Spotlight Case June 2004

1. Spotlight Case June 2004 The Wrong Shot: Error Disclosure

2. Source and Credits • This presentation is based on the June 2004 AHRQ WebM&M Spotlight Case in Pediatrics • CME credit is available through the Web site • See the full article at http://webmm.ahrq.gov • Commentary by: Thomas H. Gallagher, MD, University of Washington; Wendy Levinson, MD, University of Toronto • Editor, AHRQ WebM&M: Robert Wachter, MD • Spotlight Editor: Tracy Minichiello, MD • Managing Editor: Erin Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Describe the rationale for disclosing harmful errors to patients • Appreciate the features of disclosure considered most important to patients • Define the “disclosure gap” • Recognize the emotional impact that errors have on health care workers • List specific steps that institutions can take to enhance the disclosure of harmful errors to patients

4. Case: The Wrong Shot A 10-year-old child from India presented to his pediatrician’s office for a school physical. The child had no past medical history; all immunizations were up to date with the exception of Hepatitis B. The physician discussed vaccination with the patient’s father and obtained consent. The nurse drew up the vaccine and the physician administered it. After administration, the physician went to record the lot number and discovered that vaccine for Hepatitis A had been given instead of Hepatitis B.

5. Frequency of Adverse Drug Events • Adverse drug events (ADE) are common in both inpatient and outpatient setting • In hospitalized patients up to 6.5% of patients have ADE; up to 25% of these preventable • In outpatient setting over 25% have experienced ADE, 40% of which were ameliorable or preventable Bates DW, et al. JAMA. 1998;280:1311-6; Gandhi TK, et al. N Engl J Med. 2003;348:1556-64.

6. Disclosure of Medical Errors • Increasingly, hospital boards and regulatory agencies are requiring disclosure of “unanticipated outcomes” • Actual disclosure of events and discussion of details is uncommon • Only 1/3 of patients surveyed who had experienced a medical error said health care professional had disclosed error or apologized Blendon RJ, et al. N Engl J Med. 2002;347:1933-40.

7. Disclosure: What Patients Want • Jargon-free statement that error occurred • Description of the error and why it happened • Implications of the error for their health and how to deal with the consequences • Outline of steps that will be taken to prevent future errors • An apology from the health care worker Gallagher TH, et al. JAMA. 2003:289:1001-7.

8. Barriers to Disclosure for Physicians • Fear of litigation • Unlikely to apologize due to concern about consequences of admitting fault • Discomfort with discussing such issues • Physician may choose words carefully to avoid explicitly stating that an error occurred • Concern that information may harm patient • Belief that disclosure may impact patient’s trust in the physician Gallagher TH, et al. JAMA. 2003:289:1001-7; Robinson AR, et al. Arch Intern Med. 2002:162:2186-90; Wu AW, et al. JAMA. 1991;265:2089-94.

9. The Disclosure Gap • “Disclosure gap”—mismatch between recommendations that all harmful errors be disclosed and the evidence that, in practice, disclosure is uncommon. Reasons: • Physicians believe disclosure is the right thing to do, but encounter insurmountable obstacles; or • Physicians unclear about whether and how to disclose errors

10. Case (cont.): The Wrong Shot Without hesitation, the physician informed the father that the the boy had received the wrong vaccine. He explained the usual indications for Hepatitis A vaccination and emphasized that this vaccine would not harm the boy and may protect him from future illness. He suggested that the boy still receive the Hepatitis B vaccine. The father became extremely angry, refused to allow further vaccination, and reported the incident to the clinic administrator.

11. Improving Disclosure Outcome • Approach disclosure as integral component of quality improvement • Employ empathic communication techniques • Work closely with risk managers throughout disclosure process

12. Disclosure and Malpractice Litigation • Some argue that skillful disclosure will lessen malpractice claims • Others argue that the reason few injured patients sue is because they are unaware error occurred • Physicians are unlikely to willfully contribute to increasing malpractice suits • Disincentives include soaring malpractice premiums and reporting requirements • Wholesale tort reform and transition to no-fault malpractice system would facilitate full disclosure of medical errors Kachalia A, et al. Jt Comm J Qual Saf. 2003;29:503-11; Levinson W, et al. JAMA. 1997;277:553-9; Vincent C, et al. Lancet. 1994;343:1609-13; Studdert DM, et al. N Engl J Med. 2004;350:283-92.

13. Case (cont.): The Wrong Shot After the incident, the physician in this case felt responsible for the loss of trust and the missed opportunity to administer an important vaccine to a child.

14. Impact of Medical Errors on Physicians • Physicians frequently feel powerful emotions following medical error • Disappointment about failing to practice medicine to their own standards • May include physical symptoms such as insomnia, anxiety, difficulty concentrating • Physicians may fail to disclose errors due to embarrassment, guilt, or fear of litigation Gallagher TH, et al. JAMA. 2003;289:1001-7; Levinson W, et al. JAMA. 1989;261:2252; Christensen JF, et al. J Gen Intern Med. 1992;7:424-31; Newman MC. Arch Fam Med. 1996;5:71-5.

15. Institutional Interventions to Improve Error Disclosure • Provide emotional support to clinicians as component of patient safety program • Offer communication skills training • Standardized patients, role-playing • Educate physicians about causes and prevention of errors • Dispel myth that fault usually lies with the individual

16. Take-Home Points • Harmful errors should be disclosed to patients • Error disclosure should include an explicit statement that an error occurred, a review of the cause, plans for prevention, and an apology • Physicians should seek help from institutional risk managers prior to discussions

17. Take-Home Points • The link between error disclosure and quality improvement should be emphasized • Institutions should provide communication skills training and support programs that facilitate error disclosure • Further research is needed to examine the relationship between disclosure and malpractice