Rational PharmacotherapyRational Pharmacotherapy

AndAnd

Drug InformationDrug Information

Rational PharmacotherapyRational Pharmacotherapy

The best medical treatment The best medical treatment

under the present under the present

circumstancescircumstances

Best from the viewpoint of Best from the viewpoint of

the patient and societythe patient and society

'The right pill'The right pill

inin

the right mouth'the right mouth'

Drug information:Drug information:

AAll facts and evidence on ll facts and evidence on drug, in particular its drug, in particular its therapeutic usetherapeutic use

IIn contrast to:n contrast to:

DDrug advertisementrug advertisement

Chain of events:Chain of events:

SSources of informationources of information

DDecision on rational pharmacotherapyecision on rational pharmacotherapy

CCreation of informationreation of information

DDisseminationissemination

Sources of informationSources of information

RRandomized clinical trialsandomized clinical trials

EEpidemiological studiespidemiological studies

OOther studiesther studies

If no studies: If no studies: EExtrapolationxtrapolation

Extrapolation is a Extrapolation is a necessity!necessity!

When and how to do it When and how to do it ??

EExamples:xamples:

Gender – age – raceGender – age – race

Diseases – drugs Diseases – drugs (synonymous/analogues)(synonymous/analogues)

Rules for extrapolation Rules for extrapolation between drugs:between drugs:

''AAnalogous' chemistrynalogous' chemistrySSame mode of actioname mode of actionCComparable chemistryomparable chemistry

Studies have – in some Studies have – in some respects – shown similar respects – shown similar efficacy and adverse reactionsefficacy and adverse reactions

The Life StudyThe Life Study

aatenolol versus tenolol versus llosartanosartan

llosartan,osartan,better than better than aatenololtenolol

Press Press RRelease:elease:COZAAR,COZAAR,better than ß-blockersbetter than ß-blockers

All doctors and agencies haveAll doctors and agencies have

to take a greater responsibilityto take a greater responsibility

in demanding and supportingin demanding and supporting

needed studiesneeded studies

((iimportant head-to-head studies)mportant head-to-head studies)

Decision on rationalityDecision on rationality

EffectEffect

Adverse Reactions Adverse Reactions xx Price Price

Parameter of efficacy:Parameter of efficacy:

QQualitatively correctualitatively correct

RReal versus surrogateeal versus surrogate

QQuantitatively correctuantitatively correct

RReduction:eduction:

per cent or per cent or per cent per cent

pointpoint

How large shouldHow large shouldthe effect be the effect be ??

It depends on:It depends on:

TThe diseasehe disease

OOther treatmentsther treatments

AAdverse reactionsdverse reactions

PPricerice

Have to solve the Have to solve the problem ?problem ?

AAsk the patientssk the patients

StatisticsStatistics

SSignificantignificant

AAlmost significanlmost significan

TTrends towards significant rends towards significant

differencedifference

NNumerial differenceumerial difference

AAnd much morend much more

Drug Information should beDrug Information should be

CCorrectorrect

CCompleteomplete

CComparativeomparative

CComprehensibleomprehensible

ImplementationImplementation

TThe most difficult part he most difficult part !!

Many studies:Many studies:

wwritten feed-back is easyritten feed-back is easy

but not very effectivebut not very effective

Academic detailing isAcademic detailing is

time-consuming and difficult,time-consuming and difficult,

but more effectivebut more effective

http://www.eu2002.dk/

J01J01 intervention:intervention: - 6,1 %- 6,1 %

control:control: + 4,8 %+ 4,8 %

MacrolidesMacrolides intervention:intervention: - 18,5 %- 18,5 %

(J01FA)(J01FA) control: control: - 3,1 %- 3,1 %

PivmecillinamPivmecillinam intervention:intervention: - 15,7 %- 15,7 %

(J01CA08)(J01CA08) control:control: + 3,7 %+ 3,7 %

Development in the use of antibiotics Development in the use of antibiotics

(from 1999-2 to 2000-2)(from 1999-2 to 2000-2)

Disturbing factor (barriers)Disturbing factor (barriers)AAggressive advertisingggressive advertising

TThe press creating dramatic storieshe press creating dramatic stories

DDoctors indolenceoctors indolence

PPatients unrealistic and selfish atients unrealistic and selfish

demandsdemands

LLegal views versus biologyegal views versus biology

CComplacent and bureaucratic omplacent and bureaucratic

administrationadministration

Politicians:Politicians:

IndustrialIndustrial

versusversus

Health PolitiesHealth Polities

Wishes for the dayWishes for the day

WWhat is rational pharmacotherapy hat is rational pharmacotherapy ??

HHow it is created and implemented ow it is created and implemented ??

WWhy so many differences in EU hy so many differences in EU ??

MMutual benefit utual benefit ??

Honesty and Honesty and ssincerityincerity

withoutwithout

HHypocrisyypocrisy