two options include a qualitative description, “Confirm” and “Cancel”. However, other qualitative descriptions may equally well apply, such as “yes / no”, “continue / cancel”, “confirm / back”. Any other suitable indication method may also be used, such as numbers, pictorial indications (e.g. emojis), or the like.

[0113] The provision of two options allows the user to confirm whether or not they have administered the scheduled dose. In the event that the user has not yet taken the dose and / or selected the second option in error, the user is able to input a negative response. In response to detecting a negative response (or input) from the user indicating that the scheduled dose has not been administered, the application is configured to close the screen of Figure 5d and display the preceding screen of Figure 5c. In response to detecting a positive response (or input) confirming that the user has taken the scheduled dose, the application is configured to display another screen. The screen may be for logging the dose taken (as discussed further below).

[0114] Referring now to Figures 6a to 6d, screenshots illustrating a telephone call between the user and an HCP are shown.

[0115] In this example, the application is additionally configured to initiate a telephone call between the user and an HCP in relation to the scheduled dose. The application may be configured to initiate contact with the HCP in response to determining that the scheduled dose is ready and / or a user interaction confirming that they are ready to administer the scheduled dose. For instance, the application may be configured so that a user interaction with the notification area 506 of Figure 5b or the notification area 510 of Figure 5c initiates a telephone call to the HCP. The HCP may be a nurse or other health care professional.

[0116] Where a user is taking a dose for the first time, is inexperienced in administering the medicament for treating or managing one or more of their medical conditions or lacks confidence to take the scheduled dose independently, the application can initiate contact with an HCP. The application may initiate contact with the HCP via a phone call or a video call or the like, via the user’s device. In response to the telephone call, the HCP is able to discuss the administration of the scheduled dose, answer any questions that the user may have, and generally provide advice, education, guidance and support to the user in respect of the scheduled dose and the general health conditions of the user. The application is configured to provide a direct link or real-time access to the HCP, so that the user may feel supported and confident in taking the scheduled dose. In turn, this can help to improve user adherence to a medicament regimen(s).

[0117] Where the application initiates a telephone call with an HCP, the screen shown in the first screenshot 600 of Figure 6a may be displayed. The step shown in the screenshot 600 of Figure 6a is optional and may be omitted. Where the screen is displayed, it includes a notification area that informs the user that they may be charged for the telephone call with the HCP depending on their service provider. The notification area may include two user selectable options for response, namely a positive response option and a negative response option. In Figure 6a, the two options include a qualitative description, “OK” and “Cancel”. However, other qualitative descriptions may equally well apply, such as “yes / no”, “confirm / cancel”, “confirm / back”. If a negative response is detected, the application cancels the operation and returns to the previous screen, such as the screen shown in Figure 5b or 5c. If a positive response is detected, the application may display the screen shown in the second screenshot 602 of Figure 6b. Similar to Figure 6a, the screen of Figure 6b includes two user selectable options to provide the user with a further opportunity to confirm that they would like to proceed with or cancel the telephone call with the HCP. If a negative response is detected, the application cancels the telephone call. If a positive response is detected, the application initiates a telephone call with the HCP and a screen, such as the screen shown in the third screenshot of Figure 6c may be displayed.

[0118] Once the telephone call with the HCP has ended, the application may be configured to display the screen shown in the fourth screenshot 606 of Figure 6d. In this example, the lock screen of the user device 1400 is shown. The lock screen has a notification area 608 and the application pushes a push notification to the lock screen, prompting the user to administer the scheduled dose. The notification may prompt the user to record pertinent details or their impression regarding their call with the HCP in a journal entry and / or complete their treatment (e.g., by continuing with the step-by-step guide and / or administering the scheduled dose). Interacting with the push notification shown in Figure 6d may open the screen shown in the third screenshot 508 of Figure 5c. From the screen shown in Figure 5c, the application enables the user to select the second option 514 to continue with the step-by-step guide in order to complete the administration process and their treatment.

[0119] It will be understood that it is not essential for the application to initiate a call with the HCP every time that a scheduled dose is due. The telephone call with a HCP is optional and may be omitted.

[0120] In other examples, once the telephone call with the HCP has ended, the application may display an option to continue with the step-by-step guide or the next step of the step-by-step guide in response to a user interaction. The user interaction may confirm that the scheduled dose is ready, the time set by the timer has elapsed, and / or the user is ready to take the scheduled dose. In other examples, the user input may confirm that the call with the health care professional is finished.

[0121] Referring now to Figures 7a to 7i, screenshots illustrating further content included in the step- by-step guide are shown.

