By APICS CEO Abe Eshkenazi CSCP, CPA, CAE | 0 | 0 | February 17, 2012
What happens when a medicine exists that can save lives, but there is just not enough of it? What do we do when the companies that supply critical drugs are shut down? Sadly, these situations are cropping up in the news more and more. Erin R. Fox, manager at the University of Utah Drug Information Service (an organization that tracks drug shortages), says there are 283 drugs in short supply in North America. This includes 27 shortages reported this year, as well as a whopping 215 shortages from 2010 and 2011 that remain unresolved.
One recent incident surrounds the supplies of the drug methotrexate, a treatment for the common childhood cancer called acute lymphoblastic leukemia (ALL). According to an Associated Press story by Linda A. Johnson, which was picked up by a number of news outlets, the drug is highly effective and has been a mainstay of childhood cancer treatment for 40 years, curing up to 90 percent of children with ALL. Now, it is "in very short supply because a leading maker of the drug shut down some of its factories late last year."
The drug maker in question is Ben Venue Laboratories, which temporarily closed its Bedford, Ohio, factory last November after a federal inspection of its facilities pointed to badly maintained equipment, defective batches, and sterility issues. The remaining manufacturers of methotrexate are pledging to resolve the shortages, but they are vague in listing the exact steps they will take to end the crisis. Peter Adamson, chair of the Children's Oncology Group (a network of hospitals specializing in pediatric cancer) says officials from the US Food and Drug Administration "have been reassuring in discussions that this is not going to be a prolonged shortage ... [but] until the drug is actually delivered, we can't be sure."
The pharmaceutical supply chain
On Tuesday, February 14, APICS and the Drug Information Association (DIA) hosted a meeting in Washington, DC, to explore the issues that compromise the drug supply. Attending the meeting were representatives from government agencies, manufacturers, distributors, and pharmaceutical associations__all with the goal of sharing their perspectives on critical drug shortages, what currently is being done to address the situation, and what needs to happen to ensure a sufficient supply of high-quality medicines.
Many factors are responsible for the complexity of pharmaceutical supply chains, including the necessary role of government regulatory agencies; the wide distribution of suppliers of active pharmaceutical ingredients; and the fact that shortages, which often are caused by inadequate demand data, are a threat to public health. Thousands of individuals who have attained APICS Certified in Production and Inventory Management and Certified Supply Chain Professional designations work in pharmaceutical manufacturing and distribution. This puts APICS in a unique position to work with the DIA and other organizations to better educate the health care community on issues affecting the supply of critical drugs. We hope that, through our combined efforts, we can improve the performance of pharmaceutical supply chains.
In the months to come, I will share our progress with you as we work with the DIA and other public and private organizations to make a positive impact on this situation. In the meantime, we have set up a pharmaceutical supply chain community on the APICS Supply Chain Channel. Please join in and contribute to the discussion.
In other news
How APICS Operations Management Now relates to you
Operations management is everywhere. Today, operations management professionals have unprecedented impacts on the global economy. Consider these questions and how today's edition of APICS Operations Management Now relates to you and your career.
- Even if you are not in the pharmaceutical industry, what happened the last time your business experienced a critical shortage?
- What steps do you take to mitigate shortages in your supply chain? What contingency plans are in place if a shortage occurs?
- How might you begin to resolve complex issues in the pharmaceutical supply chain, such as hoarding and adulterated medicines?