Ottobre 2009 - Volume XXVIII - numero 8
Focus
Già responsabile del Servizio di Farmacovigilanza, Agenzia Italiana del Farmaco (AIFA)
Indirizzo per corrispondenza: m.venegoni@aifa.gov.it
Key words: ADR, Case report, Pharmacovigilance, Paediatrics
The publication of case reports is one of the useful didactic instrument to disseminate the knowledge on many or very rare adverse reactions that physicians must know whenever they make prescriptions. Moreover, the activity of pharmacovigilance and the recommendations that have to follow certain rules are an indispensable collaboration tool by the physicians for the drug regulatory agencies.
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Focus
1Laboratorio per la Salute Materno-Infantile, Dipartimento di Salute Pubblica
2Istituto di Ricerche Farmacologiche “Mario Negri”, Milano
Indirizzo per corrispondenza: antonio.clavenna@marionegri.it
Key words: ADR, Drug, Safety, Efficacy, Paediatrics
A meta-analysis of 8 prospective studies performed in the United States and Europe in the 2001-2007 period estimated that the incidence of ADRs in hospitalised children is 10.9% and in paediatric outpatients 1.0%. The contribution of ADRs to the hospitalisation of children was estimated at 1.8%. The skin and gastrointestinal system were the organs most commonly affected and antibiotics were the drugs most commonly associated with ADRs. During the same observation period, the international drug regulatory agencies issued safety alerts concerning the paediatric population for 28 drugs or drug classes, 5 of which were for psychotropic drugs and Food and Drug Administration issued safety alerts for 20 drugs. The Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) issued warnings for 12 drugs: antidepressants, aspirin, cefaclor, ceftriaxone, codeine, desmopressin nasal spray, dolansetron, domperidone, lopinavir/ritonavir, metoclopramide, nasal decongestants and oseltamivir. For 3 medications (cefaclor, dolansetron, domperidone) measures were taken only in Italy. In some cases (e.g. nasal decongestants, domperidone) the decision was based on the scant evidence of efficacy in addition to the safety concerns. The drug safety issue is related to the rational use of drugs, and educational programmes for health professionals and parents are needed with the aim of improving the rational use of drugs and ensuring safe and effective medicines for children.
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Focus
Responsabile Nazionale FIMP Ricerca e Sperimentazione sui Farmaci
Indirizzo per corrispondenza: ettorenapoleone@tiscali.it
Key words: ADR, Pharmacovigilance, Family paediatricians
Pre-marketing trials cannot define the safety of drugs introduced into the market sufficiently. Therefore, the spontaneous signalling of suspected adverse drug reactions (ADRs) becomes an important tool to promote justified safety alerts. FIMP has formed a pharmcovigilance team whose aim consists in: a) organizing trainings; b) setting up a pharmacovigilance network of family paediatricians; c) setting up a territorial survey (drug and/or disease registers); d) active participation in independent research tenders to assess risks/ benefits of drugs in paediatrics; e) inviting drug producers to insert a link in their programmes for spontaneous signalling; f) enhancing a strict collaboration with the national regulatory action.
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