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PHARMACEUTICAL INFORMATIONS ON THE WEB

PHARMACEUTICAL INFORMATIONS ON THE WEB. ZAJZON, Gergely Dr. Med. HOW TO START SEARCH?. www.google.com „Viagra” – 68.200.000 hits „Aspirin” – 15.000.000 hits Is it all relevant information?. KEYWORDS FOR DRUGS. Tradename / brand name Active ingredient ATC code

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PHARMACEUTICAL INFORMATIONS ON THE WEB

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  1. PHARMACEUTICAL INFORMATIONS ON THE WEB ZAJZON, Gergely Dr. Med.

  2. HOW TO START SEARCH? www.google.com • „Viagra” – 68.200.000 hits • „Aspirin” – 15.000.000 hits • Is it all relevant information? PHARMACEUTICAL INFORMATIONS ON THE WEB

  3. KEYWORDS FOR DRUGS • Tradename / brand name • Active ingredient • ATC code • Disease: indication, contraindication PHARMACEUTICAL INFORMATIONS ON THE WEB

  4. Trade / Brand name • „phantasy” name given by the company • Eg.: • Aspirin • Viagra • .... PHARMACEUTICAL INFORMATIONS ON THE WEB

  5. Active substance • INN: enalapril • Enalapril maleat • Chemical name: (2S)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}propanoyl]pyrrolidine-2-carboxylic acid • Form: C20H28N2O5 PHARMACEUTICAL INFORMATIONS ON THE WEB

  6. INN • International Non-proprietary Name • WHO database of active substances • Was started in 1953 • Currently around 7000 substances • ACE-inhibitor names ends with PRIL: • eg.: enalaPRIL, captoPRIL • SARTAN – AT-II-inhibitors: • Eg.: candeSARTAN, loSARTAN PHARMACEUTICAL INFORMATIONS ON THE WEB

  7. ATC classification system ATC: acronym • Anatomy • Therapy • Chemie • Classification of active drug substances into anatomic organ groups, ordered by therapeutical effects and chemical entities. PHARMACEUTICAL INFORMATIONS ON THE WEB

  8. What can we use ATC for? • ATC 7 = „equivalent”* medicinal products, having the same active ingredients, which are usually replacable with eachother. • (* In Hungary products can be replaced, only if the National Institute of Pharmacy (NIP) certifies them to be bioequivalent.)Eg.: staying abroad knowing the ATC code it is easier to find the drug you need. PHARMACEUTICAL INFORMATIONS ON THE WEB

  9. What can we use ATC for? • The more equal level two product has, the more „similar” they are • Marketing: level 4 ATC groups used for getting information on competitor products • Competitor product: a product from the same therapeutic group with the same or a similar active ingredient. A product which might be used for the same indication. PHARMACEUTICAL INFORMATIONS ON THE WEB

  10. What can we use ATC for? • For defining pricing and reimbursement rules • For Pharmaceutical Utilisation purposes: how many drug was used in this theraputic group? PHARMACEUTICAL INFORMATIONS ON THE WEB

  11. Official ATC/DDD site: http://whocc.no PHARMACEUTICAL INFORMATIONS ON THE WEB

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  13. ATC classification system • Human ATC code has 7 characters, but 5 levels: • Anatomical classification1. level: ATC1 (1. char – string) • Therapeutical classification 2. level: ATC2 (2-3.char – numbers) 3. level: ATC3 (4. char – string) 4. level: ATC4 (5. char – string) • Chemical classification 5. level: ATC5 (6-7.char – numbers) PHARMACEUTICAL INFORMATIONS ON THE WEB

  14. ATC classification system • ATC code has not only human, but also a veterinary use • ATC vet:8 character code1 letter is alwasy Q – the following 7 characters are same, as in the human use • Eg.: ketamin N01AX – human use QN01AX – veterinary use PHARMACEUTICAL INFORMATIONS ON THE WEB

  15. RENITEC 10 mg tablets INN: enalapril • ATC1: C Cardiovascular effect ATC2: C09 Renin-angiotensin syst. • ATC3: C09A ACE inhib. (alone) • ATC4: C09A A ACE inhib. (alone) • ATC5: C09A A02 enalapril PHARMACEUTICAL INFORMATIONS ON THE WEB

  16. CO-RENITEC tablets INN: enalapril + hydrochlorothiazid • ATC1: C Cardiovascular effect • ATC2: C09 Renin-angiotensin syst. • ATC3: C09B ACE inhib. (comb.) • ATC4: C09BA ACE gátlók (with diuretics) • ATC5: C09B A02 enalapril + diuretics PHARMACEUTICAL INFORMATIONS ON THE WEB

