Adverse Events and Medical Errors

Transcription

1 Adverse Events and Medical Errors Dennis Tsilimingras, M.D., M.P.H. Director, Center on Patient Safety Assistant Professor of Family Medicine & Rural Health The Florida State University College of Medicine

2 Objectives (1) To become familiar with common patient safety definitions. (2) To become familiar with the theory for the occurrence of adverse events/medical errors in the healthcare system. (3) To become familiar with major inpatient studies and reports on adverse events/medical errors. (4) To become familiar with major postdischarge studies on adverse events/medical errors. (5) To become familiar with the common types of adverse events. (6) To become familiar with recommendation that may prevent adverse events/medical errors in the healthcare system.

3 Outline Patient safety definitions Discontinuities in care (theory for the occurrence of adverse events/medical errors) Major inpatient adverse event/medical error studies Common types of inpatient adverse events/medical errors Institute of Medicine and AHRQ reports on patient safety Post-discharge adverse event studies Common types of postdischarge adverse events Diagnostic errors/mis-diagnoses Clinical scenarios of inpatient and post-discharge adverse events/medical errors Recommendations for improvement Conclusions

4 Patient Safety Definitions Medical error, defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Adverse event, defined as an injury caused by medical management rather than by the underlying disease or condition of the patient. Preventable adverse event, defined as an adverse event injury that could have been avoided as a result of an error or system design flaw.

5 Patient Safety Definitions Ameliorable adverse event, defined as an injury whose severity could have been substantially reduced if different actions or procedures had been performed or followed. Negligence, defined as whether the care provided failed to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question. Error of omission, occurs when a necessary procedure or intervention failed to be performed leading to morbidity or mortality to the patient involved.

6 Patient Safety Definitions Most medical errors do not result in medical injury, though some do, and these are termed preventable adverse events. Many adverse events are neither preventable nor ameliorable.

7 Figure 1: Relationship between medical errors, potential adverse events, and adverse events. Errors that did not cause harm and have no potential to cause harm Medical Errors Non-preventable, Non-ameliorable Adverse Events Potential Adverse Events Adverse Events Errors that have the potential to cause harm Preventable or Ameliorable Adverse Events Miller MR, et al. Medication errors in pediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Saf Health Care. 2007;16:

8 Patient Safety Definitions For example, an unavoidable adverse event can occur from an unknown drug reaction in a patient who received the appropriate administration of a particular drug for the first time. However, if a drug reaction occurred in a patient who knowingly had a previous allergic reaction to that particular drug, the adverse event would be considered preventable, and might be considered negligent.

9 The patient developed a hoarse voice after being discharged with a prescription for an inhaled steroid. The patient did not recall being taught about gargling or rinsing after using the inhaled steroid. This scenario describes: 50% 1. Adverse Event 2. Error of omission 3. Medical error 30% 20% 1 2 3

10 A patient with no known drug allergies has an allergic reaction to a drug administered. This scenario describes: 81% 1. A preventable adverse event 2. An ameliorable adverse event 3. An unavoidable adverse event 6% 13% 1 2 3

11 A diabetic patient had the wrong foot amputated. This scenario describes: 89% 1. Preventable adverse event 2. Ameliorable adverse event 3. Unavoidable adverse event 9% 2% 1 2 3

12 Most medical errors result in medical injury. 1. True 2. False 98% 2% 1 2

13 Discontinuities in Care Discontinuities or gaps in care (the theory for the occurrence of adverse events/medical errors): -occur in complex systems, such as the healthcare system, that involves the interaction of numerous health professionals. -health professionals are faced with the responsibility to deliver optimal care within a limited time frame, to focus on cost-saving efforts, and to develop new skills and judgment abilities for advances in medical knowledge and technology.

14 Discontinuities in Care -all of these factors create pressures for healthcare professionals to efficiently deliver care and are major contributors in raising the level of risk for medical errors and adverse events. -such complexity within a system increases the potential for error when multiple and expedient handoffs are necessary throughout the system. -during hand-offs is when the system is most vulnerable for gaps that result between multiple tasks along the continuum of care.

