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Aims: Many drugs belonging to different therapeutic classes appear to share a potentially fatal side-effect: ventricular tachyarrhythmias associated with QT prolongation. The aim of this study was to assess the relevance and the magnitude of the problem in seven countries by grouping all nonantiarrhythmic drugs according to the type of evidence on QT prolongation and analysing their sales data., Methods: We divided all nonantiarrhythmic QT-prolonging agents into the following categories (in increasing order of clinical relevance): group A, drugs with published clinical or preclinical evidence on QT prolongation or with relevant official warnings; group B, drugs with published clinical or preclinical evidence; group C, drugs with published clinical evidence; group D, drug with published clinical evidence on torsades de pointes or ventricular arrhythmias associated with QT prolongation; group E, drugs belonging to group D with official warnings. We retrieved 1998 sales data from community pharmacies in seven countries (Australia, Denmark, England, Germany, Greece, Italy and Sweden). Data for individual agents were expressed as defined daily doses per 1000 inhabitants per day (DDD/1000/day). Overall use in each country was calculated for each drug group. Groups D and E were considered as the most clinically relevant., Results: Among the 102 nonantiarrhythmic agents meeting at least one of the inclusion criteria, 33 drugs had sales data > or =1 DDD/1000/day and 71 drugs had a use > or =0.1 DDD/1000/day in at least one country. Among the 37 nonantiarrhythmic agents with published reports of ventricular arrhythmias associated with QT prolongation, 12 compounds had sales data > or =1 DDD/1000/day. Total consumption in each country ranged: from 51.9 to 94.7 DDD/1000/day for group A; from 51.6 to 92.7 DDD/1000/day for group B; from 37.1 to 76.6 DDD/1000/day for group C; from 12.9 to 29.1 DDD/1000/day for group D; and from 5.8 to 15.3 DDD/1000/day for group E., Conclusions: In spite of wide variations in the sales of individual agents, the overall extent of use of nonantiarrhythmic QT-prolonging drugs was of the same order of magnitude in all countries. The significant use of drugs belonging to categories D and E should prompt careful risk/benefit assessment of each agent.

Germany is frequently cited as an example of reference based pricing (RBP) in ongoing controversial discussions on the effect of RBP. There are thorough analyses of phase I and II RBP on Germany's drug market. However, any conclusions on the overall economic and public health impact of RBP, solely on the basis of aggregated data, must be suspect to substantial bias, since too many factors in a rapidly changing health care system remained uncontrolled. Parallel to the introduction of phase II RBP in 1992/1993, the second health care reform became active. The two major confounding factors were the introduction of fixed drug budgets and the many changes due to the unification of Germany that took place in the beginning of the 1990s. Published and unpublished aggregated data do not allow any conclusions on the etiology of adverse health events due to this change in drug reimbursement policy. Conclusions drawn from the German experience will be based on assumptions or speculations that are hard to prove. A health care system that identifies enough evidence and need to introduce RBP as a measure of cost control should make every effort to evaluate the effects in order to increase program compliance or, if indicated, make adaptations to the RBP policy. The introduction of RBP in British Columbia in 1995-1997 and its computerized administrative health databases covering a large proportion of the population should give rise to a thorough analysis of this policy.