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  25. ATC –anatomical classification • A- ALIMENTARY TRACT AND METABOLISM • B - BLOOD AND BLOOD FORMING ORGANS • C - CARDIOVASCULAR SYSTEM • D – DERMATOLOGICALS • G - GENITO URINARY SYSTEM AND SEX HORMONES PHARMACEUTICAL INFORMATIONS ON THE WEB

  26. ATC –anatomical classification • H - SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS • J (I) - ANTIINFECTIVES FOR SYSTEMIC USE • L* - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS • M - MUSCULO-SKELETAL SYSTEM • N - NERVOUS SYSTEM PHARMACEUTICAL INFORMATIONS ON THE WEB

  27. ATC –anatomical classification • P - ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS • R - RESPIRATORY SYSTEM • S - SENSORY ORGANS • V - VARIOUS PHARMACEUTICAL INFORMATIONS ON THE WEB

  28. DDD • DDD: Defined Daily Dose • Avarage daily dose of an active substnce in the main indication use • WHO orders a defined daily dose to each ATC code, grouped by route of administration • WHO defined DDDs might differ from dosages given in the nationally improved SPCs. PHARMACEUTICAL INFORMATIONS ON THE WEB

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  30. DDD Dependent on the way of dosage : • INHAL = inhalation (inhalator) • N = nasal (nasal drop) • O =oral (tablet, capsule) • P = parenteral (injection, infusion), • SL= sublingual/buccal (subling. spray) • TD = transdermal (TD patch) • R = rectal (r. suppository) • V= vaginal (v. cream / tablet) PHARMACEUTICAL INFORMATIONS ON THE WEB

  31. DDD • Example:enalapril ATC: C09A A02 O: 10 mg (oral) Renitec 10 mg tablets P: 10 mg (parenteral) Renitec 1 mg/ml inj. inf. PHARMACEUTICAL INFORMATIONS ON THE WEB

  32. Renitec tablets (SPC 4.2) • Essential hypertonia • Starting dose is between 10 to 20 mg, which has to be taken once a day. • … • Maximal dosage: 40 mg (Source: SPC approved by NIP Hungary) PHARMACEUTICAL INFORMATIONS ON THE WEB

  33. WHERE TO FIND APPROPRIATE, RELEVANT DRUG INFORMATION? PHARMACEUTICAL INFORMATIONS ON THE WEB

  34. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT PHARMACEUTICAL INFORMATIONS ON THE WEB

  35. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • R&D = Research & Development – searching for new active substances, new indications, new dosage forms • Preclinical trials: in vitro / in vivo in animals • Clininical trials: trying out the dosage / effects on human • IF THESE STEPS ARE FINISHED, CAN IT BE DIRECTLY MARKETED? PHARMACEUTICAL INFORMATIONS ON THE WEB

  36. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • Getting a Marketing Authorization… • National Competent Authorities or European Medicines Agency can do certificating: • after checking the informations given by the company regarding Quality (chemical dossier) / Efficacy and Safety (preclinical and clinical dossier) PHARMACEUTICAL INFORMATIONS ON THE WEB

  37. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • Getting a Marketing Authorization… • The National Competent Authority in Hungary is the National Institute of Pharmacy (Országos Gyógyszerészeti Intézet – OGYI) PHARMACEUTICAL INFORMATIONS ON THE WEB

  38. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • After having a Marketing Authorization… • Price and reimbursement of the product has to be defined: • National Health Insurance Fund = OEP, they take care of the reimbursement of the product. PHARMACEUTICAL INFORMATIONS ON THE WEB

  39. WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • FACTORY • WHOLESALER • PHARMACY • Public Pharmacy / Hospital • PATIENT PHARMACEUTICAL INFORMATIONS ON THE WEB

  40. PHARMACEUTICAL LEGISLATIONS • OGYI (NIP) website • Eudralex PHARMACEUTICAL INFORMATIONS ON THE WEB

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  42. PHARMACEUTICAL LEGISLATIONS • Hungarian legislations • Can be found easily on the OGYI website • Regularly updated, consolidated informations • Source: a CompLexhungarian legal database • Available only in Hungarian language PHARMACEUTICAL INFORMATIONS ON THE WEB

  43. PHARMACEUTICAL LEGISLATION • EU legislations: • http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/ PHARMACEUTICAL INFORMATIONS ON THE WEB

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