Between 2000 and 2018, shortages in the EU increased 20-fold and according to a note by the European Commission are rising for widely used essential products. More specifically, the report identified three main causes of drug shortages: In response to this request from Congress, the FDA convened an inter-agency Drug Shortages Task Force (“Task Force”) of senior officials drawn from its own ranks and several partner opacity: 1; Troy Trygstad, PharmD, MBA, PhD: When you think about a “single point of failure,” Erin, as a national expert, how does this relate to public health, bioterrorism, and the US Department of Defense? Can you describe this interconnected supply exchange? The report concludes there are three root causes causing drug shortages: Lack of incentives for manufacturers to produce less profitable drugs When manufacturers have limited profitability opportunities, they are less likely to invest in older drugs and expanding capacity. When there’s a problem there, clearly the manufacturers can’t make the product. Troy Trygstad, PharmD, MBA, PhD: We had Hurricane Florence and 3 other hurricanes meander through North Carolina this year, as well as one of the largest typhoons ever in the other hemisphere. } How does this affect patients’ lives? } Some companies will either be purchased or drop the product line for profit margin. How has that affected drug supply? Where do drug shortages start, and how do they end up on our doorstep? .section-about .region--featured-bottom form { Structural Overview of Supply Maintenance, 4. border: solid 1px #fff; The rate of new shortages is slowing, however ongoing and active shortages are not resolving. background: #f2f2f3; For example, for the McPherson, Kansas, closure, we found out about that months later, and that was only because the drug company chose to tell us. background-color: #e5f7fb; The task force noticed that when drug producers were limited in production, they chose to produce drugs that were more marketable and more consistently in demand. background-image: url(/sites/default/files/assets/images/strategic-plan/strategic-plan-banner1900x400.jpg?v=123); max-width: 100%; An estimated 90 percent of the 3.000 children afflicted with T-cell acute lymphoblastic leukemia (ALU are curable (5-year event-free survival). } Unexpected Benefits and Personal Responses to Drug Shortages, 9. ]]>*/, Copyright © 2021 ISPE | International Society for Pharmaceutical Engineering, Study Reveals Multiple Root Causes for Drug Shortages, www.ISPE.org/DrugShortages/2013JuneReport. They can have all the product they want, but if you don’t have power, there’s nothing arriving. width: 100%; Troy Trygstad, PharmD, MBA, PhD: Erin, you’re widely known in the press and in a circle of folks who live and breathe drug shortages. display: block; That’s the gold standard. An important cause of drug shortages seems to beInstituut voor). Is this an issue that is discussed in Washington? What are the pragmatic results of these shortages? Known Causes of Drug Shortages To address the question of what causes drug shortages, GAO in 2014 performed an extensive literature review and interviews of key players in the drug supply chain. Erin Fox, PharmD, BCPS, FASHP: Yes. Active ingredients for European products are made at 4420 sites in India, 2794 in China, 1936 in Europe, and 599 in the US.9 Medicines are cheaper to make in developing countries, but disruptions to infrastructure are more likely, distant factories are difficult to inspect frequently, and long supply chains are fragile. There was a recent shutdown in McPherson, Kansas. There’s the evolution of generic dispensing rates—somewhere about 90% now. The report identifies three root causes for drug shortages: Lack of incentives for manufacturers to produce less profitable drugs; .section-about .region--featured-bottom .block-webform-block { /*-->