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Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs Hardcover – July 26, 2011

ISBN-13: 978-0470616178 ISBN-10: 0470616172 Edition: 1st
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Editorial Reviews

Review

“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)

 



From the Back Cover

Effective strategies to deal with the growingproblem of counterfeit drugs

Counterfeit and illegally diverted drugs are a global problem representing a serious threat to patients and to our healthcare systems. To combat fake medicines you need to understand both the problems and the solutions. This book gives you these vital perspectives. It not only provides a detailed examination of the causes and consequences of pharmaceutical counterfeiting, it also provides practical advice and tested and proven strategies to deal with this growing threat to the international drug supply. Moreover, it investigates and explains the tactics and technologies you need to protect your patients, brands, and profits.

Addressing both business and technical issues, this book enables you to understand and tackle the problem of counterfeit and illegally diverted drugs on all fronts:

  • Guides you through the complex legal and compliance issues

  • Explores the complexities of the drug supply chain, demonstrating why certain approaches to reducing counterfeit drugs are more likely to work than others

  • Sets forth the pros and cons of technologies designed to authenticate drugs and secure packaging, to enable traceability or e-pedigree, and to protect the supply chain

  • Offers an easy-to-read guide for patients to help them avoid counterfeit drugs

  • Illustrates key problems and solutions using realistic examples

  • Features anti-counterfeiting case studies from Africa, Asia, Europe, Latin America and North America

Covering pharmaceutical security from factory to patient, this book helps you better understand the issues around counterfeiting and diversion and then implement effective strategies to fight back against these pharmaceutical crimes.

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Product Details

  • Hardcover: 426 pages
  • Publisher: Wiley; 1 edition (July 26, 2011)
  • Language: English
  • ISBN-10: 0470616172
  • ISBN-13: 978-0470616178
  • Product Dimensions: 6.4 x 1.2 x 9.4 inches
  • Shipping Weight: 1.2 pounds (View shipping rates and policies)
  • Average Customer Review: 4.3 out of 5 stars  See all reviews (14 customer reviews)
  • Amazon Best Sellers Rank: #1,728,945 in Books (See Top 100 in Books)

More About the Author

Mark Davison is one of the foremost experts on authentication, anti-counterfeiting, and product security. His company (see www.bluespherehealth.com) helps drug companies to get to grips with serialization, epedigree and traceability issues both for legal compliance requirements and to enhance supply chain efficiency. He started his career in the drug industry by joining Beecham in the year that it merged with SmithKline and long before the marriage to Glaxo. After a career in anti-infectives R&D, he moved into the commercial world and sold high-value services such as clinical trials. He got into anti-counterfeiting when he realised the rising magnitude of the global fake drugs problem. After spending the last five years travelling the world trying to help governments and drug companies to control this growing threat, he set up his own company, Blue Sphere Health Ltd, to advise and help corporate and government clients. Many of the things he learned along the way, and many more insights that he researched and learned from others, are in "Pharmaceutical Anti-Counterfeiting". Pharmaceutical scientists, managers and executives represent the majority of Mark's professional clients, but he also has plenty to say for physicians, pharmacists, and the interested public about how to avoid counterfeit drugs.

A Guide to Avoiding Counterfeit Drugs

It is useful to think about practical actions that we can all take, as physicians, pharmacists, patients and members of the public, to reduce the market for fake drugs by becoming better informed and more discerning consumers. What can we all do to spot counterfeit medicines before they cause harm? Are there any steps that almost anyone can take, with no special training or tools?

As with other threats to our safety, the key behavior is vigilance. Many people don't give their medication a second thought, but by being more observant about what drugs look like, where they come from etc, we can help to eliminate at least the more obvious counterfeits.

Here are some of the things to think about when buying and consuming drugs:

Is This Medication Needed?

Many chronic medical conditions are accompanied by internet myths about supposed new cures or new uses for established drugs. The desperate or incautious patient can be lured by online advertising into putting their faith in these untried and off-label drugs, often in conjunction with their existing prescribed medication. For those who suspect they have a serious or embarrassing medical condition but have not consulted a doctor about it, the desire to avoid a diagnosis can be a strong motivator to seek anonymous, unauthorized channels for their medication. The reason for avoiding their physician may be simply shyness or it may be the wish to avoid having something on their medical record that may be a perceived disadvantage in obtaining insurance or employment. The first step in avoiding counterfeits is to seek the advice and endorsement of a qualified medical practitioner for any medication you wish to take, and to buy drugs only from approved channels.

Is The Drug Approved and Available in My Country?

