Abstract

IMPLEMENTING PHARMACOVIGILANCE THROUGH PHARMACEUTICAL CARE: A THREE-MONTH PILOT STUDY WITH PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Cecilia Maldonado, Rossina Figliolo, Adriana Mouta, Carmen Duré, Pietro Fagiolino, Marta Vázquez,*

ABSTRACT

Diseases related to the immune system have seen their incidence grown in the latest years and Systemic Lupus Erythematosus (SLE) is not the exception. Pharmacological treatments include several immunosupressants and other drugs which expose patients to an ample variety of Drug Related Problems (DRPs) and Adverse Drug Reactions (ADRs). This study aimed to determine the incidence and type of ADRs among patients with SLE of the Autoimmune Disease Clinic in the University Hospital of Uruguay following the implementation of a Pharmaceutical Care Programme. During a 3-month study, 13 women, aged 21 to 67 years old, were included. DRPs were classified according to the Second Consensus of Granada. ADRs were categorized using the WHO severity grading scale for ADRs and attribution of causality was assessed using Naranjo´s algorithm. Twenty-five DRPs were detected, 15 of them in the safety category, Hydroxychloroquine was the drug commonly involved in ADRs. Fatigability and rash were the ADRs the patients complained the most. Three patients on hydroxychloroquine and prednisone referred visual disturbances. Rash and visual disorders were categorized as moderate or severe according to the WHO severity scale. The rest of the ADRs were classified as mild. All ADRs were notified using the National Form for ADRs. Pharmacists Interventions were handed out to treating physicians and written information was given to patients. Performing active pharmacovigilance in SLE patients showed that ADRs in this population are not negligible, and that pharmacists play a key role contributing to better patient care and improving ADRs notification.

Keywords: Systemic Lupus Erythematosus, Adverse Drug Reactions, Active Pharmacovigilance.