Epidemiology of Medication Errors Almut G. Winterstein, PhD College of Pharmacy, and Masters of Public Health Program at the College of Public Health and Health Professions University of Florida Epidemiology of Medication Errors 1. Drug therapy outcomes: As good as it gets? 2. Medication errors: How do they look like? 3. In my xxx there are no errors – What do you know about your own environment and how do you find out? “Health Care is a decade or more behind high-risk industries in its attention to ensure basic patient safety” (IOM, 2000) z “... more people die in a given year as a result of medical errors than from motor vehicle accidents, breast cancer, or AIDS.” z “... medication-related error is “one of the most common types of errors.” [S]ubstantial numbers of individuals are affected, and it accounts for a sizeable increase in health care costs.” Definitions z Medical error {Slips and lapses (10-fold overdose, wrong leg amputated) {Suboptimal care (not following clinical guidelines or best practices) {Errors of omission (indirectly related to medical intervention: no therapy, underdose) {Errors of commission (directly related to medical intervention: overdose, contraindicated therapies) z Preventable adverse drug event: clinically manifest error Quality Deficits: Delays in Implementing Evidence z Meta-analysis published 1985 emphasized efficacy of beta-blockade during and after acute myocardial infarction (AMI) (Yusuf et al. Progr Cardiovasc Dis 1985) z ISIS-1 Mega-Trial established efficacy in >16,000 MI cases (ISIS-1, Lancet 1986) z Study evaluating patient data in 1996: { Among the 45,308 AMI patients without contraindications, 50.0% had a beta-blocker as a discharge medication. (Krumholz et al. JAMA 1998) Marker for Quality Deficits: Variation z There was significant variation by state (30.3% -77.1%). z Patients with general and family practice physicians as primary care provider had lower rates (OR, 0.78; 95% CI, 0.73-0.83). z Beta-blockers were associated with a 14% lower risk of mortality at 1 year after discharge. (Krumholz et al, JAMA 1998) Life-Cycle of Quality Deficits % patients with appropriate care New evidence Clinical standard Quality Deficit Medical Error How many errors do you have? z At some point in your life have you experienced a medical error in your own care or that of your family members? {Yes / No z In your role as pharmacist have you experienced a medical error that resulted in serious patient harm in the last year? {Yes / No z What is the incidence of medication errors in your institution? {<0.1% {<1% {<5% {<10% {>10% Harvard School of Public Health/Henry J. Kaiser Family Foundation Survey (Health & Medicine Week , Feb 2003) z 35% of physicians reported experiencing a medical error in their own care or that of a family member at some point in their life; z 18% of physicians said an error caused "serious health consequences" such as death (7%), long-term disability (6%) or severe pain (11%) z 29% of all doctors said that in their role as a physician they had seen a medical error that resulted in serious harm to a patient in the last year Evidence Base for the IOM report: Significance of pADE z Harvard Medical Practice Study (Leape, N Engl J Med 1991, 1993) { stratified random sample of 51 hospitals in state NY { assessment concerned hospital-acquired adverse events { adverse event defined as injury that resulted in patients’ death, long-term disability or an extended length of stay in the hospital { primary scope was assessment of cases for litigation and negligence claims Harvard Medical Practice Study contd. z Review of 30,195 charts z assessment of two core concepts: { causality (degree of association between drug and adverse outcome) { preventability z review of medical charts by two clinical experts, in cases of disagreement 3rd broke tie z 0.72% of all patients experienced an adverse drug event z 0.32% of all admitted patients experienced a preventable adverse drug event during their hospital stay Brigham Study Series (Bates et al.) z Included events classified as “significant, serious, life-threatening, fatal Author (+)/(-) criteria Case ascertainment ADE (%) pADE (%) Bates 1995 (+) random Solicited reports & medical sample of adults of record review, implicit rd 2 hospitals judgement by 2 3 broke tie (-) obstetric units 6.5% n=4031 1.8% Bates 1995 (+) all adults Solicited reports & medical admitted to 3 units record review; implicit judgement by 1 6.6% n=379 1.4% Bates 1993 (+) all adults Solicited reports & medical admitted to 7 units record review, implicit rd judgement by 2 3 broke tie 6.4% n=420 3.6% Acute Care Estimates of pADEs z Systematic Review of 10 studies that assessed pADE incidence and nature (Kanjanarat & Winterstein, AJHP 2002) { pADE incidence: median 1.8% (range 1.3-7.8%) z Cost of pADEs (Bates et al., JAMA 1994) { Additional length of stay associated with preventable adverse drug events: 4.6 days { Increase in additional costs: $4685 { Annual costs for a 700-bed teaching hospital attributable to preventable ADES $2.8 million Ambulatory Care Estimates IOM report: “..there