Issue Statement:
Congress enacted the Drug Supply Chain Security Act (DSCSA), as a response to the rise in the number of counterfeit medicines that enter the US drug supply chain costing about $75 billion and $200 billion dollars per year worldwide and killing hundreds of thousands annually . The DSCSA aims to strengthen the integrity of US pharma supply chain, decrease vulnerabilities that lead to counterfeiting and protect patient safety. Virtually every hospital, pharmacy, clinic, physician and long-term facility (known as dispensers) that dispenses prescription medicine in the US now faces a set of DSCSA compliance requirements. However, many dispensers especially the smaller ones don’t have the resources to effectively implement DSCSA requirements. How can one ensure DSCSA drug safety solution does not disintegrate at the point closest to the patient given the implementation challenges faced by dispensers?
Background:
The United States has one of the largest drug supply chains with over $212 billion dollars in medicines flowing through. Even though the FDA has said the US has one of the safest drug supply chains in the world, the complexity of the pharmaceutical distribution chain still gives ample opportunity for falsified or counterfeit drugs to infiltrate the market. In the US, the distribution chain includes drug manufacturers, wholesale distributors, repackagers, and dispensers. Drugs change hands many times from the time they leave the manufacturer and reach the patient. Every transaction among the different stakeholders in the drug supply chain is an opportunity to introduce substandard products into the market. When these counterfeit products make their way into consumer’s hands the results can be devastating. For example, in 2011, a counterfeit version of the life-saving cancer drug Avastin reached US consumers. The counterfeit drug did not have the intended active ingredients in them and patients that unknowingly obtain them were not getting the medical treatment they needed. As a result, many of them were seriously injured and even got reduce life expectancy.
With the rise of counterfeit medicines in the USA, Congress enacted the Drug Supply Chain Security Act (DSCSA) to protect patients and ensure that safe and effective drugs are the ones reaching US consumers. The DSCSA targets all stakeholders in the drug distribution chain from manufacturers to dispensers by establishing full supply chain traceability in an electronic interoperable system. Dispensers, who include virtually every hospital, pharmacy, clinic, physician, and long-term facility that dispenses drugs to a patient, have a unique role in ensuring patient safety. These include the following: a) dispensers must be able to receive the lot-level Transaction History (TH), Transaction Information (TI) and Transaction Statement (TS), known in shorthand as "T3" compliance documentation, for every product they purchase; b) they must be able to verify this compliance data against the product that was shipped to them by their suppliers; c) store the compliance data for a period of at least 6 years; d) provide compliance data if dispensers resell to another pharmacy or loan the product; e) retrieve and respond to request for information and verification inquiries. In addition, the tight compliance deadlines might leave dispensers confused as to how best to implement these requirements. Dispensers might be tempted to make short-term decisions, trading off long-term compliance investments for the sake of expediency, and thus undermine the overall purpose of the law to protect patients and enable health.
Landscape:
Like with any new regulatory law all stakeholders will face some implementation challenges. Manufacturers might have the budget to implement the electronic system needed for tracking, however, some dispensers might not. Since dispensers can include smaller hospitals or pharmacies these providers might not have the funds or infrastructure to adequately comply with the law. The law only states that a dispenser must be able to read and retain the compliance data but it does not mention how should they do it. These interoperability standards between dispensers and manufacturers will affect all healthcare providers but especially those smaller providers that dispense prescription medicines. Most hospitals do not have a sustainable and effective DSCSA compliance system in place. The tight deadlines can further exacerbate the costs on smaller dispensers that must expediently comply. The challenges faced specifically by dispenser can include how to capture and manage large volumes of compliance documentation in diverse formats from suppliers, and verifying received product from supplies while minimizing impact to pharmacy efficiency. Furthermore, they might experience challenges managing and appropriately tracking consignment inventory and as well as tracking emergency drop shipments directly from manufacturers. Technology alone will not solve the problem since staff must also be trained in how to read and manage the compliance data.
Given the recent drug counterfeit threats to American patients in the last several years, all stakeholders agree and are committed to the goal of protecting patients and enabling health. As such, partnerships amongst the stakeholders to implement DSCSA adequately will be well received by all key players in the drug distribution chain.
Options:
In evaluating how to ensure the DSCSA drug safety solution does not disintegrate at the point closest to patients given the implementation challenges faced by dispensers, expediency, long-term efficiency, and costs are the criterion. As such, the options are 1) to maintain the status quo; 2) to initiate a fundraising campaign that would aid the costs of implementation infrastructure; 3) to leverage a network of pre-connected suppliers and trading partners with a common set of tools resulting in sustainable partnerships.
Option one: Wait and see. Maintaining the status quo by waiting and seeing can be a good option since the DSCSA compliance requirements will continue to evolve over the next several years through new FDA guidance. In terms of expediency, dispensers would still have to comply with the requirements but given the uncertainty might come up with short-term solutions. However, a quick fix would water down the ability of the compliance system to ensure effectively combat counterfeit drugs and thus would result in no long-term efficiency and higher costs that would generate from the numerous hidden costs and undo risk that would be created from a fast quick fix approach.
Option two: Initiating a fundraising campaign to aid in costs associated with infrastructure implementation. By having dispenser initiate a fundraising campaign, many of the costs associated with implementation would be taken care of. However, fundraising campaigns in a large scale might take up a lot of time and effort to gather all the funds needed and might not allow the dispenser to expediently comply.
Option three: Leveraging a network of pre-connected suppliers and trading partners with a common set of tools that would provide a partnership platform for DCSCA implementation throughout all its facets. This option would enable all stakeholders to work together to develop an expedient cost-effective system. Leveraging such network will help buffer dispensers’ amount and complexity of the compliance data connections they would need to manage and maintain. It will facilitate enabling a system that provides a common set of tools for data storage, acquisition and review regardless of the product or sourcing supplier. Hence, this system would provide expedient compliance. As guidance to implementation will continue to change all team players in this partnership can still continue to work together coming up with new approaches to compliance. This will result in a long-term efficient way of implementing the requirement in a cost effective way. This partnership would allow dispensers like hospitals to spend less time trying to meet between managing requirements and spend more time interacting with patients.
Recommendations:
In light of seeking an expedient, long-term efficient and cost-effective solution, option three is the recommended one. The end goal of stopping drug counterfeiting is to protect patients and enable health. Although the DSCSA regulation is an important step in ensuring patient safety it will take several years to fully implement. As time goes by and guidance regarding implementation changes, the need for partner connectivity and flexibility in configuring compliance is very important. Option three provides a long-term, sustainable compliance approach that will meet the scalability needed in order to have a comprehensive patient safety program in the US where consumers are ensured of the safety and efficacy of their prescription drugs.