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Proposal for a Substance Abuse Testing Act

This is the Report of the Task Force on the Drug-Free Workplace, sponsored by the Institute of Bill of Rights Law of the College of William and Mary, Marshall-Wythe School of Law. The Report contains an introduction describing the mission of the Task Force and the guiding philosophical principles it embraced, an Executive Summary providing a summary overview of the proposed model statute, the formal text of the proposed model Substance Abuse Testing Act, including commentary illuminating the intent and rationales underlying each provision of the Act, biographical information on all members of the Task Force, and a brief individual statement by each Task Force member

Label-free detection of anticancer drug paclitaxel in living cells by confocal Raman microscopy

Confocal Raman microscopy, a non-invasive, label-free, and high spatial resolution imaging technique is employed to trace the anticancer drug paclitaxel in living Michigan Cancer Foundation-7 (MCF-7) cells. The Raman images were treated by K-mean cluster analysis to detect the drug in cells. Distribution of paclitaxel in cells is verified by calculating the correlation coefficient between the reference spectrum of the drug and the whole Raman image spectra. A time dependent gradual diffusion of paclitaxel all over the cell is observed suggesting a complementary picture of the pharmaceutical action of this drug based on rapid binding of free tubulin to crystallized paclitaxel. (C) 2013 American Institute of Physics. [http://dx.doi.org/10.1063/1.4794871

A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms

Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases. This study surveyed the top 200 US drugs to assess the common practice in industry. The top 200 drugs prescribed in the United States were included in this survey. The drugs containing active pharmaceutical ingredient (API) salts were selected for analysis. Generic or combination products with redundant API salts were excluded. The package insert of each selected drug was reviewed, and the information on drug strength expression was extracted and categorized. Out of the top 200 drugs, 59 unique API salts were identified. The drug strengths were expressed as salts for 32 drugs (54%) and as free acids/bases for 27 drugs (46%). The survey results revealed the inconsistent practice among the industries regarding the drug strength expression for salts. Non-harmonized labeling practice can lead to confusions, potential calculation/dosing errors, and complications in labeling new products. The authors recommend the US Food and Drug Administration to standardize the labeling format for salts and preferably express the drug strengths based on the free acid/base forms. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association

Disparity by Design: How Drug-free Zone Laws Impact Racial Disparity -- and Fail to Protect Youth

Thanks to the work of concerned policymakers and reform advocates across the country, public discussions have been sparked in many states about the fairness and efficacy of drug-free zone laws. This report is designed to inform those discussions by reviewing empirical findings, primarily from three states -- Massachusetts, New Jersey, and Connecticut -- where enough information is available to answer key questions. The report also documents efforts by policymakers and advocates in a few other states -- Illinois, Utah, and Washington -- to challenge long-held assumptions that drug-free zone laws are protecting children and enhancing public safety

Ligation of anti-cancer drugs to self-assembling ultrashort peptides by click chemistry for localized therapy

Self-assembling ultrashort peptides from aliphatic amino acids were functionalized with platinum anti-cancer drugs by click chemistry. Oxaliplatin-derived hybrid peptide hydrogels with up to 40% drug loading were tested for localized breast cancer therapy. Stably injected gels showed significant tumor growth inhibition in mice and a better tolerance compared to the free platinum drug

Balancing Consumer Protection and Scientific Integrity in the Face of Uncertainty: The Example of Gluten-Free Foods

In 2009, gluten-free foods were not only hot in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term gluten-free. The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers

Knowledge-based best of breed approach for automated detection of clinical events based on German free text digital hospital discharge letters

OBJECTIVES: The secondary use of medical data contained in electronic medical records, such as hospital discharge letters, is a valuable resource for the improvement of clinical care (e.g. in terms of medication safety) or for research purposes. However, the automated processing and analysis of medical free text still poses a huge challenge to available natural language processing (NLP) systems. The aim of this study was to implement a knowledge-based best of breed approach, combining a terminology server with integrated ontology, a NLP pipeline and a rules engine. METHODS: We tested the performance of this approach in a use case. The clinical event of interest was the particular drug-disease interaction "proton-pump inhibitor [PPI] use and osteoporosis". Cases were to be identified based on free text digital discharge letters as source of information. Automated detection was validated against a gold standard. RESULTS: Precision of recognition of osteoporosis was 94.19%, and recall was 97.45%. PPIs were detected with 100% precision and 97.97% recall. The F-score for the detection of the given drug-disease-interaction was 96,13%. CONCLUSION: We could show that our approach of combining a NLP pipeline, a terminology server, and a rules engine for the purpose of automated detection of clinical events such as drug-disease interactions from free text digital hospital discharge letters was effective. There is huge potential for the implementation in clinical and research contexts, as this approach enables analyses of very high numbers of medical free text documents within a short time period

Determining the solubility and crystal form of clenbuterol in thin films of eudragit NE30D

The solubility of the drug clenbuterol in thin films of surfactant-free Eudragit NE30D has been measured. Light microscopy and differential scanning calorimetry were supplemented by a technique based on measurement of the rate of drug release from the films. The clenbuterol crystals had the form of a fractal, as could be shown by a computer simulation of diffusion-controlled aggregation