Counterfeit drugs pose a significant threat as they can harm patients and reduce pharmaceutical company profits. To combat this threat, a multi-level anti-counterfeiting strategy is needed that utilizes various technologies like RFID, ePedigrees, and security labeling. While no single solution is sufficient, a combination of approaches can better secure the drug supply chain, reduce counterfeits in the marketplace, and improve patient safety and brand protection.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
1. Counterfeit drugs are a major global problem that negatively impact public health and pharmaceutical companies. They range from lacking active ingredients to having incorrect dosages and can lead to treatment failure, increased antimicrobial resistance, and even death.
2. India accounts for a large portion of the global counterfeit drug trade due to its large pharmaceutical industry, lack of regulation, and high drug prices. Many counterfeit drugs originate in India and are distributed worldwide.
3. Strategies to reduce counterfeiting include strengthening drug regulation, increasing inspections, consumer awareness campaigns, implementing track-and-trace technologies like barcodes and RFID in supply chains, and harsher penalties for counterfeiters.
Counterfeit medicines are drugs produced with the intention to deceive that contain incorrect or insufficient active ingredients which can lead to therapeutic failure or drug resistance and sometimes death. Substandard medicines are genuine drugs that do not meet quality specifications due to manufacturing problems and may contain less or more active ingredients than stated. The most frequently counterfeited drugs are expensive medicines like hormones, antibiotics, and anticancer drugs. Globally, 10% of drugs are counterfeit, rising to 25% in developing countries and 50% in some places. Counterfeiting is encouraged by the profitability, weak laws, and large price differences between identical drugs. Actions to address the problems include strong legislation, authentication markings on packages, surveillance, and education.
The document provides information on counterfeit drugs, including definitions, global and Indian statistics, examples of counterfeited drugs, and potential solutions. Some key points:
- The WHO defines counterfeit drugs as deliberately mislabeled regarding identity and/or source, and they may contain incorrect ingredients, insufficient active ingredients, or no active ingredients.
- India accounts for 10% of global drug production but also has high rates of counterfeiting, estimated at 20% of drugs. Globally, counterfeiting costs the legitimate pharmaceutical industry $75 billion annually.
- Many popular drugs are frequently counterfeited, such as Viagra, Lipitor, and cancer treatments. Counterfeits are found to contain
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
The document discusses counterfeit medicines, which the WHO defines as deliberately mislabeled drugs regarding identity and/or source. Counterfeits can include both branded and generic drugs with incorrect ingredients, dosages, or packaging. Medicines are targeted due to lax regulations in some countries, price differences globally, and the complexity of distribution systems. Counterfeits pose health risks as they provide ineffective treatment and can spread drug-resistant diseases. Stronger enforcement is needed across governments, industries, and distribution networks to prioritize combating counterfeit drugs.
White paper stopping counterfeit pharmaceuticals 0309NEW Momentum
This white paper discusses the growing problem of counterfeit pharmaceuticals and proposes four ways for pharmaceutical companies to address it. It notes that 10% of global drug supply is counterfeit, with some countries over 50%, and counterfeit drug sales are growing much faster than the legitimate market. The paper advocates for counterfeit protection on packaging, RFID tracking in supply chains, security features on dosages, and advanced web monitoring to identify counterfeits. It argues the private sector must lead solutions to protect patients, brands, and industry profits from counterfeiting.
This document discusses counterfeit medicines and measures to combat them. It defines counterfeit medicines according to WHO as those deliberately mislabeled regarding identity and/or source. The most common types of counterfeits are those without active ingredients or with incorrect quantities. Counterfeiting is prevalent in developing countries and online pharmacies. It poses dangers like treatment failure, toxicity, and drug resistance. Detection methods include chemical kits, barcodes, and Raman spectroscopy. Measures to combat counterfeits involve legislation, regulation, international cooperation, and awareness campaigns. Pharmacists play a role in preventing counterfeits from entering the supply chain.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
1. Counterfeit drugs are a major global problem that negatively impact public health and pharmaceutical companies. They range from lacking active ingredients to having incorrect dosages and can lead to treatment failure, increased antimicrobial resistance, and even death.
2. India accounts for a large portion of the global counterfeit drug trade due to its large pharmaceutical industry, lack of regulation, and high drug prices. Many counterfeit drugs originate in India and are distributed worldwide.
3. Strategies to reduce counterfeiting include strengthening drug regulation, increasing inspections, consumer awareness campaigns, implementing track-and-trace technologies like barcodes and RFID in supply chains, and harsher penalties for counterfeiters.
Counterfeit medicines are drugs produced with the intention to deceive that contain incorrect or insufficient active ingredients which can lead to therapeutic failure or drug resistance and sometimes death. Substandard medicines are genuine drugs that do not meet quality specifications due to manufacturing problems and may contain less or more active ingredients than stated. The most frequently counterfeited drugs are expensive medicines like hormones, antibiotics, and anticancer drugs. Globally, 10% of drugs are counterfeit, rising to 25% in developing countries and 50% in some places. Counterfeiting is encouraged by the profitability, weak laws, and large price differences between identical drugs. Actions to address the problems include strong legislation, authentication markings on packages, surveillance, and education.
The document provides information on counterfeit drugs, including definitions, global and Indian statistics, examples of counterfeited drugs, and potential solutions. Some key points:
- The WHO defines counterfeit drugs as deliberately mislabeled regarding identity and/or source, and they may contain incorrect ingredients, insufficient active ingredients, or no active ingredients.
- India accounts for 10% of global drug production but also has high rates of counterfeiting, estimated at 20% of drugs. Globally, counterfeiting costs the legitimate pharmaceutical industry $75 billion annually.
- Many popular drugs are frequently counterfeited, such as Viagra, Lipitor, and cancer treatments. Counterfeits are found to contain
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
The document discusses counterfeit medicines, which the WHO defines as deliberately mislabeled drugs regarding identity and/or source. Counterfeits can include both branded and generic drugs with incorrect ingredients, dosages, or packaging. Medicines are targeted due to lax regulations in some countries, price differences globally, and the complexity of distribution systems. Counterfeits pose health risks as they provide ineffective treatment and can spread drug-resistant diseases. Stronger enforcement is needed across governments, industries, and distribution networks to prioritize combating counterfeit drugs.
White paper stopping counterfeit pharmaceuticals 0309NEW Momentum
This white paper discusses the growing problem of counterfeit pharmaceuticals and proposes four ways for pharmaceutical companies to address it. It notes that 10% of global drug supply is counterfeit, with some countries over 50%, and counterfeit drug sales are growing much faster than the legitimate market. The paper advocates for counterfeit protection on packaging, RFID tracking in supply chains, security features on dosages, and advanced web monitoring to identify counterfeits. It argues the private sector must lead solutions to protect patients, brands, and industry profits from counterfeiting.
