At this year’s 2015 Annual ISPE Meeting, one particular presentation focused on drug shortages and prevention. Titled “Business Continuity Planning for Prevention of Drug Shortages: Introducing the ISPE Drug Shortages Assessment and Prevention Tool,” this presentation gathered a panel of experts from a variety of different backgrounds to explore what companies can do to help establish a reliable supply chain.
According to the FDA, 37 percent of drug shortages in the U.S. are due to manufacturing issues. In addition, 27 percent of drug shortages are on account of raw materials, and another 27 percent is due to delays/capacity. A mere five percent of drug shortages result from an increased demand. That means, according to the FDA’s data, that more than one third of drug shortages could potentially be prevented.
Recap to last Friday’s listing of current drug shortages.
Fran Zipp, President of Lachman Consultant Services, Inc., reported that 45 percent of hospital pharmacies within the European Association of Hospital Pharmacies experience drug shortages every week. However, it was rather interesting to note that most European shortages are dealt with at a national level—quite unlike the U.S. Instead, it is left to pharmaceutical companies in the U.S. to prioritize who receives a drug that is in shortage. Quite often, this is based on who pays the most.
In 2012, the ISPE formed a drug shortage team and eventually developed a survey to assess the landscape of drug shortages. The ISPE Board’s vision is the “identification and delivery of programs and tools for assuring the continuous availability of quality pharmaceuticals to patients.” Consequently, the ISPE created the ISPE Drug Shortage Assessment and Prevention Tool for just that purpose.
According to a press release by the IPSE, this tool is intended to aid manufacturers in “locating gaps between their current operations and the desired state of a reliable supply of quality pharmaceuticals.” In simpler terms, it’s to help companies assess their processes and locate where there is room for improvement. Ultimately, the intention is to increase supply reliability in these six areas:
- Corporate culture
- Robust quality systems
- Business continuity planning
- Communication with regulatory authorities
- Building capacity
This tool is globally applicable, particularly for both the U.S. and the EU. Zipp referred to it as a “living document.”
In the past, the questions for this tool were strictly yes/no questions. According to Zipp, the team quickly realized that this outlook was not helpful in locating weakness and areas for improvement. As a result, the assessment tool offers participants a scale of 1-5 as their answer options (rather than yes/no) for each of the questions. This way, both strengths and weakness can be easily identified. Most importantly, companies can now understand where their vulnerabilities are.
Zipp also divulged the five steps to preparedness and prevention for drug shortage:
- Corporate commitment
- Gap assessment
- Embed in corporate culture
- Engage with stakeholders
“This is a trailblazing time for leaders within the pharmaceutical industry to be involved at the forefront of an important global initiative impacting our industry,” said John Bournas, President and CEO of ISPE. “I am confident the ISPE Drug Shortage Assessment and Prevention Tool will make an immediate and tangible impact on the way companies handle their day-to-day activities.”
Later in the presentation, the panelists were given opportunity to discuss their points of view with regards to drug shortages, as well as to answer questions from the audience.
In this latter portion of the presentation, Sumanth Venugopal, Partner, Healthcare Practice, PricewaterhouseCoopers LLP, USA, acted as the host. He introduced the three R’s to a corporate quality system, which are:
- Robustness: Monitoring the supply chain; risk assessment.
- Redundancy: A well-defined system that identifies and addresses key risks, thereby putting mitigation plans in place
- Resiliency: Response.
Rod MacLea, Supply Chain Director at Amgen, said that when there was a shortage in Japan, Amgen had to manually do research to see if they were impacted. They did not previously have a system set up to be able to locate specific impacts, which led to a mapping of the supply chain (robustness, the first R on the corporate quality system). In the beginning of this mapping process, the internal Amgen team had to use Excel in order to address the issue with Japan. They quickly realized that they needed software.
As a CMO, however, drug shortages impact a company differently. Harry Gill, Senior Vice President of Patheon Pharmaceuticals, USA, recommended starting with “redundancy” (the second R on the corporate quality system) while you are developing a drug (specifically, before the regulatory process). The earlier you start, said Gill, the better.
David Lowndes, Senior Vice President, Supply Chain Management, at Shire, said, “Our CMOs like to be treated as full partners.”
Overall, there seemed to be an agreement to address the three R’s of the corporate quality system.
“The industry is still more reactive than proactive right now,” said Sabine Haubenreisser, PhD, EMA-FDA Liason, DHHS/FDA/OC/OGROP/OIP, USA.
“The earlier you pay for the three R’s, the cheaper it is,” said Gill. “Compared to paying the price at the end of the process.”
“Doing something is far better than doing nothing,” adds Haubenreisser. “Don’t wait for someone to find something. Come to use and we can solve the problem together.”
For more information about the ISPE Drug Shortage Assessment and Prevention Tool, go to: http://www.ispe.org/Drug-Shortages-Initiative.