Pharmaceutical Commerce - July/August 2013 - (Page 22)

Information Technology Preparing for a serialized supply chain continued from page 1 who added that once we have widespread adoption of serialization and are exchanging serialized information, financial processes like chargeback administration, rebate processing and pricing of returned goods can also be streamlined. Rich Feldman, VP of trade and product security at EMD Serono, also touches on the topic of returned products, but from the viewpoint of protecting product authenticity and lowering healthcare costs. If manufacturers have the ability to track units, then they can better ensure that patients are taking authentic medicine. With the rise of Internet pharmacies and increased purchasing of products over country borders, the risk that a patient could accidentally purchase and take a nonauthentic product is growing. On top of that, if the product is then returned, it could then re-enter the supply chain and potentially be resold. With serialization in place, manufacturers will be able to track individual unit serial numbers and better identify incorrect returned product. As these nonauthentic products are taken out of the supply chain, the risk is lowered that patients could obtain goods that do not have therapeutic effect, and will therefore reduce the impact of higher healthcare costs for the individual and the system. Improving business processes with better data Manufacturers anticipate that improved business processes will likely result from widespread product serialization data access. A common process that will be improved is recall management. According to Staver, serialization data will help to more quickly identify where recalled product is in the supply chain and more efficiently remove that product before it reaches patients, enhancing patient safety. In addition, in the case of in-transit cargo theft, Staver points out that a manufacturer would know what serial numbers were involved in the stolen shipment and this may avoid the need to recall an entire lot of product, if only a portion of the lot is stolen. Feldman adds that the ability to recall only certain serial numbers could also help prevent product shortages that may come as a result of a full lot recall. Better data access can also help streamline accuracy of orders, and returns processing because manufacturers will be able to verify data about delivered shipments, according to Rose. Sharing data: point-to-point vs. the cloud When it comes to sharing serialized product data there are two options: point-to-point or cloud-based solutions. Point-to-point solutions are typically the starting point for manufacturers as they begin the data-sharing process, but these solutions have their limitations. According to Kimberly Fleming, senior manager, product security at EMD Serono, the company started using point-to-point on pilot projects and is now familiar with its restrictions. Based on their work, point-to-point has proven to be time consuming and hard to manage. Lloyd Mager, manager, strategic initiatives, supply chain operations at AbbVie, also mentions that he evaluated point-to-point solutions, but determined that they were not likely to be a manageable alternative and could lead to issues with master data downstream. Cloud-based solutions offering a repository and communication hub to receive, analyze and transmit data between trading partners are emerging as a next step for many companies. These systems enable supply chain visibility, chain of custody reporting and track and trace functionality across the supply chain. Staver says that while much of the work Pfizer has done so far has been with point-topoint, it is starting to look at cloud solutions as a real opportunity moving forward. The cloud will allow Pfizer to post information and push it to trading partners seamlessly. This point is echoed by Mager, who said he feels data will be more secure in a cloud, than spread-out across the supply chain. Another benefit of a cloud-based solution, according to Rose, is that it does not require a heavy footprint at the customer level. The flexibility of the cloud opens up opportunities for other services like track-and-trace and product authentication. Roadblocks: the hiccups to every new process New processes implementation usually has a few roadblocks along the way. According to Feldman, industry participants need to put in the effort to make product serialization happen instead of focusing on reasons why it can’t be done. If stakeholders engage at the same time, and test solutions together, then this will help eliminate potential issues. Increased trust among trading partners will also help push the process along, said Rose, who suggested industry participants should not focus on monetizing the data, and instead focus on sharing it to benefit healthcare as a whole. When it comes to internal roadblocks, Fleming and Feldman report few hiccups with their own efforts to utilize serialized data in pilots. There were some initial master-data issues with slightly different wholesaler names and addresses in different databases, but once this data was cleaned up, they reported no technological issues with transmitting data in their pilot projects. The question is whether this pilot project success will translate to the entire industry. Looking at their own trading partners, some manufacturers are concerned that technology barriers will hinder the widespread use of serialized data, especially on the provider side. Mager and Staver mention lack of provider technical capabilities as a concern, particularly with small, independent pharmacies. The investment in the technology to allow shared data may be too high for some providers, says Rose, accentuating the need to develop lower cost solutions for pharmacies. While some pharmacies have scanners today, a culture among all parties to ABOUT THE AUTHOR As executive director, global strategy at GHX, Margot Drees leads strategy for an organization that brings together healthcare providers, manufacturers, distributors and GPOs in a collaborative and connected community to improve efficiencies, visibility and accuracy in the healthcare supply chain. Drees is responsible for development of an industry solution for track and trace and e-pedigree. 22 Visit our website at July | August 2013 GHX and the VHA e-pedigree pilot GHX was founded in 2000 to reduce inefficiencies in the healthcare supply chain, primarily in med-surg supplies. Today, it is owned by 20 organizations representing manufacturers, distributors, hospitals and group purchasing organizations (GPOs). As a healthcare technology and services company, GHX helps reduce the cost of doing business in healthcare and assists customers in providing and tracking critical supplies to enhance patient safety. GHX connects 6,130 hospitals and clinics to more than 10,000 supplier divisions, representing more than 85% of the medical-surgical hospital spend in the US. In 2012, purchase order volumes exceeded $51 billion and GHX customers have achieved more than $3 billion in savings since January 2010. GHX is owned by the healthcare industry, has an open and neutral position in the supply chain landscape, and a very strict data-governance policy. These characteristics, along with the ability to securely handle large transaction volumes, led a subset of owners to ask GHX to work on an industry model for pharmaceutical traceability and e-pedigree in 2010. From 2010 to 2013 the group gathered requirements, built a prototype and piloted the system. In March 2013, this work was recognized when the Healthcare Distribution Management Assn. (HDMA) announced a pilot led by GHX as the winner of its fourth annual Distribution Management Award (Pharmaceutical Commerce, May/June, p. 25). This first-of-its-kind pilot, “Track and Trace for Serialized Product,” studied a traceability system for securing the pharmaceutical supply chain, allowing for greater visibility and interoperability. The pilot used products that were manufactured and serialized at AbbVie, Inc., delivered to a McKesson Corp. distribution center and then distributed to the Veterans Health Administration (VHA) Consolidated Mail Outpatient Pharmacy. The chain of custody tracing was achieved using a serialized Global Trade Identification Number on the product, and leveraging the GHX traceability system that had implemented the Electronic Product Code Information System. Supply chain processes and concepts that were tested included serialization, aggregation, authentication, inference, product recall and data sharing using a one-up-one-down model in a cloud-based repository. The pilot also tested a new concept called a pedigree check, which allows trading partners to check the status of a product before shipping or receiving it, as well as an automated recall process using serialized information. This was the first time that AbbVie and McKesson were able to provide serialized product, product authentication and chain of custody reporting to VHA using an interoperable platform. Based on the performance of the trial, it is estimated that this cloudbased software will help minimize points of connectivity between trading partners, which would help to reduce healthcare costs. Moreover, the pilot led to greater supply chain efficiencies, with processing times reduced by as much as six times with the use of an inexpensive Bluetooth barcode reader. In addition to GHX, AbbVie, VHA and McKesson, the system was developed in collaboration with AmerisourceBergen Corp., Cardinal Health, Inc. and Johnson & Johnson Health Care Systems Inc.

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2013

Pharmaceutical Commerce - July/August 2013
Top News
Brand Marketing & Communications
Supply Chain/Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatoryv
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2013