15 Figure 2: Conceptual Model for the Occurrence of Medical Errors/Adverse Events Numerous Professionals [ Discontinuities in Care ] Poor Information Transfer Faulty Communication [ Hand-Offs ] During a Hospitalization and/or After Hospital Discharge Ambulatory Care Medical Errors Adverse events

16 Discontinuities in Care -Discontinuities in care arise mainly from poor information transfer and faulty communication that often take place: (1) between inpatient and outpatient pharmacies (increased risk of overmedication & harmful drug interactions). (2) as a result of unstructured cross-coverage physician sign-outs (patient s medical condition, laboratory data, resuscitation status, problem list, medication allergies, and follow-ups).

17 Discontinuities in Care (3) as a result of unstructured physician discharge summaries (invite inaccuracies & significant delays in transmitting pertinent info to outpatient providers; structured, database-generated discharge summaries). (4) inadequate discharge planning process (early home return, assessment of plans & needs for discharge by a nurse at admission, and early involvement of a social worker & home nurse if indicated). (5) inadequate patient notification and follow-up of abnormal laboratory test results.

18 During a Hospitalization Anesthesiology, the 1 st medical specialty to investigate medical errors/adverse events in the mid-80 s: -improved mortality rates in the operating room: 1 death/10,000 patients (mid-80 s) to 1 death/400,000 patients (present) Orkin FK. Con: Is pulse oximetry still worthwhile? J Clin Monit. 1998;14:

19 During a Hospitalization (Adults) Harvard Medical Practice Study (NEJM 1991): -landmark study on medical errors/adverse events. -fueled the 1 st Institute of Medicine report on patient safety, To Err Is Human. -1 st patient safety study to randomly select a large number of records involving many institutions and develop more current and more reliable estimates for the incidence of adverse events and negligence. -sampled 30,000 patients from 51 institutions in New York State using 1984 data.

20 During a Hospitalization Results of the Harvard Medical Practice Study: -adverse events related to treatment occurred in 3.7% of patients with 27.6% of those involving negligence. -over 70% of adverse events contributed to disability lasting less than 6-months, with 2.6% resulting in permanent disability, and 13.6% leading to death.

21 During a Hospitalization (continued): -patients aged 65 years and older accounted for 27% of the hospitalized population but 43% of all adverse events. -patients aged 65 years and older had a two-fold risk for developing adverse events when compared to individuals between 16 and 44 years.

22 Table 1: Rates of Adverse Events and Negligence among Clinical-Specialty Groups in New York State (1984) Specialty Rate of Adverse Events(%) Rate of Negligence(%) Orthopedics Urology Neurosurgery Thoracic and cardiac surgery Vascular surgery Obstetrics Neonatology General surgery General Medicine P value < Brennan TA, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:

23 Table 2: Types of Adverse Events and Proportion of Events Involving Negligence in New York State (1984) Type of Event In Population(%) Due to Negligence(%) With Serious Disability(%) Operative Wound infection Technical complication Late complication Non-technical complication Surgical Failure Non-operative Drug-related Diagnostic mishap Therapeutic mishap Procedure-related Fall Fractures Postpartum Anesthesia-related Neonatal P value <0.01 Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:

24 Table 3: Drug-Related Adverse Events, According to Class of Drug Involved in New York State (1984) Drug Class Adverse Events (%) Antibiotic 16.2 Anti-tumor 15.5 Anticoagulant 11.2 Cardiovascular 8.5 Anti-seizure 8.1 Diabetes 5.5 Antihypertensive 5.0 Analgesic 3.5 Anti-asthmatic 2.8 Sedative or hypnotic 2.3 Antidepressant 0.9 Antipsychotic 0.7 Peptic ulcer 0.5 Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:

25 Table 4: Sites of Care that Resulted in Adverse Events in New York State (1984) Site of Care In Sample(%) Due to Negligence(%) With Serious Disability(%) In hospital Operating room Patient s room Emergency room Labor and delivery room Intensive care unit Radiology Cardiac catheterization laboratory Ambulatory care unit Outside hospital Physician s office Home Ambulatory care unit Nursing home P value <0.01 Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:

26 During a Hospitalization Utah and Colorado Medical Practice Study (Med Care 2000): -2 nd medical practice study to randomly select a large number of records involving many institutions and develop more current and more reliable estimates for the incidence of adverse events and negligence. -sampled 15,000 hospitalized patients in adverse events related to treatment occurred in 2.9% of patients. -overall results were similar to those of the Harvard Medical Practice Study.

