Pharmaceutical Commerce - July/August 2011 - (Page 8)

Top News [ Book Review ] Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs The US pharmaceutical industry remains in something of a lull regarding counterfeit drugs. After a flurry of activity in the early years of the past decade, abetted by an FDA push to establish a reliable anti-counterfeiting and anti-diversion program, various states tightened their licensure and regulation of wholesale distributors, bringing some order to what had been a near Wild West of product diversion. The state-level campaign culminated with a drive by the California Board of Pharmacy to mandate a fully built out trackand-trace system—which was postponed, as the state’s continued financial difficulties arose in 2008, to the 2015-17 timeframe. Meanwhile, nearly everyone concerned with preventing counterfeit drugs from circulating is looking to Washington and the FDA to establish a national program. A parallel effort, with more or less the same time frame, is occurring in Europe, and in most parts of the developing world—where counterfeiting rises to a national public health crisis in some cases—some lower-cost workable solutions are being deployed. Despite intense effort by some industry leaders, and by some technology vendors, no single method or process for protecting against counterfeits is in the offing. But in fact that fits with one of the fundamental tenets of anti-counterfeiting—that multiple layers of defense are needed, and that the entire supply chain needs to cooperate in a collaborative manner to secure the drug supply. In that context, Pharmaceutical AntiCounterfeiting: Combating the Real Danger from Fake Drugs (Wiley; www.wiley.com) provides a useful service: it surveys a considerable part of the technology scene, enabling the reader to get an overview of the dozens of techniques and practices that are available, from RFID tags to security inks to analytical chemistry. Its 402 densely written pages cover the spectrum of options well. Authored by Marc Davison, a former executive at a leading anti-counterfeiting technology and consulting business (SICPA), Pharmaceutical Anti-Counterfeiting is valuable if only for putting a context around the two main approaches to anti-counterfeiting: on-dose or on-package security features; and track-and-trace (aka “pedigree”) systems. Both have value; both have limitations and both, ultimately, may be necessary to secure the supply chain. The former approach is suited to individual manufacturers who have the desire (and resources) to monitor their own products in distribution channels or to provide security to patients; the latter pools all manufacturers’ and distributors’ efforts into a collaborative process that secures supply chains for all participants. Anti-anticounterfeiting proponents (if such a term can be used) claim that a “normal channel of distribution” exists that covers most if not all pathways of drugs from maker to consumer—but the many exceptions to this channel highlight the risks we continue to suffer. Deloitte Assesses the Implications of Federal Comparative Effectiveness Research (CER) The Patient Centered Outcomes Research Institute is gradually taking form—and differs significantly from non-US CER efforts If—as the writer F. Scott Fitzgerald said a long time ago, “The test of a first-rate intelligence is the ability to hold two opposing ideas in mind at the same time and still retain the ability to function—then, there are a lot of first-rate intelligences in the comparative effectiveness research (CER) today. While there has been some progress since $1.1 billion was committed in the American Resource Recovery Act of 2009, the desired machinery for sponsoring research studies is still in the process of setting up. And it is clearer now, according to a recent study by The Deloitte Center for Health Solutions (Washington, DC), that the CER effort, now centered on the Patient-Centered Outcomes Research Institute (PCORI), will lack the input of cost data that CER efforts outside the US routinely employ: “International CER experience has found that the inclusion of cost data in CER studies increases the usefulness of technology assessments; however, cost data and the computation of cost-effectiveness metrics such as the QALY [quantity of life years] are strictly prohibited …” Thus, the ability to talk about effectiveness, without the ability to talk about cost. Deloitte’s study compares the evolving patterns of US CER research to other programs in Europe and Asia. Everyone has heard about the UK National Institute for Health and Clinical Excellence (NICE), which has had a handful of dust-ups over disallowing drug coverage at some times; but there is also the Institute