Annual Report 2006 - Mario Negri - Istituto di Ricerche ... · Annual Report 2006 ... Istituto de...

MOTHER and

CHILD HEALTH

Laboratory for

Annual Report

2006

“Mario Negri” Institute for Pharmacological Research

20157 MILAN, Italy - Via Eritrea, 62 - Tel. 0039 02 39014.511 - Telefax 0039 02 3550924 E-mail: [email protected] - http://www.marionegri.it

Annual Report 2006

Laboratory for Mother and Child Health

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RESEARCH, AS A MULTIDIMENSIONAL APPROACH TO PRODUCING KNOWLEDGE, CHARACTERISES THE LABORATORY’S ACTIVITY. RESEARCH PROVIDES THE BASIS FOR PLANNING AND CARRYING OUT THE LABORATORY’S ACTIVITY IN A CRITICAL WAY AND INVOLVES THE PARTICIPATION OF HEALTH PROFESSIONALS, SOCIAL WORKERS, MOTHERS, CHILDREN, AND PARENTS. SPECIAL ATTENTION IS GIVEN TO ACTIVITIES INVOLVING COUNTRIES IN THE NORTH AND SOUTH OF THE WORLD.

Annual Report 2006


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THE MAIN OBJECTIVE OF THE LABORATORY FOR MOTHER AND CHILD HEALTH IS TO EN-SURE A BETTER MOTHER AND CHILD WELL-BEING BY UNDERTAKING INTERDISCIPLINARY AND COLLABORATIVE WORK IN THE FIELD. FOUR BROAD AREAS, OR SPHERES, OF RESE-ARCH HAVE BEEN SELECTED:

♦ MONITORING AND EPIDEMIOLOGICAL EVA-

LUATION OF UTILISATION AND EFFECTS OF DRUGS AND VACCINES;

♦ RESEARCH METHODOLOGY IN GENERAL HO-SPITAL AND PAEDIATRIC COMMUNITY PRAC-TICE;

♦ PUBLIC HEALTH DETERMINANTS OF CHIL-DREN’S WELL-BEING;

♦ TRANSFER OF HEALTH INFORMATION TO THE COMMUNITY.

THE DRUG AND HEALTH INFORMATION CEN-TRE (CENTRO DI INFORMAZIONE SUL FARMA-CO E LA SALUTE), WHOSE MAIN ACTIVITY EN-TAILS PROMOTING RATIONAL DRUG USE DU-RING BREASTFEEDING AND IN CHILDHOOD, IS PART OF THE LABORATORY.

Annual Report 2006


Current Laboratory Staff (January 2005)

Laboratory Head

Maurizio BONATI, MD. Scientists

Marina BIANCHI, MD. PhD Rita CAMPI, STAT.D. Antonio CLAVENNA, MD. PhD Student of the Open University, London Filomena FORTINGUERRA, PHARM.D. Lorena LABATE, STAT.D. Fellows of the Pharmacological Research Specialist Course Chiara PANDOLFINI, PhD

Assistants

Maria Grazia CALATI Secretary for the Center for Drug and Health Information

Daniela MIGLIO Editorial Secretary for Ricerca & Pratica

Nicoletta RASCHITELLI, MOT.SCI.D. Secretary for the Laboratory for Mother and Child Health

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Annual Report 2006


Visiting Scientists

Jasna KUSTURICA, MD. (from 21/01/06 to 28/01/06)

Istituto di Farmacologia e Tossicologia, facoltà di Medicina, Università di Sarajevo Andrijana HRKAĆ, PHARM.D. (from 21/01/06 to 28/01/06) Melifico d.o.o. Mostar Tijana SPASOJEVIĆ, PHARM.D. (from 21/01/06 to 28/01/06) Agenzia del Farmaco della Repubblica Srpska Filipa MARCOTIĆ, MD. (from 21/01/06 to 28/01/06) Ospedale Universitario di Mostar, Mostar Djanilson BARBOSA dos SANTOS, PHARM.D. (from 01/09/06 to 30/09/06) Istituto de Saúde Coltiva - Universidade Federal da Bahia - Salvador - Brasil

Scientists

Silvia MASCHI, PHARM.D. Alessandra ROSSIGNOLI, PHARM.D.

The Laboratory’s activity was made possible also with the help of the Insti-tute’s technicians and administrative service, and, aspecially, with the as-sistance of the Laboratory of Medical Informatics (Eugenio Santoro, Va-lentina Rossi, Lorenzo Marco Rossi) and the “G.A. Pfeiffer” Library’s per-sonnel (Vanna Pistotti, Giusy Petruzzelli, Elena Alaimo).

Staff present in 2005 who no longer work in the Laboratory /Visiting

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Annual Report 2006


Publications in Peer-Reviewed Journals

Bonati M, Breitkreutz J, Choonara I, Hoppu K, Jacqz-Aigrain E, Langhendries JP, Pons G, Rane A, Seyberth H, van den Anker J on behalf of the ENDIC. Paediatric Clinical Pharmacology in Europe. Paed Perinat Drug Ther 2006;7:134-37.

Bonati M, Clavenna A, Rossi E, De Rosa M. Antidepressant prescriptions in children

and adolescents in general practice. BMJ.com 2006;http://bmj.bmjjournals.com/cgi/eletters/331/7530/1451#125977. Bonati M, Maschi S, Clavenna A. Differences in generic sertraline for children: real or

artefact from cost containing to clinical quality of generics use. Eur J Clin Pharmacol 2006;62:1083-85.

Bonati M, Pandolfini C. Trial registration, the ICMJE statement, and paediatric jour-

nals. Arch Dis Child 2006;91:93. Bonati M, Pandolfini C. Trial registration, the International Committee of Medical

Journals Editors statement, and paediatric journals. Pediatr Anesth 2006;16:92-99. Bonati M, Pandolfini C, Rossi V, Santoro E, Arnau de Bolos JM, Danes Carreras I,

Fuentes Camps I, Castel Llobet JM, Jacqz-Aigrain E, Zarrabian S, Choonara I, Sammons H, Smith C. Registering paediatric clinical trials. Paed Perin Drug Ther 2006;7:170-171.

Santoro E, Rossi, V, Pandolfini C, Bonati M. DEC-net: the development of the Euro-

pean Register of Clinical Trials on Medicines for Children. Clinical Trials 2006;3:366-375.

Varona Rodriquez F, Bonati M, Reder M, Choonara I. Health care in Cuba. Lancet.com

2006; http://www.thelancet.com/journals/lancet/article/PIIS014067360669171X/comments?page=2&prev=1&totalcomments=3#645.

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Transfer of Information

Bonati M. Guida ai perchè delle scienze infermieristiche. Quaderni ACP 2006;13: 26. Bonati M. Intervista jurados internacionales de la 8a Bienal Saludarte 2006;4:269-271.

Bonati M, Campi R e Gruppo di Lavoro per la Convenzione sui Diritti dell’Infanzia e dell’Adolescenza. I diritti dell’Infanzia e dell’Adolescenza in Italia. In: II rapporto di aggiornamento sul monitoraggio della convenzione sui diritti dell’infanzia e dell’ado-lescenza in Italia anno 2005-2006. Gruppo di Lavoro per la CRC c/o Save the Chil-dren Italia, Roma. 2006;7-70.

Bonati M, Campi R. Salute e assistenza. In: I diritti dell’infanzia e dell’adolescenza in Italia. 2° rapporto di aggiornamento sul monitoraggio della convenzione sui diritti dell’infanzia e dell’adolescenza in Italia. Anno 2005-2006. 2006;25-34.

Bonati M, Campi R, Labate L. La ripartizione del Fondo Sanitario Nazionale non do-vrebbe anche considerare le disuguaglianze di sviluppo tra le Regioni? R&P 2006; 2-2:61-64.

