Why Drug Shortages Occur – Analysis
As a member of research group ReMediES, Intersys’ Risk Director Catherine Geyman collaborated with leading pharma companies and the University of Cambridge on a groundbreaking white paper. Here’s what it said.
Download the industry-leading white paper Understanding Risk in Pharmaceutical Supply Chains, produced by ReMediES
A collaboration of leading pharma companies, the University of Cambridge and Intersys (the company behind SCAIR®).
Our blog delves deeper into some of the challenges facing Life Science Supply chains.
What is ReMediES?
The Advanced Manufacturing Supply Chain Initiative (AMSCI) ReMediES project consortium aimed to remove inefficiencies in pharma supply chains by bringing together a wide range of stakeholders.
This innovative collaboration of more than 22 companies led by GlaxoSmithKline and the University of Cambridge’s Institute for Manufacturing included leading global contract manufacturing organisations, equipment manufacturers, regulators, knowledge transfer networks, and healthcare providers.
Revealing the Cause of Supply Chain Disruptions.
One of the ReMediES sub-projects identified the spectrum of supply chain threats to drug supply continuity and delved deeply into the root cause of disruptions. With the challenge of today’s complex, multi-tiered supply chains, monitoring disruptions that have potential to impact a company is a key element of a strong supply chain risk management programme. The addition of an alerting module to SCAIR®’s suite of risk management tools was a significant contribution to this project.
Key Areas Explored in the Understanding Risk in Pharmaceutical Supply Chains White Paper
Intersys’ Risk Director Catherine Geyman was one of three authors of the ReMediES white paper Understanding Risk in Pharmaceutical Supply Chains.
The result of a four-year-long collaboration with University of Cambridge, AstraZeneca, GSK and other industry leaders, the paper looks at different aspects of risk management in the pharmaceutical supply chain.
The many areas covered include triggers for drug shortages and a risk-benefit analysis of clinical just-in-time manufacture.
The paper features three distinct methods to help our understanding of drug shortages. These are:
- Real-world analysis, to help better predict disruptions and supply shortages
- Expert-driven risk prioritisation, to unravel complex inter-dependencies between potential causes of supply failure
- Simulation-based assessment of new manufacturing technologies, to mitigate disruption and reduce inventory
Catherine Geyman was involved in all areas of the project and led the disruption prediction analysis, using analytics that are integral to SCAIR®’s Regulatory Incident Monitor.
What Did the White Paper Reveal?
The key finding is of real significance to the pharma industry, confirming a link between regulatory incidents and supply chain breakdown.
The study revealed that an FDA inspection with an Official Action Indicated (OAI) preceded 69% of drug shortages – and almost three quarters if product discontinuations are excluded.
This is significant because it proves that by properly tracking regulatory incidents, companies can take appropriate action and help avoid factors leading to drug shortages.
This is significant because it proves that by properly tracking regulatory incidents, companies can take appropriate action and help avoid factors leading to drug shortages.
Where Can I find Out More?
You can:
- Download the paper below
- Read the SCAIR® blog to stay up to date with issues around pharma supply chains, such as concerns around pharma supply chain reliance on India and China in the wake of COVID-19, the real reasons for UK drug shortages, and much more.
Download whitepaper
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