for Quality and Efficiency in Health Care (IQWIG) in Germany; the Pharmacy Benefits Advisory Committee (PBAC) in Australia; and the Canadian Agency for Drugs and Technologies in Health Care (CADTH). In varying ways, these other organizations include economics in their studies, although their authority to disallow reimbursement varies considerably. What is at stake—and what is relevant to any discussion of healthcare reform in the US—is the belief that healthcare should not be “rationed,” and yet the understanding that the costs of Setting the scene for Comparative Effectiveness healthcare are out of Research pre-ACA control. To get this far, federal agencies and the medical research community have developed a list of 100 candidate CER study topics; and an interim Federal Coordinating Council for Comparative The American Resource Effectiveness Research was set Recovery Act (ARRA) funded existing federal up to guide the development agencies, along with the and funding of PCORI. The Institute of Medicine, to Coordinating Council also develorganize the CER effort. The Federal Coordinating oped a definition of CER that will Council for Comparative guide future development: Effectiveness Research “Comparative effectiveness research (FCCCER) is being superseded by PCORI. is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which 8 July | August 2011 www.PharmaceuticalCommerce.com http://www.wiley.com http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
http://www.nxtbook.com/nxtbooks/pharmcomm/201911
http://www.nxtbook.com/nxtbooks/pharmcomm/201909
http://www.nxtbook.com/nxtbooks/pharmcomm/201906
http://www.nxtbook.com/nxtbooks/pharmcomm/201903
http://www.nxtbook.com/nxtbooks/pharmcomm/201811
http://www.nxtbook.com/nxtbooks/pharmcomm/201809
http://www.nxtbook.com/nxtbooks/pharmcomm/201806
http://www.nxtbook.com/nxtbooks/pharmcomm/20180304
http://www.nxtbook.com/nxtbooks/pharmcomm/20171112
http://www.nxtbook.com/nxtbooks/pharmcomm/20170910
http://www.nxtbook.com/nxtbooks/pharmcomm/20170708
http://www.nxtbook.com/nxtbooks/pharmcomm/20170506
http://www.nxtbook.com/nxtbooks/pharmcomm/20170304
http://www.nxtbook.com/nxtbooks/pharmcomm/20170102
http://www.nxtbook.com/nxtbooks/pharmcomm/20161112
http://www.nxtbook.com/nxtbooks/pharmcomm/20160910
http://www.nxtbook.com/nxtbooks/pharmcomm/20160708
http://www.nxtbook.com/nxtbooks/pharmcomm/20160506
http://www.nxtbook.com/nxtbooks/pharmcomm/20160304
http://www.nxtbook.com/nxtbooks/pharmcomm/20160102
http://www.nxtbook.com/nxtbooks/pharmcomm/20151112
http://www.nxtbook.com/nxtbooks/pharmcomm/20150910
http://www.nxtbook.com/nxtbooks/pharmcomm/20150708
http://www.nxtbook.com/nxtbooks/pharmcomm/20150506
http://www.nxtbook.com/nxtbooks/pharmcomm/20150304
http://www.nxtbook.com/nxtbooks/pharmcomm/20150102
http://www.nxtbook.com/nxtbooks/pharmcomm/20141112
http://www.nxtbook.com/nxtbooks/pharmcomm/coldchaindirectory2014
http://www.nxtbook.com/nxtbooks/pharmcomm/20140910
http://www.nxtbook.com/nxtbooks/pharmcomm/20140708
http://www.nxtbook.com/nxtbooks/pharmcomm/20140506
http://www.nxtbook.com/nxtbooks/pharmcomm/20140304
http://www.nxtbook.com/nxtbooks/pharmcomm/20140102
http://www.nxtbook.com/nxtbooks/pharmcomm/dataservicedirectory
http://www.nxtbook.com/nxtbooks/pharmcomm/20131112
http://www.nxtbook.com/nxtbooks/pharmcomm/20130910_hubreport
http://www.nxtbook.com/nxtbooks/pharmcomm/20130910
http://www.nxtbook.com/nxtbooks/pharmcomm/20130708
http://www.nxtbook.com/nxtbooks/pharmcomm/20130506
http://www.nxtbook.com/nxtbooks/pharmcomm/coldchain2013
http://www.nxtbook.com/nxtbooks/pharmcomm/20130304
http://www.nxtbook.com/nxtbooks/pharmcomm/20130102
http://www.nxtbook.com/nxtbooks/pharmcomm/20121112
http://www.nxtbook.com/nxtbooks/pharmcomm/20120910
http://www.nxtbook.com/nxtbooks/pharmcomm/20120708
http://www.nxtbook.com/nxtbooks/pharmcomm/20120506
http://www.nxtbook.com/nxtbooks/pharmcomm/20120506_coldchain
http://www.nxtbook.com/nxtbooks/pharmcomm/20120304
http://www.nxtbook.com/nxtbooks/pharmcomm/20120102
http://www.nxtbook.com/nxtbooks/pharmcomm/20111112
http://www.nxtbook.com/nxtbooks/pharmcomm/20110910
http://www.nxtbook.com/nxtbooks/pharmcomm/20110708
http://www.nxtbook.com/nxtbooks/pharmcomm/20110506
http://www.nxtbook.com/nxtbooks/pharmcomm/20110304
http://www.nxtbook.com/nxtbooks/pharmcomm/20110102
http://www.nxtbook.com/nxtbooks/pharmcomm/20101112
http://www.nxtbook.com/nxtbooks/pharmcomm/20100910
http://www.nxtbook.com/nxtbooks/pharmcomm/20100708
http://www.nxtbook.com/nxtbooks/pharmcomm/20100506
http://www.nxtbook.com/nxtbooks/pharmcomm/201004
http://www.nxtbook.com/nxtbooks/pharmcomm/201003
http://www.nxtbook.com/nxtbooks/pharmcomm/20100102
http://www.nxtbook.com/nxtbooks/pharmcomm/20091112
http://www.nxtbookMEDIA.com