[0122] The screenshots of Figures 7a to 7i, similar to Figures 3a to 3d, show a variety of user selectable menu options 702 representing one or more steps included in the guide for assisting the user with administering the schedule dose. Here, the screens show further pages of the guide showing additional menu options. Interacting with the menu option may cause the menu to display the content of the step associated with that menu option. The menu options 702 are directed to steps performed once the scheduled dose is ready for administration (e.g., the time set by the timer has elapsed). These steps are provided to ensure that the medicament is safe to administer and that the dosage to be delivered is correct in terms of quantity and / or type. The steps may include one or more of washing hands, choosing a site for administration, preparing the administration site, preparing the medicament delivery device, administering the scheduled dose and disposing of the medicament delivery device after use. This is not an exhaustive list and other steps may equally well be provided and / or the combination of steps may vary.

[0123] The application is configured to display the information provided by a step in response to a user interaction with that step. The information provided in each step may include guidance and instructions, as well as warnings to the user in respect of the particular step of the administration process. In these examples, the steps include information as text and as an area providing a user selectable link to a video for assisting the user with performing the step. However, steps may include information in various different combinations including one or more of: a qualitative description (text), a document, a link to a website, an audio file, a video, an image or pictorial indications, and the like,

[0124] In the screenshots of Figures 7a to 7i, the top of the screen may include a progress area 706 showing the progress or position of the user through the step-by-step guide, as described above with respect to Figures 3a to 3e (see also, Figure 4a).

[0125] In the screenshots of Figures 7a to 7i, the bottom of the screen includes two user selectable options 704 allowing the user to elect to proceed to the next step of the step-by-step guide or revert to the previous step. This enables the user to toggle backwards and forwards through the steps of the guide (see also description above with respect to Figures 3a to 3e).

[0126] In response to a user interaction to continue with the step-by-step guide as described above with respect to Figures 5c, 6c and 6d the application may display the screen shown in the first screenshot 700 of Figure 7a. Here, the screen shows another page of the guide showing additional menu options 702 directed to steps to be performed once the scheduled dose is ready for administration (e.g., the time set by the timer has elapsed).

[0127] In the second screenshot 708 of Figure 7b, a screen displaying the step 710 to “Choose an injection site” is shown. Here, the step-by-step guide provides instructions on the selection of a suitable site (position) on the user’s body for administering the scheduled dose. In this example, in addition to a qualitative description, the step also includes a graphic providing a visual indication of suitable locations on the body for administration. The qualitative description may describe different suitable areas and / or indicate those areas that are suitable for selfadministration and those that are suitable only for administration by an HCP. The graphic may indicate areas that have previously been used and / or recommend an area suitable for administering the scheduled dose. The area may be indicated through the application of colour, texture (e.g., hash marks), a bold outline or any other suitable means of indicating the relevant area. Selecting a suitable location for administration is important to reduce the likelihood of infection, injury or discomfort during administration. Accordingly, the screen may also include text providing a warning not to inject at a site that is sensitive or injured or not to inject through clothing, which may interfere with the administration process. In the third screenshot 712 of Figure 7c, a screen displaying the step 714 to “Prepare the injection site” is shown. Here, the step-by-step guide provides instructions on the how to prepare the area of the user’s body that has been selected for administration of the scheduled dose. For example, the area may be prepared by cleaning the skin. Instructions directed to preparing the site for administration are beneficial as they can help to reduce the risk of infection when administering a dose. This is important for a user that is inexperienced with selfadministration as any infection could reduce the likelihood that they will adhere to the medicament regimen and user confidence in self-administration.

[0128] In the fourth screenshot 716 of Figure 7d, further content of the step-by-step guide is shown. Here, a new set of menu options 718 are displayed. Once the user has reached the last step displayed on a particular screen and the user wishes to continue to the next step, a new screen is displayed to show the next step(s) in the guide. In this example, the next steps are displayed on a new page of the guide which is displayed on a new screen. The screen of Figure 7d may be displayed in response to a user interaction with the Continue button of the user selectable options 704 shown in Figure 7c, but this is not essential.

[0129] In the fifth screenshot 720 of Figure 7e, a screen displaying the step 722 to “Remove cap” is shown. Here, the step-by-step guides provides instructions on how to prepare the medicament delivery device for administration of the scheduled dose.

[0130] In the sixth screenshot 724 of Figure 7f, a screen displaying the step 726 to “Place” is shown. Here, the step-by-step guides provides instructions on how to arrange and / or orientate the medicament delivery device with respect to the user’s body in order to administer the scheduled dose. For instance, the optimum angle for dose administration may be about 90 degrees with respect to the user’s body. This step may be important to ensure that the medicament delivery device is arranged in a way that should minimise discomfort, avoid injury, and / or introduce the medicament into the user’s body in the most efficacious way.

[0131] In the seventh screenshot 728 of Figure 7g, a screen displaying the step 730 to “Press down” is shown. Here, the step-by-step guides provides instructions on how to actuate the medicament delivery device to administer the scheduled dose.