The blunt fact of the matter is that if a patient lives in a developed country and their national regulator has not approved the medication the patient wants (and the drug is therefore not for sale or obtainable locally) there is likely a very good reason. If that patient resides in the United States, they are part of the world's most commercially attractive and profitable medical marketplace. In general, if an American patient's desired drug doesn't appear on the FDA approved drugs database, known as 'Drugs@FDA' then this is a major warning sign. The database lists both approved drugs and approved manufacturers.


Are The Drug Sources and Methods of Purchase Safe?

Some buying behaviors are more risky for patients than others, and buying prescription drugs over the internet is the riskiest of all. There are many reputable internet pharmacies, but unfortunately on a global basis these are in a small minority. The genuine sites are crowded out by a large number of bogus sites, many of which may be controlled by organized crime groups involved with various other illegal activities including money laundering, selling counterfeit products, credit card fraud and identity theft. Unless the website shows a physical location and a phone number which can be fully verified (by making a call to a pharmacist, for example) then it is safer to assume that it is not a genuine site. Patients should also check the site's accreditation. In the USA, the National Association of Boards of Pharmacy (NABP) operates the Verified Internet Pharmacy Practice Sites™ scheme which certifies and approves online pharmacies. Similar schemes operate in some European countries. Buyers should beware, though: counterfeiters will also fake online accreditations. Nothing should be taken at face value and everything should be checked out. A bona fide pharmacy site should also ask for a medical prescription before dispensing. If the patient has not been asked to provide one, then they should ask themselves why not.

The risk of fake drugs is not limited to online pharmacies. Those buying drugs abroad should also take care when in unfamiliar surroundings or when buying unfamiliar brands. Even when getting medication from well-known chain drug stores, a little vigilance never does any harm.

What Does the Packaging Look Like?

The external appearance of a product can give often some important clues to its authenticity, especially if it is an unsophisticated copy or a refilled pack. Does it look as though it has been opened or tampered with? If there is a closure seal, has it been slit or does it look like it might have been replaced (glue residues, ripped area on package)? If there is a plastic shrink sleeve around the neck of the bottle, check that it looks like an original and has not been re-sealed in any way. If it is a liquid product for injection, check the rubber seal for needle holes and look for apparent damage or alteration to the aluminum collar or the flip cap.

Does the package or bottle look scuffed or dirty, like it has been recycled? Genuine pharmaceutical products from legitimate supply channels should normally arrive with the consumer in pretty good shape having been carefully transported. Criminals frequently re-use medical packaging scavenged from waste, or the products may have been stored and transported frequently leading to abrasion.

If the patient has used this drug before, does the product and packaging received this time look exactly the same as previous ones? Look for small differences - different fonts, changes in text size, mis-spellings, color changes, logo not quite right etc. Many counterfeits are very good copies of the original but few are perfect. Patients should check new packaging against previous packs and take the product to a pharmacist if unsure.

Is the manufacturer's label on straight? Genuine drugs are usually machine-labelled by the manufacturer to strict quality controls. If the label is poorly applied or not straight, the product may have been labelled by hand. This may have a simple explanation if the bottle has been made up to order by a busy pharmacist, but if the product was labelled by the manufacturer then this may be a warning sign.

What Does the Product Itself Look Like?

Does the shape and size of the pill look right? Manufacturers are not allowed to change the appearance of their products without a formal regulatory process and therefore it is not done lightly. If the appearance is not the same as the last time the patient received this medication then there could be an innocent explanation (substitution of a generic equivalent product, change by the manufacturer with an accompanying explanatory note etc). However, an unexplained change could indicate either an unidentified quality issue or a counterfeit. In either case, the patient's pharmacist should be informed.

Do the pills (or vials etc) in the consignment all look the same as each other? Genuine drugs are manufactured in bulk by automated, quality-controlled processes and have a consistent appearance. If there is noticeable variation between individual pills or capsules this is a warning sign.

Are the pills cracked or chipped or crumbling? Some counterfeit drugs are made with identical machinery to the original and are therefore very difficult to tell apart. However, often the fakes will be made with a different tablet press and using different bulk materials. These will not have the same physical characteristics as the original machinery and ingredients and often counterfeit drugs are coarse-grained, gritty or crumbly compared to the genuine product.

Has the pill color changed compared to previous prescriptions? Manufacturing of genuine medicines is highly controlled and they should look the same every time. Even subtle changes from the usual appearance, or differences between pills in the same batch, can indicate fake product. If the product is a clear liquid, check for precipitates, cloudiness, or color. If it is a white powder, check for grayness or specks. If there are any features which not usually present then seek advice.

