PHARMACEUTICAL INFORMATIONS ON THE WEB ZAJZON, Gergely Dr. Med.
HOW TO START SEARCH? www. google. com • „Viagra” – 68. 200. 000 hits • „Aspirin” – 15. 000 hits • Is it all relevant information? PHARMACEUTICAL INFORMATIONS ON THE WEB 2
KEYWORDS FOR DRUGS • • Tradename / brand name Active ingredient ATC code Disease: indication, contraindication PHARMACEUTICAL INFORMATIONS ON THE WEB 3
Trade / Brand name • „phantasy” name given by the company • Eg. : – Aspirin – Viagra –. . PHARMACEUTICAL INFORMATIONS ON THE WEB 4
Active substance • INN: enalapril • Enalapril maleat • Chemical name: (2 S)-1 -[(2 S)-2 -{[(2 S)-1 -ethoxy-1 -oxo-4 phenylbutan-2 -yl]amino}propanoyl]pyrrolidine-2 carboxylic acid • Form: C 20 H 28 N 2 O 5 PHARMACEUTICAL INFORMATIONS ON THE WEB 5
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. : enala. PRIL, capto. PRIL SARTAN – AT-II-inhibitors: Eg. : cande. SARTAN, lo. SARTAN PHARMACEUTICAL INFORMATIONS ON THE WEB 6
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 7
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 8
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 9
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 10
Official ATC/DDD site: http: //whocc. no PHARMACEUTICAL INFORMATIONS ON THE WEB 11
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ATC classification system • Human ATC code has 7 characters, but 5 levels: • Anatomical classification 1. level: ATC 1 (1. char – string) • Therapeutical classification 2. level: ATC 2 (2 -3. char – numbers) 3. level: ATC 3 (4. char – string) 4. level: ATC 4 (5. char – string) • Chemical classification 5. level: ATC 5 (6 -7. char – numbers) PHARMACEUTICAL INFORMATIONS ON THE WEB 13
ATC classification system • ATC code has not only human, but also a veterinary use • ATC vet: 8 character code 1 letter is alwasy Q – the following 7 characters are same, as in the human use • Eg. : ketamin N 01 AX – human use QN 01 AX – veterinary use PHARMACEUTICAL INFORMATIONS ON THE WEB 14
RENITEC 10 mg tablets INN: enalapril • ATC 1: C Cardiovascular effect ATC 2: C 09 Renin-angiotensin syst. • ATC 3: C 09 A ACE inhib. (alone) • ATC 4: C 09 A A ACE inhib. (alone) • ATC 5: C 09 A A 02 enalapril PHARMACEUTICAL INFORMATIONS ON THE WEB 15
CO-RENITEC tablets INN: enalapril + hydrochlorothiazid • ATC 1: C Cardiovascular effect • ATC 2: C 09 Renin-angiotensin syst. • ATC 3: C 09 B ACE inhib. (comb. ) • ATC 4: C 09 BA ACE gátlók (with diuretics) • ATC 5: C 09 B A 02 enalapril + diuretics PHARMACEUTICAL INFORMATIONS ON THE WEB 16
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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 25
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 26
ATC –anatomical classification • P - ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS • R - RESPIRATORY SYSTEM • S - SENSORY ORGANS • V - VARIOUS PHARMACEUTICAL INFORMATIONS ON THE WEB 27
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 28
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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 30
DDD • Example: enalapril ATC: C 09 A A 02 O: 10 mg (oral) Renitec 10 mg tablets P: 10 mg (parenteral) Renitec 1 mg/ml inj. inf. PHARMACEUTICAL INFORMATIONS ON THE WEB 31
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 32
WHERE TO FIND APPROPRIATE, RELEVANT DRUG INFORMATION? PHARMACEUTICAL INFORMATIONS ON THE WEB 33
WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT PHARMACEUTICAL INFORMATIONS ON THE WEB 34
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 35
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 36
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) – UK is the MHRA: Medicines and Healthcare Products Regulatory – mhra. gov. uk PHARMACEUTICAL INFORMATIONS ON THE WEB 37
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: – In HU by National Health Insurance Fund = OEP – In UK by NICE (National Institute for Health and Care Excellence) and NHS (National Health Service) they take care of the reimbursement of the product. PHARMACEUTICAL INFORMATIONS ON THE WEB 38
WAY OF THE DRUG FROM THE FACTORY TO THE PATIENT • • • FACTORY WHOLESALER PHARMACY Public Pharmacy / Hospital PATIENT PHARMACEUTICAL INFORMATIONS ON THE WEB 39
PHARMACEUTICAL LEGISLATIONS • OGYI (NIP) website • Eudralex PHARMACEUTICAL INFORMATIONS ON THE WEB 40
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PHARMACEUTICAL LEGISLATIONS • Hungarian legislations – Can be found easily on the OGYI website – Regularly updated, consolidated informations – Source: a Comp. Lex hungarian legal database – Available only in Hungarian language PHARMACEUTICAL INFORMATIONS ON THE WEB 42
PHARMACEUTICAL LEGISLATION • EU legislations: – http: //ec. europa. eu/enterprise/pharmaceutical s/eudralex/ PHARMACEUTICAL INFORMATIONS ON THE WEB 43
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PHARMACEUTICAL DATABASES, PRODUCT LISTS • • OGYI (NIP website) EMC – UK Eudra. Pharm database OEP lists PHARMACEUTICAL INFORMATIONS ON THE WEB 51
• Sm. PC vagy SPC (Summary of Product. Characteristics): attachment of the Marketing Authorization, including detailed information for doctors and pharmacists, like indications, contraindicstions, dosage, etc. PHARMACEUTICAL INFORMATIONS ON THE WEB 52
• PIL (Patient Information Leaflet): attachment of the Marketing Authorization, including „easily understandable” information for the patients. PHARMACEUTICAL INFORMATIONS ON THE WEB 53
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www. medicines. org. uk PHARMACEUTICAL INFORMATIONS ON THE WEB 55
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Eudrapharm Main purpose: To include all medicinal products approved in the Eurpean Union, both for human and veterinar use. Jogszabályi alap: Legislaton background: (EC) 726/2004 Regulation PHARMACEUTICAL INFORMATIONS ON THE WEB 57