[0132] In the eighth screenshot 732 of Figure 7h, a screen displaying the step 734 to “Remove” is shown. Here, the step-by-step guides provides instructions on how to safely remove the medicament delivery device from the administration site on the body after administration of the scheduled dose. In the ninth screenshot 734 of Figure 7i, further content of the step-by-step guide is shown. Here, a new screen is displayed to show the next step in the guide. In this example, the next step is displayed on a new page of the guide which is displayed on a new screen. The screen of Figure 7i may be displayed in response to a user interaction with the Continue button of the user selectable options 704 shown in Figure 7h, but this is not essential. In Figure 7i, the step- by-step guide provides instructions on how to dispose of the medicament delivery device after the scheduled dose has been administered. Educating a user in the best practice for device disposal is important in respect of both a safety and hygiene. Minimising adverse effects resulting from poor device management can help to improve the user’s adherence to a medicament regime. The step of disposing of the medicament delivery device may represent the last step in the guide.

[0133] It will be understood that the particular content shown in Figures 7a to 7i is exemplary and that information may be omitted. Other information to assist the user in taking the scheduled dose may equally well be provided or combined in different ways. Similarly, it will be understood that content can be provided in accordance with the particular medicament delivery device that is used (e.g., a syringe or an infusion device). In other words, the information provided by the guide is appropriate and relevant to the medicament delivery device used to administer the scheduled dose treating the one or more medical conditions of the user.

[0134] The application may display a screen including a user selectable option for the user to confirm that the scheduled dose has been administered. The user selectable option may be displayed on a screen of the last step of the step-by-step guide. Alternatively, the user selectable option may be provided on a screen displayed by the application after the last step of the guide has been viewed. For instance, the screen may be displayed in response to the user selecting the continue button shown in Figure 7i. In other examples, the user selectable option may be displayed on a screen of one or more of the user selectable tabs, such as the Home screen, Treatment, or Journal tabs. One or more of these examples may be combined, such that the option to confirm that a dose has been administered is provided on multiple screens by the application.

[0135] In response to detecting a user input confirming that the treatment has been completed (i.e., the scheduled dose has been administered), the application is configured to log the scheduled dose The user input confirms that the scheduled dose has been taken. The application is configured to log a record of the scheduled dose. The application is configured to store the record (or dose log) in a memory of the application. Alternatively or additionally, the application may store the record remotely, for instance in a cloud storage or an external server. The application may also be configured to transmit the record to an HCP.

[0136] The application may log a variety of information associated with the scheduled dose. The information may include one or more of a day, date, time and / or amount of the scheduled dose. The information may further include a location on the user’s body where the scheduled dose was administered and / or a user survey documenting the user’s experience in administering the scheduled dose. The user survey may represent or form a component of a journal entry documenting the management and treatment of the user’s medical condition(s).

[0137] Referring now to Figures 8a to 8c, first to third screenshots 800, 802, 804 illustrating screens configured to prompt the user to indicate where on the user’s body the scheduled dose was administered are shown. The screens of Figures 8a to 8c may be shown in response to the user input confirming that the scheduled dose has been administered. Alternatively, the screens of Figures 8a to 8c may be shown at another stage in logging the journal entry.

[0138] As described above, keeping a record of the administration site can prompt the user to vary the area of the body at which the dose in administered. This can be beneficial in preventing any potential discomfort or harm that might occur from repeatedly selecting the same administration site. Similar to what is shown in Figures 4e and 4f, the application may display a screen including a representation of a body having a predetermined form. The predetermined body form may be set in accordance with a user preference. For instance, as shown in the first to third screenshots 800, 802, 804 of Figures 8a to 8c respectively, the body displayed on the user interface may have a female 806, androgynous 808 or male 810 form. The representation may show different areas of the body on which the dose may be administered. In this example, the selectable areas include the abdomen and the thighs, but other areas may be equally applicable depending on the medicament delivery device and / or medicament regimen for treating the one or more medical conditions of the user. The different areas shown on the body representation may be selectable by the user. In response to detecting a user selection on the body, the application may be configured to highlight, identify or mark in some way the position on the body selected by the user. In this example, the area selected by the user is highlighted in a colour.

[0139] Referring now to Figure 9, a screenshot 900 illustrating a screen configured to prompt the user to complete a survey is shown. The survey may include one or more questions intended to document the user’s experience in administering the scheduled dose. In the screenshot 900 of Figures 9, the screen displays a question of the survey. The question asks the user to rate or rank the ease with which the scheduled dose was administered using a numerical indicator. Here, the numerical indicator is from 0 to 4. A qualitative description is also provided to indicate that the numeral 0 indicates that administration was very difficult and the numeral 4 indicates that administration was very easy. It will be understood, however, that for each question of the survey any other suitable range of numerals or indication method may be used, such as a qualitative description (e.g. “difficult”, “average”, “good), a quantitative description or pictorial indications, such as emojis (smiley face or unhappy face).

