The United States has the safest pharmaceutical supply chain in the world. Yet, it continues to be threatened by counterfeit medicines, a growing issue that has been estimated at between $75 billion and $200 billion dollars per year worldwide, killing hundreds of thousands of annually, according to the World Health Organization and HealthResearchFunding.org.
Counterfeit medicines – which include everything from lifestyle drugs to lifesaving treatments for diabetes and cancer – have either a fake active ingredient, the wrong levels of ingredients or lack an active ingredient entirely. To protect patients from these potentially dangerous drugs, governments around the world have enacted serialization and track and trace regulations. In the United States, this includes the Drug Supply Chain Security Act DSCSA law establishes full supply chain traceability – from pharmaceutical manufacturers to dispensers – coupled with unique saleable unit serialized identity to help strengthen the integrity of the U.S. pharma supply chain, decrease vulnerabilities that lead to counterfeiting and protect patient safety.
Virtually every hospital, pharmacy, clinic, physician and long-term care facility that dispenses prescription medicine in the US faces a set of DSCSA compliance requirements, the first phase of which began on July 1, 2015. This article will outline DSCSA regulations established to help protect patient safety and offer insight on what hospitals need to do to ensure long-term sustainable compliance.
The Realities of Drug Counterfeiting
Genuine medicines contain clearly defined ingredients and are manufactured and packaged under strict regulations to meet quality standards to ensure safety and effectiveness. In direct contrast, counterfeit drugs might have no active ingredients, diluted ingredients, the wrong ingredients, or harmful contaminants such as leaded road paint, floor wax, shoe polish, talcum powder, chalk and brick dust, nickel and arsenic – all recently found in fake drugs, according to a Forbes article. Even counterfeit products with legitimate ingredients are typically manufactured with little quality control.
According to a PBS Nova NEXT article, an estimated 80 percent of counterfeit drugs come from overseas. However, this does not prevent those drugs from reaching the U.S. The article discusses counterfeit version of the cancer drug Avastin that was widely distributed in the U.S., as well as a fake version of the ADHD drug Adderall, in high demand because of a shortage, that arrived in the U.S. through internet pharmacies.
Medicines are also adulterated or modified in other ways such as "up labeling". As was seen in the famous Timothy Fagan case, ordinarily legitimate medicines may be relabeled to represent a higher dosage, increasing their street value while simultaneously threatening patients who end up taking lower doses of medicines than indicated for their condition.
Although the United States has the safest medicine supply in the world, we also have over $370 billion dollars in medicines flowing through one of the largest and most complex supply chains. Therefore, the U.S. creates a constant target for counterfeiters and diverters.
DSCSA Regulations Today
To protect U.S. patients, DSCSA was created to implement a comprehensive national track and trace regulation to replace the growing patchwork of state-level pedigree laws which were in force. Four distinct segments are identified in DSCSA as having specific regulatory requirements: manufacturers, wholesale distributors, repackagers, dispensers. Under the DSCSA, hospitals with pharmacy operations are considered "dispensers" and have a requirement under the law.
DSCSA outlines critical steps to build an electronic, interoperable system to that will identify and trace prescription drugs from manufacturer to dispenser across the supply chain. Implementation of the 40 pages of complex DSCSA regulations can be broken down into three general phases:
- 2015: Lot-level traceability and verification of products and transactions during suspect product investigations
- 2017-2020: Serialization of drug products and enhanced verification of serialized product identity
- 2023: Unit-level traceability
DSCSA, while not a silver bullet, is an important step in protecting patient safety by enabling verification of products, improving the detection of suspect ones and facilitating product recalls.
What is Necessary for Dispenser DSCSA Compliance?
The first major DSCSA deadlines are now past – January 1, and July 1, 2015.
Effective January 1st, 2015, manufacturers, wholesale distributors and repackagers had to meet the initial tracing and verification regulations of DSCSA.
Effective July 1st, 2015, tracing and verification regulations for dispensers began. Key requirements include:
Step 1 - Receive Lot Level Compliance Data for Purchases -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.
Step 2 - Verify "T3" Compliance Data - Dispensers should verify the "T3" compliance data against the product that was shipped to them by their suppliers, and must quarantine any product they determine to be suspect or questionable. Note that DSCSA does not define how dispensers should verify the compliance documentation and different organizations approach this challenge in different ways.
Step 3 - Archive "T3" Compliance Data - Dispensers must store the compliance information associated with every shipment they receive for a period of at least six years from the date of transaction. Care should be taken in how this data is archived because the dispenser will need to query the compliance repository for information across a variety of situations.
