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Lists with This Book. This book is not yet featured on Listopia. Jan 16, Gaby rated it really liked it Shelves: Mark Davison's Pharmaeutical Anti-Counterfeiting resource is written for pharmaceutical executives, pharmacists, people who work for the Department of Health, policymakers, and others in the drug industry and their lawyers.
Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs costs / risks to consumers (toxic products, mistrust of drug companies) and. Pharmaceutical Anti‐Counterfeiting: Combating the Real Danger from Fake Drugs. Author(s). Mark Davison. First published June
The book discusses the impact of counterfeit drugs on public health through the distribution of ineffective drugs, the danger of drugs that are sub-potent and result in the development of drug resistant strains of bacteria, and the reduction of public trust in certain medicine Mark Davison's Pharmaeutical Anti-Counterfeiting resource is written for pharmaceutical executives, pharmacists, people who work for the Department of Health, policymakers, and others in the drug industry and their lawyers.
The book discusses the impact of counterfeit drugs on public health through the distribution of ineffective drugs, the danger of drugs that are sub-potent and result in the development of drug resistant strains of bacteria, and the reduction of public trust in certain medicines. Davison also discusses loss of revenue to drug companies, the difficulties facing drug companies as they identify, prosecute and stop the distribution of counterfeit copies of their drugs.
As its title suggests, the bulk of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs focuses on a variety of anti-counterfeiting tools for different stages in the distribution of drugs. The book systematically discusses the points in the creation and distribution process where counterfeiting and smuggling of drugs can occur both in developing nations and developed nations.
The author devotes considerable time to the assessment of the size, type and distribution of risks and ways to assign resources accordingly as well as the creation of an international strategy. The suggestions range from those easier to execute packaging, printing, audits, suppliers, controls, security features that can be used design and packaging to the international trade organizations and the published set of principles which seek to guide policy in this area to a discussion on owners of intellectual property establish ownership of intellectual property rights to detailed and practical suggestions on how to enact product security measures.
The book is written for those who work in the fields of pharmaceutical, health care, intellectual property, government regulation, and intellectual property and would offer them practical suggestions. Wiley; 1 edition July 26, , pages. Review copy provided by the Amazon Vine Program and the publisher. Lill'te rated it it was amazing Aug 24, Looks like you are currently in Russia but have requested a page in the United States site.
Would you like to change to the United States site? 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. Reading this book will provide any pharmaceutical brand owner with a solid and informed grounding for making any decisions related to anti-counterfeiting strategy.
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. Davison does not back away from or avoid pointing out conflicts and disagreements that exist between approaches to solving problems digital vs.
Combating the Real Danger from Fake Drugs by Mark Davison succeeds in providing a handbook for professionals involved in product security and brand protection. Use of isotope excipients: A recent study showed the ability of labeled excipients in different ratios to provide in-product, batch-specific identification using existing technology in the pharmaceutical industry [ 34 ]. For adoption in developing countries like India, a system named epothecary was proposed which is a mobile-based authentication system. This is a cost-effective approach with minimum requirement of network infrastructure [ 35 ].
A research study proposed the application of semiconductor nanostructures called quantum dots as a promising strategy against counterfeiting [ 36 ].
A drug pedigree is a paper document or electronic file that records the details of distribution of a prescription drug from its manufacture through wholesale transactions, until it is received by the dispenser, which is usually a pharmacy or physician. Pharmaceuticals policy Pharmaceutical industry Counterfeit consumer goods Medical crime. Tag with sensors Low High. Chemical and biological tags, microtaggants. By Design Complexity Addition to Packaging: This book is not yet featured on Listopia. The use of diluents in illegal drugs reduces the potency of the drugs and makes it hard for users to determine the appropriate dosage level.
Several anti-counterfeit technologies are being utilized by pharmaceutical firms to prevent the counterfeits. Some of the products with the corresponding anti-counterfeit measures are mentioned in Table 4. Along with the anti-counterfeit technologies, the analytical techniques are also used by pharmaceutical industries for authentication which are explained in a later section.
