DRUG INFORMATION

Prepared by S. Miuda
Program AISLP developed by B. kop et al.
Introduction
Access to clinically relevant, uptodate, userspeci!ic, independent, ob"ective, and unbiased drug in!ormation is
essential !or appropriate drug use. Prescribers, dispensers, and users o! medicines all need ob"ective in!ormation.
A #ealt# care system can provide access to t#e #ig#est $uality medicines, but i! t#ose medicines are not properly
used, t#ey may #ave negligible bene!its or even adverse e!!ects. Alt#oug# access to good drug in!ormation does
not guarantee appropriate drug use, it is certainly a basic re$uirement !or rational drug use decisions.
Sources of Drug Information
In!ormation sources !all into t#ree classes. Primary sources are t#e !oundation on %#ic# all ot#er drug
in!ormation is based. &#ese include "ournal publications on drugrelated sub"ects, suc# as reports o! clinical drug
trials, case reports, and p#armacological researc#. Secondary sources !unction as a guide to or revie% o! t#e
primary literature. Secondary sources include revie% articles, metaanalyses, inde'es (Inde' Medicus), abstracts
(Intemational P#armaceutical Abstracts), and combinations o! abstracts and !ullte't reprints. Tertiary or
general sources present documented in!ormation in a condensed !ormat. *'amples include !ormulary manuals,
standard treatment manuals, te'tbooks, general re!erence books, drug bulletins, and drug compendia. It is
advisable to obtain t#e most current edition available %#en using secondary or tertiary sources.
Evaluation of Information Sources
*valuating in!ormation sources is an important skill. &#e +uide to +ood Prescribing ,-./01AP 2334b5
contains a use!ul section on assessing literature.
Primary Sources. *valuating primary literature is di!!icult. &#e most reliable evidence comes !rom
reports on randomized controlled trials. Proper evaluation o! t#ese trials re$uires considerable e'perience, and
systematic revie%s o! combined trials (metaanalyses) may be necessary. &#is %ork is being undertaken by t#e
6oc#rane 6ollaboration. In "udging primary literature, one cannot assume t#at t#e results o! a study or a researc#
paper are valid simply because it #as been accepted !or publication. .o%ever, it is use!ul to consider t#e source
o! a study or paper %#en one seeks to determine its $uality. &#ere are a number o! respected medical and
p#armacy "ournals %#ose #ig# standards !or acceptance and publication make it unlikely t#at a researc# article
containing erroneous data or misrepresented in!ormation %ould survive t#e editorial and revie% process. &able
78 lists some *nglis#language "ournals t#at #ave strong editorial policies and peer revie% processes t#at include
con!2icto!interest disclosure re$uirements to minimi9e t#e possibility o! biased or unsupportable conclusions
being reported.
&able 2 Primar Information Sources
Medical and T!era"eutic #ournals
Annals o! Internal Medicine
Britis# Medical :ournal
:ournal o! t#e American Medical Association
Lancet
;e% *ngland :ournal o! Medicine
Drug and To$icolog Information and P!armacolog #ournals
Britis# :ournal o! 6linical P#armacology
6linical P#armacology and &#erapeutics
*uropean :ournal o! 6linical P#armacology
.uman and *'perimental &o'icology
:ournal o! &o'icology and 6linical &o'icology
Medical &o'icology and Adverse 1rug *'perience
P!armac #ournals
American :ournal o! .ospital P#armacy
Annals o! P#armacot#erapy
6linical P#armacy
1I6PAnnals o! P#armacot#erapy
:ournal o! 6linical and .ospital P#armacy
:ournal o! 6linical P#armacy and &#erapeutics
P#armaceutical :ournal <=
#ournals in S"ecific Areas
American :ournal o! *mergency Medicine
Annals o! *mergency Medicine
Britis# :ournal o! /bstetrics and +ynaecology
6ritical 6are Medicine
:ournal o! Antimicrobials and 6#emot#erapy
:ournal o! In!ectious 1iseases
:ournal o! Paediatrics and 6#ild .ealt#
Secondary information resources are essentially derivations o! t#e primary literature. Some revie%
articles summari9e t#e results and conclusions o! a number o! reports !rom t#e primary literature (usually %it#
comments by t#e revie%er). Bibliograp#ic, abstracting, or inde'ing services provide listings or compilations o!
publis#ed articles. Some list t#e addresses o! t#e principal aut#ors> ot#ers contain abstracts o! articles, along %it#
key %ords or sub"ect #eadings to #elp users !ind t#e articles or re!erences t#ey are looking !or. *'amples o! suc#
services include Medline, 6urrent 6ontents, International P#armaceutical Abstracts, Inde' Medicus, *'cerpta
Medica, and t#e Io%a 1rug In!ormation Service (%#ic# also includes !ullte't reprints o! articles).
