Active pharmacovigilance program in patients affected by psoriasis and inflammatory bowel diseases .

OBJECTIVE

To help identify adverse events (AEs) in new biologic therapies and to spread the culture of pharmaceutical surveillance among patients affected by psoriasis or inflammatory bowel disease (IBD).

MATERIALS AND METHODS

This active pharmacovigilance program provided all patients with telephone follow-ups (FU), carried out by a clinical pharmacologist for a total duration of 1 year. Collected AEs were classified according to the MedDRA dictionary.

RESULTS

21 patients with psoriasis and 10 patients with IBD were enrolled. In our sample, the AEs reported were frequent but mild, underlining the crucial role of active pharmacovigilance in detecting minor AEs rarely spontaneously reported by the patients.

CONCLUSION

According to our experience, a multidisciplinary team is recommended to manage complex therapies improving AE reporting and promoting greater therapeutic adherence.