What is the quality of drug safety information for patients: An analysis of REMS educational materials

Pharmacoepidemiology and Drug Safety
Hilda W ChanMeredith Y Smith

Abstract

Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. Aside from medication guides, no research has been conducted to assess the quality of patient-targeted REMS materials, including whether, and to what extent, patients find these materials understandable and actionable. To describe the readability, understandability, and actionability of patient educational materials in currently approved REMS programs, and to highlight opportunities for improving both the quality and effectiveness of these important drug safety tools. Seventy-seven REMS programs were identified from the FDA REMS database. We excluded medication guides (MGs) from our analysis because of the fact that there is a mandatory MG template. Based on this, we identified a total of 27 (non-MG) REMS patient materials on the FDA REMS website for analysis purposes. The materials were tested for readability using the Lexile Measure, th...Continue Reading

References

Sep 27, 2003·BMJ : British Medical Journal·Gerd Gigerenzer, Adrian Edwards
Jun 28, 2006·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·Lorraine S WallaceBarry D Weiss
Jul 29, 2006·BMJ : British Medical Journal·Bob Roehr
Aug 4, 2006·Patient Education and Counseling·Michael S WolfRuth M Parker
Dec 1, 2006·Annals of Internal Medicine·Terry C DavisRuth M Parker
Mar 14, 2007·Journal of General Internal Medicine·Nancy M Allen LaPointeKevin J Anstrom
Aug 29, 2007·Clinical Journal of Oncology Nursing·Clare Karten
Jun 20, 2008·Journal of General Internal Medicine·Katherine R WaiteMichael S Wolf
Jan 6, 2009·Patient Education and Counseling·Elizabeth A H Wilson, Michael S Wolf
Jan 13, 2010·Archives of Internal Medicine·Michael S WolfRuth M Parker
Mar 24, 2011·The Annals of Pharmacotherapy·Saul ShiffmanJeffrey M Rohay
May 19, 2011·Clinical Transplantation·Elisa J GordonMichael S Wolf
Jul 20, 2011·Annals of Internal Medicine·Nancy D BerkmanKaren Crotty
Sep 21, 2011·Journal of the National Cancer Institute·Angela FagerlinPeter A Ubel
Jan 27, 2012·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·Laura M CurtisLeslie C Grammer
May 9, 2012·Journal of General Internal Medicine·Michael S WolfBruce Lambert
Mar 20, 2013·Research in Social & Administrative Pharmacy : RSAP·Meredith Y Smith, Lorraine S Wallace
Aug 8, 2013·JAMA Pediatrics·Jeremiah D MomperGilbert J Burckart
Apr 1, 2012·Therapeutic Advances in Drug Safety·Carla Kurkjian, Edward S Kim
Mar 27, 2015·Pharmacoepidemiology and Drug Safety·Caitlin KnoxGerald Dal Pan
Nov 8, 2016·Research in Social & Administrative Pharmacy : RSAP·Amber YoungAlesha Smith
Feb 10, 2017·Journal of Hospital Medicine : an Official Publication of the Society of Hospital Medicine·Ndidi I UnakaKaren E Jerardi
Feb 17, 2017·The Journal of Dermatological Treatment·Elias OussedikSteven R Feldman
Jul 15, 2017·Education for Health : Change in Training & Practice·Pranay Jindal, Joy C MacDermid

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Citations

Sep 16, 2020·The International Journal of Pharmacy Practice·Marissa SeeAlex Banh
Mar 9, 2019·British Journal of Clinical Pharmacology·Michael Anthony FajardoJesse Jansen
Oct 22, 2020·Pharmacoepidemiology and Drug Safety·Rema PanickarZoriah Aziz
Jan 26, 2021·Expert Opinion on Pharmacotherapy·Maria Rosaria GualanoRoberta Siliquini
Apr 28, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ameet SarpatwariAaron S Kesselheim

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Software Mentioned

Lexile Analyzer
PEMAT
Text Content Analysis Tool
REMS

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