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PHARMACEUTICAL DATABASES, PRODUCT LISTS • OGYI (NIP website) • Eudra. Pharm database • OEP lists PHARMACEUTICAL INFORMATIONS ON THE WEB 68
OEP lists • • • Országos Egészségbiztosítási Pénztár Hungarian Health Insurance Fund Price and reimbursement information in Hungary • Supporting the prescription of economic („cheaper”) medicines in Hungary PHARMACEUTICAL INFORMATIONS ON THE WEB 69
PRICE AND REIMBURSEMENT • • • 1000 HUF FACTORY Factory Price WHOLESALER Wholesaler Price 1200 HUF PHARMACY Public Trade Price Public Pharmacy / Hospital - Reimbursement PATIENT Price Paid by the Patient 1400 HUF 800 HUF 600 HUF PHARMACEUTICAL INFORMATIONS ON THE WEB 70
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Pu. PHA • • • PUblic PHArma Core Information Price and reimbursement information Downloadable from the website of OEP Purpose: giving actual price information for pharmacies PHARMACEUTICAL INFORMATIONS ON THE WEB 72
Pu. PHA Purpose: • giving actual price information for pharmacies (pharmacy system administartors) • Giving up to date information on drugs for health experts (doctors, pharmacists, etc. ) and for patients PHARMACEUTICAL INFORMATIONS ON THE WEB 73
Pu. PHA Informations: • Basic Product Info: name, Mark. Auth. Number, active ingredient, ATC code, dosage form • Price Info: Factory / Wholesaler / Public • Prescription / Reimbursement Information • Calculated Info: Daily Therapy Price (NTK), WHO DDD PHARMACEUTICAL INFORMATIONS ON THE WEB 74
Buying pharmaceutical products online PHARMACEUTICAL INFORMATIONS ON THE WEB 75
According to the legislations in Hungary it is not allowed to trade with medicinal products online, these products can only be sold at pharmacies. In more and more countries, for example in the US, Canada and the United Kingdom, patients are able to buy their drugs from the web. As the internet and cargo trade can easily cross borders, we also have to take care of this illegal form of pharmaceutical trade in Hungary. PHARMACEUTICAL INFORMATIONS ON THE WEB 76
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In the UK the Ministry of Healthcare started an experimtal programme, that allowed the pharmacies to accept electronic prescription requests and deliver the products to the patients. The online trade of OTC products is already allowed at the UK. In the following period pharmacies will have the possiblity to give their usual medicines for the patients suffering from chronic disease without new prescrption, that means that patients do not have visit their doctors so frequently. (Source: SCRIP No 2577 Sep 22 nd 2000 p. 4 ) PHARMACEUTICAL INFORMATIONS ON THE WEB 78
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Even in Hungary, people get more and more spams in our mailboxes, advertising online drug buying possiblitis. The subjects of this advertisement are usually expensive, popular drugs, especially products increasing male sexual potency. The advertisements tell the people, that ordering these drugs online, could be very comfortable for the patients, because they can avoid visiting their urologist, but it might be dangerous in case of some medicines. Therefore e-Pharmacies recommend their consumers, to ask their doctor before taking these medicines. PHARMACEUTICAL INFORMATIONS ON THE WEB 80
In Hungary it was told by pharmaceutical leaders on several forum, that people should not buy their drugs online. The source of the products selled online are often unknown. A megbízhatatlan eredetű készítmények az egészséget is veszélyeztetik. In case of some expensive, popular drugs, it happened the online ordered product was only an imitation. If e-Pharmacies are well controlled, as we have seen it in the UK example, people can safely buy drugs, without any risk. PHARMACEUTICAL INFORMATIONS ON THE WEB 81
Marketing effects of online drug trade: Medicinal products are much cheaper in Canada comparing to the US. In both countries people can legally buy medicines online. Therefore people in the northern part of the US started to order their drugs from Canadian sites. US healthcare lobby groups asked the Canadian government to decrease online drug trade in Canada, because it might be dangerous for the healt of Canadian patients. Canadians were told, that if US people buy drugs from Canada, that can cause serious deficits in the selling of drugs in Canada and also may have a price increaing effect. US pharmacists say that buying products from abroad is not safe enough, because safety and quality can not be controlled well. PHARMACEUTICAL INFORMATIONS ON THE WEB 82
The UN is against the online trade of prescprion only (not OTC) medicines. According to the measurments of the company Clearswift, who is working with online content filtering softwares: 59% of our spam e-mails are drug adverisements. Before this measurement, 9 months ago, the spam index was known to be around 18%, which is a huge difference. That means that spam senders are very succesful in using this illegal, uncontrollable way of selling medicinal products. PHARMACEUTICAL INFORMATIONS ON THE WEB 83
Scientific Informations • Available for free at the university: • www. lib. sote. hu – Databases • • • Med. Line, Pub. Med OVID, EBM Nature Science Journals Micromedex Web of science. . PHARMACEUTICAL INFORMATIONS ON THE WEB 84
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ZAJZON, Gergely Dr. Med. E-mail: Web: Phone: zajzon. gergely@zazacom. hu http: //www. gyogyszerugy. hu +36 -20 -9604294 PHARMACEUTICAL INFORMATIONS ON THE WEB 87
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