The Center participates in relevant international Phase III clinical trials, taking advantage of the pool of adult and child dyslipidaemic patients followed with the outpatient activity. In particular, is active in the clicnical study of new pharmacological biotechnological approaches for the treatment of the most severe forms of dyslipdaemia, when not responsive to on market available standard therapeutic care.
The Center is constantly focused on the promotion and development of the research activity on cardiovascular, Biochemistry, Molecular Biology and Pharmacology fields. In particular, the center includes and promotes the joining of healthcare system professionals and physicians in for a deep interest and study of these topics. This aim is reached via meetings, congresses, symposia ans science fairs, with relevant public and patients engagement. The communication to scientific community is ceritified via the continuous contact with the European Atherosclerosis Society (the major in the filed, ww.eas-society.org) and the numer of publication on high impact factor journals, especially in the last years.
SEFAP aims to promote and conduct research in the fields of pharmacoepidemiology, pharmacoutilization/pharmacoeconomics and pharmacovigilance, designing studies to investigate various aspects of use, effectiveness and safety of medicines, and to develop skills pertaining to the interpretation of epidemiological data and the identification of performance indicators. It also involved in training and education regarding the issues specified, including its website update, the publication of monthly newsletters and the organization of a second level Master and a Postgraduate Course in Pharmacovigilance.
MAIN ACTIVITIES
- Study of prescribing appropriateness with pharmacoepidemiological methods for the assessment of specific indicators (Beers criteria, prescriptions of potential interacting drugs, prescription of generics, off-label prescriptions, adverse drug reactions, etc.) and development of intervention strategies to improve critical situations, including training of health personnel and patient education.
- Characterization of the drug use profile at national and local level, pharmacoeconomic analysis and impact assessment of national and/or regional health policies aimed at improving rational use of drugs and of the available economic resources.
- Evaluation of the risk/benefit profile of drugs in the context of real-life clinical practice, by estimating the association between their use and the reduction in the incidence of events (effectiveness) or the development of adverse events (safety).
- Epidemiological studies on chronic diseases of greatest clinical and social relevance (eg. cardiovascular disease) or in fragile populations (eg. elderly people with multimorbidity) and on the prevalence and incidence of the main risk factors, to support the development and implementation of treatment recommendations by the regulatory authorities and scientific societies.
- Organization of an annual second level Master course in Pharmacovigilance in collaboration with local and national health agencies and private companies.
SEFAP is also engaged in initiatives to stimulate interdisciplinary cooperation and to promote the scientific debate about the appropriate use of drugs, through seminars and training courses on topics of interest and the publication of a scientific journal (GIFF, Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione) and monthly newsletters (SEFAPnews).
The research activities of SEFAP are carried out mainly using administrative databases containing information on socio-demographics of patients, on drug prescriptions reimbursed in A class and on hospital admission and discharge, and datasets containing clinical information, elaborated by the Centre in the context of epidemiological projects. Record linkage procedures allow to merge different databases using the anonymized patient code as primary key in order to construct his health care history.
Pharmacoutilization and pharmacoepidemiology analyses involve the application of advanced statistical methodologies (descriptive and inferential statistics). At SEFAP, different study designs are developed and implemented (Cohort study, Prospective cohort, Retrospective cohort and Case-control study). Some risk/benefit evaluations are also carried out trough meta-analyses, based on published data from clinical trials or observational studies.
