RATIONAL PHARMACOTHERAPY: DIFFERENCES AMONG EUROPEAN COUNTRIES SILVIO GARATTINI Istituto di Ricerche Farmacologiche Mario Negri - Milan Italy COPENHAGEN 6 NOVEMBER 2002

Pharmaceutical products among the 50 most sold drugs in Italy, UK, Germany and France Omeprazole Simvastatin --Atorvastatin -Amlodipine --Cyclosporine Ranitidine - Nifedipine-- Enalapril-- Captopril - Acyclovir--

ACTIVE PRINCIPLES COMMON TO THREE COUNTRIES ACTIVE PRINCIPLES COMMON TO TWO COUNTRIES ACTIVE PRINCIPLES PRESENT ONLY IN ONE COUNTRY

CEFTRIAZONEMORNIFLUMATEESAMEPRAZOLEFENOFIBRATE CLARITHROMYCINGOSERELINE NADROPARINEPARACETAMOL LORAZEPAM LAMOTRIGINECERTOPARINEROXYTHROMYCIN ALPRAZOLAMGABAPENTINEENOXAPARINEBUPRENORPHINE TAMSULOSINESUMATRIPTANFILGASTRIMGLICAZIDE BICALUTAMIDEMIRTAZAPINEDONEXEPIL TICLOPIDINECERIVASTATIN 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) ITALY81 10BELGIUM NETHERLANDS8 PORTUGAL9 SPAIN16 GERMANY10 UNITED KINGDOM32 TOTAL166

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 restrictedbroad

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? INDUSTRIAL vs PUBLIC HEALTH INTEREST THE CASE OF EMEA

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? SPC vs ADVERTISEMENT HOW TO PROMOTE INDIPENDENT INFORMATION?

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? PASSIVE vs ACTIVE PHARMACOVIGILANCE THE NEED TO CENTRALIZE INFORMATIONS ON ADVERSE REACTIONS

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? REVISION OF USELESS DRUGS ONLY FOR TOXICITY?

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? MORE COMPARATIVE STUDIES AND LESS EQUIVALENCE STUDIES THE EUROPEAN LEGISLATION

WHY IS SO DIFFICULT TO IMPLEMENT RATIONAL PHARMACOTERAPY ? THE NEED OF INDIPENDENT STUDIES A PUBLIC EUROPEAN FUND FOR CLINICAL TRIALS