Brazil has announced a new drug serialization and traceability system. The National System of Drug Control proposal published this week by ANVISA essentially provides for serialized drug identity and supply chain-wide drug traceability from production to dispensing where each node in the supply chain maintains their own database of product and transaction information.

The proposal has a 180-day implementation timeline for manufacturers and 1 year for the rest of the supply chain participants, to start upon publication of the final regulation. The proposal is now open for a 30 day comment period with final publication date to follow at some point thereafter.

Complete analysis of the serialization and traceability requirements is underway but below is an initial snapshot of the scope of the proposal.

Key Provisions

• Serialization: Serialized identification on secondary packaging (and hospital packs), using a 2D DataMatrix, which includes ANVISA drug registration number, unique randomized serial number, lot number, expiration date. These combine to form the ANVISA Unique Identifier of Medicines (IUM).
• Supply Chain Transactions: Tracing and capture of all product movements from point of manufacture to point of dispensation at pharmacy, including reverse logistics. Importation and transportation is also mentioned in the draft proposal although it is unclear exactly how these movements are to be captured.
• Manufacturer: Maintain in a database the following information: IUM, identification number (CNPJ) of drug recipients, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Distributor: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Pharmacy: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Data Archival: Two (2) years after the expiration date of the drug product

Note: Although the official document mentions serialization at the secondary packaging level, it also specifically defines that the Unique Identifier and Serial Number should be encoded on the smallest unit of product marketed in Brazil. So this implies item-level serialization.

Here is the official ANVISA announcement link.

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

The California Board of Pharmacy has posted the agenda for the upcoming 3/14 meeting of the Enforcement Committee and Public Meeting on E-Pedigree.

E-Pedigree Agenda Topics

• SNI: Update on proposed regulations to implement serialized numeric identifiers
• Grandfathering: Update on proposed regulations for identifying drugs which may be shipped into CA after the Jan 1, 2015 deadline without serialization and ePedigree
• 50 percent calculations: Proposed regulations on calculating the 50 percent of products each manufacturer must serialize and ePedigree by Jan 1, 2015
• Inference: Update from the Board on their proposal for regulations concerning the use of inference. Read our notes from the Feb. 2013 BoP meeting on Inference.
• Drop Ship: Discussion on the use of drop shipments in the supply chain and their ePedigree requirements
• Implementation Timelines: Presentations and questions from pharma supply chain participants on their readiness to meet the staggered implementation timeline as laid out in California state law
• Certification Process: Discussion on the certification process to comply with the ePedigree law

TraceLink will be there capturing the discussion and providing a summary for our industry friends. Here is the link to the official PDF of the meeting and agenda.

NOTE: Our CA Board of Pharmacy LIVE Q&A webinar (3/20) will bring out many of the answers and discussions which went on at the meeting. So join us!

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In the last five years we have seen a very rapid growth in recalls and drug shortages. The ramifications are not only a lack of life saving drugs for patients but also a rise in drug prices and counterfeiting. The recent issues with Avastin counterfeits and Doxil supply shortages clearly indicate the problem is growing and becoming more life-threatening. The situation keeps getting worse and the root causes need to be understood and addressed.

In parallel, we have seen the biopharmaceutical supply chain undergo massive changes based upon a fundamental change in the business model and organizational structure. Historically, biopharmaceutical companies were predominantly vertically integrated where they owned their own active pharmaceutical ingredient and bulk product manufacturing plants as well as their own packaging plants. In recent years, however, supply has become globalized and production virtualized. This has rapidly created a significant increase in the inherent risk in the supply chain. Products can now be manufactured in stages from all over the world and through a network of complex relationships. While the manufacturing network has grown in complexity the global distribution network has substantially grown in volume. China, India, Brazil and Turkey are all major growth markets, however their distribution networks are inherently vulnerable to diversion and counterfeiting. The US and EU markets are also threatened by the larger global distribution market with the diversion of counterfeits through importation or distributors engaged in illegal practices.

