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Adverse Drug Event Rates Involving Nephrotoxic and Renally Excreted Drugs In Community Hospitals

Adverse Drug Event Rates Involving Nephrotoxic and Renally Excreted Drugs In Community Hospitals Balthasar L. Hug, MD, MBA Division of General Internal Medicine, Brigham and Women‘s Hospital, Boston, MA Division of Internal Medicine, Basel University Hospital. Background I: Incidence

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Adverse Drug Event Rates Involving Nephrotoxic and Renally Excreted Drugs In Community Hospitals

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  1. Adverse Drug Event Rates Involving Nephrotoxic and Renally Excreted Drugs In Community Hospitals Balthasar L. Hug, MD, MBA Division of General Internal Medicine, Brigham and Women‘s Hospital, Boston, MA Division of Internal Medicine, Basel University Hospital SGMI Sierre June 5th, 2008 Dr. B. Hug

  2. Background I: Incidence • Adverse Drug Events (ADEs) are common: • 19.4% of in-hospital harm is medication related (Harvard Medical Practice Study, Brennan TA, NEJM 1991;324:370) • Large academic hospitals: 6.5 ADEs/100 admissions (Bates DW, JAMA 1998;280:1311) SGMI Sierre June 5th, 2008 Dr. B. Hug

  3. Background II: Incidence Renal Failure • 1% on hospital admission • 2-5% during hospitalization • 4-15% in patients with certain surgical procedures such as cardiopulmonary bypass surgery(Thadhani R et al, NEJM 1996;334(22):1448) SGMI Sierre June 5th, 2008 Dr. B. Hug

  4. Background III: Definitions • Medication Error (ME): “Error anywhere in the process of drug ordering, delivering or application regardless of whether or not it harmed the patient”.(Bates DW J Gen Intern Med 1995;10:199) • Adverse Drug Event (ADE): “Injury resulting from a medical intervention related to a drug” (Bates DW, JAMA 1995;274:29) • Near Miss (=potential ADE): ME with potential for harm. Intercepted: Harm did not reach patient, non-intercepted: error did no harm. SGMI Sierre June 5th, 2008 Dr. B. Hug

  5. Background IV: Politics • Massachusetts Hospital CPOE Initiative 2006: CPOE in all acute care hospitals by 2010 (www.mtpc.org) CPOE=Computerized Physician Order Entry SGMI Sierre June 5th, 2008 Dr. B. Hug

  6. Specific Aim • To assess the incidence and severity of adverse drug events (ADEs) in patients with renal failure in six community hospitals. SGMI Sierre June 5th, 2008 Dr. B. Hug

  7. Methods • Design: Multicenter, retrospective cohort study • Study sites: 6 community hospitals 150-300 beds in MA • Study Duration: 20 months (1/05-8/06) • Randomly selected 150 patient charts/hospital in patients with creatinin > 1.5 mg/dL (114.4µmol/L) • 2 independent reviewers SGMI Sierre June 5th, 2008 Dr. B. Hug

  8. Results I: Demographics • All patients n=109,641 • Age – mean 63.2 y (range 18-107) • 18-44 23,599 (21.5%) • 45-54 12,344 (11.3%) • 55-64 14,809 (13.5%) • 65-74 18,095 (16.5%) • 75-84 25,413 (23.2%) • 85 and > 15,380 (14.0%) • Gender: Female 58.1% • Race: Caucasian 89.9% SGMI Sierre June 5th, 2008 Dr. B. Hug

  9. Results II: Demographics: Unique patients with ADE (n=89) • Age – mean 70.3 y (SD 15.2) p<0.001 (vs. all patients, T-test) • 18-44 6 (6.7%) • 45-54 7 (7.9%) • 55-64 16 (18.0%) • 65-74 19 (21.4%) • 75-84 23 (25.8%) • 85 and > 18 (20.2%) • Gender: Female 37 (41.6%) p=0.002 (Fisher’s exact test) • Race: Caucasian 82 (96.5%) p=0.88 (Fisher’s exact test) • 1 patient with two ADEs, others with 1 ADE/patient SGMI Sierre June 5th, 2008 Dr. B. Hug

  10. Results III: Incidents by severity (all sites) • ADEs n (%) R/100 adm (95% CI) • Significant 40 (44.4) 4.4 (3.2,6.0) • Serious 46 (51.1) 5.1 (3.8,6.7) • Life-threat. 4 (4.5) 0.44 (0.14,1.0) • Total 90 (100) 10.0 (8.1, 12.2) • Near Misses • Significant 219 (44.0) 24.4 (21.4,27.8) • Serious 271 (54.4) 30.1 (26.7,33.8) • Life-threat. 8 (1.6) 0.9 (0.41,1.7) • Total 489 (100) 55.3 (50.6,60.3) SGMI Sierre June 5th, 2008 Dr. B. Hug

