Pharmaceutical product and communication tool

Abstract

The present invention relates to a substance with pharmaceutical activity against a medical condition for use in a treatment of said medical condition in combination with a computer program product comprising instructions causing a computer to perform a method comprising the steps providing a patient with a set of questions according to a question schedule, wherein said set of questions is specific to the pharmaceutical product; collecting answers to said questions from said patient; subjecting said answers to a set of functions specific for the set of questions and the pharmaceutical product thereby generating patient specific feedback information; providing said feedback information to the patient; and optionally extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of said substance. The invention further relates to a corresponding kit-of-parts comprising the substance and the computer program product, and the computer program product and its method as such.

1 . Method for treatment or prevention of Acute Coronary Syndrome comprising the use of ticagrelor in combination with a computer program product comprising instructions causing a computer to perform a method comprising the steps
 providing a patient with a set of questions according to a question schedule, wherein said set of questions is specific to ticagrelor;   collecting answers to said questions from said patient;   subjecting said answers to a set of functions specific for the set of questions and ticagrelor thereby generating patient-specific feedback information;   providing said feedback information to the patient.   
     
     
         2 . The method according to  claim 1 , further comprising extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of said substance. 
     
     
         3 . The method according to  claim 1 , wherein the computer program product comprises instructions causing a computer to perform a method comprising the steps
 h) providing a patient and optionally a further respondent with sets of questions according to a question schedule, wherein said sets of questions are specific for ticagrelor;   i) collecting answers to said questions from said patient and optionally said further respondent;   j) subjecting said answers to a set of functions specific for the sets of questions and the pharmaceutical product thereby generating patient-specific feedback information;   k) providing said feedback information to the patient and optionally to the further respondent;   l) extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of ticagrelor;   m) obtaining a revised set of questions and/or a revised set of functions by subjecting the sets of questions and/or the sets of functions to a review based on clinically relevant information collected during clinical use of ticagrelor; and   n) repeating steps a)-f) for the duration of said treatment.   
     
     
         4 . The method according to  claim 3 , wherein said review is based on information collected from the patient. 
     
     
         5 . The method according to  claim 3 , wherein said review is based on information collected from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using ticagrelor in combination with said computer program product. 
     
     
         6 . The method according to  claim 1 , wherein said review is based on clinically relevant information obtained during clinical trials of the substance and/or commercial use of ticagrelor. 
     
     
         7 . The method according to  claim 1 , wherein the clinical relevance of the combination of ticagrelor, said set of questions and said set of functions has been validated in clinical trials. 
     
     
         8 . The method according to  claim 1 , wherein said set of questions and said set of functions are related to patient compliance to a preferred or prescribed dosage and/or administration regimen of said pharmaceutical product. 
     
     
         9 . The method according to  claim 1 , wherein at least a subset of said set of questions and said set of functions are related to an indication of possible occurrence or development of an adverse event and/or side effect. 
     
     
         10 . The method according to  claim 1 , wherein at least a subset of said set of questions and said set of functions are related to the patient's quality of life. 
     
     
         11 . The method according to  claim 1 , wherein at least a subset of the set of questions is related to the actual administration; actual dosage; perceived and/or measured therapeutic effects; test results and/or perceived quality of life. 
     
     
         12 . A method according to  claim 1 , wherein the method further comprises subjecting said answers to a set of functions specific for the set of questions and ticagrelor thereby generating an updated question schedule, wherein said set of functions optionally use Computer Adaptive Testing and/or Item Response Theory. 
     
     
         13 . The method according to  claim 1 , wherein said set of functions include functions selected from the group consisting of: calculations of target parameters, threshold values and trend lines; prediction of development of a condition; rules and thresholds for defining when to give notifications. 
     
     
         14 . The method according to  claim 1 , wherein said computer program product comprises instructions causing a computer to provide feedback selected from graphs, diagrams, graphical illustrations, such as traffic light type color signals, and text messages. 
     
     
         15 . The method according to  claim 1 , wherein said method provides feedback only to the patient, or to the patient and to other individuals. 
     
     
         16 . The method according to  claim 1 , wherein said computer program product is provided on a physical medium or by means or instructions for accessing and installing the computer program product on a computer. 
     
     
         17 . The method according to  claim 1 , wherein the set of questions comprises at least one question relating to the patient's intake of ticagrelor, subjecting the answer to a set of functions generating patient-specific feedback on the adherence to the prescribed ticagrelor dosage regimen, and providing the generated patient-specific feedback to the patient. 
     
     
         18 . The method according to  claim 17 , wherein the patient-specific feedback on adherence comprises a color signal. 
     
     
         19 . The method according to  claim 17 , wherein the patient-specific feedback on adherence comprises a graph. 
     
     
         20 . The method according to  claim 17 , wherein the patient-specific feedback on adherence comprises information about the patient's adherence to the prescribed ticagrelor dosage regimen for the past seven days. 
     
     
         21 . The method according to  claim 17 , wherein the patient-specific feedback on adherence comprises a text message. 
     
     
         22 . The method according to  claim 17 , wherein the patient-specific feedback on adherence comprises a numerical value representing the relation between the number of actual ticagrelor doses taken and the prescribed number of ticagrelor doses in a time interval. 
     
     
         23 . The method according to  claim 1 , wherein the set of questions further comprise questions relating to at least one of: level of physical activity; weight; smoking habits; blood levels of cholesterol, lipids and/or LDL; blood levels of glucose and/or HbA1c; blood pressure. 
     
     
         24 . The method according to  claim 1 , wherein adherence to ticagrelor treatment is improved. 
     
     
         25 . The method according to  claim 1 , wherein the patient has an increased likelihood of lowering his or her Body Mass Index. 
     
     
         26 . The method according to  claim 1 , wherein the patient has an increased likelihood of increasing his or her level of physical activity. 
     
     
         27 . The method according to  claim 1 , wherein the patient's blood levels of LDL are lowered. 
     
     
         28 . The method according to  claim 1 , wherein the patient has an increased likelihood of smoking cessation. 
     
     
         29 . The method according to  claim 1 , wherein the patient's quality of life is improved. 
     
     
         30 . Method for reducing patient mortality during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         31 . Method for improving patient adherence to a prescribed ticagrelor dosage regimen during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         32 . Method for reducing Body Mass Index of a patient during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         33 . Method according to  claim 33 , wherein said patient has a Body Mass Index>30 before start of the ticagrelor treatment. 
     
     
         34 . Method for aiding a patient to quit smoking during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         35 . Method for enhancing patient assessed quality of life during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         36 . Method for lowering blood levels of Low Density Lipoprotein (LDL) in a patient during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         37 . Method for increasing physical activity in a patient population during ticagrelor treatment, comprising a method according to  claim 1 . 
     
     
         38 . The computer program product of  claim 1 . 
     
     
         39 . A kit of parts comprising
 a) ticagrelor; and   b) the computer program product according to  claim 1 .   
     
     
         40 . A kit according to  claim 39 , wherein said computer program product is provided on a physical medium or by means or instructions for accessing and installing the computer program product on a computer. 
     
     
         41 . A kit according to  claim 39 , wherein said computer program product is provided by means or instructions for accessing and installing the computer program product on a computer. 
     
     
         42 . A kit according to  claim 39 , wherein said computer program product is provided by means or instructions for accessing and installing the computer program product on a computer and said kit further comprises an identifier unique to the kit