Adverse Drug Events (ADEs)

1. Adverse Drug Events(ADEs) Holli Temple, PharmD Chief Pharmacy Advisor for the Partnership for Patients Initiative through CMS Clinical Assistant Professor University of Texas at Austin College of Pharmacy

2. Definition of an ADE • World Health Organization (WHO) definition • An ADE is “noxious and unintended and occurs at doses used in man for prophylaxis, diagnosis, therapy, or modification of physiologic functions.” • WHO definition includes ADEs from medication errors • Med errors occur at any stage from ordering to administering • Some ADEs are harmless, cause injury, or are “near misses”

3. Definition of an ADE • IHI Global Trigger Tool definition • Harm is defined as “unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or that results in death.” • IHI focuses on errors of commission (active delivery of care) and excludes errors of omission • Includes all adverse events – whether preventable or not • IHI tool measures harm over time

4. Measuring Harm from Medications • ADEs – single greatest risk of harm to patients in hospitals • Voluntary reporting and tracking of med errors • Low yield – only 10-20% of errors are reported • Of those reported, 90-95% did not cause harm • Conventional method of sifting through the medical record to uncover errors costly and largely ineffective

5. Measuring Harm from Medications • National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Error Categorization • Categories below do NOT cause harm • Category A: capacity to cause error • Category B: error did not reach the patient • Category C: error reached the patient, no harm • Category D: error reached patient and required monitoring or intervention to confirm that it resulted in no harm to the patient

6. Measuring Harm from Medications • Categories below DO cause harm: • Category E: temporary harm to patient; intervention required • Category F: temporary harm to patient and required initial or prolonged hospitalization • Category G: permanent patient harm • Category H: intervention require to sustain life • Category I: patient death

7. ADE Triggers • Before starting chart review, team to agree on list of medication related triggers to review at your hospital. • Example triggers: • M1: C. Diff positive stool • M2: PTT greater than 100 seconds • M3: INR greater than 6 • M4: Glucose less than 50 mg/dl

8. ADE Triggers • M5: Rising BUN or serum creatinine 2x over baseline • M6: vitamin K administration (Aqua-mephyton®, Mephyton®, phytonadione) • M7: diphenhydramine (Benadryl®) administration • M8: flumazenil (Romazicon®) administration • M9: naloxone (Narcan®) administration • M10: anti-emetic administration ondansetron (Zofran®), promethazine (Phenergan®)

9. ADE Triggers • M11: over-sedation/hypotension • M12: abrupt medication stop • M13: Other • Trigger yield (from Rozich study): • anti-emetic use most numerous -- ~ 7% of ADEs • abrupt medication stop accounted for ~ 35% of ADEs • most common: anticoagulants, sedatives, pain medications, antibiotics, insulin

10. Identifying and Measuring ADEs Form multi-disciplinary team – at least 3 people Decide on list of triggers for your facility Review trigger tool; each chart review requires its own form whether or not an ADE is identified

11. Identifying and Measuring ADEs • Random sample of 10 patient charts every 2 weeks • Obtain a few extra in case those selected do not match criteria for evaluation • Records need to be: • Closed and complete • Inpatients with LOS at least 24 hours • Patient age 18 years or older • Exclude inpatient psych and rehab patients

12. Identifying and Measuring ADEsWhere to look? • Discharge summary – may include adverse events • Medication Administration Record (MAR) • Laboratory results • Prescriber orders • Nursing notes • Physician progress notes

13. Identifying and Measuring ADEs If time permits, review other areas of record (e.g. H&P, ED report) Set a 20 minute limit for each chart reviewed (after training completed) An ADE is defined as unintended harm to a patient (from the patient’s viewpoint) Would you be happy if event happened to you? If not, likely an ADE

14. Identifying and Measuring ADEs Systematically/selectively review portions of the chart where the triggers are most likely found If trigger found, review portion of chart that will reveal whether or not an ADE occurred If harmful event found, determine level of harm (E – I) and briefly describe ADE Use professional judgment to make determination

15. Identifying and Measuring ADEs • Complete ADE Patient Record Review Sheet for the sampled charts • Summarize findings in the ADE Monthly Summary Sheet • For each chart reviewed, document • Whether or not an ADE occurred • Number of ADEs • Total number of medication doses received (optional)

16. Outcome Measures/Calculations • Percent of Admissions with an ADE • Total N# with ADE from sample/total N# of records in sample • If a patient experienced more than one ADE, only count that patient once in the numerator.   • ADEs per 1000 doses •  Total N# of ADE from sample/total N# of medication doses administered to the patients in the sample

17. Outcome ADE Measures We will track your measures (Percent of Admissions with an ADE and ADEs per 1000 doses) over time in a run chart http://www.ihi.org/knowledge/Pages/Tools/RunChart.aspx Are changes to processes making medication use safer in the hospital? Graph results to see if improving

18. Tools available on IHI.org Trigger Tool for Measuring ADEs – http://app.ihi.org/Workspace/tools/trigger/CreateTool.aspx Improvement Tracker available for use -- http://app.ihi.org/Workspace/tracker/CreateTracker.aspx?MeasureId=606

19. Tools available on IHI.org • Other trigger tools available • ICU Adverse Event Trigger Tool • Pediatric Trigger Toolkit: Measuring ADEs in the Children’s Hospital • Trigger Tools for Measuring ADEs in the Nursing Home

20. Questions?