Bonati M, Clavenna A, Maschi S, Biasini G, Campi R, Labate L, Longoni P, Miselli M, Narducci M, Nobili A, Zanfi D. Le inserzioni pubblicitarie pubblicate sulle riviste del medico di famiglia. R&P 2006;22:65-78.

Bonati M, Pandolfini C. Perchè gli studi clinici vanno registrati? @Partecipasalute http://www.partecipasalute.it/partecipa/commenti-001.php:2006.

Bonati M, Zuddas A, Panei P, Masi G. Psicofarmaci e bambini. R&P 2006;22:184-188.

Centro Informazione sul Farmaco e la Salute. Bambini e Farmaci. Quaderni ACP 200-6;13:226.

Cerzani M, Pasina L, Clavenna A, Nobili A, Garattini L. Uso dei nuovi farmaci antin-fiammatori non steroidei in medicina generale. R&P 2006;22:152-167.

Clavenna A. L’ospedale a portata di ... mouse. R&P 2006;22:222-223.

Clavenna A, Bonati M. Bambini e Farmaci. Quaderni ACP 2006;13:173.

Colombo C, Clavenna A. Farmaci per curare la febbre nei bambini? Meglio usarli con moderazione. @Partecipasalute ht tp: / /par tecipasalute . i t / rubrica-1/rubrica017.php:2006.

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Gangemi M, Siani P, Bonati M. Cultura, intelligenza ed etica al XVII Congresso Nazio-nale dell’Associazione Culturale Pediatri. Quaderni ACP 2006;13:18-19.

Garattini S, Bonati M. L’informazione indipendente sul farmaco: un’urgenza inderogabi-le. R&P 2006;22:105-107.

Gruppo di Lavoro multidisciplinare sul metilfenidato. Disturbo da Deficit di Attenzione con Iperattività (ADHD): le tappe per un uso razionale dei farmaci. BIF 2006;5:197-203.

Jacqz-Aigrain E, Zarrabian S, Pandolfini C, Bonati M, Sammons H, Choonara I, Danés I, Fuentes I, Arnau J. DEC-net, le registre européen des essais cliniques pédiatriques, est une réalité. An european clinical trial register in the paediatric field: DEC-net. Archives de Pédiatrie 2006;13:333-335.

Jacqz-Aigrain E, Zarrabian S, Pandolfini C, Bonati M, Sammons H, Choonara I, Danes I, Fuentes I, Arnau J. Le registre européen des essais clniques pédiatriques est une ré-alite. [A complete clinical trial register is already a reality in the paediatric field]. Thérapie 2006;61:121-4.

Labate L. L’analisi della concordanza. R&P 2006;22:114-118.

Maschi S, Clavenna A, Bonati M. Sertralina in età pediatrica: un caso di (dis)equivalenza. Informazione sui Farmaci 2006;30:26-28.

Pandolfini C. ProMED-mail. R&P 2006;22:222-223.

Pandolfini C, Bonati M. Comunicazione e informazione sanitaria via internet. Come na-vigare fra i siti web sulla Fibrosi Cistica. In: IV seminario di primavera. Progressi recen-ti e sviluppi futuri della ricerca in fibrosi cistica. Verona, 20 maggio 2006;21-27.

In the last five years, the Laboratory has produced 179 publications, 50 of which in primary journals (37 are indexed in MEDLINE). In 2005, 28 publications were produced, 10 of which in primary journals (6 indexed in MEDLINE). The Impact Factor in the 2002-2006 period was 203,2 (average 6,2), while it was 28,8 in 2006 (average 7,2).

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Annual Report 2006


Clavenna A, Bonati M. Epidemiological aspects of drug use in children. In: Textbook

on paediatric Pharmacology. Jacqz-Aigrain E, Choonara I eds. Taylor & Francis Group, New York 2006;73-83.

Pandolfini C, Bonati M. A register of clinical trials in children. In: Textbook on pae-

diatric Pharmacology. Jacqz-Aigrain E, Choonara I eds. Taylor & Francis Group, New York. 2006;63-72.

Bonati M. The Italian saga of ADHD and its treatment. In: Lloyd G,Cohen D, Stead J,

eds. International Critical Perspective on ADHD. Routledge, Abingdon, Oxon (UK) 2006;128-136.

Bonati M, Campi R. La salute materno infantile. In: A caro prezzo. Le diseguaglianze

nella salute. 2° Rapporto dell’Ossevatorio Italiano sulla Salute Globale. Edizioni ETS, Sesto Fiorentino (FI) 2006;71-84.

Bonati M, Clavenna A. Malattie rare, farmaci orfani, ricerca clinica in pediatria. In:

Dermatologia basata sulle prove di efficacia. ed Masson, Milano 2006;376-381. Bonati M, Clavenna A, Rossi E, De Rosa M. Nuovi farmaci e loro utilizzo con piccoli

pazienti. Scheda 24. In: 7° Rapporto Nazionale sulla Condizione dell’Infanzia e dell’-Adolescenza. Eurispess e Telefono Azzurro, Roma 2006;369-377.

Book Chapters

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International Abstracts

Bonati M. Use of antidepressant drugs in childhood and adolescence. In: 4th Summer School of neuroscence. Depressive disorders: from neurobiology to pharmacological treatment. Catania, 2006, 22-28 July. 2006;16.

Bonati M, Clavenna A, Rossi E, De Rosa M. Use of Psychotropic Medications in Ital-

ian Children and Adolescent. In: ESDP Xth Congress Stocholm, Sweden 2006, June 14-17. 2006.

Maschi S, Clavenna A, Bonati M. Analgesic drugs for paediatric needs. Paed Per Drug

Ther 2006;7:111. Rossignoli A, Clavenna A, Bonati M. Antibiotic prescriptions in the outpatient paediat-

ric population. Paed Per Drug Ther 2006;7:110-111. Santoro E, Rossi V, Pandolfini C, Bonati M. DEC-net: the development of the Euro-

pean Register of Clinical Trials on medicines for children. Clinical Trials 2005;2:s40. Usala T, Clavenna A, Bonati M, Zuddas A. Is controversial efficacy of SSRI in treating

depression in children and adolescent related to differences in study design? Eur Neu-ropsychopharmacol 16 Supplement 2006;4:S177.

Ventura ML, Paterlini G, Doni D, Bonati M, Tagliabue P. Nasal continuous positive air-

way pressure and high frequency oscillatory ventilation for the treatment of respiratory distress syndrome in preterm babies: a randomized control trial. Pediatr Crit Care Med 2006;6:244.

Annual Report 2006


IN ADDITION TO PUBLISHING RESULTS OF RE-

SEARCH IN PEER-REVIEWED JOURNALS, THE LABORATORY UNDERTAKES A RANGE OF AC-

TIVITIES TO FOSTER THE WIDEST POSSIBLE DEBATE AND DISCUSSION OF RESEARCH FINDINGS AND PROBLEMS DEALING WITH PUBLIC HEALTH, IN PARTICULAR MOTHER AND CHILD CARE. DISSEMINATION STRATE-

GIES INCLUDE ACTIVELY PARTICIPATING IN AND PRESENTING FINDINGS AT SCIENTIFIC AND PUBLIC CONFERENCES, HOLDING FO-

RUMS AND BRIEFINGS, GIVING TALKS AND LECTURES, RESPONDING TO MEDIA INQUIR-

IES, AND PRODUCING PAMPHLETS AND RE-

PORTS. COLLABORATION WITH PROFESSIONALS AND LAY PEOPLE, AS WELL AS CONTINUING EDU-

CATION-INFORMATION ARE COMMON STIMULI OF THE LABORATORY’S ACTIVITY.