27 During a Hospitalization The 1 st Institute of Medicine Report on Patient Safety, To Err is Human (2000): -estimated 44,000-98,000 deaths, with 1 million injuries, from medical errors annually in US hospitals based on the Harvard and Utah/Colorado Medical Practice Studies. -annual cost estimated between $17 and $29 billion in set forth a national agenda to reduce errors and improve the quality of care. -stimulated national initiatives from governmental, business, and medical leaders to reduce errors.

28 During a Hospitalization The 2 nd Institute of Medicine Report on Patient Safety, Crossing the Quality Chasm (2001): -highlighted quality-related issues by providing strategies to redesign the current health care system. -emphasized the use of existing medical knowledge and information technology by clinicians to properly care for their patients.

29 During a Hospitalization Hospital Patient Safety Indicators (PSIs) (AHRQ Report 2002): -developed by the Stanford U UCSF Evidence Based Practice Center for AHRQ. -purpose to screen for potential inhospital safety problems (surgical complications and some medical care) using a computerized algorithm involving ICD-9-CM codes. -resulted from a 4-step process: literature review, evaluation of candidate PSIs by clinical panels, consultation with coding experts, and empirical analyses of candidate PSIs.

30 During a Hospitalization Accepted AHRQ Hospital PSIs: (1) Complications of Anesthesia (2) Death in low mortality DRGs (3) Decubitus ulcer (4) Failure to rescue (5) Foreign body left during procedure (6) Iatrogenic pneumothorax (7) Infection due to medical care (8) Accidental puncture or laceration

31 During a Hospitalization (continued): (9) Postoperative hip fracture (10) Postoperative hemorrhage or hematoma (11) Postoperative physiologic and metabolic derangements (12) Postoperative respiratory failure (13) Postoperative PE or DVT (14) Postoperative sepsis (15) Postoperative wound dehiscence (16) Transfusion reaction

32 During a Hospitalization (1) Postoperative PE or DVT: definition and numerator = discharges with ICD-9- CM codes for PE or DVT in any secondary diagnosis field per 1000 surgical discharges. denominator = includes all surgical discharges; excludes pts with a principal diagnosis of DVT; excludes all obstetric admissions; and excludes pts with secondary procedure codes for PE, when PE procedures occur on the day of or previous to the day of the principle procedure.

33 During a Hospitalization (2) Postoperative physiologic & metabolic derangements: definition and numerator = discharges with ICD-9- CM codes for physiologic & metabolic derangements in any secondary diagnosis field per 1000 surgical discharges; and discharges with acute renal failure must be accompanied by a procedure code for hemodialysis.

34 During a Hospitalization (continued): denominator = include all elective surgical discharges; exclude pts with both a diagnosis code of ketoacidosis, hyperosmolarity, or other coma, and principle diagnosis of diabetes mellitus; exclude pts with both a secondary diagnosis code for acute renal failure and a principal diagnosis of acute MI, cardiac arrhythmia, cardiac arrest, shock, hemorrhage or GI hemorrhage; and exclude all obstetric admissions.

35 During a Hospitalization (3) Failure to rescue: definition and numerator = all discharges with disposition of deceased per 1000 population at risk. denominator = include discharges with potential complications of care listed in failure to rescue definition (e.g., pneumonia, PE/DVT, sepsis, acute renal failure, shock/cardiac arrest, or GI hemorrhage/acute ulcer); and exclude pts transferred to an acute care facility, transferred from an acute care facility, or admitted from a long-term care facility.

