Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization’s Reporting? A Pharmacovigilance Study in Southern Italy

Abstract

Despite the well-recognized role of vaccines, coverage is far from optimal especially in children, representing a growing concern also in Italy. In order to reverse this emergency, the Italian Ministry approved in July 2017 the Law 119/2017, which renders mandatory and free of charge 10 vaccinations for patients aged 0–16. We aim to investigate the effects of the new Law 119/2017 on the reporting of adverse events following immunization related to mandatory vaccines into the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza – RNF). Therefore, we analyzed the spontaneous reports of suspected adverse events following immunization recorded in Campania Region (South of Italy) from December 1, 2016, to March 31, 2018. During the study period, 69 reports, covering 179 AEFIs, related to mandatory vaccines were sent to Campania Pharmacovigilance Regional Center. A substantial increase in AEFIs reporting was observed after the adoption of Law 119/2017. Out of 69 reports, 62% reported AEFIs that were considered as not serious and 78% had a favorable outcome. Out of 179 AEFIs, more than half referred to the following SOC: “general disorders and administration site conditions,” “nervous system disorders,” and “psychiatric disorders.” The highest number of reports came from patient/citizen. After the adoption of the Law 119/2017, there was an increase in the number of reports (18 before the adoption of the Law vs. 51 after). According to reported AEFIs during the entire period, no worrying safety data have emerged. In our opinion, the increase in the number of AEFIs’ reports should be related to the increase in vaccination coverage as well as to the intense debate that has followed the new Law. In this context, the continuous monitoring of vaccine safety and the fully implementation of vaccine–vigilance programs play a key role in achieving higher confidence in immunization programs and optimal vaccination coverage rate.

Severe Cutaneous Adverse Drug Reactions Associated with Allopurinol: An Analysis of Spontaneous Reporting System in Southern Italy

“…Whilst men have an increased risk of gout and hyperuricemia and, therefore, are more prone to be treated with allopurinol, we found that ADRs, especially serious cutaneous ADRs, were more common in women. This is not surprising because females seem to be more likely at risk to experience ADRs due to sex-specific differences in the pharmacokinetics and pharmacodynamics of drugs [34][35][36][37]. Furthermore, literature data confirm that both SJS and TEN could occur at any age, but appear to be more prevalent in adults, with a slight predominance in women [38,39].…”

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database

“…Furthermore, hypercholesterolaemia seems to be more common in women, particularly after menopause, which has been shown to be associated with an increase in total and LDL-cholesterol [32][33][34][35][36][37][38][39]. Lastly, it should be noted that, independently by drug classes, women are more susceptible to experience ADRs due to hormonal factors, as well as changes in pharmacokinetics [40][41][42].…”

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post-Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

“…Noteworthy, vaccination safety was confirmed by the evidence that the majority of ADE reports were not associated to vaccines, nor increased risk of hospitalization due to AEFI occurrence was observed among sexes. Although vaccines represent one of the most frequent cause of ADE in specific subgroups, such as children, their safety was confirmed by several observational studies and by health care authorities: adverse events following immunization are mostly non-serious and rarely cause ED visits and hospitalization [15].…”