PharmaCare 2018

[Italiano]: Il farmaco, nella sua accezione più ampia e generale, può essere ritenuto un bene sociale, la cui valenza simbolica e curativa varia in relazione alla dimensione ambientale e culturale nel quale si inserisce. In tal senso, le prescrizioni farmaceutiche rappresentano un indicatore privilegiato per la conoscenza del sistema salute di un determinato territorio, poiché costituiscono un punto di intersezione ideale tra la prospettiva medica e quella di mercato. Siffatte considerazioni hanno sollecitato l’elaborazione di questo Report che si pone, come obiettivi dichiarati, quello di essere uno strumento utile alla pianificazione di interventi di sanità pubblica, quanto quello di svolgere analisi approfondite sulle caratteristiche dei soggetti che usano i farmaci e sulle modalità di trattamento degli stessi, permettendo studi di appropriatezza prescrittiva su specifiche aree di rilevanza clinica e su specifiche coorti di soggetti. “PharmaCaRe Report 2018” è stato realizzato dal CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione) dell’Università degli Studi di Napoli Federico II, in collaborazione con la Direzione Generale della Tutela della Salute della Regione Campania, per delineare un quadro dettagliato circa il consumo e la prescrizione dei farmaci in Campania nel 2018. Questo Report intende infatti fornire una fotografia dettagliata dell’utilizzo che, in Campania, viene fatto dei farmaci in termini di spesa, volumi e tipologia. Le analisi dei dati prodotte offrono spunti importanti per correlare la prevalenza delle patologie nel territorio con il corrispondente utilizzo dei farmaci e suggeriscono un’interpretazione dei principali fattori che influenzano la variabilità nella prescrizione. La disponibilità di una banca dati che copre una popolazione assistibile di circa sei milioni di abitanti è d’altronde un potente strumento di ricerca per studiare gli effetti dell’utilizzo dei farmaci in condizioni di Real-World. La conoscenza delle dinamiche prescrittive, in termini qualitativi (appropriatezza d’uso), oltre che quantitativi (volumi di utilizzo) è la condizione necessaria per inquadrare in un contesto razionale la politica del farmaco, anche sotto il profilo della valutazione degli effetti degli interventi che il mercato, le normative o la cultura del farmaco sviluppano nel tempo. Per tali ragioni, “PharmaCaRe Report 2018” rappresenta un utile quanto prezioso supporto ai decisori per individuare strategie volte a ottimizzare l’allocazione delle risorse, nonché migliorare i percorsi di cura attraverso un monitoraggio costante, la promozione di più elevati standard di cura e l’uso sicuro, efficiente ed efficace dei farmaci ./[English]: In its broadest and most general sense, the drug can be considered a public resource, whose symbolic and curative value varies in relation to the environmental and cultural dimension in which it is embedded. In this sense, pharmaceutical prescriptions represent a privileged indicator for the knowledge of the health system of a given territory, since they constitute an ideal intersection point between the medical and the market perspective. Such considerations prompted the preparation of this Report. “PharmaCaRe Report 2018” has been produced by CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione) of the Federico II University of Naples, in collaboration with the Directorate-General for Health Protection of the Campania Region, to provide a detailed overview of the pharmaceutical consumption and prescriptions in Campania in 2018. This Report aims to provide a detailed picture of the use of medicines in the general population in Campania, in terms of expenditure, volumes and type. The analyses of the data produced offer important clues for correlating the prevalence of diseases in this area with the respective use of medicines and suggest an interpretation of the main factors influencing prescriptions' variability. The availability of a database covering a patient population of around six million is a powerful research tool for studying the effects of drug use in Real-World conditions. Knowledge of the dynamics of prescription, in qualitative terms (appropriateness of use), as well as quantitative (volumes of use) is the necessary condition to frame the drug policy in a rational context, also in terms of evaluating the effects of the interventions that the market, regulations or drug culture develop over time. For these reasons, “PharmaCaRe Report 2018” represents a useful and valuable tool for political decision-makers in identifying strategies aimed at optimizing the allocation of resources, as well as improving care pathways through constant monitoring, the promotion of higher standards of care and safe, efficient and effective use of drugs