36 Table 5: Rates of Patient Safety Indicator (PSI) Events in VA Data (FY 2001) (n=430,552)* PSI # Patient Safety Indicator Numerator Denominator Unadjusted Risk- Adjusted HCUP-NIS Medicare Complications of anesthesia Death in low mortality DRGs Decubitus ulcer Failure to rescue Foreign body left in during procedure Iatrogenic pneumothorax Infection due to medical care Postoperative hip fracture Postoperative hemorrhage or hematoma Postop physiologic & metabolic derangements Postoperative respiratory failure Postoperative pulmonary embolism or DVT Postoperative sepsis Postoperative wound dehiscence Technical difficulty with procedure Transfusion reaction ,482 55, ,097 21, , , ,442 71,053 97,479 40,788 31,207 97,231 17,283 20, , , Note: All rates are reported per 1000 discharges at risk using Patient Safety Indicator software, Version 2.1, Revision 1. (Revision 2 was recently released. Preliminary results suggest that only rates for postoperative hip fracture and postoperative pulmonary embolism or changed noticeably- both decreased.) *Rates are calculated based on 430,552 acute care hospitalizations using the VA Health Economics Resource Center s (HERC) definitions of acute and non-acute bedsections. Adjusted for age, sex, age-sex interactions, modified DRGs, and modified comorbidities (reference population is Healthcare Cost and Utilization Project State Inpatient Database (HCUP-SID 2000)). VA risk-adjusted rates are significantly higher based on 95% confidence intervals. VA risk-adjusted rates are significantly lower basde on 95% confidence intervals. National Healthcare Quality Report 2003 (all rates are risk-adjusted as above except for transfusion reaction ). Report to the Congress: Medicare Payment Policy 2004 (all rates are risk-adjusted as above). PSIs #1,5, and 16 were not calculated due to infrequent events. Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care. 2005;43:

37 Figure 3: Comparison of Median Length of Stay (Days) for Hospitalizations with PSI Events Versus Hospitalizations without PSI Events in the VA (FY 2001) PSI No PSI Postoperative Wound Dehiscence P< Postoperative Sepsis P< Postoperative Respiratory Failure P< Postoperative Physiologic and Metabolic Derangements P< Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care. 2005;43:

38 Figure 4: Comparison of In-Hospital Mortality (Deaths per 1000) for Hospitalizations with PSI Events Versus Hospitalizations without PSI Events in the VA (FY 2001) PSI No PSI Postoperative Physiologic and Metabolic Derangements P< Postoperative Sepsis P< Postoperative Respiratory Failure P< Postoperative Wound Dehiscence P< Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Med Care. 2005;43:

39 Figure 5: Comparison of Median Estimated Cost (Thousands of Dollars) for Hospitalizations with PSI Events Versus Hospitalizations without PSI Events in the VA (FY 2001) $80 $60 $40 $57.00 $53.47 $49.17 $48.44 PSI No PSI $ $0 Postoperative Wound Dehiscence P< Postoperative Sepsis P< Postoperative Respiratory Failure P< Postoperative Physiologic and Metabolic Derangements P< Rosen AK, et al. Evaluating the Patient Safety Indicators: How Well Do They Perform on Veterans Health Administration Data? Medical Care. 2005;43:

40 Medical errors and adverse events result primary because of 1. poor information transfer 2. faulty communication 3. poor information transfer & faulty communication 93% 5% 2% 1 2 3

41 The inpatient adverse event rate identified in the Harvard Medical Practice Study was % % % 28% 63% 10% 1 2 3

42 During a Hospitalization (Children) Utah and Colorado Study (Pediatrics 2005): -1 st study to randomly select a large number of records involving several institutions and reliably estimate the incidence of adverse events and preventable adverse events in children. -data suggested that ~70,000 children hospitalized in the United States experience an adverse event annually. -sampled 3,719 discharged hospitalized children and 7,528 discharged hospitalized nonelderly adults using 1992 data.

