Home » Pharmacovigilance, how and why to report suspected adverse drug reactions — Health

Pharmacovigilance, how and why to report suspected adverse drug reactions — Health

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Pharmacovigilance, how and why to report suspected adverse drug reactions — Health

Donini: “Collective commitment for an increasingly safer use of medicines, to protect patients’ health
Created by the Department of Health Policies in collaboration with the Regional Center for Pharmacovigilance, the video lasts about a minute and is available on the Region’s YouTube page and social profiles

November 6, 2023 – Report suspicions adverse effects caused from a medicine al your doctor or pharmacisthelping to make the use of medicines more Safe a benefit all patients. In a word, pharmacovigilancethat set of activities that contribute to the promotion of public health through the identification, evaluation and prevention of problems related to the use of medicines, with the aim of ensuring a favorable benefit/risk ratio, compared to taking a medicine, for the population.

Per explain to citizens and healthcare professionalsfrom doctors to nurses, to pharmacists, in what way make a report correctlythe Emilia Romagna region – in particular the Department of Health Policies, in collaboration with the Regional Pharmacovigilance Centre – He has made a video pill of one minute dedicated to pharmacovigilanceavailable on the Youtube page (https://www.youtube.com/watch?v=4Rx8x_YFUt0) and on the Region’s social profiles.

“As a Region we are on the front line, and we also do so with this video – highlights the councilor for health policies, Raffaele Donini -, to raise awareness among citizens and professionals of our healthcare system regarding the importance of pharmacovigilance, and to combat the phenomenon of under-reporting. The objective – concludes Donini – is to contribute to making the use of medicines increasingly safer and to protect, thanks to everyone’s efforts, the health of our community”.

“Pharmacovigilance – as underlined by Ester Sapigni, head of the Regional Pharmacovigilance Center – plays a role of fundamental importance in protecting people’s safety. Thanks to reports from citizens and healthcare professionals, it allows constant monitoring of drugs after their marketing, in order to promptly identify any unwanted or adverse effects. If necessary, this system allows the competent authorities to adopt regulatory measures aimed at ensuring the prompt protection of public health.”

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In one region, Emilia-Romagna, which is among those that contribute most to the reporting of suspected adverse reactions to drugs and vaccines at a national level, in 2022 some were carried out 5.874 (reporting rate of Emilia Romagna region you seem to 1,327 reports/1 million inhabitantsversus average reporting rate in Italia you seem to 1,128.78 reports/1 million inhabitants).

The video pill

In recent years there has been a growing interest on the part of public opinion in pharmacovigilance, also thanks to the greater attention paid to the topic of prevention. However, the under-reporting – or the failure to report a more or less high number of suspected adverse events, for example due to lack of knowledge of the reporting system, the belief that the reaction is already known or the difficulty, for those taking multiple drugs concomitantly, to identify the one actually responsible – still remains the main limitation of spontaneous reporting systems. It is essential, therefore, to ensure that safety information is not lost, that everyone contributes to the reporting system.

Come the video suggests, “If you think you have had a side effect after taking a medicine or vaccine, it is important to report it to your doctor or pharmacist. Whether you are a healthcare worker working in the area or in the hospital, or a citizen, you can report.” With a final invitation: “Report side effects, to increase knowledge on the safety of medicines and make them safer for the benefit of all patients.”

The contribution of citizens, doctors and pharmacists

For pharmacovigilance to work, everyone’s contribution is essential.

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Il citizen: can count on the precious support offered by healthcare professionals in listening to what happened and can access the service through a pharmacy or their GP, or they can use the tools provided by AIFA, the Italian Medicines Agency, to independently carry out an report online or via the downloadable form, carefully filling in all the required fields to provide information, as detailed as possible, on the specific case.

The pharmacist: on the one hand it contributes to strengthening the relationship between citizens and the healthcare system, focusing on the safety of treatments and, in interaction with the patient, it promotes awareness of the importance of pharmacovigilance reporting. On the other hand, specific training gives them the skills necessary to promptly detect suspected adverse reactions, even less serious ones.

The doctor: participating in the pharmacovigilance system allows you to monitor the progress of the therapy prescribed to the patient and, if necessary, make changes to improve the expected result. Furthermore, as a healthcare professional who has in-depth knowledge of the patient’s health status, the doctor can provide contextual, accurate and timely data to the pharmacovigilance system, facilitating the activities of the relevant authorities (regional, national, European).

Pharmacovigilance and its functioning (120.77 KB)

The poster

The information page on Pharmacovigilance

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