Experts provide guidance to address drug shortages caused by manufacturing and quality issues.
ISPE has just released its new Drug Shortages Prevention Model.
The 2023 ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. The ISPE Drug Shortages Team developed the model as a follow up to the ISPE Drug Shortages Prevention Plan that was released in 2014. The model provides expanded guidance that reflects the new insight and best practices that have emerged in the past several years.
“With the COVID-19 pandemic, various natural disasters and other unforeseen large-scale events, the importance of ensuring drug supply chain has never been more apparent,” says Tom Hartman, President and CEO of ISPE. “The Drug Shortages Prevention Model is a crucial step forward in ensuring that patients have access to the medicines they need. By providing guidance for manufacturers to prevent and mitigate potential shortages, the model will improve patient access to life sustaining medicines and the reliability of supply."
The Drug Shortages Prevention Model describes three foundational areas for accountability: Quality and Manufacturing Maturity; Regulatory; and Technology & Innovation. The three areas cover twelve performance domains:
Pharmaceutical Quality System
Cultural Excellence
Workforce Capability
Supply and Distribution Resilience
Risk Management Planning
Data Analytics
Advanced Technology
Digital Solutions
Sustainability
Lifecycle Management
Regulatory Execution
Evolving Regulations
If companies want to ensure they are prepared to avoid drug shortages whenever possible, they should strive to excel in each of the foundational performance domains outlined in the ISPE DSPM model. Developing and implementing robust drug shortage prevention planning involves risk management at organizational, operational, and product-specific levels. It is truly an enterprise-wide endeavor.
