Download 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?
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KEYWORDS FOR DRUGS
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Tradename / brand name
Active ingredient
ATC code
Disease: indication, contraindication
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Trade / Brand name
• „phantasy” name given by the company
• Eg.:
– Aspirin
– Viagra
– ....
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Active substance
• INN: enalapril
• Enalapril maleat
• Chemical name:
(2S)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxo-4phenylbutan-2-yl]amino}propanoyl]pyrrolidine-2carboxylic acid
• Form: C20H28N2O5
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INN
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International Non-proprietary Name
WHO database of active substances
Was started in 1953
Currently around 7000 substances
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ACE-inhibitor names ends with PRIL:
eg.: enalaPRIL, captoPRIL
SARTAN – AT-II-inhibitors:
Eg.: candeSARTAN, loSARTAN
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ATC classification system
ATC: acronym
• Anatomy
• Therapy
• Chemie
• Classification of active drug substances
into anatomic organ groups, ordered by
therapeutical effects and chemical entities.
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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.
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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.
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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?
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Official
ATC/DDD site:
http://whocc.no
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ATC classification system
• 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)
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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
N01AX – human use
QN01AX – veterinary use
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RENITEC 10 mg tablets
INN: enalapril
• ATC1: C
ATC2: C09
• ATC3: C09A
• ATC4: C09A A
• ATC5: C09A A02
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Cardiovascular effect
Renin-angiotensin syst.
ACE inhib. (alone)
ACE inhib. (alone)
enalapril
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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
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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
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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
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ATC –anatomical classification
• P - ANTIPARASITIC PRODUCTS,
INSECTICIDES AND REPELLENTS
• R - RESPIRATORY SYSTEM
• S - SENSORY ORGANS
• V - VARIOUS
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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.
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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)
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DDD
• Example:
enalapril
ATC: C09A A02
O:
P:
10 mg
(oral)
Renitec 10 mg tablets
10 mg
(parenteral)
Renitec 1 mg/ml inj. inf.
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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)
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WHERE TO FIND APPROPRIATE,
RELEVANT DRUG
INFORMATION?
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WAY OF THE DRUG FROM
THE FACTORY TO THE PATIENT
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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?
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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)
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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
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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.
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WAY OF THE DRUG FROM THE
FACTORY TO THE PATIENT
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FACTORY
WHOLESALER
PHARMACY
Public Pharmacy / Hospital
PATIENT
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PHARMACEUTICAL
LEGISLATIONS
• OGYI (NIP) website
• Eudralex
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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
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PHARMACEUTICAL
LEGISLATION
• EU legislations:
– http://ec.europa.eu/enterprise/pharmaceutical
s/eudralex/
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PHARMACEUTICAL DATABASES,
PRODUCT LISTS
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OGYI (NIP website)
EMC – UK
EudraPharm database
OEP lists
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• SmPC vagy SPC (Summary of
ProductCharacteristics): attachment of the
Marketing Authorization, including detailed
information for doctors and pharmacists,
like indications, contraindicstions, dosage,
etc.
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• PIL (Patient Information Leaflet):
attachment of the Marketing Authorization,
including „easily understandable”
information for the patients.
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www.medicines.org.uk
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Eudrapharm
Main purpose:
To include all medicinal products approved in the Eurpean Union, both for human
and veterinar useJogszabályi alap:
Legislaton background:
(EC) 726/2004 Regulation
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PHARMACEUTICAL DATABASES,
PRODUCT LISTS
• OGYI (NIP website)
• EudraPharm database
• OEP lists
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OEP lists
• Országos Egészségbiztosítási Pénztár
• Hungarian Health Insurance Fund
• Price and reimbursement information in
Hungary
• Supporting the prescription of economic
(„cheaper”) medicines in Hungary
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PRICE AND REIMBURSEMENT
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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
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PuPHA
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PUblic PHArma Core Information
Price and reimbursement information
Downloadable from the website of OEP
Purpose:
giving actual price information for
pharmacies
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PuPHA
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
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PuPHA
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
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Buying pharmaceutical products
online
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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.
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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 22nd 2000 p.4 )
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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.
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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.
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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.
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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.
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Scientific Informations
• Available for free at the university:
• www.lib.sote.hu
– Databases
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MedLine, PubMed
OVID, EBM
Nature Science Journals
Micromedex
Web of science
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ZAJZON, Gergely Dr. Med.
E-mail:
Web:
Phone:
[email protected]
http://www.gyogyszerugy.hu
+36-20-9604294
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