The Interplay of Perceived Risks and Benefits in Deciding to Become Vaccinated against COVID-19 While Pregnant or Breastfeeding: A Cross-Sectional Study in Italy.

The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July-September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accepting of vaccination if they were not pregnant. COVID-19 risk perception predicted intention to become vaccinated, but not behavior. In conclusion, the overall risks/benefits tradeoff is key in predicting vaccination behavior and intention, but the concerns for the baby weigh more than those for the mother in the decision, shedding light on this previously neglected aspect.

Acute appendicitis in a patient immunised with COVID-19 vaccine: A case report with morphological analysis.

Although the benefit/risk profile for mRNA COVID-19 vaccines is recognised as extremely favourable, appendicitis is currently considered an adverse event (AE) of special interest. We describe the case of a 58-year-old female who presented with signs and symptoms of appendicitis approximately 48 hours after her first injection of the Pfizer-BioNTech vaccine. Abdominal ultrasound revealed fluid collection in the right iliac fossa and cecal wall thickening. Following the surgical visit, CT scan with contrast showed a distended appendix with thickened walls, suggestive of acute appendicitis. The patient tested negative to upper respiratory COVID-19 reverse transcription-polymerase chain reaction. Clinical trials and observational studies suggest a possible association between appendicitis and COVID-19 vaccines. Th-1 driven granulomatous inflammation reported in our case represents an infrequent nonspecific chronic inflammation of the appendix, especially in the setting of delayed or interval appendectomy. In view of the current paediatric vaccination campaign, we recommend monitoring the safety profile and potential gastrointestinal AEs associated with mRNA COVID-19 vaccines to swiftly manage subjects with gastrointestinal symptoms and prevent potential complications.

Exposures and Suspected Intoxications to Pharmacological and Non-Pharmacological Agents in Children Aged 0-14 Years: Real-World Data from an Italian Reference Poison Control Centre.

This study describes the exposures and suspected intoxications in children (0-14 years) managed by an Italian reference poison control center (PCC). A seven-year observational retrospective study was performed on the medical records of the Toxicology Unit and PCC, Careggi University Hospital, Florence (Italy). During the study period (2015-2021), a total of 27,212 phone call consultations were managed by the PCC, of which 11,996 (44%) involved subjects aged 0-14 years. Most cases occurred in males (54%) aged 1-5 years (73.8%), mainly at home (97.4%), and with an oral route of intoxication (93%). Cases mainly occurred involuntarily. Consultations were generally requested by caregivers; however, in the age group 12-14 years, 70% were requested by healthcare professionals due to voluntary intoxications. Cleaners (19.44%) and household products (10.90%) were the most represented suspected agents. Pharmacological agents accounted for 28.80% of exposures. Covariates associated with a higher risk of emergency department visit or hospitalization were voluntary intoxication (OR 29.18 [11.76-72.38]), inhalation route (OR 1.87 [1.09-3.23]), and pharmacological agents (OR 1.34 [1.23-1.46]), particularly central nervous system medications. Overall, consultations do not burden national and regional healthcare facilities, revealing the activity of PCCs as having a strategic role in reducing public health spending, even during the COVID-19 pandemic.

Attitudes and Perceptions of University Students in Healthcare Settings towards Vaccines and Vaccinations Strategies during the COVID-19 Pandemic Period in Italy.

BACKGROUND: Healthcare students that refuse to get vaccinated may expose themselves and their patients to several vaccine-preventable diseases, especially during outbreaks or at peak epidemic activity, becoming a threat to themselves and their patients. This study aimed to assess their attitudes towards and perception of vaccines and vaccination. METHODS: An anonymous questionnaire was shared with medical students, pharmacy students and medical residents in Hygiene and Preventive Medicine at the University of Florence (Italy), in February 2021. The questionnaire contained 39 questions with open, multi-choice, yes-no, Likert scale answers. A Vaccine Hesitancy Index (VHI) was then calculated. A descriptive statistical analysis was performed. RESULTS: A total of 473 students participated in this study. All students were in favour of vaccination (99.2%) but a relatively low number of participants judged their level of knowledge about vaccinations as "good" (21.8%) or "excellent" (0.6%). About half of students declared that they are not adequately trained during their academic courses. The VHI showed low levels of vaccine hesitancy (mean ± SD 0.38 ± 0.16); moreover, the students were willing to get vaccinated against SARS-CoV-2 when recommended (88.2%) and thought that these vaccines are generally safe. Few students considered the development of SARS-CoV-2 vaccines (13.1%) and the procedures for evaluating clinical trials for marketing authorisation of these vaccines (12.9%) too fast to guarantee their efficacy and safety. CONCLUSIONS: Since vaccination and vaccine hesitancy and acceptance topics are being paid increasing attention by the population, new strategies to increase future healthcare professionals' willingness to promote vaccination and get vaccinated, as well as knowledge on vaccines and vaccination, will be of the utmost importance to fight vaccine preventable diseases.

