The role of a pharmacist in pharmacovigilance system

Adverse drug reactions in the ambulatory internal patients at the emergency department: Focus on causality assessment and drug-drug interactions

“…Pharmacists play a major role in pharmacovigilance, particularly in monitoring and reporting ADRs. They are an indispensable source of information and critical evaluation of drug-related information (41), and make an integral part of a multidisciplinary pharmacovigilance team to participate in ADR assessments. Moreover, clinical pharmacy services in hospitals and other medical settings, e.g., medication history taking, medication use review and clinical medication review are important tools in ADR prevention or recognition (42).…”

Pharmacovigilance in Serbia: a Ten-Year Pharmacoepidemiologic Analysis

“…For example, in its 2020 report, HALMED warned the public that a number of suspected ADRs had been received for the new formulation of Euthyrox® 75 . It should be noted that the ALIMS reports registered a very small number of ADRs that are listed in the literature as potentially most dangerous 6 ; from 2010 to 2019, only 195 cases of various forms of bleeding, 82 cases of heart rhythm disorders, and 59 cases of hypotension were reported. However, this information should also be considered carefully, having in mind the previously mentioned problems in the activities of ADR monitoring and reporting in Serbia.…”

“…It would be certainly useful for the improvement of clinical practice in Serbia to include reports on the number of cases that met at least one criterion for consideration of any ADR as serious. Those criteria include immediate death or endangerment of the life of the user of the drug, occurrence of the need of hospitalization or its prolongation due to drug use, causing permanent and/or severe disability of the drug user, causing congenital defects or anomalies of the newborn whose mother was user of a certain drug, or another medically significant serious condition 6,74 . As potentially serious are also considered ADRs listed in the Important Medical Event List, which are classified in the last listed criterion, i.e., in the category of medically significant serious conditions 76 .…”

“…There is no drug that can be claimed to be completely safe 6 . The use of any drug correlates with the risk of more or less significant or severe side effects, i.e., all those effects that may occur during therapeutic use of some preparation but do not have a therapeutic purpose.…”

“…ADRs are considered as one of the most common iatrogenic health disorders, whether they occur as a result of prescribing an inappropriate drug, administering an inappropriate dose (the most common mistake in practice), inappropriate way of administration, or irrational dispensing of drugs in pharmacies [11][12][13] . It should be noted that the prevalence of certain ADRs is very different; considering that, all these reactions can be classified into several groups as very common (in more than 10% of patients), frequent (1%-10% of patients), occasional (0.1%-1% of patients), rare (0.01%-0.1% of patients) or very rare (less than 0.01% of patients treated with the drug) 6,7 . Regardless of differences in the ADR prevalence that occur as a result of heterogeneity of the global population (specificity related to the prevalence and manifestation of particular diseases, genetic characteristics, dietary habits, as well as differences in the practice of drug prescribing), all countries in the world are obliged to organize a system of monitoring the safety of drugs on the market 14,15 .…”