Step 4 – Provide "T3" Compliance Data for Sales - Dispensers must provide "T3" documentation to another pharmacy or hospital if they are selling or loaning the product and the ownership of that product changes hands. Note that there are certain exclusions to this provision for products provided for specific patient need other scenarios documented in DSCSA.
Step 5 - Retrieve & Respond to Request for Information - If the FDA or appropriate federal or state official issues a Request for Information (RFI) related to a suspect product investigation or to facilitate a product recall, the dispenser in question must retrieve specific compliance data within two business days.
Step 6 - Respond to Verification Inquiries - If the determination is made that the dispenser possesses a suspect product or if a request for verification is received from the FDA, quarantine such product and conduct an investigation in coordination with trading partners that shall include validating any applicable "T3" compliance data.
In 2020, serialization requirements will phase in, mandating that you purchase and sell only drug products encoded with a barcode containing a unique standardized numerical identifier (SNI) including a serial number. Enhanced verification processes involving the SNI also begin in 2020.
So today, dispensers have a diverse – and often confusing – set of new DSCSA regulatory requirements to meet. While the FDA also exercised enforcement discretion for dispensers to give them a few more months (October 1, 2015) to perfect their compliance, the law is in effect today.
Deadlines are Here, but are Hospitals in Compliance?
With tight compliance timelines, many dispensers had to make short term decisions, trading off long-term compliance investments for the sake of expediency. Based on our experience working with hundreds of companies in the pharmaceutical supply chain, we believe that most hospitals do not have a sustainable, truly effective DSCSA compliance system in place.
DSCSA compliance requirements will continue to evolve over the next several years through new FDA guidance of existing regulations, new phases of the law which begin and changes in compliance approaches from your suppliers. The focus is to create a streamlined approach that lets you continue spend your valuable time with your patients rather than on administrative work to comply with DSCSA.
DSCSA Challenges and Ensuring Best Practices
Given the flexibility afforded by the regulations, many companies believe that they can solve the challenges of DSCSA on their own. In doing so, these companies face some key challenges including:
- Capturing and managing large volumes of "T3" documentation in diverse formats from suppliers
- Verifying received product from suppliers while minimizing impact to pharmacy efficiency
- Managing central receiving and direct to pharmacy shipments
- Preparing for verification or inspection inquires
- Enabling compliant resale, loan or borrowing of prescription drugs
- Appropriately tracking consignment inventory stored at hospital locations
- Managing emergency drop shipments directly from manufacturers
Given these and other DSCSA complexities, most dispensers quickly realize that they simply do not have the sustainable infrastructure or in-house expertise to tackle it themselves.
The right DSCSA compliance approach should simplify the DSCSA compliance process and minimize the impact of the regulation for your organization. If you can leverage a network of pre-connected suppliers and trading partners, it will help buffer your organization from the number and complexity of the compliance data connections you need to manage and maintain. It's also crucial to enable a central DSCSA compliance repository which is accessible to all required pharmacy personnel and locations, providing a common set of tools for data storage, acquisition and review regardless of product or sourcing supplier.
As a hospital dealing with compliance documentation, it's important to work with a compliance partner that can deliver regulatory expertise and future perspective, not just a piece of software. The right DSCSA compliance partner will keep you from having to choose between managing requirements and interacting with patients that need your help. In addition, done right, track and trace platforms can form the basis for enabling new patient care opportunities.
The end goal in stopping drug counterfeiting is to protect patients and enable health. DSCSA is an important step in ensuring patient safety, one that will take several years to realize full implementation. Weaving together custom manual processes and one-off technology systems to facilitate "just getting by" with DSCSA compliance may sound like a reasonable option in the short term. But this approach not only generates numerous hidden costs across the organization and creates undo risk as requirements evolve; it also waters down the ability of the compliance system to be used to effectively combat counterfeit drug threats. Instead, hospitals need to look to the long term, putting into place a compliance approach to meet the scalability, partner connectivity and flexible configuration requirements that dispensers will face while enabling the foundation of a comprehensive patient safety program.
Brian Daleiden is Vice President of Industry Marketing at TraceLink, a company focused on helping pharmaceutical manufacturers, distributors and dispensers deliver safe prescription medicines to patients everywhere with the largest track and trace network in the Life Sciences industry. In this capacity, Brian leads the company's thought leadership, global regulatory analysis and market education programs that help industry stakeholders understand and respond to emerging regulatory, business and technical requirements. Brian holds an MBA from Vanderbilt University and a BS from the University of Wisconsin.