PHARMACEUTICAL PRODUCT AND COMMUNICATION TOOL

• US 20150193597A1
• Filed: 07/12/2013
• Published: 07/09/2015
• Est. Priority Date: 07/24/2012
• Status: Abandoned Application

• Current Assignee: ScientificMed Sweden AB
• Original Assignee: ScientificMed Sweden AB
• Inventors: Cederlund, Johan
• Application Number:
  US14/417,371
• Publication Number:
  US 20150193597A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G16C 20/90 Programming languages; Computing architectures; Database systems; Data warehousing
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A substance with pharmaceutical activity against a medical condition for use in a treatment of the medical condition in combination with a computer program product including instructions causing a computer to perform a method including:

• • providing a patient with a set of questions according to a question schedule, wherein the set of questions is adapted to the pharmaceutical product;
  • collecting answers to the questions from the patient;
  • subjecting the answers to a set of functions adapted for the set of questions and the pharmaceutical product thereby generating patient-specific feedback information;
  • providing the feedback information to the patient; and extracting information from the answers and providing the information to a database adapted to collect information during clinical use of the substance, and store a multitude of relevant information.

Claims

1. 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 adapted to the pharmaceutical product;

collecting answers to said questions from said patient;

subjecting said answers to a set of functions adapted for the set of questions and the pharmaceutical product thereby generating patient-specific feedback information;

providing said feedback information to the patient; and

extracting information from said answers and providing said information to a database adapted for collecting information during clinical use of said substance, wherein said database is adapted to store information comprising one or more of;

patient identifier, respondent identifier, individual caregiver identifier, organizational caregiver identifier, substance identifier, substance combination identifier, respondent answers, type and date of occurrence of adverse events, type and degree of adverse effects of one or more substance or substance combination, probability of an adverse event, probability of an adverse effect, patient health status, patient history, patient family history, patient genetic information, prescribed dosage or administration regimen, drug-drug interactions, life style factors.

2. Substance according to claim 1, wherein the computer program product comprises instructions causing a computer to perform a method comprising the steps

providing at least one further respondent in addition to said patient with a second set of questions according to a second question schedule, wherein said second set of questions is adapted to the pharmaceutical product;

collecting answers to said questions from said further respondent;

subjecting said answers from said further respondent to a second set of functions adapted for the second set of questions and the pharmaceutical product thereby generating patient-specific feedback information;

providing said feedback information to the patient and, optionally, to the further respondent; and

extracting information from said answers from said further respondent and providing said information to a database adapted for collecting information during clinical use of said substance, wherein said database is adapted to store information comprising one or more of;

patient identifier, respondent identifier, individual caregiver identifier, organizational caregiver identifier, substance identifier, substance combination identifier, respondent answers, type and date of occurrence of adverse events, type and degree of adverse effects of one or more substance or substance combination, probability of an adverse event, probability of an adverse effect, patient health status, patient history, patient family history, patient genetic information, prescribed dosage or administration regimen.

3. Substance according to claim 1, wherein the computer program product comprising instructions causes a computer to perform a method comprising the steps

a) providing a patient and optionally a further respondent with sets of questions according to a question schedule, wherein said sets of questions are adapted to the pharmaceutical product;

b) collecting answers to said questions from said patient and optionally said further respondent;

c) subjecting said answers to a set of functions adapted for the sets of questions and the pharmaceutical product thereby generating patient-specific feedback information;

d) providing said feedback information to the patient and optionally to the further respondent;

e) extracting information from said answers and providing said information to said database adapted for collecting information during clinical use of said substance;

f) providing information stored in said database to a reviser subjecting the sets of questions and/or the sets of functions to a revision based on said information stored in said database;

g) obtaining a revised set of questions and/or a revised set of functions from said reviser; and

h) repeating steps a)-g).

4. Substance according to claim 1, wherein said database is adapted for storing information collected from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using said combination of substances in combination with said computer program product.

5. Substance according to claim 3, wherein said revision is based on information collected from said patient and/or other patients clinically using said combination of substances in combination with said computer program product.

6. Substance according to claim 3, wherein said revision is based on information obtained during clinical trials of the substance and/or commercial use of the substance.

7. Substance according to claim 1, wherein said database is adapted to store information comprising two, five, ten, fifteen, or more of:

patient identifier, respondent identifier, individual caregiver identifier, organizational caregiver identifier, substance identifier, substance combination identifier, respondent answers, type and date of occurrence of adverse events, type and degree of adverse effects of one or more substance or substance combination, probability of an adverse event, probability of an adverse effect, patient health status, patient history, patient family history, patient genetic information, prescribed dosage or administration regimen, drug-drug interactions, life style factors.

