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Discover the power of e-learning! RFID systems for pharmaceutical distributors to meet the new FDA regulations on drugs.
Abstract : The US FDA has decided to implement the “Pedigree provisions” of the Prescription Drugs Marketing Act after December 2006, when the current stay on it expires. There is a lot of concern that many pharma supply chain participants, may not be able to meet this deadline and hence risk non compliance with the provisions of the act. This White Paper attempts to present a solution to ensure timely compliance and get added side benefits in the process.
Background : The Prescription Drug Marketing Act (PDMA) was signed as a law, as far back as 1998 but a number of amendments introduced later, finalized the pedigree requirements only in 1999. It would have been implemented in that year itself, were it not for several representation received by the FDA from the pharmaceutical industry, essentially requesting them to the act “put on hold” , citing several reasons for this, one of them being “the technology required for this system is unproven and not in place.” The FDA then issued a stay on the implementation not once but for several times since 1999. Meanwhile the counterfeit & illegal prescription drugs menace continued to grow. In 2004 there were 58 cases filed by the FDA against counterfeiters. If this appears low, consider the fact that in 2001, there were hardly 10. Though the number of cases is lower than for other goods, the implications for public health and safety are enormous. The FDA patience finally wore thin. Therefore it was decided that they will allow the current stay on this act, to expire in December 2006. This means that by this time, the pharmaceutical business will have to get its act together and implement a “pedigree” system for all prescription drugs in the supply chain. This may not be a big problem for the drug makers, but it could be a really big problem for supply chain intermediaries like distributors, wholesale suppliers and traders, who may not know much about “electronic track and trace” technology, which is necessary for the compliance. This White Paper attempts to explain how this pedigree system can be implemented and how it will be beneficial in the long run to all sections of society— pharma companies as well as intermediaries and ultimately the end users.
Understanding the Pharma Supply Chain Before attempting to explain the whys and hows of the pedigree system, it will be worthwhile to examine how the pharma supply chain works. The lay reader may assume that it is like any other supply chain, which brings goods from the manufacturers' factories to the retail shelves, but it is not so. The pharma supply chain is inherently different in its organization. To start with, you have the big pharma companies who manufacture prescription drugs. Then the next stage in this distribution chain are the large wholesalers who buy in bulk quantities. They then supply these drugs at varying prices to big traders, regional distributors, national level pharmacy chains and large retailers like Wal-Mart, as well as to hospitals. Between these entities, there are the large logistics service providers, warehousing companies and transporters who physically ship these drugs. Hence your corner pharmacy may have received its stock through at least two or
© 2006 Abhisam Software. All rights reserved. No part of this publication may be used without express written permission.
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