The World Health Organization (WHO) estimates that 7-10% of all drugs sold worldwide each year are counterfeit. In addition, the Organization for Economic Co-operation and Development counted more that 1,700 pharmaceutical product security incidents last year due to counterfeiting, diversion, and theft. In today's complex supply chain that includes manufacturers; a tangled web of distributors and wholesalers; plus pharmacies, hospitals, and clinics, there is ample opportunity for malfeasance to occur, and for counterfeits to enter the market -- and ultimately, consumers' bodies. Add in the increased energy in globalization programs and the risks ratchet up. When safety assumptions go wrong, the results can be devastating, such as the death of at least 81 Americans from taking counterfeited Heparin, a blood thinner.
According to the U.S. Department of Health and Human Services, at least half of all Americans take at least one prescription drug, with one in six taking three or more medications. It's assumed by consumers that when their local pharmacist, hospital, pharmacy or other caregiver hands them their bottle of pills, what's in the bottle is what is supposed to be in the bottle and it is safe for human consumption. But can we be sure?
Proven solutions to safeguard the drug supply through electronic pedigrees-a documented and complete history of a given product's chain of custody, from the manufacturer to the point of dispensing-are available today and in use across the United States, selectively. Yet, delays in government action to arrive at a unified drug pedigree mandate limit their adoption and are dangerously increasing the risk that counterfeits in the drug supply chain could directly affect unsuspecting patients. The result is that companies who are concerned about patient safety and look to electronic pedigrees as a cornerstone in their efforts to enhance product security are left to blaze their own trail in the hopes of protecting patients.
e-Pedigrees: Systemic Security Protection and Foundation for Value Creation
Electronic pedigrees provide a comprehensive set of tools to bear on securing the legitimate supply chain. Product information such as NDC, lot number, and expiration date are gathered from the original manufacturing process and then securely linked to extensive transaction detail about the changes of possession that a drug undergoes from manufacture to final dispensation. If serialized products are shipped, these serial numbers are also incorporated into the pedigree. As a result, the e-Pedigree secures the chain of custody, preventing phony transactions and products from getting into or remaining in the legitimate supply chain.
This comprehensive nature of electronic pedigree truly provides the foundation for a systemic approach to product security. We see this in how e-Pedigree provides holistic prevention, detection, and investigation support for protecting the supply chain. Prevention by significantly raising the financial investment required for individuals who seek profit by injecting adulterated products into the legitimate supply chain. The integration of digital certificates, self-authentication capabilities, and forge-resistant data security technologies used in pedigrees initiated at the manufacturer help deter individuals by creating a chain of custody that is hard to attack or reinvent. Detection through electronic pedigree systems that identify forged pedigrees for products as they are received and analyze transaction trails to identify suspicious product flow patterns. Investigation by providing a complete, verifiable, and non-repudiated transaction trail with extensive detail on product, organizations, facilities, and related financial transactions that can be used as legal evidence.
This cross-section of product, transaction, trading partner, and financial information driven by integrated pedigree systems can also provide the basis for powerful, tightly-linked supply chain and business collaboration solutions that drive supply chain efficiencies.
Hurdles to Safeguarding the Drug Supply Chain
The pharmaceutical pedigree concept and the electronic pedigree model of implementing it are not new. Currently, 27 states have pedigree requirements with a number of others considering new mandates. In addition, the federal PDMA requirement is also in force, even though certain elements of it are in question due to recent legal action. The expectation is that renewed FDA action is not far behind.
While the concept is simple, the industry faces several problems with implementation. First, the regulatory landscape is a mish-mash of conflicting requirements that challenge the development of a comprehensive compliance strategy. Second, companies who may not have a regulatory requirement today may run into one as they seek to grow their business by establishing new trading relationships or expand into new regions. Third, companies with patient safety and product security as key imperatives encounter hurdles in implementing their strategy, even within their current trade networks, as trading partners hesitate to start pedigree programs that may force them into a regulatory environment.
These hurdles would be tough enough even without a changing landscape. And, as California showed, legislation has a way of changing without a moment's notice. Just when you think a bill is forgotten, or lost in sub-committee, it becomes law.
What was a relatively straightforward requirement for electronic pedigrees a couple years ago became a combined pedigree-serialization requirement for first 2007, then 2009, then 2011 and eventually 2015. Now, all manufacturers selling drugs within the state must have an e-pedigree and serialized product for 50% of its products by the start of 2015, some four years after already-delayed date. The remaining 50% must be serialized and have e-pedigrees before January 1, 2016. Another wave of legislation comes into effect on July 1, 2016 prohibiting wholesalers or repackagers from receiving, selling, trading, or transferring a dangerous drug without a pedigree.
This is not to say that implementing an e-Pedigree system is child's play. Indeed, there are technological, operational, and trade collaboration questions to address in implementing an e-Pedigree system. The challenges can be significant but existing systems demonstrate that these challenges can be overcome. A much greater concern arises when item serialization requirements are layered on top of e-Pedigree mandates, drastically increasing complexity and cost with a modest addition in security. While these two capabilities, e-Pedigree and Serialization, are mutually supporting, all too often we see that the dialogue inappropriately blends the two, thus losing the unique value and benefits that each bring to the table. So the question is: Are regulatory requirements the driving factor for product and patient security or the excuse to maintain the status quo? The time to act is now rather than wait for arbitrary mandates and dates to determine the strategic direction a company takes.
Patient Safety is Good Business: One Company's View
So what is a company to do in this environment when they are concerned about the safety of the drugs they manufacture, distribute, or dispense? Is now the time to implement an e-Pedigree solution, or is it more prudent to wait until unified legislation makes it mandatory?
Novis Pharmaceuticals, a leading distributor of biotherapeutic products to healthcare providers, didn't wait for legislation to move forward with a Patient Safety Initiative Program. In September 2007, Novis launched a prototype to strengthen product security using electronic pedigrees for all the products it handles, starting with high risk drugs like heparin and ones that provide its customers the most value.
Novis has also taken the proactive step of blending the SupplyScape E-Pedigree system with an internal serialization solution based on SAP to further product tracking throughout the supply chain. This newly launched inventory tracking system, NOVIS RxID, is set to protect product integrity by enhancing drug product traceability and extend protection to customers. In addition to security benefits of electronic pedigree, Novis is also leveraging the SaaS-based E-Pedigree solution to drive operational efficiencies across multiple locations and meet national security requirements.
With Novis' forward-thinking program, customers can also more easily access information about their drugs-something the competition cannot claim. Novis' customers will be able to use a Web-based portal to view and manage their drug and pedigree through their entire process. The value-add is the ability to develop event management functionality that can alert customers based on predefined business rules. For example, alerts can be sent prior to a drug reaching its expiration date or if a drug, needing refrigeration, is not scanned into its proper storage location.
With an official launch of its NOVIS RxID program slated for mid-2009, Novis will become one of the leaders in demonstrating that you can navigate the complex regulatory environment if you keep your eye on your key strategic imperatives, be they patient safety, operational efficiency, customer service, or other.
Brian Daleiden is director of marketing, SupplyScape Corp, which is a provider of software and consulting services to secure the safety and value of the global life sciences supply chain. SupplyScape offers an integrated set of business process applications for Global Serialization, Product Authentication, ePedigree and Track and Trace built on the Nexus supply chain collaboration environment. http://www.supplyscape.com/.
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