Fresenius Kabi Response to Drug Shortages

Alice Romie, PharmD

As a global health care company with a significant focus on sterile injectable medicines, Fresenius Kabi understands the responsibility of producing high-quality products in a reliable manner.

The sterile injectable process and production planning are very complex, so when there is a shortage in the market, there are a significant number of steps needed to continue to manufacture products and adjust production schedules to help address shortages.1 Determining what will be filled, packaged, and shipped for the day or week can be a challenge because of line constraints. It is a daily art of prioritizing and weighing multiple factors to make the right decision, and knowing and accepting that, as one manufacturer, we can only do so much.

Unlike past shortages, which occurred in one category or drug class, the current challenge is broad, impacting more product categories,2 including IV solutions, antibiotics, neuromuscular blocking agents, and opioids. The immediate steps we have taken—and are taking—to help in the short-term are significant, and the investments we are taking to help improve supply reliability long-term are even greater. In fact, our manufacturing plan and investments were in place prior to 2017 and have been a critical part of our long-term expansion plans in the U.S.3

In January 2016, Fresenius Kabi acquired a facility in Wilson, North Carolina, that produces prefilled syringes.4 Since then, Fresenius Kabi has increased production of the Simplist® prefilled syringes significantly, providing many products routinely used in the OR including sedatives, induction agents, and opiates that have been in short supply. This increase requires substantial investment in staffing, training, accreditation, and quality processes to maintain the stringent current good manufacturing practices (cGMP) standards necessary to supply quality product.5 In 2017, the Wilson plant operated essentially five days a week. Today, with the appropriate staffing and processes in place, the plant operates seven days a week, with significantly increased workflow efficiency and increased production. Although many patients and clinicians have benefited from the increased supply that we’ve produced, there is still greater demand. The shortfall created by the shutdown of a large manufacturing facility is far too great for one manufacturer to surmount. A large manufacturing facility may have many production lines, whereas other manufacturers may only have few lines and would therefore need to prioritize what is produced on each line on a daily basis.

Fresenius Kabi produces injectable drugs across the world, including three sites in the U.S., and since 2014, production at these sites has grown significantly.6 We are continuing to implement plans to expand our capacity and improve workflow. We have not only increased production of current products, but we’ve continued to launch new products, like glycopyrrolate vials,7 atropine vials,8 and many other anesthesia products to meet the needs of providers and their patients.

In addition to our current and future internal investment, we are committed to working with national organizations and regulatory bodies to manage the drug shortages and mitigate these issues moving forward. We are also in constant communication with providers, government agencies, the American Society of Health System Pharmacists (ASHP), the Institute for Safe Medication Practices (ISMP), and the American Society of Anesthesiologists (ASA) to prioritize and address shortages wherever possible. Our dedication to our customers and their patients include helping to address the ongoing shortage challenges.

 

Dr. Romie is currently director of Professional Strategies at Fresenius Kabi, USA, LLC, Lake Zurich, Illinois.

References

  1. https://www.npr.org/2018/07/20/629942414/doctors-raise-alarm-about-shortages-of-pain-medications
  2. https://www.mayoclinicproceedings.org/article/S0025-6196(13)01043-4/pdf
  3. https://www.businesswire.com/news/home/20160817005556/en/Fresenius-Kabi-Announces-Major-Investment-U.S.-Manufacturing
  4. https://www.in-pharmatechnologist.com/Article/2017/11/22/Fresenius-Kabi-investing-100m-and-adding-445-jobs-in-North-Carolina
  5. https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
  6. https://www.pharmaceutical-technology.com/projects/fresenius-kabis-pharmaceutical-manufacturing-facility-expansion-melrose-park-illinois/
  7. https://www.businesswire.com/news/home/20180718005233/en/Glycopyrrolate-Injection-USP-Fresenius-Kabi
  8. https://www.businesswire.com/news/home/20180719005042/en/Atropine-Sulfate-Injection-USP-Fresenius-Kabi