Conflicts of Interest/Disclosure

To disclose, • Faculty declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or or not to disclose service mentioned in this program, including grants, (a ) – employment, gifts, stock holdings and honoraria. • This research was funded by the Chicago College of that is the question Student Research Program at Midwestern University.

Jennifer L. Mazan, Pharm.D., Associate Professor of Pharmacy Practice Ana C. Quiñones-Boex, Ph.D., Associate Professor of Pharmacy Administration Midwestern University Chicago College of Pharmacy

Pharmacist and Technician Assessment Slide Objectives • professionals must disclose At the conclusion of this program, the will be medical to and/or their able to: 1. Review the recent medical literature on how to family? approach disclosure of a medical error. A. Yes 2. Describe the results of a survey of Illinois ’ attitudes and behaviors on medication errors and their B. No disclosure. 3. Identify a framework for dealing with the disclosure of medication errors.

Medical Error Disclosure

• Why the increased interest? → Institute of ’s report • Errors in health care are very common

• “ Safety Movement” Emphasis on: → full disclosure / transparency

1 Medical Error Disclosure Medical Error Disclosure

Patient Safety Movement and Disclosure Disclosure Standards • Disclosure Standards • 2001 - The Joint Commission • Legal Developments • 1st nationwide standard • Prominent Disclosure Programs • Standard RI 2.90 : “ Patients and, when appropriate, their families are informed about the outcomes of care, treatment, and services that have been provided, including unanticipated outcomes .” • Does not require an apology

Key Elements of the Safe Practice for Disclosing Unanticipated Medical Error Disclosure Outcomes to Patients. Disclosure Standards • 2006 - National Quality Foundation (NQF) Safety Practices (updated 2009) • Safe Practice 7 - Disclosure : “ Following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event .” • Disclosure as a concern

Gallagher TH et al. N Engl J Med 2007;356:2713-2719.

Medical Error Disclosure Assessment Slide

Disclosure Standards • Is disclosure of medical errors to patients • 2006 - National Quality Foundation (NQF) required by law? • Safe Practice 7 - Disclosure: Patient communication should include A. Yes • The “facts” B. No • Empathic communication of the “facts” • An explicit and empathic expression of regret • A commitment to investigate and as possible prevent future occurrences • Feedback of results of the investigation provided in sufficient detail to support informed decision making by the patient • “Timeliness”

2 Medical Error Disclosure Medical Error Disclosure

Legal Developments Disclosure Programs As of 2010 • Great variability • 34 states + DC have apology laws • VA Hospital – Lexington, KY (1999) • 25 with specific medical laws • No significant changes after implementation • University of Michigan • 9 states have disclosure laws • Decrease in claims and litigation expenses • 6 states have both • COPIC 3Rs Program – CO (2000) • 16 have nothing… • Recognize, Respond, and Resolve What about IL? NO • Data thus far suggest claims can be resolved less adversarially than when using traditional litigation

Key Elements of COPIC's 3Rs Program. Medical Error Disclosure

Disclosure Programs • Two approaches in American institutions: • Train the • Train the risk managers or patient safety experts • Full disclosure (including an apology) + an offer (to pay?) is probably most effective

Gallagher TH et al. N Engl J Med 2007;356:2713-2719.

Medical Error Disclosure Assessment slide

Literature Review Full disclosure of a medication error will • No article related to pharmacy increase the risk of litigation. • Medical literature A. True • Patients B. False • Attitudes and preferences • Administrators • Clinicians • Physicians attitudes • Barriers to disclosure

3 Medical Error Lit. Review Medical Error Lit. Review

Patients Patients • Attitudes • What do patients want if an error occurs? • • Understand medical errors are inevitable Explanation of what happened • Why it happened • Want to be told about an error that caused • harm How will it affect their health • How the problem will be corrected • Believe disclosure will increase trust • How future errors will be prevented • Believe it’s natural for health care workers to • Accept responsibility want to hide the error • APOLOGY

Medical Error Lit. Review Medical Error Lit. Review

Patients Patients • Want assurance • Emotions • • Won’t suffer financially Sadness, anxiety, depressed, traumatized • Fear of additional errors • Clinician learned from the mistake • Anger • Prevention of future occurrences • Believe that how the error is disclosed affects emotions • Disclosed honestly and with empathy = less anger • Incomplete or evasive = increased anger and anxiety