Implementing an ict-based polypharmacy management program in Italy

Although there is evidence of a growing awareness of the problem, no official policy statements or regulatory guidelines on polypharmacy have been released up to date by Italian Health Authorities. Medication review, application of appropriateness criteria and computerized prescription support systems are all possible approaches in order to improve the quality of prescribing in older persons. More focused training courses on multimorbidity and polytherapy management are encouraged. Furthermore a multidisciplinary approach integrating different health care professionals (physicians, pharmacists, and nurses) may positively impact on reducing the sense of fear related to discontinue or substitute drugs prescribed by others; the fragmentation of therapy among different specialists; reducing costs; and improving adverse drug reaction detection and reporting. Aiming at achieving the individualized pharmacotherapy, a multidisciplinary approach starting with identification of patients and risk for drug-related problems, followed by medication review overtime and use of inappropriateness criteria, supported by computerized systems has been proposed

An evidence-based debate on epigenetics and immunosenescence in COVID-19

Immunosenescence contributes to the decline of immune function leading to a reduced ability to respond to severe coronavirus disease 2019 (COVID-19) in elderly patients. Clinical course of COVID-19 is widely heterogeneous and guided by the possible interplay between genetic background and epigenetic-sensitive mechanisms underlying the immunosenescence which could explain, at least in part, the higher percentage of disease severity in elderly individuals. The most convincing evidence regards the hypomethylation of the angiotensin-converting enzyme 2 (ACE2) promoter gene in lungs as well as the citrullination of histone H3 in neutrophils which have been associated with worsening of COVID-19 outcome in elderly patients. In contrast, centenarians who have showed milder symptoms have been associated to a younger “epigenetic age” based on DNA methylation profiles at specific genomic sites (epigenetic clock). Some large prospective studies showed that the acceleration of epigenetic aging as well as the shortening of telomeres were significantly associated with lymphopenia and poor outcome suggesting prognostic biomarkers in elderly COVID-19 patients. Furthermore, randomized clinical trials showed that statins, L-arginine, and resveratrol could mediate anti-inflammatory effects via indirect epigenetic interference and might improve COVID-19 outcome. Here, we discuss the epigenetic-sensitive events which might contribute to increase the risk of severity and mortality in older subjects and possible targeted therapies to counteract immunosenescence

Treatment patterns and medication adherence among newly diagnosed patients with migraine: a drug utilisation study

Objectives Prophylactic drugs currently used for migraine treatment are not specific. Furthermore, few studies in existing literature describe drugs utilisation patterns and adherence to migraine prophylactic treatment. This study is aimed to describe utilisation patterns of migraine drugs, evaluate adherence to prophylactic medications and investigate drug-related costs.Design Retrospective population-based study using an administrative health-related database.Setting Primary care setting in the Campania region, Southern Italy.Participants This study was carried out between 1 January 2016 and 31 December 2018, involving 12 894 subjects with any primary or secondary hospital discharge with migraine diagnosis, or at least two medical dispensations of migraine-specific acute or prophylactic medications (triptans or pizotifen). Subjects were classified into four treatment cohorts: no treatment, acute, prophylactic and both acute and prophylactic. Subjects were followed-up for 1 year.Outcome measures Utilisation patterns of migraine drugs at treatment initiation; adherence to prophylactic treatment; discontinuation, restart and switching rates; annual migraine drug costs per patient.Results Overall, 81.1% of subjects received acute treatment as their initial migraine treatment regimen, 10.7% prophylactic treatment, 8.2% both acute and prophylactic treatment. 599 patients were treated prophylactically; of these, 26.2% adhered to their initial treatment while 73.8% reported interruptions in treatment. Among the latter, 46.4% of patients discontinued the treatment completely within 103 days (IQR 89.0), 31% restarted treatment 46 days after interruption (IQR 60.0) and 22.6% switched to another treatment within 98 days (IQR 57.5) (p<0.001). The median annual cost of drugs per patient was €103 for those treated acutely, €75 for those treated prophylactically, €163 for those treated both.Conclusions Migraine treatment with acute medications is still prevalent in Italy; only few patients received prophylactic treatment with poor adherence to treatment. These findings reflect an unmet need for improved prophylactic therapies in order to provide a better disease management

