Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements

Background: Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization’s (WHO’s) minimum PV requirements for a Functional National PV System. Methods: A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results: All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion: A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices

The reduced genome of the parasitic microsporidian Enterocytozoon bieneusi lacks genes for core carbon metabolism

© The Authors, 2010. This article is distributed under the terms of the Creative Commons Attribution-Noncommercial 2.5 License. The definitive version was published in Genome Biology and Evolution 2 (2010): 304, doi:10.1093/gbe/evq022.Reduction of various biological processes is a hallmark of the parasitic lifestyle. Generally, the more intimate the association between parasites and hosts the stronger the parasite relies on its host's physiology for survival and reproduction. However, some systems have been held to be indispensable, for example, the core pathways of carbon metabolism that produce energy from sugars. Even the most hardened anaerobes that lack oxidative phosphorylation and the tricarboxylic acid cycle have retained glycolysis and some downstream means to generate ATP. Here we describe the deep-coverage genome resequencing of the pathogenic microsporidiian, Enterocytozoon bieneusi, which shows that this parasite has crossed this line and abandoned complete pathways for the most basic carbon metabolism. Comparing two genome sequence surveys of E. bieneusi to genomic data from four other microsporidia reveals a normal complement of 353 genes representing 30 functional pathways in E. bieneusi, except that only 2 out of 21 genes collectively involved in glycolysis, pentose phosphate, and trehalose metabolism are present. Similarly, no genes encoding proteins involved in the processing of spliceosomal introns were found. Altogether, E. bieneusi appears to have no fully functional pathway to generate ATP from glucose. Therefore, this intracellular parasite relies on transporters to import ATP from its host.This work was supported by grants from the Canadian Institutes for Health Research (MOP-84265), the National Institutes of Health (NIH AI31788, R21 AI52792, and R21 AI064118), and the National Science Foundation (MCB- 0135272). N.C. is a Scholar of the Canadian Institute for Advanced Research and is supported by a fellowship from the Swiss National Science Foundation (NSF) (PA00P3- 124166). D.E. is supported by the Swiss NSF. P.J.K. is a Fellow of the Canadian Institute for Advanced Research and a Senior Scholar of the Michael Smith Foundation for Health Research

Summary Tables: 2017 Henrico County, Virginia Shoreline Inventory

The Shoreline Inventory Summary Tables quantify observed conditions based on river systems, such as the combined length of linear features (e.g. shoreline miles surveyed, miles of bulkhead and revetment), the total number of point features (e.g. docks, boathouses, boat ramps) & total acres of polygon features (tidal marshes)

Is the dynamics of open quantum systems always linear?

We study the influence of the preparation of an open quantum system on its reduced time evolution. In contrast to the frequently considered case of an initial preparation where the total density matrix factorizes into a product of a system density matrix and a bath density matrix the time evolution generally is no longer governed by a linear map nor is this map affine. Put differently, the evolution is truly nonlinear and cannot be cast into the form of a linear map plus a term that is independent of the initial density matrix of the open quantum system. As a consequence, the inhomogeneity that emerges in formally exact generalized master equations is in fact a nonlinear term that vanishes for a factorizing initial state. The general results are elucidated with the example of two interacting spins prepared at thermal equilibrium with one spin subjected to an external field. The second spin represents the environment. The field allows the preparation of mixed density matrices of the first spin that can be represented as a convex combination of two limiting pure states, i.e. the preparable reduced density matrices make up a convex set. Moreover, the map from these reduced density matrices onto the corresponding density matrices of the total system is affine only for vanishing coupling between the spins. In general, the set of the accessible total density matrices is nonconvex.Comment: 19 pages, 3 figures, minor changes to improve readability, discussion on Mori's linear regime and references adde

Chesterfield County and the Cities of Colonial Heights, Petersburg, and Richmond, Virginia - Shoreline Inventory Report: Methods and Guidelines

