Drug Shortages Summit Summary Report Page 3 Regulatory and Legislative Factors Summary of Causes: Regulatory barriers and ambiguities, including the lack of FDA authority to require notification and other actions, were .banner-content .field-name-field-event-banner-links .field-item a { Based on their overall findings, the researchers determined there are three root causes of increasing drug shortages in the United States: A lack of incentives for drug manufacturers to produce less profitable treatments; 6 In this report, manufacturing and economic factors were cited as the non-company) views. 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. /* New ui component for Video Slider */ } That isn’t always available to us. /*-->*/, Copyright © 2021 ISPE | International Society for Pharmaceutical Engineering, Study Reveals Multiple Root Causes for Drug Shortages, www.ISPE.org/DrugShortages/2013JuneReport. The American FDA has a list of possible causes. 30 See Chart 3 for a } Palliative Fixes, Drug Essentiality, and Collateral Effects, 6. There is a thought that some medications are so critical, like saline, that they should be considered a part of the critical infrastructure; there should be a required backup plan and redundancy. .field-node--field-files .field-item::before { Manufacturers consolidating, limiting or eliminating production. .section-about .region--featured-bottom .form-submit { Richard Montgomery, RPh, MBA: I think we’ve had a few people drop out of the market. width: 100%; } ISPE deployed the Drug Shortages Survey to its global database of members and non-members for five weeks beginning February 20, 2013. Can you describe this interconnected supply exchange? padding: 0; /* hide topics on page */ 1. The manufacturer is in charge of making sure it has good supplies of all its products, including the raw materials. ISPE is also concurrently conducting a study on clinical trial packaging to help industry better understand how packaging and labeling of clinical trial medicines is viewed from the perspective of patients. many of the drugs used to treat children with ALL (the most common childhood cancer) are older drugs. background-color: #e5f7fb; Physicians enumerate the ways drug shortages begin, with an emphasis on the McPherson, Kansas, facility shutdown, a lack of active pharmaceutical ingredients, and market consolidation. .featured-tabs .hp-view-row .node--type-training-courses .icon { All of those additional materials can pose some manufacturing problems. In this way, duplication of data was minimized while still allowing individuals in the industry to share their personal (i.e. Patients are at risk as well. width:100%; Do we not have an early-warning system for this? Richard Montgomery, RPh, MBA: We were a bit; the vendors we used weren’t quite as affected as some other hospitals. .section-about .region--featured-bottom .block-webform-block { } Corruption and drug smuggling have also been stated as possible causes for insulin shortages, but not by the Iranian government. The main causes of drug shortages are due to complex supply chains that lead to manufacturing and quality issues. Can that affect you as well? Complete anonymity was assured for all respondents. -ms-flex-direction:column; Supply-Chain Communication and Drug Reallocation, 12. Tags: causes,drug shortages,peer exchange,Retail, Generic/Brand Drug Shortages & Medical Professional Impact, Unmet Needs in Treating Serious Mental Health, Copyright Specialty Pharmacy Times 2006-2019, 2 Clarke Drive Suite 100 Cranbury, NJ 08512 P:609-716-7777 F:609-716-9038, 1. .section-about .region--featured-bottom label { Unprecedented demand due to large numbers of critically ill patients with COVID-19 is worsening shortages, especially analgesics, sedatives, and paralytics. About ISPE Causes The causes of shortages are often complex. background: #f2f2f3; Unexpected Benefits and Personal Responses to Drug Shortages, 9. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the Economic Analysis of the Causes of Drug Shortages The Supply of Direct Support Professionals Serving Individuals with Intellectual Disabilities and Other Developmental Disabilities: Report to Congress Drug Testing Welfare Recipients: Recent Proposals and Continuing Controversies Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin … Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. Loss of drug manufacturing site or production line: 2% 4. Is this part of the evolution, as well as what has caused some issues? Half the time the drug companies don’t even do a good job of telling the FDA, and that’s a law that’s required. .field-node--field-files .field-item::before { } 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. ISPE envisions using the results to support industry and regulators in the development of risk-based approaches to mitigating these occurrences. } Erin Fox, PharmD, BCPS, FASHP: In most of the raw materials, the active pharmaceutical ingredient…is similar: the raw materials come from China and India in the majority of cases. .webform-submission-contact-ispe-form .description { /* homepage lead banner adjustments */ When a manufacturing problem happens, it almost always results in a drug shortage. border-radius: 0; Big pharmaceutical companies discontinuing or actively combatting generics in order to enhance sales of newer, more expensive, brand-name drugs. margin: 0; Shortage Effects on Clinical Trials and Future Hopes, 2. That’s why I say it starts with the manufacturers. } 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. I think the problem is knowing what the issue is that’s causing the problem. In addition to seeking respondents to answer the survey items based on their individual experiences and opinions, ISPE also encouraged companies to compile an enterprise-level response and to designate a member of their staff to enter the information into the electronic survey system. About the ISPE Drug Shortages Survey Report Richard Montgomery, RPh, MBA: Well, we don’t see the shutdown. } We’ve had some consolidation mergers in which products lines had to be divested, after which there was a whole other process. Erin Fox, PharmD, BCPS, FASHP: Sure. max-width: 20rem; border: solid 2px #ececec; Today, this leading organization for technical and regulatory advancements throughout the global pharmaceutical lifecycle released the findings of its 2013 Drug Shortages Survey, which was aimed at identifying the technical, engineering, quality and regulatory issues impacting drug shortages. [CDATA[/* >