PHARMACEUTICAL INFORMATIONS ON THE WEB ZAJZON, Gergely Dr. Med

PHARMACEUTICAL INFORMATIONS ON THE WEB

ZAJZON, Gergely Dr. Med.

PHARMACEUTICAL INFORMATIONS ON THE WEBPHARMACEUTICAL INFORMATIONS ON THE WEB 2

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

• Disease: indication, contraindication

Trade / Brand name

• „phantasy” name given by the company

• Eg.:– Aspirin– Viagra– ....

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

• 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

ATC classification system

ATC: acronym

• Anatomy

• Therapy

• Chemie

• Classification of active drug substances into anatomic organ groups, ordered by therapeutical effects and chemical entities.

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.

• 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.

• For defining pricing and reimbursement rules

• For Pharmaceutical Utilisation purposes: how many drug was used in this theraputic group?

Official ATC/DDD site:

http://whocc.no

• Human ATC code has 7 characters, but 5 levels:• Anatomical classification

1. 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)

• 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.: ketaminN01AX – human use

QN01AX – veterinary use

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

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

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

• 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

• P - ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS

• R - RESPIRATORY SYSTEM

• S - SENSORY ORGANS

• V - VARIOUS

• 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.

DDDDependent 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)

• Example:enalapril

ATC: C09A A02

O: 10 mg (oral)

Renitec 10 mg tablets

P: 10 mg (parenteral)

Renitec 1 mg/ml inj. inf.

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)

WHERE TO FIND APPROPRIATE, WHERE TO FIND APPROPRIATE, RELEVANT DRUG RELEVANT DRUG INFORMATION?INFORMATION?

WAY OF THE DRUG FROM WAY OF THE DRUG FROM THE FACTORY TO THE PATIENTTHE FACTORY TO THE PATIENT

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?

• 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)

• 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

• Getting 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.

• After having a Marketing Authorization…

• FACTORY

• WHOLESALER

• PHARMACY

• Public Pharmacy / Hospital

• PATIENT

PHARMACEUTICAL LEGISLATIONS

• OGYI (NIP) website

• Eudralex

PHARMACEUTICAL LEGISLATIONS

• Hungarian legislations– Can be found easily on the OGYI website– Regularly updated, consolidated informations– Source: a CompLex hungarian legal database– Available only in Hungarian language

PHARMACEUTICAL LEGISLATION

• EU legislations:– http://ec.europa.eu/enterprise/

pharmaceuticals/eudralex/

PHARMACEUTICAL DATABASES, PRODUCT LISTS

• OGYI (NIP website)OGYI (NIP website)

• EMC – UKEMC – UK

• EudraPharm databaseEudraPharm database

• OEP listsOEP lists

• SmPC vagy SPC (Summary of ProductCharacteristics): attachment of the Marketing Authorization, including detailed information for doctors and pharmacists, like indications, contraindicstions, dosage, etc.

• PIL (Patient Information Leaflet):

attachment of the Marketing Authorization, including „easily understandable” information for the patients.

www.medicines.org.uk

EudrapharmMain purpose:

To include all medicinal products approved in the Eurpean Union, both for human and veterinar useJogszabályi alap:

Legislaton background:

(EC) 726/2004 Regulation

PHARMACEUTICAL DATABASES, PRODUCT LISTS

• OGYI (NIP website)

• EudraPharm database

• OEP listsOEP lists

OEP lists

• Országos Egészségbiztosítási PénztárOrszágos Egészségbiztosítási Pénztár

• Hungarian Health Insurance FundHungarian Health Insurance Fund

• Price and reimbursement information in Hungary

• Supporting the prescription of economic („cheaper”) medicines in Hungary

PRICE AND REIMBURSEMENT

• FACTORY

• WHOLESALER

• PHARMACY

• Public Pharmacy / Hospital

• PATIENT

Factory Price

Wholesaler Price

Public Trade Price

- Reimbursement

Price Paid by the Patient

1000 HUF

1200 HUF

1400 HUF

800 HUF

600 HUF

• PUblic PHArma Core InformationPUblic PHArma Core Information

• Price and reimbursement information

• Downloadable from the website of OEP

• Purpose:

• giving actual price information for pharmacies

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

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

Buying pharmaceutical productsBuying pharmaceutical products

onlineonline

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.

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 22nd 2000 p.4 )

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.

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.

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.

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.

Scientific Informations

• Available for free at the university:

• www.lib.sote.hu– Databases

• MedLine, PubMed• OVID, EBM• Nature Science Journals• Micromedex• Web of science• ....

ZAJZON, Gergely Dr. Med.

E-mail: zajzon.gergely@zazacom.hu

Web: http://www.gyogyszerugy.hu

Phone: +36-20-9604294

PHARMACEUTICAL INFORMATIONS ON THE WEB ZAJZON, Gergely Dr. Med

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