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      Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity

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          Abstract

          US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies have resulted in patient safety concerns, injury, and death. Because approval pathways for follow-on forms do not involve cooperative disclosure of methods and manufacturing processes by innovator companies and follow-on manufacturers, the potential for expanded immunogenicity must be taken into account from a risk management and patient safety perspective. The US Institute of Safe Medication Practices (ISMP) has principles of medication safety that have been applied in the past to high-risk drugs. We propose adapting ISMP principles to follow-on biologic forms and creating systems approaches to warn, rapidly identify, and alert providers regarding this emerging patient safety risk. This type of system can be built upon and provide lessons learned as these new drug forms are developed and marketed more broadly.

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          Author and article information

          Journal
          Ther Clin Risk Manag
          Therapeutics and Clinical Risk Management
          Therapeutics and Clinical Risk Management
          Dove Medical Press
          1176-6336
          1178-203X
          2011
          2011
          07 December 2011
          : 7
          : 489-493
          Affiliations
          [1 ]Institute of Health Law Studies, California Western School of Law, San Diego, CA, USA
          [2 ]Department of Anesthesiology, University of California, San Diego School of Medicine, San Diego, CA, USA
          [3 ]San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA, USA
          [4 ]Joint Program in Global Health, University of California San Diego-San Diego State University, San Diego, CA, USA
          Author notes
          Correspondence: Bryan A Liang, Institute of Health Law Studies, California Western School of Law, San Diego Center for Patient Safety, University of California, San Diego School of Medicine, 350 Cedar Street, San Diego, CA 92101, USA, Tel +619 515 1568, Fax +619 515 1599, Email baliang@ 123456alum.mit.edu
          Article
          tcrm-7-489
          10.2147/TCRM.S27495
          3253755
          22241945
          © 2011 Liang and Mackey, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Commentary

          Medicine

          health care reform, immunogenicity, law, biosimilars, patient safety, follow-on biologics

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