Gender Differences in Medication Use: A Drug Utilization Study Based on Real World Data

A gender-specific drug utilization study was performed in the Campania region, Southern Italy. Data were based on outpatient drug prescriptions collected from administrative databases. The study population included all patients with at least one drug prescription in 2018. Prevalence was used as a measure to estimate the degree of exposure to drugs. A total of 3,899,360 patients were treated with at least one drug (54.2% females). The number of prescriptions was higher in females than males (55.6% vs. 44.4%). Females recorded higher prevalence for the majority of therapeutic groups (ATC II-anatomical therapeutic chemical), as well as for anti-inflammatory and antirheumatic products drugs (M01) (25.6% vs. 18.7%, risk ratio (RR): 0.73), beta blocking agents (C07) (14.5% vs. 11.6%, RR: 0.80), psychoanaleptics (N06) (7.1% vs. 3.7%, RR: 0.52), and antianemic preparations (B03) (2.8% vs. 6.7%, RR: 0.4). Higher prevalence was identified for males only for drugs used in diabetes (A10) (6.8% vs. 6.2%, RR: 1.1), particularly for biguanides (A10BA). Conversely, treatment duration was longer among males, explaining the higher mean cost per treated patient. This real-world study showed substantial gender differences in terms of medication use and duration of treatment and costs. These results are relevant to promoting and supporting the emerging role of precision and personalized medicine

Risk of SARS-CoV-2 Infection Breakthrough among the Non-Vaccinated and Vaccinated Population in Italy: A Real-World Evidence Study Based on Big Data

SARS-CoV-2 infection after vaccination can occur because COVID-19 vaccines do not offer 100% protection. The study aim was to assess duration of vaccination coverage, disease symptoms and type of hospitalization among non-vaccinated and vaccinated subjects to evaluate the vaccination trend over time. A retrospective cohort study was carried out among people testing COVID-19 positive in Campania Region using information from the Health Information System of Campania Region (Sinfonia). Vaccination status was assessed considering: no vaccination, partial vaccination and effective vaccination. Univariate and multivariate logistic regression models were constructed to evaluate the association between ICU admissions caused by COVID-19 and gender, age groups and vaccine type. Vaccine coverage duration trends were investigated using segmented linear regression and breakpoint estimations. Vaccination coverage was assessed by analyzing COVID-19 positive subjects in the 9 months after an effective dose vaccination. A significant risk of hospitalization in the ICU was caused by vaccination status: subjects non-vaccinated (OR: 7.14) and partially vaccinated (OR: 3.68) were 3 and 7 times more at risk of hospitalization, respectively, than subjects effectively vaccinated. Regarding subjects with an effective vaccination, the vaccine’s ability to protect against infection in the months following vaccination decreased. The risk of contracting COVID-19 after vaccination was higher 5 months (β = 1441, p p < 0.001) after administration of an effective dose. COVID-19 vaccines were demonstrated to protect from symptomatic infection by significantly reducing hospitalization risk, and their full protection against SARS-CoV-2 was demonstrated to decrease after 5 months regardless of age, gender or vaccine type

Postvaccination SARS-CoV-2 Infections among Healthcare Professionals: A Real World Evidence Study

Due to the COVID-19 pandemic, all countries with a global mobilization started to produce and authorize vaccines, prioritizing healthcare professionals (HCPs) to reduce transmission. The aim of this study was to assess post-vaccination infections' occurrence among HCPs and their correlation with symptom onset. A retrospective cohort study was carried out in the Campania Region from December 2020 to April 2021. Data were retrieved from the Regional Health Information System of the Campania Region (Sinfonia). The study cohort included subjects that had all received at least one vaccine dose. Risk ratios (RRs) adjusted for age and sex (95% confidence intervals) were performed to assess differences in the prevalence between HCPs who tested positive or negative for COVID-19. Univariate and multivariate logistic regression models were used to evaluate the association between symptoms and vaccination status. Findings revealed that HCPs had a lower risk of contracting COVID-19 after receiving at least one vaccine dose, and this risk decreased with age. Furthermore, not having full vaccination coverage may predict a severe/critical evolution of the disease. This study provides a snapshot of the initial state of the Italian vaccination campaign on HCPs. A surveillance approach using Big Data matched to clinical conditions could offer a real analysis in the categorization of subjects most at risk

