SynTegra Highlights The FDA's "Combatting Counterfeit Drugs - describes how to achieve modern, comprehensive security protections for the US drug supply. Read more... Contact Information For more information, contact: Thomas Menighan, President, SynTegra

Integrity Solutions - Division Overview

Enhancing Secure Business Practices
in the Drug Supply Chain

Health Pathways formed Integrity Solutions in September 2003 to provide comprehensive Inventory Management Advisory Services including:

• Inventory Management Agreement (IMA) analysis, development,
  and administration
• Charge backs and rebates analysis assistance
• Regulatory compliance audits
• Fee for service development and industry reference data
• Distributor agreement analysis and benchmarking
• Drug distribution audit and assessment
• Distributor Education Services

Further, the division provides comprehensive pharmaceutical supply audit services to verify distributor compliance with federal and state regulations as well as HDMA’s “Recommended Guidelines.”

Taking Necessary Steps to Keep Our Nation's Drug Supply Safe and Secure

The Pharmaceutical supply chain is plagued with issues regarding counterfeit and diverted products. Mark McClellan, the Food and Drug Administration (FDA) Commissioner stated in January 2004 “The number of discovered counterfeit drugs in the U.S. has increased four fold in the last decade. The counterfeiters are getting smarter and more sophisticated.”

Drug counterfeiters not only defraud consumers, they also deny patients the therapies that can alleviate suffering and save lives. Counterfeiters produce and introduce near-perfect copies of the most popular and expensive drugs through diversionary tactics by employing sophisticated schemes. Some counterfeits have passed undetected through wholesalers and chain warehouses to the shelves of community and hospital pharmacies.

The FDA report (COMBATING COUNTERFEIT DRUGS - February 2004) describes how to achieve modern, comprehensive security protections for the US drug supply so we can keep pace with the increasingly sophisticated criminal efforts to introduce counterfeit drugs. The FDA’s comprehensive report highlights ways to insure that the nation's drug distribution system protects Americans from counterfeit drugs.

If these measures and voluntary consensus guidelines are adopted and enforced, the U.S. pharmaceutical market will serve as a worldwide example of self regulation. By doing so, we will avoid further governmental intervention to insure the integrity of pharmaceuticals for American consumers.

About Health Pathways Integrity Solutions Division

HPI met with over 25 of the major pharmaceutical and biotech companies to validate our proprietary audit solutions, Secure Supply Solutions (S3) services. We’ve sought input from the leading experts in the pharmaceutical and distribution sectors, including Joint Commission on Accreditation of Healthcare Organizations and FDA as well as corporate finance professionals. We conducted preliminary audits at eight distribution locations and from the knowledge gained, combined with our deep knowledge of pharmaceutical distribution, we have constructed comprehensive and flexible Audit Services.

Integrity Solution’s procedures were developed by industry experts who combined standard audit practices with techniques developed from field tests. By employing these procedures, we assist all stakeholders in the distribution chain to identify ways that counterfeits may be penetrating. By closing the gaps, we can assure pharmaceutical product distribution system integrity.

Distribution Process and Audit Service
‘ A Process to Protect and Optimize Pharmaceutical Distribution’

Health Pathways offers manufacturers and wholesalers a menu of options, including buy and sell side audit assessments and a comprehensive look at the wholesalers’ operations, IMA & regulatory compliance, and IT systems integrity.

The Integrity Solutions team audits in a manner consistent with the rigorous GSA contracts standard for the Department of Health & Human Services, FDA, DEA and other government agencies. Our goal is to rigorously demonstrate the integrity of manufacturers’ products distributed in the U.S. by Company-authorized distributors.

Integrity Solutions Advantage and Savings

Health Pathways’ team of highly qualified experts has developed sophisticated audit procedures that use advanced IT systems to document and analyze the distribution of manufacturers’ products. Our proprietary field tested procedures identify gaps in the distribution chain where counterfeits can enter, diversion can occur, or multiple accounting systems can obscure audit trails.

Risk Reduction of Counterfeit Drugs and Identification of Diverted Product.

Based on the increasing trend in counterfeited drugs and FDA experience, the top twenty pharmaceutical companies may experience at least one counterfeited product every three years. Assuming annual revenue for a branded, promoted product is $800 million and potential disruption of product sales is three months, the potential exists for $66 million (three months over three years) in lost revenues.

For more information on our Audit Services Division's services and products contact: Tom Menighan, General Manager, Audit Services at tmenighan@healthpathways.com.