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.

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.

Washington will rethink its foreign chip strategy

2021 ◽  
Keyword(s):  
United States ◽  
Supply Chain ◽  
The United States ◽  
Export Controls ◽  
Political Pressure ◽  
Technical Standards ◽  
Content Type ◽  
The Us ◽  
Technology Competition ◽  
Business In China

Significance Follow-on action from Washington and responses from foreign actors will shape the US government’s adversarial policy towards China in semiconductors and other strategic technologies. Impacts The Biden administration will likely conclude that broad-based diversion of the semiconductor supply chain away from China is not feasible. The United States will rely on export controls and political pressure to prevent diffusion to China of cutting-edge chip technologies. The United States will focus on persuading foreign semiconductor leaders to help develop US capabilities, thereby staying ahead of China. Washington will focus on less direct approaches to strategic technology competition with China, notably technical standards-setting. Industry leaders in the semiconductor supply chain worldwide will continue expanding business in China in less politically sensitive areas.

Critical minerals demand will boost Canadian mining

2021 ◽  
Keyword(s):  
Supply Chain ◽  
Rare Earth ◽  
Electric Vehicle ◽  
Carbon Emissions ◽  
High Performance ◽  
Commodity Prices ◽  
Alternative Source ◽  
Content Type ◽  
The Us ◽  
Critical Minerals

Significance Although low commodity prices deterred investment in recent years, this is changing as the market rallies. The creation of a regional electric vehicle (EV) supply chain straddling the Canada-US border has the potential to transform the Canadian mining sector while loosening China’s grip on the minerals used in high-performance batteries. Impacts Canada is the world’s eighth-largest cobalt producer and has significant copper, graphite and rare earth deposits. Fortune Minerals, which is developing a cobalt mine in Northwest Territories, has held funding talks with the US Export/Import Bank. First Cobalt is building North America’s only cobalt refinery to give battery makers an alternative source to the DRC. Several of the country’s mines are using cutting-edge technologies to reduce their carbon emissions.

Measuring performance of government-supported drug warehouses using DEA to improve quality of drug distribution

2020 ◽  
Vol 17 (4) ◽  
pp. 567-581
Author(s):  
Anuj Dixit ◽  
Srikanta Routroy ◽  
Sunil Kumar Dubey
Keyword(s):  
Supply Chain ◽  
Storage Capacity ◽  
Generic Drugs ◽  
Drug Distribution ◽  
Operational Cost ◽  
Fill Rate ◽  
Time Efficiency ◽  
Productivity Level ◽  
Content Type ◽  
Temperature Controlled

PurposeDrug warehouses (DWs) play a crucial role in drug distribution of government-supported healthcare supply chain as it controls both the cost and responsiveness of the logistics activities. The current study proposes a methodology using data envelopment analysis (DEA) to estimate the performance along different dimensions and was applied to 30 government-supported DWs.Design/methodology/approachThis study employs DEA to evaluate the performance and relative technical efficiency of DWs. In this research, four inputs and six outputs are identified based on intensive literature review and discussion with all stakeholders of DWs. The inputs are warehouse storage capacity, temperature-controlled storage capacity, number of skilled employees and operational cost, while the outputs are fill rate, number of generic drugs, volume of drugs, consumption points, inventory turns ratio and time efficiency.FindingsResults show that 30% DWs operate at the most productive scale size with 100% efficiency level while 47% DWs have a significant possibility for further enhancement in productive efficiency and 23% DWs should diminish their operational size to increase their productivity level. It was also found that achieving 100% operational productivity along warehouse space capacity needs significant effort, whereas other three inputs, namely temperature-controlled capacity, number of skilled employees and operational cost, require comparatively less effort. Similarly, it was observed that the performance along the fill rate and time efficiency is satisfactory, whereas the performance along other fours output variables (i.e. number of generic drugs, volume of drugs, consumption points and inventory turns ratio) needs to be improved.Practical implicationsThe findings offer insights on the inputs and outputs that significantly contribute to efficiencies so that inefficient DWs can focus on these factors.Originality/valueAlthough many issues related to DEA have been widely researched and reported, but no literature has been found for analysis of DWs in general and government-supported DWs specifically to find out efficiencies for supply chain performance improvement.

scholarly journals Trade in Conflict Minerals -- Congolese Warlords, MNC’s, and Dodd-Frank 1502

Perceptions ◽  
2019 ◽  
Vol 5 (2) ◽  
Author(s):  
Ankit Deshmukh
Keyword(s):  
Supply Chain ◽  
Multinational Corporations ◽  
Primary Source ◽  
Market Prices ◽  
News Sources ◽  
Conflict Minerals ◽  
The Us ◽  
Face Threats ◽  
Using Data ◽  
The Eu

