USP convenes pharmaceutical supply chain integrity workshop

FDA's Ilisa B.G. Bernstein to keynote event

The increasing globalization of the drug supply presents a host of public health challenges: theft and diversion of medicines, growth of illegal Internet pharmacies and insertion of adulterated medicines or ingredients into the supply chain. As pharmaceutical companies, regulatory authorities, lawmakers, healthcare practitioners and others continue to determine the best approaches to securing increasingly complex supply chains and protecting patients from potentially dangerous products, the U.S. Pharmacopeial Convention (USP) is convening a Supply Chain Integrity Workshop, May 22-23 in Rockville, Md., to consider key issues and solicit feedback on its newly proposed informational standard.

"The issues surrounding pharmaceutical supply chain integrity are not theoretical. On the contrary, they are very real, as evidenced by the discovery of counterfeit Avastin in various U.S. medical clinics in February and April," said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. "Legislative proposals circulating in Congress, continuing debate over product- versus lot-level tracking, gray markets growing in the face of drug shortages and other circumstances are converging, making it clear that the status quo is no longer adequate. Through this workshop, we hope to bring the different and sometimes disparate stakeholders together to find some common ground in addressing these difficult topics and to help determine a path forward on an overall approach to supply chain integrity."

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain. As current approaches vary based on individual companies, and present guidelines consider specific aspects of this issue but not supply chain integrity as a whole, USP is encouraging comprehensive public standards through its proposed informational standard contained in the draft General Chapter <1083> Good Distribution Practices-Supply Chain Integrity. The proposed general chapter will be part of the United States Pharmacopeia-National Formulary (USP-NF), which contains quality specifications for medicines and their ingredients in the United States (these standards also are widely used internationally). The proposed standard covers four areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft. Based on feedback provided at the workshop and through other channels, USP will consider whether changes to its proposed standard are needed.

The keynote presenter at the workshop will be Ilisa B.G. Bernstein, Pharm.D., J.D., director (acting), Office of Compliance, Center for Drug Evaluation and Research, FDA. Broad areas to be addressed at the workshop will include Supply Chain Members: Role, Responsibilities and Risks; Industry Perspective on Safeguarding the U.S. Drug Supply; and USP: Role, Processes and General Chapters.

Specific sessions and topics will include:

• Regulations and Guidance Impacting the Supply Chain-Representatives from North America (California State Board of Pharmacy, FDA and Health Canada), South America (Brazil, Argentina), Europe (European Directorate for the Quality of Medicines, World Health Organization, United Kingdom MHRA and Turkish Ministry of Health) and Africa (Nigeria National Agency for Food and Drug Administration and Control) will present regulatory supply chain approaches from around the world.

• Regulatory Issues and Standards-Topics will include an FDA update on standardizing numerical identification for prescription drug packages, FDA unique device identification and GS1-Global Standards (both unique identification numbers and track and trace standards).

• Technologies and Enablers-Different presentations on track and trace, including global efforts and industry's response, pilot studies and best practices will be featured.

Other presentations will consider tamper-evident packaging and impact and implementation issues related to new technologies from the perspectives of wholesalers, pharmacies and pharmacists.