RATIONAL PHARMACOTHERAPY: DIFFERENCES

AMONG EUROPEAN COUNTRIES

SILVIO GARATTINI

Istituto di Ricerche FarmacologicheMario Negri - Milan Italy

COPENHAGEN 6 NOVEMBER 2002

Pharmaceutical products among the 50 most sold drugs in Italy, UK, Germany and France

1992 1996 2001

Omeprazole Omeprazole Omeprazole

Simvastatin Simvastatin Simvastatin

- - Atorvastatin

- Amlodipine Amlodipine

- - Cyclosporine

Ranitidine Ranitidine -

Nifedipine - -

Enalapril - -

Captopril Captopril -

Acyclovir - -

ACTIVE PRINCIPLES COMMONTO THREE COUNTRIES

ACTIVE PRINCIPLES COMMONTO TWO COUNTRIES

ACTIVE PRINCIPLES PRESENTONLY IN ONE COUNTRY

19

17

63

CEFTRIAZONE MORNIFLUMATE ESAMEPRAZOLE FENOFIBRATE

CLARITHROMYCIN GOSERELINE NADROPARINE PARACETAMOL

LORAZEPAM LAMOTRIGINE CERTOPARINE ROXYTHROMYCIN

ALPRAZOLAM GABAPENTINE ENOXAPARINE BUPRENORPHINE

TAMSULOSINE SUMATRIPTAN FILGASTRIM GLICAZIDE

BICALUTAMIDE MIRTAZAPINE DONEXEPIL

TICLOPIDINE CERIVASTATIN

NIMESULIDE

ITALY UK GERMANY FRANCE

50 MOST SOLD DRUGS BY VALUE: DRUGS PRESENT IN ONLY ONE COUNTRY (2001)

Surveying antibiotic policy for bacteraemia in different countries

BASIC (BActeraemia Study in Intensive Care)

ITALY 81

10BELGIUM

NETHERLANDS 8

PORTUGAL 9

SPAIN 16

GERMANY 10

UNITED KINGDOM 32

TOTAL 166

Duration of antibiotic therapy in primary bacteremia

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

UNITED KINGDOM

NETHERLAND

GERMANY

ITALY

BELGIUM

SPAIN

PORTUGAL

short (<6 days) medium (6-9 days) long (>9 days)

Duration of antibiotic therapy in peritonitis related bacteremia

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

UNITED KINGDOM

NETHERLAND

GERMANY

ITALY

BELGIUM

SPAIN

PORTUGAL

short (<6 days) medium (6-9 days) long (>9 days)

Spectrum of antibiotic therapy in community acquired Gram + bacteremia

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

UNITED KINGDOM

GERMANY

ITALY

BELGIUM

SPAIN

NETHERLAND

PORTUGAL

restricted broad

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

INDUSTRIAL vs PUBLIC HEALTH INTEREST

THE CASE OF EMEA

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

SPC vs ADVERTISEMENT

HOW TO PROMOTE INDIPENDENT INFORMATION?

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

PASSIVE vs ACTIVE PHARMACOVIGILANCE

THE NEED TO CENTRALIZE INFORMATIONS ON ADVERSE REACTIONS

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

REVISION OF USELESS DRUGS

ONLY FOR TOXICITY?

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

MORE COMPARATIVE STUDIES AND LESS EQUIVALENCE STUDIES

THE EUROPEAN LEGISLATION

WHY IS SO DIFFICULT TO IMPLEMENTRATIONAL PHARMACOTERAPY ?

THE NEED OF INDIPENDENT STUDIES

A PUBLIC EUROPEAN FUND FOR CLINICAL TRIALS