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Pharmaceutical Distribution in the US

Published by: Urch Publishing

Published: Jul. 1, 2009 - 83 Pages


Table of Contents


Chapter 1: The US Pharmaceutical Supply Chain

The pharmaceutical supply chain

The US pharmaceutical industry

The role of pharmaceuticals

US pharmaceutical manufacturers

Pharmaceutical Research and Manufacturers of America (PhRMA)

The US biotech industry

The Biotechnology Industry Organization (BIO)

Case study: the pharmaceutical and biotech industries at a state level

The US pharmaceutical market

The US healthcare system

Medicare and Medicaid

State Children’s Health Insurance Program

Pharmaceutical legal obligations

Wholesale distribution

The US wholesale market

Primary wholesalers

Secondary wholesalers

Prescription Drug Marketing Act

PDMA revisions

The pedigree requirement

State-level actions

US pharmacy market

Pricing freedom

US pharmaceutical spending

Pharmaceutical pricing issues in the US

US consumer pricing studies

Outlook for US biopharmaceutical R&D

Average wholesale price and average sales price

Internet trading

Parallel trade


Chapter 2: The US Wholesale Sector

Wholesaling in the US

The Healthcare Distribution Management Association

The National Coalition of Pharmaceutical Distributors

Wholesaler consolidation

Challenges to the dominance of the Big Three

Case study: RxUSA launches legal challenges against the Big Three

Cardinal Health Inc

McKesson Corporation

AmerisourceBergen Corporation

Wholesaler technology solutions

Electronic data interchange

Collaborative planning, forecasting and replenishment

Enterprise resource planning

Order fulfilment packages

Database technology

Electronic point-of-sale technology

Barcoding

Case study: US highlights benefits of barcode and RFID technologies

Costs and benefits of EPC/RFID implementation

Warehouse technology

Dispensing technology

Future systems

The US supply chain and direct distribution

Development of direct distribution in Europe

Rationale behind changes in the supply chain

Challenges to direct distribution in the US

US wholesalers and globalisation


Chapter 3: Pharmacy in the US

The US pharmacy sector

The American Pharmacists Association

Case study: the AphA and medication therapy management

The Academy of Managed Care Pharmacy

Chain drug stores


Walgreens

CVS Caremark


National Association of Chain Drug Stores

Case study: the National Trust for Historic Preservation responds to chain drug stores

Independent pharmacies

National Community Pharmacists Association

Mail-order pharmacies

Online pharmacies

Case study: PharmacyChecker.com

Pharmacists and parallel trade

OTC products

Rx-to-OTC switching

Pharmacists and OTCs

Case study: US pharmacists and Rx-to-OTC switching of allergy products

Pharmacy benefit managers

The Pharmaceutical Care Management Association

Case study: PBMs force patients to switch medications

The future of US pharmacy

Patient compliance

Pharmacies and retail health clinics

Case study: 2008 survey of patient use of retail health clinics

Case study: Florida tightens pharmacy regulations

Biogenerics

Case study: biogenerics legislation restrictions for pharmacists

Pharmacy groups launch Project Destiny


Chapter 4: Protecting the US Supply Chain

Safeguarding the supply chain

Disaster planning and the supply chain

Alternative strategies for mass distribution of medicines

Case study: US community pharmacies launch Rx History

Case study: ICERx.org

Product shortages in the supply chain

The Food and Drug Administartion (FDA) and drug shortages

Case study: vaccine shortages and the effect on the supply chain

Counterfeiting

Anti-counterfeiting cooperation

Counterfeiting and the pharmaceutical industry

FDA anti-counterfeiting measures

FDA recommendations on combating counterfeits

Case study: the FDA’s Counterfeit Alert Network

Case study: AstraZeneca opts for mass serialisation to prevent counterfeiting

Using nanotechnology to combat counterfeiting

Case study: FDA Nanotechnology Task Force report


References


List of Tables

Table 1.1 Types of manufacturer medicines

Table 1.2 The four parts of Medicare

Table 2.1 Cardinal Health corporate business units

Table 2.2 McKesson corporate business units

Table 2.3 AmerisourceBergen Corporation business segments

Table 2.4 Overall risks of DTP identified by the OFT

Table 2.5 Challenges for a US direct distribution model

Table 3.1 Potential patient benefits of medication therapy management

Table 3.2 Potential competitive advantages of mail-order pharmacies

Table 3.3 PharmacyChecker.com classification of online pharmacies

Table 3.4 Top five major players in the pharmacy/retail clinic sector

Table 3.5 The four components of Project Destiny

Table 4.1 The application of the HIPAA in emergency situations

Table 4.2 Recommendations to improve mass distribution of medicines during an emergency through using the private sector

