Methods and systems for optimizing drug selection for individuals who react or object to drug and cosmetic ingredients

Abstract

Disclosed are methods, systems, and tools to variously and in different combinations identify, note, and catalog prescription drugs, over-the-counter drugs, and homeopathic compositions, and their active and inactive ingredients; relating those drugs and ingredients to patient allergies, sensitivities, reactions, and ingredient source preferences; and present information so that the patient can avoid undcsircd reactions and sources of those drugs and ingredients, so that the patient can be made aware of other drugs and ingredients that the patient might also react to, and / or so that the patient can be made aware of other drugs containing the same active ingredient that do not have the same risk of patient reaction.

Description

[0001] ATTORNEY DOCKET NO. JBJ 100 PCT

[0002] METHODS AND SYSTEMS FOR OPTIMIZING DRUG SELECTION FOR INDIVIDUALS WHO REACT OR OBJECT TO DRUG AND COSMETIC INGREDIENTS CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Application No.

[0003] 63 / 754,283, filed on February 5, 2025, which is hereby incorporated by reference in its entirety.

[0004] FIELD OF THE INVENTION

[0005] The disclosed invention is generally in the field of drug reactions and source objections and specifically in the area of avoiding drug reactions and objectionable ingredients.

[0006] BACKGROUND OF THE INVENTION

[0007] Many individuals have adverse reactions to drugs that have often been attributed to the active ingredient(s) in the drugs. However, recent research as well as personal experience has shown that many individuals have adverse reactions to the inactive ingredients (called excipients) used in the manufacturing process or delivery mechanism for drugs. The average drug contains many ingredients, with the vast majority being excipients. For example, the Centers for Disease Control (CDC) estimated in 2022 that over 450,000 individuals in the United States have Alpha-Gal Syndrome (AGS). These individuals need to avoid all ingredients derived from mammals, and many commonly used excipients are derived from mammals (for example, glycerin). Adverse reactions to one or more excipients in a drug may cause a patient to use a drug with a less effective active ingredient or require the use of a more powerful drug than is medically required.

[0008] Some patients wish to avoid certain ingredients due to personal choice. For example, vegans would like to avoid all ingredients derived from animals. It is very difficult and timeconsuming for medical personnel to assist patients in avoiding all of the ingredients derived from animal sources as this requires extensive knowledge about each excipient. Today, medical professionals (the prescribers) have to do a time-consuming manual look up of a drug to determine the ingredients, and then must have extensive knowledge of the sources of the ingredients to identify an alternative drug with different excipients that a patient could easily tolerate.

[0009] Another issue is that the patients as well as medical and insurance industry are very cost conscious and prefer use of generic sources of a drug whenever possible. Generic drugs contain the same active ingredient(s) as the original proprietary drug, but often contains different excipient ingredients. Some drugs are available in many forms, including pills, capsules, softgels, injections, suppositories, intravenous, creams, or solutions to name some, each of which 45823018.1 1ATTORNEY DOCKET NO. JBJ 100 PCT

[0010] may have different excipients to facilitate delivery of the active ingredient. To avoid an adverse reaction for a patient, the prescriber must specify the drug labeler or the National Drug Code (NDC) / appropriate Drug Code depending on the jurisdiction with the proper formulation of the drug to avoid the excipients the patient is sensitive or allergic to. This has the same difficulties as previously described for the prescriber regarding knowledge of the excipients.

[0011] Furthermore, many generic drugs have dozens of formulations using a variety of ingredients. For example, according to the FDA database in 2026, the drug Gabapentin is available under >500 different NDC labels in >100 different formulations drawing from a subset of >70 different “inactive ingredients”. To safely prescribe a medication to a sensitive patient, each ingredient should be understood as to the raw material source or sources, the manufacturing process used for pharmaceutical grade ingredients including filtering and purification, and whether possible reactions arc due to the presence of a protein or a carbohydrate (which survives most purification processes). Each drug formulation should then be assessed to determine if it meets the criteria need for the specific patient. This is an impossible manual task in the context of a prescription medication.

[0012] An additional concern is that many drugs (including cosmetic products) are “selfprescribed” over-the-counter medications or homeopathic medicine, and the patient may not consult with medical professionals to determine if it is safe for their use. Individuals may know what they are allergic to, but generally will not have the knowledge to understand the details regarding the excipients constituting the over-the-counter product.

[0013] Another challenge for medical professionals and patients is understanding why an individual reacts to one formulation of a drug but not another. The process to resolve these issues is typically cumbersome, involving trying different formations of the drug and manually correlating the responses to the ingredients to determine possible suspect excipients. Another approach is testing allergic responses to each of the ingredients in the drugs. Both are time consuming and expensive. These approaches may also fail to detect when excipients interact with each other to cause an adverse response in an individual.

[0014] Thus, there is a need for better and more efficient ways for patients to avoid reactions to drags and undesired ingredients.

[0015] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each claim of this application.

[0016] 45823018.1 2ATTORNEY DOCKET NO. JBJ 100 PCT

[0017] Throughout this specification the word “comprise,” or variations such as “comprises” or “comprising,” will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0018] BRIEF SUMMARY OF THE INVENTION

[0019] Disclosed are methods, systems, and tools to variously and in different combinations identify, note, and catalog prescription drugs, over-the-counter drugs, and homeopathic compositions, and their active and inactive ingredients; relating those drugs and ingredients to patient allergies, sensitivities, reactions, and ingredient source preferences; and present information so that the patient can avoid undesired reactions and sources of those drugs and ingredients, so that the patient can be made aware of other drugs and ingredients that the patient might also react to, and / or so that the patient can be made aware of other drugs containing the same active ingredient that do not have the same risk of patient reaction.

[0020] In some forms, the disclosed methods involve (a) receiving a query from a user, where the query identifies a drug and a subject; (b) retrieving drug information for the identified drug from a Drug Database; (c) matching one or more items of the retrieved drug information to one or more Subject Drug records related to the subject in a Subject Database; (d) calculating a Risk Score for the identified drug based on the matched Subject Drug records; and (e) sending an answer to the user, where the answer identifies the matched Subject Drug records and includes the Risk Score for the identified drug.

[0021] In some forms, the Subject Drug records comprise a Reaction Component field, one or more Ingredient fields, and one or more Reaction fields,

[0022] where the Reaction Component field in each of the Subject Drug records comprises:

[0023] (a) (i) a National Drug Code (NDC) subfield, or

[0024] (ii) a Drug Name subfield, a Labeler subfield, a Dosage subfield, and a Delivery Mechanism subfield; and

[0025] (b) a Pharmaceutical Class subfield,

[0026] where each Ingredient field in the Subject Drug record comprises:

[0027] (a) (i) a Unique Ingredient Identifier (UNII) subfield, or

[0028] (ii) an Ingredient Name subfield;

[0029] (b) an Active / Excipient subfield;

[0030] (c) a Type subfield; and

[0031] (d) a Subtype subfield,

[0032] 45823018.1 3ATTORNEY DOCKET NO. JBJ 100 PCT

[0033] where each Reaction field in the Subject Drug record comprises a Reaction Type subfield, and a Reaction Intensity subfield.

[0034] In some forms, the disclosed methods can also include creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the retrieved drug information.

[0035] In some forms, the disclosed methods can also include (bl) identifying one or more drugs that are therapeutically related to the identified drug; (b2) retrieving drug information for each the therapeutically related drugs from the Drug Database; (cl) matching one or more items of the retrieved drug information for each of the therapeutically related drugs to one or more Subject Drug records in the Subject Database related to the subject; and (dl) calculating a Risk Score for each of the therapeutically related drugs based on the Subject Drug records matched to the items of the retrieved drug information for the respective therapeutically related drug.

[0036] In some forms, the answer sent to the user identifies the Subject Drug records matched to the items of the retrieved drug information for each of the therapeutically related drugs and includes the Risk Score, reaction type, and reaction intensity for each of the therapeutically related drugs. The risk score may be displayed as a numeric value or visual representation of an analog meter or a “stop light” style of representation where the colors displayed indicate the numeric risk score.

