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The ageing process is associated with an increased probability of accumulating health deficits, chronic conditions and geriatric syndromes, leading to a growing prevalence of multimorbidity, defined as the co-occurrence of two or more chronic conditions (of which, at least one physical condition). One of the most frequent and direct consequences of multimorbidity, especially amongst older adults, is polypharmacy, a condition characterized by the concomitant use of five or more drugs per day. Polypharmacy is one of the main risk factors for adverse clinical outcomes, including drug-drug interactions and adverse drug reactions, also resulting in increased hospitalizations, morbidity, and increased use of healthcare resources, with considerable implications for healthcare costs. Deprescribing is one of potential approaches to reduce inappropriate prescribing and it is defined as the stopping or dose reduction of medications that are either inappropriate or unnecessary, especially among patients with polypharmacy. In this review, the major issues associated with polypharmacy among older people, the current guidelines for the management of polypharmacy and the strategies to implement deprescribing in different settings (i.e., hospital setting, nursing homes and general practice) are discussed. [ABSTRACT FROM AUTHOR]

In recent years, there has been an exponential increase in the generation and accessibility of electronic healthcare data, often referred to as "real-world data". The landscape of data sources has significantly expanded to encompass traditional databases and newer sources such as the social media, wearables, and mobile devices. Advances in information technology, along with the growth in computational power and the evolution of analytical methods relying on bioinformatic tools and/or artificial intelligence techniques, have enhanced the potential for utilizing this data to generate real-world evidence and improve clinical practice. Indeed, these innovative analytical approaches enable the screening and analysis of large amounts of data to rapidly generate evidence. As such numerous practical uses of artificial intelligence in medicine have been successfully investigated for image processing, disease diagnosis and prediction, as well as the management of pharmacological treatments, thus highlighting the need to educate health professionals on these emerging approaches. This narrative review provides an overview of the foremost opportunities and challenges presented by artificial intelligence in pharmacology, and specifically concerning the drug post-marketing safety evaluation. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy is a primary risk factor for the prescription of potentially inappropriate medications (PIMs), drug–drug interactions (DDIs), and ultimately, adverse drug reactions (ADRs). Medication review and deprescribing represent effective strategies to simplify therapeutic regimens, minimize risks, and reduce PIM prescriptions. This systematic review and meta‐analysis of experimental and observational studies aimed to evaluate the impact of different medication review and deprescribing interventions in hospitalized older patients. Methods: Experimental and observational prospective cohort studies evaluating the clinical effects of medication review and deprescribing strategies in older hospitalized patients were searched in the bibliographic databases, PubMed, Embase, and Scopus, from inception until January 8, 2024. A narrative synthesis of the results was provided, along with a meta‐analysis of dichotomous data (i.e., re‐hospitalizations and mortality). Results: Overall, 21 randomized controlled trials, 7 non‐randomized interventional studies, and 2 prospective cohort studies were included in the systematic review. Of these, 14 (46.7%) assessed medication appropriateness as the primary outcome, while the remaining evaluated clinical outcomes (e.g., length of hospital stay, hospital readmissions, emergency department visits, and incidence of ADRs) and/or quality of life. The meta‐analysis revealed a slight but statistically significant 8% reduction in hospital readmissions (HR: 0.92; 95% CI: 0.85–0.99) following medication review and deprescribing, but no significant impact on mortality (HR: 0.98; 95% CI: 0.96–1.00). Of the 30 included studies, 21 were considered at high risk of bias, mostly due to potential deviations from intended interventions and randomization processes. The remaining nine studies had "some concerns" (eight studies) or were considered at "low" risk of bias (one study). Conclusion: Medication review and deprescribing are associated with potential benefits in reducing hospital readmission rates among hospitalized older patients, particularly through the reduction of PIM prescriptions. The integration of thorough medication review and deprescribing protocols in hospital settings may improve post‐discharge outcomes and reduce overall healthcare costs. [ABSTRACT FROM AUTHOR]

Background: Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. Methods: From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. Results: Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64–91% vs. 56–79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (p < 0.001). Conclusions: Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines. [ABSTRACT FROM AUTHOR]

Since its first approval by the Food and Drug Administration in 1989 for strabismus, botulinum toxin indications of use have been widely expanded. Due to its anticholinergic properties, this toxin is currently approved in adult patients for the treatment of a wide range of neuromuscular, otolaryngologic, orthopedic, gastrointestinal, and urologic disorders. Approved pediatric indications of use include the treatment of blepharospasm associated with dystonia, strabismus, lower-limb spasticity, focal spasticity in patients with cerebral palsy, and neurogenic detrusor overactivity. Alongside these approved indications, botulinum toxin is extensively used off-label. Although several clinical studies have shown that botulinum toxin is effective and well-tolerated in children, uncertainties persist regarding its long-term effects on growth and appropriate dosing in this population. As such, further research is needed to better define the botulinum toxin risk–benefit profile and expand approved uses in pediatrics. This narrative review aimed to provide a broad overview of the evidence concerning the clinical effectiveness and safety of BoNT with respect to its principal authorized and non-authorized pediatric therapeutic indications, as well as to describe perspectives on its future use in children. [ABSTRACT FROM AUTHOR]

Background Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy. Methods and findings We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. Exposure risk period (0 to 21 days from the vaccination day, subdivided in 3 equal intervals) for first and second dose was compared with baseline period. The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose, age, sex, and vaccine product. Calendar period was included as time-varying confounder in the model. During the study period 2,861,809 persons aged 12 to 39 years received mRNA vaccines (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed myocarditis/pericarditis (346 BNT162b2; 95 mRNA-1273). Within the 21-day risk interval, 114 myocarditis/pericarditis events occurred, the RI was 1.99 (1.30 to 3.05) after second dose of BNT162b2 and 2.22 (1.00 to 4.91) and 2.63 (1.21 to 5.71) after first and second dose of mRNA-1273. During the [0 to 7) days risk period, an increased risk of myocarditis/pericarditis was observed after first dose of mRNA-1273, with RI of 6.55 (2.73 to 15.72), and after second dose of BNT162b2 and mRNA-1273, with RIs of 3.39 (2.02 to 5.68) and 7.59 (3.26 to 17.65). The number of EC for second dose of mRNA-1273 was 5.5 per 100,000 vaccinated (3.0 to 7.9). The highest risk was observed in males, at [0 to 7) days after first and second dose of mRNA-1273 with RI of 12.28 (4.09 to 36.83) and RI of 11.91 (3.88 to 36.53); the number of EC after the second dose of mRNA-1273 was 8.8 (4.9 to 12.9). Among those aged 12 to 17 years, the RI was of 5.74 (1.52 to 21.72) after second dose of BNT162b2; for this age group, the number of events was insufficient for estimating RIs after mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after first dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after second dose of BNT162b2 and mRNA-1273; the numbers of EC were 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) after first and second dose of mRNA-1273. The main study limitations were that the outcome was not validated through review of clinical records, and there was an absence of information on the length of hospitalization and, thus, the severity of the outcome. Conclusions This population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273. The highest risks were observed in males of 12 to 39 years and in males and females 18 to 29 years vaccinated with mRNA-1273. The public health implication of these findings should be considered in the light of the proven mRNA vaccine effectiveness in preventing serious COVID-19 disease and death., Author(s): Marco Massari 1, Stefania Spila Alegiani 1, Cristina Morciano 1,*, Matteo Spuri 2, Pasquale Marchione 3, Patrizia Felicetti 3, Valeria Belleudi 4, Francesca Romana Poggi 4, Marco Lazzeretti 5, [...]