Knowledge of University Students in Health Care Settings on Vaccines and Vaccinations Strategies: Impact Evaluation of a Specific Educational Training Course during the COVID-19 Pandemic Period in Italy.

BACKGROUND: Training future healthcare professionals on vaccination through specific courses is important to properly promote active immunization among the general population and to fight fake news and false beliefs on vaccinations. The aim of the study was to assess the impact of an elective course about vaccinations on the knowledge of medical students, pharmacy students, and medical resident in Hygiene and Preventive Medicine in Italy. METHODS: The participants were asked to complete an anonymous questionnaire before and after an elective teaching activity (ETA) on vaccination. The two questionnaires contained the same 30 questions and focused on different aspects of vaccines and vaccination. The students who had attended the seminar were allowed to fulfil the post-lecture questionnaire. Both descriptive and inferential analysis were performed on the results; in particular, Student's t-test for independent samples was used to compare the total score obtained before and after attending the ETA. RESULTS: A total of 449 students participated in the ETA. Overall, the participation in the ETA allowed them to significantly improve their final score (+27.28%, p < 0.001). Good results were obtained even when comparing the three groups (medical students, pharmacy students and medical residents) separately. Females improved more than males, especially among pharmacy students. DISCUSSION: The present study highlights the importance and the impact that extracurricular activities can have in improving knowledge about vaccinations. With vaccination and vaccine hesitancy and acceptance topics with increasing attention paid by the population, especially after the COVID-19 pandemic, it is fundamental to develop new strategies to increase future healthcare professionals' knowledge about vaccinations.

Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist

Recent years, particularly the COVID-19 pandemic, can be considered a turning point for pharmacovigilance and pharmacoepidemiology in terms of their role in drug safety and drug utilisation monitoring in clinical practice [...]

Recommendations for a safe restart of elective aerosol-generating oral surgery procedures following the COVID-19 pandemic outbreak: An Italian multicenter study.

Among healthcare workers, oral and maxillofacial surgeons are some of the most exposed to coronavirus disease (COVID-19). The aim of this retrospective study was to develop suggestions for continuing the work of oral and maxillofacial surgeons using a safe protocol for elective and urgent aerosol-generating procedures that could prevent the onset of new clusters. Based on the results obtained and a guidelines review of those Asian countries that had promptly managed the current pandemic, the following safety protocol was developed.

Exposures and suspected intoxications during SARS-CoV-2 pandemic: preliminary results from an Italian poison control centre.

Data on cleaner and disinfectant exposure and misuse-related acute intoxications in Italy during SARS-CoV-2 pandemic are still lacking. The aim of the present study was to analyse and describe cleaner and disinfectant-related intoxications during SARS-CoV-2 pandemic in an Italian poison control centre. Data were obtained from the toxicological consultations requested to the Toxicology Unit and Poison Centre, Careggi University Hospital, Florence (Italy). We compared data from January 1st to April 30th of 2019 and 2020. Data concerning probable or acute intoxication from any causative agent in the general population (all age groups), from private individuals or from Regional and National health structures, were included in the analysis. A toxicological evaluation was also performed to calculate the Poisoning Severity Score.In 2019, 451 phone counselling sessions were performed and compared to a total of 410 calls received during the same period of 2020. In both periods, the majority of events occurred in paediatric (0-17 years) and adult (18-65 years) patients, who were mainly exposed to one toxic agent, and intoxications took place principally at home due to domestic accidents. The oral route of intoxication was the most frequently observed one, followed by inhalation of toxic agents, which increased by 4.7% in 2020. In 2020, sanitizers and cleaners were reported in 21.6% of cases compared to 12.5% in 2019. This is the first study describing cleaner and disinfectant-related intoxications in Italy. Our results suggested a possible misuse of these products during the SARS-CoV-2 pandemic, underling the effects of home isolation on mental health and unintentional toxic exposures.

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug-drug interactions.

Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug-drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients' demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.