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Pharmaceutical Anti–Counterfeiting: Combating the Real Danger from Fake Drugs (Anglais) Relié – 12 août 2011
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Description du produit
Revue de presse
The book is an excellent resource and I would recommend it to anyone with either an interest in anti–counterfeiting technology or pharmaceutical counterfeiting in general. (International Journal of Comparative and Applied Criminal Justice, 26 April 2012)
"Pharmaceutical Anti–Counterfeiting" covers the key concepts and explains the available options in pharmaceutical anti–counterfeiting including a mix of policy, strategy, tactics and practical implementation tips. A must–read for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Chemanager, 24 January 2012)
"For those determined to take an action against counterfeit pharmaceutical and healthcare products, will find the book useful." (The Holography Times, 1 December 2011)
"Using accessible and interesting language, Mark Davison talks the reader right the way through the issue of drug counterfeiting – its origins and context within healthcare , the risks presented to companies and consumers alike, anti–counterfeiting strategies and technologies – the result being a definitive guide to the inner workings of the counterfeit industry and a myriad of ways to stymie the counterfeiter′s every step ... Reading this book will provide any pharmaceutical brand owner with a solid and informed grounding for making any decisions related to anti–counterfeiting strategy." (Notofakes.com, 16 November 2011)
"In writing this book Davison has made a great contribution to the global fight against counterfeit drugs. For the first time we have a single reference that collects explanations of every significant anti–counterfeiting technology and approach used around the globe, including both sensory authentication and traceability technologies." (RxTrace, September 2011)
"Best Pharma Anit–Counterfeiting Book Ever...Davison does not back away from or avoid pointing out conflicts and disagreements that exist between approaches to solving problems (digital vs. physical authentication), but he is quick to help the reader find the strongest solution by seeing the ways that solutions and technologies can work together." (Randall Burgess, Pharmaceutical AntiCounterfeiting Blog, October 5, 2011)
"Pharmaceutical Anti–Counterfeiting: Combating the Real Danger from Fake Drugs by Mark Davison succeeds in providing a handbook for professionals involved in product security and brand protection. . . Davison has a great deal of industry experience in pharmaceuticals as well as product security and is well positioned and qualified to be the one to write this book. The industry owes him a debt of gratitude for committing himself to this effort." (Pharma AntiCounterfeiting News, 1 August 2011)
"Cambridge–based consultant and entrepreneur Mark Davison, CEO of Blue Sphere Health Ltd, has written a comprehensive guide for drug company executives, technology vendors, healthcare professionals and policy–makers. . . This newly–released 426pp volume is a must–read primer for those determined to do something about counterfeit pharmaceutical and healthcare products, and will prove useful to brand protection professionals in other industries." (Cambridge Network , 6 September 2011)
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Commentaires client les plus utiles sur Amazon.com
This book is aimed at people who need to have a full understanding of approaches being taken or considered to combat drug counterfeiting around the world. This includes executives and other corporate leaders in pharmaceutical supply chain organizations including security, sourcing, manufacturing, packaging, distribution, supply chain, marketing and IT. Technology solution providers, policy-makers, legislators, media, educators and students will also find this to be a valuable reference. I found this book to be very complete and easy to read. If you are interested in pharmaceutical anti-counterfeiting then this is the book you should read.
Luckily, the target market will also find it highly readable, for the most part. Before I get into why, that means that if you're an interested layperson who wants to know more about any of the following:
1, why counterfeiting is such a problem
2, how it can be detected
3, how it can be prevented
then you should not be scared off by the apparently academic nature of this book. It is engaging enough to sit down and read through.
However, to use this book most effectively you'll pretty much have to read through it rather than treat it as an occasional reference. There's lots of three-letter abbreviations/acronyms peppered throughout the text. Although these are well-defined initially AND in the excellent glossary at the back of the book, they will still prevent this book from being something you can dip into for a quick answer, unless you know the material so well that the book will no longer really be useful anyway.
The first portion of the book explains why counterfeiting is such a big issue, highlighting the fascinating and highly current example of anti-malarials. There was a bubble and blip in the market for the latest treatments, which played havoc with the economics for legitimate pharmaceutical manufacturers, and ultimately created a situation that endangered human lives AND threatens the long-term use of our most effective anti-malarial drugs. The next quarter of the book is a practical catalog of analytical methods for detecting counterfeit bulk material, finished product, and packaging. The third section investigates how product can be tracked, including future expected advances. The last portion of the book is a list of useful resources, references, and the excellent glossary.
In summary, it is useful to have the problem and potential non-proprietary solutions laid out so clearly in one place. I found myself wishing for a little more detail in terms of logistics (how long do certain detection methods take, how much do they cost, what are the trade-offs I should be considering?) fairly often, but that would come at the cost of readability. The book is current right up to the end of 2010. Editing, etc, obviously took some time, but the results were worth it.
