The pharmaceutical industry faces a mounting challenge in the form of drug shortages, particularly for sterile parenteral products. This poses substantial risks to patients, healthcare providers, and the industry itself.
 
According to David Shenberger, Vice President, Strategic Development, at CAI, the main drivers behind drug shortages include supply chain interruptions, increased demand, market withdrawals, limited flexibility to increase production to meet demand, and quality-related issues.
 
Quality-related issues, such as regulatory approval delay, API production delay, reduced yield due to development, and legacy product site transfer delay, are the leading drivers behind shortages. Supply chain disruptors, including global events, material shortages, financial instability, site events (such as labor unrest), or local events (weather), are other key reasons for drug shortages.
 
What is the best way to avoid drug shortages? According to Shenberger, a resilient supply chain ensures the availability and safety of essential medicines, which is where drug availability risk assessment becomes indispensable.

Risk Assessment Across the Supply Chain

Understanding and assessing risks across the entire supply chain are essential facets of ensuring a robust supply of parenteral products. Identifying potential vulnerabilities empowers companies to proactively address issues before they escalate into major disruptions.
 
Strategies may encompass supply chain optimization, the adoption of cutting-edge technologies, or diversification of sourcing channels. Improving market forecasts also emerges as a pivotal factor in averting drug shortages. Accurate demand prediction facilitates precise production and distribution planning, reducing the likelihood of supply chain disruptions.
 
Another crucial aspect of ensuring the resilience of the supply chain is the implementation of regular supplier quality audits. These audits serve as a proactive measure to assess and enhance the quality and reliability of raw materials and components provided by suppliers. By maintaining rigorous quality standards throughout the supply chain, companies can further mitigate the risk of disruptions and uphold patient safety.
 
Finally, Shenberger underlines the significance of increased collaboration and regulatory engagement in addressing the root causes of drug shortages. Collaboration with regulatory authorities, founded on strategic regulatory pathways, enables expedited approvals and adjustments to manufacturing processes. This proactive engagement fosters seamless production continuity.
 
Effective communication, including business continuity planning, is the lifeline of supply chain management, says Shenberger, because it ensures seamless coordination and swift responses to critical issues for patient well-being.
 
In an environment where patient safety is paramount, quality assurance and regulatory affairs are crucial for uninterrupted access to life-saving medications.