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A 10-day “Stage” was organised by the Laboratory and held at the “Mario Negri” Institute in Milan as part of the third Master’s Course in Analysis and Management of Projects for Development (www.eco-dip.unimi.it), an inter-university course aimed at specialising stu-dents in the planning and management of co-operation projects for development. The Stage involved a thorough examination of the problems associated with public health in develop-ing countries, taking into consideration their primary importance to the entire world’s population in this new millennium. The course was based on both theory and practice. The lessons involved issues such as coping with emergency situations, providing assistance for extreme needs, addressing the problem of access to drugs, health and well-being indexes, analyses of living conditions, and intervention programs, and were complemented by hands-on practice sessions that also involved the basics of epidemiology.

MASTER’s Course

Invited Speakers:

Albonico M*, Fondazione Ivo de Carneri - Milano Anselmi M, Centro Malattie Tropicali, Negrar - Verona Buzzetti C, Master’s student 2004 Caccamo ML, CESVI - Bergamo Cattaneo A*, Ufficio Cooperazione Internazionale Materno Infanti-

le - Trieste El-Hamad I, Società Italiana di Medicina delle Migrazioni - Bre-

scia Fateh-Moghadam P*, Osservatorio Epidemiologico - Trento Fumagalli A, Novate Milanese - Milan La Corte PM, Care the People - Milan

Li Bassi L, Global Fund - Switzerland Maciocco G*, Università di Firenze - Florence Pacileo G*, Università Bocconi - Milano Pezzoli MC, Dipartimento di Malattie Infettive Spedali Civili -

Brescia Russo S, Master’s student 2004 Stefanini A*, Università di Bologna - Bologna Tediosi F*, Swiss Tropical Institute, Swiss Center for Internatio-

nal Health - Basilea, Switzerland Tognoni G*,

Tribunale Permanente dei Popoli - Fondazione Inter-nazionale “Lelio Basso”

* Italian Observatory an Global Health

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13-24 March 2006, Milan

Accademic Year 2005-2006 Stage

V Master

Cooperazione e Salute

Pubblica

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Participants: Nicoletta Dentico, Drugs for Neglected Diseases initiative (DNDi) Valerio Reggi, World Health Organization (WHO) Sergio Dompe’, FARMINDUSTRIA, president Norberto Perico, International Society of Nephrology Research and Prevention Committee (ISN)

Co-ordinators:

Silvio Garattini, Director Mario Negri Institute for Pharmacological Research (IRFMN)

Maurizio Bonati, Italian Observatory an Global Health

A meeting/debate was organised a the beginning of the course, entitled

“DISUGUAGLIANZE NELLA SALUTE: LA RICERCA, LO SVILUPPO L’ACCESSO

AI FARMACI NEI PAESI CON SCARSE RISORSE”

A CD contain

ing the stag

e’s

contents i

s availa

ble

Annual Report 2006


Workgroup on the Workgroup on the “Convention for child and “Convention for child and

adolescent rights”adolescent rights”

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The Laboratory for Mother and Child Health is part of the Workgroup on the “Convention for child and adolescent rights” (CRC) in Italy. The group was set up in December 2000 with the aim to prepare a report on the status of children in Italy that would act as a supplementary (not alternative) report to that presented by the Italian government, to be submitted to the United Nations Committee on child and adolescent rights. The first report was presented in Rome in 2001 and underwritten by 42 associations and non-governmental organisations. While carrying out the monitoring activity, the workgroup decided on the creation of an an-nual, updated report on the status of children and adolescents in Italy and on the related United Nations Committee’s recommendations, focusing on priority issues. The report is not only intended to identify our health system’s faults, but also to be an op-portunity to prompt a timely and constructive debate among the institutions responsible for the status of children and adolescents in Italy, and, therefore, for the implementation of the rights guaranteed by the convention. In the 2006 update report, the second one created by the group, the issues already addressed in the first report concerning the overall action measures (Chapter I) and the special meas-ures for the protection of vulnerable groups (Chapter IV), are taken up again and updated, enriching the analysis with additional contributions and more detailed observations. Two new chapters have been added, concerning health and care (Chapter II), education, and rec-reational and cultural activities (Chapter III). All this is carried out with the hope that it will stimulate, and contribute to, the development of standard procedures and legislative reforms that will bring about a tangible improvement in the condition of all youths in Italy.

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The ARNO Observatory (http://osservatorioarno.cineca.org) was set up in 1986, following the experience acquired at the CINECA (Consorzio Interuniversitario di Bologna; www.cineca.it) through the collaboration with the drug services of the local health units that are part of the ARGO system for the online monitoring of the drug prescription data. The Observatory is a multicentre system distributed throughout the territory that uses an epide-miologic approach focused on the population and its problems. The ARNO Paediatric Pro-ject, active since 1998 and in collaboration with the “Mario Negri” Pharmacological Re-search Institute in Milan, evaluates drug prescriptions in paediatric primary care. The ARNO Paediatric Project (but, more generally, the entire ARGO-ARNO database), fol-lows one and a half million children aged less than 18 years (15% of the Italian population of the same age group), one third of whom have been followed for the past 6 years. These children make the project an efficient tool for evaluating outcomes (the health of children and their parents), which are made available both to health care workers who guarantee clinical assistance in primary health care and to those working towards the planning and or-ganisation of health care services and policies. The project represents a unique tool at the national level and a rare one at the international level. An evaluation of the psychotropic drug prescribing profile was carried out in addition to the analysis of the data collected by the ARNO Observatory during 2005. During this period, psychotropic drugs (antidepressants and/or antipsychotics) were prescribed to 2 per thou-sand children and adolescents. Antidepressants were prescribed to 1.7‰ of the children and antipsychotics to 0.4‰.

Four percent of the children and adolescents treated with psychotropic drugs were given both antidepres-sants and antipsychotics. Antidepressants were prescribed mostly to females (M/F=0.7), while the prevalence of antipsychotics was higher in males (M/F=2). The prevalence increased with age, reaching a maximum among the adolescents: 7 females in 1000 between 14 and 17 years old re-ceived at least one psychotropic drug prescription. SSRIs were the most common antidepressant drug class and were prescribed to 79% of patients treated with drugs from this class; 14% received tricyclics and 12% atypical antidepressants. Five percent received antidepressants belonging to two different classes.

ARNO paediatric project and ARNO paediatric project and PsYCHOTROPIC DRUGS PsYCHOTROPIC DRUGS

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A total of 16 antidepressants and 20 antipsychotics was prescribed. Sertraline was the most prescribed antidepressant (0.6‰) followed by paroxetine (0.3‰), and citalopram (0.2‰), while, among the antipsychotics the most prescribed were risperidone (0.2‰) and olanzap-ine (0.1‰). The psychotropic drug prescription prevalence increased in the 1998-2005 period, reaching a maximum in 2002 (2.8‰). The overall antidepressant drug prevalence pattern is similar to that of all psychotropic drugs, while the prevalence of antipsychotics did not vary over time. The increase in antidepressant prescriptions is mostly due to SSRIs, whose prevalence in-creased by 4,5 times between 2000 and 2002. Trend of prevalence rate (per 1000 youths) of antidepressant prescription in children < 18 years, 2000 to 2005.

0,0

0,5

1,0

1,5

2,0

2,5

2000 2001 2002 2003 2004 2005

Year

Prev

alen

ce (p

er 1

000)

SSRITCAOthersOverall

The collaboration with CINECA involves, in particular, Marisa De Rosa, Elisa Rossi e Alessandra Berti.