Anti-counterfeit technologies used in brand pharmaceutical products [ 39 , 40 ]. Authentication using the various anti-counterfeit technologies can verify the supply chain, while analytical methods like chromatography, optical spectroscopy, and isotopic characterisation confirm the composition [ 41 ]. Several analytical techniques were being employed by different pharmaceutical industries for the detection of counterfeits.
They include simple techniques like colorimetry and thin-layer chromatography, to advanced methods like NMR, mass, and raman spectroscopies [ 42 ]. Handheld devices are currently gaining more importance and numerous instruments are being developed.
Mainly portable devices like the handheld raman and IR spectrometers are being utilized owing to their non-destructive, rapid, and reliable properties. An increased demand for these is seen not only by the pharma companies, but also by health authorities, regulators, and law enforcement agencies. Some of the reasons owing to such demand are that these are rapid, indestructible, portable, and easy to use by non-experts.
There are also other handheld devices like the X-ray and mid IR spectrometers [ 43 ]. Some of these devices developed by different firms are mentioned in the following table. Federal law requires all dealers except manufacturers and ADRs to pass pedigree requirements, but state requirements show several variations. A limited number of transactions are allowed without the pedigree requirement, as in Nevada: Wholesale distributors and repackagers must bring their systems to be compliant by July 1, , while pharmacies and pharmacy warehouses must by July 1, [ 21 ].
According to a French Official Journal dated March 16, , the French Health Products Safety Agency notified distributors mandating the following in their healthcare system by the 31st of December in [ 47 ]: According to the public notice issued by the Directorate General of Foreign Trade dated January 10 th , , exported pharmaceutical products should have track and trace capability using barcode technology as per GS1 global standards [ 49 ].
The stated requirements are: However, this system does not ensure the absence of counterfeits as effectively as serialization. Barcodes increase the risk of being caught if counterfeits are present, whereas serialization uniquely identifies every entity and ensures the absence of counterfeits. Serialization using barcodes as data carriers is a more secure strategy and is even more economical compared to the RFID system.
Counterfeit-resistant technologies must be rotated regularly as they can themselves be duplicated, often within 12—18 months. Neither pharmacists nor patients can be expected to be aware of the wide range of overt features if they are rotated on a regular basis. Overt and covert packaging technologies are rendered useless if a drug is repackaged [ 50 ]. Every stakeholder is crucial in combating counterfeiting, as counterfeit drug prevention is a collective job.
Healthcare professionals as well as patients should be vigilant about the medicines procured and their source. They should evaluate the response, educate others regarding inspection of the authenticity of the drug acquired, and report in the case of suspicion.
Business personnel must be educated about the implementation of good anti-counterfeit technology and make consumers aware of such strategies used. Regulatory authorities must conduct checking plans and devise necessary measures to ensure the absence of counterfeits, increasing the penalty of the pharmaceutical counterfeiting based on the risk imposed on public health [ 7 ].
Drug counterfeiting is an important problem addressed by several countries. This requires multiple measures to protect the supply chain. The implementation of anti-counterfeit technologies is an important strategy taken up by several drug manufacturers and regulatory authorities. The track and trace system and serialization are given importance and are widely used among all anti-counterfeit technologies in different countries.
Recent notification from the Indian government mandated the use of barcodes on all drug products manufactured and imported. Patented Anti-counterfeit Technologies [ 37 , 38 ]. Examples of portable devices [ 43 ]. This article is available from: National Center for Biotechnology Information , U. Journal List Sci Pharm v. Published online Oct 9. Author information Article notes Copyright and License information Disclaimer. S Nagar, Punjab, India. Received Feb 7; Accepted Oct 9. This article has been cited by other articles in PMC. Abstract Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide.
Introduction A medical product is counterfeit when there is a false representation in relation to its identity or source. Need for anti-counterfeit technologies Counterfeit drugs can lead to drug recalls and liability suits. Characteristics of Ideal Anti-counterfeit Technology An ideal anti-counterfeit technology should possess a high level of security non-clonable , higher product application and authentication speed, proven standards, be difficult to remove and reapply, easy to check, have automatic authentication, be useable by consumers, and must be legally compliant by the industries [ 11 ].
Overview of Current Anti-counterfeit Technologies Multiple anti-counterfeit technologies with distinct advantages and drawbacks exist today [ 13 , 14 ].