[0140] In the example of Figure 9 a numerical scale is shown, however a binary indicator may equally well apply (e.g., 0 / 1 , Good / Bad, Smile / Frown, tick / cross). The survey is intended to be straightforward and easy to complete in order to encourage the user to input a response so that the application can generate a complete log. In some examples, the survey may only include one question and / or may only include questions with binary indicators for response.

[0141] In other examples, the application may be configured to prevent the user from continuing to the next screen unless the user inputs a response to the survey question. In this case, the application may deactivate a user selectable option to continue to the next screen unless a user input providing a response is detected. In the screen of Figure 9, the application may deactivate the Continue button 904 provided at the bottom of the screen and only activate the Continue button 904 when a response is detected.

[0142] Referring now to Figures 10a and 10b, screenshots illustrating a notification confirming that the scheduled dose has been administered are shown.

[0143] In response to determining that the scheduled dose has been administered and / or a record of the scheduled dose has been completed, the application may display the screenshot of Figure 10a or Figure 10b. Interacting with the user selectable options provided in the last step of the guide, in Figures 8a to 8c or Figure 9, may display the screens of Figures 10a and / or 10b.

[0144] In the first screenshot 1000 of Figure 10a, the screen includes a graphic 1002 indicating that the scheduled dose has been administered and / or a record of the administered dose has been recorded. Additionally or alternatively, the screen may include text providing further information or suggestions to support and encourage the user to adhere to their treatment regimen. For instance, the text may suggest that the user contact an HOP if they have any questions about their treatment regimen. The text may also provide a warning that the user should not stop and / or alter their treatment regimen without consulting an HCP first. The content of the text may change, for instance, based on the response of the user to the survey.

[0145] In the bottom of the screen of Figure 10a, a user selectable option 1004 to close the screen may be provided. For instance, a button with a qualitative description (e.g. “Done”) may be provided, although other indications may equally well apply. The bottom of the screen may also show a user selectable option 1006 allowing the user to select not to see the step-by-step guide the next time a scheduled dose is due. Interacting with this option, causes the application to enable the user to skip the contents of the step-by-step guide when the next scheduled dose is due. This option may only be provided when the application determines that the user is an experienced user. It enables the user to indicate that they are now experienced enough in administering the required dose of medicament, that they no longer need to review every step of the guide.

[0146] In the second screenshot 1008 of Figure 10b, a screen is displayed in which a Home tab 1010 is selected. The Home screen may include a notification area 1012 indicating that the scheduled dose has been administered. Similar to what is shown in Figure 2b, the home screen may include different areas provided a range of information and / or user selectable options. For instance, one area may provide a suggested user action, another area may provide a notification of when the next scheduled dose is due, etc.

[0147] The above description relates to an example in which the application determines that the user is inexperienced. In the following, an example in which the application determined that the user is experience will be described.

[0148] Referring back to the screenshots 214, 220 of Figures 2c and 2d, screens displaying content relating to user preparation for the scheduled dose are shown. As described above, the application determines an experience level of the user and displays content based on the experience level of the user. At least a part of the content displayed is content associated with an experience level of the user.

[0149] In this example, in response to determining that the experience level of the user is equal to or more than a threshold level, the application may display a screen, such as the screen shown in Figure 2d. When the application determines that the experience level of the user is equal to or more than a threshold level, the user is an experienced user. The experience level of the user and the threshold level have been discussed above with respect to Figures 2a to 2d, such that corresponding description therefore will be omitted. In the exemplary screenshot 220 shown in Figure 2d, the screen includes a user selectable option 224 allowing the user to elect to proceed with the scheduled dose.

[0150] Referring now to Figure 11 a to 11c, screenshots illustrating a timer for preparing the scheduled dose for administration are shown. In particular, the screen may include options for a user to start a timer to notify the user when the scheduled dose is ready and / or to confirm that the scheduled dose is ready for administration.

[0151] Interacting with the user selectable option 224 shown in Figure 2d may cause the application to display a screen, such as the screen shown in the first screenshot 1100 of Figure 11a. Here, the screen displays content relating the step of preparing for a scheduled dose for administration by removing the medicament and / or medicament delivery device from storage and waiting a predetermined period of time before proceeding with administration. Even for an experienced user, it is beneficial for the application to provide some information and / or warnings to the user for steps that are important to the process of preparing the scheduled dose for delivery.

[0152] In Figure 11a, the top half of the screen has a notification area including a user selectable link to a video 1102 providing information to assist the user in preparing the scheduled dose for administration according to a predetermined waiting time. Similar to the screen of Figure 4a, the notification area may also include a qualitative description (text) with additional information and / or a warning. For instance, the notification area may include a warning to the user not to put the medicament in a microwave, hot water or direct sunlight, in order to reach a certain temperature.