If you need to know how insidious the problem is, and how to think about wrapping your head around it, this book is the primer you've been looking for. If you're already immersed in the problem of counterfeit pharmaceuticals and need more than a very solid introduction, you should probably get the book anyway to ensure you haven't missed anything, but you'll probably need something more detailed/even more practical.
The book deals with all relevant aspects of health care product manufacturing (raw materials sourcing, packaging, regulations, etc.), promotion, and market vulnerability (few case studies are included); it gives some explanations to why some pharmaceuticals and other health care products are really expensive; it details common counterfeiting and anti-counterfeiting techniques, and also how to detect and reduce counterfeiting in general. One important reminder that pops up occasionally is that adding security features in both the product and packaging should not be seen by companies as a "cost". Instead adding security features should be seen as an "investment" to protect integrity of the product, to protect the company's reputation, and to fend off counterfeiters.
Here I provide the part and chapter titles and a few things that can be found in them (this is not exhaustive):
Part 1 - General Themes
Ch. 1 - Introduction
Ch. 2 - Origins and Context of Counterfeiting in Healthcare
How expensive and lengthy the drug development process is for legitimate companies to bring a product to the market; the low costs of counterfeiting; reasons why the internet used widely as a venue for counterfeit drugs; counterfeiting as a global phenomenon
Ch. 3 - A Snapshot of the Problem
Some data on the number of counterfeits that have emerged in some markets; organized crime controls most of the counterfeiting; difficulties in assessing the actual number of counterfeits; case study of malaria and how counterfeits cause preventable casualties
Ch. 4 - Risks and Costs of Counterfeit Pharmaceuticals
Elaborates on some general effects of counterfeits on many levels; risks to consumers such as confusion or loss of trust between patients and doctors; risks to businesses such as heavy revenue loss due to cheap look alike brands, reluctance to buy due to consumer fears of buying a counterfeit, difficulties on companies detecting counterfeits, brand erosion (Tylenol example given), loss of faith between consumer and company; risks to governments such as loss of faith in regulatory agencies, increasing healthcare costs; new governmental measures taken to impede bad products from reaching the market such as US FDA offices being active inside other countries to regulate products before entering the US
Ch. 5 - Anti-Counterfeiting Definitions
Provides examples of different definitions of counterfeiting; gives examples of different ways counterfeiting occurs such as fake product & fake packaging, repackaging of genuine product in fake packaging, refilling or reusing genuine packaging with fake product (e.g. fake ingredients), relabeling expired genuine product, relabeling genuine low dose product with fake higher dosage label, relabeling intentionally diluted product, selling unauthorized products, forging documents, using substituted raw materials, reselling product against intention of original producer
Ch. 6 - Protecting and Educating Consumers
Using social networking and blogging as education and warning mediums for consumers; using cultural tools for education and warning mediums
Ch. 7 - Business Risks and Strategy
Suggestions for businesses to increase counterfeit deterring strategies; the author's "DRASTIC" framework; simple things that can be done to reduce chances of products being counterfeited; adding layers of measures to deter counterfeiters
Ch. 8 - Government Issues
Government actions that are being take and should be taken to reduce counterfeiting
Ch. 9 - Intellectual Property and Anti-Counterfeiting
Considerations on intellectual properties; Patents may not be good since one has to make disclosed technical information available which could be used by counterfeiters in international markets (Coca Cola does not patent formula, they simply protect it really well); trademarked materials (logos, slogans, etc) may be good to have to help differentiate one's own product from counterfeits; international difficulties with intellectual properties from other nations
Ch. 10 - Traceability or Authentication?
Products pass through many hands. Tracking technologies along with non digital identification can help monitor products.
Part 2 - Authentication
Ch. 11 - What is Authentication?
