Background World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19). Methods We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. Results At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. Conclusions These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151 ; ClinicalTrials.gov number, NCT04315948 .)
ObjectiveDrug counterfeiting has serious public health and safety implications. The objective of this study was to systematically review the evidence on the effectiveness of interventions to combat or prevent drug counterfeiting.Data sourcesWe searched multiple electronic databases and the grey literature up to March 2014. Two reviewers completed, in duplicate and independently, the study selection, data abstraction and risk of bias assessment.Study eligibility criteria, participants and interventionsWe included randomised trials, non-randomised studies, and case studies examining any intervention at the health system-level to combat or prevent drug counterfeiting. Outcomes of interest included changes in failure rates of tested drugs and changes in prevalence of counterfeit medicines. We excluded studies that focused exclusively on substandard, degraded or expired drugs, or that focused on medication errors.Appraisal and synthesisWe assessed the risk of bias in each included study. We reported the results narratively and, where applicable, we conducted meta-analyses.ResultsWe included 21 studies representing 25 units of analysis. Overall, we found low quality evidence suggesting positive effects of drug registration (OR=0.23; 95% CI 0.08 to 0.67), and WHO-prequalification of drugs (OR=0.06; 95% CI 0.01 to 0.35) in reducing the prevalence of counterfeit and substandard drugs. Low quality evidence suggests that licensing of drug outlets is probably ineffective (OR=0.66; 95% CI 0.41 to 1.05). For multifaceted interventions (including a mix of regulations, training of inspectors, public-private collaborations and legal actions), low quality evidence suggest they may be effective. The single RCT provided moderate quality evidence of no effect of ‘two extra inspections’ in improving drug quality.ConclusionsPolicymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions. Future effectiveness studies should address the methodological limitations of the available evidence.Trial registration numberPROSPERO CRD42014009269.
Background: In the international agenda, it has become common to assert that the assessment of health system governance using a practical tool is crucial. This approach can help us better understand how health systems are being steered as well as to identify gaps in the decision-making process and their causes. The authors developed a new assessment tool, the Health Policymaking Governance Guidance Tool (HP-GGT), that was designed to be conceptually sound and practical. This tool enables policy-makers and stakeholders to systematically review and assess health system governance at policy-making level. This article presents first use of the HP-GGT in Lebanon, together with generated results, recommendations, and discusses how these results improve governance practices when initiating new health policy formulation processes. Methods: The HP-GGT, which is a multidimensional structured tool, was used retrospectively to assess and review the process used to develop a new mental health strategy; this process was compared against consensus-based good governance principles, focusing on participation, transparency, accountability, information and responsiveness. The assessment was conducted through face-to-face interviews with 11 key informants who were involved in the development of the strategy. Results: The HP-GGT enabled policy-makers to reflect on their governance practices when developing a mental health strategy and was able to identify key areas of strengths and weaknesses using good governance practice checklists given by the questions. The insights generated from the assessment equipped the national policy-makers with a better understanding of the practice and meaning of policy-making governance. Identifying weaknesses to be addressed in future attempts to develop other national health policies helped in this regard. Using the tool also increased awareness of alternative good practices among policy-makers and stakeholders. Conclusions: Assessing a health policy formulation process from a governance perspective is essential for improved policy-making. The HP-GGT was able to provide a general overview and an in-depth assessment of a policy formulation process related to governance issues according to international good practices that should be applied while formulating health policies in any field. The HP-GGT was found to be a practical tool that was useful for policy-makers when used in Lebanon and awaits applications in other low-and middle-income countries to further show its validity and utility.
Introduction: Lebanon is facing challenges affecting the whole health sector, including access to medications. Lebanon has only proposed very few short-term national pharmaceutical strategic solutions. Previous reform attempts targeting the pharmaceutical sector, could not protect it from the crises and their detrimental consequences on patient and population health. Purpose: This document unveils the critical elements that should be addressed in the planned National Pharmaceutical Sector Strategy (NPS) being developed by the Order of Pharmacists of Lebanon (OPL) in consultation with the concerned stakeholders. Method: Strategic goals were proposed for adoption and implementation by the competent authorities based on consultations, situational assessments, and gap analyses. The objectives and an implementation plan were developed based on the available resources and policy dialogue, respectively. Conclusion: The National Pharmaceutical Strategy would help the Lebanese authorities/policy-makers, aided by competent healthcare professionals, develop and implement a time-bound roadmap to attain a nation with access to quality and safe medications for the whole population. Implementing this strategy would require the commitment of decision-makers, the accountability of involved parties, innovation in finding solutions, close collaboration between stakeholders, and lengthy efforts to attain the stated vision.
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