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.

Background: Recent information on regulation of the pharmaceutical sector in Iraq is scarce. Aim: 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.

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.

Objective: This study aimed to prepare and evaluate oral disintegrating tablets (ODTs) of Daclatasvir dihydrochloride (DCV) using different co-processed excipients to enhance drug dissolution and improve oral bioavailability for the treatment of hepatitis C infection. Methods: Ten Daclatasvir-ODTs formulae were prepared using co-processed excipients via direct compression. The prepared formulae were evaluated according to taste masking, weight variation, thickness, friability, hardness, drug content, and wetting time. In vitro disintegration time, in vivo disintegration time, and in vitro dissolution tests were also evaluated and taken as parameters for the selection of the best formula. The selected best formula was subjected to an in vivo study on volunteers and compared to a marketed product. Results: All DCV-ODTs had acceptable physical properties in accordance with pharmacopeial standards. DCV-ODTs prepared with Pharmaburst® (F10) recorded the shortest wetting time (14±0.08s), fastest in vitro disintegration time (46±0.16s), shortest in vivo disintegration time (27±0.16s), and attained the fastest onset of dissolution (94.3±0.03 %) at 5 min to all other excipients and has been identified as the best formula. The in vivo pharmacokinetic study showed that the Pharmaburst-based formula has a significant Cmax increase of (2.17±0.28 μg/ml) compared to (1.42±0.59) for the marketed product and a significant decrease of Tmax to 60 min instead of 110 min for the marketed product. Conclusion: The in vivo pharmacokinetic study in humans showed that the ODTs was found to be appropriate for delivery of Daclatasvir with a faster drug absorption rate when compared to the marketed products with applicable taste related to the nature of dosage form.