Could adverse reactions of antibiotic drugs in children be detected in a prescription database?

Purpose: To explore the possibility to detect adverse drug reactions (ADRs) from a pharmacy prescription database by examining the use of proxy-drugs during the treatment.

Methods: From a pharmacy prescription database we selected all children of 0-6 years old who started an antibiotic drug between 1999 and 2006. In the period of 5 days before till 12 days after the initiation of the antibiotic, we examined the number of prescriptions of 5 groups of proxy-drugs associated with adverse reactions: propulsives, skinmedication, antihistaminics, drugs against candidiasis and diarrhea. We did this also for cases where the children did not use any other drugs on the start day (t = 0) and the 5 days before, to focus on the use of proxy-drugs not related to the infection.

Results: A total of 105,804 antibiotic courses were selected. The use of the proxy-drugs was the highest at the first day with no significant increase in the days thereafter. In case of no use of any other drugs from day -5 till day 0 a significant increase of antihistaminic use on day 7 and 8 and of skin medication use on day 7 was found.

Conclusions: Examining prescriptions of proxy drugs is not an optimal method to detect adverse reactions. An increase of antihistaminic use and skin medication use around day 7 in patients who had no other prescriptions 5 days before and on the first day of the course could be an indication for a skin reaction or allergy.