Why DSCSA Matters More Than You Think 

Part 2 of 3 

By Martin Dennis, Pharmacist 

A Crisis that Changed Everything  

Pharmacy compliance starts with meticulous rule following, and today, DSCSA compliance and drug supply chain security are essential parts of every pharmacist’s responsibility. Kill Shot. It sounds like the title of an espionage thriller or a sniper’s memoir, doesn’t it? It’s the chilling name of a book that covers the deadliest drug contamination crisis in American history. The full title is “Kill Shot: A Shadow Industry, A Deadly Disease” by Jason Dearen. The contents of this book are disturbing to any self-respecting pharmacist. It details the events leading up to the 2012 New England Compounding Center (NECC) meningitis outbreak, where 64 people died and over 750 patients were infected with fungal meningitis from contaminated compounded steroid shots. These sterile compounded injections were prepared in the most unsterile manner, then shipped across the country and used in intrathecal injections for chronic back pain, among other conditions. The book is a journalistic exposé that covers the trials, outcomes, and reforms following this event and will leave you feeling disgusted, angry, and uneasy.  

A History of Tragedy: From Sulfanilamide to Steroid Injections  

Our profession was severely tarnished by this scandal. The scale of the NECC tragedy rivals the infamous 1937 sulfanilamide disaster, which led to the creation of the Food, Drug, and Cosmetic Act of 1938. In that case, the S.E. Massingill Company developed an oral sulfanilamide formulation, an antibiotic elixir. The formula was simple: mix raspberry flavoring with sulfanilamide powder and dissolve it in diethylene glycol (DEG). Yes, you’re correct, DEG is antifreeze, it’s poisonous and will damage your kidneys, and in 1937 it did just that, killing at least 107 people.  

Legislative Response: The Birth of DSCSA  

Thanks to the NECC scandal, seventy-four years after its creation, the Food, Drug, and Cosmetic Act was about to receive a significant  amendment. These changes were signed into law by President Barack Obama on November 27, 2013, with broad bipartisan support.  

This amendment came into two parts: 

  • Title I: Drug Quality and Security Act (H.R. 3204) – granted the FDA more authority to regulate and monitor compounded drugs, creating new categories of compounding pharmacies, such as 503B. 
  • Title II Drug Supply Chain Security Act (DSCSA) – addressed the vulnerabilities in the pharmaceutical supply chain exposed by gray market activities 

The purpose of Title II (DSCSA) was to: 

  • Strengthen the FDA’s ability to protect consumers from counterfeit, contaminated, or dangerous drugs. 
  • Create a system for tracking and tracing prescription drugs from manufacturer to dispenser. 
  • Improve detection and removal of illegitimate drugs from the pharmacy supply chain 

Rethinking Clinical Assumptions  

Many pharmacists believe these safeguards have always been in place. However, DSCSA marks a turning point by shifting from assumption to responsibility. Consider all the clinical truths that come into question if we cannot trust the product on our shelves to be what it should be.   

  • Is the patient truly allergic to a drug, or are they reacting to a contaminant or expired medication?  
  • Is the patient resistant to therapy, or could the drug be diluted, subtherapeutic, or counterfeit?  
  • Is the patient experiencing an unusual reaction to a drug, suggesting a unique biological response or a possible problem with the product not being what it’s labeled as?  

How many times have we claimed that all generics are identical, or that the AB-rated generic is just as good as the brand? How many times have we raised an eyebrow at a patient who says that one color of pill works better than another? Our ignorance, condescension, judgment, and opinions are often based on the assumption that the product in our hand is the product it is supposed to be. Fakery, forgery, and adulteration rarely enter clinical evaluation or professional thought.   

Lengthy Implementation  

But finally, all the problems caused by the illicit gray market supply chains were resolved, right? Not so fast. DSCSA brought significant changes to the way business is conducted in the pharmacy supply chain. The supply chain is massive and global. Before the legislation was even signed, pushbacks, excuses, extension requests, and delays became common. That’s why an amendment signed into law twelve years ago is only now starting to influence the pharmacy industry today.   

Key components of DSCSA  

The key element of DSCSA is to be able to track a single package from manufacturer to pharmacy using the following:  

  • Serialization:  Unique product identifiers on each package  
  • Transaction Information: Required data exchange between Manufacturers, wholesalers, and dispensers 
  • Verification: Requires trading partners to verify product authenticity  
  • Interoperability: Systems must communicate effectively across the supply chain.  

Stay Tuned for Part 3: DSCSA in Action

The hard part is here, pharmacies now carry the responsibility for tracking and tracing every product on their shelves.

Liberty Software makes DSCSA compliance simple, helping you meet requirements, protect your patients, and keep your pharmacy running smoothly.

Learn More About How Liberty Software Supports Compliance →

Stay tuned part three to learn how Liberty’s Pharmacy One software supports DSCSA compliance.