[0037] In some forms, the disclosed methods can also include identifying one or more ingredients of the identified drug that do not appear in any Subject rug records related to the subject and create in the Subject Database a Subject Drug record related to the subject for each of the identified ingredients and populating the created Subject Drug record with a default reaction type, a default reaction intensity, and an indication that the ingredient is new to the subject for each of the identified ingredients. In some forms, the Risk Score is based on the default reaction type and a default reaction intensity for each of the identified ingredients.

[0038] In some forms, the disclosed methods can also include identifying one or more ingredients of the identified drug that match a preference of the subject and, if any ingredient matches a preference, adding to the created Subject Drug record that corresponds to the identified drug a reaction type corresponding to the matched preference and setting the reaction intensity of added reaction type to 10 on a scale of 0 to 10. Any other scale of intensity could be used instead. In some forms, the answer sent to the user identifies the matched preference(s) and the corresponding ingredient(s).

[0039] In some forms, the disclosed methods can also involve (a’) receiving an input from a user, where the input identifies a drug, a subject, a reaction type, and a reaction intensity; (b’) 45823018.1 4ATTORNEY DOCKET NO. JBJ 100 PCT

[0040] searching a Subject Database to identify a Subject Drug record related to the subject that corresponds to the identified drug; and (c’j if a Subject Drug record related to the subject that corresponds to the identified drug is not identified, creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the reaction type and reaction intensity received from the user and drug information for the identified drug retrieved from a Drag Database; or (d’j if a Subject Drag record related to the subject that corresponds to the identified drag is identified, determining if the identified Subject Drug record includes the reaction type received from the user and, if so, replacing the reaction intensity in the identified Subject Drag record that corresponds to the reaction type received from the user with the reaction intensity received from the user.

[0041] In some forms, the disclosed methods involve using a system. In some forms, the system can include (i) a User Interface Program in a first non-transitory computer-readable medium; (ii) a Subject Database in a second non-transitory computer-readable medium; (iii) a Drug Database in a third non-transitory computer-readable medium; and (iv) a Drag Analysis Program in fourth a non-transitory computer-readable medium. In some forms, the User Interface Program provides input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drag Database. In some forms, the Drug Analysis Program provides query handling, input from and output to the User Interface Program, input from and output to an external source of the drag information, input from and output to the Subject Database, and input from and output to the Drag Database.

[0042] In some forms, the User Interface Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (a) and (e). In some forms, the Drag Analysis Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b), (c), and (d).

[0043] In some forms, the User Interface Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute step (a’). In some forms, the Drag Analysis Program comprises instractions that, when executed by a processor in a computer system, cause the computer system to execute steps (b’j, (c’j, and (d’j.

[0044] In some forms, if the reaction intensity is other than 0 (or the lowest value of any other intensity scale being used) the disclosed methods can also include (e’) identifying one or more Subject Drag records related to the subject that include one or more ingredients that match an ingredient of the identified drag; and (f ) for each of the identified Subject Drag records, adding

[0045] 45823018.1 5ATTORNEY DOCKET NO. JBJ 100 PCT

[0046] to the identified Subject Drug record an indication the one or more matched ingredients are suspected of the reaction type of the identified drug.

[0047] In some forms, if the reaction intensity is 0 (or the lowest value of any other intensity scale being used) the disclosed methods can also include (e’) identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drag; and (f ) for each of the identified Subject Drag records, adding to the identified Subject Drag record an indication the one or more matched ingredients are not suspected of a reaction.

[0048] In some forms, the user is the subject. In some forms, the user is a service provider. In some forms, when the user is not the subject, the user can receive or obtain some or all of the information for a user input from the subject. In some forms, the identified drag comprises a prescription drag, a non-prcscription drag, or a cosmetic. In some forms, the drag information comprises one or more of brand, labeler, re -packager, dietary source(s), active ingredient(s), excipient(s), inactive ingredient(s), filler(s), and combinations thereof. In some forms, each of the Subject Drag records includes a reaction component, one or more subject reactions, and a reaction intensity for each of the one or more subject reactions, where, for each Subject Drag record, the subject reactions comprise one or combinations of allergies, sensitivities, reactions, and preferences of the subject to the reaction component. In some forms, the one or more subject reactions and the reaction intensities for the one or more subject reactions are based on the reaction of the subject to the reaction component when the reaction component has been used by the subject. In some forms, the one or more subject reactions and the reaction intensities for the one or more subject reactions were input via the User Interface Program. In some forms, the one or more subject reactions and the reaction intensities for the one or more subject reactions were input by the subject, by one or more service providers, or by a combination of the subject and one or more service providers. In some forms, when the user is not the subject, the user can receive or obtain some or all of the information for a user input from the subject.

[0049] In some forms, the Risk Score(s) are calculated by averaging the reaction intensity separately for each of the types of subject reactions for each of the reaction components of the Subject Drag records matched to the items of the retrieved drug information for the identified drag, and, if applicable, averaging the reaction intensity separately for each of the types of subject reactions for each of the reaction components of the Subject Drag records matched to the items of the retrieved drag information separately for each of the therapeutically related drags. In some forms, the averaging is weighted based on the recency of the entry of the reaction intensity or the averaging is a straight average. In some forms, the averaging puts less weight on the 45823018.1 6ATTORNEY DOCKET NO. JBJ 100 PCT

[0050] current or recent reaction intensity when the reaction intensities are decreasing over time and increased weight on the current or recent reaction intensity when the reaction intensities are increasing over time.

[0051] In some forms, the Risk Score(s) calculation can include a “stability index’’ that can be calculated based on the frequency and recency of label changes, optionally both on the drug, on the labeler, or on the manufacturer & facility, or any combination thereof. Tn some forms, the stability index can be increased based on the time since the last update of the drug.

[0052] Also disclosed are systems. In some forms, the systems include (i) a User Interface Program in a first non-transitory computer-readable medium; (ii) the Subject Database in a second non-transitory computer-readable medium; (iii) the Drug Database in a third non-transitory computer-readable medium; and (iv) a Drug Analysis Program in fourth a non-transitory computer-readable medium.

[0053] In some forms, the User Interface Program provides input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drug Database. In some forms, the Drug Analysis Program provides query handling, input from and output to the User Interface Program, input from and output to an external source of the drug information, input from and output to the Subject Database, and input from and output to the Drug Database.

[0054] In some forms, the User Interface Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (a) receiving a query from a user, where the query identifies a drug; and (e) sending an answer to the user, where the answer identifies one or more matched Subject Drug records and includes a Risk Score for the identified drug.

[0055] In some forms, the Drug Analysis Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b) retrieving drug information for the identified drug from the Drug Database; (c) matching one or more items of the retrieved drug information to one or more Subject Drug records in the Subject Database; and (e) calculating the Risk Score for the identified drug based on the matched Subject Drug records.

[0056] In some forms, the User Interface Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute step (a’) receiving an input from a user, where the input identifies a drug, a subject, a reaction type, and a reaction intensity.

[0057] In some forms, the Drug Analysis Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b’) searching a 45823018.1 7ATTORNEY DOCKET NO. JBJ 100 PCT

[0058] Subject Database to identify a Subject Drug record related to the subject that corresponds to the identified drug; and (c’j creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the reaction type and reaction intensity received from the user and drug information for the identified drug retrieved from a Drug Database; and (d’j determining if the identified Subject Drug record includes the reaction type received from the user and, if so, replacing the reaction intensity in the identified Subject Drug record that corresponds to the reaction type received from the user with the reaction intensity received from the user.

[0059] In some forms, the Drug Analysis Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (e’j identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drug; (f ) adding to the identified Subject Drug record an indication the one or more matched ingredients are suspected of the reaction type of the identified drug; and (f) adding to the identified Subject Drug record an indication the one or more matched ingredients are not suspected of a reaction.

[0060] In some forms, the first non-transitory computer-readable medium is comprised in a computer system having a processor, where the fourth non-transitory computer-readable medium is comprised in a computer system having a processor, where the second non-transitory computer-readable medium is comprised in a storage system, where the third non-transitory computer-readable medium is comprised in a storage system, where the computer systems can each interface with each other and with both the storage systems.

[0061] In some forms, the storage system comprising the second non-transitory computer-readable medium is comprised in the computer system comprising the first non-transitory computer-readable medium.

