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General and Risk Management, Patient Safety (including: medication errors, quality control)
Improving pharmacovigilance in psychiatry
  1. E. Galfrascoli,
  2. E. Magni,
  3. C. Panciroli,
  4. C. Bonfatti,
  5. G. Cerveri,
  6. A.M. Boschiero,
  7. G. Muserra
  1. 1A.O. Fatebenefratelli e Oftalmico, Servizio di Farmacia Aziendale, Milano, Italy
  2. 2A.O. Fatebenefratelli e Oftalmico, U.O. Psichiatria, Milano, Italy
  3. 3A.O. Fatebenefratelli e Oftalmico, U.O. Medicina d’Urgenza, Milano, Italy


Background In the last years, Regione Lombardia, on behalf of the Italian Regulatory Agency (AIFA), promoted some pharmacovigilance projects: our hospital, that since 1980 has become one of the most representative for pharmacovigilance in Italy, is taking part in four projects (FARMAMONITO, FARMAONCO, MEREAFAPS and MEAP). These projects actively involve healthcare professionals in spontaneous ADRs (adverse drug reactions) report. Since ADR to antipsychotic drugs are often under-reported, a collaboration was started, between the Department of Neuroscience and the Hospital Pharmacy.

Purpose Aim of the collaboration is to improve the awareness of the drugs used daily, in particular concerning the indications, uses, and ADRs of antipsychotics, in psychiatrics, psychologists and nurses. Better knowledge of antipsychotics may lead to a faster detection of side effects, helping in appropriate patient care.

Materials and methods The pharmacist, as pharmacovigilance monitor, takes part to briefing at psychiatric ward and to periodic equipe meeting at CPS (community mental health centre): he develops and presents summaries of selected molecules toxicity profile, facilitating and soliciting the ADRs reporting. The pharmacist collects the case information, fills the report form and enters the reactions into the database RNF (Rete Nazionale di Farmacovigilanza) and answers to questions asked by pharmaceutical companies.

Results This collaboration has improved the ADRs attention and report: between 2008 and 2011 the report has increased about two folds. In particular, in 2011, 18 ADRs to antipsychotics were identified (69% not serious, 27% serious). Molecules suspected were haloperidol, olanzapine, risperidone and ziprasidone. Most common ADRs were weight gain, hyperglycaemia, long QT syndrome, sedation and confusion. In the light of the initial results, the collaboration will continue for 2012.

Conclusions This initiative started a collaboration among pharmacists, psychiatrics, psychologists and nurses who provide appropriate patient care and to ensure treatment safety, detecting early alarm signals to estimate the risk/benefit drug profile.

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