Pharmaceutical regulation in context: the case of Lao People's Democratic Republic.
An explosive development of private pharmacies in the Lao People's Democratic Republic (Lao P.D.R.) has led to 80% of pharmaceuticals being provided by the private sector. In order to achieve the goal of access to good quality health care for all citizens, the Lao government is making an effort to regulate the private pharmaceutical sector using the emerging legal system of laws, decrees, and regulations. The aim of this paper is to describe and analyze the system of drug regulation in Lao P.D.R. in relation to the public social goals. Relevant official documents at the central, provincial and district levels have been reviewed, interviews were held with 30 key informants and 15 pharmacies were surveyed. The public social goals have been expressed in terms of equity and quality of care. However, total drug expenditure may be as low as US$1 per person per year which is far below any minimum standard and does not make it possible to achieve reasonable access to drugs for all. The regulatory system has so far been focused on entry into the pharmaceutical retail market and dealing with basic issues of product quality and conditions of sale. An enforcement system including sanctions is being developed; other policy instruments such as information and economic means are hardly being used at all. The government presently faces a trade-off between quality of pharmaceutical services and geographical equity of access. The study shows that regulation is strongly influenced by the general socioeconomic context. (+info)
The ToxChip, a DNA microarray chip, allows the monitoring of the expression levels of thousands of different genes at a time, thereby condensing months of painstaking laboratory tasks into a day's work. For toxicology researchers in particular, this tool is important because it promises a more effective way to identify environmental hazards and their effects on DNA. The ToxChip, developed by NIEHS scientists J. Carl Barrett, Cynthia Afshari, and Emile F. Nuwaysir, could transform the way toxicologists approach environmental problems. (+info)
Recent progress in safety evaluation studies on plasticizers and plastics and their controlled use in Japan.
Recent experimental studies in Japan on the evaluation of potential health hazards from phthalate esters used in manufacturing poly (vinyl chloride) as well as several plastics for medical devices and for food containers and packages were introduced. Development of pulmonary granuloma formation after intravenous injection of diethylhexyl phthalate was assumed to be dependent on the particle size of the phthalate in vehicle used. Dietary administration of large amount of diethylhexyl phthalate and dibutyl phthalate produced renal cysts in mothers and in descendants in reproduction studies in mice. Cytotoxicity and mutagenicity of the phthalates and several plastics and resins were also examined by in vivo and in vitro studies. Hematological parameters examined in rabbits after repeated intravenous injection of diethylhexyl phthalate and after implantation of plastics in aorta for 3--6 months did not show any significant change. A slow decrease of radioactivity was observed in adipose tissue of rats following oral administration of 14C-labeled diethylhexyl phthalate. tthe administrative action on phthalates by the Japanese Ministry of Health and Welfare is briefly reviewed. (+info)
Parlaying digital imaging and communications in medicine and open architecture to our advantage: the new Department of Defense picture archiving and communications system.
The Department of Defense (DoD) undertook a major systems specification, acquisition, and implementation project of multivendor picture archiving and communications system (PACS) and teleradiology systems during 1997 with deployment of the first systems in 1998. These systems differ from their DoD predecessor system in being multivendor in origin, specifying adherence to the developing Digital Imaging and Communications in Medicine (DICOM) 3.0 standard and all of its service classes, emphasizing open architecture, using personal computer (PC) and web-based image viewing access, having radiologic telepresence over large geographic areas as a primary focus of implementation, and requiring bidirectional interfacing with the DoD hospital information system (HIS). The benefits and advantages to the military health-care system accrue through the enabling of a seamless implementation of a virtual radiology operational environment throughout this vast healthcare organization providing efficient general and subspecialty radiologic interpretive and consultative services for our medical beneficiaries to any healthcare provider, anywhere and at any time of the night or day. (+info)
Acceptance testing of integrated picture archiving and communications systems.
An integrated picture archiving and communication system (PACS) is a large investment in both money and resources. With all of the components and systems contained in the PACS, a methodical set of protocols and procedures must be developed to test all aspects of the PACS within the short time allocated for contract compliance. For the Department of Defense (DoD), acceptance testing (AT) sets the protocols and procedures. Broken down into modules and test procedures that group like components and systems, the AT protocol maximizes the efficiency and thoroughness of testing all aspects of an integrated PACS. A standardized and methodical protocol reduces the probability of functionality or performance limitations being overlooked. The AT protocol allows complete PACS testing within the 30 days allocated by the digital imaging network (DIN)-PACS contract. AT shortcomings identified during the testing phase properly allows for resolution before complete acceptance of the system. This presentation will describe the evolution of the process, the components of the DoD AT protocol, the benefits of the AT process, and its significance to the successful implementation of a PACS. This is a US government work. There are no restrictions on its use. (+info)
Virtual management of radiology examinations in the virtual radiology environment using common object request broker architecture services.