[0062] In some forms, the storage system comprising the third non-transitory computer-readable medium is comprised in the computer system comprising the fourth non-transitory computer-readable medium.

[0063] In some forms, the storage system comprising the third non-transitory computer-readable medium is comprised in the computer system comprising the first non-transitory computer-readable medium.

[0064] In some forms, the storage system comprising the second non-transitory computer-readable medium and the storage system comprising the third non-transitory computer-readable medium are comprised in the computer system comprising the fourth non-transitory computer-readable medium.

[0065] 45823018.1 8ATTORNEY DOCKET NO. JBJ 100 PCT

[0066] In some forms, the computer system comprising the first non-transitory computer-readable medium is the computer system comprising none of or any combination of the second non-transitory computer-readable medium, the third non-transitory computer-readable medium, or the fourth non-transitory computer-readable medium.

[0067] In some forms, the computer system comprising the second non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the third non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium.

[0068] In some forms, the computer system comprising the third non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the second non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium,

[0069] In some forms, the computer system comprising the fourth non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the second non-transitory computer-readable medium, and the third non-transitory computer-readable medium.

[0070] Also disclosed are machine learning and artificial intelligence implementations of the disclosed methods and systems. In some forms, one or more of the steps and / or processes are performed by a transformer trained on drug information and reactions of patients.

[0071] Additional advantages of the disclosed methods, systems, and components will be set forth in part in the description which follows, and in part will be understood from the description, or can be learned by practice of the disclosed method and compositions. The advantages of the disclosed method and compositions will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.

[0072] BRIEF DESCRIPTION OF THE DRAWINGS

[0073] The accompanying drawings illustrate several embodiments of the disclosed method and compositions and together with the description, serve to explain the principles of the disclosed method and compositions.

[0074] Figure 1 is a diagram illustrating the information and flow of information in an example of the disclosed methods and systems in use by a user to obtain and / or input information to a system.

[0075] 45823018.1 9ATTORNEY DOCKET NO. JBJ 100 PCT

[0076] Eigure 2 is a diagram illustrating the information and flow of information in an example of the disclosed methods and systems in use for providing information when a new drug is to be used by a patient.

[0077] DETAILED DESCRIPTION OF THE INVENTION

[0078] The disclosed methods, systems, and components can be understood more readily by reference to the following detailed description of particular embodiments and the Example included therein and to the Figures and their previous and following description.

[0079] The purpose of the disclosed methods and systems is to assist individuals and medical professionals with drug and cosmetic selections designed to avoid or minimize patient sensitivities and reactions to various substances by avoiding products in medications and skin treatments (including cosmetics) that react adversely with known reactions of the individual, as well as allowing individuals to avoid certain ingredients that they have a personal objection to consuming. Described herein are solutions to one or combinations of these problems with multiple embodiments supporting both individual and professional use.

[0080] Some forms of the disclosed methods and systems allow medical professionals and individuals to easily and accurately determine if any of the ingredients contained in a drag or cosmetic are ingredients that the consumer may be allergic to, sensitive to, or choose to avoid by personal choice. This contrasts to the current practice of assessing active ingredients or classes of active ingredients as the indicator for a patient reaction. As shown in Figure 1, in an example of the disclosed methods and systems, there are two primary logical components of the system: (1) a user-facing computer-assisted means (“user means”) for the user to input, store, request, and receive information, and (2) a “back-end” database (“Drag Database”) with supporting computer code and storage that includes a current set of drags including information for the set of drags. The two logical components of the disclosed methods and systems may reside on a single computer or on two or more computers as in a client / server relationship or “cloud-based” implementation.

[0081] In some forms, the information in the Drag Database includes all ingredients (both the active ingredient and all excipients), the labeler of the product, the dosage, the delivery mechanism, and pharmacological class of the drag. In some forms, ingredients in the Drug Database are classified by plant, animal, or chemical. In some forms, the ingredients in the Drug Database are further identified by the type or species of plant or animal, or by the chemical class or composition of the ingredient. A means is provided to update the Drag Database information as new drags and ingredients are introduced to the market.

[0082] 45823018.1 10ATTORNEY DOCKET NO. JBJ 100 PCT

[0083] The user means can include a computer program. Such a computer program can be of several different forms, including via an edge device app (such as a phone or tablet app), an application on other types of computing devices, or a web-based app accessed via a web site. Such a computer program can be implemented in different devices and systems, including via an edge device (such as a phone or tablet) or other types of computing devices. Such an application can query and accept user information about their allergies, sensitivities, reactions, and undesired ingredients. For example, such an application can query a subject or user as to whether any side effects or other adverse drug event had been experienced after receiving a prescription. In some forms, a service provider or other entity can query subjects for drug reaction and / or other information that can then be input by the service provider or other entity in an instance of the disclosed system maintained by the service provider or other entity.

[0084] The user means can also include or can interface with a Subject Database. The Subject Database is the repository of user reactions. Allergies, sensitivities, reactions, and preferences (collectively, “reactions”) experienced by a patient or user generally can include a “Reaction Component” (i.e., the thing that the user associates with causing the reaction) and a reaction type (i.e., the symptom, effect, or preference experienced by the user as the reaction). Reaction types include, for example, allergic reactions, a sensitivity effect, a physical, neurological, or mental reaction, or a moral, ethical, or personal preference of avoidance. Reaction Components include, for example, drugs, ingredients, preferences, classes of drugs, classes of ingredients, classes of preferences. The Subject Database is the repository of reaction types and user Reaction Components of the user. The Subject Database generally can also include additional information relating to the user reactions and user Reaction Components.

[0085] Reaction Components can be defined as single ingredients, chemical elements, classes of ingredients, classes of chemical elements, or as collections of ingredients. Examples of components could be “com,” an element (Nickel), or collections of ingredients. Examples of collections of ingredients include “Alpha-Gal” (including all mammal-based ingredients), “Vegan” (including all animal-based ingredients), “Sulfa” (including all sulfa-based ingredients), and common food allergy groups such as the Food Allergen Labeling and Consumer Protection Act (FALCPA) list maintained by the FDA.

[0086] In some forms of the disclosed method or systems, the user can select from a list of common allergies and allergy groups or enter specific ingredients they are allergic to. The Subject Database can be maintained on the user device, in the cloud, within the Subject Database stored locally by the user, along with the Drug Database, or in a database including both the Drug Database and the Subject Database.

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[0088] A history of the drugs used by the patient can be maintained in the Subject Database. Tor these drags, the patient can indicate if they have an adverse reaction to a drag. Patients can also enter information from their history that pre-dates their use of the disclosed methods and systems. As the patient uses different drags, they can enter a “reaction score” (also referred to as “reaction intensity”) indicating the intensity of the patient’s reaction. The reaction score could, for example, be a scale of 0-10, where zero would indicate no adverse reaction and 10 indicates a severe adverse reaction. Any other scale of intensity could be used instead.

[0089] It is the accumulation of patient reaction information in the Subject Database that drives the usefulness of the disclosed methods and systems. This is because the methods and systems allow correlation of the drags to which the user had a reaction (“reactive drags”) to the drags to which the user did not have a reaction (“non-reactive drags”) and correlation of the ingredients of the reactive drags to the ingredients of the non-rcactivc dugs. The con-elation of the ingredients of reactive drags can be used to identify suspect excipients and so to avoid future drags with the same suspect excipients. The correlation of non-reactive drags can be used to identify non-suspect excipients and so to clear future drags that include only non-suspect excipients. For example, a patient may use the proprietary or generic form of a drag and have no reaction. At a later date, they may refill the prescription and receive a generic from a different manufacturer that that causes an adverse reaction. Comparing all of the excipients of the two drags will identify the different excipients in the two drags, and the excipients in the refill that are different from the original prescription will be identified as possible reaction-causing excipients. By comparing these excipients with excipients previously identified as safe or reaction-causing, one or more of the “suspect excipients” is identified as a possible reactioncausing excipient. A list of all non-suspect excipients can be kept in the Subject Database. A list of all suspect excipients can be kept in the Subject Database. Suspect excipients can be confirmed by allergy testing or other appropriate test for the reaction involved.

