Nominativi dei referenti per la Farmacovigilanza di ASL, Aziende Ospedaliere, I.R.C.C.S., Policlinici Universitari.

ORGANISATION AND FACILITIES OF THE PHARMACOVIGILANCE OFFICES IN ITALY.

*G. Polimeni, **S. Roncoroni, ***F. Mazzeo, **M. Iacobelli, ***F. Rossi and *A.P.Caputi
*Istituto di Farmacologia, Università di Messina (Messina); **Industria Farmacobiologica Crinos, Villa Guardia (Como) and ***Istituto di Farmacologia e Tossicologia II Università di Napoli (Napoli); Italy.

Pharmacovigilance activities on medicinal products in the European Community are regulated by a series of Directives (75/319/EEC, 93/39/EEC, 2000/38/EC) describing the respective obligations of Pharmaceutical Companies and of competent Authorities to set up a pharmacovigilance system in order to collect and evaluate information about suspected adverse drug reactions.
The system aims to improve the cooperation and exchange of information between the Member States relating to the supervision of medicinal products and in particular the monitoring of adverse reactions under pratical condition of use.
According to these European Directives, the Member States established a national pharmacovigilance system and have to take all appropriate measures to encourage physicians and other health care professionals to report suspected adverse reactions to competent Authorities as well as have to ensure that reports of suspected serious adverse drug reactions are immediatly brought to the attention of the European Agency for the Evaluation of Medicinal Products.
To comply with the European Directives, the Italian Minister of Health issued the legislative decree n°44 - 18.02.97, establishing the rules of the national pharmacovigilance system, according to which each Hospital, University Clinic, Institute of Research and Cure of Scientific Character (IRCCS) and Peripheral Health District (ASL) must have its own pharmacovigilance office, where health care professionals have to send suspected ADR reports.
All these offices have to transmit the ADRs reports received directly to the Italian Minister of Health, to the Regional Health Authorities and to Pharmaceutical Companies
We investigated the organisation and facilities of these pharmacovigilance offices in two different steps.
About one year ago, we sent to 359 centres (119 Hospitals, 46 I.R.C.C.S. and 195 ASL) a form, to be returned filled in with the name of the person responsible for pharmacovigilance, address of the office, telephone and fax number, e-mail , as well as facilities to access drug information.
Only 131 responses (36 %) were received, 31 from Hospitals (response rate 26 %), 11 from IRCCS (24 %) and 89 from ASL (45,6%),. The response rates were similar in Northern (38 %), Centre (30 %) and Southern (35 %) regions.

Number of responses received from Hospitals and Institute of Research and Cure of Scientific Character (I.R.C.C.S.)

The result of this research are available on www.farmacovigilanza.org , an italian educational website created in order to promote the reporting of adverse drug reactions.
Recently we investigated the use of the Internet in Pharmacovigilance activities by sending a questionnaire to all the above mentioned 131 centres. The questionnaire , structurated in simply questions with preordinated answers (YES/NOT), was prepared on the basis of a similar one, used for a prospective survey performed among French Pharmacovigilance Centres (Morel P., Vandel B. Therapie 1999; 54:525-532.)
The use of the Internet is becoming widespread throughout the world and the access to medical information via the Internet is transforming the attitude of physicians, health care professionals and patients.
In particular, the use of the Internet in the domain of drug safety and Pharmacovigilance is spreading rapidly. Infact, it may be considered an important tool in pharmacovigilance, for collecting information about drugs and ADRs and for improving drug safety and minimize the risks of severe ADRs, since the information can be given and obtained in real time.
Several websites are already available in the field of drug safety and pharmacovigilance, including websites of Regulatory Agencies (FDA, EMEA, MCA, ecc), Ministers of Health and other Institutions or Scientific Societies. These sites contain an enormous amounts of generic information on pharmacovigilance and specific information on drugs.
The analysis of the 58 questionnaires received (response rate 44%) showed that 72 % of these pharmacovigilance offices are connected to the Internet, and almost all the remaining offices will be soon connected.
The result of the research shows that 64 % of the centres connected to the Internet visit pharmacovigilance websites, 55 % visit www.farmacovigilanza.org , 64 % visit epidemiological and medical information websites and 71 % of the centres access to scientific societies websites.
"Search engines" are used by 71 % of the centres.
The Internet is used for bibliographic research by 76 % of the centres, 57 % frequent Medline and 59 % medical press, expecially British Medical Journal, The New England Journal of Medicine and Jama.
As for the use of newsgroups, 73 % of the centres don't know what they are.

Questionnaires received from ASL , Hospitals, University Clinics and I.R.C.C.S.

Evaluation of the use of the Internet by Italian pharmacovigilance centres

Websites used by pharmacovigilance centres connected to Internet

Therefore, the use of the Internet by italian pharmacovigilance centres appears to be moderate.
Finally, the analysis of questionnaires indicates that the Internet is considered a good system for of communication and an important source of information, but there are some problems in using it for everyday activities, above all cause to difficulties in using it appropriately and lack of time.
Surely, the increasing use of electronic networks for communication of information on adverse drug reactions into the European Community, intended to allow all competent authorities to share the information at the same time, will facilitate the access to the Internet and its use also among italian pharmacovigilance centres.

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