This document discusses counterfeit medicines and measures to combat them. It defines counterfeit medicines according to WHO as those deliberately mislabeled regarding identity and/or source. The most common types of counterfeits are those without active ingredients or with incorrect quantities. Counterfeiting is prevalent in developing countries and online pharmacies. It poses dangers like treatment failure, toxicity, and drug resistance. Detection methods include chemical kits, barcodes, and Raman spectroscopy. Measures to combat counterfeits involve legislation, regulation, international cooperation, and awareness campaigns. Pharmacists play a role in preventing counterfeits from entering the supply chain.
Counterfeit drugs: what a doctor should knowMark Davison
Short lecture to medical students on risks, prevalence and detection of fake medicines and protection of patient safety. Essential training for new doctors and pharmacists.
This summary provides an overview of the key points from the document:
- The document discusses a work that is licensed under a Creative Commons license. It states that use of materials from the site constitutes acceptance of the license terms and conditions.
- Copyright is held by Johns Hopkins University and Thomas Layloff for the materials, and all rights are reserved. Materials are provided "as is" and no representations or warranties are provided. Users are responsible for ensuring accuracy.
- The document is a session on drug manufacture, industrial pharmacy considerations, quality assurance, and regulation. It covers topics like GMP, requirements for domestic manufacturing, brand vs generic drugs, and procedures to prevent counterfeiting.
The document discusses the issue of counterfeit prescription drugs, particularly those imported from other countries. It notes that while the FDA's drug distribution system in the US is considered the safest in the world, the number of counterfeit drug cases has risen in recent years. The FDA ordered drugs from a website claiming to offer cheaper generics from Canada, but testing showed the drugs actually came from China and were either too strong or weak, or contained dangerous impurities. Importing drugs from other countries is not safe and raises legal and health issues.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
This document summarizes a study on the impact of stronger patent protection on access to drugs in India. It notes that India's 1970 Patent Act allowed copying of patented drugs, keeping prices low. From 2005, pharmaceutical firms could obtain product patents, potentially increasing prices. The study uses data on anti-malarial and anti-retroviral drug prices from 1991-2004 to analyze how factors like competition, infrastructure, R&D costs, and government price controls influence prices, and the extent to which stronger patents may affect access. It aims to address limitations of previous studies by considering multiple interacting factors.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
The pharmaceutical industry invests heavily in research and development, with biopharmaceutical companies spending $65.2 billion annually on R&D. Developing a new drug takes an average of 10-15 years and costs $2.6 billion. Only about 20% of experimental drugs make it through clinical trials to receive FDA approval. After approval, many drugs fail to become commercial successes. However, post-approval research on existing drugs often leads to new uses that provide important medical advances. The industry and government play complementary roles in supporting medical research.
Orphan drugs have attractive attributes for development as they are potentially cheaper, faster, and less risky to develop compared to non-orphan drugs. They also have high sales potential in small distinct patient populations. Specifically, orphan drug development costs are about half that of non-orphans and their time to market is faster. They also have a higher regulatory approval success rate. This makes orphan drugs a growth opportunity, with their market forecast to reach 20% of prescription drug budgets by 2020 due to an 11.7% CAGR, higher than the 4.7% CAGR for non-orphans. Top orphan drugs are primarily in oncology and command very high prices, with the median orphan drug costing $66
1) The biotech drug market continued steady expansion in 2005, though no new blockbuster drugs were launched.
2) Certain biologic therapies saw over 50% growth, and biologics make up nearly half of drug candidates in development and one in ten FDA filings.
3) Cancer research still dominates biotech drug development areas, followed by AIDS and other infectious diseases, though drug delivery also receives significant attention.
The Ones to Watch, Oct. - Dec. 2009 -- Pharma Matters ReportThomson Reuters
This document summarizes the five most promising drugs that were launched or received approval, as well as the five most promising drugs entering each of the clinical trial phases (Phase III, Phase II, Phase I) between October and December 2009. Several of the drugs are treatments for rare diseases that have been granted orphan drug status, including treatments for hereditary angioedema, urea cycle disorders, and various forms of cancer. Many of the drugs are monoclonal antibodies, enzyme replacements, or other biologic therapies in development by large pharmaceutical companies for oncology and other therapeutic indications.
Illicit Trade in Counterfeit Medicine by Kristina M. Lybecker, The Colorado C...OECD Governance
Presentation made by Kristina M. Lybecker, The Colorado College at the 3rd meeting of the OECD Task Force on Charting Illicit Trade - OECD, Paris, 30-31 March 2015
For more information see http://www.oecd.org/gov/risk/charting-illicit-trade-third-task-force-meeting.htm
The document discusses the challenges facing the follow-on biologics (FOB) market in the United States. It states that entry into the FOB market will be more difficult than expected, as companies will face high costs of market entry, potential physician reluctance to switch patients to biosimilars, price competition from branded products, and challenges with patent litigation. However, the document predicts the FOB market will eventually emerge and flourish, though it may grow more slowly than the generic small molecule market and biosimilars are unlikely to capture as much market share as quickly. Success in the FOB market will depend on getting products to market first and having the right strategies to navigate these challenges.
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
False Advertising in the Drug and Food Industries JoshuaRiger
This document discusses the regulation of false advertising in the food and drug industries. It outlines that the FDA regulates prescription drug advertisements while the FTC oversees over-the-counter drug ads. Both agencies want to ensure ads are truthful and not misleading to consumers. Food and drug labels must include accurate ingredient and dosage information. Failure to do so or making unsupported health claims can result in products being deemed misbranded or legal action from the FTC and FDA.
Pfizer and Ranbaxy were sued for allegedly engaging in an anticompetitive scheme to delay the entry of generic Lipitor into the market. The plaintiffs claim that Pfizer and Ranbaxy agreed to delay generic Lipitor for 20 months, costing purchasers more than they would have paid for the generic version. As a result of the delayed entry, which was not until November 2011, the plaintiffs and others were forced to pay billions more for Lipitor. Both drug companies were previously sued for similar allegations of holding back the generic version in the US and then fixing its price.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
The document discusses generic medicines and their evolution. It notes that generic medicines provide significant economic advantages to consumers and the pharmaceutical industry by decreasing drug prices after brand name patents expire. Approximately 50% of prescriptions in many countries are now filled by lower cost generic drugs. The generic drug market in India, which supplies over 30% of the global generic market, is growing substantially and expected to reach $72 billion by 2020. While generic drugs must demonstrate bioequivalence to the brand name version, they provide significant cost savings over branded drugs for both consumers and healthcare systems.