8. A substance according to claim 1, wherein the clinical relevance of the combination of said set of questions and said set of functions has been validated in clinical trials.

9. A substance 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.

10. A substance according to claim 1, wherein 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.

11. A substance according to claim 1, wherein said set of questions and said set of functions are related to the patient'"'"'s quality of life.

12. A substance 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.

13. A substance according to claim 1, wherein the method further comprises subjecting said answers to a set of functions adapted for the set of questions and the pharmaceutical product thereby generating an updated question schedule, wherein said set of functions optionally use Computer Adaptive Testing and/or Item Response Theory.

14. A substance according to claim 1, wherein said set of functions include functions selected from the group consisting of:

calculations of target parameters and trend lines;

prediction of development of a condition;

rules and thresholds for defining when to give notifications.

15. A substance according to claim 1, wherein said computer program product comprises instructions causing a computer to provide feedback selected from graphs, diagrams, graphical illustrations and text messages.

16. A substance according to claim 1, wherein said method provides feedback only to the patient, or to the patient and to other individuals.

17. A substance 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.

18. A kit of parts comprising a substance and a computer program product according to claim 17, 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.

19. A substance according to claim 1, wherein said substance is selected from the group consisting of Aripiprazol (Abilify), Rimonabant (Acomplia), Pioglitazon (Actos), glucoseamine (Glucosine), Octocog alfa (Adnate, Advair), Flutikason in combination with Salmeterol (Seretide), zolpidem (Ambien, Stilnox), Insulin glulisin (Apidra), Donepezil (Aricept), irbesartan (Avapro, Aprovel), rosiglitazone (Avandia), metformin in combination with rosiglitazone (Avandamet), glimepiride in combination with rosiglitazone (Avandaryl), bevacizumab (Avastin), Interferon beta (Avonex), Darbepoetin alfa (Aranesp), anastrozole (Arimidex), Kandesartan (Atacand), olmesartan (Benicar, Olmetec), Interferon beta-lb (Betaseron), Interferon beta (Betaferon), exenatide (Byetta), Bikalutamid (Casodex), Celecoxib (Celebrex, Celebra), Escitalopram (Cipralex/Lexapro), duloxetine (Cymbalta), Vareniklin (Champix), Glatiramer (Copaxone), Carvedilol (Coreg), Losartan (Cozaar), Rosuvastatin (Crestor), Ramipril (Tritace), Valsartan (Diovan), Venlafaxin (Efexor), oxaliplatin (Eloxatin), Etanercept (Enbrel), raloxifene (Evista), ezetimibe (Ezetrol, Zetia), Tamsulosin (Flomax, Flomaxtra, Urimax), fluticasone (Flovent, Flixotide), Alendronic acid (Fosamax), Gemcitabine (Gemzar), imatinib mesylate (Gleevec, Glivec), Trastuzumab (Herceptin), insulin lispro (Humalog), Adalimumab (Humira), Lopinavir/ritonavir (Kaletra), Sumatriptan (Imitrex, Imigran), Sitagliptin (Januvia), insulin glargin (Lantus), Fenofibrate (Lipanthyl, TriCor), atorvastatin (Lipitor), Insulin Detemir (Levemir), amlodipine and benazepril (Lotrel), Leuprorelin, (Lupron, Leuplin), pregabalin (Lyrica), rituximab (Mabthera, Rituxan), Telmisartan (Micardis), Esomeprazole (Nexium), amlodipine (Norvasc), insulin aspart (NovoLog, NovoMix, NovoRapid), repaglinid (NovoNorm), Rabeprazole (Pariet), paroxetine (Paxil, Seroxat), Pantoprazole (Protonix, Pantozol, Pantoloc), Clopidogrel (Plavix), pravastatin (Pravachol), Epoetin Alfa (Procrit, Eprex), takrolimus (Protopic), budesonid (Pulmicort), interferon beta-1a (Rebif), sibutramin (Reductil), Infliximab (Remicade), Risperidon (Risperdal), Metoprolol (Seloken, Toprol), quetiapine (Seroquel), Tiotropium (Spiriva), budesonide and formoterol (Symbicort), Montelukast (Singulair), Docetaxel (Taxotere), Topiramat (Topamax), Emtricitabin and Tenofovirdisoproxil (Truvada), ezetimibe and simvastatin (Vytorin), bupropion (Wellbutrin), Betametason in combination with Kalcipotriol (Xamiol) calcipotriene (Taclonex), simvastatin (Zocor), Sertralin (Zoloft), zoledronic acid (Zometa), Olanzapin (Zyprexa), cetirizine (Zyrtec), ticagrelor (Brilique).

20. The computer program product of claim 1.

21. The method of claim 1.