http://repub.eur.nl/res/aut/13796/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/10399/ 2005-01-01T00:00:00Z OBJECTIVE: To analyse trends in antibiotic use in Dutch hospitals over the period 1997 to 2002. METHODS: Data on the use of antibiotics and hospital resource indicators were obtained by distributing a questionnaire to all Dutch hospital pharmacies. Antibiotic use was expressed as the number of defined daily doses (DDD) per 100 patient-days and as DDD per 100 admissions. RESULTS: Between 1997 and 2002, the mean length of stay decreased by 18%. The mean number of admissions remained almost constant. Total antibiotic use significantly increased by 24%, from 47.2 in 1997 to 58.5 DDD per 100 patient-days in 2002 (p<0.01), whereas expressed as DDD per admissions it remained constant. Antibiotic use varied greatly between the hospitals. Moreover, the mean number of DDD per hospital of amoxicillin with clavulanic acid, clarithromycin, cefazolin, clindamycin and ciprofloxacin increased by 16, 38, 39, 50 and 52%, respectively. Total antibiotic use was higher in university hospitals than in general hospitals. CONCLUSIONS: Between 1997 and 2002, patients hospitalised in the Netherlands did not receive more antibiotics but, since they remained in the hospital for fewer days, the number of DDD per 100 patient-days increased. For macrolides, lincosamides and fluoroquinolones increases in both DDD per 100 patient-days and in DDD per 100 admissions were observed. It is arguable whether these trends result in an increase in selection pressure towards resistance in the hospitals. Continuous surveillance of antibiotic use and resistance is warranted to maintain efficacy and safety of antibiotic treatment. http://repub.eur.nl/res/pub/22853/ 2001-02-21T00:00:00Z Since the 'thalidomide disaster' in 1961, there is extensive national and intemationallegisiation for the registration and monitoring of drugs. The current drug approval process in most developed countries includes pre-clinical animal testing followed by three phases of clinical testing during which the efficacy and safety of drugs are detennined. Despite this process, however, not all drug effects are known at the moment of marketing approval. For most indications less than 3,000 patients are exposed to a drug during the pre-registration phase. This implies that an adverse reaction can only be detected with 95% certainty if the occurrence is at least 1 per 1,000 patients and the background incidence is zero. After regulatory approval, however, millions of people will use the drug with the possibility that less common unknown adverse drug reactions can emerge. In order to enable continuous reassessment of the benefit/risk ratio of a specific drug in the post-marketing phase, it is necessary to continuously monitor utilisation and effects of drugs after their approval.