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BRIANTEA Paediatric Surveillance UnitBRIANTEA Paediatric Surveillance Unit

The Laboratory for Mother and Child Health is co-ordinator of the Briantea Paediatric Sur-veillance Unit group, in which paediatric wards from 7 different hospitals in the Lombardy region participate. The aim of the group is to monitor paediatric hospital admissions and the health care and services offered to patients with any of 15 diseases chosen for their rela-tively low incidence/prevalence but their importance for public health and clinical research. During 2006, a total of 87 children were reported to have: 31 cases of Schonlein-Henoch purpura, 9 of idiopathic thrombocytopenic purpura, 7 of bacterial meningitis, and 7 of com-plications caused by chicken pox.

Cinisello Balsamo Lecco

Melegnano Merate Monza

Sesto San Giovanni Vimercate

IRFMN, Milano

Italian Drug AgencyItalian Drug Agency

A paediatric group of the Italian Drug Agency (AIFA) was set up on April 4th, 2006. The Laboratory for Mother and Child Health, along with the Associazione Culturale Pediatri (ACP), Centro Salute del Bambino (CSB), Federazione Italiana Me-dici Pediatri (FIMP), Società Italiana Farmacia Ospedaliera (SIFO), Società Italiana di Pediatria (SIP), and experts in the sector and members of the AIFA, partecipates. The group’s function is to support the AIFA’s regulatory activities, informational initiatives, pharmacovigilance work, and promotion of independent clinical research concerning drug use in the paediatric population.

Annual Report 2006


National ADHD RegisterNational ADHD Register

The marketing authorisation for methylphenidate and atomoxetine in Italy makes monitoring the use of this drug in children with attention deficit hyperactivity disorder (ADHD) necessary in order to assure the safety of its use. In order to meet this need, a national registry co-ordinated by the Istituto Superiore di Sanità was set up. The registry’s aims are to monitor the use of methylphenidate and atomoxetine, evaluate the safety and compliance of therapies with methylphenidate and atomoxetine, alone or in combination with other therapeutic interventions (pharmacological or not) in the medium and long term, identify the probability of having ADHD in the school-age population, define the optimal management strategy for ADHD through the standardisation of the most appropriate diagnostic and therapeutic strategies, evaluate the effectiveness of psychotropic drugs and/or behavioural therapy in the evolution of ADHD in school-aged children, and calculate the long term risk of persistence of the disorder, of being left behind in school, and of the development of psychosis or other psychiatric disorders. The first evaluation of the outcomes will be made after 24 months of the register’s activation.

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http://www.farmaco-iss.org/

Technical commission for the elaboration Technical commission for the elaboration of the regional therapeutic formularyof the regional therapeutic formulary

The Valle d’Aosta Autonomous Region set up an agreement with the “Mario Negri” Pharmacological Research Institute, assigning the Laboratory for Mother and Child Health, as temporary representative of the “Mario Negri” In-stitute, the periodic task of providing technical advice on the fulfillment of the following activities: updating and revision of the regional therapeutic formu-lary (PTR), predisposing opinions on trial protocols on pharmaceutical drug products and other therapeutic remedies, and creating documentation material concerning the topics on which the collaboration is based.

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Paediatric pain guidelinesPaediatric pain guidelines

The Presidio Ospedaliero degli Spedali Civili di Brescia’s health management committee set up 3 work groups, selecting members from among physicians and nurses representing various paediatric wards, in order to create guidelines concerning:

Pain evaluation and treatment in a paediatric emergency ward;

The use of analgesics during venipuncture procedures, positioning of the needle cannula, and capillary blood sampling in neonates;

Topical analgesic use during venipuncture procedures and positioning of the needle cannula.

The scientific co-ordination, necessary for the creation and evaluation of the guidelines, has been assigned to the Laboratory for Mother and Child Health.

Vaccine commissionVaccine commission

The Laboratory for Mother and Child Health is part of the Technical Consultation Commis-sion and assists in guiding the activities concerning vaccine prophylaxis. The group is called the “Technical-scientific commission for the planning and verification of vaccinations”, based on its assigned tasks. The main goals are: the elaboration of vaccine strategies, based on epidemiologic profiles, evaluation of the ongoing interventions, in terms of protective efficacy and unwanted effects, promotion of the qualitative improvement of vaccine management difficulties, including the vaccine registry. During 2006, the commission created a document entitled “Form for the evaluation of vaccine interventions - heptavalent antipneumococcal vaccine” and addressed the preparation of a document concerning the antimeningococcal vaccine.

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BOLIVIABOLIVIA

Decrease in the high maternal mortality in the town of

Tinguipaya, Department of Potosì

CUBACUBA

Taller Internacional Salud Infanto Juvenil Camagüey 2006

In February, in Camaguey, the first International Course on child health was held in Cuba. The Laboratory participated in its implementation and in the course, along with 20 delegates and several speakers. The course’s aims were to inform participants of Cuba’s health system concerning paediatric care and to encourage and support local physicians in their research and in publishing its results.

The program began in 2005 with a contribution by the Lombardy Region and will last 2 years. The programme’s aims are to improve the health of women during pregnancy and of young mothers by facilitating access to health centres through initiatives aimed at integrating the official health system with the traditional and community health systems. The Laboratory for Mother and Child Health is

the scientific and working partner for the project in Italy.

A CD containing the course’s con-

tents is available

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Annual Report 2006


ECUADORECUADOR

The Laboratory for Mother and Child Health, as epidemiologic scientific advisor and organisational partner, has participated since 2005 in the project entitled “Project for the reduction of maternal and perinatal mortality in the S.Lorenzo District - Esmeraldas -Ecuador Region”. The project is co-ordinated by the Bussolengo’s (VR) local health unit as part of its work in carrying out decentralised cooperation interventions for international development and solidarity.

The Laboratory has two other projects in Ecuador, in collaboration with Cecomet (Centro de Epidemiologia comunitaria y Medicina tropical) in Borbòn’s health district, situated north of the Esmeraldas province, Ecuador’s rural area. The names of the projects are:

“Improving vaccine coverage along the Santiago and Cayapas rivers” and

“Reducing child mortality through the supplementation of vitamins and nutri-tional elements”

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Prize was initiated in Colombia in 1992 with the aim to develop and promote paediatric research. The prize, which has social and community connotations, is aimed at health care workers in Central and South America and was designed to form a network though which knowledge, analysis, study, and equity involving child health can be exchanged. This network joins ethical solidarity with social and professional responsibility. The prize is set up by Colsubsidio (CAJA COLOMBIANA SUBSIDIO FAMILIAR), a private, mutual society with more than 850.000 members. Colsubsidio is a non-profit organisation that has been working in the social, health, and economic areas in different sectors of society since 1957 and is known for its high quality, professional work. Over 90 projects from 10 countries were submitted for the 2004 edition.

The projects represented over 200 authors and were evaluated by an international jury (GLORIA ARIAS e JORGE

MAURICIO PALÁU CASTANO, Colombia; MAURIZIO BONATI, Italy; CELIA BEATRIZ GIANOTTI, Brazil; RAÚL MERCER, Argentina; SERGIO RIESTRA, Mexico).

The abstracts and integrated texts of the projects that received an award are published on the SALUDARTE journal.

~

COLOMBIA

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DECDEC--net register: net register: conclusion of the projectconclusion of the project

8 preventive steps to safeguard 8 preventive steps to safeguard children’s healthchildren’s health

The DEC-net register, a project supported by the European Union and aimed at creating an updated, freely accessible register of paediatric drug therapy clinical trials, has come to an end. DEC-net collected information on over 270 trials reported by four countries (Italy, France, Spain, and the UK), a third of which were multinational. The register was success-ful, although it was small compared to the few, much larger, well-known registers. DEC-net remains the only paediatric-oriented register of clinical trials and, with its multilingual

characteristic, could be considered more user-friendly for the general public than most international registers that only provide (often limited) information in English. An international paediatric clinical trial register is therefore possible, and we are glad for the ongoing, powerful, worldwide movement towards trial registration and transparency of information and hope that it will lead to improved scientific testing and inter-pretation of its results, especially for children.