The 2017Inventory for Chesterfield County and the Cities of Colonial Heights, Petersburg, and Richmond was generated using on-screen, digitizing techniques in ArcGIS® -ArcMap v10.4.1while viewing conditions observed in Bing high resolution oblique imagery, Google Earth, and2013imagery from the Virginia Base Mapping Program (VBMP).Four GIS shapefiles are developed. The first describes land use and bank conditions (Chesterfield_lubc_2017). The second portrays the presence of beaches (Chesterfield_beaches_2017). The third reports shoreline structures that are described as arcs or lines(e.g. riprap)(Chesterfield_sstru_2017). The final shapefile includes all structures that are represented as points (e.g. piers)(Chesterfield_astru_2017).The metadata file accompanies the shapefiles and defines attribute accuracy, data development, and any use restrictions that pertain to data

Gloucester County, Virginia Shoreline Inventory Report Methods and Guidelines

The data inventory developed for the Shoreline Inventory is based on a three tiered shoreline assessment approach. This assessment characterizes conditions that can be observed from a small boat navigating along the shoreline or by using observations made remotely at the desktop using high resolution imagery. The three tiered shoreline assessment approach divides the shorezone into three regions: 1) the immediate riparian zone, evaluated for land use; 2) the bank, evaluated for height, stability, cover and natural protection; and 3) the shoreline, describing the presence of shoreline structures for shore protection and recreational purposes. The 2014 Inventory for Gloucester County was generated using on-screen, digitizing techniques in ArcGIS® - ArcMap v10.0 while viewing conditions observed in 2012 Pictometry imagery from Gloucester County, and 2013 imagery from the Virginia Base Mapping Program (VBMP). These data sources allowed the inventory to be generated without additional field work. Three GIS shapefiles are developed. The first describes land use and bank conditions (gloucester_lubc_2014). The second reports shoreline structures that are described as arcs or lines (gloucester_sstru_2014). The final shapefile includes all structures that are represented as points (gloucester_astru_2014).\u3e The shapefiles use a shoreline basemap updated in-house from the 2011 VBMP high resolution digital terrain model. The shoreline is re-coded to reflect features and attributes observed. The metadata file accompanies the shapefiles and defines attribute accuracy, data development, and any use restrictions that pertain to dat

Isle of Wight County, Virginia - Shoreline Inventory Report: Methods and Guidelines

The 2017 Inventory for the Isle of Wight County was generated using on-screen, digitizing techniques in ArcGIS® -ArcMap v10.4.1while viewing conditions observed in Bing high resolution oblique imagery, Google Earth, and2013imagery from the Virginia Base Mapping Program (VBMP). Four GIS shapefiles are developed. The first describes land use and bank conditions (IsleofWight_lubc_2017). The second portrays the presence of beaches (IsleofWight_beaches_2017). The third reports shoreline structures that are described as arcs or lines(e.g. riprap)(IsleofWight_sstru_2017). The final shapefile includes all structures that are represented as points(e.g. piers)(IsleofWight_astru_2017).The metadata file accompanies the shapefiles and defines attribute accuracy, data development, and any use restrictions that pertain to data

Summary Tables: King George County, Virginia Shoreline Inventory Report

The Shoreline Inventory Summary Tables quantify observed conditions based on river systems, such as the combined length of linear features (e.g. shoreline miles surveyed, miles of bulkhead and revetment), the total number of point features (e.g. docks, boathouses, boat ramps) & total acres of polygon features (tidal marshes)

Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, HighQuality Medicines

Background Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India’s pharmaceutical industry and its large export market makes the problem more acute. Methods The focus of this study is a case study of Maharashtra, which has 29% of India’s manufacturing units and 38% of its medicines exports. India’s regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. Results In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee’s recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India’s pharmaceutical industry. Conclusion The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee’s recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes

Correcting India's Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High- Quality Medicines

Abstract Background: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. Methods: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports. India's regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall