Traceability Solutions To Mitigate Pharma Supply Chain Risks

The global pharmaceutical industry has found itself under the intense glare of public scrutiny, and this scrutiny has been fueled by a multitude of factors. These factors encompass a wide range of concerns, from the cyclical and uneven availability of medications to pressing issues related to environmental, social, and governance (ESG) transparency. Furthermore, the industry has been grappling with a disturbing surge in incidents involving counterfeit medications. In this comprehensive analysis, we delve into the evolving landscape of the pharmaceutical sector, a sector whose foundations are being profoundly reshaped by the imperatives of the digital age.

The pharmaceutical industry, like many others, has witnessed the transformative potential of Industry 4.0. This fourth industrial revolution, characterized by the integration of digital technologies into manufacturing and distribution processes, presents a watershed moment for pharmaceutical companies. The traditional model, often referred to as Industry 3.0, which has underpinned the operations of the majority of pharmaceutical companies, is no longer sufficient to meet the demands of an increasingly complex and interconnected world.

In a recent report published in the esteemed International Journal of Pharmaceutics, titled “Industry 4.0 for Pharmaceutical Manufacturing: Preparing for the Smart Factories of the Future,” experts underscore a critical point: pharmaceutical companies must undergo a profound evolution in their operations. This transformation involves embracing an unprecedented level of data digitalization, particularly in the realm of supply chain management.

At the heart of this digital transformation is the inclusion of supply chain-related data that goes beyond the traditional parameters. It encompasses crucial information about raw materials, their variability, and the global tracking of these materials as they traverse the intricate network of pharmaceutical facilities. This digitalization is not just a technological nicety; it’s a strategic imperative driven by a confluence of forces that extend far beyond the confines of supply chain efficiency.

Navigating Towards Regulatory Compliance

One of the most compelling drivers for the digital transformation of pharmaceutical supply chains is the ever-tightening web of regulations imposed by governments and regulatory agencies worldwide. These regulations are designed with a singular focus: ensuring the safety and quality of pharmaceutical products.

A prime example is the Drug Supply Chain Security Act (DSCSA) in the United States, a sweeping piece of legislation that carries profound implications for pharmaceutical businesses. DSCSA mandates the implementation of a serialized, electronic, and interoperable system to track and trace prescription drugs across the entire supply chain, involving all stakeholders. The deadline for compliance with DSCSA is rapidly approaching, set for November 27, 2023.

However, DSCSA is just the tip of the regulatory iceberg. Around the world, countries and governmental bodies are adopting increasingly stringent measures, pushing pharmaceutical companies towards a digitalized future. The goal is to enhance traceability, accountability, and ultimately, the safety of pharmaceutical products.

Supply chain digital maturity is no longer a desirable luxury; it’s an essential frontier for pharmaceutical companies to navigate successfully in the face of mounting risks within their industry. Organizations such as GS1, responsible for establishing traceability standards in healthcare, the World Economic Forum (WEF), and the World Health Organization (WHO) are providing guidance on the development of best practices for traceability in the healthcare sector. Compliance with these directives has become an imperative for pharmaceutical companies, as non-compliance can lead to costly penalties and legal entanglements. Such consequences not only erode trust among healthcare providers but also tarnish the reputation of pharmaceutical companies in the eyes of patients, regulatory bodies, media outlets, financial institutions, and investors.

Battling the Scourge of Counterfeit Medications

Counterfeit drugs pose a grave threat to global healthcare, and the statistics are alarming. According to estimates by the World Health Organization (WHO), approximately 11% of medications in developing countries fall into the category of substandard or falsified drugs. These substandard products jeopardize the health and well-being of patients, particularly in low- and middle-income countries where the economic burden of counterfeit drugs is disproportionately felt.

Disturbingly, the issue of counterfeit medications is on the rise. Data from the Pharmaceutical Security Institute reveals a 38% increase in pharmaceutical crime incidents between 2020 and 2021. These incidents have had a pervasive impact, reaching 142 countries across all seven regions of the world. North America and the Asia-Pacific region have been particularly affected. Experts estimate that the global pharmaceutical counterfeit market is worth a staggering range of US$200 to US$432 billion, a testament to the scale of this challenge.

It’s essential to recognize that the counterfeit drug problem extends beyond shadowy, illegal street markets. Legitimate online pharmacies that claim to sell U.S. FDA-approved medicines to American consumers present a daunting challenge. The sheer number of active online pharmacies, estimated at 35,000, is staggering. Even more concerning is the fact that a staggering 96% of these online pharmacies operate in violation of applicable laws, as reported by the National Association of Boards of Pharmacy.

Addressing this grave issue requires proactive measures. Industry experts and governmental bodies advocate for real-time traceability solutions that empower pharmaceutical companies to respond swiftly to nonconformities and counterfeiting alerts. These solutions enable more efficient recalls, thus safeguarding patients from the potentially life-threatening consequences of counterfeit medications. The implications of this reach far and wide, protecting not only individual health but also the integrity of the entire pharmaceutical supply chain.

Rising to the ESG and Transparency Challenge

In an era where environmental, social, and governance (ESG) concerns are at the forefront of global discourse, the pharmaceutical industry faces a unique set of challenges and opportunities. Historically, the industry has not been perceived as a leader in the battle against climate change and social injustices. Some pharmaceutical companies have been accused of “greenwashing,” using their image as producers of life-saving drugs to deflect concerns about their environmental impact.

However, this perception is being challenged, and rightfully so. In an article from Pharmaceutical Technology, Lotfi Belkhir, an associate professor of engineering at McMaster University and chair of eco-entrepreneurship, made a pointed observation: “The pharma industry appears to have conveniently hid behind its image of clean factories making life-saving drugs. Who cares about carbon footprint when you’re doing so much for humanity, right?”

Contrary to this perception, research from 2019 revealed a stark reality: large pharmaceutical companies were found to be more carbon-intensive and generated 55% more emissions than the automotive industry. This discrepancy is partly attributed to the need for extensive cold storage in pharmaceutical operations.

Nevertheless, change is afoot. Businesses within the pharmaceutical sector are increasingly taking concrete actions to meet ESG targets and uphold principles of sustainability. Initiatives such as the Pharmaceutical Supply Chain Initiative, EcoVadis ratings, and the monitoring of Scope 1, 2, and 3 emissions are becoming standard practices.

Yet, regardless of the specific actions taken, the crucial role of supply chain traceability in achieving and demonstrating sustainability standards cannot be overstated. Transparency at every stage of pharmaceutical production and distribution is essential to substantiate the true impact that companies are making in their journey toward environmental and social responsibility.