The Associazione Culturale Pediatri (ACP), or Paediatricians’ Cultural Association, created a document, in collaboration with the Laboratory for Mother and Child Health, entitled “8 PASSI DI PREVENZIONE A TUTELA DELLA SALUTE DEI BAMBINI” (8 PREVENTIVE STEPS TO SAFEGUARD CHILDREN’S HEALTH). The issue addressed is: protecting children’s health with immunisations, overcoming the inequalities in regional interventions. The 8 steps to take involve: informa-tion to families, their educated choice, paediatrician’s education, communication between paediatricians and centres involved in infectious disease monitoring, the co-ordination centres and methods, and the carrying out, of preventive strategies controlled by laws and rigorous methodological criteria, research, and costs. The primary goal is to favour the homogeneity of the information aimed at families, inspired by transparency and scientific rigour.

The DEC-net Register is supported under the European Union’s Fifth Framework Programme,

Thematic Programme “Quality of Life” (contract QLG4-CT-2002-01054)

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Annual Report 2006


Ricerca & Pratica was born in January, 1985, as a manifestation of the “Mario Negri” Institute for Pharmacological Research. Today, the journal is enhanced by the collaboration of the most advanced clinical research groups in Italy and by national, independent journals belonging to the International Society of Drug Bulletins (ISDB). How should a clinical study be interpreted? How can the difference between real and false news in the drug market be distinguished? How can the quality of health interventions be determined? R&P has helped readers respond to such questions for more than twenty years by addressing issues that are fundamental to research and practice in an in-depth manner. These issues involve clinical epidemiology, medical statistics, clinical pharmacokinetics, drug interactions, and drug-related economic and epidemiological investigations. The journal is appreciated for its independence as well as that of its authors and for its presence as an arena for all those professionals that collect data and carry out studies in general practice with the aim to increase their knowledge and to improve their practice. Ricerca & Pratica is also appreciated for its ability to go beyond the merely clinical aspect of medicine, without, however, forgetting that it is to this aspect that the readers dedicate most of their time and effort. R&P aims to continue in this direction, dedicating space to paediatrics and to issues related to public health as well, also at the European level. Through its activity, Ricerca & Pratica can therefore represent an exclusive, independent observation point. It is also an area that promotes contemplation, evaluation, and information by applying “tools” such as data trustworthiness and importance, the balance between benefits and risks and between benefits and costs, independence from conflicts of interest, and the realistic objective to contribute to a progressive, equally distributed improvement in the population’s health.

Editor: Maurizio Bonati Editorial board: Roberto Alfieri, Vittorio Bertelè, Guido Bertolini, Antonio Clavenna,

Daniele Coen, Vittorio Demicheli, Paolo Longoni, Alessandro Nobili, Chiara Pandolfini, Giacomo Toffol Scientific Committee: Giancarlo Biasini, Albano Del Favero, Silvio Garattini, Alessandro Liberati,

Valerio Reggi, Gianni Tognoni, Massimo Valsecchi, Giampaolo Velo Secretary: Daniela Miglio

E-mail: [email protected] Internet: www.ricercaepratica.it

24

RicercaRicerca&&PraticaPratica

ISTITUTO MARIO NEGRIISTITUTO MARIO NEGRI

Annual Report 2006


Health and Drug Health and Drug Information CentreInformation Centre

25

breastfeeding children total

0

500

1000

1500

2000 2001 2002 2003 2004 2005 2006

The Health and Drug Information Centre, initially created to promote the policy on hospital drug formularies, progressively expanded to cover out-of-hospital practice and to involve different types of users, including professionals and members of the public. The core of the HDIC’s activities is the daily telephone service providing information and advice on drug therapy and needs during breastfeeding and in childhood. In January 2004, the centre’s activity concerning drug information in pregnancy was taken over by Bergamo’s Clinical Toxicology Unit’s Poison Control Centre (Centro Antiveleni, Unità di Tossicologia Clinica, Ospedali Riuniti di Bergamo). Together, the Poison Control Centre and the Laboratory of Mother and Child Health form the Department of Clinical Pharmacy and Pharmacology. All queries, and their replies, are inputted into a database in order to monitor the centre’s activity with respect to both pharmacoepidemiological analysis and follow-ups performed.

Annual Report 2006


During 2006, 948 people contacted the Health and Drug Information Centre with a total of 1589 questions. In all, 74% were from women who were directly involved, 14% from general/hospital paediatricians, 7% from general practitioners or other non-paediatric specialists, and 5% from other health care workers. A total of 1309 requests for information concerned drug use, 280 the use of parapharmaceuticals, general information, and diagnostic exams. In all, 95% of the questions received by the centre concerned the safety of drugs during breastfeeding, while 5% concerned the administration of drugs to children. Although people called from all of Italy, most called from the north of the country (68%), especially from the Milan (403) and Brescia provinces (45). 18% of the requests were received from central Italy and 13% from the south.

Drugs and breastfeeding

Of the 1507 requests for information on breastfeeding, 72% came from 762 mothers and/or relatives, while the remaining 28% from 290 health care workers, of whom 161 were paediatricians. The mothers’ average age was 34 years (range 22-46) and that of the breastfed babies was 5 months (range 0-42). Half of these babies was ≤ 3 months. In all, 75% of the newborns were exclusively breastfed and 15% were fed artificial formula in addition to breast milk. The type of

nutrition was still undecided for the remaining 10%. Concerning the main therapeutic groups, based on the ATC classification, the drug classes for which information during breastfeeding was most often requested were: analgesics/antiinflammatories (M01/N02; 10%), psychotropic drugs (N05/N06; 9%) and systemic antibacterials (J01; 8%). More specifically, the psychotropic drugs (14%) and the antiepileptic agents (7%) were the classes for which information was most often requested on the part of health care workers. The indication most frequently associated with drug use was symptomatic pain control (136 queries), followed by allergy (113), and psychiatric disorders (104). By December 31st, 2006, a follow-up for 169 mothers whose child turned 6 months old was completed. Of these mothers, 78% continued exclusive breastfeeding, 6% had introduced artificial milk in the baby’s diet, and 16% had stopped breastfeeding. In all, 133 mothers had taken the drug for which they had asked information, 36 did not take it, and 6 substituted it with another drug. The reasons for not having taken the drug were: “because it was no longer necessary” (n=19), and “following the centre’s advice” (n=4), and “for fear” (n=13). In all, 59% of the newborns whose mothers were re-contacted for follow-up had been given one or

26

Annual Report 2006


more drugs in the first 6 months of life: 44/106 were anti-antinfectives, 40 analgesics and 22 antacids/proton pump inhibitors. Paracetamol was the most commonly prescribed drug (39), followed by amoxicillin (23), beclomethasone (13) and amoxicillin+clavulanic acid (11). The most common reason for prescribing drugs was “respiratory tract infections” (n=75). Drugs and Children

The requests for paediatric drug therapy information concerned 62 children aged 17 days to 17 years. In all, 45 mothers/fathers, 12 paediatricians and health care workers contacted the centre. Of the 82 queries received, 51 concerned general drug information, 16 concerned side effects, 6 concerned

dosage, 1 efficacy, and 8 the child’s health. The most common queries concerned anti-acids/proton pump inhibitors (8), followed by psychotropic drugs (6) and antibiotics (5). The most common reason for prescribing drugs was gastro-oesophageal reflux (8). Folic acid and SIDS

As part of the centre’s activity involving the monitoring of the general population’s level of health awareness, the information the mothers received on the use of folic acid in pregnancy to prevent neural tube defects and on the recommendations concerning sudden infant death syndrome (SIDS) was collected.

