Pharmacovigilance 

Pharmacovigilance refers to the set of activities aimed at identifying, evaluating, understanding, and preventing adverse events or any other problems associated with the use of drugs and therapies. The purpose of pharmacovigilance is to ensure that the overall benefits of using these products outweigh the risks and potential adverse effects. All drugs and vaccines are extensively tested before being placed on the market and are therefore considered safe. However, preclinical and clinical studies often lack adequate representation of certain genders: scientific research does not sufficiently account for biological and physiological differences between men and women. This can lead to an underestimation of the risk of adverse reactions in underrepresented groups—particularly women.

Several factors can influence both the occurrence and severity of adverse drug reactions. Among these, pharmacokinetic differences (how the body absorbs, distributes, metabolizes, and eliminates a drug) and pharmacodynamic differences (how the drug affects the body) play a crucial role. These differences can be especially pronounced among individuals of different sex, age, or clinical conditions, and may be further exacerbated in cases of polypharmacy—meaning the simultaneous use of multiple medications—which increases the risk of drug interactions. Another critical aspect involves the commonly used dosages: often, standard drug dosages are based on clinical studies primarily involving young, healthy male subjects, typically weighing around 70 kg. This approach may not be suitable for other patient categories, such as women, transgender individuals, older adults, or those with significantly different body weights. Hormonal fluctuations, related to different stages of the reproductive life cycle (puberty, menstrual cycle, pregnancy, menopause), are an additional factor that can influence drug efficacy and safety in women, altering both metabolism and pharmacological effects.

In this mission, the contribution of everyone is essential, in order to expand the existing knowledge regarding the effectiveness, side effects, and adverse events of therapies.

If you have experienced unusual adverse events or have encountered contraindications that you wish to report, please fill out the following form.