Food supplement, as defined by the Food and Drug Administration (FDA), is a product intended to supplement the diet by increasing the total daily intake, or an extract, metabolite, concentrate, constituent or combination of at least one of the following dietary ingredients: vitamins, minerals, herbs or other botanicals, amino acids. [1] In some peculiar clinical conditions, such as oncological or hematological diseases, the use of food supplements can take on great importance in supporting patients with alterations in the state of nutrition, particularly by defect. [2] [3]
At European level, the use of vitamins and minerals in supplements and their addition to food is regulated by the most recent European Community (EC) text 1170/2009 of 30th November 2009, which amends EC Directive 2002/46/EC and Regulation 1925/2006. According to the Italian Ministry of Health, vitamin supplements should not be used as food substitutes, whilst as a diet supplement with the aim of nutritional intake optimization, substances of nutritional interest with a protective or trophic effect provision or metabolism and physiological functions of the organism improvement". [4]
The list of substances and plant preparations allowed for use in food supplements, as well as the indications on the requirements to be respected for the safety and protection of consumers, are reported in the Italian Decree of 10th August 2018 entitled "Discipline for use in food supplements of and herbal preparations "and its subsequent amendments (Italian Ministerial Decree of 09/01/2019). Food supplements are usually available in pre-dosed forms such as capsules, tablets, liquids contained in ampoules or bottles with droppers.
Currently, the food supplement industry is one of the fastest growing: in 2018 there were 32 million Italians who consumed food supplements, the majority of whom were adult (approximately 63%) and female (60%). This sales volume in 2018 produced a growth in the market value of 3.3 billion (+126%) and in employment in the sector, which grew by 44% in 3 years. [5] Among the factors that have contributed to this growth in consumption are the growing ageing of the population, greater awareness of the cause-effect relationship between disease and diet as well as the importance of preventive health practices for the protection of health individual. [6] [7] For these reasons, consumers probably increasingly rely on food supplements to achieve the recommended daily amount of vitamins and trace elements in their diet, sometimes attaching little importance to their intake through food. [8]
However, the inappropriate use of supplements can potentially cause adverse effects, such as for example an increased risk of bleeding from vitamin E overdose, the onset of ataxia, alopecia, hepatotoxicity and teratogenicity from chronic vitamin A overdose; moreover, important drug interactions can arise with certain drug classes such as between vitamin K and oral anticoagulants. [9] [10] [2] According to EC Regulation 852/2004, food supplements can only be marketed by food business operators. In Italy, the purchase of food supplements is free at pharmacies and specifically authorized commercial establishments, the so-called para-pharmacies, in accomplishment with 32nd article of the decree no. 201 of 6th December 2011, and its subsequent amendments (law no. 214 of 22nd December 2011). [4] [11]
Being pharmacies one of the main places to buy food supplements, [4] pharmacists play a key role in advising citizens on the purchase and use of these products, as reported by the Italian Centre for Social Studies and Policies (CENSIS) [4] and QuintilesIMS (IQVIA) 2019 data; [12] indeed, 82% of Italians received advice for food supplements buying either from a doctor or a pharmacist [4] and 95% of the supplement food market is developed in pharmacies (86%) and para-pharmacies (9%). [12] [13] However, as revealed by a survey conducted on Italian pharmacists in 2016, the 26.4% of the interviewees report a lack of information regarding the choice of the most appropriate product for the user, on possible side effects or interactions with other products. [12] In addition, consumer confidence in the pharmacist as an adequate professional figure to provide advice on the use of supplements is not always adequate. [14] [15] In this regard, in 2018 the Scientific Association of Italian Pharmacists (ASFI) proposed that food supplements with health purposes and nutraceuticals become the subject of more stringent legislation to prevent possible abuses and at the same time limit the current confusion and disorientation of both pharmacists and citizens. [16]
Considering pharmacies a strategic and central hub for many aspects of the population health, with the regional law no. 70 of 5th December 2019, the Italian Friuli-Venezia Giulia (FVG) Region has given pharmacies the role of health points, [17] and therefore food supplement counselling could be one of the main topic to be improved. This study aims to evaluate knowledge, attitudes and professional experiences of pharmacists operating in FVG Region concerning food supplements. [18]