Concerning folic acid, 91% of the mothers had taken it during pregnancy, but only 21% had begun to take it before conception. Of the 486 newborns for whom information could be collected, 374 were placed in the supine sleep position, 90 on their side, and 22 face down. In 30% of the cases, the position was incorrect for SIDS prevention: 10% of the mothers had not received any information concerning the safest sleep position to place their children in and 49% had received advice from their paediatrician.

27

Annual Report 2006


February ♦ CÓMO INVESTIGAR IDENTIFICANDO LOS OBETIVOS PRIMARIES. QUÉ ANALIZAN

LOS RESULTADOS I LOS MÉTODOS ESTADÍSTICOS SIMPLES. Taller International Salud Infanto Juvenil Camagüey 2006. Direción Provincial de Salud, Camagüey, Cuba.

♦ IMPACT OF COMPLIANCE IN CHILDREN, THE ROLE OF PROPER INFORMATION TO

CHILDREN AND PARENTS. Evaluation of medicinal products in children - 4th course. Eudipharm, Bruxelles.

March

♦ LA SALUTE MATERNO INFANTILE. Corso “Le Politiche Globali per la Salute”. Os-servatorio Globale per la Salute; Melegnano (MI).

♦ MAGGIOR RIGORE NEL MONDO DEI FARMACI. Congresso “Farmaci: tra mito e re-altà”. F.I.D.A.P.A. Sezione di Terni; Terni.

♦ PSICOFARMACI E MEDICINA DELL’EVIDENZA NEL BAMBINO E NELL’ADOLESCEN-

TE. Seminari di aggiornamento 2006 “L’Urgenza in Neuropsichiatria dekk’Infanzia e dell’Adolescenza”. Facoltà di Medicina e Pediatria di Varese, Ospedale di Circolo e Fondazione Macchi; Varese.

♦ LA SALUTE INFANTILE IN UN MONDO GLOBALE TRA PROGRAMMA E DIRITTI. Cor-so di Laurea Infermieristica “La tutela della salute dei bambini dipsrità di risorse e diritti negati”. AO della Valtellina e della Valchiavenna Sez. di Sondrio, Facoltà di Medicina e Chirurgia Università degli Studi Milano-Bicocca; Faedo (SO).

♦ REVISIONE SISTEMICA E METANALISI. Corso: La risoluzione di scenari clinici con il supporto della EBM come strumento di formazione continua per il pediatra. Asso-ciazione Culturale Pediatri (ACP); Bologna.

April

♦ CRITERI DI VALUTAZIONE DI UNA PUBBLICAZIONE SCIENTIFICA IN GENERE ED AP-PLICAZIONE AL CAMPO SPECIFICO DELLA PSICOFARMACOLOGIA. Piano Formati-vo Dipartimentale 2006 “Psicofarmacologia: qualità dell’informazione della lettura scientifica”. Azienda Ospedaliera Ospedale di Circolo di Melegnano; Vizzolo (MI).

♦ LETTURA CRITICA DELLA LETTERATURA SCIENTIFICA.BANCHE DATI BIBLIOGRA-

FICHE - PERCORSI DI RICERCA. I DATABASE DELLE AGENZIE INTERNAZIONALI: IL GIOCO DEGLI INDICATORI. Corso di perfezionamento in Medicina Tropicale e Sa-lute Internazionale. Università degli Studi di Brescia; Brescia.

Conferences, Workshops, Presentations, ...

28

Annual Report 2006


May ♦ UTILIZZO DEGLI PSICOFARMACI IN ETÀ PEDIATRICA. Congresso. Dipartimento di

Medicina Sperimentale Sezione di Farmacologia “L. Donatelli” Centro di Farmaco-vigilanza e Farmacoepidemiologia - Seconda Università degli Studi di Napoli, Fa-coltà di Medicina e Chirurgia; Napoli (NA).

♦ L’AIDS UCCIDE L’AFRICA? Incontri: “L’Africa tra noi”. Comune di Ponteranica; Ponteranica (BG).

♦ QUANDO LE EVIDENZE SCARSEGGIANO: I DISTURBI NEUROPSICHIATRICI DELL’Età

EVOLUTIVA. Corso “Introduzione alla metodologia della salute mentale basata sulle prove. Dipartimento di Salute Mentale AO Ospedale Niguarda Ca’Granda; Milano.

♦ APPROPRIATEZZA PRESCRITTIVA IN ANTIBIOTICOTERAPIA. Corso aggiornamento PLS. ASL Milano Due, Dipartimento Cure Primarie; San Donato Milanese (MI).

♦ COMUNICAZIONE SANITARIA VIA INTERNET: SPECIALITA’ PER LA FIBROSI CISTI-

CA. IV Seminario di Primavera “Progressi Recenti e Sviluppi Futuri nella Ricerca sulla Fibrosi Cistica”. Fondazione per la Ricerca sulla Fibrosi Cistica - onlus; Vero-na.

♦ TRATTAMENTO PEDIATRICO E RELATIVE ESIGENZE TERAPEUTICHE. Corso “Preparazioni pediatriche allestite in farmacia: normativa e protocolli tecnici”. So-cietà Italiana Farmacisti Preparatori; Roma.

♦ REAZIONI AVVERSE IN GRAVIDANZA. REAZIONI AVVERSE IN PEDIATRIA. Master Farmacovigilanza. SEFAP, Milano.

♦ GLI STUDI DIAGNOSTICI. TRA SIGNIFICATIVITA’ STATISTICA E RILEVANZA CLINI-

CA: I LIMITI DELLE EVIDENZE. Corso: La risoluzione di scenari clinici con il sup-porto della EBM come strumento di formazione continua per il pediatra. Associa-zione Culturale Pediatri (ACP); Bologna.

June

♦ EPIDEMIOLOGY OF PSYCHOTROPIC DRUGS IN ITALY. 10th Biannual Congress Sto-ckholm. European Society for Developmental Perinatal & Paediatric Pharmacology - ESDPPP; Stoccolma, Svezia.

♦ IL TRIAL CLINICO: LETTURA E INTERPRETAZIONE. Corso di formazione e aggior-namento “Come interpretare un trial clinico”. Associazione Italiana Informatori Scientifici del Farmaco; Lodi.

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Annual Report 2006


30

♦ LA TERATOGENICITA’ DEI FARMACI ANESTETICI. 4° Congresso Nazionale. Società Italiana di Anestesia Rianimazione Emergenza e Dolore (SIARED); Napoli.

July

♦ USE OF ANTIDEPRESSANT DRUGS IN CHILDHOOD AND ADOLESCENCY. Quarta scuo-la estiva di Neuroscenze “I disturbi depressivi: dalla neurobiologia al trattamento farmacologico”. Federazione delle Società Europee di Farmacologia (EPHAR), So-cietà Italiana di Farmacologia (SIF); Catania.

September

♦ 8 PASSI DI PREVENZIONE A TUTELA DELLA SALUTE DEI BAMBINI. Associazione Culturale Pediatri. Camera dei Deputati; Roma

♦ FARMACOTERAPIA IN PEDIATRIA. XXVII Congresso Nazionale SIFO “La preven-zione e la cura del paziente nelle politiche sanitarie regionali”. Società Italiana di farmacia Ospedaliera (SIFO); Genova.

October ♦ ANTIBIOTICI. USO/ABUSO. “62° Congresso Nazionale Società Italiana di Pediatria”.

Società Italiana di Pediatria (SIP); Catania.