When Taking the Drug:

Does it feel, smell or taste different? Genuine manufacturers' product will usually be consistent, so changes could indicate a counterfeit - especially if there seems to be a strong 'masking' flavor or smell present which was not in previous batches. Sometimes an unusual or unpleasant taste or odor may reflect a quality issue at the manufacturer, rather than a counterfeit. However, this should still be reported to a pharmacist as strange odors and tastes can be an indicator of fungal or bacterial contamination or a tainting of the product during manufacture.

Does the product behave unexpectedly (e.g. dissolve differently)? The differences in manufacturing processes and ingredients between genuine drugs and counterfeits mean that there will almost always be differences in their behavior. The fake drug may dissolve badly or not at all when it should be soluble, or it may crumble on the tongue when it should be swallowed whole. For injectable drugs supplied as powder or freeze-dried, any remaining particulates after reconstitution are a strong indicator of a quality problem or a counterfeit.

After Taking the Drug:

Any unexpected adverse reactions (side effects) should be noted and followed up with a pharmacist or physician. Many drugs have well-known side effect profiles which are explained on the patient information leaflet. However, if the patient has taken the drug before without problems, minor symptoms (headache, nausea, dizziness etc) after starting a new batch of the medication may be a sign of fake or sub-standard drugs. Major adverse events (palpitations, shortness of breath etc) should be followed up with immediate medical consultation. Often, these events are explainable by other factors, but in some cases counterfeit drugs may be to blame. If the patient has any unusual adverse event relating to their medication, they should keep all drug packaging as evidence. It is important that if the patient has bought additional drugs, vitamins, supplements etc off the internet then these should be included in the discussion with the doctor - whether the physician authorized or recommended the product or not. If the patient hides the fact that they are taking something else on top of what their doctor is aware of, it only makes investigating potential counterfeiting or quality incidents harder and could put other people at risk.


Don't get the problem out of proportion - almost all drugs are safe - but take these few precautions to protect yourself from counterfeits.

Customer Reviews

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Most Helpful Customer Reviews

1 of 1 people found the following review helpful By a scientist VINE VOICE on November 4, 2011
Format: Hardcover Vine Customer Review of Free Product ( What's this? )
There is quite a limited audience for this book. It is clearly aimed at general pharmaceutical executives and pharmacists. It's probably also worth reading if you run a Ministry of Health for a government. One of the points made early on in the book is that pharmaceutical counterfeiting happens everywhere (even in the UK, an island with a very tightly controlled pharmaceutical supply chain). That having been said, I would expect that pharma/pharmacist/consumer retail pharmacy chains who have international business are the target market for this book.

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.
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1 of 1 people found the following review helpful By Dirk A. Rodgers on September 19, 2011
Format: Hardcover Verified Purchase
In writing this book author Mark 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.

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.
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1 of 1 people found the following review helpful By Misanthrope™ VINE VOICE on December 28, 2011
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As a pharmacist, I would recommend that pharmacists, doctors, and any other medical professional with interest, as well as pharmaceutical company executives, familiarize themselves with the issues explained in this text by Davison. He explains the issues we face, whether safety or business oriented, and lays out methods to handle the issue of counterfeiting drugs. This is, of course, more relevant for the companies that produce pharmaceuticals, as well as the governmental administrations that are responsible for regulation, but all parties from there to the end user, the patient, should be educated.
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1 of 1 people found the following review helpful By reviewer on November 29, 2011
Format: Hardcover Vine Customer Review of Free Product ( What's this? )
The was no surprise in the narrative of pharmaceutical anti-counterfeiting as a problem. The surprising part is how much different technology exists in creating a drug in the process through the supply chain to make it harder to counterfeit. The book is not aimed at the general laymen but rather as a reference for pharmaceutical manufacturers or buyers the tools and technology that would make anti-counterfeiting more effective. An interesting read for the interested layman though.
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Format: Hardcover Vine Customer Review of Free Product ( What's this? )
In the Introduction the author notes that this book is meant to be a general introduction/overview of counterfeiting of drugs and medical devices because if more specific details were given, it may end up educating counterfeiters of more options. He notes that this book is aimed for pharmaceutical executives, pharmaceutical employees, R &D personnel, manufacturing supervisors, sales representatives, patients and any other people involved in buying or producing health related products. I have been at the forefront of many aspects of production (R&D, manufacturing, lab technician, production line worker, logistics, ingredient sourcing, regulations) for the skin care and dietary supplements industries and found this book to be extremely useful and applicable for these industries as well since they also face issues that the pharmaceutical industry faces. Therefore, this book has wide applicability and should be used by other health care product industries, not just pharmaceuticals.

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.
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