This cross-sectional study compares demand for drugs for treatment of coronavirus disease 2019 (COVID-19) between the period directly before the COVID-19 outbreak in Italy and the early period of the outbreak.
Background In Italy both the consumption of antibiotics and the prevalence of bacterial resistance are higher than in other European countries. In 2017, the first National Action Plan on Antimicrobial Resistance (PNCAR) was adopted in Italy. In response to the PNCAR two national reports on antibiotic use in the human setting have been published. This article's aim is to describe the pattern of antibiotic consumption in the community setting in Italy from 2013 to 2018. Methods To analyse the consumption for reimbursed antibiotics dispensed by community pharmacies different data sources were used. Consumption was measured in terms of defined daily dose (DDD), prescriptions or prevalence of use. Results In 2018, the consumption of antibiotics in Italy amounted to 16.1 DDD per 1000 inhabitants per day. The rates of consumption by geographical area were: 12.7 DDD in the north, 16.9 in the centre and 20.4 in the south. The use was greater in the extreme age groups than in the population aged from 20 to 64 years. The consumption was higher in winter season, with high peaks in the incidence of flu syndromes. In the paediatric population, a utilization rate of 1010 prescriptions per 1000 children, with a prevalence of use of 40.8%, was found. Conclusion The study provides useful information on the geographical variability of antibiotic use in Italy to guide decision makers in the introduction of tailored interventions, as suggested by PNCAR, aimed at promoting a more rational use of antibiotics for humans and reducing antimicrobial resistance.
IntroductionIt is well acknowledged that the price of orphan drugs is normally higher than that resulting from the value-based pricing. A correlation between the cost of therapy for orphan drugs and the epidemiology (prevalence and incidence) of the related rare disease can be hypothesized.MethodsThis analysis includes all approved orphan drugs by European Medicines Agency whose reimbursement was granted for the first therapeutic indication in the years 2014–2019 in Italy. Regression and correlation analyses were performed to analyze the possible correlations between the logarithm of the annual therapy cost and the epidemiology of the rare diseases, between orphan drugs consumption and epidemiology of related rare disease and between therapy cost and the consumption.ResultsThe regression analysis between the annual cost of therapy estimated on the published ex-factory price and the prevalence showed a slightly decreasing, not statistically significant, trend (coefficient: −0.10, p-value: 0.41). The results were similar when using the price resulting from the application of Managed Entry Agreements (coefficient: −0.11, p-value: 0.40). The regression analysis between sales volume and prevalence showed a positive slope without an acceptable level of significance (p-value: 0.04). The correlation analysis between the therapy cost and the sales volume highlighted again an absence of significant association, similarly if considering only ATC L orphan drugs, or the incidence.DiscussionThe definition of the price of an orphan drug seems not to depend on the rarity of the disease, and sales volumes do not correlate with the epidemiology of the rare disease and with the annual cost of therapy.
Background: Evidence-based recommendations for outpatient management of COVID-19 were published by the Italian Medicines Agency (AIFA) to limit the use of off-label treatments. The aim of this study is to measure the use of outpatient drug treatments in a COVID-19-positive population, taking into account the Italian regulatory agency’s advices.Methods: A descriptive observational study was conducted. All patients testing positive for COVID-19 residing in Lazio region, Italy, with diagnosis date between March 2020 and May 2021 were selected, and outpatient medicine prescription patterns were identified.Results: Independent of AIFA recommendations, the use of drug therapy in the management of outpatient COVID-19 cases was frequent (about one-third of the cases). The most used drug therapy was antibiotics, specifically azithromycin, despite the negative recommendation of AIFA, while the use of corticosteroids increased after the positive recommendation of regulatory agency for the use in subjects with severe COVID-19 disease. The use of hydroxychloroquine was limited to the early pandemic period where evidence on its potential benefit was controversial. Antithrombotics were widely used in outpatient settings, even if their use was recommended for hospitalized patients.Conclusion: In this study, we show a frequent use of drug therapy in the management of outpatient cases of COVID-19, mainly attributable to antibiotics use. Our research highlights the discrepancy between recommendations for care and clinical practice and the need for strategies to bridge gaps in evidence-informed decision-making.
Objective This study aims to analyse the impact of the pandemic on the amount of use and new medication dispensation for chronic diseases in the Italian population aged 65 years and older (almost 14 million inhabitants). Methods The “Pharmaceutical Prescriptions database”, which gathers data on medications, reimbursed by the National Health Service and dispensed by community pharmacies, was employed. Data were analysed as amount of use (defined daily dose—DDD per 1000 inhabitants); variation in DDD between 2020 and 2019 was calculated for the 30 categories with major consumption in 2020. Trends in prevalence and incidence of dispensations between 2020 and 2019 were calculated for four categories: antidiabetics, antihypertensives, antidepressants and drugs for respiratory diseases. Results All medications showed a negative variation in DDD/1000 inhabitants between 2020 and 2019 except for anticoagulants (+ 5%). The percentage variation ranged from − 27.7% for antibiotics to − 6.4% for antipsychotics in 85 + year-old persons, but increased for most classes in the youngest (65–69 years). On the other hand, a decrease of the dispensation incidence of antidiabetics, antihypertensives, antidepressants and drugs for pulmonary disease was high, especially in the two extreme age groups, the youngest and the oldest one. Conclusions and relevance Great variation in medication use between 2020 and 2019 was observed probably reflecting the low rate of infectious diseases due to the widespread use of protective devices and self-isolation, reduced healthcare access because of the lockdowns and the fear of going to hospital, and the reduction of screening and diagnostics due to health-care system overload.
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