[0153] In the bottom half of the screen of Figure 11 a, a number of user selectable options are shown, representing a suggested action or prompt for the user. A first user selectable option 1104 is shown suggesting that the user starts a timer to prepare the scheduled dose for administration. In this example, the first option 1104 includes a qualitative description (“Start my timer”). However, any other suitable description or indication method may be used, such as numbers or pictorial indications (e.g. emojis). Alternatively or additionally, the application may display a second user selectable option 1106 to enable the user to confirm that the scheduled dose is ready for administration. Here, the second option 1106 includes a qualitative description (“My dose has been out for at least 45 min. Confirm”) prompting the user to confirm that the scheduled dose is ready. However, any other suitable description or indication method may be used, such as numbers or pictorial indications (e.g. emojis). The second option 1106 allows the user to confirm that the scheduled dose has already been removed from storage for a sufficient period of time and / or confirm that the scheduled dose has reached the required ambient temperature for administration.

[0154] In response to detecting an input from the user selecting the second option 1106 confirming that the scheduled dose is ready, the application may display the screen shown in the second screenshot 1108 of Figure 11 b. Here, the screen includes a notification 1110 prompting the user to confirm again that the scheduled dose is ready. The notification may be a pop-up notification. The notification may be a silent notification or it may be accompanied by an audible, visual or haptic alert. The notification may also include a warning informing the user to wait the required amount of time set by the timer before administering the dose, otherwise they may experience discomfort during administration. Similar to Figure 4b, the notification 1110 provides two options for response, namely a positive response and a negative response. The two-step confirmation process allows the user to confirm that the second option 1106 has not been selected in error. In response to detecting an input (positive response) indicating that the scheduled dose is ready, the application displays another screen, such as the screen shown in Figure 12c (described below). In response to detecting an input (negative response) indicating that the scheduled dose is not ready, the application displays another screen or reverts to the previous screen, such as the screen shown in Figure 11a.

[0155] Referring back to Figure 11a, in response to detecting an input from the user selecting the first option 1104 to start the timer, the application displays the screen shown in the third screenshot 1112 of Figure 11c, showing or confirming that the timer is started. The screen includes a notification area 1114, which may include an indication showing the time remaining on the timer. The indication method may include a graphic, an icon, a thumbnail, a widget, or the like. Additionally or alternatively, the notification area may further include a qualitative description of the time remaining on the timer and / or a suggested action for the user whilst the timer is active. Similar to Figure 4c, the screen shown in Figure 11c may also include a user selectable option 1116 to allow the user to confirm that they have understood that the timer has started. The user selectable option 1116 may be implemented as a button. Interacting with the button may cause the application to close the screen shown in Figure 11c.

[0156] Referring to Figures 12a to 12d, screenshots illustrating exemplary screens that may be displayed once the timer has started and / or in response to detecting interaction with the user selectable option 1116 shown in Figure 11c are shown.

[0157] Once the timer is started, the application may display screens including content showing the time remaining on the timer. Figures 12a, 12b, and 12d show exemplary screenshots, in which the application displays the time remaining on the timer and additional content associated with the scheduled dose. Similar to Figures 4d to 4f, the content may further include information such as the day, date, and amount of the scheduled dose, the location on the user’s body at which the previous dose of medicament was delivered, and provide the user with an opportunity to learn more about correctly administering a self-injection. It will be understood that a variety of content associated with the scheduled dose can be displayed and that content, such as that shown in the exemplary screen shots, can be combined or omitted in different ways.

[0158] In the first screenshot 1200 shown in Figure 12a, the application displays a screen, similar Figure 2b, where the Home tab 1202 is selected. Here, the top area of the home screen includes an indication 1204 of the time remaining on the timer, similar to Figure 4d. The home screen may further include an area including a user selectable option 1206 with a suggested action for the user to learn more about administering a medicament correctly. This information is to support and / or educate the user in administering the scheduled dose. This may include learning resources such as access to a Learning Centre hosted on the internet and / or a document, video or audio file providing information associated with the scheduled dose or the particular medical condition of the user. For instance, the information may include the step-by- step guide, as described above.

[0159] Although not shown in the first screenshot 1200 of Figure 12a, the screen may also include a user selectable option to receive a call from an HCP. For instance, the user selectable option 1206 may include an additional or alternative suggested action for the user to receive a call from an HCP. This option may be beneficial even for an experienced user as there may be an instance where further advice or support would be of assistance. For instance, the experienced user may wish to discuss a change in the particular medicament delivery device being used, the dose of medicament or the introduction of a different or additional medicament(s) to their treatment regimen or a change in their general wellbeing or physical state. Interacting with the user selectable option may cause the application to open one or more of the screens shown in the screenshots of Figures 6a to 6d. As this has been described above with respect to Figures 6a to 6d, corresponding description will be omitted here.