This document provides an overview of research methodology for studying the Indian pharmaceutical market and the effect of healthcare products. The objectives are to understand the market contribution of healthcare products and evaluate consumers' and doctors' attitudes towards these products. Secondary research will gather data from company sources, while primary research will involve interviews with chemists, doctors, and consumers. The study aims to benefit researchers, the sponsoring organization, and colleagues by providing insights into opportunities in the domestic pharmaceutical market.
Counterfeit drugs: what a doctor should knowMark Davison
Short lecture to medical students on risks, prevalence and detection of fake medicines and protection of patient safety. Essential training for new doctors and pharmacists.
This summary provides an overview of the key points from the document:
- The document discusses a work that is licensed under a Creative Commons license. It states that use of materials from the site constitutes acceptance of the license terms and conditions.
- Copyright is held by Johns Hopkins University and Thomas Layloff for the materials, and all rights are reserved. Materials are provided "as is" and no representations or warranties are provided. Users are responsible for ensuring accuracy.
- The document is a session on drug manufacture, industrial pharmacy considerations, quality assurance, and regulation. It covers topics like GMP, requirements for domestic manufacturing, brand vs generic drugs, and procedures to prevent counterfeiting.
The document discusses the issue of counterfeit prescription drugs, particularly those imported from other countries. It notes that while the FDA's drug distribution system in the US is considered the safest in the world, the number of counterfeit drug cases has risen in recent years. The FDA ordered drugs from a website claiming to offer cheaper generics from Canada, but testing showed the drugs actually came from China and were either too strong or weak, or contained dangerous impurities. Importing drugs from other countries is not safe and raises legal and health issues.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
This document summarizes a study on the impact of stronger patent protection on access to drugs in India. It notes that India's 1970 Patent Act allowed copying of patented drugs, keeping prices low. From 2005, pharmaceutical firms could obtain product patents, potentially increasing prices. The study uses data on anti-malarial and anti-retroviral drug prices from 1991-2004 to analyze how factors like competition, infrastructure, R&D costs, and government price controls influence prices, and the extent to which stronger patents may affect access. It aims to address limitations of previous studies by considering multiple interacting factors.
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
The pharmaceutical industry invests heavily in research and development, with biopharmaceutical companies spending $65.2 billion annually on R&D. Developing a new drug takes an average of 10-15 years and costs $2.6 billion. Only about 20% of experimental drugs make it through clinical trials to receive FDA approval. After approval, many drugs fail to become commercial successes. However, post-approval research on existing drugs often leads to new uses that provide important medical advances. The industry and government play complementary roles in supporting medical research.
Orphan drugs have attractive attributes for development as they are potentially cheaper, faster, and less risky to develop compared to non-orphan drugs. They also have high sales potential in small distinct patient populations. Specifically, orphan drug development costs are about half that of non-orphans and their time to market is faster. They also have a higher regulatory approval success rate. This makes orphan drugs a growth opportunity, with their market forecast to reach 20% of prescription drug budgets by 2020 due to an 11.7% CAGR, higher than the 4.7% CAGR for non-orphans. Top orphan drugs are primarily in oncology and command very high prices, with the median orphan drug costing $66
1) The biotech drug market continued steady expansion in 2005, though no new blockbuster drugs were launched.
2) Certain biologic therapies saw over 50% growth, and biologics make up nearly half of drug candidates in development and one in ten FDA filings.
3) Cancer research still dominates biotech drug development areas, followed by AIDS and other infectious diseases, though drug delivery also receives significant attention.
The Ones to Watch, Oct. - Dec. 2009 -- Pharma Matters ReportThomson Reuters
This document summarizes the five most promising drugs that were launched or received approval, as well as the five most promising drugs entering each of the clinical trial phases (Phase III, Phase II, Phase I) between October and December 2009. Several of the drugs are treatments for rare diseases that have been granted orphan drug status, including treatments for hereditary angioedema, urea cycle disorders, and various forms of cancer. Many of the drugs are monoclonal antibodies, enzyme replacements, or other biologic therapies in development by large pharmaceutical companies for oncology and other therapeutic indications.
Illicit Trade in Counterfeit Medicine by Kristina M. Lybecker, The Colorado C...OECD Governance
Presentation made by Kristina M. Lybecker, The Colorado College at the 3rd meeting of the OECD Task Force on Charting Illicit Trade - OECD, Paris, 30-31 March 2015
For more information see http://www.oecd.org/gov/risk/charting-illicit-trade-third-task-force-meeting.htm
The document discusses the challenges facing the follow-on biologics (FOB) market in the United States. It states that entry into the FOB market will be more difficult than expected, as companies will face high costs of market entry, potential physician reluctance to switch patients to biosimilars, price competition from branded products, and challenges with patent litigation. However, the document predicts the FOB market will eventually emerge and flourish, though it may grow more slowly than the generic small molecule market and biosimilars are unlikely to capture as much market share as quickly. Success in the FOB market will depend on getting products to market first and having the right strategies to navigate these challenges.
Counterfeit drugs pose a major global problem and public health risk. According to the World Health Organization, over half of counterfeit drug cases found no active ingredients, while others contained incorrect or dangerous ingredients. Developing countries are especially impacted, with up to 60% of reported counterfeit drugs. Counterfeiting undermines healthcare systems and can have deadly consequences. The document warns that weak drug regulation and an unsecured supply chain allow for counterfeits to proliferate. It advocates purchasing from authorized drug distributors only to help strengthen oversight of the pharmaceutical supply system.
False Advertising in the Drug and Food Industries JoshuaRiger
This document discusses the regulation of false advertising in the food and drug industries. It outlines that the FDA regulates prescription drug advertisements while the FTC oversees over-the-counter drug ads. Both agencies want to ensure ads are truthful and not misleading to consumers. Food and drug labels must include accurate ingredient and dosage information. Failure to do so or making unsupported health claims can result in products being deemed misbranded or legal action from the FTC and FDA.
Pfizer and Ranbaxy were sued for allegedly engaging in an anticompetitive scheme to delay the entry of generic Lipitor into the market. The plaintiffs claim that Pfizer and Ranbaxy agreed to delay generic Lipitor for 20 months, costing purchasers more than they would have paid for the generic version. As a result of the delayed entry, which was not until November 2011, the plaintiffs and others were forced to pay billions more for Lipitor. Both drug companies were previously sued for similar allegations of holding back the generic version in the US and then fixing its price.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
The document discusses generic medicines and their evolution. It notes that generic medicines provide significant economic advantages to consumers and the pharmaceutical industry by decreasing drug prices after brand name patents expire. Approximately 50% of prescriptions in many countries are now filled by lower cost generic drugs. The generic drug market in India, which supplies over 30% of the global generic market, is growing substantially and expected to reach $72 billion by 2020. While generic drugs must demonstrate bioequivalence to the brand name version, they provide significant cost savings over branded drugs for both consumers and healthcare systems.
This document provides an overview of research methodology for studying the Indian pharmaceutical market and the effect of healthcare products. The objectives are to understand the market contribution of healthcare products and evaluate consumers' and doctors' attitudes towards these products. Secondary research will gather data from company sources, while primary research will involve interviews with chemists, doctors, and consumers. The study aims to benefit researchers, the sponsoring organization, and colleagues by providing insights into opportunities in the domestic pharmaceutical market.
The document discusses the Indian pharmaceutical industry and the market for generic drugs. It provides background on key policies that promoted the growth of the Indian generic drug industry, including the Patent Act of 1970. It outlines the strengths and weaknesses of the Indian pharmaceutical industry. It also discusses the significant role of the Indian pharmaceutical industry in supplying generic drugs globally, particularly to regulated markets like the US. The industry is expected to continue growing and shifting to focus more on R&D and manufacturing of value-added drugs.
Detection of Counterfeit Drugs and Other ProductsNancy Sperling
This document discusses the issue of counterfeit drugs and products. It provides statistics showing the vast scale of the counterfeit drug market globally and its health impacts. Specific drugs that have been counterfeited are listed. The document explores how counterfeits enter legitimate supply chains and the risks they pose to consumers. It outlines analytical methods used for detecting counterfeits and various anti-counterfeiting technologies and enforcement efforts. In addition to health concerns, it notes counterfeits violate pharmaceutical company patents and erode consumer trust in legitimate products.
Managers in the pharmaceutical industry face both opportunities and threats due to a dynamic environment. Demand for pharmaceuticals has grown steadily for decades due to demographics and successful new drugs can be highly profitable. However, developing new drugs takes 10-15 years and costs $800 million on average, with many failing. Additionally, incumbent firms face challenges such as upcoming patent expirations, potential price controls, and reduced prices negotiated by large health providers.
Is European market access becoming an incubator for rare disease development?...KateBenson18
FIECON's white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.
1) The FDA is implementing new regulations in December 2006 requiring pharmaceutical distributors to track drug pedigrees electronically from manufacturer to pharmacy.
2) RFID is proposed as a solution to help the pharmaceutical industry comply with these regulations in a cost effective way by leveraging existing EPCglobal standards and systems.
3) Training industry stakeholders on RFID technology through an online e-learning program can help ensure successful and fast implementation before the deadline.
The document discusses the dark and unethical practices of the pharmaceutical industry. It notes that corruption is endemic at every step of the pharmaceutical business according to the WHO. Unethical marketing practices are used to increase profits by raising customer demand. Doctors and pharmacists face conflicts of interest as their earnings depend on drug sales. Technical solutions have been proposed like reforming drug approval and increasing regulatory independence, but the industry opposes changes due to its political influence.
The document summarizes several important drug regulatory news and safety updates from regulatory authorities including Health Canada and the US FDA. It provides warnings and updates to healthcare professionals in Nepal about potential drug interactions and risks, including:
1) The risk of high anion gap metabolic acidosis with concomitant use of flucloxacillin and paracetamol.
2) The possible risk of hypothyroidism in infants given iodine-containing contrast agents.
3) The removal of a boxed warning about asthma deaths for medicines containing inhaled corticosteroids and long-acting beta agonists.
4) The rare risk of subacute cutaneous lupus erythematosus with proton
This document provides an overview of key trends in the generic pharmaceutical industry in South Africa, as reported by the National Association of Pharmaceutical Manufacturers. It discusses challenges facing generic medicine suppliers, including prescriber and consumer perceptions, intellectual property issues, regulatory delays, and pricing factors. It also summarizes the chairman's comments on recent generic market growth trends and provides details on guidelines proposed for biosimilar medicines.
This document summarizes a research article about counterfeit medicinal products and parallel trade. It discusses how counterfeiting is a major global issue, especially in developing countries, due to lack of regulation and availability of medicines. Counterfeit drugs often contain incorrect doses of active ingredients or wrong/no ingredients at all, posing serious health risks to patients. The document examines which drug categories are most commonly counterfeited and the consequences of consuming fake medicines in terms of public health impacts and economic effects.
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
This document discusses marketing strategies used by pharmaceutical companies. It begins by providing background on the pharmaceutical industry and market in India. It then discusses some of the challenges faced by pharmaceutical companies in their marketing processes. The rest of the document focuses on and compares two main marketing models - the super core model targeting chronic therapies using a pull system, and the core model targeting acute therapies using a push system. It provides details on how each model approaches marketing through medical representatives, customers, and supply chain management.
Global orphan drug market future outlook 2020Rajesh Sarma
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Global orphan drug market future outlook 2020KuicK Research
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
This document discusses trends in conducting clinical trials in emerging markets. It finds that 59% of surveyed companies have already begun trials in emerging markets, with 41% planning to within 2 years. Asia is the main target region. Conducting trials in emerging markets allows companies to potentially lower costs and access new patient populations. However, it also presents challenges around partnerships, supply chains, and ensuring data quality and regulatory compliance. The document examines differences between pharmaceutical, biotech, and life sciences companies in their approaches to emerging market trials.
Consumers love to save money and companies love to make it. So why do all pharmaceutical manufacturers not supply generics to the animal health industry?
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
Similar to Multiple Strategies and Technologies to Combat Counterfeit Drugs (20)
Multiple Strategies and Technologies to Combat Counterfeit Drugs
1. MULTIPLE STRATEGIES AND TECHNOLOGIES TO COMBAT
COUNTERFEIT DRUGS
Authors: Sanjay Modi and Sanjeev Wadhwa
An anti-counterfeiting The U.S. Food and Drug Administration (FDA) has seen a rise of
strategy helps to counterfeit drug cases since 2000 when there were only six. In 2006,
effectively detect the number of cases rose dramatically to 54 (Bernstein, 2007). The
counterfeit products, market for counterfeit drug is approximately $40 billion (WHO, 2006).
increase audit compliance, According to the Center for Medicines in the Public Interest, counterfeit
and enhance supply chain drug sales globally will reach $75 billion by 2010. This represents an
management capabilities. increase of 90 percent from 2005 (WHO, 2006) and will represent 14
This strategy can identify percent of the total drug market (Pitts, 2005). Furthermore, it is
the multiple best-fit estimated that 10 percent of the global medicines are counterfeit.
solutions for meeting a Approximately 60 percent of counterfeit drug cases occur in less-
company’s requirements developed countries in which 25 percent of their drug supply is
via Radio Frequency counterfeit (Morris, 2006). The largest producers of these drugs are
Identification Devices Southeast Asia, Nigeria, Russia, Mexico, Brazil, and Latin America (U.S.
(RFID), ePedigrees, label Immigration and Customs Enforcement, 2006).
security, dosage unit level
Counterfeit drugs are an increasing threat in the marketplace. These sub-
security, nanotechnology,
standard drugs affect human lives as the quality and/or type of drug is
and other capable
harmful to the patient. These products may not cure the targeted
solutions to combat
diseases and could possibly even kill patients. Also, they affect the
counterfeiting of drug
profits of the companies which manufacture the drugs. Pharmaceutical
products. One item alone
companies invest large amounts of resources to create drugs. They
will not protect the
spend up to 12 years and $1.2 billion on clinical development for drugs
companies from counter-
(Archarya, 2006). However, only 30 percent of drugs which are
feit drugs, but one with a
approved and marketed produce revenues that match or exceed initial
multi-level approach will
costs (DiMasi, 2002). Therefore, any counterfeit drugs sold as legitimate
lead to safeguarding the
drugs reduce the companies’ revenues and lead to lower profits.
supply chain, prevent
erosion of the brand There are five different types of counterfeit mechanisms in which drugs
image, and increase are manufactured or distributed without proper regulatory approval and
revenues. This will result do not meet the determined standards of safety, quality, and efficacy
in decreasing the number (WHO, 2007):
of counterfeit products in
• No active ingredient (43 percent)
the marketplace and
improving patient safety • Low levels of active ingredient (21 percent)
and enhancing product • Poor quality drugs (24 percent)
authenticity and • Wrong ingredients (2 percent)
identification. • Wrong packaging or source (7 percent)
Counterfeiting can apply to both branded and generic products. In
wealthy developed countries, expensive drugs such as hormones,
steroids, and antihistamines are frequently counterfeited due to lifestyle
preferences. While in developing countries, those used to treat life-
threatening conditions such as malaria, TB, and HIV/AIDS are chosen to
be imitated due to their relatively high costs. As this trend continues,
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 1
2. other drugs such as anti-cancer and anti-virals might Therefore, counterfeit drugs are passed as real drugs
be next on the list due to the high costs of these due to the counterfeiters’ abilities to reproduce items.
drugs and the lucrative returns by the counterfeiters.
Sources of Counterfeit Medicines C o u n terfeit A u th en tic
Counterfeit drugs can be diverted and sold from 1 1. Logo background
various channels within the drug distribution system 2 LO G O LOG O color
due to its complexity. There is no enforced 2. Logo font not bolded
3. Colored protective
government mandate to track the drugs efficiently 3 Logo Logo packaging on rim
on top of bottle
within the system which allows for openings for 4. Border type
counterfeiters throughout the system. Drugs can be 5. Font size
4 6. Border size
diverted from their original purpose and sold outside D ru g D ru g 7. Pill size and shape
the regulated distributed channels. For example, free 5 N am e 8. Name of pill varies
N am e
samples to doctors may be sold illegally within the 50m g
6 50m g Can you tell the difference
if one of the above items
system. Patients may, in turn, sell their prescription were changed?
drugs for a profit. Also, drugs sold for lower prices in
various countries can be sold to other markets where 7
D P5
the price is higher. These drugs are not regulated 8
through safeguards as they are sold outside the
normal distribution channels Figure 1: Difference between Counterfeit and
Authentic Drugs
The 1988 Prescription Drug Marketing Act (PDMA)
introduced a need for paper drug pedigree to track As a result of illegal medical drugs within the system,
the drug from manufacturer to end user. However, it the companies that manufacture and sell the
has yet to be fully implemented throughout the authentic products incur large losses of revenue. This
industry and supply chain due to the high record- decreases sales and profit margins due to other
keeping effort needed to maintain this type of unauthenticated “substitute” products that people
system. Incomplete paper pedigrees lead to are buying in place of the authenticated drug
increasing the risk of counterfeit drugs in the product. Large inventory losses and write-offs are
marketplace as the ingredients or products are not placed on the balance sheets due to routing leakages
tracked within the supply chain. On the other hand, and medicines which were not purchased legally. As
complete paper pedigrees help validate the noted earlier, these drugs threaten patient safety
authenticity of the drug but counterfeiters are finding leading to possible deaths. There are audit and
ways around this paper-based process. For example, regulatory compliance issues with counterfeit drugs
illegitimate secondary wholesalers can prepare fake as they do not follow the regulated channels.
paper pedigree documents which pharmacies detect Furthermore, the supply chain for the drugs is
as valid. An increasing trend is to use tools and complicated due to higher inventory carryover
processes to copy drug labels and packages. This leading to increased costs. The supply chain issues
makes it difficult to identify the real drug from the push for an efficient and reliable tracking mechanism
fake copy due to the striking similarities between the which has yet to be mandated by the industry or
two. Repackaging is another way to bring expired or regulators due to high initial costs and lack of
compromised drugs into the distribution system and industry standards.
mix them with genuine drugs. Finally, the lack of
tamper-evident packaging allows the original Anti-Counterfeit Strategies
packaging to be reused for unregulated drugs An anti-counterfeiting strategy helps to effectively
(HHS, 2004). detect counterfeit products, increase audit
compliance, and enhance supply chain management
The differences between counterfeit and authentic
capabilities. This strategy can identify the multiple
drugs can be difficult to detect unless one looks
best-fit solutions for meeting a company’s
closely at the bottle or packaging. These can be
requirements via Radio Frequency Identification
minor changes in the product container, label, or the
Devices (RFID), ePedigrees, label security, dosage
individual pill that can be hard to visually detect by
unit level security, nanotechnology, and other capable
the human eye. For example, a change in the type of
solutions to combat counterfeiting of drug products.
font, border type, or logo color is difficult to detect
One item alone will not protect the companies from
unless someone knows how they are packaged by the
counterfeit drugs, but one with a multi-level approach
manufacturer (Palmer, 2004; Genentech, 2001).
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 2
3. will lead to safeguarding the supply chain, prevent training for the end-users. A study by A.T. Kearney
erosion of the brand image, and increase revenues. believes implementation of a RFID system for a
This will result in decreasing the number of manufacturer with $10 billion in prescription sales will
counterfeit products in the marketplace and receive annual benefits of $20 – $55 million with the
improving patient safety and enhancing product system excluding initial and recurring costs. A large
authenticity and identification. It also meets the distributor with $40 billion in prescription product
necessary increased audit compliance by reducing sales will have an annual benefit of $12 – $24 million
the supply chain issues such as time to account and (Paddison, 2005).
inventory tracking. Therefore, this leads to an
In 2005, Pfizer announced it would use RFID tags on
increased bottom-line by effectively locating its
its Viagra® bottles which are sold in the United States.
products within the supply chain from manufacturer
GlaxoSmithKline took the initiative by planning to
to patients. This enables the drug manufacturer to
implement RFID tags on one of its anti-HIV drugs
capture higher revenues for legitimate drugs in the
within the next 18 months. Furthermore, Purdue
marketplace.
Pharma utilized RFID tags on Oxycotin® bottles to
RFID better track and authenticate the medications (FDA,
New trends in the industry are creating unique 2004). RFID tags can be embedded into the label of
opportunities within the anti-counterfeiting market. the medicine bottle or within the blister pack to
The FDA has also recommended that pharmaceutical
companies start using RFID as a means of better
tracking drugs. These are radio transmitters that can RFID
be attached to drug packages, medicine bottles, or XYZ
Pharma
RFID
active ingredient containers and scanned to emit an D ru g
RFID N am e
electronic product code. Individual packages of drugs 50m g
XYZ
or their respective ingredients can be monitored Pharma
throughout the supply chain from manufacturers to
distributors and wholesalers to pharmacies (Wyatt, A. Cartons of B. RFID Tag C. Blister Pack
Drugs Medicine Bottle
2006). As a result of enhanced inventory
management practices, RFID can decrease revenue
losses as a result of stock-outs and drug expirations
and create cost savings of $2 billion worldwide
(Paddison, 2005).
One major obstacle for RFID tags is the costs
associated with the system. As RFID tags become
more of a commodity, the prices for tags and readers
will be significantly lower and lead to more cost
1 2 3
savings. Each passive tag costs $0.25 – $1.00 while Scanner Computer Server
the each reader costs $500 – $3000. Furthermore,
there is the need for other resources such as Figure 3: RFID Tags Embedded Within Cartons of Drugs,
computers, networks, databases, and additional Medicine Bottle Labels or Blister Packs
Benefits and Costs (M = Millions) • Large Manufacturer
Benefits Costs — $10 billion in
Type Total Annual Ongoing Total Costs
One-time Annual Benefits Intangible Benefits One-time prescription
Initially Long-term
product sales
Large Not $20 – $55 $20 – $55 1. Protect Overall $15 – $20 $20 – $40 $8 – $16 $35 – $60 $23 – $36
Manufacturer significant Supply Chain • Large Distributor —
$ 10 bilion in 2. Prevent Stolen
prescription and Lost Products $40 billion in
product sales
prescription
Large $2 – $4 $10 – $20 $12 – $24 3. Decrease Recovery $9 – $20 $3 – $4 $3 – $4 $12 – $24 $12 – $24
Distributor
product sales
Costs of Lost or
$ 40 billion in Recalled Products Source: Paddison, 2005
prescription 4. Protect Brand
product sales Loyalty
Figure 2: Cost and Benefits for RFID Implementations
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 3
4. prevent easy removal. This is very similar to airline This will provide information on the “chain of
initiatives to utilize RFID tags rather than traditional custody” of the drug and decrease counterfeit drugs
barcodes to track the baggage location in real-time. in the supply chain. As the drug flows through the
The tags have a read rate of 99 percent, whereas bar supply chain from manufacturer to wholesaler(s) to
codes have a read rate of 85-90 percent. This higher pharmacy, each step is tracked via an Internet portal.
read rate leads to less manual sorting due to In the ePedrigree system, the medical product’s
unreadable bar codes. This also decreases the time information is verified and documented during each
and costs in getting the bags to the customers. The step within a secure environment. Therefore, a
current cost for bag retrieval is estimated to be $2.5 product’s path is followed in real-time via the portal
billion a year by The International Air Transport to ensure it is coming into the system from a valid
Association (Demerjian, 2005). source. A new data management infrastructure to
store and share the data has to be implemented
ePedigrees
within the company. A few vendors are already
Another development is the focus on ePedigrees to
providing services for the new system in order to
create a more efficient supply chain in a secure
easily transition into this environment.
environment. The PDMA states that pedigrees are
required for all non-Authorized Distributor of Record The ePedigree shows detailed real-time information
wholesale distributions (SupplyScape, 2006). In regarding the product and its distribution within the
2006, ePedigrees were implemented in only 200 supply chain. It provides general product information
along with a tracking number for easier identification.
As it travels from one location to another, it will
ePedigree System provide the transaction details including names,
addresses, and drug license numbers. It will also have
Tracking Number the receiving person’s name and electronic signature.
Date In addition, it will include details such as the
production number and expiration date so it can
Manufacturer Drug Information easily be traced back in the future for recalls or
Special Handling Information
quality checks (Bernstein, 2007).
Wholesaler/
Manufacturer:
Pharmacy Overt Strategies
Name Name Pharmaceutical companies are experimenting with
Address Address overt strategies such as optically variable devices
Phone Phone
(OVDs) that can help track/authenticate drugs. Some
Email Email
Wholesaler companies are testing holograms, color-shifting inks
License No. License No.
and watermarks that can help them authenticate
Electronic Signature/ID medicine bottles and packages. Similar techniques
Name
Date and Time
Production Number
Expiration Date
Pharmacy
Figure 4: ePedigree System Tracks Real-Time Drug
Information from Manufacturer to Pharmacy
million medicine bottles and blister packs. In
comparison, the number of prescriptions dispensed in
2006 was 3.7 billion (Lamb, 2007). As drug D ru g
Dr
shipments arrive within the various elements of the N am e u
Na g Logo
supply chain, ePedigrees are matched and signed to 50m g 50 m e
m
Lo g
confirm and validate the authenticity of the drugs. Logo go
Software programs show the detailed information of
the validated drugs within the supply chain and their Logo
specific location at various time periods. ePedigree
will be utilized within all steps of the supply chain Figure 5: Color Shifting Logo — Changing the Viewing
from manufacturer to retailer and customer. Angle Shifts the Color
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 4
5. are currently utilized in safeguarding the U.S. the packaging. For the highest level of security, the
currency. The currency utilizes multiple safeguards markers can be added to the individual pills in order
which makes it difficult, time-intensive, and costly for to identify if the drug is counterfeit. The markers are
counterfeiters. It utilizes a dual color-shifting ink, odorless, tasteless, and approved for human
watermark, security thread within the paper, and new consumption. A quick test kit, similar to a pregnancy
symbols on the bill. In 2004, the pharmaceutical test, can be performed in the field to determine the
companies started using color-shifting ink that authenticity. The pill is put into a special receptor-
changed color depending on the viewing angle so binding liquid, and a test strip is placed into the
counterfeits can be easily recognized by members liquid. If the specified marker is in the pill, the strip
downstream within the supply (Palmer, 2004). Others turns a specific color (Weinberg, 2007). Also, Kodak’s
are experimenting with using inks or dyes and some Traceless® technology incorporates an odorless and
are already using tamper-resistant packaging tape on colorless powder within the medicine packaging label
some of their products. Also, there is a change to or within the drug ingredients. The package is read in
raised printing in which letters are raised above the real-time with a patented handheld reader to
paper for easy inspection and detection for authenticate the drugs. For medicine packaging
counterfeits. labels, this method works with conventional printing
methods and can be utilized during the
Covert Strategies
manufacturing process (Kodak, 2007).
Companies are also shifting to covert strategies
which utilize special devices to authenticate the Benefits
drugs. Authentix utilizes a new method incorporating Pharmaceutical companies are more concerned about
nanotechnology markers (50 nM to 5000 nM in size) brand image and reputation these days than ever
which are mixed into the drug packaging and before. This is one of the key reasons to protect the
individual pills. They can be specifically added to the supply chain by utilizing the latest technologies.
inks, labels, and pill ingredients for easy detection. Counterfeit drugs can lead to drug recall and liability
These markers have spectral properties that “light up” suits which can cost the company millions and billions
when a light with a specific wavelength is placed on of dollars. Fen-Phen was recalled in 1997 and led to
50,000 liability lawsuits. The total costs for the recall
A. Markers Emit Light at Specific Wavelength
and lawsuits were estimated at $14 billion (Gilchrist,
2005). In addition, brand loyalty is compromised as
consumers perceive additional risk when using a
company’s products. It might take several months or
years for a product to regain its market share
D ru g
depending on the severity of the initial damage. This
N am e will result in lost sales and revenue along with the
50m g
high costs of marketing and public relations to bring
the drug back to the market (Paddison, 2005).
An anti-counterfeiting strategy can better analyze
Nanotechnology Specific Wavelength how these methods benefit the client most effectively
Markers Light depending on business needs, requirements, desired
B. Receptor Binding Test level of security, and geographic location. However,
for this strategy to work properly, a multi-step
Pill with approach has to be implemented because an
Marker 3 Authentic individual strategy alone has not worked in the past.
1 2 A multi-level strategy uses complementing
technologies that can provide the most protection for
a company’s brand and the highest level of security.
Counterfeit This will also result in additional costs as the
technologies become more sophisticated and the
Add Pill to Add Test
Receptor Strip quantity of products becomes marked or tagged. A
Binding Liquid basic foundation for protecting the Pharma Value
Chain focuses on tracking methods such as RFID and
Figure 6: Nanotechnology Markers Emit Light at Specific ePedigrees. The next step is to protect the medicine
Wavelengths and Bind to Specific Receptor Binding Liquid
bottles and blister packs with overt technologies by
(Weinberg, 2007)
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 5
6. Technologies Increased Layers of
Protection
3 Individual Pills
Covert
Pill
• Nano-
Technology
• Ink Markers +
Increasing Costs
Patented Reader
Medicine Bottles
3 Blister Packs
• Color Shift Ink
• Hologram
• Watermarks
3 Boxes RFID
Overt and
• RFID and ePedigree XYZ
Pharma
Pallets
Figure 7: Pharma Value Chain — Shifting Strategies and Technologies from
Overt to Covert Results in Increased level of Security at Higher Costs
increasing safeguards such as raised fonts, color- All of these items will lead to better-guarded supply
shifting inks and logos, holograms, and watermarks chain and costs savings. This will result in decreasing
so they can’t be reproduced by other sources. The the number of counterfeit products in the
final step utilizes covert technologies to protect the marketplace, improving patient safety, and enhancing
individual pills, medicine bottles, and blister packs by product authenticity. It also meets the necessary
incorporating nanotechnology markers and patented increased audit and regulatory compliance by
ink markers and readers for authentication. By using reducing the supply chain issues. Therefore, this
multiple safeguards into a specific product, it makes complementing strategy based on client’s needs
it expensive and time-consuming for the leads to an increased bottom-line by effectively
counterfeiters. Furthermore, higher risk geographic locating its products within the supply chain from
areas for counterfeit drugs require enhanced security manufacturer to patient and reducing leakage during
levels and increased layers of protection in order to the routing process. This enables the drug
protect the Pharma Value Chain. manufacturer to capture higher revenues for
legitimate drugs in the marketplace and protecting
the brand reputation.
Increased Layers of
Technologies
Protection
Nano-
Technology
Pill
Ink Markers+
Reader
Protect Supply Maintain Brand
Increased Layers
Color Shift Ink Chain Reputation
of Protection
Holograms
Watermarks
+
Increase Revenue Enhance Patient
RFID
RFID+ and Profits and Drug Safety
XYZ
Pharma
ePedigrees
Figure 8: Implementation of Multiple Strategies for Protecting the Supply
Chain, Maintaining Brand Reputation, Increasing Revenue and Profits, and
Enhancing Patient and Drug Safety
6
7. References McCarthy, Joe. 2006. “The Practicalities, Perils, and
Acharya, Satish. 2006. “The Productivity Tiger- Time and Promise of RFID.” http://interrelativity.com/rfid/RFID-
Cost Benefits of Clinical Drug Development in India.” Dorkbot-2006-03-01-final.pdf
Pharmalicensing. Morris, Julian and Steven Philips. 2006. “Counterfeit
http://pharmalicensing.com/features/disp/1153412098_4 Medicines in Less Developed Countries.”
4bfac02291f1 www.fightingdiseases.org/pdf/IPN_Counterfeits.pdf
Bernstein, Illasa. 2007. “FDA’s Counterfeit Drug Paddison, Chris. 2005. A.T. Kearney “Executive Agenda -
Initiative.” Busting the Myths of Pharma RFID.”
http://www.unitdose.org/Bernstein.FDA.ppt#499,11,E-
Pedigree http://www.atkearney.com/shared_res/pdf/Busting_the_
Myths_of_Pharma_RFID.pdf
Credit Union National Association. 2007. “New Money’s
Coming.” http://googolplex.cuna.org/12433/privacy.html Palmer, Gary. 2004. “For Pharmacists: Description and
Identification of Counterfeit Drugs.”
Dahold, Shabbir. 2007. “Safeguarding the drug supply http://www.pfizer.com/pfizer/subsites/counterfeit_impor
chain with ePedigrees.” tation/mn_pharmacist_viagra.jsp
http://www.bizjournals.com/masshightech/stories/2007/
05/21/focus2.html Pitts, Peter. 2005. “21st Century Health Care Terrorism:
The Perils of International Drug Counterfeiting.”
