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Business & Regulation Business Practice, Supply Chain, Quality & Compliance, Ingredients

Greater Transparency; Fewer Shortages

In 2011, the number of new drug shortages in the US spiked at 267, but the regulatory response was thorough and prompt, including the 2012 FDA Safety and Innovation Act and the 2013 Drug Supply Chain Security Act. Industry consortiums also leapt into action. To name a few initiatives, the Parenteral Drug Association (PDA) established preventive end-to-end controls for drug shortage risks based on criticality of the drug product, patient impact, and overall product risk evaluation. And Xavier University published Good Supply Practices for the 21st Century.

But after three years of relative stability in the US, the number of new drug shortages rose to 186 in the year 2018; the highest number since 2012 and up 26 percent from 2017. There are a number of complex dynamics and market forces implicated in drug shortages, and the issue is amplified by rapid pipeline growth and the push for geographic expansion. The same factors are leading to increased investments in global biopharmaceutical manufacturing capacity. Growth and expansion results in an increase in the length, depth and breadth of supply chains, which in turn, increases their vulnerability to disruptions.

A major contributing factor to drug shortages is the availability of raw materials. Though it can be difficult to pinpoint the exact culprits captured in this broad category, issues with raw material supply and quality can most certainly jeopardize the consistent manufacture of drugs. In addition to regulatory initiatives and the efforts of industry organizations, suppliers to biopharmaceutical manufacturers must become active participants themselves in mitigating the risk of supply disruptions and enhancing process predictability and control. But they can only do this if biopharmaceutical manufacturers and regulatory authorities engage with them. For example, biopharmaceutical manufacturers should share basic information with suppliers about the chemicals and consumables specified in their manufacturing processes, their batch requirements, and their production schedules.  If these bill-of-materials are used to manufacture a drug on the World Health Organization List of Essential Medicines or a drug for childhood cancer, the chemicals and consumables could be deemed critical by the supplier and result in more robust risk mitigation. Such information could influence suppliers’ supply chain activities, such as forecasting, capacity planning, safety stock inventory planning and dual-sourcing, as well as allocation activities in the unfortunate event of capacity constraints. 

Similarly, sharing information related to critical process parameters and unit operation results could lead to an improvement in quality control and a reduction in raw material variability – contributing to enhanced process characterization and control, and a more mature quality management system. Ultimately, this could support biopharmaceutical manufacturers in their pursuit of a competitive quality rating. 

Even one drug shortage is too many for the patient who suffers the most. Though it is unlikely that we could achieve the goal of zero drug shortages, biopharma manufacturers could realize better success if they collaborated more with their key suppliers. Greater transparency and trust in partnerships is a must to develop more robust supply chains.

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About the Author
Dawn MacNeill

Head of Supply Robustness, Process Solutions, MilliporeSigma

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