[0160] In the second screenshot 1208 of Figure 12b, an alternative screen is shown in which, similar to Figure 4e, the content further includes information 1210 such as the day, date, and amount of the scheduled dose. The screen may include an area 1212 displaying an indication of the location on the user’s body at which the previous dose of medicament was administered. The screen may also include areas 1214, similar to Figure 2d, in which the user can access patient information and / or prescribing information. The screen may additionally include a user selectable option 1216 to confirm that the dose has already been administered.

[0161] In response to detecting an input from the user to select the option 1216 confirming that they have administered the scheduled dose, the application displays a screen, such as the screen shown in the third screenshot 1220 Figure 12c, including a notification 1222 prompting the user to confirm again that the scheduled dose has been administered. This two-step confirmation process has already been described above with respect to Figure 5d, such that corresponding description will be omitted.

[0162] Referring back to Figure 12b, the application may also be configured to prevent the user from continuing with the next step of the guide until the time set by the timer has elapsed. In the second screenshot 1208 of Figure 12b, the application is configured to deactivate a user selectable option 1218 displayed on the screen that allows the user to continue with the treatment process. The application disables the option to select or continue with the treatment process until the time set by the timer is complete (i.e., the time set by the time has elapsed). This is intended to prevent the user from progressing to the next step (screen) until the dose is ready for administration.

[0163] The application is configured to allow the user to continue with the treatment process, in response to detecting that the time set by the timer has elapsed. In response to determining that the time set by the timer has elapsed, the application may display the fourth screenshot 1224 of Figure 12d, in which the user selectable option 1218 to continue treatment has been activated to allow the user to select to continue with the treatment process. Here, the continuing the next step or the treatment process includes recording a log of the scheduled dose.

[0164] Alternatively or additionally, in another example, in Figure 12b the application is configured to prevent the user from selecting to continue with the treatment process (next step), unless the application detects confirmation from the user that the scheduled dose has already been administered. In response to detecting an input at the user selectable option 1216 of Figure 12b and a positive response at the notification area of Figure 12c confirming that the user has administered the scheduled dose, the application may activate the user selectable option 1218 to allow the user to select to continue treatment. In response to detecting that the time set by the timer has elapsed and / or an input from the user selecting the (now active) option 1218 to continue with the treatment process, the application is configured to display another screen for logging the administered dose.

[0165] The of process of recording a log of the scheduled dose is substantially the same as that described above with respect to Figures 8a to 8c, 9, 10a and 10b, such that corresponding description will be omitted.

[0166] Referring now to Figure 13, a flow chart 1300 illustrating a method for facilitating user preparations for administering a scheduled dose is shown. The method may be performed by a non-transitory computer readable storage medium comprising instructions that when executed on a computer performs the steps described in respect of the Figure 13. In the following, the method is described with respect to an application executed on the user device, but other configurations and devices may equally well apply.

[0167] At step 1302, the application generates a notification indicating that a scheduled dose is due is generated and displays the notification to a user on a display of a user device 1400. At step 1304, the application determines whether the user is an experienced user or an inexperienced user.

[0168] In response to determining that the user is an inexperienced user (S1304 = No), at step 1306 the application displays a user interface on the screen of the user device 1400 including content for facilitating user preparations for administering a scheduled dose. The content includes a guide providing step-by-step instructions for assisting the user in administering the scheduled dose. At step 1308, the application instructs or prompts the user to remove the medicament and / or the medicament delivery device containing the medicament from storage. The application displays a user interface including a timer set to a duration that allows sufficient time for the scheduled dose of medicament to reach an ambient temperature prior to taking the dose. The application may receive an input from the user to start the timer.

[0169] At step 1310, the application provides the user with the option to receive a telephone call with a health care provider to support the user in administering the scheduled dose. In response to detecting a positive response from the user to select the option to receive a telephone call with an HCP, the application initiates a telephone call with the HCP at step 1312. Alternatively, the application may initiate a telephone call with the HCP at step 1312 automatically once the timer has started. At step 1314, the application may also provide the user with the option to confirm that the scheduled dose has been administered. At step 1312, in response to detecting a positive response from the user to confirm that the scheduled dose has been administered, at step 1320 the application displays a screen for creating a log (or record) of the administered dose.

[0170] At step 1310, if the scheduled dose is ready and / or the time set by the timer has elapsed, at step 1316 the application allows the user to continue with the next step of the step-by-step guide. The application may display a notification informing the user that the time set by the timer has elapsed, such that the scheduled dose is ready to be administered by the user and / or the user may continue with the next step of the step-by-step guide. At step 1318, the user administers the scheduled dose and confirms that the scheduled dose has been administered. In response to detecting a user input confirming that the scheduled dose has been administered, at step 1320 the application displays a screen for creating a log (or record) of the administered dose.

