ABSTRACT
Title
The relevance of fostering paediatric pharmacovigilance for appropriateness in therapy of chilhood disorder. The experience from a study in the lombardy.
Authors
S. Radice1, S. Antoniazzi1, V. Perrone1, C. Carnovale1 and E. Clementi1,2
1 Unit Clinical Pharmacology, Depat. of Clinical Sciences, University Hospital "Luigi Sacco", Milan, Italy; 2 E. Medea Scientific Institute, Bosisio Parini, Lecco, Italy
1 Unit Clinical Pharmacology, Depat. of Clinical Sciences, University Hospital "Luigi Sacco", Milan, Italy; 2 E. Medea Scientific Institute, Bosisio Parini, Lecco, Italy
Abstract
The potential risk of adverse drug reactions (ADRs) in children has become a public health concern and regulatory agencies in Europe have acknowledged the need for urgent research efforts in this area. In particular in the case of children such post marketing surveillance studies are important; in general the randomized controlled clinical trials (RCCTs) used in the clinical development process have limited capacity to detect serious, rare and unexpected ADRs. Pharmacokinetics, pharmacodynamics and epidemiology differ between children and adults in general as well as between children of different age groups, with very diverse adverse event and ADR profiles. To date, the paucity of studies in the paediatric populatation has led as a consequence to drug prescritions to children on an unlicensed or “off-label” basis.
Fifteen hospitals and 2 territorial services belonging to the Lombardy Regional Health System were enrolled in the project. All physicians were provided with the official italian ADRs reporting form in an online version, which rendered its filling an easy to perform task. Paediatricians involved in the project were adequately trained in it. The reported ADRs were included in a specific database created by our Unit. Every month the data obtained from the database were analysed and inserted in reports containing an overview of the ADRs classified by SOC, ATC, patients features and drugs. For each unknown and serious ADRs a specific report was send by mail to all physicians enrolled in the project.
The training, the reporting form being online, and the informative feedback provided to participating paediatricians led to high success in the project both in terms of number of ADRs reported and their quality. A total of 440 reports of suspected ADRs were reported for individuals from birth to 17 years of age during the 1 yerar study period of which 55.5% were reported in boys and 45.5% in girls. A significant proportion of ADRs was reported in early childhood (3 to 11 years old). 37% of all ADRs were classified as serious and 12% as unknown. Significnatly the proprtion of vaccines-related ADRs which is abnormally high in Italy was normalised. Among the class of drus for which ADRs were reported were anti-infectives, anti-inflammatory, analgesics and drugs for nervous system disorders.
This project demonstrates that an approach of pharmacoviglinace accompanied by continuoustraining, sharing of results and easy to fill reporting forms, enhances the effectiveness of generating new informative data which can be exploited for benefit/risk analysis, improve drug prescribing and ameliorate current regulation, thus ultimately impacting on paediatric patient safety.
Fifteen hospitals and 2 territorial services belonging to the Lombardy Regional Health System were enrolled in the project. All physicians were provided with the official italian ADRs reporting form in an online version, which rendered its filling an easy to perform task. Paediatricians involved in the project were adequately trained in it. The reported ADRs were included in a specific database created by our Unit. Every month the data obtained from the database were analysed and inserted in reports containing an overview of the ADRs classified by SOC, ATC, patients features and drugs. For each unknown and serious ADRs a specific report was send by mail to all physicians enrolled in the project.
The training, the reporting form being online, and the informative feedback provided to participating paediatricians led to high success in the project both in terms of number of ADRs reported and their quality. A total of 440 reports of suspected ADRs were reported for individuals from birth to 17 years of age during the 1 yerar study period of which 55.5% were reported in boys and 45.5% in girls. A significant proportion of ADRs was reported in early childhood (3 to 11 years old). 37% of all ADRs were classified as serious and 12% as unknown. Significnatly the proprtion of vaccines-related ADRs which is abnormally high in Italy was normalised. Among the class of drus for which ADRs were reported were anti-infectives, anti-inflammatory, analgesics and drugs for nervous system disorders.
This project demonstrates that an approach of pharmacoviglinace accompanied by continuoustraining, sharing of results and easy to fill reporting forms, enhances the effectiveness of generating new informative data which can be exploited for benefit/risk analysis, improve drug prescribing and ameliorate current regulation, thus ultimately impacting on paediatric patient safety.