[0090] In some forms, the disclosed methods and systems can build correlations. For example, if a patient took a drag and did not have a reaction to the drag, then all of the ingredients of that non-reactive drag can be presumed to not cause a patient reaction. Further, all of the ingredients of a reactive drag can be suspected (at least as a starting point) to be a source of the reaction. These correlations and designations can be made for all of the drugs in the Subject Database. By correlating the list of all ingredients in non-reactive drags for the patient to the ingredients of the reactive drags, some of the ingredients for the reactive drags can be presumed to not be the cause of the patient reactions to those drags. As the reaction information in Subject Database grows, more ingredients can be cleared as non-reactive and the identities of reactive ingredients can be 45823018.1 12ATTORNEY DOCKET NO. JBJ 100 PCT

[0091] more precisely focused. By these calculations, the disclosed methods and systems allow a patient to avoid drugs that have one or more ingredients that remain listed as presumed reactive.

[0092] A rating system for drugs can be assigned by the system for all of the reaction types (e.g., allergic reactions, a sensitivity effect, a physical, neurological, or mental reaction, or a moral, ethical, or personal preference of avoidance). This can generally be based on patient reactions to drags and / or ingredients previously identified as reactive for the user. Ingredients that are “new to the patient” can be assigned a default reaction score based on, for example, how common a reaction is across the industry to the ingredient. The reaction scores can be automatically adjusted higher or lower based on exposure and reaction observed by the patient and may be manually modified by the user based on their experience. A similar rating for patient preferences can be manually controlled by the patient to assist them in avoiding specific ingredients.

[0093] Adjustment of reaction intensity based on subject reactions at later times can be calculated in any suitable ways. For example, the maximum or minimum reaction intensity for the subject could be used. Alternatively, the most recent reaction intensity can be substituted for the prior reaction intensity. This makes sense where the most recent subject reaction reflects the current effect on the subject. Relatedly, the recent reaction intensity can be averaged or combined with older reaction intensities but with extra weight given to the recent intensity. Another approach can be to use trends in time-series data for the recent and earlier reaction intensities. For example, a time-domain method of analysis that places more or less emphasis on the most recent reaction intensities. These methods include "sliding window" methods, where only the most recent "n measurements" are included, and various non-linear methods that place more or less emphasis on the most recent observation. A preferred approach for the disclosed methods and systems is to use an algorithm that puts less emphasis on the current or recent reaction intensity when the observed reactions are decreasing, but an increased emphasis on an observed reaction when the reaction is increasing.

[0094] In some forms of the disclosed methods and systems, the user means can serve multiple individual patients (i.e., a multi-patient system). This form generally can be used by healthcare providers and personnel (such as a hospital, a medical practice, a pharmacy, a senior center, or in an integrated medical records system). The goal remains to catalog and use patient reaction information to identify and eliminate or minimize patient reactions. In these forms, the Subject Database can include multiple users and reaction information for those multiple users.

[0095] The disclosed user and Drag Databases can be created, modified, updated, and / or crosscorrelated using algorithms used in the disclosed methods and embodied in the disclosed systems.

[0096] 45823018.1 13ATTORNEY DOCKET NO. JBJ 100 PCT

[0097] Eigure 2 shows an example of how the disclosed methods and systems can analyze and score a new prescription for a patient. In the example, the system performs a search within the database to identify the drug(s) that match the prescription being written. The system returns a list of one or more drugs matching the prescription, and provides a “desirability score” on three categories: The active ingredient(s), the inactive ingredient(s), and the undesired ingredients(s) used in each drug formulation. If the active or inactive ingredients are present in a previously used drug, the user-entered score associated with that ingredient is be displayed with the drug. Each new inactive ingredient not previously observed is assigned a value indicating that the patient reaction to the ingredient is unknown and raises the risk of a drug reaction. Each undesired ingredient is also assigned a value based on user preference. These are totaled and presented to the user to allow them to make an informed decision as to which formulation of the drug (particularly for generic drugs) arc best for the patient. This allows the patient to select or medical professional to prescribe the best drug by using a specific NDC for the exact formulation that is best for the patient. Note that this could also be used both in a “patient-facing pharmacy” when patients fill prescriptions as well as a large patient care setting to identify the “best drug available” by providing the list of best candidate drugs to an existing drug inventory management system via manual or automated means.

[0098] The disclosed methods and systems can also include the pharmacological class for each drug, and in the event a patient has a reaction to a particular active ingredient, other drugs in the same pharmacological class can be displayed along with the associated ingredient scores to facilitate selection of similar drug without the medical professional having to look up alternative drugs manually.

[0099] The disclosed methods and systems can involve computer code and database structures, such as relational databases with associated computer code as the means to take inputs, process information and data, and present results to the user. The disclosed methods and systems can also involve an machine learning system or Al System as replacement for the database and associated computer code by training the Al System as the means to take inputs, process information and data, and present results to the user. Such an Al system can be trained manually (i.e., by providing selected or curated training data) or via automated training of the system. This can be done by, for example, iterating through querying each of the drugs in the database implementation with multiple user parameters and feeding the results into the Al System. Forms of the disclosed methods and systems involving computer code and database structures can be transitioned to an Al Systems by, for example, training an Al model using the databases built up in use of code and database systems.

[0100] 45823018.1 14ATTORNEY DOCKET NO. JBJ 100 PCT

[0101] It is to be understood that the disclosed method and compositions are not limited to specific synthetic methods, specific analytical techniques, or to particular reagents unless otherwise specified, and, as such, can vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0102] The term “drug” is used as a general term to denote a prescription drug, a nonprescription drag (i.e., “over-the-counter” drags), or a cosmetic. Prescription and over-the-counter drags in the US have a National Drag Code (NDC) product code. The NDC is a universal product identifier for human drags in the United States. Most countries possess a similar drag identification system, such as the Drag Identification Number (DIN) in Canada and the Actual Medicinal Product Pack (AMPP) in the United Kingdom. These drug identification systems generally provide a Medicinal Product Identification (MPID) for each drag that is required for the unique identification and the detailed description of the medicinal product, which conform to guidelines provided by the International Organization for Standardization (ISO). The NDC is used throughout the following description as an exemplary drag identification system, but any national / intemational drag identification system can be used interchangeably with the NDC in the disclosed compositions and methods.

[0103] The term “excipient” refers to an inactive ingredient present in a drag.

[0104] The term “labeler” refers to the entity that is indicated as the seller or provider of the drag. The labeler is often the manufacturer of the drag, but may also be a drag repackaged by another entity. For example, generic drags can be drags obtained by the labeler from the manufacturer and repackaged drags.

[0105] The term “Al” refers to an “artificial intelligence” system or a “large language model,” such as ChatGPT.

[0106] The term “Transformer” as used herein, refers to a Deep learning architecture based on parallel attention mechanism.

[0107] The term “Attention mechanism” as used herein, refers to a data-adaptive neural network component that dynamically focuses on the relevant information in the input to compute the output.

[0108] The term “Self-attention” as used herein, refers to a type of attention mechanism that focuses solely on the relationships between the input embeddings, unlike traditional attention mechanisms that focus on the relationships between the input embeddings, unlike traditional attention mechanisms that focus on the relationship between the input and output embeddings as well.

[0109] 45823018.1 15ATTORNEY DOCKET NO. JBJ 100 PCT

[0110] The terms “Key”, “query”, and “value” as used herein, refer to components of the attention mechanism in transformer models. Queries are elements for which the model seeks relevant information. Keys are compared to queries to produce attention scores and values are the actual content that the model retrieves, which is finally weighted based on the query-key comparison.

[0111] The term “Multihead attention” as used herein, refers to a neural network composed of multiple attention mechanisms (heads), each with a separate set of parameters.

[0112] The term “Eoundation model” as used herein, refers to a machine learning model trained on a large quality of data that can be effectively adapted to a wide range of downstream tasks.

[0113] A. Data Structures

[0114] The information stored and processed in the disclosed methods and systems can be organized in any suitable manner. For example, Subject Drug records can have any suitable data structure. An example of a Subject Drug record can include a Reaction Component field, one or more Ingredient fields, and one or more Reaction fields. The Reaction Component field in each of the Subject Drug records can include a Drug Name subfield, a Labeler subfield, a Dosage subfield, a Delivery Mechanism subfield, and a Pharmaceutical Class subfield. Alternatively, the Reaction Component field in each of the Subject Drug records can include:

[0115] (a) (i) a National Drug Code (NDC) subfield, or

[0116] (ii) a Drug Name subfield, a Labeler subfield, a Dosage subfield, and a Delivery Mechanism subfield; and

[0117] (b) a Pharmaceutical Class subfield.

