Will serve as a roadmap that when implemented could significantly reduce drug shortages
ISPE, the Society for Pharmaceutical Engineering, based in Tampa, Florida in the US, is to work with stakeholders worldwide to produce a Drug Shortages Prevention Plan to guide the pharmaceutical and biopharmaceutical industry in establishing reliable, robust and resilient supply chains that provide quality medicines to patients without interruption.
The plan, which will be based on ISPE research with input from its membership, pharmaceutical companies and regulators, will serve as a roadmap that when implemented, could significantly reduce drug shortages. It will address organisational strategies, such as aligned governance and communication practices, effective manufacturing and quality systems, and appropriate measures of supply chain robustness and quality.
The aim is to address rising concerns about drug shortages within companies, among global health authorities, and for patients who depend on a reliable and available supply of quality medicines.
The ISPE Drug Shortages Prevention Plan will be the Society’s second major output on this topic since launching its Drug Shortages Initiative in 2012.
The aim is to address rising concerns about drug shortages within companies
In 2012, ISPE formed a Drug Shortage Task Force to help stakeholders better understand the root causes of global drug shortages and to define strategies that could help prevent these shortages. The group led a survey in 2013 that revealed the many causes of drug shortages, as well as suggesting strategies for avoiding supply interruptions. Those companies that adopted organisational drug shortage prevention strategies, including contemporary governance, progressive cultures and effective quality systems, were successful in avoiding drug shortages and supply interruptions.
'Recognising the impact of these strategies motivated ISPE to develop its Drug Shortages Prevention Plan and to develop guidance on organisational strategies for drug shortages prevention, which include the engagement of company leadership and execution of governance, culture, especially a culture of quality risk management throughout the supply chain, and insightful quality metrics,' said Nancy Berg, ISPE’s President and CEO.
The plan will provide a key component of the Society’s input to a European multi-association task force, moderated by ISPE, which intends to provide the European Medicines Agency (EMA) with a proposal and plan that address the prevention of drug shortages due to manufacturing quality issues.
'I’m delighted to be collaborating with colleagues from the Parenteral Drug Association to deliver our proposal to the EMA later this year, and appreciate the support we are receiving from EFPIA, EGA, AESGP and PPTA as well as regulators representing the EMA, the UK, Irish, Spanish and French national agencies,' said John Berridge, ISPE’s Advisor and inter-Association task force moderator.
ISPE’s Drug Shortages Prevention Plan will feature an organisation and product lifecycle approach to ensuring a more reliable supply of medicines through development of company-wide drug shortages strategic plans, aligned governance, good communication, ongoing capability building (which includes training), proactive regulatory interaction and integrated quality systems.
The development of industry-wide quality metrics is being addressed by the Society through a parallel Quality Metrics Initiative, led by another ISPE expert team recommending to the FDA and other health authorities a set of common metrics on which the health and reliability of a company’s production and quality systems and products can be assessed.