♦ RICERCA TRASLAZIONALE ED ENDPOINTS SURROGATI. 18° Congresso Nazionale dell’Associazione Culturale Pediatri (ACP) “Il mondo per i bambini”; Asolo, TV.

♦ LA PRESCRIZIONE DEGLI ANTIBIOTICI IN PEDIATRIA: DALL’EPIDEMIOLOGIA ALLE-

EVIDENZE. Corso d’aggiornamento Pediatri “La terapia antibiotica in pediatria”. A-zienda USL Roma C, Regione Lazio; Roma.

♦ OSPEDALE E TERRITORIO. I NOSTRI CASI CLINICI. Congresso. Antonio Cardarelli, Scuola Medica Ospedaliera della Campania; Napoli.

November

♦ LA SALUTE INFANTILE IN UN MONDO GLOBALE TRA PROGRAMMI E DIRITTI NEGA-TI. Congresso “L’isola che non c’è. Diritti negati ai bambini e ragazzi”. Dipartimen-to di Psicologia Università Cattolica del Sacro Cuore; Milano.

December

♦ PRODURRE FARMACI PER LE PERSONE SANE: SOGNO O REALTA’. Incontro pubblico “A un bambino darei le ali, ma lascerei che imparasse a volar da solo”. Assessorato ai Diritti della Persona - Comune di Malgrate; Malgrate, Lecco.

Annual Report 2006


31

January Sole 24 ORE Sanità Pediatria, la lettura nei "bilanci di salute" M. Gangemi; P. Siani; M. Bonati (2 January 2006 - pag. 22)

Corriere della Sera Ai bambini troppi antibiotici M. Bonati (15 January 2006 - pag. 54)

DIALNET Registros de ensayos clínicos y el proyecto DEC-net (registro europeo de ensayos clínicos en niños) J M Arnau, I Danés, I Fuentes (ICB digital n.38 enero de 2006)

Consumer El primer registro europeo de ensayos con fármacos para niños estará coordinado en España por el Hospital Vall d'Hebron de Barcelona http://www.consumer.es/web/es/salud/2006/01/17/148632.php

websalud.com farmacia España liderará el primer Centro de Registro de Ensayos Clínicos con niños http://www.websalud.com/articulo.html?xref=20060117salwsdfar_ 3&type=Tes&anchor=wsdfarntc

DOYMA Primer registro europeo de ensayos clínicos con fármacos para niños http://db.doyma.es/cgi-bin/wdbcgi.exe/doyma/press.plantilla?ident=42548

El Pais Ensayos de pediatría http://www.elpais.es/articulo/elpsalpor/20060117elpepisal_3/Tes/P%C3%8DLDORAS

CONFORT Primer registro europeo de ensayos clínicos con fármacos para niños http://www.confort.es/noticias/news_text.asp?id=35725

D (inserto Bambini dentro di Repubblica) L. Lazzaroni (28 January 2006 - pag. 58-66) February

Radio BASE - Mestre Il sistema Sanitario Cubano a confronto L. Boranga (14 February 2006)

Radio BASE - Mestre Quali farmaci contro l'influenza aviaria? L. Boranga (14 February 2006)

El Global.net España liderará el primer centro de registro de ensayos clínicos con niños España, Italia, Francia y el Reino Unido forman parte de esta iniciativa (del lunes 13 febrero de 2006 al domingo 19 de febrero de 2006 n. 282)

In the media ...

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Annual Report 2006


32

March

Dica 33 Farmacologia. Rischi da correre M. Imperiali http://www.dica33.it/argomenti/farmacologia/farmaci/farmaci8.asp

Dica 33 Pediatria. Stesso farmaco, pericoli diversi? M. Imperiali http://www.dica33.it/argomenti/pediatria/pediatria22.asp April Radio BASE - Mestre Le case farmaceutiche inventano le malattie L. Boranga (27 april 2006)

Radio Italia anni '60 Psicofarmaci e iperattività (27 aperile 2006) http://www.radioitaliaanni60.it/

Corriere della Sera "Non si cura con psicofarmaci". Via da scuola S. Ravizza (27 april 2006 - pag. 18) May

Gente "Capiscono se sono accettati o rifiutati" (19 May 2006)

Gente Bimbi troppo vivaci? Curarli è complicato R. Magosso (19 May 2006)

Dica33 Farmacologia (TGN1412) M. Imperiali www.dica33.it/%5Cargomenti%5Cfarmacologia%5Cfarmaci%5Cfarmaci8.asp June

Corriere della Sera Prozac ai bambini Via libera dall'Europa M. De Bac (9 June 2006 - pag. 21)

Radio Montecarlo Prozac per i bambini in Europa A. Costantini (9 June 2006)

RTL (radio) Bambini e Prozac E. Lo Russo (9 June 2006)

Studio di Pediatria La depressione nei bambini è la quinta causa di malattia R. D'Errico (New e Newsletter - 14 June 2006)

Salute Europa Depressione: l'uso della fluoxetina nei bambini http://www.saluteeuropa.it/news/2006/06/0613002.htm

Yahoo Notizie Farmaci: Prozac; Mario Negri, Attivare Registro Nazionale http://it.news.yahoo.com/13062006/2/farmaci-prozac-mario-negri-attivare-registro-naz-printable.html

Mednad.org Prozac al sapore di arancia per i bambini http://www.mednat.org/psicofarmaci2.htm

Libero.it Prozac ai bambini. Via libera dall'Europa http://blog.libero.it/navaspa/view.php?msg=1270333

TF Telefree Prozac ai bambini, via libera dall'Europa P. Pelo http://www.telefree.it/news.php?op=view&id=28987

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33

Vertici network Prozac ai bambini, via libera dall'Europa http://www.vertici.com/news/stampa/template.asp?cod=11202

www.DIFINFORMAZIONE.IT Bambini depressi, via libera dall’Europa al Prozac dagli 8 anni http://www.disinformazione.it/via_libera_al_prozac.htm

opsonline.it Prozac ai bambini, via libera dall'Europa http://www.opsonline.it/?m=show&id=5925

ECplanet Allarme psicofarmaci. Prozac al sapore d'arancia per i bambini A. Mannucci www.ecplanet.com/canale/salute-7/neurologia-69/0/0/12005 /it/ecplanet.rxdf

Portale di Pignataro Se il sud fosse uno stato indipendente Maggiore http://www.comunedipignataro.it/modules.php?name=News&file=article&sid=5634

Sole 24 ORE Sanità Cauti sil Prozac ai bambini (26 June 2006 - pag. 28)

Bimbisani e belli Farmaci e allattamento i numeri utili (June 2006 - pag. 85) July

Radio 101 Farmaci e bambini in vacanza Roletto (Wednesday 26 July 2006) August

Bimbisani e belli Bambinni depressi: curarli con Prozac? P. Masini

Insieme Vaccini: si cancella l'obbligo? O. Mai (August 2006; pag. 34-35)

Io e il mio Bambino Piccolo prontuario medico M. Campanelli (August 2006; pag. 50-54)

Notiziario FFC IV seminario di primavera: Progressi recenti e sviluppi futuri nella ricerca CF, in tema di diabete, nutrizione e comunicazione via internet (n. 16 - August 2006; pag.13-14)

Donna Moderna I farmaci più usati per i bambini L. Dorsi September

Corriere della Sera Troppe ragazzine prendono psicofarmaci S. Ravizza (Sunday 10 September 2006; pag. 1 e 5)

Il Sole 24 ore sanità Bimbi vivaci: lo screening di massa è una leggenda Comitato scientifico del Registro nazionale adhd (12 September 2006;pag.1;16-17)

Il Pensiero Otto mosse contro… il federalismo vaccinale Scientifico ed. L. Tonon (http://www.pensiero.it/news/news.asp?IDNews=255)

