Improving Patient Safety by Reducing Medication Errors

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Improving Patient Safety by Reducing Medication Errors. BackgroundPatient SafetyInstitutional ContextThemeOverall ApproachFour Specific Projects. Improving Patient Safety by Reducing Medication Errors. BackgroundPatient SafetyInstitutional ContextThemeOverall ApproachFour Specific Projects

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Improving Patient Safety by Reducing Medication Errors

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1. Improving Patient Safety by Reducing Medication Errors Brian L. Strom, M.D., M.P.H. Professor of Biostatistics and Epidemiology Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine

2. Improving Patient Safety by Reducing Medication Errors Background Patient Safety Institutional Context Theme Overall Approach Four Specific Projects

3. Improving Patient Safety by Reducing Medication Errors Background Patient Safety Institutional Context Theme Overall Approach Four Specific Projects

4. Background Patient Safety Institutional Context

5. Background: Patient Safety Patient Safety and Medical Errors The Culture of Medical Practice, Root Causes, and Predisposing Factors Risks Associated With the Use of Drugs Medication Errors The Elderly at Risk Drug Class of Risk Determinants of Physician Prescribing Errors Patient Adherence and Medication Errors Technological and Other Innovations

6. Patient Safety and Medical Errors Iatrogenic injuries: up to 180,000 US deaths each year, and disability or prolongation of hospital stay in another 1.3 million Medical errors: 44,000-98,000 annual deaths, more than MVA, breast cancer, or HIV Medical errors: annual costs of $17-29 billion

7. Definitions Patient safety: “freedom from accidental injury; ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur” Adverse event: “an injury resulting from a medical intervention” An error: “failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim; the accumulation of errors results in accidents”

8. Philosophy: “To Err is Human: Building a Safer Health System” Even apparently single events or errors are due most often to the convergence of multiple contributing factors Preventing errors and improving safety for patients requires a systems approach in order to modify the conditions that contribute to errors The problem is not bad people; the problem is that the system needs to be made safer.” Concern is not about substandard or negligent care, but rather, errors made by even the best trained, brightest, and most competent professional health caregivers and/or patients

9. The Culture of Medical Practice, Root Causes, and Predisposing Factors Historically Perfectionism, stoicism, and an expectation that practitioners should function without error Errors considered a failure of character, and admitted or discussed rarely JCAHO concept of root cause faulted for implying that a single factor can be identified as cause

10. The Culture of Medical Practice, Root Causes, and Predisposing Factors Instead, a systems approach Examines interdependent elements interacting to achieve a common aim, thus focuses on both human and non-human elements Investigates the interrelationships between humans, the tools they use, and their environment

11. Risks Associated With the Use of Drugs Adverse drug events are the most common iatrogenic causes of patient injuries

13. Risks Associated With the Use of Drugs Type A reactions are the result of an exaggerated but otherwise usual pharmacological effect of the drug dose-related, predictable, less serious, common patients receiving more drug than customarily required, a conventional amount but metabolize or excrete the drug unusually slowly, on an additional drug which interferes with excretion or metabolism, or are overly sensitive to the drug In principle, these factors all are predictable and thereby potentially preventable These complications could all be considered medication errors

14. Risks Associated With the Use of Drugs Type B reactions are aberrant effects Uncommon, not related to dose, potentially more serious, but unpredictable May be due to hypersensitivity reactions or immunologic reactions, or some other idiosyncratic reaction to the drug, either due to some inherited susceptibility or some other factor Most difficult to predict Yet, historically have represented the major focus of commercial and regulatory interest, and thereby the major focus of pharmacoepidemiology studies of adverse drug reactions

16. Medication Errors Adverse drug event (ADE) is an injury resulting from a drug Between 2.4 and 6.5% of hospitalized pts estimated to have ADEs, prolonging hospital stays by an average of two days and increase costs by $2,000-2,600 per pt More than 7,000 deaths were attributed to medication error in the US in 1993 Med errors are highly preventable

17. Medication Errors Of 10,070 med orders: 530 med errors were identified 25 ADEs & 35 potential ADEs Five (20%) of the ADEs associated with medication errors; all preventable Although medication errors are common, relatively few result in ADEs Targeting those errors that are most likely to cause ADEs will have the greatest public health impact

18. Medication Use Process Diagnosis Prescribing Dispensing Administration Ingestion Monitoring and control

19. The Elderly at Risk Rates of ADEs rise with age Incidence of adverse events in pts aged >65 almost twice as high as in younger patients Incidence of preventable adverse events in pts aged > 65 almost twice as high as in younger patients Percentage of ADEs due to negligence markedly higher among elderly In the outpatient elderly population, almost a quarter have received at least 1 of 20 contraindicated drugs; a fifth had received two or more such drugs