In the Department of Defense (DoD), US Army Medical Command is now embarking on an extremely exciting new project--creating a virtual radiology environment (VRE) for the management of radiology examinations. The business of radiology in the military is therefore being reengineered on several fronts by the VRE Project. In the VRE Project, a set of intelligent agent algorithms determine where examinations are to routed for reading bases on a knowledge base of the entire VRE. The set of algorithms, called the Meta-Manager, is hierarchical and uses object-based communications between medical treatment facilities (MTFs) and medical centers that have digital imaging network picture archiving and communications systems (DIN-PACS) networks. The communications is based on use of common object request broker architecture (CORBA) objects and services to send patient demographics and examination images from DIN-PACS networks in the MTFs to the DIN-PACS networks at the medical centers for diagnosis. The Meta-Manager is also responsible for updating the diagnosis at the originating MTF. CORBA services are used to perform secure message communications between DIN-PACS nodes in the VRE network. The Meta-Manager has a fail-safe architecture that allows the master Meta-Manager function to float to regional Meta-Manager sites in case of server failure. A prototype of the CORBA-based Meta-Manager is being developed by the University of Arizona's Computer Engineering Research Laboratory using the unified modeling language (UML) as a design tool. The prototype will implement the main functions described in the Meta-Manager design specification. The results of this project are expected to reengineer the process of radiology in the military and have extensions to commercial radiology environments. (+info)
Benchmark testing the Digital Imaging Network-Picture Archiving and Communications System proposal of the Department of Defense.
The Department of Defense issued a Request for Proposal (RFP) for its next generation Picture Archiving and Communications System in January of 1997. The RFP was titled Digital Imaging Network-Picture Archiving and Communications System (DIN-PACS). Benchmark testing of the proposed vendors' systems occurred during the summer of 1997. This article highlights the methods for test material and test system organization, the major areas tested, and conduct of actual testing. Department of Defense and contract personnel wrote test procedures for benchmark testing based on the important features of the DIN-PACS Request for Proposal. Identical testing was performed with each vendor's system. The Digital Imaging and Communications in Medicine (DICOM) standard images used for the Benchmark Testing included all modalities. The images were verified as being DICOM standard compliant by the Mallinckrodt Institute of Radiology, Electronic Radiology Laboratory. The Johns Hopkins University Applied Physics Laboratory prepared the Unix-based server for the DICOM images and operated it during testing. The server was loaded with the images and shipped to each vendor's facility for on-site testing. The Defense Supply Center, Philadelphia (DSCP), the Department of Defense agency managing the DIN-PACS contract, provided representatives at each vendor site to ensure all tests were performed equitably and without bias. Each vendor's system was evaluated in the following nine major areas: DICOM Compliance; System Storage and Archive of Images; Network Performance; Workstation Performance; Radiology Information System Performance; Composite Health Care System/Health Level 7 communications standard Interface Performance; Teleradiology Performance; Quality Control; and Failover Functionality. These major sections were subdivided into workable test procedures and were then scored. A combined score for each section was compiled from this data. The names of the involved vendors and the scoring for each is contract sensitive and therefore can not be discussed. All of the vendors that underwent the benchmark testing did well. There was no one vendor that was markedly superior or inferior. There was a typical bell shaped curve of abilities. Each vendor had their own strong points and weaknesses. A standardized benchmark protocol and testing system for PACS architectures would be of great value to all agencies planning to purchase a PACS. This added information would assure the purchased system meets the needed functional requirements as outlined by the purchasers PACS Request for Proposal. (+info)
Committee proposals and restrictive rules.
I analyze a game-theoretic model of committee-legislature interaction in which a majority decision to adopt either an open or closed amendment rule occurs following the committee's proposal of a bill. I find that, in equilibrium, the closed rule is almost always chosen when the dimension of the policy space is >1. Furthermore, the difference between the equilibrium outcome and that which would have occurred under the open rule can be arbitrarily small. (+info)