[0118] Each Ingredient field in the Subject Drug record can include:

[0119] (a) (i) a Unique Ingredient Identifier (UNII) subfield, or

[0120] (ii) an Ingredient Name subfield;

[0121] (b) an Active / Excipient subfield;

[0122] (c) a Type subfield: and

[0123] (d) a Subtype subfield.

[0124] Each Reaction field in the Subject Drug record can include a Reaction Type subfield, and a Reaction Intensity subfield.

[0125] The Subject Drug record can also include a field to indicate that the ingredient is new to the subject for each of the identified ingredients. Subject preferences can be indicated by certain Reaction Types. The Subject Drug record can also include a field to indicate that ingredients of a drag are suspected of producing the reaction of drag. The Subject Drag record can also include a field to indicate that ingredients of a drag are not suspected of producing the reaction of drag.

[0126] 45823018.1 16ATTORNEY DOCKET NO. JBJ 100 PCT

[0127] As another example, the data structure of a Subject Drug record can be as shown below. Subject Drug 1

[0128] Reaction Component

[0129] Name

[0130] Labeler

[0131] Dosage

[0132] Delivery Mechanism

[0133] Pharmaceutical Class

[0134] Ingredient 1

[0135] Name

[0136] Active / Excipient

[0137] Type

[0138] Subtype

[0139] Ingredient 2

[0140] Name

[0141] Active / Excipient

[0142] Type

[0143] Subtype

[0144] Ingredient 3

[0145] Name

[0146] Active / Excipient

[0147] Type

[0148] Subtype

[0149] Reaction 1

[0150] Reaction Type

[0151] Reaction Intensity

[0152] Reaction 2

[0153] Reaction Type

[0154] Reaction Intensity

[0155] Alternatively, the Reaction Component field can be as shown below.

[0156] Subject Drug 1

[0157] Reaction Component

[0158] National Drug Code

[0159] Pharmaceutical Class.

[0160] Alternatively, the Ingredient field can be as shown below.

[0161] Ingredient 1

[0162] Unique Ingredient Identifier (UNII)

[0163] Active / Excipient

[0164] Type

[0165] 45823018.1 17ATTORNEY DOCKET NO. JBJ 100 PCT

[0166] Subtype.

[0167] The list of suspect Reaction Components and the list of non-suspect Reaction Components can have any suitable data structure. As an example, the data structure of the list of suspect Reaction Components can be as shown below.

[0168] Record 1

[0169] Ingredient 1

[0170] Name

[0171] Reaction 1

[0172] Reaction Type

[0173] Reaction Intensity

[0174] Reaction 2

[0175] Reaction Type

[0176] Reaction Intensity

[0177] Record 2

[0178] Ingredient 2

[0179] Name

[0180] Reaction 1

[0181] Reaction Type

[0182] Reaction Intensity

[0183] Reaction 2

[0184] Reaction Type

[0185] Reaction Intensity

[0186] Alternatively, the Ingredient field can be as shown below.

[0187] Ingredient 1

[0188] Unique Ingredient Identifier (UNII).

[0189] As an example, the data structure of the list of non-suspect Reaction Components can be as shown below.

[0190] Record 1

[0191] Ingredient 1

[0192] Name

[0193] Active / Excipient

[0194] Type

[0195] Subtype

[0196] 45823018.1 18ATTORNEY DOCKET NO. JBJ 100 PCT

[0197] Record 2

[0198] Ingredient 2

[0199] Name

[0200] Active / Excipient

[0201] Type

[0202] Subtype

[0203] Record 3

[0204] Ingredient 3

[0205] Name

[0206] Active / Excipient

[0207] Type

[0208] Subtype

[0209] Record 4

[0210] Ingredient 4

[0211] Name

[0212] Active / Excipient

[0213] Type

[0214] Subtype

[0215] Alternatively, the Ingredient field can be as shown below.

[0216] Ingredient 1

[0217] Unique Ingredient Identifier (UNII).

[0218] B. Algorithms

[0219] The disclosed Subject Database and Drug Database can be populated, queried, updated, supplemented, and analyzed through the use of the disclosed steps and algorithms.

[0220] One important algorithm involves queries to assess a potential drug’s suitability for a subject and / or identify an acceptable (or most acceptable) drug for a given indication. An example of such an algorithm includes:

[0221] (a) receiving a query from a user, wherein the query identifies a drug and a subject; (b) retrieving drug information for the identified drug from a Drug Database;

[0222] (c) matching one or more items of the retrieved drug information to one or more Subject Drug records related to the subject in a Subject Database;

[0223] (d) calculating a Risk Score for the identified drug based on the matched Subject Drug records; and

[0224] (e) sending an answer to the user, wherein the answer identifies the matched Subject Drug records and includes the Risk Score for the identified drug.

[0225] These steps can be supplemented with, for example, with one or more steps or combination of steps.

[0226] 45823018.1 19ATTORNEY DOCKET NO. JBJ 100 PCT

[0227] • Creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the retrieved drug information.

[0228] • (bl) identifying one or more drugs that are therapeutically related to the identified drug;

[0229] (b2) retrieving drug information for each the therapeutically related drugs from the Drag Database;

[0230] (cl) matching one or more items of the retrieved drag information for each of the therapeutically related drags to one or more Subject Drag records in the Subject Database related to the subject; and

[0231] (dl) calculating a Risk Score for each of the therapeutically related drugs based on the Subject Drug records matched to the items of the retrieved drug information for the respective therapeutically related drag.

[0232] • Identifying the Subject Drag records matched to the items of the retrieved drag information for each of the therapeutically related drags and includes the Risk Score, reaction type, and reaction intensity for each of the therapeutically related drugs.

[0233] • Identifying one or more ingredients of the identified drag that do not appear in any Subject Drag records related to the subject and creating in the Subject Database a Subject Drug record related to the subject for each of the identified ingredients and populating the created Subject Drag record with a default reaction type, a default reaction intensity, and an indication that the ingredient is new to the subject for each of the identified ingredients.

[0234] • Identifying one or more ingredients of the identified drug that match a preference of the subject and, if any ingredient matches a preference, adding to the created Subject Drag record that corresponds to the identified drag a reaction type corresponding to the matched preference and setting the reaction intensity of added reaction type to 10 on a scale of 1 to 10 (any other scale of intensity could be used instead).

[0235] Another important algorithm involves adding reactions and non-reactions of the subject to drugs.

[0236] An example of such an algorithm includes:

[0237] (a) receiving an input from a user, wherein the input identifies a drug, a subject, a reaction type, and a reaction intensity;

[0238] (b) searching a Subject Database to identify a Subject Drag record related to the subject that corresponds to the identified drag; and

[0239] 45823018.1 20ATTORNEY DOCKET NO. JBJ 100 PCT

[0240] (c) if a Subject Drug record related to the subject that corresponds to the identified drug is not identified, creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the reaction type and reaction intensity received from the user and drug information for the identified drug retrieved from a Drug Database; or

[0241] (d) if a Subject Drug record related to the subject that corresponds to the identified drug is identified, determining if the identified Subject Drug record includes the reaction type received from the user and, if so, replacing the reaction intensity in the identified Subject Drug record that corresponds to the reaction type received from the user with the reaction intensity received from the user.

[0242] These steps can be supplemented with, for example, with one or more steps or combination of steps.

[0243] • (e) identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drug;

[0244] (f) for each of the identified Subject Drug records, adding to the identified Subject Drug record an indication the one or more matched ingredients arc suspected of the reaction type of the identified drug.

[0245] • (e) identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drug;

[0246] (f) for each of the identified Subject Drug records, adding to the identified Subject Drug record an indication the one or more matched ingredients are not suspected of a reaction.

[0247] The list of suspect Reaction Components and the list of non-suspect Reaction Components can be built and maintained by any suitable algorithm. As an example, the lists of suspect and non-suspect Reaction Components can be built and maintained by the following algorithm performed whenever a new Subject Drug is added to the Subject Database by a user.

[0248] (A) If the new Subject Drug includes any Reaction Type other than None, then

[0249] (1) Add the Reaction Component of the new Subject Drug as a new record in the Suspect Reaction Component List,

[0250] and

[0251] (2) For each Ingredient in the new Subject Drug,

[0252] (a) If the Ingredient is not in the Suspect Reaction Component List, add the Ingredient as a new record in the Suspect Reaction Component List and copy

[0253] 45823018.1 21ATTORNEY DOCKET NO. JBJ 100 PCT

[0254] the Reactions in the new Subject Drug to the new Ingredient record in the Suspect Reaction Component List,

[0255] or

[0256] (b) If the Ingredient is in the Suspect Reaction Component List,

[0257] (i) For each Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List:

[0258] (A) average the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List and the Reaction Intensity of the Reaction Type in the new Subject Drug, weighting the Reaction Intensity of the Reaction Type in the new Subject Drug higher if the trend of the reaction intensities is decreasing and weighting the Reaction Intensity of the Reaction Type in the new Subject Drug higher if the trend of the reaction intensities is increasing, and replace the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List with the averaged Reaction Intensity,

[0259] (B) set both the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List and the Reaction Intensity of the Reaction Type in the new Subject Drug to the higher of the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List and the Reaction Intensity of the Reaction Type in the new Subject Drug; or

[0260] (C) average the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List and the Reaction Intensity of the Reaction Type in the new Subject Drug and replace the Reaction Intensity of the Reaction Type in the Ingredient record for the Ingredient in the Suspect Reaction Component List with the averaged Reaction Intensity, wherein the averaging is weighted based on the recency of the entry of the Reaction Intensity or the averaging is a straight average,

[0261] and

[0262] 45823018.1 22ATTORNEY DOCKET NO. JBJ 100 PCT

[0263] (ii) For each Reaction Type in the new Subject Drug that is not in the Ingredient record for the Ingredient in the Suspect Reaction Component List, add the Reaction for the Reaction Type into the Ingredient record for the Ingredient in the Suspect Reaction Component List,

[0264] or

[0265] (B) If the new Subject Drug has a Reaction Type of None, then

[0266] (1) For each Ingredient in the new Subject Drug,

[0267] (a) If the Ingredient is in the Suspect Reaction Component List, remove the Ingredient from the Suspect Reaction Component List,

[0268] and

[0269] (b) Add the Ingredient as a new record in the Non-Suspcct Reaction Component List,

[0270] and

[0271] (2) Add the Reaction Component of the new Subject Drag as a new record in the Non-Suspect Reaction Component List.

[0272] The disclosed methods and systems can be used to assess potential drugs for a patient to use. This can be accomplished using any suitable algorithm. As an example, potential drugs for a patient to use can be assessed by the following algorithm.

[0273] (A) List drugs under consideration or that fit entered criteria

[0274] (B) Retrieve ingredients of drugs on the list from the Drug Database

[0275] (C) Check each ingredient of each drug on the list to see if the ingredient is in the Suspect Reaction Component List, the Non-Suspect Reaction List, or neither list

[0276] (D) Calculate a Risk Score for each drug on the list by averaging the non-zero Reaction Intensities of the ingredients in a given drug

[0277] (E) Add the Risk Scores to the list of drugs.

[0278] C. Systems

[0279] Disclosed are systems useful for performing, or aiding in the performance of, the disclosed method. Systems generally comprise combinations of articles of manufacture such as structures, machines, devices, and the like, and compositions, compounds, materials, and the like. Such combinations that are disclosed or that are apparent from the disclosure are contemplated. For example, disclosed and contemplated are systems comprising (i) a User Interface Program in a first non-transitory computer-readable medium; (ii) the Subject Database in a second non-transitory computer-readable medium; (iii) the Drug Database in a third non- 45823018.1 23ATTORNEY DOCKET NO. JBJ 100 PCT

[0280] transitory computer-readable medium; and (iv) a Drug Analysis Program in fourth a non-transitory computer-readable medium.

[0281] The User Interface Program can provide input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drug Database. The User Interface Program can also or alternatively include instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (a) receiving a query from a user, where the query identifies a drug; and (e) sending an answer to the user, where the answer identifies one or more matched Subject Drug records and includes a Risk Score for the identified drug. The User Interface Program can also or alternatively include instructions that, when executed by a processor in a computer system, cause the computer system to execute step (a’) receiving an input from a user, where the input identifies a drug, a subject, a reaction type, and a reaction intensity.

[0282] The Drug Analysis Program can provide query handling, input from and output to the User Interface Program, input from and output to an external source of the drug information, input from and output to the Subject Database, and input from and output to the Drug Database. The Drug Analysis Program can also or alternatively include instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b) retrieving drug information for the identified drug from the Drug Database; (c) matching one or more items of the retrieved drug information to one or more Subject Drug records in the Subject Database; and (e) calculating the Risk Score for the identified drug based on the matched Subject Drug records. In some forms, the Drug Analysis Program includes instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b’) searching a Subject Database to identify a Subject Drug record related to the subject that corresponds to the identified drug; and (c’j creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the reaction type and reaction intensity received from the user and drug information for the identified drug retrieved from a Drug Database; and (d’j determining if the identified Subject Drug record includes the reaction type received from the user and, if so, replacing the reaction intensity in the identified Subject Drug record that corresponds to the reaction type received from the user with the reaction intensity received from the user. The Drug Analysis Program can also or alternatively include instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (e’) identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drug; (f ) adding to the identified Subject Drug record an indication the one or more 45823018.1 24ATTORNEY DOCKET NO. JBJ 100 PCT

[0283] matched ingredients are suspected of the reaction type of the identified drug; and (f) adding to the identified Subject Drug record an indication the one or more matched ingredients are not suspected of a reaction.

[0284] The first non-transitory computer-readable medium can be comprised in a computer system having a processor. The fourth non-transitory computer- readable medium can be comprised in a computer system having a processor. The second non-transitory computer-readable medium can be comprised in a storage system. The third non-transitory computer-readable medium can be comprised in a storage system. The computer systems can each interface with each other and with both the storage systems.

[0285] The storage system comprising the second non-transitory computer-readable medium can be comprised in the computer system comprising the first non-transitory computer-readable medium. The storage system comprising the third non-transitory computer-readable medium can be comprised in the computer system comprising the fourth non-transitory computer-readable medium. The storage system comprising the third non-transitory computer-readable medium can be comprised in the computer system comprising the first non-transitory computer-readable medium. The storage system comprising the second non-transitory computer-readable medium and the storage system comprising the third non-transitory computer-readable medium can be comprised in the computer system comprising the fourth non-transitory computer-readable medium.

[0286] The computer system comprising the first non-transitory computer-readable medium can be the computer system comprising none of or any combination of the second non-transitory computer-readable medium, the third non-transitory computer-readable medium, or the fourth non-transitory computer-readable medium.

[0287] The computer system comprising the second non-transitory computer-readable medium can the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the third non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium.

[0288] The computer system comprising the third non-transitory computer-readable medium can be the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the second non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium,

[0289] The computer system comprising the fourth non-transitory computer-readable medium can be the computer system comprising none of or any combination of the first non-transitory

[0290] 45823018.1 25ATTORNEY DOCKET NO. JBJ 100 PCT

[0291] computer-readable medium, the second non-transitory computer-readable medium, and the third non-transitory computer-readable medium.

[0292] D. Data Structures and Computer Control

[0293] Disclosed are data structures used in, generated by, or generated from, the disclosed methods and systems. Data structures generally are any form of data, information, and / or objects collected, organized, stored, and / or embodied in a composition or medium. A program stored in electronic form, such as in RAM or on a storage disk, is a type of data structure.

[0294] The disclosed methods, or any part thereof or preparation therefor, can be controlled, managed, or otherwise assisted by computer control. Such computer control can be accomplished by a computer controlled process or method, can use and / or generate data structures, and can use a computer program. Such computer control, computer controlled processes, data structures, and computer programs arc contemplated and should be understood to be disclosed herein.

[0295] E. Machine Learning and Al System

[0296] The disclosed methods can be implemented with and performed using any machine learning or Al systems or techniques. For example, deep learning transformers can be used. As an example, the disclosed methods can be implemented using a deep learning (DL) model. In some forms, the DL model can be generated by the steps of: (i) pre-training the DL model using a collection of unlabeled drug information and patient reactions; (ii) fine-tuning the DL model using a collection of labeled drug information and patient reactions.

[0297] It is understood that the disclosed method and compositions are not limited to the particular methodology, protocols, and reagents described as these can vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.

[0298] Disclosed are materials, compositions, and components that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed method and compositions. These and other materials are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these materials are disclosed that while specific reference of each various individual and collective combinations and permutation of these compounds may not be explicitly disclosed, each is specifically contemplated and described herein. For example, if a step is disclosed and discussed and a number of modifications that can be made to a number of steps including the step are discussed, each and every combination and permutation of the step and the modifications that are possible are 45823018.1 26ATTORNEY DOCKET NO. JBJ 100 PCT

[0299] specifically contemplated unless specifically indicated to the contrary. Further, each of the steps, records, fields, reactions, components, etc. contemplated and disclosed as above can also be specifically and independently included or excluded from any group, subgroup, list, set, etc. of such items. Thus, if there are a variety of additional steps that can be performed it is understood that each of these additional steps can be performed with any specific embodiment or combination of embodiments of the disclosed methods, and that each such combination is specifically contemplated and should be considered disclosed.

[0300] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. Thus, for example, reference to “a reaction” includes a plurality of such reactions, reference to “the reaction” is a reference to one or more reaction and equivalents thereof known to those skilled in the art, and so forth.

[0301] Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps.

[0302] “Optional” or “optionally” means that the subsequently described event, circumstance, or material may or may not occur or be present, and that the description includes instances where the event, circumstance, or material occurs or is present and instances where it does not occur or is not present.

[0303] Unless the context clearly indicates otherwise, use of the word “can” indicates an option or capability of the object or condition referred to. Generally, use of “can” in this way is meant to positively state the option or capability while also leaving open that the option or capability could be absent in other forms or embodiments of the object or condition referred to. Unless the context clearly indicates otherwise, use of the word “may” indicates an option or capability of the object or condition referred to. Generally, use of “may” in this way is meant to positively state the option or capability while also leaving open that the option or capability could be absent in other forms or embodiments of the object or condition referred to. Unless the context clearly indicates otherwise, use of “may” herein does not refer to an unknown or doubtful feature of an object or condition.

[0304] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, also specifically contemplated and considered disclosed is the range from the one particular value and / or to the other particular value unless the context specifically indicates otherwise. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value 45823018.1 27ATTORNEY DOCKET NO. JBJ 100 PCT

[0305] forms another, specifically contemplated embodiment that should be considered disclosed unless the context specifically indicates otherwise. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint unless the context specifically indicates otherwise. It should be understood that all of the individual values and sub-ranges of values contained within an explicitly disclosed range are also specifically contemplated and should be considered disclosed unless the context specifically indicates otherwise. Finally, it should be understood that all ranges refer both to the recited range as a range and as a collection of individual numbers from and including the first endpoint to and including the second endpoint. In the latter case, it should be understood that any of the individual numbers can be selected as one form of the quantity, value, or feature to which the range refers. In this way, a range describes a set of numbers or values from and including the first endpoint to and including the second endpoint from which a single member of the set (i.c. a single number) can be selected as the quantity, value, or feature to which the range refers. The foregoing applies regardless of whether in particular cases some or all of these embodiments are explicitly disclosed.

[0306] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed method and compositions belong. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present method and compositions, the particularly useful methods, devices, and materials are as described. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such disclosure by virtue of prior invention. No admission is made that any reference constitutes prior art. The discussion of references states what their authors assert, and applicants reserve the right to challenge the accuracy and pertinency of the cited documents. It will be clearly understood that, although a number of publications are referred to herein, such reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art.

[0307] Although the description of materials, compositions, components, steps, techniques, etc. can include numerous options and alternatives, this should not be construed as, and is not an admission that, such options and alternatives are equivalent to each other or, in particular, are obvious alternatives.

[0308] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the method and compositions described herein. Such equivalents are intended to be encompassed by the following claims.

[0309] 45823018.1 28

Claims

ATTORNEY DOCKET NO. IBI 100 PCTCLAIMSWe claim:

1. A method comprising:(a) receiving a query from a user, wherein the query identifies a drug and a subject; (b) retrieving drug information for the identified drug from a Drug Database:(c) matching one or more items of the retrieved drug information to one or more Subject Drug records related to the subject in a Subject Database;(d) calculating a Risk Score for the identified drug based on the matched Subject Drug records; and(e) sending an answer to the user, wherein the answer identifies the matched Subject Drug records and includes the Risk Score for the identified drug,wherein the method is performed using a system comprising:(i) a User Interface Program in a first non-transitory computer-readable medium;(ii) the Subject Database in a second non-transitory computer-readable medium;(iii) the Drug Database in a third non-transitory computer-readable medium; and (iv) a Drug Analysis Program in fourth a non-transitory computer-readable medium, wherein the User Interface Program provides input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drug Database,wherein the Drug Analysis Program provides query handling, input from and output to the User Interface Program, input from and output to an external source of the drug information, input from and output to the Subject Database, and input from and output to the Drug Database, wherein the User Interface Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (a) and (e), wherein the Drug Analysis Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b), (c), and (d).

2. The method of claim 1, wherein each of the Subject Drug records comprises a Reaction Component field, one or more Ingredient fields, and one or more Reaction fields, wherein the Reaction Component field in each of the Subject Drug records comprises:(a) (i) a National Drug Code (NDC) subfield, or(ii) a Drug Name subfield, a Labeler subfield, a Dosage subfield, and a Delivery Mechanism subfield; and(b) a Pharmaceutical Class subfield,wherein each Ingredient field in the Subject Drug record comprises:45823018.1 29ATTORNEY DOCKET NO. JBJ 100 PCT(a) (i) a Unique Ingredient Identifier (UN11) subfield, or(ii) an Ingredient Name subfield;(b) an Active / Excipient subfield;(c) a Type subfield; and(d) a Subtype subfield,wherein each Reaction field in the Subject Drug record comprises a Reaction Type subfield, and a Reaction Intensity subfield.

3. The method of claim 1 or 2 further comprising creating in the Subject Database a Subject Drug record related to the subject that corresponds to the identified drug and populating the created Subject Drug record with the retrieved drug information.

4. The method of any one of claims 1-3 further comprising:(bl) identifying one or more drugs that arc therapeutically related to the identified drug; (b2) retrieving drug information for each the therapeutically related drugs from the Drug Database;(cl) matching one or more items of the retrieved drug information for each of the therapeutically related drugs to one or more Subject Drug records in the Subject Database related to the subject; and(dl) calculating a Risk Score for each of the therapeutically related drugs based on the Subject Drug records matched to the items of the retrieved drug information for the respective therapeutically related drug.

5. The method of claim 4, wherein the answer sent to the user identifies the Subject Drug records matched to the items of the retrieved drug information for each of the therapeutically related drugs and includes the Risk Score, reaction type, and reaction intensity for each of the therapeutically related drugs.

6. The method of any one of claims 1 -5 further comprising identifying one or more ingredients of the identified drug that do not appear in any Subject Drug records related to the subject and creating in the Subject Database a Subject Drug record related to the subject for each of the identified ingredients and populating the created Subject Drug record with a default reaction type, a default reaction intensity, and an indication that the ingredient is new to the subject for each of the identified ingredients.

7. The method of claim 6, wherein the Risk Score is based on the default reaction type and a default reaction intensity for each of the identified ingredients.

8. The method of any one of claims 1-7 further comprising identifying one or more ingredients of the identified drug that match a preference of the subject and, if any ingredient 45823018.1 30ATTORNEY DOCKET NO. JBJ 100 PCTmatches a preference, adding to the created Subject Drug record that corresponds to the identified drug a reaction type corresponding to the matched preference and setting the reaction intensity of added reaction type to the highest value on a scale of intensity.

9. The method of claim 8, wherein the answer sent to the user identifies the matched preference(s) and the corresponding ingredient(s).

