Changes in monitoring of adverse drug reactions in Poland

Political changes in Poland in 1989 initiated a transition period for country's economy into a free market. This new situation prompted the pharmaceutical sector to apply for marketing authorization of a huge number of drugs. Subsequently, the availability, supply and variety of drugs was changing to resemble the one existing on the European Union market. We have analyzed the pattern of adverse drug reactions reported in Poland during the past 10 years. Subsequently we compared our data for years 1991-1995 with the reports received by the Belgian National Center for Monitoring of Adverse Drug Reactions over period 1990-1994. It was found that the number of reports increased in parallel with the number of drugs available. Also the variety of reported reactions was greater. Spontaneous reporting by individual physicians increased and the number of reports from the pharmaceutical inspection diminished. Comparison with the patterns of reporting in Belgium showed the range of drugs included in the reports to be similar in both countries during the studied period.

we found that the increase in range and availability of drugs changed substantially the patterns of reporting of adverse drug reactions in Poland. It became similar to that observed in EU countries.