Food supplements are freely available products and should be used according to the instructions on the label. Improper use, which does not take into account age (such as infants and children), particular physiological conditions (such as pregnancy and breastfeeding), or ongoing pathological situations, could turn out to be counterproductive. It is therefore important to inform the doctor when using supplements, especially when prescribing drugs, also to avoid the risk of reactions from drug interactions. It is necessary to improve knowledge of the benefit/risk profile for the health use of a plant, considering in particular the nature of its specific derivative, the proposed intake amounts, the sensitivity and condition of possible users, and the concomitant consumption of other health products or drugs. For these reasons, it is necessary to carefully screen for adverse reactions to such products. Monitoring is aimed at increasing knowledge about the activity profile of the individual components and their possible interactions, which must necessarily go through ‘spontaneous reporting’ systems that are sufficiently sensitive to highlight any risk or warning signals at an early stage.
Since 12 December 2018, the VigiErbe website has been active
where you can submit your report online.
Pharmacovigilance is the combination of the businesses that contribute to the safeguarding of public health. These are in fact designed for the identification, evaluation, comprehension and prevention of adverse effects or any other type of problem associated with the use of medicinal products, to ensure a benefit/risk ratio which is favourable for the population.
No medicine is actually risk free and therefore it is necessary to constantly monitor the security profile of products on the market.
The fundamental aims of pharmacovigilance are many and include:
Identifying as quickly as possible new adverse reactions caused by medicines and vaccines; Expanding the information available regarding suspected or already known adverse reactions;
Identifying risk factors predisposing the onset of suspected adverse reactions in relation to age, sex, dosage, underlying pathologies and pharmalogical interactions;
Confronting the safety profile of medicines belonging to the same medicinal group and assessing the advantages of a medicinal product compared with other available treatments for the same illness;
Communicating such information regarding safety with care to all health workers to improve clinical practice.
Regulation (EU) No 1235/2010 of 2nd July 2012, that amends Regulation CE No
Guideline No 2010/84/UE of the 21 July 2021 that amends Guideline No 2001/83/CE
WHAT IS AN ADVERSE DRUG REACTION
Based on the legislation in the field of pharmacovigilance for adverse reactions (adverse drug reactions or ADR), means a “harmful and unwanted effect as a result of the use of a medicinal product”.
HOW TO REPORT AN ADVERSE REACTION
The European legislation regarding pharmacovigilance requires all health workers and citizens to report any suspected adverse reaction (severe and non severe, known and unknown).
The Health Ministers Decree of the 30th April 2015 reiterates the obligation to report immediately suspected adverse reactions to medicines and vaccines and has established time limits within which health workers are required to carry out a report to the National Pharmacovigilance Network (RNF), part of the AIFA.
Suspected adverse reactions by medicinal products are to be reported within 2 days from when the health worker comes to be aware of the reaction.
The obligation to report goes down to 36 hours in cases of ADR when the reaction comes from medicinal products of an organic origin (including vaccines).
It is possible to carry out a report of suspected adverse reaction according to one of the following procedures:
By filling out the suspected adverse reaction report form and sending it to the head of the Pharmacovigilance of the actual participating facility by email or fax Or online directly on the VigilFarmaco website following the guided procedure The report forms for health workers and citizens are available on the AIFA website in the forms section
Alternatively, the reporting of suspected adverse reactions can be communicated to the proprietor of the Community Register of Medicinal Products (AIC) of the medicinal product that is believed to have caused the adverse reaction.
The suspected adverse reaction can also be reported following the taking of
medicinal plant based products and nutritional supplements and of medical devices.
Below are the contact details for the relative competent institution websites and to the relevant forms:
Reporting of suspected adverse reactions to medicinal plant based products and nutritional supplements
To report online see the vigierbe website
To report suspected adverse reactions to medical devices
QPPV- Claudia Piccolo
Director of the Pharmacovigilance Service
Cell +39 3209655221
Tel +39 0818986293
Fax +39 08119713635