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 . A method for treatment or prevention of a medical condition comprising use of a pharmaceutical product with pharmaceutical activity against the medical condition, in combination with a computer having installed thereon a computer program product, the method comprising:
 providing, to a first patient undergoing an administration and dosing regimen with the pharmaceutical product, a first set of questions according to a first question schedule, wherein the first set of questions is specific to the pharmaceutical product;   collecting first answers to the first set of questions from the first patient;   subjecting the first answers to a first set of functions specific for the first set of questions and the pharmaceutical product, thereby generating a first patient-specific feedback information; and   providing the first patient-specific feedback information to the first patient.   
     
     
         2 . The method according to  claim 1 , further comprising:
 providing a first respondent with a second set of questions according to a second question schedule, wherein the second set of questions is specific to the pharmaceutical product;   collecting second answers to the second set of questions from the first respondent;   subjecting the second answers to a second set of functions specific for the second set of questions and the pharmaceutical product, thereby generating a second patient-specific feedback information; and   providing the second patient-specific feedback information to the first patient and the first respondent.   
     
     
         3 . The method according to  claim 1 , further comprising:
 providing the first patient with the first set of questions according to the first question schedule, wherein the first set of questions is specific to the pharmaceutical product;   collecting second answers to the first set of questions from the first patient and a first respondent;   subjecting the second answers to a set of functions specific for the first set of questions and the pharmaceutical product, thereby generating second patient-specific feedback information;   providing the second patient-specific feedback information to the first patient and the first respondent;   extracting clinically relevant information from the second answers;   providing the clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of the pharmaceutical product; and   obtaining at least one of a revised set of questions or a revised set of functions by subjecting at least one of the first set of questions or the set of functions to a review based on clinically relevant information collected during clinical use of the pharmaceutical product.   
     
     
         4 . The method according to  claim 3 , wherein the review is based on information collected from the first patient. 
     
     
         5 . The method according to  claim 3 , wherein the review is based on information collected from at least 50% of patients clinically using the pharmaceutical product in combination with the computer program product. 
     
     
         6 . The method according to  claim 3 , wherein the review is based on clinically relevant information obtained during at least one of clinical trials of the pharmaceutical product or commercial use of the pharmaceutical product. 
     
     
         7 . (canceled) 
     
     
         8 . The method according to  claim 1 , wherein a clinical relevance of a combination of the first set of questions and the first set of functions has been validated in clinical trials. 
     
     
         9 . The method according to  claim 1 , wherein the first set of questions and the first set of functions are related to patient compliance to at least one of a preferred dosage, a prescribed dosage, or an administration regimen of the pharmaceutical product. 
     
     
         10 . The method according to  claim 1 , wherein the first set of questions and the first set of functions are related to an indication of possible occurrence or development of at least one of an adverse event or a side effect. 
     
     
         11 . The method according to  claim 1 , wherein the first set of questions and the first set of functions are related to a quality of life of the first patient. 
     
     
         12 . The method according to  claim 1 , wherein at least a subset of the first set of questions is related to at least one of an actual administration, an actual dosage, a perceived therapeutic effect, a measured therapeutic effect, test results, or a perceived quality of life. 
     
     
         13 . The method according to  claim 1 , further comprising:
 subjecting the first answers to a set of functions specific for the first set of questions and the pharmaceutical product, thereby generating an updated question schedule, wherein the set of functions use at least one of Computer Adaptive Testing or Item Response Theory.   
     
     
         14 . (canceled) 
     
     
         15 . The method according to  claim 1 , wherein the first set of functions include at least one function selected from the group consisting of calculations of target parameters and trend lines, prediction of development of a condition, and rules and thresholds for defining when to give notifications. 
     
     
         16 . The method according to  claim 1 , wherein the computer program product comprises instructions causing a computer to provide feedback comprising at least one of a selected from graph, a diagram, a graphical illustration, or a text message. 
     