43 During a Hospitalization -adverse events related to treatment occurred in 1% of hospitalized children. -60% of these adverse events may be preventable. -future research should focus on adolescent hospitalized patients, birth-related medical care, and diagnostic errors in pediatrics.

44 Table 6: Rates and Preventable Adverse Events by Age Group Age Group Adverse Events Proportion of Preventable Adverse (Years) Rate (95% CI) Preventable Adverse Events Events Rate (95% CI) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:

45 Table 7: Distribution of Adverse Events and Preventable Adverse Events by Type: Children and Nonelderly Adults Type Proportion (%) of Proportion (%) of Proportion of Adverse Events Preventable Adverse Preventable Adverse (95% CI)* Events (95% CI) Events (95% CI) in Nonelderly Adults Birth related 29.6 ( ) 32.2 ( ) Diagnostic 21.3 ( ) 30.4 ( ) 10.1 ( ) Medication 19.1 ( ) 21.3 ( ) 6.6 ( ) Surgical 16.3 ( ) 3.5 (0 9.9) 54.6 ( ) Postpartum 6.1 ( ) 8.7 (0 18.6) 5.5 (0 11.0) Therapeutic 0.8 ( ) 2.8 (0 8.6) 5.7 ( ) Nonsurgical procedures 7.7 (0 17.2) 1.1 (0 4.8) 9.6 ( ) Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:

46 Table 8: Estimated Frequency Distribution of Pediatric Adverse Events and Preventable Adverse Events by Covering Service and Location of the Event Adverse Events Preventable Adverse (95% CI) Events (95% CI) Service Obstetrics 34.2 ( ) 38.6 ( ) Surgery 18.0 ( ) 8.5 (0 18.3) Pediatrics 14.5 ( ) 11.4 ( ) Family practice 10.3 ( ) 16.7 ( ) Pharmacy 9.4 ( ) 21.4 ( ) Gynecology 1.6 (0 5.8) 6.8 ( ) Location Labor and delivery 26.2 ( ) 26.2 ( ) Pharmacy 14.9 ( ) 21.4 ( ) Ambulatory care 17.8 ( ) 18.9 ( ) Operating room 19.5 ( ) 11.0 (0 22.0) Patient room 11.8 ( ) 15.7 ( ) Newborn nursery 4.8 (0 10.6) 6.9 (0 15.7) Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:

47 During a Hospitalization A Multicenter Study of Children s Hospitals (Pediatrics 2008): -to determine excess charges and lengths of stay attributable to adverse patient-care events during pediatric hospitalizations. -pediatric-specific quality indicators were used to identify adverse events in 431,524 discharges from 38 pediatric hospitals in the United States participating in the Pediatric Health Information System (PHIS) database in 2006.

48 During a Hospitalization -primary outcomes were excess lengths of stay and charges attributable to adverse patient-safety events as determined by 12 pediatric-specific quality indicators.

49 Table 9: PHIS Rates for AHRQ PDIs in 2006 Variable PHIS, No. PHIS Risk PHIS Rate per 1000 Children s Hospitals of Events Pool Discharges at Risk Rate Reported by AHRQa Accidental puncture and laceration Decubitus ulcer Foreign body left in during procedure Iatrogenic pneumothorax neonate Iatrogenic pneumothorax non-neonates In-hospital mortality after pediatric heart surgery b Postoperative hemorrhage or hematoma Postoperative respiratory failure Postoperative sepsis Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A Multicenter Study of Freestanding Children s Hospitals. Pediatrics. 2008;121:e1653-e1659.

50 Table 9: PHIS Rates for AHRQ PDIs in 2006 (continued) Variable PHIS, No. PHIS Risk PHIS Rate per 1000 Children s Hospitals of Events Pool Discharges at Risk Rate Reported by AHRQa Postoperative wound dehiscence Infection because of medical care Transfusion reaction a Data are based on the Healthcare Cost and Utilization Project KID b Data show the overall rate. The children s hospital rate was not reported by the AHRQ. Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A Multicenter Study of Freestanding Children s Hospitals. Pediatrics. 2008;121:e1653-e1659.

