SGMI Sierre

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• 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 Womens Hospital, Boston, MA
• Division of Internal Medicine,
• Basel University Hospital

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• 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
  1991324370)
• Large academic hospitals 6.5 ADEs/100 admissions
  (Bates DW, JAMA 19982801311)

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• 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 1996334(22)1448)

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• 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
  199510199)
• Adverse Drug Event (ADE) Injury resulting from
  a medical intervention related to a drug (Bates
  DW, JAMA 199527429)
• Near Miss (potential ADE) ME with potential for
  harm. Intercepted Harm did not reach patient,
  non-intercepted error did no harm.

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• Background IV Politics
• Massachusetts Hospital CPOE Initiative 2006 CPOE
  in all acute care hospitals by 2010
  (www.mtpc.org)
• CPOEComputerized Physician Order Entry

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• Specific Aim
• To assess the incidence and severity of adverse
  drug events (ADEs) in patients with renal failure
  in six community hospitals.

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• 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 gt 1.5 mg/dL (114.4µmol/L)
• 2 independent reviewers

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• Results I Demographics
• All patients n109,641
• 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 gt 15,380 (14.0)
• Gender Female 58.1
• Race Caucasian 89.9

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• Results II Demographics Unique patients with
  ADE (n89)
• Age mean 70.3 y (SD 15.2) plt0.001 (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 gt 18 (20.2)
• Gender Female 37 (41.6) p0.002
  (Fishers exact test)
• Race Caucasian 82 (96.5)
  p0.88 (Fishers exact test)
• 1 patient with two ADEs, others with 1
  ADE/patient

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• 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)

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• Results IV Incident rates and preventability
  (all sites)
• n () Rate/100 admissions (95 CI)
• ADEs 90 (15.2) 10.0 (8.1, 12.2)
  p0.04
• Preventable 82 (91.1) 9.1 (7.3, 11.2)
  p0.02
• Non-prev. 8 (8.9) 0.9 (0.41, 1.65)
  N/A
• Near Misses 498 (84.1) 55.3 (50.6, 60.3)
  p0.0006
• Non-interc. 481 (96.6) 53.4 (48.8, 58.4)
  p0.002
• Intercepted 17 (3.4) 1.9 (1.1, 2.9)
  p0.44
• 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

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• 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.

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• Potential ADE reduction by CPOE
• Prevention Strategy Preventable ADEs
  Preventable 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)

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• 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)

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• 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.

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• 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.

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Thank you
bhug_at_uhbs.ch
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• IHI Trigger Tool
• Triggers for potential ADEs (T1-T19)
• Examples
• Diphenhydramine anti-allergic
• Vitamine K (warfarine)
• INR gt6
• Anti-emetics (droperidol, metoclopramine etc.)
• Naloxone (opiates)
• Kayexalate (hyperkalemia)
• (www.ihi.org)

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• ADR Definition WHO
• noxious and unintended, and which occurs at
  doses used in man for prophylaxis, diagnosis and
  therapy.

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• Challenge Switzerland
• Swiss Technology Collaborative?
• Teamwork, Stakeholders
• Academia
• Industry
• Insurance companies
• Politics