Special Issue "Challenges to Safety in the Global Drug Supply Chain"

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A special issue of Challenges (ISSN 2078-1547).

Deadline for manuscript submissions: closed (1 October 2013)

Special Issue Editors

Guest Editor
Prof. Dr. Bryan A. Liang
1 Department of Anesthesiology, University of California, San Diego School of Medicine, 200 West Arbor Drive, San Diego, CA 92103, USA
2 San Diego Center for Patient Safety, University of California, San Diego School of Medicine, 200 West Arbor Drive, San Diego, CA 92103, USA
3 Institute of Health Law Studies, California Western School of Law, 350 Cedar Street, San Diego, CA 92101, USA
4 Joint Program on Health Policy & Law, University of California, San Diego, California Western School of Law, San Diego, CA 92037, USA
Website: http://www.sandiegocps.org
E-Mail: baliang@alum.mit.edu
Phone: +1-619-515-1568
Fax: +1-619-515-1599
Interests: patient safety; global health; health policy; global drug supply; online pharmacies; e-Health

Guest Editor
Professor Timothy K. Mackey
1 Department of Anesthesiology, University of California, San Diego School of Medicine, 200 West Arbor Drive, San Diego, CA 92103, USA
2 San Diego Center for Patient Safety, University of California, San Diego School of Medicine, 200 West Arbor Drive, San Diego, CA 92103, USA
3 Institute of Health Law Studies, California Western School of Law, 350 Cedar Street, San Diego, CA 92101, USA
4 Joint Program on Health Policy & Law, University of California, San Diego, California Western School of Law, San Diego, CA 92037, USA
E-Mail: tmackey@ucsd.edu
Phone: +1-619-515-1568
Fax: +1-619-515-1599
Interests: global governance; global health; health policy; global drug supply; online pharmacies; e-Health; e-Marketing

Special Issue Information

Dear Colleagues,

Pharmaceuticals are critical health delivery system instruments within medicine that lead to improved quality and quantity of life. Yet the convergence of global sourcing, facilitated international trade, and emerging worldwide criminal networks have led to tremendous challenges to ensure safety of the global drug supply chain. Recent penetrations of the legitimate supply chain by counterfeit and illicit forms in developed and developing countries, encompassing lifestyle and lifesaving medications, including generic and branded forms, spanning oral and injectable medications, and treating communicable and noncommunicable diseases illustrate this expanding global patient safety threat is not limited to any geopolitical unit or area. Further, illicit sourcing, marketing, and sales through avenues such as the Internet and business-to-business forums have vastly increased this reach and potential harm from the criminal activities associated with counterfeit and illicit medication sales.

Recognizing this, international efforts have been made to address the challenges to a safe, robust supply chain, including those centered about WHO, the UN, Interpol, and private sector stakeholders. However, at present, strategies to address the vulnerabilities of the global drug supply chain have been limited and ineffective, suffering from technical, exclusionary, and competency-based weaknesses across forums and stakeholders. Consequently, new research, conceptions, collaborations, theoretical frameworks, global governance, and health policy approaches are urgently needed to reflect the rapidly increasing presence of illicit actors exploiting vulnerabilities in global drug supply chain.

This Special Issue will focus on new strategies, methodologies, and thinking to address the deep patient safety risks associated with global drug supply chain vulnerabilities. Importantly, these papers will provide insights using inter- and cross-disciplinary efforts to tackle this complex issue, reflecting upon root causes and informed approaches. Through these insights, global health policy can emerge and facilitate promotion of patient safety in the drug supply chain worldwide while bringing the criminals exploiting these vulnerabilities to justice.

Prof. Dr. Bryan A. Liang
Prof. Timothy K. Mackey
Guest Editors

Submission

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. Papers will be published continuously (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are refereed through a peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Challenges is an international peer-reviewed Open Access biannual journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. For the first couple of issues the Article Processing Charge (APC) will be waived for well-prepared manuscripts. English correction and/or formatting fees of 250 CHF (Swiss Francs) will be charged in certain cases for those articles accepted for publication that require extensive additional formatting and/or English corrections.

Keywords

  • global health
  • drug supply safety
  • counterfeit drugs
  • organized crime
  • online pharmacies
  • patient safety
  • global health policy
  • global governance

Published Papers

No papers have been published in this special issue yet, see below for planned papers.

Planned Papers

The below list represents only planned manuscripts. Some of these manuscripts have not been received by the Editorial Office yet. Papers submitted to MDPI journals are subject to peer-review.

Type of Paper: Article
Title: Accelerated Entrance to and Delayed Exit from the Medicine Market; A Game Theoretic Approach
Authors: Ozhan Zurel 1,*, Wim Marneffe 1, Dominique Vandijck 1, Jochen Bergs 1, Johan Hellings 2 and Irina Cleemput 1
Affiliations: 1. Department of Economics and Public Policy, Hasselt University, Campus Diepenbeek, Agoralaan, Building D, Room B52, 3590 Diepenbeek, Belgium;
2. Department of Patient Safety, Hasselt University, Diepenbeek, Belgium
Author to whom correspondence should be addressed; E-Mail: ozhan.zurel@uhasselt.be; Tel: +32 487 906 660.
Abstract: Since two decades certain drugs, for the treatment of serious unmet medical needs, can enter both the American and the European drug market based on limited clinical evidence. The purpose is to get important new drugs to patients earlier. Recent examples have shown an incapability of regulatory agencies to compel reliable post-marketing studies or to act in a swift and efficient manner when post-marketing studies demonstrate clinical harm or no clinical benefit. This manuscript exposes mechanisms that cause drugs to be sometimes too rapidly approved, withdrawn late or not withdrawn at all. We reveal how conflicts of interest and asymmetric information play a crucial role in this process. Many agents on the drug market bear preventable financial or social costs assignable to inefficient constructions of the drug market. We formulate several policy recommendations for a more efficient market. First, the provision of information should be done by an independent entity other than the regulatory agencies. Second, the execution of post-marketing studies should be guaranteed through sufficient staff, financed by the public. Third, clinical harm or absence of the expected clinical benefit should lead to a swift removal of the drug. Finally, the conflicting forces on the regulatory agencies should be internalized through a better representation of society by the regulatory agencies.
Keywords: drug market; post-marketing studies; regulatory capture; fast track process; conditional approval; Food and Drug Administration; European Medicines Agency; asymmetric information

Last update: 14 June 2013

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