Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years.

OBJECTIVE

To describe our pharmacovigilance program and to analyze the reported adverse drug  reactions.

METHOD: Observational longitudinal study conducted from 2008 to 2016. The Pharmacy Department  leads the pharmacovigilance program and performs prospective, retrospective, intensive, and  spontaneous reporting of inpatients and outpatients (emergencies, day hospital, external consultations, and nursing homes). Each adverse drug reaction is incorporated in the  electronic health record of the patient along with an alert.

RESULTS

A total of 2,631 adverse drug reactions were reported in 2,436 patients. Of these patients,  52% were men with a mean age of 63.3 [0-98] years. A total of 92.8% drug events were reported by the pharmacists and 7.2% by doctors, nurses, and technicians. A total of 63.7% were reported in  inpatients, 19.2% in emergencies, 10.6% in external consultations, 6.2% in the day hospital, and  0.3% in diagnostic radiology. There was an increase in adverse drug reactions detected by  prospective and intensive pharmacovigilance. Principal therapeutic groups involved in adverse drug  events were antineoplastic agents (21.3%), antibacterials (12.3%), antithrombotics (7.7%),  analgesics (6.7%), corticosteroids (5.2%), psycholeptics (5.2%), diuretics (4.9%),  antivirals (4.9%),  antiinflammatories and antirheumatics (4.2%), and immunosupressants (3.3%). Adverse  drug reactions mainly affected the skin and appendages (19.7%) and gastrointestinal tract (19.1%).  Adverse drug reactions were mild (38.7%), severe (30.8%), and moderate (30.5%). In total, 60.9%  of patients recovered from drug events and 31.7% were in recovery. The most frequent response was reatment interruption in 65% of cases and the patients received additional specific treatment in 56%  of cases.

CONCLUSIONS

The incorporation of the pharmacovigilance program within the daily routine of the  hospital pharmacist provides added value to the safety and pharmacotherapy of the patient.