Medical Error Lit. Review Medical Error Lit. Review

Patients Administrators • Concerns • If desired information is not provided: • Mandatory reporting and making reports public • Hinder patients’ clinical decision making will discourage disclosure within the organization • Decrease trust in • Favor disclosure to patients • • Possibly increased risk of lawsuit Hesitant regarding disclosing minor or moderate to the state reporting systems • Overall, no evidence of full disclosure * Findings above from one study surveying administrators in 6 states: having negative consequences • 2 mandatory reporting and public disclosure • 2 mandatory reporting w/out public disclosure • 2 w/out mandatory reporting

4 Medical Error Lit. Review Medical Error Lit. Review

Clinicians Clinicians • Attitudes • Attitudes (cont.) • Worry regularly about errors • Agreed with patients that it’s natural for health • Lawsuits, loss of patients trust, loss of colleague's care workers to want to hide the error respect, decreased self-confidence • What/how to disclose: • Concerned an apology will lead to liability • Put most positive “spin” on event • Agreed errors that caused harm should be • Choose words carefully-discuss adverse event but disclosed to the patient not explicitly state that an error occurred

Medical Error Lit. Review Assessment Slide

Clinicians • Regardless of practice site, pharmacists in Illinois have similar attitudes and • Emotions behaviors regarding the disclosure of • Upset, guilty, disappointed medication errors. • Fearful of a lawsuit A. Yes • Anxious about reputation B. No • Difficult to find emotional support post event

Medication Error Disclosure Medication (Med) Error Study Disclosure Study Objective “Pharmacists’ attitude on disclosure of • To examine attitudes and behaviors related to harmful medication errors to patients ” medication errors and their disclosure • ChungYun (Christina) Kim, PharmD candidate Compare community and hospital pharmacists

Research proposal funded by the Chicago College of Pharmacy Student Research Program at Midwestern University

Results from Poster: Kim C, Mazan J, Quiñones-Boex A, “Pharmacist Attitudes and Behaviors on Medication Errors and their Disclosure ”

5 Assessment Slide Med Error Disclosure Study

• Pharmacist agree that medication errors Methods are inevitable. • Online questionnaire (SurveyMonkey ) A. True • Pharmacist knowledge of medication error • Past experiences with medication errors B. False • Disclosure process • Demographics • 2 state associations (ICHP, IPhA) • Follow-up email 4 weeks after initial message • Fall 2014 • Statistical analyses performed using SPSS 19.0

Med Error Disclosure Study Med Error Disclosure Study

Results: Response Rate Results: Demographics

Results: Practice Setting • Community pharmacists n = 135 • Hospital pharmacists n = 110

Med Error Disclosure Study Med Error Disclosure Study

Results: Disclosure Environment Results: Error outcome of worst medication error

Near miss

No patient harm

Patient harm

Patient death

6 Med Error Disclosure Study Med Error Disclosure Study

Results: Results: When disclosing, what did you include? What were your emotions afterwards?

Med Error Disclosure Study Med Error Disclosure Study

Results: Attitudes Limitations • Convenience sample • Only 1 state • Social desirability bias

Items listed above were found to be statistically significant (p<0.05). *SD/D: Strongly Disagree, Disagree **SA/A: Strongly Agree, Agree

Med Error Disclosure Study Assessment Slide • When disclosing an error, what do you Conclusions think patients want to hear? • Pharmacist attitudes on medication errors and their disclosure were slightly different A. An explicit statement of what when comparing the community and hospital happened setting. B. An explicit statement of why the error • Regardless of practice setting, pharmacists happened agreed that medication errors are inevitable C. An explicit statement of how it may and that disclosure is necessary. have been prevented D. An apology E. All of the above

7 Medication Error Medication Error Disclosure Framework Disclosure Framework What the Literature tells us… What the Literature tells us… • “Disclosure Gap” • “Being more open with patients about • Error disclosure rates vary greatly errors represent a paradigm shift for the • Physicians support disclosure but don’t do so medical profession .” because of perceived barriers: Gallagher, et al. 2006, “Choosing your words carefully,” Arch Intern Med, • Fear of lawsuit 166, 1585-1593. • Emotions • Lack of training - not knowing what to say • Who, what, when, and how Might be the same for pharmacy… • Whether or not to use the word error

Medication Error Medication Error Disclosure Framework Disclosure Framework What the Literature tells us… “Initial” Disclosure • ASAP after discovering error • In the USA - NQF practices (even if all the facts are not yet known) • Review and summary of disclosure • Acknowledge error to the patient and their guidelines in: family • Australia • Provide an apology / expression of regret • Canada • Describe all known facts and consequences • United Kingdom → Will require additional disclosure meeting(s) in case of a serious event