is evidence indicating that adverse drug events account for a sizeable number of admissions to inpatient facilities, but we do not know what proportion of these are attributable to errors.” Ambulatory Care Estimates (Winterstein et al, Ann Pharmacother 2002) z Meta-analysis of 15 studies reporting prevalence of preventable drug-related hospital admissions { pADEs acquired in ambulatory care leading to hospitalization { pADE prevalence: median 4.3% (range 1.3 – 14%) { Stratum-specific prevalence estimates z Re-admissions vs. all admissions: OR 3.7 (1.5 – 8.9) z Mean age > 70 vs. ≤ 70y.: OR 2.0 (0.95 – 4.2) z Omission errors included vs. excluded: OR 1.9 (0.92 – 3.9) Can you think of medication errors that frequently cause hospital admission? Can you think of medication errors that frequently occur in the ER? Summary z Medication errors occur frequently { Any instance where new evidence is not implemented can be considered a medication error { Any instance where peers are able to deliver superior quality than you can be considered medication errors { Errors don’t include only causing harm with drugs but also causing harm by omitting drugs Patient Safety Solutions In our opinion, medical error is an issue for cognitive science and engineering, not medicine. (Zhang et al., JAMIA 2002) Nursing Shortage Poses Serious Health Care Risk: Joint Commission Expert Panel Offers Solutions To National Health Care Crisis (JCAHO 2002) Based on overwhelming scientific evidence, The Leapfrog Group decided to focus on three practices that have tremendous potential to save lives by reducing preventable mistakes in hospitals. First things first: "medical error" is not "medicine" it is "error." The discipline appropriate to its study and diagnosis is not medicine but theory of error - errorology! (visualexpert.com) How do we know? What is the most important (prevalent) error cause? What is effective in accomplishing the IOM goal for a 50% reduction in medical error by 2005? What is efficient? What would address the specific concerns of our institution? What would utilize pharmacists’ time and expertise most optimally? Description of Medication Errors z By drug z By outcome z By cause Information on Medication Errors 1. Drug alerts by federal agencies and other organizations / voluntary reporting ISMP, JCAHO MedMarx, Studies on voluntary reporting systems (Winterstein, Hatton et al. AJHP 2002) 2. Quality Indicators based on Clinical Guidelines and Best Practices AHRQ, NCQA, JCAHO, CMMS 3. Systematic Studies of medication errors Systematic Review of published studies Solicited institution-specific reporting Solicited Medication error reports by an interdisciplinary team (Winterstein, Johns et al., AJHP 2004) Solicited Medication Omission error reports by physician attendings (Winterstein, Rosenberg et al., SIGGM 2004) 1. Alerts: Institute of Safe Medication Practice (ISMP) z Sounds-alike: New drug Procet® (hydrocodone & acetaminophen) Similar to: Perocet® (oxycodone & acetaminophen) z Calculation errors: Calculators may round results when depending on the number of decimal places set; in this example the calculator rounded 3.75mg to 4mg z Look-alike: ACIPHEX (rabeprazole sodium), and ARICEPT (donepezil HCl), MedMARx Database at United States Pharmacopeia (USP) z z z z z Voluntary database on medication errors Standardized reporting and classification format 56 participating hospitals in 1999 6,224 medication errors reported 97% of reported medication errors did not cause harm (because they were averted or not manifest) z Node: administration (40%), documenting (21%), dispensing (17%), prescribing (11%), monitoring (1%) z Most frequent error types: omission (1,689), improper dose/quantity (1,323), unauthorized drug (751) z Top causes: performance deficit, protocol not followed, knowledge deficit 2. CMMS Quality Indicators (Jencks et al., JAMA 2000) Quality varies… (Jencks et al., JAMA 2000) Assessment of Quality across States (Jencks et al., JAMA 2000 – update 2003) z Estimates for Florida (ranks 41st) { 77% (88%) receive aspirin / 60% (76%) BB within 24 h { 78% (90%) receive aspirin / 69% (90%) BB at discharge { 29% (49%) of smokers receive smoking cessation counseling when admitted for MI { 76% (89%) admitted with CAP receive Abx within 8h { 74% (75%) receive Abx consistent with current recommendations { 69% (82%) of all diabetes patients have annual HbA1c { (%) for State with highest ranking (New Hampshire) Update ranking 3. Systematic Studies z Prospective follow-up on consecutive admissions or retrospective chart review z Expert assessment of { causal association between drug therapy and morbidity { preventability z Description by type of drug, type of outcome, type of drug-related problem z Limited assessment of causes pADEs in patients at an intensive care unit (4.8% pADE incidence) (Darchy et al., 1999) Adverse outcome Severe bleeding* Metabolic disorder Fluid overload* Acute renal failure Respiratory failure Hyperkalemia GI bleeding Cardiac failure Hypokalemia % of ADEs 15.4 10.2 10.2 10.2 10.2 7.7 5.1 5.1 5.1 Medication associated with