51 Table 10: Excesses in LOS and Total Charges for Patient Safety Events Flagged in the PHIS Variable Matched Excess LOS Excess Total Charges Rate, % a Mean (SE), days Mean (SE), dollars Accidental puncture and laceration (1.06)b (8891)b Decubitus ulcer (1.73)b (17 581)b Foreign body left in during procedure (7.23)b (79 488) Iatrogenic pneumothorax neonate (26.51) ( ) Iatrogenic pneumothorax (2.11) (19 355)b In-hospital mortality after pediatric heart surgery (4.40) (44 039)b Postoperative hemorrhage or hematoma (2.70) (35 094)b Postoperative respiratory failure (2.09)b (18 769)b Postoperative sepsis (2.29)b (22 795)b Postoperative wound dehiscence (4.85) (43 851) Infection because of medical care (1.02)b (9400)b Transfusion reaction (13.76) (59 340) a Data show the percentage of case subjects who could be matched to1 control subject. b Data denote the statistically significant difference (P.006) after the Bonferroni correction. Kronman MP, et al. Charges and Lengths of Stay Attributable to Adverse Patient-Care Events Using Pediatric-Specific Quality Indicators: A Multicenter Study of Freestanding Children s Hospitals. Pediatrics. 2008;121:e1653-e1659.

52 After Discharge United States Post-Discharge Study (Forster AJ, et al. The incidence and severity of adverse events affecting patients after discharge from hospital. Ann Intern Med. 2003;138:161-7) -landmark study on post-discharge adverse events. -reported a 19% adverse event incidence rate among patients discharged home from the general internal medicine service of a major teaching hospital (Brigham & Women s Hospital in Boston). -66% were adverse drug events, 17% were procedure-related problems, 5% were nosocomial infections, and 4% were falls. -1/3 were preventable and 1/3 were ameliorable adverse events.

53 After Discharge Canadian Post-Discharge Study (Forster AJ, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170:345-9) -reported a 23% adverse event incidence rate among patients discharged home from the general internal medicine service of a major teaching hospital (Ottawa Hospital in Ottawa, Canada). -76% were adverse drug events, 16% were therapeutic errors, 11% were nosocomial infections, 7% were procedure-related problems, 7% were pressure ulcers, 6% were diagnostic errors, and 2% were falls.

54 After Discharge As a result of post-discharge adverse events, both the US and Canadian studies reported: 9% - 21% of pts required an additional physician visit 17% - 24% of pts required a hospital readmission 11% - 12% of pts required an ED visit 3% of pts experienced death

55 After Discharge In the Canadian post-discharge study: 14% of hospital readmissions were preventable 2% of hospital readmissions were ameliorable 6% of ED visits were preventable 6% of ED visits were ameliorable 14% of deaths were preventable

56 Table 11: Common Types of Post-Discharge Adverse Events Adverse Event Type IR Preventable IR Ameliorable IR Drug Related* Drug Related Drug Related 72% 66% 25% N/A 50% 11% N/A 76% 28% Procedure Related Procedure Related* 17% 7% 8% N/A 12% N/A Therapeutic Errors* 16% N/A N/A Nosocomial Infections* Nosocomial Infections 11% 5% N/A 0% N/A 4% Pressure Ulcers* 7% N/A N/A Diagnostic Errors* 6% N/A N/A Falls Falls* 4% 2% IR=Incidence Rate. N/A=Not Available. *Forster AJ, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170: Forster AJ, et al. The incidence and severity of adverse events affecting patients after discharge from hospital. Ann Intern Med. 2003;138: Gandhi TK, et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348: % N/A 0% N/A

57 Figure 6: The Most Common Drugs Causing Post-Discharge Adverse Events Post-Discharge Adverse Events (Percent) Antibiotics 16 Cortico- 14 Cardio- 10 Analgesics 8 Anti- steroids vascular coagulants Drugs Forster AJ, et al. The incidence and severity of adverse events affecting patients after discharge from hospital. Ann Intern Med. 2003;138:161-7.

