Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problem..
The responses of each organism to the intake of a medicine may vary and generate undesirable effects, precisely called adverse reactions.
When a drug is placed on the market, the only known adverse effects are those resulting from pre-registrative clinical trials, generally conducted on a number of patients suitable for identifying the most common reactions.
After commercialization, the drug is administered to a wider number of patients, opening the possibility of knowing in depth the risk/benefit ratio related to use, through the systematic collection of adverse events. The reporting of suspected adverse reactions by healthcare professionals and patients is the main source of safety information about the drug for pharmacovigilance.
In compliance with specific legal obligation, the SPA Pharmacovigilance Service collects and evaluates every report, constantly updating the safety information of its medicines. According to the provisions of Italian law, it is possible to report the appearance of any undesirable effect in different ways.
- For the patient/citizen: report the information to your doctor/pharmacist or directly fill in the appropriate form for reporting a suspected adverse reaction at the link: https:/ //www.aifa.gov.it/web/guest/content/segnalazioni-reaction-adverseevents httptps://www.aifa.gov.it/modules-signalling-adverse reactions
- For the health care professional: fill in the appropriate form for reporting a suspected adverse reaction at the following link: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse or https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse
In both cases, the completed form must be forwarded to the Pharmacovigilance Officer of the health facility to which it belongs. The updated list of Pharmacovigilance Officers for the different health facilities, divided by region, can be found at the link: https:///www.aifa.gov.it/web/guest/responsabili-pharmacovigilance
The SPA Pharmacovigilance Service can be contacted by calling 348 8605323 (24h) or 06 45479406 (office) or via the contact page.
In accordance with the responsibilities provided for by the current Pharmacovigilance Legislation, the organization is required to collect its data and process them in full compliance with EU Regulation 679/2016.
Your data will be collected by authorized personnel with appropriate skills and adequate to meet legal requirements and processed for purposes relating to the protection of public health in accordance with the provisions of Legislative Decree 196/03, as amended by Legislative Decree 101/2018 art 2 sexies and art 9 c.2 of GDPR 679/2016.
The data will be recorded in a special Pharmacovigilance database, whose access is allowed only to authorized personnel, and will be used by the AIC Holder to verify and confirm the safety of the product.
The subject of processing will be exclusively your contact data and special categories related to the adverse event.
The data you provide will be processed in full compliance with the current Privacy Policy, in computer and/or paper. This data will only be used to manage reports of suspected adverse reactions.
Reports of suspected adverse reactions are an important source of information on the safety of use of a medicine: for this reason, the AIC Holder is required to investigate and report all cases of which they become aware.
The data and information communicated by you will be used for the purposes of Pharmacovigilance, to fulfil the obligations imposed on us by the Italian and European Legislation on the safety and efficacy of medicines. This legislation requires us to provide the Health Authorities with information on possible adverse reactions resulting from use or exposure to a medicinal product and to respond to any requests from the Competent Authorities.
Please note that you or your doctor may be contacted if it becomes necessary to collect additional information for a more thorough medical assessment. As established by the regulations in force, these data may be brought to the attention of the Regulatory Authorities.
We also inform you that the personal data communicated by you will be processed and stored in the databases used by the Data Controller of AIC for the sole purpose of allowing the completion of the operations necessary and required by law for the management of the report by you effected. The personal data of the patient will be processed in accordance with current legislation ensuring confidentiality and confidentiality of the information provided.
In accordance with the regulatory requirements, the collected data will be kept for the duration of the existence of the Pharmacovigilance System and for at least another ten years of its termination unless otherwise requested by the interested party.
In compliance with the provisions of the GDPR art. 15-19, at any time may request the integration, updating, rectification, limitation of processing, cancellation of your data. If you believe that the processing has taken place in a way that does not comply with the Regulation, you can also contact the Supervisory Authority, pursuant to art. 77 of the same Regulation.
The data controller is SPA Società Prodotti Antibiotici S.p.a.
The Data Controller is Skillpharma S.r.l. with registered office in via Umberto Saba 4, 00144 Rome, which can be contacted at 06/45479406.
We also remind you that the failure to provide data will not allow the management of the Pharmacovigilance report as a fundamental means for the protection of public health and for the monitoring of the benefit risk ratio of the drug.
For further information on Pharmacovigilance: https://www.aifa.gov.it/farmacovigilance1