     
         17 . The method according to  claim 1 , wherein the method provides feedback only to the first patient, or to the first patient and to other individuals. 
     
     
         18 . (canceled) 
     
     
         19 . The kit according to  claim 22 , 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. 
     
     
         20 . The method according to  claim 1 , wherein the pharmaceutical product is selected from the group consisting of Aripiprazol, Rimonabant, Pioglitazon, glucoseamine, Octocog alfa, Flutikason in combination with Salmeterol, zolpidem, Insulin glulisin, Donepezil, irbesartan, rosiglitazone, metformin in combination with rosiglitazone, glimepiride in combination with rosiglitazone, bevacizumab, Interferon beta, Darbepoetin alfa, anastrozole, Kandesartan, olmesartan, Interferon beta-lb, Interferon beta, exenatide, Bikalutamid, Celecoxib, Escitalopram, duloxetine, Vareniklin, Glatiramer, Carvedilol, Losartan, Rosuvastatin, Ramipril, Valsartan, Venlafaxin, oxaliplatin, Etanercept, raloxifene, ezetimibe, Tamsulosin, fluticasone, Alendronic acid, Gemcitabine, imatinib mesylate, Trastuzumab, insulin lispro, Adalimumab, Lopinavir/ritonavir, Sumatriptan, Sitagliptin, insulin glargin, Fenofibrate, atorvastatin, Insulin Detemir, amlodipine and benazepril, Leuprorelin, pregabalin, rituximab, Telmisartan, Esomeprazole, amlodipine, insulin aspart, repaglinid, Rabeprazole, paroxetine, Pantoprazole, Clopidogrel, pravastatin, Epoetin Alfa, takrolimus, budesonid, interferon beta-la, sibutramin, Infliximab, Risperidon, Metoprolol, quetiapine, Tiotropium, budesonide and formoterol, Montelukast, Docetaxel, Topiramat, Emtricitabin and Tenofovirdisoproxil, ezetimibe and simvastatin, bupropion, Betametason in combination with Kalcipotriol calcipotriene, simvastatin, Sertralin, zoledronic acid, Olanzapin, cetirizine, and ticagrelor. 
     
     
         21 . The method according to  claim 1 , further comprising:
 extracting clinically relevant information from the first answers; and   providing the clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of the pharmaceutical product.   
     
     
         22 . A kit of parts comprising:
 a pharmaceutical product; and   a computer program product comprising instructions causing a computer to:
 provide, to a first patient undergoing an administration and dosing regimen with a pharmaceutical product, a first set of questions according to a question schedule, wherein the first set of questions is specific to the pharmaceutical product; 
 collect first answers to the first set of questions from the first patient; 
 subject the first answers to a first set of functions specific for the first set of questions and the pharmaceutical product, thereby generating a first patient-specific feedback information; and 
 provide the first patient-specific feedback information to the first patient. 
   
     
     
         23 . The kit according to  claim 22 , wherein the computer program product further comprises instructions causing the computer to:
 provide a first respondent with a second set of questions according to a second question schedule, wherein the second set of questions is specific to the pharmaceutical product;   collect answers to the second set of questions from the first respondent;   subject the answers to a second set of functions specific for the second set of questions and the pharmaceutical product, thereby generating a second patient-specific feedback information; and   provide the second patient-specific feedback information to the first patient and the first respondent.   
     
     
         24 . The kit according to  claim 22 , wherein the 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. 
     
     
         25 . A computer comprising:
 at least one processor; and   at least one memory comprising instructions that, when executed by the at least one processor, cause the computer to:
 provide, to a first patient undergoing an administration and dosing regimen with a pharmaceutical product, a first set of questions according to a question schedule, wherein the first set of questions is specific to the pharmaceutical product; 
 collect first answers to the first set of questions from the first patient; 
 subject the first answers to a first set of functions specific for the first set of questions and the pharmaceutical product, thereby generating a first patient-specific feedback information; and 
 provide the first patient-specific feedback information to the first patient.