58 Diagnostic Errors Diagnostic error, is defined as a diagnosis that is missed, wrong, or delayed, as detected by some subsequent definitive test or finding. Not all diagnostic errors result in harm to the patient, and harm may be due to either disease or intervention. Misdiagnosis related harm, is defined as preventable harm that results from the delay or failure to treat a condition actually present (when the working diagnosis was wrong or unknown) or from treatment provided for a condition not actually present. Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A: Newman-Toker DE, et al. Diagnostic errors: the next frontier for patient safety. JAMA. 2009;301:

59 Diagnostic Errors An estimated 40,000 to 80,000 hospital deaths result from mis-diagnosis annually in the US. Approximately 5% of autopsies reveal lethal diagnostic errors. During a hospitalization (Harvard Medical Practice Study), 8% of adverse events resulted from misdiagnoses, 75% of misdiagnoses were considered negligent, and 47% of misdiagnoses resulted in serious disability to the patient. After discharge from the hospital (Canadian Post- Discharge Study), 6% of adverse events resulted from misdiagnoses. Newman-Toker DE, et al. Diagnostic errors: the next frontier for patient safety. JAMA. 2009;301: Leape LL, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324: Forster AJ, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170:

60 Diagnostic Errors Comparison of Types of Preventable Adverse Events Between Children and Adults (Utah and Colorado Study) Types of Preventable Adverse Events OR (Odds Ratio) P Value Diagnostic <0.001 Surgical <0.001 Postpartum <0.001 Nonoperative procedure <0.001 Medication <0.001 Therapeutic <0.001 All types <0.001 Children are 1.35 times more likely to experience a preventable adverse event as a result of a diagnostic error than adults during a hospitalization. Woods D, et al. Adverse Events and Preventable Adverse Events in Children. Pediatrics. 2005;115:

61 The adverse event rate after discharge from the hospital ranges between 1. 19%-23% 2. 15%-18% 3. 4%-7% 58% 35% 8% 1 2 3

62 Recommendations for Improvement (A) Identifying System Failures: If a misdiagnosis is not detected or reported, the identification of systemic failures and the initiation of immediate medical attention (for a condition that was missed) will not occur. The failure to identify systemic failures and to initiate immediate medical attention will result in avoidable harm to patients.

63 Recommendations for Improvement (1) Physicians must detect and report a misdiagnosis. (2) Identify underlying system failures that resulted in a misdiagnosis. Example: Identify a new-onset of a condition and retrospectively outline the sequential chain of clinical events leading to its (condition) occurrence. The sequential chain of clinical events may include human factors as the reason that physicians failed to recognize the occurrence of a condition, technical factors involving a computer system, or organizational factors such a payment system that required preauthorization for the care of patients. Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:

64 Recommendations for Improvement (3) By outlining the sequence of clinical events that led to a misdiagnosis, physicians would be able to identify systemic failures and develop solutions to reverse their outcome.

65 Recommendations for Improvement (B) Improving Transitional Care: (1) By creating transitional care teams that include a physician, nurse coordinator, dietician, pharmacist, psychologist, and social worker. (2) Transitional care teams should follow a patient during the inpatient setting, transitional interface, and outpatient setting. (3) Transitional care teams have significantly reduced readmissions, ER visits, deaths, adverse events, and cost of care. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

66 Recommendations for Improvement (C) Improving Information Transfer Through Strategic Use of Electronic Health Records (EHRs): (1) Implementing inpatient and outpatient EHRs. (2) Linking inpatient and outpatient EHRs. (3) Creating and linking patient personal EHRs. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

67 Recommendations for Improvement Example: a physician that examines a patient in the hospital for the 1 st time should have access to the patient s recent outpatient and/or inpatient EHR prior to making medical decisions for the care of that particular patient. By outlining the sequence of clinical events and therapeutic modifications for that particular patient, physicians would be able to make informed decisions in the care of patients when they are seen inside and outside the hospital. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

