Candida tropicalis-A systematic review to inform the World Health Organization of a fungal priority pathogens list.

In response to the growing global burden of fungal infections with uncertain impact, the World Health Organization (WHO) established an Expert Group to identify priority fungal pathogens and establish the WHO Fungal Priority Pathogens List for future research. This systematic review aimed to evaluate the features and global impact of invasive candidiasis caused by Candida tropicalis. PubMed and Web of Science were searched for studies reporting on criteria of mortality, morbidity (defined as hospitalization and disability), drug resistance, preventability, yearly incidence, diagnostics, treatability, and distribution/emergence from 2011 to 2021. Thirty studies, encompassing 436 patients from 25 countries were included in the analysis. All-cause mortality due to invasive C. tropicalis infections was 55%-60%. Resistance rates to fluconazole, itraconazole, voriconazole and posaconazole up to 40%-80% were observed but C. tropicalis isolates showed low resistance rates to the echinocandins (0%-1%), amphotericin B (0%), and flucytosine (0%-4%). Leukaemia (odds ratio (OR) = 4.77) and chronic lung disease (OR = 2.62) were identified as risk factors for invasive infections. Incidence rates highlight the geographic variability and provide valuable context for understanding the global burden of C. tropicalis infections. C. tropicalis candidiasis is associated with high mortality rates and high rates of resistance to triazoles. To address this emerging threat, concerted efforts are needed to develop novel antifungal agents and therapeutic approaches tailored to C. tropicalis infections. Global surveillance studies could better inform the annual incidence rates, distribution and trends and allow informed evaluation of the global impact of C. tropicalis infections.

Fusarium species,Scedosporium species, and Lomentospora prolificans: A systematic review to inform the World Health Organization priority list of fungal pathogens.

Recognizing the growing global burden of fungal infections, the World Health Organization established a process to develop a priority list of fungal pathogens (FPPL). In this systematic review, we aimed to evaluate the epidemiology and impact of infections caused by Fusarium spp., Scedosporium spp., and Lomentospora prolificans to inform the first FPPL. PubMed and Web of Sciences databases were searched to identify studies published between January 1, 2011 and February 23, 2021, reporting on mortality, complications and sequelae, antifungal susceptibility, preventability, annual incidence, and trends. Overall, 20, 11, and 9 articles were included for Fusarium spp., Scedosporium spp., and L. prolificans, respectively. Mortality rates were high in those with invasive fusariosis, scedosporiosis, and lomentosporiosis (42.9%-66.7%, 42.4%-46.9%, and 50.0%-71.4%, respectively). Antifungal susceptibility data, based on small isolate numbers, showed high minimum inhibitory concentrations (MIC)/minimum effective concentrations for most currently available antifungal agents. The median/mode MIC for itraconazole and isavuconazole were ≥16 mg/l for all three pathogens. Based on limited data, these fungi are emerging. Invasive fusariosis increased from 0.08 cases/100 000 admissions to 0.22 cases/100 000 admissions over the time periods of 2000-2009 and 2010-2015, respectively, and in lung transplant recipients, Scedosporium spp. and L. prolificans were only detected from 2014 onwards. Global surveillance to better delineate antifungal susceptibility, risk factors, sequelae, and outcomes is required.

Pharmaceutical policies and regulations of oral antiviral drugs for treatment of hepatitis C in Egypt-case study.

BACKGROUND: There are limited studies on the role of efficient regulatory mechanisms in facilitating greater access to Hepatitis C virus (HCV) treatment. Evidence to support the importance of effective pharmaceutical policies and regulations in improving access to oral viral drugs towards the elimination of HCV is needed. This study aims to explore the adequacy of the implemented pharmaceutical policies and regulations in Egypt and their role to improve the availability and affordability of direct-acting antivirals (DAAs) to achieve universal access to the treatment of HCV. METHODS: The study adopts a qualitative methodology using desk review of regulatory and legislative information, literature review, and semi-structured interviews with key experts from the concerned governmental regulatory agencies, pharmaceutical industries, academic organizations, professional associations, civil society organizations, and clinicians who are working in researching treatments for hepatitis C. FINDINGS: The common DAAs available in the market are Daclatasvir, Sofosbuvir, and Sofosbuvir-based direct-acting antiviral combinations. Fast-track medicines registration pathway for marketing authorization of DAAs is used to reduce market access time frames. The pricing policies are supplemented using price negotiation to set up affordable prices that led to a reasonable price for DAAs. Using Trade-Related Aspects of Intellectual Property Rights (TRIPs) flexibility and local production of quality generics DAAs at lower prices. In addition, political will and collaboration between the government, civil society, and pharmaceutical companies improved patients' access to affordable DAAs and succeeding hepatitis C treatment in Egypt. CONCLUSIONS: The study findings indicated that the implemented pharmaceutical policies and regulations have an immense role in enhancing access to medicines towards the elimination of hepatitis C in Egypt.

Pharmaceutical regulations in Iraq: from medicine approval to postmarketing.

BACKGROUND: Recent information on regulation of the pharmaceutical sector in Iraq is scarce. AIMS: This report summarizes the regulations governing pharmaceutical products in Iraq, assesses the challenges faced and makes recommendations to tackle these issues. METHODS: The Iraq pharmaceutical country profile 2020, prepared by the Iraqi Ministry of Health in collaboration with the World Health Organization (WHO) in 2020, was the main source of information. RESULTS: Despite all the efforts by the Ministry of Health to provide adequate and safe medicines, the Iraqi pharmaceutical sector has several challenges, including inadequate budget allocated to the ministry, shortages in essential medicines, underutilization of electronic technologies in the management of regulation-related work, a large number of substandard and falsified medications in the private sector and a stagnant national pharmaceutical industry. CONCLUSION: The Ministry of Health needs more financial support from the federal government to fund its activities and technical support from international health organizations to provide training and resources.

An Assessment of the Impact of Coronavirus Disease (COVID-19) Pandemic on National Antimicrobial Consumption in Jordan.

Coronavirus disease 2019 (COVID-19) has overlapping clinical characteristics with bacterial respiratory tract infection, leading to the prescription of potentially unnecessary antibiotics. This study aimed at measuring changes and patterns of national antimicrobial use for one year preceding and one year during the COVID-19 pandemic. Annual national antimicrobial consumption for 2019 and 2020 was obtained from the Jordan Food and Drug Administration (JFDA) following the WHO surveillance methods. The WHO Access, Watch, and Reserve (AWaRe) classification was used. Total antibiotic consumption in 2020 (26.8 DDD per 1000 inhabitants per day) decreased by 5.5% compared to 2019 (28.4 DDD per 1000 inhabitants per day). There was an increase in the use of several antibiotics during 2020 compared with 2019 (third generation cephalosporins (19%), carbapenems (52%), macrolides (57%), and lincosamides (106%)). In 2020, there was a marked reduction in amoxicillin use (-53%), while the use of azithromycin increased by 74%. National antimicrobial consumption of the Access group decreased by 18% from 2019 to 2020 (59.1% vs. 48.1% of total consumption). The use of the Watch group increased in 2020 by 26%. The study highlighted an increase in the use of certain antibiotics during the pandemic period that are known to be associated with increasing resistance. Efforts to enhance national antimicrobial stewardship are needed to ensure rational use of antimicrobials.