Benefits of a National Program for Adverse Drugs Reactions (ADRS) Surveillance in Diabetic Patients

Abstract

Voluntary notification of suspected adverse drug reactions (ADR) is the most worldwide method to detect these events. Unfortunately, health professionals in Latin American countries have no “culture” to notify ADR. For this reason, the National Diabetes Program (NDP) in Paraguay decided to regularly contact their patients, in order to increase ADR detection. To evaluate the results of this experience, this study was performed.
 Methods: a descriptive, observational, cross-sectional study with an intervention phase was performed. A non-probabilistic sample of patients belonging to NDP was selected and compared with historical results of the program. The intervention activities consisted in a monthly contact of the patients by a member of the program. 
 Results: 2,390 patients with type II diabetes were enrolled in the study and compared with the same number of patients belonging to the program but with classical follow-up. Concerning the adverse drug reactions, 146 reports were registered during the study period, which mean 6.1% of all patients enrolled, while in the same period, historically the ADR reports were 0.94%. 66.9% of these reports were performed by the patients while 42.1% were notified by health professional. Main ADRs reported were vomiting 28.8%, dizziness 28.4%, diarrhea 10.8%, hypoglycemia 10.2% or abdominal pain 6.5%. The antidiabetic drugs that presented the greatest suspicion of ADRs were metformin 45.31%, glimepiride 21.8%, glibenclamide 6.25% and insulin 3.13%.
 Conclusion: Periodical contact of patients covered by a National Diabetes program was able to increase 6 times the historically annual of report of pharmacovigilance adverse drug reactions.
 Keywords: pharmacovigilance, adverse drug reactions, reports, voluntary, active notification, program.