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'.     

Four Lessons for Developing Countries from the Trade Negotiations Over Access to Medicines

After the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into operation in 1995 developing countries have found themselves in a process of continual negotiation over intellectual property rights and access to medicines. These negotiations have taken place in the World Trade Organization and in the context of free trade agreements. The paper suggests that the only real win for developing countries has been the Doha Declaration on the TRIPS Agreement and Public Health in 2001. What have been the lessons for developing countries in a decade of negotiations over access to medicines? Drawing on themes of rule complexity and regulatory ritualism the paper discusses four key lessons for developing countries. It concludes by arguing that developing countries will do better if they adopt a networked governance approach to negotiation rather than continuing to rely on traditional coalition formation.     

“The Spectacle of Fearsome Acts”: Crime in the Melting P(l)ot in <Emphasis Type="Italic">Gangs of New York</Emphasis>

This paper explores the multi-layered representations of violence and crime in the recent Hollywood film Gangs of New York [Scorcese (2003) Miramax]. We use our exploration of this film to suggest that popular culture, even through its most mainstream products, can be seen as a critical criminological space where alternative views of law, crime and the state are made available. Rather than understanding Hollywood movies simply as vehicles for disseminating conventional mores, we suggest that they can furnish critical (and complex) points of view on law and crime and that the project of a critical criminology can be strengthened by engaging more forthrightly with these ubiquitous cultural forms.     

The challenge of institution-building in Asia and its implications for Asia-Europe relations

  East Asia, including Northeast Asia and Southeast Asia, has developed tightly-linked production/distribution networks through globalizing corporate activities. The vertical chain of production in East Asia has been even more sophisticated than economic integration in East Europe or Latin America. However, the political environment of East Asia for trade and investment has been far from borderless. The integration effort at the policy level has been very much limited so far, due to the historical background as well as geopolitics surrounding East Asia. The Asian currency/financial crisis provided these countries a historical turning point. After the burst of the crisis, East Asians realized that they have to take care of themselves in their difficulties, not depending on outside forces. A natural choice for them was to step into the realm of regionalism. In 1998, Japan and Korea officially announced that they would discard the long-lasting GATT/WTO-only approach and adapt the multi-layered approach, including both regionalism and multilateralism. The ultimate goal of regionalism would be a region-wide integration including ASEAN+3. As a steppingstone, Japan signed the Japan-Singapore Economic Partnership Agreement (JSEPA) in January 2002. In a parallel move, the ASEAN and China Leaders announced in November 2001 the establishment of an ASEAN-China Free Trade Area (ACFTA) within 10 years. This article will follow up the most recent advancement of regional institutional building in East Asia with the emphasis on peculiar characteristics of economic integration in the region and discuss its implications for Asia-Europe relations. This paper is heavily drawn from Kimura (2002, 2003).