Tertiary references, %ritten by individuals or groups, are o!ten developed %it# t#e input o! consultant
revie%ers and may be %idely peer revie%ed. In general, t#e more t#oroug# t#e peer revie% process is, t#e more
sound t#e in!ormation is likely to be. In many countries, t#e most %idely available tertiary resources are
!ormulary manuals and standard treatment manuals produced by t#e #ealt# system. List o! most respected
tertiary resources is in &able 2.
&able 2 %ist of most res"ected tertiar resources&
Essential Drugs %ists and T!era"eutic Formularies
Britis# ;ational ?ormulary, updated every si' mont#s
*ssential 1rugs List !or @imbab%e, Ministry o! .ealt#, Aepublic o! @imbab%e (2334)
&#e -./ Model Lists o! *ssential 1rugsB &#e <se and Selection o! 1rugs. &ec#nical Aeport
Series C27, C42, DEE, DD8, F78 (23DD, 23D3, 23FG, 23F7, 23FF, 233E, 2337), -orld
.ealt# /rgani9ation, +eneva
-./ Model Prescribing In!ormationB 1rugs <sed in Anest#esia, Parasitic 1iseases,
Mycobacterial 1iseases, Se'ually &ransmitted 1iseases,Skin 1iseases
Manufacturers' Promotional Information
1rug in!ormation provided by manu!acturers is secondary or tertiary in!ormation. &#e type and $uality o!
in!ormation provided by drug manu!acturers vary considerably !rom country to country, depending on
governmentsH regulations and ability to en!orce t#em. It is important to remember t#at in materials sponsored by
a p#armaceutical company, only !avorable vie%s o! t#e sponsorHs products may be presented, and t#e materials
may not !urnis# ade$uate in!ormation !or good prescribing decisions. Sales representatives may provide only
partial in!ormation about products t#ey are promoting. Moreover, product inserts and labelling provided by drug
manu!acturers do not necessarily re!lect all current accepted uses o! a drug. In many instances, t#e indications on
a productHs approved labelling do not matc# #o% t#at drug is routinely used in medical practice. /nce a medicine
is approved !or marketing and used !or one indication, subse$uent clinical trials and e'perience may s#o% t#at it
is use!ul !or ot#er indications as %ell. 6#anges in product labeling to re!lect t#is ne% in!ormation need to be
aut#ori9ed by t#e drug approval agency. /!ten t#is is not done !or years a!ter t#e ne% use is !irst reported in t#e
medical literature. In some cases, ne% in!ormation is never added to a productHs approved labelling because it is
not economically advantageous !or t#e drug company to go t#roug# t#e approval process. In cases in %#ic# a
drugHs generally accepted uses go beyond its government approved labelling, t#e drug in!ormation specialist or
#ealt# care pro!essional #as to rely on t#e medical literature !or #elp in "udging %#ic# uses are appropriate and
%#ic# are inappropriate.
/n t#e ot#er #and, Official %a(elling Information ) Summar of Product *!aracteristics +SP*, !or
t#e product as approved by t#e national regulatory aut#ority is "uridical document %#ere veracity o! all
in!ormations are guaranteed by t#e producer. &#ere!ore many #ealt# pro!essionals regularly use re!erences t#at
compile approved product labelling provided by p#armaceutical manu!acturers. An e'ample is P#ysicianIs 1esk
Ae!erence, %#ic# is available !ree o! c#arge to p#ysicians in <nited States.
Drug Information *entres +DI*,
Anot#er possibility #o% to get in!ormation about t#e p#armaceutical product, t#eirs clinical use etc. are 1I6.