Table 4.3 ICERx.org partnerships

Table 4.4 Key areas of focus for the International Medical Products Anti-counterfeiting Taskforce (IMPACT)


List of Figures

Figure 1.1 Outline of the traditional supply chain

Figure 1.2 Global R&D expenditure

Figure 1.3 Pharmaceutical revenues for major companies (2007)

Figure 1.4 Pharmaceutical R&D for major companies (2007)

Figure 1.5 Revenues for major biopharmaceutical companies (2007)

Figure 1.6 R&D for major biopharmaceutical companies (2007)

Figure 1.7 US pricing environment compared with Europe and Japan

Figure 1.8 Ongoing US pharmaceutical R&D dominance

Figure 1.9 Share of parallel imports in European pharmacy markets

Figure 2.1 Annual revenues for Cardinal Health and subsidiaries

Figure 2.2 Annual revenues for McKesson Corporation

Figure 2.3 Annual revenues for AmerisourceBergen Corporation

Figure 3.1 Annual revenues for Walgreens

Figure 3.2 Annual revenues for CVS Caremark

Figure 3.3 Average annual sales per US pharmacy location

Figure 3.4 Staff costs as a percentage of US pharmacy operating expenses

Figure 3.5 Online pharmacy price analysis for select brands

Figure 3.6 Online pharmacy price analysis for select generics

Figure 3.7 Flow of goods and payment in the US supply chain

Figure 4.1 Counterfeit drug cases opened by the FDA


Abstract

In the US, the pharmaceutical supply chain involves the daily delivery of approximately 13 million prescription products to pharmacies, hospitals, clinics and other healthcare provider locations

In recent years, the US government and interested parties have made increasing efforts to protect the national supply chain for medicines distribution. Since it represents the means for medicines to reach patients, any breaches in the system would be catastrophic and could affect millions of people. The system faces numerous external threats, including counterfeiting, terrorism and disruption resulting from man-made and natural disasters. Industry challenges include the dominance of 3 wholesalers, growth of mail order and the wave of pharmacy consolidation.

The US supply chain is set to undergo great changes in the next decade. Although a number of external factors will have an impact, the complex relationship between each of the parties in the supply chain will be the most important. Although they all depend on each other for maintaining the supply chain, they all wish to have greater control of the process of delivering medicines to patients. Pharmaceutical manufacturers and pharmacists all have their own opinions regarding the structure of the supply chain, and their actions to reinforce their views will shape the future of the system.

Pharmaceutical Distribution in the US - Current and Future Perspectives from URCH Publishing, delivers a comprehensive and expert overview of the distribution of medicines in the United States. This 40,000 word report will provide the reader with accurate insight into this complex and rapidly changing sector.

Some key findings from this report include: In 2008 the US pharmaceutical wholesale market was worth $275bn McKesson, AmerisourceBergen and Cardinal Health Inc, known as the ‘Big Three', account for between 90-95% of revenue within the US pharmaceutical wholesale sector.

The ‘Big Three' have been responsible for over 100 buyouts since 1980, at least 57 of which have occurred over the past decade. It is estimated that US chain drug stores currently account for 41% of all prescription sales, with the dominant players being Walgreens and CVS Caremark. A change from wholesale to direct distribution in the US is unlikely. A US wide direct distribution model would cost the pharmaceutical industry $47.9bn to operate. This would be 15.5% increase on current distribution costs. Use This Report To:
  • Understand the environment for medicines distribution in the US.
  • Identify where the sector might change in the next few years. Analyse threats and opportunities.
  • Spot potential areas of pharmaceutical distribution market growth and opportunities for delivering successful sales growth
  • This unique report will deliver insight into:
Efforts to protect the medicines supply chain and disaster plan, in particular to deal with counterfeiting.

The 3 major wholesalers AmerisourceBergen Corporation, Cardinal Health and McKesson Corporation and the growing concern about their dominance.

The sophisticated technology that underpins distribution in particular EPoS, Barcoding and RIFD

The practice of pharmacy and the main players in the pharmacy sector and current issues regarding dispensing including Rx-to-OTC switching, patient compliance and biogeneerics.

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