Pharmacovigilance profile in a reference center in Ecuador: A retrospective study

Background: The development of new health technologies – drugs has allowed to change the therapeutics of some diseases, however, despite the advantages in various clinical scenarios – prevention, prophylaxis, treatment, etc., there is evidence that adverse drug reactions (ADR) are a frequent but preventable cause of disease, disability, or death.

Therefore, it is estimated that in some countries ADRs represent between the fourth and sixth cause of mortality.

Objectives: To determine the prevalence and profile of ADRs in a reference center in Ecuador.

Design and setting: This historical cohort study included patients aged ≥ 18 years with diagnosed Adverse Reaction to Medications in the period March 2018 – March 2019, at a reference center in Ecuador. Patients were divided into three groups: I) Adverse drug reaction; ii) medication error (ME); and iii) therapeutic failure, according to WHO and ARCSA definitions.

Methods: Continuous variables were compared using t-test or Mann-Whitney test, when distributional assumptions were in doubt. Categories were compared via chi-square test or Fisher exact test, when needed. The analyses were conducted with IBM-SPSS version 25. P values < 0.05 were deemed statistically significant.

Results: Antibiotics and analgesics - antipyretics were the pharmacological groups responsible for the highest number of cases of ADRs (accounting for 9.0% and 7.6% respectively) and EM (24.7% and 20.8% respectively).

Conclusion: The ADRs, ME present an important prevalence, for this reason all health institutions have pharmacovigilance systems that allow early detection of these events within a public policy of quality and safety of care.