Technological Roles in Combating Drug Diversion and Counterfeiting

2006 ◽  
Vol 19 (3) ◽  
pp. 146-152 ◽  
Author(s):  
Lucia Deus
Keyword(s):  
Supply Chain ◽  
Pharmaceutical Products ◽  
Business Value ◽  
Sildenafil Citrate ◽  
Pharmaceutical Companies ◽  
Counterfeit Drugs ◽  
Drug Diversion ◽  
The Us ◽  
Life Threatening ◽  
Customer Trust

Reports of life-threatening consequences of counterfeit drugs appear in the US media more and more frequently. Technological protections are seen by many as the best way to keep illegitimate drugs off pharmacy shelves. The supply chain for pharmaceutical products is already extensively developed with technology to improve efficiency; building on those systems to protect patients leads to enhanced customer trust and delivers business value on several other levels. Pharmaceutical companies such as Pfizer Inc have taken steps to stop counterfeit drugs from reaching patients. Pharmacies can now determine whether individual units of its Viagra (sildenafil citrate) product are authentic using an Internet-based service. As electronic pedigree laws go into effect in a number of states, pharmaceutical distributors such as H. D. Smith are using the pedigrees to stop drugs that are from an unknown source or a source that is not trusted.

scholarly journals Blockchain technology in the pharmaceutical supply chain: researching a business model based on Hyperledger Fabric

2019 ◽  
pp. 134-140
Author(s):  
S R Bryatov ◽  
A A Borodinov
Keyword(s):  
Supply Chain ◽  
Control System ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Counterfeit Drugs ◽  
Development Environment ◽  
Pharmaceutical Supply Chain ◽  
Russian Market ◽  
Medical Products ◽  
Blockchain Technology

Pharmaceutical companies that manufacture, ship and supply products face difficulties in tracking their products, allowing counterfeiters to inject counterfeit drugs into the system. This situation is observed, in particular, in the Russian market of turnover of pharmaceutical products, although the problem has long been global. The ability of blockchain systems to pinpoint the origin of data makes them particularly suitable for pharmaceutical supply chain applications. The data stored in the blockchain distributed register on the identification of drugs produced by the plant, as well as records of their movements throughout the supply chain, can accurately determine the authenticity of pharmaceutical products lying on the shelves of pharmacies. The development and implementation of such a system can be a big step towards winning the exhausting fight against the easy availability of counterfeit drugs and medical products. In the first part of this work, the main characteristics and features of the functioning of blockchain systems will be studied. In the second and final part, the designed concept of the pharmaceutical turnover control system based on the blockchain technology Hyperledger Fabric using the Hyperledger Composer development environment will be investigated.

Prescription Drug Wholesalers: Drug Distribution and the Inspection Process (A Florida Perspective)

2006 ◽  
Vol 19 (4) ◽  
pp. 196-214 ◽  
Author(s):  
David L. Laven
Keyword(s):  
Supply Chain ◽  
Drug Distribution ◽  
Drug Market ◽  
Regulatory Oversight ◽  
Drug Products ◽  
Enforcement Action ◽  
Drug Diversion ◽  
Similar Drug ◽  
The Us ◽  
Inspection Process

Counterfeit and diverted drugs are a growing problem not only in the US drug distribution supply chain but also in similar drug distribution supply chains the world over. These systems are being infiltrated by a growing trend in the illegal trade of pharmaceuticals, the result of activities of unscrupulous drug wholesalers, rogue Internet sites, foreign pharmacies, and organized criminal elements, all of which are motivated by huge profits. Efforts must be taken and new paradigms implemented on many fronts that will ultimately lead to maintaining the integrity of drug products and their packaging, securing the movement and safety of drug products as they travel through the US drug distribution supply chain. In addition, enhancing regulatory oversight and enforcement, increasing penalties for counterfeiters and drug diverters, advocating and pursuing heightened vigilance and awareness of counterfeit and diverted drugs, and increasing international collaboration are avenues that will aid in combating drug diversion and counterfeiting. This article will address several topics pertaining to drug wholesale distribution practices and how avenues for counterfeit and diverted drugs can permeate this process, notably through the secondary or shadow or gray drug market. Discussion will also highlight the emergence of Florida's drug pedigree laws and what were the goals to be obtained through enhanced legislative and enforcement action since 2003, coupled with the current state of these pedigree laws today as a result of action emanating from the 2006 Florida legislature (notably House bills HB371 and HB1540). Trends and developments in these major areas will be reviewed, with some analysis rendered noting strengths and areas of remaining weakness that require additional attention in the ongoing battle to stem the tide of drug diversion and counterfeiting, both nationally and within the state of Florida.

scholarly journals The NTD Supply Chain Forum—Strengthening the backbone of NTD programs

2020 ◽  
Vol 14 (11) ◽  
pp. e0008818
Author(s):  
Ashley A. Souza ◽  
Cassandra Holloway ◽  
Tijana Williams
Keyword(s):  
Supply Chain ◽  
United States Of America ◽  
Large Scale ◽  
Neglected Tropical Diseases ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Scale Production ◽  
Preventive Chemotherapy ◽  
The People ◽  
Large Scale Production

Global programs targeting 5 preventive chemotherapy neglected tropical diseases (PC-NTDs) have scaled up rapidly in recent decades due, in large part, to the generous drug donations from 6 pharmaceutical companies—Eisai; Johnson & Johnson (J&J); GlaxoSmithKline (GSK); Merck & Co., Inc., Kenilworth, New Jersey, United States of America (MSD); Merck KgaA; and Pfizer. Today, the scale of the PC-NTD drug donation programs is staggering. Nearly 15 billion tablets have been manufactured, packaged, shipped, and distributed in order to reach the people in need. The supply chains established to support such massive operations are enormously complex. Here, we describe a unique public–private partnership that was formed to bring together supply chain expertise to overcome the critical challenges associated with such large-scale production and delivery of donated pharmaceutical products.