20. Drug Class of Risk Hospital data: ADEs: analgesics, antibiotics, anticoagulants Med errors: antimicrobials, cardiovascular agents, gastrointestinal agents, non-narcotic analgesics and antipyretics USP MedMARx program: warfarin, insulin, heparin, cefazolin, vancomycin, lorazepam, potassium chloride, meperidine, furosemide, and famotidine 41 of 100 consultations for nephrotoxicity were iatrogenic, half drug-induced: 7 from antibiotics, 5 from diuretics, 4 from NSAIDs, 3 from ACE inhibitors, and 1 from a contrast medium

21. Selected Determinants of Physician Prescribing Errors Lack of patient & practitioner edn/training Incomplete patient information Lack of information resources available to prescribing docs & dispensing pharmacists Reliance on error-prone manual checks for drug-drug interactions Multiple and changing formularies Lack of access to widely disbursed pt data Commercial influences Time constraints and interruptions

22. Patient Adherence and Medication Errors In ambulatory setting, the pt’s role is key Nearly 3 billion new and repeat prescriptions are filled in the ambulatory setting in the US, an increase of 50% in seven years Estimates of the frequency of drug-related hospital admissions have varied from 0.2% to 22% of all hospitalizations, with most studies reporting figures between 3% and 10% >5% hospital admissions attributed to drugs, 23% induced by poor adherence Meta-analysis of 7 studies and 2942 admissions attributed 5.5% of admissions specifically to drug therapy nonadherence, including over-use, under-use, and erratic use of drugs

25. Technological and Other Innovations Process changes: bar-coding; colored wristbands for allergies; unit dosing; computerized physician order entry; standardizing processes such as doses, times, scales, prescription writing, and rules; automated dispensing devices; automated medication administrative records; computerized adverse drug event detection; robots for filling outpatient prescriptions; etc. Programs: adding a pharmacist to patient-care rounds, pharmacokinetic monitoring services, etc.

26. Background Patient Safety Institutional Context

27. Drug Use and Effects Program Adverse drug reaction reporting Drug usage evaluation Pharmacy cost containment

28. Goals of the DUEC Program Improve the quality of patient care by improving the clinical use of medications and minimizing adverse drug reactions Decrease hospital costs by eliminating the inappropriate use of drugs or by offering acceptable low cost substitutions Decrease liability associated with the inappropriate use of high risk drugs Bring HUP into compliance with JCAHO requirements Contribute new methodology and new clinical information to hospital pharmacoepidemiology

30. ADE Annual Report

31. Adverse Drug Experiences - 1998

32. CPUP-DUE Starting in 1998, DUEC’s activities were extended to CPUP, and outpatient practice

33. July 1999-June 2000 DUEC Data: Top Meds Resulting in Reported ADRs (N=608)

34. July 1999-June 2000 DUEC Data: Top Meds Resulting in Serious ADRs (N=301)

35. July 1999-June 2000 DUEC Data: Top Meds Resulting in Admission (N=148)

36. July 1999-June 2000 DUEC Data: Most Common ADRs

37. Improving Patient Safety by Reducing Medication Errors Background Patient Safety Institutional Context Theme Overall Approach Four Specific Projects

38. Improving Patient Safety by Reducing Medication Errors: Theme AHRQ: Center of Excellence for Patient Safety Research and Practice Theme: Improving Patient Safety Through Reduction of Errors in the Medication Use Process PRIME: Program for Reduction In Medication Errors

39. Improving Patient Safety by Reducing Medication Errors Background Patient Safety Institutional Context Theme Overall Approach Four Specific Projects

40. Overall Approach Entire range of places where errors can arise Select drugs with ubiquitous use, capacity to lead to errors, and severity of the consequences of errors Include different settings and various populations Examine both human psychosocial factors and technical system factors Perform evaluations in sites prepared to rapidly implement the studies’ findings, implementations that could then be evaluated in future studies Take advantage of local versions of existing systems, to evaluate those characteristics which protect against errors, and those which do not

41. Improving Patient Safety by Reducing Medication Errors: Overall Organization Four projects Four cores: Administrative Core Data Collection Core Biostatistics and Data Management Core Dissemination Core

42. Improving Patient Safety by Reducing Medication Errors Background Patient Safety Institutional Context Theme Overall Approach Four Specific Projects

43. Project 1: Medication Errors Leading To Hospitalization Among The Elderly (Joshua Metlay, MD, PhD--PI) To identify predisposing factors for hospitalizations due to errors in medication use among large, representative cohorts of community-dwelling elderly patients initiated or maintained on warfarin, phenytoin, or digoxin To develop a prediction rule to identify elderly patients at high risk for hospitalization due to errors in use of these drugs To estimate the costs associated with hospitalization due to errors in use of these drugs

44. Project 1 Study Design Prospective cohort study enrolling members of PACE Five cohort studies: new and chronic users of phenytoin, new users of warfarin, chronic users of warfarin, new users of digoxin, and chronic users of digoxin Baseline interviews to identify psychosocial, behavioral, & clinical risk factors Coordination of medical and pharmaceutical care, existence of methods for communicating instructions for new medications, level of home support, and level of visual and cognitive function

