| The US FDA has decided to implement the "Pedigree | | | | and diversion, pharmaceutical wholesalers, traders and |
| provisions" of the Prescription Drugs Marketing Act | | | | retailers, get the added benefit of looking into their |
| after December 2006, when the current stay on it | | | | businesses and track the movement of prescription |
| expires. There is a lot of concern that many | | | | drugs with full transparency. This will no doubt yield |
| pharmaceutical supply chain participants, may not be | | | | added benefits of inventory optimization, demand |
| able to meet this deadline and hence risk non | | | | forecasting and increasing their knowledge of what is |
| compliance with the provisions of the act. This | | | | selling and how fast. |
| pharmaceutical article is excerpts from the RFID | | | | RFID Implementation issues: |
| technology white papers written by Sangeeta of | | | | To implement this system fast, before the deadline |
| Abhisam Software. The RFID technology white | | | | of December approaches, it is essential to train all |
| papers attempts to present an RFID Systems | | | | stakeholders (pharmaceutical company personnel, |
| solution to ensure timely compliance and get added | | | | wholesalers, traders, retailers and others) fast but, at |
| side benefits in the process. | | | | a competitive cost. However, the present cost of |
| Problems with the present pharmaceutical supply | | | | classroom based training is expensive, besides having |
| chain: There are two major problems with the | | | | other related costs like travel and hotel stay. A |
| present pharmaceutical supply chain model of the | | | | better system would be to go for a vendor-neutral |
| pharma industry, as it exists today. The first one is | | | | e-learning program, which can be deployed |
| not of counterfeiting, but of diversion. More details | | | | immediately and across several locations |
| will be explained in in the background information | | | | simultaneously. |
| below and in Sangeeta's RFID technology white | | | | This has the effect of bringing up all staff, to a level |
| papers, but some highlights are below. | | | | necessary for them to implement an RFID based |
| Drug diversions can be of two types. Drugs meant | | | | pedigree system. The e-learning program should |
| for Medicare or Medicaid programs, public hospitals or | | | | cover all aspects of the RFID technology including the |
| charitable institutions, are diverted to the open | | | | history, advantages over traditional automatic |
| market. Unscrupulous persons sell prescription drugs | | | | identification like bar codes, practical RFID systems, |
| or "controlled" substances to consumers, without | | | | RFID standards and middleware as well as other |
| proper prescriptions. Counterfeiting (by FDA | | | | issues like RFID privacy and RFID security. It should |
| definition) Dummies/ Placebos, which means that | | | | ideally also offer a self assessment and a glossary. |
| there is no active ingredient at all Products with a | | | | We believe, that deploying such a program, across |
| lesser quantity of active ingredient than stated | | | | many companies is the only option to effectively |
| Products with the wrong active ingredient Products | | | | train hundreds of people, in a cost-effective manner, |
| with a packaging that wrongly suggests that it was | | | | so that the actual implementation of the system can |
| made by an FDA approved manufacturer To give | | | | be done smoothly. It is essential to bring all people on |
| you an idea of the scale of the counterfeiting just | | | | board, make them understand this RFID technology |
| one of these cases involves $42 million of counterfeit | | | | better and only then talk of implementing it. |
| Lipitor. Other high value cases include a case involving | | | | Conclusion: |
| a $200 million nationwide drug diversion conspiracy | | | | RFID track and trace is a technology whose time has |
| and a $45 million Medicaid fraud involving diversion of | | | | come. It not only will meet the FDA requirements for |
| blood products. | | | | compliance but also prevent pharmaceutical |
| The FDA's solution to the problem: The FDA's vision | | | | counterfeiting (lost opportunity sales of genuine |
| of a safe and secure pharmaceutical supply chain is | | | | drugs), prevent diversion, optimize pharmaceutical |
| based on transparency and accountability by all | | | | supply chains as well as fulfill social responsibilities of |
| participants in the (prescription drugs) pharmaceutical | | | | the pharmaceutical industry fraternity. |
| supply chain. The FDA had nominated a task force to | | | | Training large numbers of people in a short time, is |