68 Recommendations for Improvement (4) Implementing Computerized Physician Order Entry (CPOE) & computerized alert monitors within EHRs: (a) in hospitals and home care. (b) to properly transfer a patient s drug info between inpatient and outpatient pharmacies (and vice -versa). (c) these systems have reduced prescribing errors by more than 50%. (d) these systems are effective and imperative for reducing the rate of potential adverse drug events. Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:

69 Recommendations for Improvement (5) An early intervention by a pharmacist can improve poor information transfer and faulty communication between inpatient and outpatient care in addition to EHRs. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

70 Recommendations for Improvement Example: Randomized trial included 92 pts in the intervention group and 84 pts in the control group from the IM service of a large teaching hospital (Arch Intern Med 2006). - A pharmacist reviewed all meds and counseled pts regarding potential side effects at discharge, along with a follow-up phone call 3-5 days after discharge. - Only 1% of patients in the intervention group experienced preventable adverse drug events compared to 11% of patients that experienced preventable adverse drug events in the control group. Schnipper JL, et al. Role of pharmacist in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166:

71 Recommendations for Improvement (6) Implementing structured database-generated physician discharged summaries. (7) Implementing structured cross-coverage sign-outs between physicians. (8) Implementing a comprehensive discharge planning process. (9) Require proper patient notification and follow-up of abnormal laboratory test results. Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A: Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

72 Recommendations for Improvement (D) Medication Reconciliation: (1) A process of identifying the most accurate list of all medications a patient is taking at interfaces of care. (2) Includes the identification of a medication s name, dose, frequency and route, and the subsequent use of this information to provide correct medications for patients within the health care system. (3) The process also involves comparing a patient s current list of medications with a physician s admission, transfer, and/or discharge orders. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

73 Recommendations for Improvement (E) Utilizing Screening Methods to Identify Patients With Adverse Events: (1) Inpatient computerized programs which use ICD-9-CM codes to identify medical or surgical complications. (2) Inpatient computerized programs that combine microbiology, pharmacy, and clinical laboratory data to identify adverse events. (3) Outpatient computerized programs which use ICD-9- CM codes and combine laboratory and pharmacy data to identify adverse events. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

74 Recommendations for Improvement (F) Performing Root Cause Analysis (RCA): (1) To identify the underlying system and organizational problems that led to the adverse event or events. (2) It will not be practical for every adverse event. (3) It should be performed when a pattern of events is identified or even a single very serious event. (4) A systematic RCA may expose common root causes that link several serious adverse events at a particular time of occurrence and help design systems to prevent future incidents. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

75 Recommendations for Improvement (G) Improving Residency and Fellowship Programs: (1) No matter how clinically skilled physicians may be, they will not be able to provide optimal patient care unless the system is appropriately structured. (2) Advocating for such a system is not easy and requires advocacy and management skills that are not part of current residency programs. (3) Residency programs should emphasize the recommendations mentioned here and continue to emphasize skills in patient-centered care and evidence-based practice. Tsilimingras D, et al. Patient Safety in Geriatrics: A Call for Action. J Gerontol Med Sci. 2003;58A:

76 Conclusions (A) Enhanced care can be achieved by adopting wellestablished safety recommendations such as the ones mentioned here. (B) The recommendations mentioned here, are only the tip of the iceberg in confronting the magnitude of this problem. (C) Additional recommendations and further research in this area are critical in improving the quality and safety of patient care. Tsilimingras D, et al. Addressing Post-Discharge Adverse Events: A Neglected Area. Joint Commission Journal on Quality & Patient Safety. 2008;34(2):85-97.

77 The Second Victim The second victim of a medical error, besides the patient, is the physician that cared for the patient. Implications for the second victim: -emotional and psychological -may result in a career change Patient Safety Organizations (PSO) -created by the Patient Safety Act of encourages clinicians and health care organizations to voluntarily report and share quality and patient safety information without fear of legal discovery. Wu AW. Medical error: the second victim. BMJ. 2000;320: AHRQ,