45. Project 1 Outcomes Outcome of interest: hospitalization due to dose-related errors in medication use Regular subject phone contact using a screening instrument to identify all hospitalizations and exclude those unlikely to be medication related Medical records abstracted to confirm the nature of the hospitalization, timing in relation to drug use, and drug level at admission Drug-specific analyses identifying predisposing factors for hospitalization, and developing a prediction rule to identify subjects at high risk of hospitalization due to medication errors

46. Project 2: Predictors for Poor Adherence to Warfarin Therapy (Stephen Kimmel, MD, MSCE--PI) To determine the clinical, demographic, organizational, behavioral, and psychosocial predictors of poor adherence To develop a predictive index that can identify patients at high risk for medication errors before starting therapy

47. Project 2 Study Design Prospective cohort design, enrolling adult patients requiring warfarin who are treated at the outpatient pharmacist-managed HUP Anticoagulation Clinic (AC) Patients presenting to the AC clinic will be identified at the start of therapy and followed throughout their course An addition to a funded NIH study designed to examine the effects of genetic polymorphisms and adherence on clinical outcomes (INR levels, bleeding, and thromboembolism)

48. Project 2 Data Collection Data collection: 1) demographics, 2) clinical characteristics, 3) health-care structure characteristics, 4) pill taking practices, 5) psychosocial variables, 6) study outcomes The primary outcome is adherence, to be measured using an electronic data monitoring system

49. Project 3: Inpatient Medication Errors Leading to Acute Renal Failure (Harold Feldman, MD, MSCE--PI) Explore the predisposing factors for inappropriate inpatient aminoglycoside dosing that leads to acute renal failure, examining: The failure to use pharmacokinetic monitoring Delays in initiating pharmacokinetic monitoring Failure to implement recommendations from the pharmacokinetic monitoring service Pharmacokinetic monitoring service characteristics/procedures systems

50. Project 3: Inpatient Medication Errors Leading to Acute Renal Failure Secondary aims are to identify other potentially modifiable predisposing factors for acute renal failure among patients receiving aminoglycoside antibiotics, including: Systems to assure interactions with nursing and pharmacy to avoid drug errors, supervision on the teaching service, etc. Type of clinical service Other potentially modifiable predisposing factors for acute renal failure among pts receiving aminoglycosides

51. Project 3 Study Design Hospital-based case-control study nested within a cohort of HUP patients receiving aminoglycosides Cases of ARF occurring among patients receiving aminoglycoside antibiotics will be identified by DUEC, and compared to controls selected randomly who are not experiencing ARF Data collection: structured review of medical records and evaluation of their interaction with the pharmacokinetic monitoring service prior to the occurrence of ARF for the cases, or during an analogous exposure time for controls

52. Project 4: Medication Errors Related to Workplace Stressors (Ross Koppel, PhD--PI) To determine if, and to what extent, the organization of work within a hospital, e.g., schedules, shifts, workloads, etc., affects houseofficers’ commission of medication errors To determine if houseofficers’ experience of workplace stress (the cognitive, behavioral, physiological, and psychological experience of stress--called “strains”) increase the risk of medication errors

53. Project 4: Medication Errors Related to Workplace Stressors To determine how hospital workplace stressors interact with houseofficers’ strains to influence the risk of medication errors To determine how hospital workplace stressors and strains interact with houseofficers’ baseline psychological profiles to influence the risk of medication errors

54. Project 4 Study Design A series of cross sectional studies Data collection: 1) analysis of houseofficers’ workloads, shifts, and schedule data from hospitals; 2) surveys administered to houseofficers at several points in their training about workplace stressors and the personal experiences of stress (strain); 3) one-on-one interviews about workplace organization and stressors; 4) focus groups on this topic; and 5) an annual psychometric personality inventory

55. Project 4 Outcomes The “near misses” for medication errors detected by the DUEC-supervised Pharmacy Intervention Program In particular, each houseofficer will be evaluated for the numbers of HUP interventions required by their prescriptions, using the number of HUP inpatient prescription orders they have written as the denominator

56. Improving Patient Safety By Reducing Medication Errors: Overall Goal To improve patient safety by identifying the factors that predispose to medication errors, and to create a research base for the design of interventions to reduce the frequency of medication errors

57. PRIME Project/Core PIs Project 1: Josh Metlay, MD, PhD Project 2: Stephen Kimmel, MD, MSCE Project 3: Harold Feldman, MD, MSCE Project 4: Ross Koppel, PhD Core A: Brian Strom, MD, MPH Core B: Brian Strom, MD, MPH Core C: Russell Localio, JD, MS Core D: David Asch, MD, MBA

58. PRIME: Other Investigators

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