| study whether this system could be implemented | | | | not a problem at all since a vendor-neutral, |
| with the currently available state of the technology. | | | | technology and implementation focused e-learning |
| They came to this conclusion after studying the | | | | program is now easily available. |
| various technologies currently commercially available, | | | | By Sangeeta Phadke |
| which could meet the pedigree requirements, including | | | | Some Additional Background Information ... |
| RFID or Radio Frequency Identification technology. | | | | Pharmaceutical distributors Background : The |
| Amongst all technologies studied including bar coding, | | | | Prescription Drug Marketing Act (PDMA) was signed |
| RFID seemed to be the most promising and the | | | | as a law, as far back as 1998 but a number of |
| committee felt that the pedigree requirement could | | | | amendments introduced later, finalized the pedigree |
| be met by easily leveraging something that is readily | | | | requirements only in 1999. |
| available. (More details in the complete RFID | | | | The pharmaceutical industry, essentially requesting |
| technology white paper "RFID-FDA-Regulations.pdf" | | | | them to the act "put on hold" , citing several reasons |
| referenced below) | | | | for this, one of them being "the technology required |
| How the pharma companies can approach this issue: | | | | for this system is unproven and not in place." The |
| The million dollar question is "Who can ensure an ROI | | | | FDA patience finally wore thin. Therefore it was |
| on this RFID technology, especially after millions have | | | | decided that they will allow the current stay on this |
| already been spent?" Even if a full scale RFID | | | | act, to expire in December 2006. |
| implementation were done now, how can it be done | | | | This may not be a big problem for the pharmaceutical |
| fast, before the December 2006 deadline? | | | | manufacturers, but it could be a really big problem for |
| Rather than resist implementation of a pedigree | | | | supply chain intermediaries like distributors, |
| system built on RFID systems , pharmaceutical supply | | | | pharmaceutical wholesale suppliers and traders, who |
| chain participants must realistically estimate the costs | | | | may not know much about "electronic track and |
| of investment in the technology, the real cost of | | | | trace" technology, which is necessary for the |
| counterfeits and the returns on a foolproof RFID | | | | compliance. Sangeeta's RFID technology white paper |
| based "track and trace" system. The RFID systems | | | | attempts to explain how this RFID track and trace |
| will virtually eliminate the counterfeit pharmaceutical | | | | system can be implemented and how it will be |
| market at one go. Secondly, it can ensure that drug | | | | beneficial in the long run to all sections of society- |
| recalls can be done swiftly without any ambiguity. | | | | pharmaceutical companies as well as intermediaries |
| This has been demonstrated many a times. Thirdly, | | | | and ultimately the end users. |
| the RFID systems need not cost too much. | | | | Understanding the pharmaceutical supply chain: The |
| How wholesalers and traders can implement track | | | | lay reader may assume that it is like any other supply |
| and trace: Ditto for other pharmaceutical supply chain | | | | chain, which brings goods from the manufacturers' |
| intermediaries. They can simply join the same global | | | | factories to the retail shelves, but it is not so. The |
| system outlined in the RFID technology white paper | | | | pharmaceutical supply chain is inherently different in |
| that is currently in place and implement the electronic | | | | its organization. For the pharmaceutical business, the |
| pedigree system easily. The only investment would | | | | pricing for each end user is different. Therefore a |
| be in the RFID readers and middleware. Even these | | | | typical hospital gets these drugs at lower rates than |
| can be bought in bulk by their associations at | | | | does a corner pharmacy. There are programs like |
| negotiated prices and implemented. This solves the | | | | Medicare and Medicaid where the procurement prices |
| issue of RFID standards too, since all participants | | | | are different than for someone who buys the same |
| would be using similar kinds of RFID readers and | | | | drug at a corner pharmacy. The pharmaceutical |
| RFID software. | | | | distributors diagram to the right shows some of the |
| Beneficial Side effects of the implementation: In | | | | various flows of prescription drugs through the |
| addition to combating pharmaceutical counterfeiting | | | | pharmaceutical supply chain. |