Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSThe American Society of Health-System Pharmacists (ASHP) and Utah Drug Information Service report that the United States faces record high drug shortages in 2024, exceeding the peak a decade ago. Essential medications, including cancer treatments, anesthetics, pain medications, as well as drugs for weight loss and diabetes, are among those currently in short supply.
These shortages stem from a complex interplay of factors beyond just manufacturing quality. Economic pressures, outsourcing practices, regulatory hurdles, data integrity issues and outdated technology all contribute to the problem.
Financial constraints greatly contribute to the drug shortage problem. As drugs go off patent, and profit margins erode, quality assurance emerges as a greater concern. Congruently, suppliers and manufacturers may elect not to make the product as there stands little financial benefit to its production. Specifically, the greater the constraints around the quality of a product, whether related to the supplier or the active pharmaceutical ingredient, the tighter the margin. As manufacturers opt out of producing certain products, further downstream effects are felt as production decreases.
Outsourcing the final production of a drug can significantly impact the supply chain. The greater the distance between the source and the finished product, the higher the risk of quality issues. Monitoring product quality and ensuring timely delivery are easier with advanced technology, however, addressing problems remotely can be challenging.
Another concern is the prevalence of outdated or disparate technology used throughout the pharmaceutical supply chain. Rapid technological advancements render some investments obsolete, limiting production capacity. Even repairing certain equipment as it becomes damaged is simply not feasible. These financial constraints create a situation where tight margins lead to compromised quality.
Regulatory bodies have made substantial efforts to mitigate drug shortages by developing stricter material and product quality guidelines. The FDA’s enforcement, in theory, is meant to amend shortages. However, when audits reveal noncompliance, some manufacturers opt, out of an abundance of caution, to pause production. While this is a precautionary step, it can further hinder drug availability. To address this, the FDA has enacted a new initiative to enhance communication between investigators, manufacturers and drug shortage and compliance teams. This latest program aims to minimize production pauses for at risk shortages and allow approved operations to continue.
So, how do pharmaceutical industry stakeholders prepare and prevent these factors that contribute to drug shortages? This can be accomplished by leveraging technology and software to better identify trends and indications of pending drug shortages. For example, the ability to identify trends of late delivery or short quantities, continual nonconformance of delivery of raw ingredients or materials and active pharmaceutical ingredients all signal emerging shortage concerns.
IQVIA's SmartSolve platform incorporates supplier management processes to identify trends in on-time delivery performance and predict potential disruptions due to expanding lead times, late deliveries or shortage quantities. This foresight empowers manufacturers to plan and adapt accordingly. SmartSolve highlights the importance of supply chain visibility and identifying issues before products even arrive at the manufacturer.
The rigor within the quality management system plays a role in addressing emerging manufacturing issues. Quality assurance examines deliveries and factors in expanding lead time, late deliveries and shortage quantities to better forecast and predict shortages ahead of time. By proactively warning the market and preparing for shortages, the industry can effectively mitigate factors contributing to drug shortages.
If you are interested in learning more about the IQVIA SmartSolve platform and our Quality Compliance consulting services, visit our site here.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.