Gazzetta di Mantova Troppi farmaci superflui per i neonati G. Mazzotti (13 September 2006 - pag. 12)

Annual Report 2006


34

Gazzetta di Mantova I problemi respiratori aumentano tra i bambini e gli adolescenti G. Mazzotti (14 September 2006 - pag. 10)

Donna&mamma Prozac ai bambini? F. Capelli (September 2006; pag. 46-47)

Un pediatra per amico Speciale Tutte le medicine dall'Agmentin allo Zovirax. I magnifici 20 V. Calia (Year 6 n.4 September-October 2006 - pag. 19-22) October

Donna&Mamma Diritto alla salute. L'ospedale giusto se è a rischio C. Sandrucci (October 2006)

Marie Claire RITALIN basta (troppo) poco e la pillola va giù F. Amoni (October 2006; pag. 833-34)

Insieme Pagine rosa L. Damascelli (October 2006 - pag. 82-84)

Insieme Campioni d'autunno M. D'Aloisio (October 2006; pag 108-112)

ISDE Italia News La salute dei bambini della nazione europea più povera: il Sud d’Italia Associazione Medici per l'Ambiente (N.140 - 6 October 2006)

Panorama Arriva l'influenza, il vaccino tarda G. Milano (n.41/42 - 10 October 2006; pag. 141-142) November

Starbene PSICOFARMACI stop alle prescrizioni inutili R. Briganti (November 2006; pag. 13-9)

Panorama Bambini tira una brutta aria G. Milano F. Amoni (16 November 2006 n. 46; pag.210-216)

IO donna Un farmaco da ragazzi E. Zuccalà (4 November 2006; 111-114)

The city Boom di psicofarmaci ai bambini. In un anno 30mila "cure", +280% Ansa (Friday 17 November 2006; pag. 5)

Salute - la Repubblica Infanzia di pillole. Abuso di farmaci dalla "prima" età. Consigli per i genitori (e per i pediatri) B. Stagno (Year 12 n. 511 - 9 November 2006; pag.10-12)

Il Giorno Troppi psicofarmaci ai bambini: dobbiamo fermarli L. Sani (17 November 2006; pag. 5) La Nazione Troppi psicofarmaci ai bambini: dobbiamo fermarli L. Sani (17 November 2006; pag. 5)

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35

Il Resto del Carlino Troppi psicofarmaci ai bambini: dobbiamo fermarli L. Sani (17 November 2006; pag. 5)

Il meridiano Bambino iperattivo? C'è lo psicofarmaco S. Tocci (17 November 2006; pag. 6) Rinascita Quotidiano La vergogna degli psicofarmaci ai bambini Liberazione Nazionale (18 November 2006; pag. 6)

Messaggero Veneto Fvg, 500 bimbi trattati con psicofarmaci (17 November 2006; pag. 5)

Il Giornale dell'Umbria Salviamo i bambini. Troppi psicofarmaci F. Petruccioli (17 November 2006; pag. 8)

Corriere Nazionale Psicofarmaci ai bambini vivaci. Scatta l'allarme (17 November 2006; pag.10-11)

Panorama Tbc un vecchio nemico mai sconfitto G. Milano (23 November 2006; pag. 212-218) December

Donna&mamma Metti i farmaci nel carrello F. Capelli (December 2006; pag,34)

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Annual Report 2006


36

1) The laboratory, along with the Associazione Culturale Pediatri (Paediatricians’ Cultural Association), participates in the initiative “Lo sai mamma?” (“Mom, did you know?”) promoted by the Lombardy Region’s Federfarma. The initiative is aimed at providing mothers with information on their children’s health through the creation of informational pamphlets distributed in pharmacies throughout the region.

Altre Iniziative /Produzioni

ACIDO FOLICO

VIAGGIARE IN AUTO (la cinetosi)

FEBBRE TOSSE MAL D’ORECCHIO

VACANZE AL MARE (sole)

VOMITO E DIARREA

PUNTURE D’INSETTO

LA PEDICULOSI (pidocchi)

MALATTIE INFETTIVE (2 parti)

Annual Report 2006


37

2) As part of an educational campaign promoted by CoopSalute on the proper use of drugs, the Laboratory for Mother and Child Health created two information leaflets on the use of medicinal products during pregnancy and in children.

http://www.coopinforma.it/dossier/dossier.html?id=15# 3) For a rational use of drugs. Counter-party: Regional Health Authority

4) 2006 Annual Report of the Drug and Health Information Centre (Centro d’Informa-

zione sul Farmaco e la Salute CIFS).

Boehringer Ingelheim

CINECA, Interuniversity Consortium

European Union

Fondazione Monzino

Il Pensiero Scientifico Editore

Lombardia Region - Assessorato alla Sanità

Valle d'Aosta Region - Assessorato alla Sanità, Salute e Politiche Sociali

Contributions, contracts, ...

Annual Report 2006


National Collaborations Agenzia Italiana del Farmaco, (AIFA)

Associazione Culturale Pediatri, (ACP)

Centro Antiveleni-Unità di Tossicologia Clinica-Ospedali Riuniti di Bergamo

Centro per la Salute del Bambino, (CSB)

Consorzio Interuniversitario, (CINECA)

Federfarma Lombardia

Istituto Superiore di Sanità (ISS)

Osservatorio Italiano Salute Globale (OSG)

Il Pensiero Scientifico Editore

Unità Operativa di Neuropsichiatria dell'Infanzia e dell'Adolescenza, Fondazione Po-

liclinico di Milano, (UONPIA)

Università degli Studi di Milano-Facoltà di Scienze Politiche

Università degli Studi di Milano, Bicocca-Facoltà di Medicina-Clinica Pediatrica

International Collaborations Centro de Epidemiologia Comunitaria y Medicina Tropical (CECOMET), Ecuador

Clinica Infantil Colsubsidio, Bogotá, Colombia

European Medicines Agency (EMEA)

European Network Drug Investigation Children (ENDIC)

European Society for Developmental Perinatal & Paediatric Pharmacology (ESDPPP)

Fundacio Institut Catala de Farmacologia, Barcelona, Spain

Hôpital Robert Debré, Paris, France

Hospital Pediatrico Provincial Docente Dr. Eduardo Agramonte Pina, Camaguey, Cuba

International Society of Drug Bulletins (ISDB)

European Union (EU)

The University of Nottingham - Derbyshire Children's Hospital, Derby, UK Whorld Health Organization (WHO)

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Annual Report 2006


39

The Laboratory’s Annual Report 2006 is accessible online:

http://www.marionegri.it/LAB=78

Via La Masa, 19 20156 MILANO (area Bovisa)

JUNE 2007

The “Mario Negri” Institute is about to take an important step: after 44 years of activity in its first, historic location in Milan, it will move to a newly built, modern site.

The new site is in the Bovisa area in Milan, directly in front of Milan’s Polytechnic Institute, with which the institute will collaborate in multidisciplinary initiatives in the future.

The 25000 square metre surface area provides sufficient space for new laboratories to be set up, thus expanding the Institute’s research areas.

The new Institute also represents a new possibility to educate young researchers (regional diplomas and PhDs), with its increased research space and suitable facilities. The cultural exchanges with other scientific institutes, both in Italy and abroad, will also be intensified.

The new building’s construction will cost about 60 million euros, which represents a significant economic effort on the Institute’s part. For this reason, we are asking all those people who have shown interest in our work in the past and who have generously helped the Institute with their large and small donations, all of which have been very important to us, for help.

The new site is a reflection of the extensive amount of hope placed in the future of research in Italy, a country that should pay more attention to science’s importance in social and economic development.

Silvio Garattini Director

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