Prescribing information in 26 countries: a comparative study.

This study was set up to document the variability of prescribing information from different sources concerning indications, side effects and cautions of selected drugs. An original method to measure the degree of information agreement among different written materials, such as summaries of product characteristics, package inserts and data sheets, and a widely accepted reference text was developed. The results show that there is substantial disagreement in the materials available to prescribers and patients in different countries. Disagreement was even found within a single country when written materials from different brands of the same drug were compared. The discordance can be explained by the fact that the evidence available for each drug is considered/assessed differently by separate countries. It is argued that the discrepancies found may mislead prescribers, patients and those comparing drug-use patterns across countries. National regulatory authorities have a key role to play in remedying this situation, and a two-pronged approach is proposed. At the international level, national authorities should strengthen collaboration and information interchange and, at the national level, should implement appropriate measures aimed at removing contradictory statements on drug-information materials that have no reason to be different. Finally, further training and continued education aimed at drug regulatory officials could provide the necessary knowledge and enable national authorities to meet the need for drug information that is independent of commercial interests.

The impact of therapeutic improvements in reducing peptic ulcer mortality in Europe.

Trends in death certification rates from peptic ulcer between 1955 and 1989 have been analysed for 24 European countries on the basis of age-specific and age-standardized rates, and a log-linear model to estimate the effects of age, cohort of birth and period of death. For males, in all Western countries there were substantial declines in mortality. In the late 1950s, the range of variation of the world standardized rates was between 4/100,000 in France and 17.8 in Portugal. In the late 1980s, only Ireland had a rate over 5/100,000, and values for most Western countries ranged between 2 and 4/100,000. The average fall in rates over the last three decades was 56%. Of this, a high proportion (45%) was registered between 1975 and 1984. In Eastern Europe, no systematic change was observed until the early 1970s, but over the last 15 years peptic ulcer mortality declined by an average of 20%. In 1985-1989 the lowest rate was 4.5/100,000 in Bulgaria, and for all other countries peptic ulcer mortality ranged between 5 and 7.2/100,000. Peptic ulcer mortality was substantially lower in females, and showed no appreciable modification in Western Europe, and several increases in Eastern Europe until the mid 1970s. Thereafter, mortality declined by an overall 25% in the West and 15% in the East. Earlier declines for males in Western Europe were chiefly related to a cohort effect, reflecting more favourable risk factor exposure (such as diet, Helicobacter pylori or smoking) of subsequent generations. The recent falls, in contrast, were mainly on a period of death basis indicating therapeutic advancements (including the introduction of H2-receptor-antagonists in the mid-1970s) as the major determinant. These falls correspond to about 20,000 deaths from peptic ulcer avoided every year in the whole of Europe.