DiMasi, J. Et al. 2002. “Returns on Research and www.pacificresearch.org/pub/sab/health/2005/21st_Cen
Development for 1990s New Drug Introduction.” tury_Counterfeiting_Report.pdf
Pharmacoeconomics 20: suppl.3, 11-29.
Roche. 2007. “Getting Prescription Tamiflu: Counterfeit
Demerjian, Dave. 2006. “Never Lose Luggage Again.” Information."
http://www.wired.com/science/discoveries/news/2006/11 http://www.tamiflu.com/getting/counterfeit.aspx
/72181
Shepherd, Marv. 2004. “Counterfeit Drugs and the
FDA. 2005. “Radiofrequency Identification Technology: Pharmacist’s Responsibility.”
Protecting the Drug Supply.” www.thecesolution.com/ce/lessons/AZ_Counterfeit_Dru
http://www.fda.gov/fdac/features/2005/205_rfid.html gs_120104/images/AZ%20Counterfeit.pdf
FDA. 2004. “FDA Announces New Initiative to Protect SupplyScape. 2006. “SupplyScape E-Pedigree.”
the U.S. Drug Supply Through the Use of http://www.supplyscape.com/documents/SupplyScape_
Radiofrequency Identification EPedigreeDatasheet.pdf
Technology”http://www.fda.gov/bbs/topics/news/2004/
NEW01133.html U.S. Immigration and Customs Enforcement. 2006. “ICE
Efforts to Combat Counterfeit Pharmaceuticals.”
Genentech. 2001. “Product Update- Nutorpin AQ.” http://www.ice.gov/pi/news/factsheets/counterfeit_phar
http://www.gene.com/gene/products/information/oppor ms.htm
tunistic/nutropin-aq/update.jsp
Weinberg, Cari. 2007. “Nanotechnology Fingerprints Can
Gilchrist, Sue and Macpherson, Helen. 2005. “Update on Certify Authenticity.”
Recent Development in the Pharmaceutical Industry.” http://www.aip.org/dbis/stories/2007/17021.html
http://www.freehills.com.au/publications/publications_52
20.asp WHO (World Health Organization). 2007. “Frequently
Asked Questions- What are the Different Types of
HHS Task Force On Drug Importation. 2004. “Report on Counterfeit Drug Reported.”
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www.hhs.gov/importtaskforce/Report1220.pdf http://www.who.int/medicines/services/counterfeit/faqs/
15/en/index.html
Kelley, Brenda. 2004. “Securing the Drug Supply from
WHO (World Health Organization). 2006. “Fact Sheet
Counterfeiting Protects Brand Profits.”
No. 275-Counterfeit Medicines.”
www.supplyscape.com/.../Securing_Drug_Supply_from_
www.who.int/mediacentre/factsheets/fs275/en/
Counterfeiting_Protects_Brand_Profits_PMPS_Winter04.
pdf Yankus, Wyatt. 2006. “Counterfeit Drugs: Coming to a
Kodak. 2007. “Kodak Security Solutions Overview- Pharmacy Near You.”
Traceless®.” www.fip.org/files/fip/counterfeit/counterfeits0608-
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Lamb, Ed. 2007. “Top 200 Prescriptions of 2006.”
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4629
7
8. About CSC’s Life Sciences R&D Solutions Enterprise Technology Integration (ETI) — Our ETI
Our solutions span the entire range of drug Practice focuses on business systems strategy — we
development, from basic research at the cellular and align the business system strategy to Business and
molecular levels to human clinical trials of potential organizational strategies to ensure that technology is
medicines that prevent and cure disease. CSC’s Life not implemented for the sake of technology; rather, it
Sciences R&D solutions encompass: serves the business strategy set for R&D. Our
solutions focus on:
Strategy and Process Innovation (SPI) — Our SPI
Practice links business and organizational strategies • Enterprise Content Management — We provide
for R&D to deliver process innovation that solutions that help collaborate, control, and
dramatically increases throughput in clinical comply to 21 CFR Part 11 and global regulatory
development. Our proven solutions in this space bodies. Our expertise includes EDMS strategy,
include: migration, optimization, eBLA, eCTD, SPL, and
PIM. Our thought leadership in this space and our
• Adaptive Clinical Trials — We provide consulting
14 years of expertise in this arena help our clients
and industry expertise to reduce dead time
achieve superior results.
between phases. We effectively leverage
modeling and simulation to reduce number of • Clinical Research Data Management — For
patients in trials and help conduct in-silico trials, structured data, our team provides drug
where appropriate — resulting in cost take-out development data management solutions that
and shortened development cycles. are ICH, HL7, and CDISC compliant. These
systems provide a better way to manage data
• Phase I Outsourcing — Through our division,
from labs, CRO’s, and imaging firms and enable
Dynport Vaccine Corp. (DVC), we provide clients
our clients to achieve significant efficiency and
the ability to outsource entire Phase I studies. We
productivity improvements for the R&D
provide the program management, quantitative
organization.
measures to reduce time and costs, and proven
process that enables clients to conduct more
trials effectively. We currently manage 11 such For more information, visit www.csc.com/lifesciences.
trials.
CSC
• In-Licensing — We implement strategies and Life Sciences Practice
cutting-edge solutions to help pharmaceuticals 1160 West Swedesford Road, Suite 200
and biotechs take full advantage of in-licensing Berwyn, Pennsylvania 19312
to augment their pipelines. Our structured Unites States
solutions ensure that no licensing opportunity is
left unnoticed, and potential blockbuster
opportunities are not given away to competition.
• Bioinformatics Partnership — With the rise of
commercial genomics, companies need to
differentiate themselves from competition by
efficiently managing biostatistics analytics and
bioinformatics. CSC’s Life Sciences Practice
serves as a strategic services partner to the client
and provides standards driven bioinformatics
solutions both through our U.S. and Indian
operations and our strategic alliances with key
partners.
• Anti-counterfeiting Solutions — We leverage our
expertise in defense, consumer products, and
supply chain to deliver novel solutions for solving
the expensive and ever-increasing drug
counterfeiting issues. Our strategy and solutions
go beyond the traditional RFID based solutions
and provide quantifiable ROI.
8
9. About the Authors
Sanjay Modi
CSC Life Sciences
+1.973.243.0023
smodi@csc.com
Sanjay Modi works in CSC Life Sciences R&D
Solutions and is based in New York City. He holds a
MBA from The University of Maryland and a
Bachelor’s of Arts degree in Biology from The
University of Delaware.
Sanjeev Wadhwa
CSC Life Sciences
+1.973.243.0023
swadhwa@csc.com
Sanjeev Wadhwa is a partner and senior strategy
expert within CSC Life Sciences R&D Solutions.
9