In order to address the growing risks in the supply chain, biopharmaceutical companies need to maintain the oversight of and collaboration with manufacturing partner companies as if they were their own plants. Many urge even greater visibility and tracking since partner companies have to manage the needs of multiple customers simultaneously. Coordination and visibility across the entire production lifecycle, including visibility into production status, quality reviews, material availability and current inventory levels, are essential to maintain the supply of quality products to the market. From a distribution perspective, China, India, Brazil and Turkey are now requiring both serialization and track and trace of products. The goal is to empower the pharmacist, the clinician and even the patient with the tools to verify the authenticity of the product before dispensation or administration. The US and EU are also moving towards comprehensive adoption of serialization, track and trace with authentication.

At TraceLink, we are working with major biopharmaceutical companies to address the need for superior collaboration, visibility, track and trace in order to achieve the supply quality, capacity and integrity required by the industry. Our approach is to create tight collaboration between supply planning, quality, logistics and manufacturing across companies in order to deliver quality products on-time and in-full. Our track and trace solutions use emerging GS1 standards being adopted by almost all countries for ePedigree and authentication delivered either through enterprise integration or mobile solutions available to patients via iPhone, Android or SMS phones.

With rapid adoption of the solutions that the industry has been developing, we can eliminate drug shortages and counterfeits from our global supply chain.

Posted by Shabbir Dahod | Comments (5) | Trackback (0) | Permalink

The industry is abuzz with Cloud and SaaS applications, but most of them take the same enterprise solution design and provide it in a new deployment model. A conventional application available in the Cloud still requires IT to configure and manage at significant time and cost. When we look at Web-based applications that truly transformed industries (such as Google and Salesforce.com) their approach was to design a new solution centered on providing immediate access of a service to a business user. By empowering an individual to use, learn and share experiences of a business service, we can eliminate the time and cost required from IT to deploy and manage solutions. Instead, we place the solution directly in the hands of the business users via a simple registration process.

Any individual or department leader can use Salesforce.com to manage a sales pipeline or customer service through a simple registration process and credit card payments. In 2000, my VP of Sales at our company came to my office to inform me that he had decided to use a new online sales management tool. Salesforce.com’s tag-line at that time was: “Just Sign-On”. Within a week all the sales people were productively using the sales automation tool. Today, Salesforce.com has over 51,000 customers and other software companies are using a similar solution design for many enterprise business processes.

At TraceLink we also broke the conventional supply chain application model by providing access to a shared workspace, business processes and partner management directly to the individuals that manage supply chain relationships. Anyone can execute any business process with any partner. In the end, we recognized that the people who need the solution everyday are both the best judge of applicability to their business problems and most effective at managing the adoption.

Furthermore, the people centered approach also enables an incremental adoption path for large organizations and complementary access to the smallest organizations. The benefit for constructing a Predictable Supply Network is that we can gracefully scale from the smallest company to the largest enterprise. The benefits of growing application functionality and no-cost of deployment are universally available to everyone on the network.

For a Predictable Supply Network to be effective, people need to be at the center of the solution, since it is their insight and experience which is the best judge for interpreting information. The network needs to support communication of their perspectives and instructions to all the relevant team members. The construction of the team itself can vary from collaboration to collaboration and the tools need to enable the individual team members to identify the appropriate individuals that are required from both companies to successfully manage supply chain operations.

By breaking the traditional model of IT-based application deployment and management, we put the controls directly in the hands of the business user. There can be concerns about overall policies and procedures and these can be addressed by providing management and IT with the tools to monitor and inspect usage for security and cost purposes. Therefore administrative functionality is available to observe the adherence of corporate rules.

Finally, complete traceability and accountability of all actions are available to all the team members. A self-policing team is a far more effective mechanism for compliance than instituting endlessly finer level of access controls. Complete visibility of all actions by users provides preventative protection which is cheaper to implement and maintain.

Empowering business users with immediate access is the first step in transforming the supply chain.

No BullWhip!

Posted by Shabbir Dahod | Comments (1) | Trackback (0) | Permalink