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Although, chronic hepatitis B (HBV) is considered to be of significant public health importance in Ghana, not many reviews detailing the burden (prevalence) of the disease have been conducted. This study was aimed at summarizing the available information and to make an accurate estimate of HBV infection prevalence in Ghana over the last two decades (1995-2015).
The benefits of statin therapy are significantly compromised by noncompliance. Although elderly patients may have particular challenges with medication adherence and persistence, previous reviews on statin adherence have not focused on this population. Additionally, comparisons of adherence and persistence specific to statin indication (primary or secondary prevention) have not been thoroughly explored.
Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
The present study sought to evaluate the cost-effectiveness of first-line (immediate) versus delayed use of combination dapagliflozin and metformin in patients with type 2 diabetes, from the perspective of the Australian healthcare system. We developed a Markov model to simulate the progress of subjects with type 2 diabetes. Decision analysis was applied to assess the cost-effectiveness of first-line combination dapagliflozin and metformin versus first-line metformin monotherapy followed by gradual addition of dapagliflozin over time. Transition probabilities, costs (in Australian dollars) and utility data were derived from published sources. All costs, years of life lived and quality adjusted life years (QALYs) lived were discounted at an annual rate of 5%. Over a 20-year model period, first-line use of combination dapagliflozin and metformin was predicted to reduce the onset of hospitalisation of heart failure, cardiovascular deaths and all cause deaths by 5.5%, 57.6% and 29.6%, respectively. An additional 2.5 years of life (discounted) and 1.9 QALYs (discounted) would be gained per patient, at a cost of AUD $23,367 (discounted) per person. These figures equated to AUD $9,535 per years of life saved (YoLS) and AUD $12,477 per QALYs saved. Sensitivity analyses indicated the results to be robust. Compared to first-line metformin monotherapy followed by gradual addition of dapagliflozin, first-line use of combination dapagliflozin and metformin is likely to be a cost-effective approach to the management of Australians with type 2 diabetes mellitus.
Human immunodeficiency virus (HIV) and hepatitis B virus (HBV) coinfection has been associated with higher morbidity and mortality and may impact significantly on healthcare resource utilization. However, in Ghana, accurate estimates of the prevalence of HIV/HBV coinfection needed to inform policy decisions and the design of public health interventions are currently lacking. In this study, our aim was to determine the HIV/HBV coinfection prevalence rate in Ghana.
We conducted a review to study antibiotic and injections use at primary care centers (PHCs) within the World Health Organization African region. This was part of a larger study on prescribing indicators at PHCs within the region. We analyzed antibiotic and injection use reported in studies published between 1993 and June 2013, which were identified through searches conducted in PubMed, Scopus, Web of science, Africa-Wide NiPAD, Africa Journals Online, Google Scholar, and International Network for Rational Use of Drugs bibliography databases. Sub-group analysis was carried out for private and public centers. Data were retrieved from 18 studies in 6 countries involving 21,283 patient encounters across 338 PHCs. The percentage of patient encounters with antibiotics prescribed was 51.5% (IQR 41.1-63.3%). The percentage of patient encounters which resulted in the prescription of an injection was 36.8% (IQR 20.7-57.6%). Injection use rate at private facilities was 38% (IQR 19.1-42.7) while that of the public was 32.3% (IQR 20.6-57.6). Rate of antibiotic prescribing at public centers was 49.7% (IQR 51.1-75.7) and that of private facilities 57.6 (IQR 39.0-69.5). The percentage use of injections and antibiotics is high in Africa. The excessive use of antibiotics and injections are particularly more problematic in private than public facilities. Further research is needed to understand fully the underlying factors for the observed patterns and ways of improving medicines use.
Several studies have associated skipping (not having) breakfast with cardiometabolic risk factors such as obesity, high blood pressure, unfavorable lipid profiles, diabetes, and metabolic syndrome. We examined the available evidence regarding the effect of skipping breakfast on cardiovascular morbidity and mortality, as well as all-cause mortality. Medline, Embase, and Web of Science were searched from inception until May 2019 to identify prospective cohort studies that examined the association between skipping breakfast and the risk of cardiovascular morbidity and mortality and all-cause death. Electronic searches were supplemented by manual screening of the references of retrieved studies. Out of 456 citations identified, four studies (from Japan and the US) were included. The included studies involved a total of 199,634 adults (aged ≥40 years; 48.5% female) without known cardiovascular disease (CVD) at baseline followed over a median duration of 17.4 years. The pooled data suggested that people who regularly skipped breakfast were about 21% more likely (hazard ratio (HR) 1.21, 95% confidence interval (CI) 1.08-1.35; I2 = 17.3%, p = 0.304) to experience incident CVD or die from it than people who regularly consumed breakfast. Also, the risk of all-cause death was 32% higher (HR 1.32, 95% CI 1.17-1.48; I2 = 7.6%, p = 0.339) in people who regularly skipped breakfast than in people who regularly consumed breakfast. However, the definition of skipping breakfast was heterogenous and adjustment for confounders varied significantly. Therefore, residual confounding could not be ruled out and caution is required in the interpretation of the findings. Hence, large prospective studies with a consistent definition of skipping breakfast, and conducted across different populations, are needed to provide more robust evidence of the health effects of skipping breakfast.
This study aimed to evaluate the impact of the risk minimisation measures issued by the European Medicines Agency in 2014 to restrict the combined use of renin-angiotensin system (RAS) blocking agents in Denmark. Data from the Danish National Prescription Registry covering all medications dispensed during January 2008-December 2018 was used. The outcome was monthly prevalence of patients codispensed RAS blockers. Autoregressive integrated moving average interrupted time series regression was used to evaluate dispensing trends. The prevalence of patients codispensed RAS blockers decreased from 0.01 to 0.0003%. Preintervention trend was declining and further decreased with an additional -0.45 (95% confidence interval -0.66, -0.25) codispensing per million population after the intervention. Overall, the intervention had minimal impact on the combined use of RAS blockers. However, as the combined use of RAS blockers is low, further interventions to restrict the combined use of RAS blockers may not be required in Denmark at this point.
In many low and middle income countries (LMICs), the distribution of adulthood nutritional imbalance is shifting from a predominance of undernutrition to overnutrition. This complex problem poses a huge challenge to governments, non-state actors, and individuals desirous of addressing the problem of malnutrition in LMICs. The objective of this study was to systematically review the literature towards providing an estimate of the prevalence of overweight and obesity among adult Ghanaians.
To fully understand the burden of hepatitis C (HCV) infection in Ghana towards informing appropriate preventive measures, accurate prevalence estimates are needed. In this study, we estimate the prevalence of chronic HCV infection by systematically reviewing primary studies published between 1995 and 2015.
The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical Abstracts database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA (n = 22) and regulatory agencies (n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for "collaborating" with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.
Due to the effectiveness of combined antiretroviral therapy and its growing availability worldwide, most people living with HIV (PLHIV) have a near-normal life expectancy. However, PLHIV continue to face various health and social challenges that severely impact their health-related quality-of-life (HRQoL). The UNAIDS Global AIDS Strategy discusses the need to optimize quality-of-life, but no guidance was given regarding which instruments were appropriate measures of HRQoL. This study aimed to review and assess the use of HRQoL instruments for PLHIV.
Magistral compounding has always been an integral part of pharmacy practice. The increasing demand worldwide for personalized drug treatments might be accommodated by an increase in magistral compounding. The new, flexible technology of 3D medicine printing could advance this process even further. However, the issue of how 3D medicine printing can be implemented within the existing magistral compounding infrastructure has not been explored.
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