Health Risk Assessment of PAHs from Estuarine Sediments in the South of Italy

: Increased concerns about the toxicities of Polycyclic Aromatic Hydrocarbons (PAHs), ubiquitous and persistent compounds, as well as the associated ecotoxicology issue in estuarine sediments, have drawn attention worldwide in the last few years. The levels of PAHs in the Sele, Sarno, and Volturno Rivers sediments were evaluated. Moreover, the cancerogenic risk resulting from dermal and ingestion exposure to PAHs was estimated using the incremental lifetime cancer risk (ILCR) assessment and the toxic equivalent concentration (TEQBaP). For Sele River, the results showed that the total PAH concentration ranged from 632.42 to 844.93 ng g-1 dw, with an average value of 738.68 ng g-1 dw. ∑PAHs were in the range of 5.2-678.6 ng g-1 dw and 434.8-872.1 ng g-1 dw for the Sarno and Volturno River sediments, respectively. The cancerogenic risk from the accidental ingestion of PAHs in estuarine sediments was low at all sampling sites. However, based on the ILCRdermal values obtained, the risk of cancer associated with exposure by dermal contact with the PAHs present in the sediments was moderate, with a mean ILCRdermal value of 2.77 × 10-6. This study revealed the pollution levels of PAHs across the South of Italy and provided a scientific basis for PAH pollution control and environmental protection

Prevalence of antibiotic prescription in southern Italian outpatients: real-world data analysis of socioeconomic and sociodemographic variables at a municipality level

PURPOSE: The aim of this study was to analyze the geographic variation in systemic antibiotic prescription at a regional level and to explore the influence of socioeconomic and sociodemographic variables. METHODS: This study was a retrospective analysis of reimbursement pharmacy records in the outpatient settings of Italy's Campania Region in 2016. Standardized antibiotic prescription rates were calculated at municipality and Local Health Unit (LHU) level. Antibiotic consumption was analyzed as defined daily doses (DDD)/1000 inhabitants per day (DID). Logistic regression was performed to evaluate the association between antibiotic prescription and sociodemographic and socioeconomic determinants at a municipality level. RESULTS: The average antibiotic prevalence rate was 46.8%. At LHU level, the age-adjusted prevalence rates ranged from 41.1% in Benevento to 51.0% in Naples2. Significant differences were found among municipalities, from 15.2% in Omignano (Salerno LHU [Sa-LHU]) to 61.9% in Moschiano (Avellino [Av-LHU]). The geographic distribution also showed significant differences in terms of antibiotic consumption, from 6.7 DID in Omignano to 41.6 in San Marcelino (Caserta [Ce-LHU]). Logistic regression showed that both municipality type and average annual income level were the main determinants of antibiotic prescription. Urban municipalities were more than eight times as likely to have antibiotic high prevalence rates compared to rural municipalities (adjusted odds ratio [OR]: 8.62; 95% confidence interval [CI]: 4.06-18.30, P<0.001). Low average annual income level municipalities were more than eight times as likely to have antibiotic high prevalence rates compared to high average annual income level municipalities (adjusted OR: 8.48; 95% CI: 3.45-20.81, P<0.001). CONCLUSION: We provide a snapshot of Campania's antibiotic consumption, evidencing the impact of both socioeconomic and sociodemographic factors on the prevalence of antibiotic prescription. The observed intraregional variability underlines the lack of shared therapeutic protocols and the need for careful monitoring. Our results can be useful for decision makers to plan educational interventions, thus optimizing health resources and improving rational drug use