Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers

This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three “parent” devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical “daughter” devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent–daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain.     

MI Implementation in Juvenile Justice: A Case Report

Motivational interviewing (MI) is a communication style focused on enhancing clients’ own motivation towards change. In the justice system MI has evidence to support that it enhances communication and change behaviors in youth. As most MI training is designed for healthcare settings training and implementation of MI must be adapted to fit the juvenile justice model. This includes both rehabilitation and restorative justice. Here we describe the details that allowed one county small county in Pennsylvania to roll out MI training and initial skills review in less than 6 months. The case reviews the details of planning, trainings, and timing of activities. We then discuss what elements of those details fit into a greater implementation plan that may be applied elsewhere. Four key elements were instrumental to implementation: 1) appreciation of JPO time constraints, 2) cost containment 3) using blending to enhance JPO flexibility with MI use, and 4) policies that normalize use of MI. This outline may assist other courts in their own implementation efforts.     

REACH: A Step Change in the Management of Chemicals

The EU has regulated chemicals since the late 1960s using both general and sectoral legislation, and exposure-based, hazard-based and risk-based decisions. A new proposal from the European Commission – on the Registration, Evaluation and Authorization of Chemicals (REACH) – will build on the experiences of the existing legislation and introduce some new concepts in the management of chemicals. This article is aimed at assessing the current chemical control mechanisms in the EU and those put forward in REACH to demonstrate how REACH is a new paradigm in chemicals management. REACH will carry forward today's experience and approach to the management of chemicals in the EU and introduces some novel aspects, such as utilizing market-based mechanisms and putting into operation the 'substitution principle'.     

The evolution of European legal integration

This article contributes to the development of theories on European integration by testing and exploring statistical models on the long-term development of legislative activity of the European Commission. Drawing on legal information gained from the European Union’s PreLex database and analyzing it with the help of statistical analyses, we map out growth patterns of EU law between 1976 and 2003. We construct time-series models and models based on non-linear regression. While the performance of models based on the traditional theoretical approaches, intergovernmentalism and neo-functionalism, is rather poor, the analysis suggests that nonlinear dynamic models might be an interesting avenue for future conceptualizations of the EU integration process. This article is based on a paper presented at the ECPR Standing Group on the European Union Second Pan-European Conference on EU Politics, “Implications of a Wider Europe: Politics, Institutions and Diversity”, 24–26 June 2004, Bologna, Italy. We would like to thank the seminar participants for useful comments.