[Adverse drug reaction surveillance in pediatric and adult patients in an emergency room].

BACKGROUND

Adverse drug reactions (ADR) in the pediatric emergency room of a tertiary care hospital in Spain are described and compared with the adult ward.

METHODS

Identification of cases was carried out through review of admission diagnoses and selection of those included in a previous list of diagnoses considered as possible ADR, that were thereafter verified.

RESULTS

During 25 months, in 47.107 pediatric consultations were detected 451 cases as suspicious of ADR (0.96%). The ADR was moderate in 29 and serious in 1, being hospitalized 4. In adults, there were 68,431 consultations, and 704 cases detected (1.03%); moderate 218, serious 34 and mortal 1, being hospitalized 101. The most common reactions were dermatological (43.9% in children, 19.5% in adults) and of digestive nature (28.5 and 36.6%, respectively). The drugs most frequently involved in children were antimicrobials (49.5%), drugs used in respiratory illnesses (19.9%), non-steroid anti-inflammatory drugs (NSAID) (10.4%) and vaccines (9.2%); only two recently marketed products were involved. In adults, drugs involved were NSAID (28.2%), cardiovascular drugs (15.9%), antimicrobials (14.5%) and drugs active in digestive system (11.1%). There were 10 cases of hypoglycemia in diabetic adults, probably by interaction of hypoglycemic agents with angiotensin-converting enzyme inhibitors, and 7 cases of gastrointestinal hemorrhage associated with ketorolac, that generated an alert; 12 recently marketed products were involved.

CONCLUSIONS

Intensive monitoring in emergency ward measures ADR problem, estimates underreporting, but it has a moderate value to generate alert or to survey new products.