F RO M T H E DATA B A S E Decline in Serious Events and Wrong-Drug Reports Involving Opioids in Pennsylvania Facilities Matthew Grissinger, RPh, FISMP, FASCP As a class of high-alert medications, opioids bear a heightened risk of causing signifi- Manager, Medication Safety Analysis cant patient harm when used in error.1 Errors with opioids have led to serious adverse Pennsylvania Patient Safety Authority events, including allergic reactions, failure to control pain, oversedation, respiratory depression, seizures, and death.2 According to data from various error reporting pro- grams, opioids—particularly morphine, HYDROmorphone, and fentaNYL—are among the high-alert medications that most frequently cause patient harm.3-5 Similarity in drug names or the mistaken belief that HYDROmorphone is the generic name for morphine have led to inadvertent mix-ups between morphine and HYDROmorphone.6 In 2007, analysis of 8,400 wrong-drug events reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) showed that mix-ups between morphine and HYDROmorphone outnumbered all other medication-pair errors.7 In 2010, analysis of reports involving HYDROmorphone found that 70% involved mix-ups with morphine.8 When errors occur with these two medications and the same milligram dose is given (e.g., HYDROmorphone 2.5 mg IV given instead of morphine 2.5 mg IV), the potential for harm exists because 1 mg of HYDROmorphone is roughly equivalent to 7 mg of morphine. So, in this example, 2.5 mg of parenteral HYDROmorphone would be equal to about 17.5 mg of parenteral morphine. In 2015, Truven Health Analytics (on behalf of the Agency for Healthcare Research and Quality) asked the Pennsylvania Patient Safety Authority about trends in events involv- ing opioids evident in the PA-PSRS database. Authority analysts queried the PA-PSRS database for medication errors that included any opioid as the medication prescribed or administered. The query of reports submitted from January 2005 through December Figure 1. Reports of Serious Events Involving Opioids Reported to the Pennsylvania Patient Safety Authority, January 2005 through December 2014 (N = 365) NUMBER OF REPORTS 80 70 64 60 54 50 44 40 37 37 31 30 27 27 24 20 20 10 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Harm Score E 31 22 30 49 58 35 21 24 17 23 F 5 6 3 3 5 8 5 3 3 0 G 0 0 0 0 1 0 0 0 0 0 Scan this code with your mobile H 1 2 3 1 0 1 0 0 0 0 device’s QR reader to access the I 0 1 1 1 0 0 1 0 0 1 Authority's toolkit MS16114 on this topic. COUNT OF REPORTS AND YEAR Vol. 13, No. 1—March 2016 Pennsylvania Patient Safety Advisory Page 29 ©2016 Pennsylvania Patient Safety Authority F RO M T H E DATA B A S E Figure 2. Reports of Wrong-Drug Events Involving Opioids Reported to the 2014 identified 41,727 events. Facilities Pennsylvania Patient Safety Authority, January 2005 through December 2014 reported 0.9 % (n = 365) of these events (N = 4,958) as Serious Events, with a downward trend NUMBER OF OPIOID REPORTS following a peak in 2009 (Figure 1). 900 Of the 41,727 events involving opioids, 11.9% (n = 4,958) were reported as 800 780 679 642 wrong-drug events. From 2005 through 700 2014, there was a 66.4% reduction in 600 543 515 the number of opioid wrong-drug events 500 443 reported (Figure 2), and a 79.4% reduc- 382 370 342 tion in the number of wrong-drug events 400 262 involving mix-ups between morphine and 300 HYDROmorphone (Figure 3). 200 Since 2007, the Authority has published 100 eight articles on opioid safety. From 2012 0 through 2014, the Authority coordinated 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 MS16112 the Pennsylvania Hospital Engagement YEAR Network’s adverse drug event project, which aimed to reduce and prevent Figure 3. Reports of Wrong-Drug Events that Mentioned HYDROmorphone harm related to opioid use. These efforts and Morphine in the Same Report to the Pennsylvania Patient Safety Authority, generated tools for facilities to improve January 2005 through December 2014 (N = 567) the safe use of opioids. Please visit the Authority’s website (http://patient- NUMBER OF REPORTS safetyauthority.org/EducationalTools/ 120 PatientSafetyTools/opioids/Pages/home. 102 aspx) for the full suite of information and 100 92 tools, including the following: 79 — Pennsylvania Patient Safety Advisory 80 73 64 articles based on analysis of opioid- 60 related events submitted to the 44 Authority 40 31 35 — An opioid-knowledge assessment 26 21 tool that can be used to assess the 20 general knowledge of opioids for practitioners who prescribe, dis- 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 pense, or administer opioid products MS16113 YEAR — An opioid-assessment tool, designed to assess the safety of opioid practices in a facility and identify opportuni- ties for improvement NOTES 1. Institute for Safe Medication Practices. patient harm from opiates. ISMP Med Saf Sep [cited 2015 Nov 23]. http:// ISMP’s list of high-alert medications Alert Acute Care 2007 Feb 22;12(4):1-3. patientsafetyauthority.org/ADVISORIES/ [online]. 2014 [cited 2015 Nov 24]. Also available at http://www.ismp.org/ AdvisoryLibrary/2004/Sep1_(3)/ http://www.ismp.org/Tools/institutional newsletters/acutecare/articles/ Pages/06.aspx highAlert.asp 20070222.asp 4. Hicks RW, Santell JP, Cousins DD, et 2. Institute for Safe Medication Practices. 3. Focus on high-alert medications. PA al. MedMARX 5th anniversary data report: High-alert medication feature: reducing PSRS Patient Saf Advis [online] 2004 a chartbook of 2003 findings and trends Page 30 Pennsylvania Patient Safety Advisory Vol. 13, No. 1—March 2016 ©2016 Pennsylvania Patient Safety Authority 1999-2003. Rockville (MD): United States 6. Institute for Safe Medication Practices. 8. Adverse drug events with Pharmacopeia Center for the Advance- Safety issues with patient-controlled anal- HYDROmorphone: how preventable are ment of Patient Safety; 2004. gesia: part I—how errors occur. ISMP Med they? Pa Patient Saf Advis [online] 2010 5. Institute for Safe Medication Practices Saf Alert Acute Care 2003 Jul 10;(8)14:1-3. Sep [cited 2015 Nov 23]. http://www. Canada. Top 10 drugs reported as causing Also available at http://www.ismp.org/ patientsafetyauthority.org/ADVISORIES/ harm through medication error [online]. Newsletters/acutecare/articles/ AdvisoryLibrary/2010/Sep7(3)/Pages/69. ISMP Canada Saf Bull 2006 Feb 24 20030710.asp aspx [cited 2015 Nov 23]. http://www.ismp- 7. Common medication pairs that canada.org/download/safetyBulletins/ contribute to wrong drug errors. PA ISMPCSB2006-01Top10.pdf PSRS Patient Saf Advis [online] 2007 Sep [cited 2015 Nov 23]. http:// patientsafetyauthority.org/ADVISORIES/ AdvisoryLibrary/2007/sep4_(3)/ Pages/89.aspx Vol. 13, No. 1—March 2016 Pennsylvania Patient Safety Advisory Page 31 ©2016 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 13, No. 1—March 2016. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2016 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (Mcare) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s website at http://www.patientsafetyauthority.org. An Independent Agency of the Commonwealth of Pennsylvania ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 50 years, ECRI Institute marries experience and indepen- dence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. 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