Authentication technologies; digital and physical sensory technologies; "Authentication Pyramid"
Ch. 12 - Authentication of the Person
Concerning prescription drugs, verifying that the people receiving the product really are patients and that need the drugs
Ch. 13 - Authentication of Bulk Products
Raw ingredient suppliers may provide defective ingredients with or without knowing; case study of the 2008 Baxter recall incident due to adulterated heparin from China; getting supplier validation, auditing the suppliers, and getting ingredient verification are important; when receiving inbound ingredient shipments one should expect to receive a clear chain of custody; Quality Assurance (QA) should test and inspect ingredients before use in production; how simple ID testing could have saved 100 people in Panama in 2006 due to contaminated glycerol; many companies rely exclusively on the Certificates of Analysis, but this could be dangerous because any distributor can put their letterhead on it
Ch. 14 - On-Dose and In-Dose Authentication
On-Dose features like adding imprints, embossing, other surface marking that requires special equipment on tablets or capsules can reduce likelihood of counterfeiting; In-Dose features like adding security ingredients which do no compromise the effects of the product can be applied to liquids and creams; one can use combinations of inactive ingredients from GRAS and IIG lists as excipients in specific ratios to make "chemical fingerprints"; best time to consider In-Dose security features is during product development; security feature disclosure in labeling considerations
Ch. 15 - Analytical Detection of Counterfeit Dosage Forms
Short summaries of various testing methods as anti-counterfeiting strategies: Considerations of using multiple portable simple chemical and physical analysis methods like colorimetry, hardness tests, dissolution tests, Thin Layer Chromatography (TLC), UV Spectroscopy testing; considerations of using laboratory analysis methods such as Atomic Absorption Spectrophotometry (AAS), X-ray testing, Nuclear Magnetic Resonance (NMR) Spectrometry, Mass Spectroscopy (MS), Gas Chromatography (GC); Liquid Chromatography like High-Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, Palynology techniques; considerations of using non-destructive methods like X-ray diffraction, Infrared Spectroscopy, Fourier Transform Infrared Spectroscopy, Near-Infrared, Raman Spectroscopy, and Terahertz Imaging
Ch. 16 - The Role of Packaging
Counterfeit packaging is much easier to do today with digital technology since many companies do not put in much effort on their packaging; the way governments do frequent changes to design, makes design more complex, and other anti-counterfeiting strategies for money can be applied to product packaging to impede counterfeiters; list of recommendations for companies to add security features
Ch. 17 - Printing Technologies
Short summaries of printing technologies such as Offset Lithography, Flexography, Gravure, Screen Printing, Laser Printing, Pad Printing, Embossing/Debossing, Laser Engraving, Inkjet Print; some considerations for applying a security feature on packaging include space and shape on packaging, budget to make the job, consistent orientation of packaging, giving more time to complete production schedule; application of security features in the printing phase or manually add labels - which is better?
Ch. 18 - Security Labels
Considerations when using labels as security features include choosing adhesive, frangibility, security cuts, and voiding
Ch. 19 - Holograms and DOVIDs
Types of holograms and Diffractive Optically Variable Image Devices (DOVIDs)
Ch. 20 - Specialty Inks
Types of inks like Colorshift, Iridescent, Metallic, Flourescent, Bi-fluorescent, Thermochromic, Photochromic, Coin Reactive, Micrtotaggants
Ch. 21 - Covert Taggants and Forensic Markers
Secret markers like Forensic, Isotopic tags, DNA markers, and others
Ch. 22 - General Conclusions on Printed Packaging and Security Labels
Ch. 23 - Security of Primary Packaging
Consideration of types of primary packaging such as blister packs, wallets, pouches, bottles, squeezable tubes, vials, ampoules, syringes, delivery devices; considerations for diagnostic products, medical devices
Ch. 24 - Security of Secondary Packaging
Considerations for secondary packaging like cartons that house blister packs; in house or outsourcing security features; considerations of tamper evidence from seals, shrink wraps, snap off caps, closures, etc ; "tamper-evident" and "tamper-proof" are two separate types of things
Ch. 25 - Analytical Methods for Packaging
Visual inspection, optical methods
Ch. 26 - Security of Other Packaging Types
Drug-Device combinations, information leaflets, forged documentation (Import licenses, Certificates of Analysis, Prescriptions)
Ch. 27 - Bulk Packaging and Transport Security
Logistics issues such as third party shipping being more vulnerable to theft, cargo and warehouse theft, losses to businesses on theft, organized thefts; countering thefts with vigilance of facilities for suspect activities, guarding sensitive information, employee training, Radio Frequency Identification (RFID), GPS, etc
Part 3 - Product Tracking
Ch. 28 - Rationale for Pharmaceutical Tracking
Ch. 29 - Tracking Technologies
Serial numbers, bar codes, matrix codes, using mobile phones, Radio Frequency Identification (RFID)
Ch. 30 - Data Format, Generation, and Storage
More detailed discussions on serialization, tracking, digital fingerprinting
Ch. 31 - Management of Packaging Hierarchy
Outline of a protocol for tracking product fro manufacturing, wholesaler, to pharmacy; Bookend approach and its limitations
Ch. 32 - Geographical Perspectives
International initiatives and systems
Ch. 33 - Product Tracking in Other Industries
Counterfeiting in other industries such as Alcohol and Tobacco, Food and Beverage, Toys
Ch. 34 - Supply Chain Security Processes
Logistics for returns & complaint, and general shipping
Ch. 35 - Implementing Anti-Counterfeiting Initiatives - Practical Issues
Part 4 - Conclusions and the Future
Ch. 36 - Where Do We Go from Here?
Ch. 37 - New Models, New Approaches
Ch. 38 - Selected Examples from Around the World
Case studies on some parts of the world
Overall, this book is quite helpful. One of the benefits of this book is that the chapters are quite short but sufficiently informative - which makes it easy for future referencing. However, more detailed case studies would have been helpful. I was going to give it 4 stars because of this, but I will give it five because I agree with the author, that case studies of specific companies may give away too much exposure which can be informative to counterfeiters and give a bad rep for legitimately good companies which had unfortunate incidents. That is one thing about writing a book about counterfeiting - you don't want to make the book be too detailed about counterfeiting because counterfeiters can use it to educate themselves and make their counterfeiting much more advanced, complex, and harder to detect. In this context it was good that the book focused on things that were already general knowledge.