[0171] Referring back to step 1304, in response to determining that the user is an experienced user (S1304 = Yes), at step 1322 the application displays a user interface on the screen of the user device 1400 including content for facilitating user preparations for administering a scheduled dose. The content includes a notification prompting the user to confirm whether or not they are ready to administer the scheduled dose. At step 1324, the application receives an input from the user confirming that the user has administered the scheduled dose. Alternatively, at step 1326, the application receives an input from the user to start a timer for preparing the dose for administration. At step 1328, the the application may display a notification informing the user that the time set by the timer has elapsed, such that the scheduled dose is ready to be administered by the user. At step 1328, the user administers the scheduled dose and confirms that the scheduled dose has been administered. In response to detecting a user input confirming that the scheduled dose has been administered, at step 1320 the application displays a screen for creating a log (or record) of the administered dose.

[0172] Figure 14 illustrates schematically a user device 1400 according to some embodiments. The user device 1400 may be a mobile phone, PDA or tablet computer. The user device 1400 is an example of a wireless communication device. The user device may alternatively be referred to as a communication device, computer, computing device or mobile device and is not necessarily associated with a single user. The user device 1400 is configured to communicate wirelessly with a communications network using a wireless communication protocol, for example but not exclusively 3GPP LTE and / or New Radio (NR) or WiFi (IEEE 802.11). The user device 1400 may also be configured to communicate using Bluetooth, NFC, Zigbee, Ultra Wideband, IrDa or similar. The communications network may comprise one or more network nodes. The communications network may further be connected via a core network and / or an intermediate network to a host computer (not shown) which may be embodied in the hardware and / or software of a standalone server, a cloud-implemented server or a distributed server. The user device 1400 and the host computer may be configured to communicate data.

[0173] The user device 1400 may comprise hardware that includes processing circuitry 1401 . The processing circuitry 1401 may comprise a processor 1402 and a memory 1404. The user device

[0174] 1400 may also comprise a wireless transceiver 1406, user inputs 1408, a display 1412, a camera 1410, a microphone 1416, and RFID reader 1418 and a speaker 1414. The wireless transceiver 1406 may be configured to set up and maintain a wireless connection to a network node. The wireless transceiver 1406 may comprise one or more radio transmitters and one or more radio receivers. The display may be a touch sensitive display and may be based on capacitive or resistive sensing technology. The processing circuitry 1401 may for instance include a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. The processor 1402 may be configured to read and / or write from the memory 1404. The memory 1404 may comprise a volatile and / or non-volatile memory, for example a cache, RAM (Random Access Memory) and / or ROM (Read-Only Memory) etc.

[0175] The user device 1400 may comprise software which is stored, for example, in memory 1404. The software may be executable by the processing circuitry 1401 . The software may include an application, for example the application described above. In some embodiments the host computer may communicate with the application. The application may request data from the host computer and / or provide user data to the host computer.

[0176] The processing circuitry 1401 may be configured to perform or cause to be performed any of the methods described herein. In some embodiments, the software / program may include instructions that, when executed by the processing circuitry 1401 cause the processing circuitry

[0177] 1401 to perform the methods described herein.

[0178] The memory 1404 may comprise both a program memory storing program code (e.g. software or firmware) and main memory storing data. The processing circuitry 1401 may be configured to execute the program code stored in the program memory and to read, write and delete data from the main memory. In some embodiments, the program code may be an application which can be downloaded and installed on the user device 1400. The application may be a disease and treatment management and tracking tool for use by patients. The program memory may for instance be a Read-Only Memory (ROM), and the main memory may for instance be a Random Access Memory (RAM).

[0179] The user device 1400 comprises one or more user inputs 1408, for example a touchscreen, keypad or keyboard, accelerometer or gyroscope, mouse or microphone 1416 for receiving voice commands. User device 1400 may also comprise a camera 1410 configured to capture images of a user and images of labels, codes and the like visible on the medicament administration devices, packaging or storage solutions. The user device 1400 may be configured to scan medicament administration devices (such as an injection device or inhaler) using a scanning device. The scanning device may refer to either the camera 1410 or RFID reader 1418. The term “scanning” as used in relation to the user device 1400 may refer to use of either of these components to read information provided externally or internally on medicament administration devices.

[0180] As discussed above, medicament administration via a pre-filled injection pen has been described in the above examples, other means (medicament delivery devices) may equally well apply. For instance, the means of dose delivery may be via an intramuscular or an intravenous method. For instance, the dose delivery may also be via a syringe or infusion. Similarly, although the term “administration” is used above, similar terminology such as “delivery” are equally applicable.

[0181] In the above examples, various “screens” are described. The “screen” may equally well be regarded as a user interface or a graphical user interface or the like, which is displayed to the user and with which the user is able to interact.

[0182] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0183] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0184] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body. The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0185] As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0186] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0187] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0188] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen. Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6R mAb (e.g., Sarilumab), and anti IL-4R mAb (e.g., Dupilumab).