  11. Results IV: Incident rates and preventability (all sites) n (%) Rate/100 admissions (95% CI) • ADEs: 90 (15.2) 10.0 (8.1, 12.2) p=0.04* • Preventable 82 (91.1) 9.1 (7.3, 11.2) p=0.02 • Non-prev. 8 (8.9) 0.9 (0.41, 1.65) N/A • Near Misses 498 (84.1) 55.3 (50.6, 60.3) p=0.0006 • Non-interc. 481 (96.6) 53.4 (48.8, 58.4) p=0.002 • Intercepted 17 (3.4) 1.9 (1.1, 2.9) p=0.44 • MEs 4 (0.7) 0.4 (0.14, 1.0) N/A • Total 592 (100) 68.5 (60.6, 71.2) *Chi-squared test for equal rates across sites N/A = not applicable SGMI Sierre June 5th, 2008 Dr. B. Hug

  12. Results V: Incident rates and preventability (all sites) • 82/82 preventable ADEs preventable by renal dose checking. • Of near misses, nearly all (99.8%; 497/498) preventable by CPOE systems with decision support: • 495 (99.4%) by renal dose checking, • 1 (0.2%) by drug dose suggestion, • 1 (0.2%) by cumulative dose check; • 1 near miss (0.2%) was not preventable by CPOE. SGMI Sierre June 5th, 2008 Dr. B. Hug

  13. Potential ADE reduction by CPOE Prevention Strategy Preventable ADEsPreventable Near Misses n (%) n (%) Drug – Laboratory Check 37 (27.4) 26 (4.7) Renal Function Check 26 (19.3) 74 (13.4) Drug – Dose Suggestion 12 (8.9) 95 (17.2) Drug Cum. Dose Check - 106 (19.2) Drug – Age Check 12 (8.9) 4 (0.7) Drug-specific Guidelines 9 (6.7) 19 (3.4) Drug – Allergy Check 5 (3.7) 12 (2.2) Drug – Frequency Check 4 (3.0) 38 (6.9) Drug – Drug Interaction Check 3 (2.2) 17 (3.1) Duplicate Drug Check 1 (0.7) 23 (4.2) Basic CPOE – Legibility - 19 (3.4) Drug route suggestion - 11 (2.0) Patient Characteristic 1 (0.7) 9 (1.6) Drug Duration Check - 4 (0.7) Not preventable by CPOE 25 (18.5) 95 (17.2) Total 135 (100) 552 (100) (Hug et al, submitted) SGMI Sierre June 5th, 2008 Dr. B. Hug

  14. Results VI: Culprit Drugs ADEs prev n (%) non-prev • Antibiotics 100 (37.0) 6 (42.9) • Analgesics 85 (31.5) 3 (21.4) • Cardiovascular 44 (16.3) 4 (28.6) • Oral Antidiabetics 12 (4.4) - • Antifungal Agents 11 (4.1) - • Neurotropic Drugs 2 (0.7) - • Others 16 (5.9) 1 (7.1) Total 270 (100) 14 (100) SGMI Sierre June 5th, 2008 Dr. B. Hug

  15. Conclusions • ADEs in patients with renal failure are common in community hospitals (10.0/100 admissions). • Virtually all of ADEs and near misses in these patients are potentially averted by CPOE with decision support. • Antibiotics, analgesics and CV drugs most prevalent in ADEs. SGMI Sierre June 5th, 2008 Dr. B. Hug

  16. Daniel J. Witkowski, M.D., M.S. Colin M. Sox, M.D. Carol A. Keohane, B.S.N., R.N. Diane L. Seger, R.Ph. Catherine Yoon, M.S. Michael E. Matheny, M.D., M.S., M.P.H. Judith A. Melin, M.D. David W. Bates, M.D., M.Sc. SGMI Sierre June 5th, 2008 Dr. B. Hug

  17. Thank you bhug@uhbs.ch SGMI Sierre June 5th, 2008 Dr. B. Hug

  18. IHI Trigger Tool • Triggers for potential ADEs (T1-T19) • Examples: • Diphenhydramine: anti-allergic • Vitamine K (warfarine) • INR >6 • Anti-emetics (droperidol, metoclopramine etc.) • Naloxone (opiates) • Kayexalate (hyperkalemia) (www.ihi.org) SGMI Sierre June 5th, 2008 Dr. B. Hug

  19. ADR Definition WHO • “…noxious and unintended, and which occurs at doses used in man for prophylaxis, diagnosis and therapy.” SGMI Sierre June 5th, 2008 Dr. B. Hug

  20. Challenge Switzerland • Swiss Technology Collaborative? • Teamwork, Stakeholders: • Academia • Industry • Insurance companies • Politics SGMI Sierre June 5th, 2008 Dr. B. Hug

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