10. A method comprising:(a) receiving an input from a user, wherein the input identifies a drug, a subject, a reaction type, and a reaction intensity;(b) searching a Subject Database to identify a Subject Drug record related to the subject that corresponds to the identified drug; and(c) if a Subject Drug record related to the subject that corresponds to the identified drug is not identified, creating in the Subject Database a Subject Drag record related to the subject that corresponds to the identified drug and populating the created Subject Drag record with the reaction type and reaction intensity received from the user and drug information for the identified drag retrieved from a Drag Database; or(d) if a Subject Drag record related to the subject that corresponds to the identified drag is identified, determining if the identified Subject Drag record includes the reaction type received from the user and, if so, replacing the reaction intensity in the identified Subject Drag record that corresponds to the reaction type received from the user with the reaction intensity received from the user,wherein the method is performed using a system comprising:(i) a User Interface Program in a first non-transitory computer-readable medium;(ii) the Subject Database in a second non-transitory computer-readable medium;(iii) the Drag Database in a third non-transitory computer-readable medium; and (iv) a Drag Analysis Program in fourth a non-transitory computer-readable medium, wherein the User Interface Program provides input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drag Database,wherein the Drag Analysis Program provides query handling, input from and output to the User Interface Program, input from and output to an external source of the drag information, input from and output to the Subject Database, and input from and output to the Drag Database, wherein the User Interface Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute step (a),45823018.1 31ATTORNEY DOCKET NO. JBJ 100 PCTwherein the Drug Analysis Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps (b), (c), and (d).

11. The method of claim 10, wherein each of the Subject Drug records comprises a Reaction Component field, one or more Ingredient fields, and one or more Reaction fields, wherein the Reaction Component field in each of the Subject Drug records comprises a Drug Name subfield, a I .aheler subfield, a Dosage subfield, a Delivery Mechanism subfield, and a Pharmaceutical Class subfield, wherein each Ingredient field in the Subject Drug record comprises an Ingredient Name subfield, an Active / Excipient subfield, a Type subfield, and a Subtype subfield, wherein each Reaction field in the Subject Drug record comprises a Reaction Type subfield, and a Reaction Intensity subfield.

12. The method of claim 10 or 11, wherein if the reaction intensity is other than the lowest value on the scale of intensity the method further comprises:(e) identifying one or more Subject Drug records related to the subject that include one or more ingredients that match an ingredient of the identified drug;(f) for each of the identified Subject Drug records, adding to the identified Subject Drug record an indication the one or more matched ingredients are suspected of the reaction type of the identified drug.

13. The method of claim 10 or 11, wherein if the reaction intensity is the lowest value on the scale of intensity the method further comprises:(e) identifying one or more Subject rug records related to the subject that include one or more ingredients that match an ingredient of the identified drug;(f) for each of the identified Subject Drug records, adding to the identified Subject Drug record an indication the one or more matched ingredients are not suspected of a reaction.

14. The method of any one of claims 1-13, wherein the user is the subject.

15. The method of any one of claims 1-13, wherein the user is a service provider.

16. The method of any one of claims 1-14, wherein the identified drug comprises a prescription drug, a non-prescription drug, or a cosmetic.

17. The method of any one of claims 1-16, wherein the drug information comprises one or more of brand, labeler, re-packager, dietary source(s), active ingredient(s), excipient(s), inactive ingredient(s), filler(s), and combinations thereof.

18. The method of any one of claims 1-17, wherein each of the Subject Drug records includes a reaction component, one or more subject reactions, and a reaction intensity for each of the one or more subject reactions, wherein, for each Subject Drug record, the subject reactions45823018.1 32ATTORNEY DOCKET NO. IBI 100 PCTcomprise one or combinations of allergies, sensitivities, reactions, and preferences of the subject to the reaction component.

19. The method of claim 18, wherein the one or more subject reactions and the reaction intensities for the one or more subject reactions are based on the reaction of the subject to the reaction component when the reaction component has been used by the subject.

20. The method of claim 19, wherein the one or more subject reactions and the reaction intensities for the one or more subject reactions were input via the User Interface Program.

21. The method of claim 20, wherein the one or more subject reactions and the reaction intensities for the one or more subject reactions were input by the subject, by one or more service providers, or by a combination of the subject and one or more service providers.

22. The method of any one of claims 1-21, wherein the Risk Score(s) are calculated by: averaging the reaction intensity separately for each of the types of subject reactions for each of the reaction components of the Subject Drug records matched to the items of the retrieved drug information for the identified drug, and, if applicable, averaging the reaction intensity separately for each of the types of subject reactions for each of the reaction components of the Subject Drug records matched to the items of the retrieved drug information separately for each of the therapeutically related drugs,wherein the averaging is weighted based on the recency of the entry of the reaction intensity or the averaging is a straight average.

23. The method of claim 22, wherein the averaging puts less weight on the current or recent reaction intensity when the reaction intensities are decreasing over time and increased weight on the current or recent reaction intensity when the reaction intensities are increasing over time.

24. The method of any one of claims 1-23, wherein one or more of the steps and / or processes are performed by a transformer trained on drug information and reactions of patients.

25. A system comprising:(i) a User Interface Program in a first non-transitory computer- readable medium;(ii) the Subject Database in a second non-transitory computer-readable medium;(iii) the Drug Database in a third non-transitory computer-readable medium; and (iv) a Drug Analysis Program in fourth a non-transitory computer-readable medium, wherein the User Interface Program provides input from and output to the user, query generation, input from and output to the Subject Database, and input from and output to the Drug Database,45823018.1 33ATTORNEY DOCKET NO. JBJ 100 PCTwherein the Drug Analysis Program provides query handling, input from and output to the User Interface Program, input from and output to an external source of the drug information, input from and output to the Subject Database, and input from and output to the Drug Database, wherein the User Interface Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps:(a) receiving a query from a user, wherein the query identifies a drug; and(b) sending an answer to the user, wherein the answer identifies one or more matched Subject Drug records and includes a Risk Score for the identified drug,wherein the Drug Analysis Program comprises instructions that, when executed by a processor in a computer system, cause the computer system to execute steps:(a’) retrieving drug information for the identified drug from the Drug Database;(b’j matching one or more items of the retrieved drug information to one or more Subject Drug records in the Subject Database; and(c’j calculating the Risk Score for the identified drug based on the matched Subject Drug records.

26. The system of claim 25, wherein the first non-transitory computer-readable medium is comprised in a computer system having a processor, wherein the fourth non-transitory computer-readable medium is comprised in a computer system having a processor, wherein the second non-transitory computer-readable medium is comprised in a storage system, wherein the third non-transitory computer-readable medium is comprised in a storage system, wherein the computer systems can each interface with each other and with both the storage systems.

27. The system of claim 26, wherein the storage system comprising the second non-transitory computer-readable medium is comprised in the computer system comprising the first non-transitory computer-readable medium.

28. The system of claim 26 or 27, wherein the storage system comprising the third non-transitory computer-readable medium is comprised in the computer system comprising the fourth non-transitory computer-readable medium.

29. The system of claim 26 or 27, wherein the storage system comprising the third non-transitory computer-readable medium is comprised in the computer system comprising the first non-transitory computer-readable medium.

30. The system of claim 26, wherein the storage system comprising the second non-transitory computer-readable medium and the storage system comprising the third non-transitory computer-readable medium are comprised in the computer system comprising the fourth non-transitory computer-readable medium.45823018.1 34ATTORNEY DOCKET NO. JBJ 100 PCT31. The system of any one of claims 26-30,wherein the computer system comprising the first non-transitory computer-readable medium is the computer system comprising none of or any combination of the second non-transitory computer-readable medium, the third non-transitory computer-readable medium, or the fourth non-transitory computer-readable medium,wherein the computer system comprising the second non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the third non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium,wherein the computer system comprising the third non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the second non-transitory computer-readable medium, and the fourth non-transitory computer-readable medium, andwherein the computer system comprising the fourth non-transitory computer-readable medium is the computer system comprising none of or any combination of the first non-transitory computer-readable medium, the second non-transitory computer-readable medium, and the third non-transitory computer-readable medium.45823018.1 35

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