Michael T. Lucas | Frequentz
This winter my son’s pediatrician wrote a prescription to alleviate his cough. We went to the pharmacy and filled it. We understood the side effects and all the counter indications associated with this medicine. While we weren’t sure the cause of the cough or if the prescription would help, we never doubted that the medicine was anything but real. We trusted it. We trusted “them”. But who was the “them” we trusted? We didn’t know who handled the drug? Nor did we know how or where it was made and if the conditions were optimal. We didn’t know where the ingredients came from or who touched the pills or pill bottle, for that matter. I found it curious that given all the unknown data points and all the things we didn’t know, we trusted that the medicine was safe for our son. I had no other choice but to blindly trust.
It got me thinking about the Avastin counterfeit incidents that have happened a few times over the year. The patients had cancer. The families were afraid of losing the patient to cancer. They were vulnerable. They hoped that the drug would work on their cancer, but never considered that their drug was counterfeit or fake. They trusted the drug and all the people involved in the drug development, manufacturing and distribution process. They trusted that all processes were executed upon and all were compliant. They had no choice but to trust. In the end, that trust was violated. Sadly, Avastin did not contain the active pharmaceutical ingredient (API), which is used to treat cancers. Yes, the patients got fake Avastin for their very real cancer. Despite discovering the violation, patients across the country continued to have their cancer treated with fake (and useless) Avastin, by trusted healthcare providers. Yes, even after the drug batch was discovered to be counterfeit, patients continued to be treated with it.
Patients and consumers have no option but to trust providers, manufacturers and regulators. Patients (and physicians) can’t eye a drug and decipher its authenticity. They rely on the honor system of the supply chain and basic trust. But in the case of Avastin, trust wasn’t enough and the honor code was violated. These patients never had a chance to benefit from being treated with one of the most noteworthy cancer treatments, Avastin. Their lives were cut short and their families lost loved ones before they had to.
Patients, consumers and even healthcare providers have responded to fake Avastin and other counterfeit medicine incidents with curiosity and confusion. Most assumed controls were in place and are surprised safeguards are not in place to ensure the integrity of medicine. They didn’t realize the amount of daily risk they were putting themselves in, and more importantly they assumed technology was already mitigating risks stemming from counterfeits, as well as, protecting them from counterfeits and substandard medicine. Finally, they were confused that if there was a way to protect them why wasn’t it being instituted? Why weren’t they protected?
In response to this realization, consumers, government representatives, patient advocates and industry leaders sought action to protect patient safety and health. Industry associations launched awareness and education campaigns and conduct studies on the impact, prevalence and loss resulting from counterfeit. Government agencies and patient advocate groups crafted policy recommendations. Before there was anytime to stop and think about it, pharmaceutical companies realized that they had to quickly adapt an approach that went beyond regulatory compliance and sought to protect their consumers, product value and brand. A movement was formed and track and trace was on the forefront of patient safety, health and protection.
Track and trace technology is a simple and effective way to leverage basic serialization and item level identifiers and protect patients and consumers against counterfeiting and substandard medicines. Its advantage is that it enables the serial number to be recorded at various points throughout the supply chain on a central server or on the product itself; facilitating the discovery of where counterfeit products have entered the supply chain – end-to-end. Track and trace goes below the surface of medicines alone, and safeguards the active and inactive / bulk ingredients. Hence, supporting the adage it is only as good as what goes into it. Track and trace also provides for full traceability of products globally as well as regionally.
An early driver for track and trace adoption was the need to eliminate theft and diversion by focusing on accountability – who physically had custody of the drug before it reached the consumer? Serialization of each unit provides companies visibility into their supply chain down to the unit level of every event. The visibility translates into chain of custody and ultimately the accountability required to safeguard patient health and safety.
In addition to accountability, track and trace creates a safety and quality control for medicine. We all know that mistakes can happen, and this often doesn’t affect the entirety of a project, process, or product, but there is a need to be able to identify those differences. If there are issues with a certain medication, companies need to be able to determine the issue, its dynamic, likelihood of an occurrence and severity level. Most important, track and trace identifies the exact medicine / item that puts patient health and safety at risk. In turn, serialization protects patient health and safety by facilitating rapid recalls, preventing production of the substandard medicine, ensuring the integrity of medicines and mitigating damages at real time speed.
Despite this capability and the ease of execution, track and trace is not in mass use. In fact, less than half of global manufacturing sites have implemented track and trace programs. Hence, the processes and data needed to generate accountability and subsequently safeguard patient safety and health are not captured. Leaving the drug supply vulnerable to counterfeits, drug shortages, diversion and substandard products. Policymakers have crafted mandates both at the state and federal level requiring chain of custody (a record of events).
One of the first and most noteworthy examples of regulatory mandates is the California e-Pedigree. California e-Pedigree requirement led the serialization movement, requiring unit level chain of custody for all drugs sold in California by 2015. Federal regulators followed suit with a few failed attempts and a recent win earlier this month where Track and Trace legislation was passed which would begin track and trace at the lot level and would gradually evolve track and trace requirements at item level, most likely via sGTIN. While additional mandates do not refer to track and trace by name, mandates such as FDASIA have required unique facility identifiers and mandatory inspection that create accountability and chain of custody – all elements of track and trace and fundamental to protecting patient health and safety.
Track and trace and serialization as a tool to protect patient safety and health is a global movement. Requirements for serialization and subsequent accountability and chain of custody has spanned across the global and has been fueled by countries demanding serialization from their import / export trading partners. For example, in order to continue to comply with regulatory mandates in European and future U.S. markets India and China have begun implementing serialization and chain of custody requirements into manufacturing processes and practices.
In the end the harm of counterfeiting goes beyond clinical practices and erodes the trust we have in our healthcare providers, regulators and the legitimacy of research, scientific development and medical treatment. Track and trace is a solution that can validate the authenticity of my son’s cough medicine and could have validated the authenticity of Avastin. Track and trace provides visibility, solid data points and chain of custody required to protect patient safety and health – and substantiate the current trust we blindly have.