adverse event Oral anticoagulant (& interactive drug ) Miscellaneous IV fluid infusion ACEI, cytotoxic drugs Anesthesia, miscellaneous ACEI&diuretics, diuretic NSAIDs Anesthesia Diuretic Systematic review of 10 acute care studies (Kanjanarat & Winterstein, AJHP 2002) { Top drugs: Cardiovascular, psychoactive/CNS, analgesics, antiinfectives, anticoagulants, antihyperglycemics { Top adverse outcomes: allergic reactions, hepatic or renal problems, cardiovascular problems, hematologic problems and bleeding, and central nervous system problems { Top causes: inappropriate prescribing decisions and inappropriate monitoring Solicited Report by an Interdisciplinary (Winterstein,Johns et al, AJHP 2004) Team z Eight clinicians on adult medical and surgical, medical hematology and oncology, bone marrow transplantation, and medical and cardiac intensive care units of large university-affiliated tertiary care institution z 3-month report period in 2002 z Validation through independent review by 2 clinicians (PharmD/BCPS and MD/internist) z Real-time assessment of causes z Validation of reports by 2 independent reviews z Clustering techniques to find prevalent pattern Results { 240 valid reports (81 discarded): 95 manifest, 94 nonmanifest, 51 averted { (240/~5000 admissions with LOS > 1 day = 4.8%) { Errors by node z prescribing (72.5%) z administration (14.6%) z dispensing (6.6%) z transcribing (6.3%) { Pharmacy averted 32 errors (18.4%) that were initiated in the prescribing node, and administering was able to avert another 10 (7%) that had passed undetected through the previous nodes. Top 10 Outcomes Type of Outcome Uncontrolled infection Cardiovascular problems (hyper-/hypotension, arrhythmia) Renal failure GI-problems Neutropenia / thrombocytopenia Electrolyte imbalances Oversedation / respiratory depression Hemorrhage Uncontrolled pain Hyperglycemia N 28 11 9 7 6 5 4 4 4 3 % 30 12 10 7 6 5 4 4 4 3 Top Causes Type of Cause N % Knowledge deficit (dosing 68, drug selection 23, prophylaxis 3) 94 39 Performance deficit 73 30 Lab values not considered 32 13 Patient condition not considered 12 5 Lack of patient monitoring 9 4 Inappropriate drug administration 8 3 Incorrect drug policy/drug information 6 3 Patient history not considered 6 3 240 100 Total Top Pattern by Outcome, Node, Drug, and Drug-related Problem Pattern of preventable adverse drug events (pADEs) n % Uncontrolled infection, prescribed underdose or failure to prescribe anti-infectives 22 23% Renal failure, prescribed overdose of anti-infective 4 4% Respiratory depression, prescribed overdose of CNS drug(s) 4 4% Uncontrolled pain, prescribed underdose or wrong choice of opioids 4 4% GI problems, prescribed unnecessary GI drugs 4 4% Hyperglycemia, prescribed underdose of insulin 2 2% Hemorrhage, prescribed overdose of blood formation and coagulation drugs 2 2% Electrolyte imbalance, prescribed underdose of electrolytes 2 2% Cardiac problems, failure to prescribe electrolytes 2 2% Uncontrolled infect, failure to transcribe/order anti-infective 2 2% Total 48 51% Solicited Report by Senior Attendings (Winterstein, Rosenberg et al, 2004) • • • 9 attending MDs on general internal medicine services recruited and trained to report medication errors that: • Represented errors of omission -- necessary medication not prescribed, underdosed, or other necessary activities to assure optimal drug therapy omitted (e.g., monitoring). • Were clinically manifest / had > 50% likelihood of becoming manifest. Manifestation defined as death, disability, disease, therapeutic intervention necessary to prevent further harm. Medical chart review and provider interview to obtain information on error etiology and causes. Validation of reports through investigator consensus Results z 34 error reports, 9 discarded z 25/320 admitted patients with errors (7.8%) Lack of drug was more prevalent than underdosing Prescribing was associated with more errors (56%) than administering (36%), transcribing (8%) or dispensing (0%) Most prominent error causes were: Drug knowledge (e.g., DVT prophylaxis vs. treatment) Ineffective communication (e.g., accessibility of MD; explicitness of PRN orders) Performance (provider forgot to order or administer drugs) often associated with work flow at rounds, patient transfers, faulty chart audit procedures (review of orders failed to detect omitted doses/drugs) “Highlights” z Lack of knowledge about heparin dosing for prophylaxis versus treatment (untreated DVT) z Failure to obtain or replace off-formulary antipsychotic in time (uncontrolled psychosis) z Failure to write complete transfer orders for bronchodilator (dyspnea, uncontrolled COPD) z Ineffective communication of morphin PRN order (uncontrolled pain) Summary: High-priority Areas of pADEs Preventable hypo- and hyperglycemia Preventable acute renal impairment/failure Preventable thromboembolic and hemorrhagic events Preventable uncontrolled infections Preventable respiratory depression and uncontrolled pain Preventable allergic and anaphylactic reactions What is your top-priority medication error in the ER and why does it occur?