&#e primary role o! a 1I6 is to give clear and de!initive in!ormation on drugs and promote t#eir rational use. A
secondary role o! t#e centre is to keep uptodate %it# p#armacological and t#erapeutic literature and
disseminate relevant in!ormation %#en it becomes available. .ealt# %orkers, and sometimes t#e general public,
can call and get #elp %it# $uestions concerning drug use, into'ications, etc. 6urrently, t#ere are !ive 1rug
in!ormation centre in t#e 69ec# Aepublic. 6ontactsB
a) 1I6 at 1epartment o! Social and 6linical P#armacy, 6#arles <niversity in Prague, ?aculty o! P#armacy in
.radec =rJlovK
&el.B L4E8 (43) 78CD 47E (GC2 or 4E2),
?a'B L4E8 (43) 7E28 88E,
*mailB mullero#M!a!.cuni.c9
b) 1I6 o! t#e 69ec# national regulatory aut#ority (StJtnN Ostav pro kontrolu lKiv SP=L)
&el.B L4E8 (E) DE2F 7GGG,
?a'B L4E8 (E) D2DG EGDD,
*mail in!sMsukl.c9, sviMsukl.c9
c) 1I6 P#oeni' in!ormation provided by drug supply company P#oeni'
Qino#radskJ DE
C2F 88 BrnoRernoSice
&el.B L4E8 (87) 4F2G 72D8,
*mailB v.!ricovaMbm.p#oeni'.c9

d) 1I6 LI6 provided by P#armacy o! t#e St. Ann &eac#ing .ospital
PekaTskJ 7G,
C7C 32 Brno
&el.B L4E8 (7) 4G2F E2D7D
&el.0!a'B L4E8 (7) 4GE2 24E3
*mailB premysl.cernyM!nusa.c9, pavla.varakovaM!nusa.c9
.omepageB #ttpB00%eb.!nusa.c90kliniky0lic0
e) 1I6 at 1epartment o! P#armacology, 6#arles <niversity in Prague, G. ?aculty o! Medicine in Prague
practise t#roug# Internet,
*mailB dole9alM!armakologie.net
.omepageB #ttpB00%%%.!armakologie.net
AIS%P
AISLP (abbreviation o! t#e 69ec# name Automati9ovanU In!ormanN systKm LKivUc# PTNpravkV) is 61A/M
version o! drug !ormulary manual. It is database t#at comprises in!ormation about all drugs t#at are on t#e
market in 69ec# republic. <nlike ot#er similar databases in 69ec# Aepublic, it contain also Summary o! Product
6#aracteristics (SP6) !or t#e products approved by t#e national regulatory aut#ority and (SP=L see above). It
is updated every G mont#.
Tas- .
Wou can see a list o! anti#ypertensive substances. <sing *nglis# version o! AISLPB
2. -rite t#e name o! t#e subclass o! anti#ypertensive agents !or every belo% mentioned substance (&able 7E)
to %#ic# it belongs (e.g. diuretics, betaadrenoceptor blocker etc.)
E. 1isplay a lists o! trade names o! drugs containing every belo% mentioned substance. -rite one trade name
to t#e table E (%#ic#ever).
&able E Anti!"ertensive su(stances
Subclass &rade name
#ydroc#lorot#ia9ide
metoprolol
labetalol
mo'onidine
verapamil
ni!edipine
captopril
enalapril
amlodipine
valsartan
Tas- /
See table G it contains list o! trade names. Wour task is to %rite t#e name o! t#e main producer, time o!
e'piration, and cardiovascular indications o! t#ese drugs.
&able G
Main producer &ime o!
e'piration
6ardiovascular indications
&rimepranol tabl.
Sandonorm tabl.
6apoten tabl.
Isoptin drg.
1opegyt tabl.
*nap 28 tabl.
;orvasc tabl.
References0
2. 1rug and t#erapeutic in!ormation. InB Managing 1rug SupplyB &#e Selection, Procurement,
1istribution, and <se o! P#armaceuticals E
nd
edition. =umarian Press 233D.
E. -./01AP (-orld .ealt# /rgani9ation0Action Programme on *ssential 1rugs). 2334b. +uide to good
prescribing. -./01AP034.22. +enevaB -./01AP.