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. 2022 Mar 24:13:825479.
doi: 10.3389/fphar.2022.825479. eCollection 2022.

Drug Prescriptions in the Outpatient Management of COVID-19: Evidence-Based Recommendations Versus Real Practice

Valeria Belleudi  1 , Marco Finocchietti  1 , Filomena Fortinguerra  2 , Aurora Di Filippo  2 , Francesco Trotta  2 , Marina Davoli  1 , Antonio Addis  1
Affiliations

Drug Prescriptions in the Outpatient Management of COVID-19: Evidence-Based Recommendations Versus Real Practice

Valeria Belleudi et al. Front Pharmacol. .

Abstract

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.

Keywords: COVID-19; drug monitoring; drug prescription; evidence-based medicine; outpatient care.

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Conflict of interest statement

FF, AD, and FT were employed by the Italian Medicines Agency (AIFA), the national authority responsible for the regulatory, pricing and reimbursement (PR), and HTA activities related to pharmaceuticals including governance of pharmaceutical expenditure. The remaining authors declare that the research was conducted in absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
AIFA recommendations on the use of specific drug categories in the outpatient treatment of COVID 19 cases. Note: Attenuated colors show information on card validity, in case of update the diagram reported a new rectangle. * From December 2020 onward, the negative recommendation regarded all antibiotic agents; § Corticosteroid use was recommended in subjects with severe COVID-19 disease mostly combined with oxygen therapy; ^ Antithrombotic use was recommended in hospitalized patients, while outpatient use was controversial.
FIGURE 2
FIGURE 2
COVID-19 cases and prevalence of study drug use among COVID-19 cases stratified by calendar month. The gray line represents the monthly percentage of COVID-19 cases with at least one study drug in the exposure window (from 3 days before to 7 days post-COVID-19); bars show the monthly prevalence of use of specific drug classes.
FIGURE 3
FIGURE 3
Ranking of the top 10 COVID-19 outpatient therapies during the period from March 2020 to February 2021 and variation by calendar month. Note: In the legend, COVID-19 outpatient therapy and the rank observed considering the entire study period are reported.
See this image and copyright information in PMC

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