information, potential confounders of a drug exposure, language of the database, record period and record linkage. For the inpatient sector, the search strategy was slightly different. First, we reviewed the main available information on hospital drug utilization for the PROTECT selected drugs by means of a website and a bibliographic database search. Then, because of the importance of antibacterial consumption in the inpatient sector linked to the emergence and selection of antibiotic-resistant bacteria, a specific literature review was conducted to establish the availabilty of inpatient macrolides and amoxicillin-clavulanic acid consumption data in the selected PROTECT countries. One of the aspects of interest was to determine the validity of the national drug consumption data. Considering the bibliography available on the validity of drug consumption data and on the validity of automated databases in research, we developed a questionnaire including most of the items considered of relevance when measuring drug exposure. The key items referred to the definition of in- and outpatient drug consumption, population coverage, drug- and patient-based information, and database validity. However, these key items are also factors helping to interpret the results obtained when comparing drug consumption across countries and/or over time. This complex methodology yielded to a list of comprehensive and more specific institutional European websites (see table 3), and international networks on DU studies (table 3). From them, we derived what we term background data: list of national medicines agencies (table 4), healthcare systems (Appendix 8.3), pricing and reimbursement agencies (table 5), pharmaceutical data sources by country(table 6) and international networks and working groups in pharmacoepidemiology (Appendix 8.4 and 8.5). For each of the international working groups, the following information was collected: website, definition, objectives, record period, country-participants, funding and publications. These international networks have been divided in those offering general information: general research groups, and those studying either
information, potential confounders of a drug exposure, language of the database, record period and record linkage. For the inpatient sector, the search strategy was slightly different. First, we reviewed the main available information on hospital drug utilization for the PROTECT selected drugs by means of a website and a bibliographic database search. Then, because of the importance of antibacterial consumption in the inpatient sector linked to the emergence and selection of antibiotic-resistant bacteria, a specific literature review was conducted to establish the availabilty of inpatient macrolides and amoxicillin-clavulanic acid consumption data in the selected PROTECT countries. One of the aspects of interest was to determine the validity of the national drug consumption data. Considering the bibliography available on the validity of drug consumption data and on the validity of automated databases in research, we developed a questionnaire including most of the items considered of relevance when measuring drug exposure. The key items referred to the definition of in- and outpatient drug consumption, population coverage, drug- and patient-based information, and database validity. However, these key items are also factors helping to interpret the results obtained when comparing drug consumption across countries and/or over time. This complex methodology yielded to a list of comprehensive and more specific institutional European websites (see table 3), and international networks on DU studies (table 3). From them, we derived what we term background data: list of national medicines agencies (table 4), healthcare systems (Appendix 8.3), pricing and reimbursement agencies (table 5), pharmaceutical data sources by country(table 6) and international networks and working groups in pharmacoepidemiology (Appendix 8.4 and 8.5). For each of the international working groups, the following information was collected: website, definition, objectives, record period, country-participants, funding and publications. These international networks have been divided in those offering general information: general research groups, and those studying either
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