This paper seeks to provide an overview of conflict mineral trade by analyzing it through an economic lens. Using data gathered from news sources, the memo first defines the term “conflict minerals” and identifies that the primary actors involved in the conflict mineral market are rebel militia groups and multinational corporations. The trade is mutually beneficial for these actors as it serves as the primary source of revenue for militia groups and allows multinational corporations to buy minerals at low costs. The memo also highlights the struggles legitimate Congolese miners face, as they face threats from militia groups and low market prices Also identified is Section 1502 of the Dodd Frank act, legislation which forces multinational corporations to list their mineral suppliers, thereby increasing supply chain transparency. While implemented with good intentions, it is extremely unsuccessful in stifling the conflict mineral trade as it lacks substantive regulatory measures. Furthermore, the EU and US plan to implement opposing conflict mineral trade policies — the EU looks to increase supply chain transparency while the US looks to repeal Section 1502 of Dodd Frank (an action which would decrease supply chain transparency). This paper believes that coordinated and homogenous action on the part of both federal governments and IGOs is necessary in order to concretely enforce restrictions on conflict mineral trade.

scholarly journals Taming the Hydra: Funding the Lithium Ion Supply Chain in an Era of Unprecedented Volatility

2020 ◽  
Author(s):  
Chris Berry
Keyword(s):  
Supply Chain ◽  
Raw Materials ◽  
Lithium Ion ◽  
Chemical Conversion ◽  
Raw Material ◽  
Battery Cell ◽  
Exogenous Shocks ◽  
China Trade ◽  
The Us ◽  
Difficult Challenge

The lithium ion supply chain is set to grow in both size and importance over the coming decade due to government-led efforts to decarbonize economies and declining costs of lithium ion batteries used in electronics and transportation. With forecasts of demand for lithium chemicals alone forecast to grow by three times later this decade, at least $10B USD is needed to flow into the upstream supply chain to ensure an efficient and timely build-out. Significant additional capital is needed for other portions of the supply chain such as other raw materials, cathode or anode production, and battery cell manufacturing. Recent exogenous shocks such as the US-China trade war and coronavirus disease 2019 (COVID-19) pandemic have made securing adequate capital for the supply chain a difficult challenge. Without the steady stream of funding for new mine and chemical conversion capacity, widespread adoption of electric vehicles (EVs) could be put at risk. This paper discusses the current structure of the lithium ion supply chain with a focus on raw material production and the need for and challenges associated with securing adequate capital in an industry that has, to date, not experienced such a robust growth profile.

Just Add Water: Why US Shale’s Next Big Supply-Chain Revolution Is Wet Sand

2020 ◽  
Vol 72 (12) ◽  
pp. 21-23
Author(s):  
Trent Jacobs
Keyword(s):  
Supply Chain ◽  
Horizontal Well ◽  
Drying Process ◽  
The Us ◽  
Cutting Out ◽  
Scaling Down ◽  
Dry Sand ◽  
Capital Intensive ◽  
Development Manager

Sand is mined. It is washed. It is dried. Then it gets wet again. Such is the unassuming life cycle of most every grain of sand ever pumped down a horizontal well along with millions of gallons of water and into the freshly opened fractures of a tight-rock formation in the US. But what if the sand never had to be dried? To start with, the unconventional sector could save tens or hundreds of millions of dollars a year, simply by cutting out the capital-intensive drying process. That might mean mines of the future could be made small enough to follow operators as they sail slowly across their vast acreages. Wet sand also lends itself to safer and more regulatory-friendly worksites, an important consideration given that more-stringent air-quality standards are coming into effect in the US next year. A wet-sand revolution may also represent a major boon for the industrywide effort to reduce CO2 emissions - making each horizontal well completed with wet sand a bit greener than one that used dry sand. This is all according to a newly shared case study (SPE 199975) from sand supplier PropX and US shale producer Ovintiv. Since the highlighted field test was completed last year, PropX has pumped more than 1 billion pounds of wet sand down wells in Texas and Oklahoma. “What we propose in this paper is the next logical step in the supply-chain reduction,” of the unconventional sand sector, said Brian Dorfman. “That is, the removal or the significant scaling down of the drying facility.” Dorfman is a business development manager at PropX and one of the authors of the whimsically titled paper, “Can Wet Sand Be Used for More Than Building Sand Castles on the Beach?” On a multiwell pad in Oklahoma, Ovintiv found that wet sand - defined as having a moisture content of 1-10% - could be used to stimulate more than a hundred fracture stages in under 2 weeks. Addressing any concerns over efficiency, the operation saw an average of nearly 4 million pounds of wet sand pumped downhole each day - well within shale-sector norms. Sand is washed to remove contaminants. It is then run through industrial-sized kilns because dry sand flows from a hopper and into a train car or a truck far easier than wet sand which clumps together, as any child at the beach knows well.

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

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