Nutraceutical and functional food regulations in the European Union

Our chapter explores the US Food and Drug Administrations (USFDAs) regulation of medical foods, a growing industry that lies between pharmaceutical drugs and food.In addition to an overall discussion of the short regulatory history of medical foods, we cover the agencys recently released revised draft guidance and other regulatory requirements for medical foods, including the applicable Current Good Manufacturing Practices and import/export requirements, as well as FDAs enforcement actions to date

[Cardiovascular screening]

To evaluate, through active call, lifestyles of an asymptomatic population in order to identify hyperglycaemic subjects and/or high-blood pressure sufferers to dispatch to their GP to perform suitable checking, and subjects to invite to a cardiovascular disease prevention programme because of their lifestyles

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly: An observational study in Liguria Region, Italy

Background: In September 2011 the European Medical Agency authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged \ue2\u89\ua550 years. The same occurred in the US in December 2011 when the Food and Drug Administration approved the use of PCV13 in the same target age-group with indication for the prevention of invasive pneumococcal diseases and community acquired pneumonia sustained by the serotypes contained in the vaccine. The Liguria Region, in Italy, implemented in 2013 an active and free of charge immunization strategy with PCV13 among adults affected by specific risk conditions and the elderly aged \ue2\u89\ua570 years. Methods: An observational study was performed in order to assess the safety and tolerability of PCV13 among elderly dwelling in the metropolitan area of Genoa, the capital city of Liguria Region. Eligible subjects, who received PCV13 following the public health immunization campaign at the Local Health Unit 3 of Genoa, provided a written informed consent to take part in the study. Eight-hundred-seventy-one subjects were enrolled between October 2013 and May 2014: all were monitored by qualified healthcare personnel for at least 30 min after vaccination at the outpatient clinics, in order to assess any possible sudden reaction. The occurrence of a series of local and systemic solicited reactions and of any unsolicited Adverse Events (AEs) was monitored using a self-administered clinical diary and by regular phone contacts up to 14 and 21 d following immunization, respectively. Moreover, a 6-months follow-up following vaccination was planned in order to monitor Severe Adverse Events (SAEs). Results: No sudden reaction occurred in vaccinees at the outpatient clinics. Pain (27.4%) was the most frequent reaction reported by subjects at the injection site, while new muscle pain (13.6%), fatigue (10.7%), and headache (9.9%) resulted the most common systemic reactions. Rates of the main reactions reported in this on-field study resulted generally lower than those registered in clinical trials performed in the elderly. The incidence of fever (2.2%) following vaccination was low at values superimposable to that reported in previous studies. Conclusion: This observational study showed a good safety and tolerability of PCV13 among the elderly in routine clinical practice further confirming the evidence coming from clinical trials in the same age-group

Attitudini e comportamenti nei confronti delle vaccinazioni contro N. meningitidis, S. pneumoniae e HPV: un’analisi multicentrica sulla popolazione generale

Introduzione: Conoscere attitudini e comportamenti della popolazione nei confronti delle vaccinazioni è indispensabile per poter intraprendere azioni mirate. Questo studio, di cui sono stati presentati parte dei risultati allo scorso congresso SItI, ha analizzato anche i fattori associati alla propensione alle vaccinazioni contro N. meningitidis, S. pneumoniae e HPV e le motivazioni alla vaccinazione/non vaccinazione. Metodi: E’ stato somministrato un questionario anonimo a un campione di 530 individui con età compresa tra 19 e 86 anni che hanno usufruito, nel 2013, dei servizi dei Dipartimenti di Prevenzione della ASL Roma A, ASL3 di Genova, ASL2 di Savona e ASL Viterbo. Risultati: Il 96,2%, il 94% e il 92,7% dei responders si è detto favorevole alla vaccinazione contro N. meningitidis, S. pneumoniae e HPV rispettivamente, e il 58,4% ha espresso parere positivo nei confronti del vaccino MenB. L’attitudine alla vaccinazione meningococcica è risultata significativamente maggiore nelle donne, quella contro HPV è risultata associata alla presenza di figli e alla conoscenza della malattia mentre quella contro lo pneumococco al proprio stato vaccinale e alla conoscenza della malattia stessa. Rispetto alla vaccinazione dei propri figli, il 68,8%, l’82,6% e l’84,5% dei responders ha dichiarato di averli vaccinati contro N. meningitidis, S. pneumoniae e HPV rispettivamente. Dal 45% a oltre il 50% ha riportato come principale motivazione la raccomandazione da parte del pediatra o di un altro medico. Anche la paura delle sequele di malattia ha rappresentato una motivazione comune. Le motivazioni alla non vaccinazione sono state invece scarsamente riferite. Conclusioni: Questi dati suggeriscono che azioni volte a incrementare il livello di conoscenza della popolazione e a promuovere un ruolo attivo dei professionisti sanitari nell’offerta vaccinale potrebbero influenzare positivamente attitudini e comportamenti nei confronti delle vaccinazioni prese in esam