[0189] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0190] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0191] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0192] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0193] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Claims

Claims1 . A non-transitory computer readable storage medium comprising instructions that, when executed by a computer, cause the computer to: execute a program for managing a user’s medical condition or treatment; monitor a current dosing schedule set within the program; determine whether a scheduled dose is due; determine an experience level of a user; in response to determining that the scheduled dose is due, generate a first notification alerting the user to the scheduled dose; and in response to detecting user interaction with the first notification, provide a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

2. The non-transitory computer readable storage medium according to claim 1 , wherein the experience level of the user corresponds to the user’s ability to independently administer a scheduled dose of medicament.

3. The non-transitory computer readable storage medium according to claim 1 or 2, wherein the instructions are further configured to cause the computer to: in response to determining that the experience level of the user is less than a threshold level, provide a user interface including a guide providing step-by-step instructions for performing the scheduled dose.

4. The non-transitory computer readable storage medium according to claim 3, wherein the threshold is a predetermined number of doses taken and / or logged by the user.

5. The non-transitory computer readable storage medium according to claim 3 or 4, wherein the instructions are further configured to cause the computer to: in response to detecting user selection of the guide, provide a series of user interfaces corresponding to each step of the guide, and optionally, wherein the step-by-step instructions comprise one or more of: a document, an audio file, a video, and a link to a webpage on the Internet.

6. The non-transitory computer readable storage medium according to claim 5, wherein the step-by-step instructions include a preparation guide comprising steps to guide the user to prepare a medicament delivery device for administering the scheduled dose, wherein the medicament delivery device comprises medicament used in the management or treatment of the user’s medical condition.

7. The non-transitory computer readable storage medium according to claim 5 or 6, wherein the step-by-step instructions include a set of instructions for actuating a medicament delivery device to administer the scheduled dose, wherein the medicament delivery device comprises medicament used in the management or treatment of the user’s medical condition.

8. The non-transitory computer readable storage medium according to claim 5, wherein the step-by-step instructions include at least one of instructions for: preparing a medicament delivery device comprising a medicament for managing or treating the user’s medical condition, for administering the scheduled dose of medicament; setting a timer to notify the user when the medicament delivery device is ready for administering the scheduled dose of medicament; requesting and / or receiving a call from a health care provider; preparing a site on the user’s body for receiving the scheduled dose; and use and / or disposal of the medicament delivery device.

9. The non-transitory computer readable storage medium according to any one of claims 5 to 8, wherein the instructions are further configured to cause the computer to: provide a user interface including user selectable options for a user to (i) start a timer to notify the user when the scheduled dose is ready to be administered, and / or (ii) confirm that the scheduled dose is ready to be administered, and optionally, wherein the scheduled dose is ready to be administered, when it has reached ambient room temperature.

10. The non-transitory computer readable storage medium according to claim 1 , wherein the instructions are further configured to cause the computer to: in response to detecting user interaction indicating that the user has taken the scheduled dose, record a log of the scheduled dose taken by the user, and optionally, wherein the log includes information relating to the scheduled dose, the information comprising one or more of: an amount of medicament administered, a time, day and / or date, an injection site location, and a user survey.11 . The non-transitory computer readable storage medium according to any one of the preceding claims, wherein the instructions are further configured to cause the computer to: in response to determining that the experience level of the user is equal to or more than a threshold level, provide a user interface including an option to confirm that the user is ready to proceed with the scheduled dose.

12. The non-transitory computer readable storage medium according to any one of the preceding claims, wherein the instructions are further configured to cause the computer to: determine a time remaining before a scheduled dose is due; and in response to determining that the time remaining before the scheduled dose is due is less than a threshold time, display the first notification alerting the user that the schedule dose is due, and optionally, wherein the threshold time is a time in minutes, hours or days and / or the threshold time is set by a health care professional or the user.

13. The non-transitory computer readable storage medium according to according to any one of the preceding claims, wherein the instructions are further configured to cause the computer to: in response to (i) determining that the scheduled dose is ready for administration and / or (ii) detecting a user input confirming that the user is ready to administer the scheduled dose, initiate a telephone call with a health care professional.

14. A user device comprising processing circuitry configured to: execute a program for managing a user’s medical condition or treatment; monitor a current dosing schedule set within the program; determine an experience level of a user; determine whether a scheduled dose is due; in response to determining that the scheduled dose is due, generate a first notification alerting the user to prepare for the scheduled dose; and in response to detecting user interaction with the first notification, provide a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

15. A computer implemented method, the method comprising: executing a program for managing a user’s medical condition or treatment; monitoring a current dosing schedule set within the program;determining an experience level of a user; determining whether a scheduled dose is due; in response to determining that the scheduled dose is due, generating a first notification alerting the user to prepare for the scheduled dose; and in response to detecting user interaction with the first notification, providing a user interface displaying content relating to the scheduled dose, wherein at least a part of the content displayed is based on the experience level of the user.

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