Medication Error Medication Error Disclosure Framework Disclosure Framework How to Disclose - Communication: The Apology • • Use simple, lay terms One must say “I am sorry ” • All directly involved in the error should • Use active listening skills apologize • Use an open approach • Sincerity is key! • Provide time for discussion/questions • Tone of voice • Body language Remorse expression • Verify that information is understood • Facial expressions • Consider language/cultural differences • Include what is being apologized for, and what is being done to address the situation

8 Medication Error Concluding Remarks Disclosure Framework • Additional Disclosure Considerations Pharmacists should disclose medication errors • IL pharmacists agreed! • Acknowledge that something didn’t go according to plan • Learn about your workplace disclosure • Acknowledge patient’s feelings guidelines • • Provide known clinical facts and discuss Consider sharing what you learned here! ongoing care • Disclosure requires preparation and should • Indicate that action is being (or will be) include taken to prevent the event from • Who, what, when, how + an apology happening again • Disclosure helps everyone • Agree to provide feedback, when available • Patients, pharmacists, , hospitals, etc.

Concluding Remarks References • Australian Commission on Safety and Quality in Health Care (2013), Australian Open Disclosure Framework, better communication, a better way to care , available at: http://www.safetyandquality.gov.au/wp- Disclosure of medication errors will lead us content/uploads/2013/03/Australian-Open-Disclosure-Framework-Feb-2014.pdf • Canadian Patient Safety Institute (2011), Canadian Disclosure Guidelines, being one step closer to enhancing patient safety open with patients and family , available at: http://www.patientsafetyinstitute.ca/English/toolsResources/disclosure/Docum and providing quality patient-centered care. ents/CPSI%20Canadian%20Disclosure%20Guidelines.pdf • Evans S, Yale School of Medicine (2012), After the Error: Disclosure Responsibilities and Controversies , available at: http://chapter.aapm.org/NE/DOCUMENTS/Presentations/2012Summer/medical %20error%20NEAAPM.pdf • Gallagher TH, et al (2003). Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA, 289(8):1001-1007 • Gallagher TH, Studdert D, Levinson W. (2007). Disclosing Harmful Medical Errors to Patients. N Engl J Med; 356:2713-9 • Gallagher TH, et al (2006). Choosing your words carefully: How physicians would disclose harmful errors to patients. Archives of Internal Medicine, 166:1585- 1593

References References • General Medical Council and Nursing and Midwifery Council (2015), Openness and honesty when things go wrong: the professional duty of candour , available • Mastroianni AC, et al. (2010). The flaws in state apology'and disclosure'laws at: http://www.nmc.org.uk/globalassets/sitedocuments/nmc- dilute their intended impact on malpractice suits. Health Aff ; 29(9):1611-9. • Mazor KM, et al. (2004). Health plan members’ views about disclosure of medical publications/openness-and-honesty-when-things-go-wrong--the-professional- errors. Ann Intern Med. 2004;140:409-418Mazor KM, et al. (2006) Disclosure of duty-of-candour.pdf Medical Errors; What Factors Influence How Patients Respond. J Gen Intern Med; • Ghalandarpoorattar, SM, Kaviani A, Asghari, F. (2012). Medical error disclosure: 21:704-710. • National Quality Forum (2009), Safe Practices , available at: the gap between attitude and practice. Postgrad Med J, 88:130-133. https://www.qualityforum.org/Projects/s- • Hobgood C, et al. (2006). Medical error identification. Disclosure, and reporting: z/Safe_Practices_2009/Safe_Practices_for_Better_Healthcare_2009_Update.asp do provider groups differ? Academic Emergency Medicine; x • Weissman JS, et al. (2005). Error reporting and disclosure systems; views from 13:443-451. hospital leaders. JAMA; 239(11):1359-1365. • Kachalia A, Bates DW (2014). Disclosing medical errors: the view from the USA. • Wojcieszak D, Banja J, Houk C (2006). The Sorry Works! Coalition: making the Surgeon; 12(2):64-7. case for full disclosure. Jt Comm J Qual Patient Saf; 32(6):344-50 • • Wu A, et al. (2009). Disclosing medical errors to patients: it’s not what you say, Loren, DJ, et al. (2008). Medical error disclosure among pediatricians; choosing it’s what they hear . J Gen Intern Med; 24(9): 1012-1017. carefully what we might say to parents. Arch Pediatr Adolesc Med;162(10):922- • Wu A, et al. (2013). Disclosure of Adverse Events in the and 927. Canada: An Update, and a Proposed Framework for Improvement . J Public Health Res; 2(3): e32

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