Acceptance and safety of the intradermal influenza vaccine among the elderly in Italy: An on-field national study

Introduction: An observational multicenter study was carried out in Italy, to evaluate the acceptability and safety of the new intradermal (ID) influenza vaccine (IntanzaR, Sanofi Pasteur SA, Lyon, France) among subjects aged 65 60 years, compared with that of other intramuscular (IM) influenza vaccines. Compliance with the use of the ID vaccine by healthcare professionals was also assessed. Methods: A previously validated and self-administered questionnaire, Vaccinees' Perception of Injection (VAPI\ua9), consisting of 21 questions, mainly focused on four dimensions (bother, arm movements, sleep, and acceptability), was administered to > 1,600 individuals with spontaneous access to outpatient clinics, located in Northern, Central, and Southern Italy, to evaluate the acceptance of the vaccines. Occurrence of solicited and unsolicited side effects and of serious adverse events was assessed in a subset of subjects (n = 500), using a clinical diary filled in by vaccinees following immunization. Compliance with the new ID vaccine by healthcare professionals was investigated using an ad-hoc questionnaire. Results: A very favorable opinion concerning the acceptability of both the vaccines under survey, with the most positive answers ranging between 75.5% and 94.9%, was registered within the study population. Also the compliance by healthcare professionals (n = 130) with the novel ID vaccine was favorable. No serious adverse event occurred during the 6-month follow-up period. The frequency of solicited systemic reactions was comparable between the two study groups, while solicited local reactions were significantly higher in the ID-vaccine group than in the IM-vaccine group, even if at values lower than those reported in phase 3 clinical trials (ranges = 18.5-32.6% vs. 29.5-70.9%). These local events were mild and transient, thus without any clinical relevance. Conclusion: The novel ID influenza vaccine can be widely recommended in clinical practice, representing a useful tool to improve immunization coverage rates, and thus the control of influenza. \ua9 Springer Healthcare 2012

Adapted Physical Activity for the Promotion of Health and the Prevention of Multifactorial Chronic Diseases: the Erice Charter

The Erice Charter was unanimously approved at the conclusion of the 47th Residential Course "Adapted Physical Activity in Sport, Wellness and Fitness: New Challenges for Prevention and Health Promotion", held on 20-24 April 2015 in Erice, Italy, at the "Ettore Majorana" Foundation and Centre for Scientific Culture, and promoted by the International School of Epidemiology and Preventive Medicine "G. D'Alessandro" and the Study Group on Movement Sciences for Health of the Italian Society of Hygiene, Preventive Medicine and Public Health. After an intense discussion the participants identified the main points associated with the relevance of physical activity for Public Health, claiming the pivotal role of the Department of Prevention in coordinating and managing preventive actions. The participants underlined the importance of the physicians specialized in Hygiene, Preventive Medicine and Public Health. The contribution of other operators such as physicians specialized in Sport Medicine was stressed. Further, the holders of the new degree in Human Movement and Sport Sciences were considered fundamental contributors for the performance of physical activity and their presence was seen as a promising opportunity for the Departments of Prevention. Primary prevention based on recreational physical activities should become easily accessible for the population, avoiding obstacles such as certification steps or complex bureaucracy. The Sport Doctor is recognized as the principal referent for preliminary physical evaluation and clinical monitoring in secondary and tertiary prevention actions based on adapted physical activities. Developing research in the field is essential as well as implementing higher education on physical activity management in Schools of Public Health