scholarly journals Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US

2021 ◽  
Vol 9 (1) ◽  
pp. 48-61
Author(s):  
Devender Kumar ◽  
Shivali Rahi ◽  
Arpana Rana
Keyword(s):  
Clinical Trial ◽  
Medical Devices ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Pharmaceutical Companies ◽  
Drug Candidates ◽  
Geographical Regions ◽  
The Us ◽  
The World ◽  
Scientific Standards

The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease. In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.

scholarly journals Securing Pharmaceutical Supply Chain using Blockchain Technology

2021 ◽  
Vol 37 ◽  
pp. 01013
Author(s):  
Vishwesh Lingayat ◽  
Isha Pardikar ◽  
Shubham Yewalekar ◽  
Shyamal Khachane ◽  
Sachin Pande
Keyword(s):  
Supply Chain ◽  
Pharmaceutical Products ◽  
Management Systems ◽  
Smart Contracts ◽  
Counterfeit Drugs ◽  
Supply Chain System ◽  
Pharmaceutical Supply Chain ◽  
Manual Operation ◽  
Blockchain Technology ◽  
Production And Distribution

The production and distribution of counterfeit drugs is an urgent and increasingly critical worldwide issue, especially in pandemics. The imperfect supply chain system in the pharmaceutical industry is one of the reasons for drug counterfeiting. Drugs ownership changes from manufacturers to wholesaler, distributor, and then pharmacist before it reaches the customer thus making it difficult to keep track of it. In this paper, we have compared the existing proposed architectures of blockchain and IoT based supply chain management systems. The system implemented using hyper ledger fabric ensures sharing, storing, transparency, and traceability of data in each link of the supply chain. On the other hand, Ethereum architecture utilized the features of smart contracts to manage the interactions between sender and receiver. Finally, the study mainly focuses on increasing the safety of pharmaceutical products and reducing the manual operation of the supply chain with the most efficient architecture.

scholarly journals The Pandemic and the Supply Chain: Gaps in Pharmaceutical Production and Distribution

2021 ◽  
pp. e1-e5
Author(s):  
Mariana P. Socal ◽  
Joshua M. Sharfstein ◽  
Jeremy A. Greene
Keyword(s):  
Public Health ◽  
Supply Chain ◽  
Acute Stress ◽  
Pharmaceutical Products ◽  
New Drugs ◽  
Pharmaceutical Supply Chain ◽  
The Us ◽  
Production And Distribution ◽  
To Come ◽  
Pharmaceutical Production

The acute stress of the COVID-19 pandemic has laid bare a series of long-term weaknesses in the US public health system, including the fragility of our supply of essential medications.1 The virus produced unprecedented shifts in demand for old as well as new drugs, while simultaneously introducing new uncertainties about the production and distribution of pharmaceutical products. COVID-19–related shortages extended beyond antivirals to include a range of drugs broadly used in intensive care and in general hospital management (Table 1). These shortages point to serious vulnerabilities in the pharmaceutical supply chain that compromise readiness for new waves of the current pandemic and crises that are yet to come. (Am J Public Health. Published online ahead of print January 28, 2021: e1–e5. https://doi.org/10.2105/AJPH.2020.306138 )

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues
Keyword(s):  
Pharmaceutical Companies ◽  
Court Decisions ◽  
Patent Holder ◽  
Trial Court ◽  
Court Of Appeals ◽  
The Us ◽  
Antitrust Laws ◽  
Per Se ◽  
Appeals Court ◽  
Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

Relationship between Cross-Border Mergers and Acquisitions and International Trade: The Case of Russian Pharmaceutical Industry

2020 ◽  
pp. 81-94
Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko
Keyword(s):  
International Trade ◽  
Mergers And Acquisitions ◽  
Volume Growth ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Cross Border ◽  
Export Volume ◽  
Relationship Of ◽  
Geographical Diversification ◽  
The Relationship

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.

US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain

2021 ◽  
pp. 174113432199431
Author(s):  
María Fabiana Jorge
Keyword(s):  
Supply Chain ◽  
Trade Policy ◽  
Pharmaceutical Products ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Us Trade Policy ◽  
Drug Supply Chain ◽  
Security Concern ◽  
The U.S

With the outbreak of the Coronavirus there is a new realization of the vulnerabilities of the U.S. drug supply chain. However, while such concerns may have been amplified by the pandemic, they preceded Covid-19 and were well documented before 2020. Indeed, in past years the U.S. Congress held several hearings addressing potential vulnerabilities in the U.S. drug supply chain, in part due to the increasing dependency on China as a dominant supplier of active pharmaceutical ingredients (APIs) and some finished pharmaceutical products. These vulnerabilities go well beyond health policy and constitute a national security concern. The article addresses how U.S. trade policy plays a significant role in shaping the pharmaceutical industry at home and abroad and is in part responsible for some of the current vulnerabilities of the U.S. drug supply chain.

Fake Pharmaceuticals: How They and Relevant Legislation or Lack Thereof Contribute to Consistently High and Increasing Drug Prices

2003 ◽  
Vol 29 (4) ◽  
pp. 525-542
Author(s):  
Merri C. Moken
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
The United States ◽  
Pharmaceutical Products ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Brand Name ◽  
Potential Factors ◽  
Counterfeit Pharmaceuticals ◽  
New Applications

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).

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