Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

IntroductionAntimicrobial resistance (AMR) is one of the most important challenges in modern clinical practice. The European regulatory network has a strategy to support prevention of AMR by applying specific referral procedures.AimThe aim of this study was to evaluate post-authorisation changes made in the product information of key antibiotics that underwent referral procedures between 2007 and 2020.MethodIn a comprehensive analysis of the changes made for antibiotics, we extracted information on changes from the European Commission community register of medicinal products and the European Medicines Agency's database for antibiotics that went through referrals. Changes made in the specific sections of the summary of product characteristics of each referral procedure were scrutinised.ResultsWe identified 15 antibiotics from seven classes of antibiotics during the study period. The outcome of all referrals included the restriction of antibiotic use. Therapeutic indications were revised for all antibiotics, with septicaemia and gonorrhoea most common diseases removed. Posology and/or method of administration was updated for all; the majority of referrals included adjustment of dosage for specific populations. Information on contraindication (most regarding hypersensitivity) and information on warnings was amended for all referrals.ConclusionOur findings highlight the importance of the regulatory actions. The changes made in the product information aim to ensure appropriate use. Ongoing harmonisation activities are likely to lead to further refinements and restrictions on individual antibiotics in support of rational use. However, further research is required to examine the impact of post-referral label changes on the clinical practice.

Pull Incentives for Antibacterial Drug Development: An Analysis by the Transatlantic Task Force on Antimicrobial Resistance.

New alternative market models are needed to incentivize companies to invest in developing new antibacterial drugs. In a previous publication, the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) summarized the key areas of consensus for economic incentives for antibacterial drug development. That work determined that there was substantial agreement on the need for a mixture of push and pull incentives and particularly those that served to delink the revenues from the volumes sold. Pull incentives reward successful development by increasing or ensuring future revenue. Several pull incentives have been proposed that could substantially reward the development of new antibacterial drugs. In this second article authored by representatives of TATFAR, we examine the advantages and disadvantages of different pull incentives for antibacterial drug development. It is TATFAR's hope that this analysis, combined with other related analyses, will provide actionable information that will shape policy makers' thinking on this important issue.

Economic Incentives for Antibacterial Drug Development: Literature Review and Considerations From the Transatlantic Task Force on Antimicrobial Resistance.

The Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR) in 2015 was tasked with exploring economic incentives for antibacterial drug development and providing recommendations for potential global implementation. Due to the continual decline of pharmaceutical companies investing in new antibiotic development and the rise in antimicrobial resistance, there is an urgent need to examine market mechanisms that are appropriate to encourage small, medium, and large companies to reinvest in this space. This review provides a summary of the various models that have been proposed and highlights positions posed by several policy documents, peer-reviewed publications, organization proposals, and government-sponsored reviews. The findings support a form of a de-linkage model and a combination of push and pull incentive mechanisms. This level of consensus could culminate in global coordination of incentives that strike a balance of rewarding innovation and ensuring appropriate antibiotic use.

Hospital antibiotic consumption-an interrupted time series analysis of the early and late phases of the COVID-19 pandemic in Poland, a retrospective study.

BACKGROUND: COVID-19 has been challenging for the entire healthcare system, due to the lack of sufficient treatment protocols, especially during initial phases and as regards antibiotic use. The aim of this study was to identify the trends of antimicrobial consumption in one of the largest tertiary hospitals in Poland during COVID-19. METHODS: This is a retrospective study conducted at the University Hospital in Krakow, Poland, between Feb/Mar 2020 and Feb 2021. It included 250 patients. All included patients were hospitalized due to COVID-19 with confirmed SARS-CoV-2 infection without bacterial co-infections during the first phase of COVID-19 in Europe and following 3-month intervals: five equal groups of patients in each. COVID severity and antibiotic consumption were assessed according to WHO recommendations. RESULTS: In total 178 (71.2%) patients received antibiotics with a incidence rate of laboratory-confirmed healthcare-associated infection (LC-HAI) was 20%. The severity of COVID-19 was mild in 40.8%, moderate in 36.8%, and severe in 22.4% cases. The ABX administration was significantly higher for intensive care unit (ICU) patients (97.7% vs. 65.7%). Length of hospital stay was extended for patients with ABX (22.3 vs. 14.4 days). In total, 3 946.87 DDDs of ABXs were used, including 1512.63 DDDs in ICU, accounting for 780.94 and 2522.73 per 1000 hospital days, respectively. The median values of antibiotic DDD were greater among patients with severe COVID-19 than others (20.92). Patients admitted at the beginning of the pandemic (Feb/Mar, May 2020) had significantly greater values of median DDDs, respectively, 25.3 and 16.0 compared to those admitted in later (Aug, Nov 2020; Feb 2021), respectively, 11.0, 11.0 and 11.2, but the proportion of patients receiving ABX therapy was lower in Feb/Mar and May 2020 (62.0 and 48.0%), whereas the highest during the late period of the pandemic, i.e., in Aug, Nov. 2020 and Feb. 2021 (78% and both 84.0%). CONCLUSIONS: Data suggest great misuse of antibiotics without relevant data about HAIs. Almost all ICU patients received some antibiotics, which was correlated with prolonged hospitalization.