Presentation on theme: "Adverse Drug Events (ADEs)"— Presentation transcript:
1 Adverse Drug Events (ADEs) Holli Temple, PharmDChief Pharmacy Advisor for the Partnership for Patients Initiative through CMSClinical Assistant ProfessorUniversity 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 errorsMed errors occur at any stage from ordering to administeringSome ADEs are harmless, cause injury, or are “near misses”Any effort to identify harm needs a clear definition of an adverse eventNear misses – do not cause injury to patient either by chance or because they are intercepted before the medication is administered.
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 omissionIncludes all adverse events – whether preventable or notIHI tool measures harm over time-- Errors of omission represent an opportunity for quality improvement, but not the focus of IHI Trigger Tools.e.g. patient whose hypertension was untreated and had a stroke is a “medical catastrophe” – error of omission, but would not be considered to have suffered and AE using the IHI Trigger Tool. However, if a patient suffered a hemorrhagic stroke as a complication of anti-coagulant therapy – error of commission-- During reviews, will find errors of omission. Refer these errors to appropriate personnel for improvement opportunities.-- reviewers should not attempt to determine preventability during a review. By IHI definition, if ADE occurred, a patient was harmed. “Unpreventable events” only an innovation away from being preventable.
4 Measuring Harm from Medications ADEs – single greatest risk of harm to patients in hospitalsVoluntary reporting and tracking of med errorsLow yield – only 10-20% of errors are reportedOf those reported, 90-95% did not cause harmConventional method of sifting through the medical record to uncover errors costly and largely ineffectivePublic health researchers established = 10-20%Historical way of ADE collection (at NAMC): ADE postcard, eMAR (using triggers), abstracted report based on discharge summary coding clues)Hospitals need a more effective way to identify events that do not cause harm to patients in order to select and test changes to reduce harm
5 Measuring Harm from Medications National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Error CategorizationCategories below do NOT cause harmCategory A: capacity to cause errorCategory B: error did not reach the patientCategory C: error reached the patient, no harmCategory D: error reached patient and required monitoring or intervention to confirm that it resulted in no harm to the patientIHI tool adapts the NCCMERP error categorization: Examples of categorical errors:A: in Rx bins, furosemide 20 mg tabs found in famotidine 20 mg bin upon routine expiration date checksB: nurse found metformin 500 mg in patient’s med bin instead of metronidazole 500 mg tabsC: Vicodin 5/500 given to patient instead of Norco 5/325D. Patient received 40 meq of potassium chloride instead of 40 mg of lasix (furosemide)
6 Measuring Harm from Medications Categories below DO cause harm:Category E: temporary harm to patient; intervention requiredCategory F: temporary harm to patient and required initial or prolonged hospitalizationCategory G: permanent patient harmCategory H: intervention require to sustain lifeCategory I: patient deathE: benadryl to treat PCN allergyF: vancomycin induced renal toxicity, iodinated contrast causing ARFG: reglan induced EPS (diabetic gastroparesis)H: excess narcotic administered, rapid response team notified; pt coded => intubated and transferred to ICU; U500 insulin instead of U100??I: death: high-dose methotrexate without leucovorin rescue (2 patients on MT only enough leucovorin for one); potassium floorstock given instead of lasix
7 ADE TriggersBefore starting chart review, team to agree on list of medication related triggers to review at your hospital.Example triggers:M1: C. Diff positive stoolM2: PTT greater than 100 secondsM3: INR greater than 6M4: Glucose less than 50 mg/dlM1: positive C.Diff assay is an ADE if patient has recently been on abxM2: look for evidence of bleeding, a drop in hgb/hct, bruising to determine if an ADE has occurred. Increased PTT by itself is not an ADE. High PTTs are not rare as heparin rates are being titrated to the patient. High PTTs may be common during cath lab procedures.M3: look for evidence of bleeding; an increased INR in itself is not an ADEM4: review nursing notes looking for symptoms such as lethargy and shakiness and also review MAR for administration of glucose, OJ, or other intervention. If patient is not symptomatic, there is no adverse event.M5: review labs for rising BUN or Scr. If a change of two times greater than baseline is found (e.g. 1.1 => 2.2, review MAR for meds known to cause renal toxicity (e.g. IV dye, NSAIDs, loop diuretics, ACE inhibitors, ARBs, aminoglycoside abx, vancomycin). Review physician progress notes and H&P for other causes of renal failure, e.g. pre-existing renal disease or diabetes than may have put patient at greater risk for renal failure. This is not an ADE, but disease progression.
8 ADE Triggers M5: Rising BUN or serum creatinine 2x over baseline M6: vitamin K administration (Aqua-mephyton®, Mephyton®, phytonadione)M7: diphenhydramine (Benadryl®) administrationM8: flumazenil (Romazicon®) administrationM9: naloxone (Narcan®) administrationM10: anti-emetic administration ondansetron (Zofran®), promethazine (Phenergan®)M5: review labs for rising BUN or Scr. If a change of two times greater than baseline is found (e.g. 1.1 => 2.2, review MAR for meds known to cause renal toxicity (e.g. IV dye, NSAIDs, loop diuretics, ACE inhibitors, ARBs, aminoglycoside abx, vancomycin). Review physician progress notes and H&P for other causes of renal failure, e.g. pre-existing renal disease or diabetes than may have put patient at greater risk for renal failure. This is not an ADE, but disease progression.M6: if vitamin K given in response to an increased INR, look for evidence of bleeding. Check labs for a drop in hgb/hct or guiac positive stools. Check progress notes for documentation of excessive bruising, GI bleeding, hemorrhagic stroke, or large hematomas.M7: Benadryl is frequently used to treat allergic reactions to medications but can also be used as a sleep aid, pre-op or pre-procedure medication, seasonal allergies, sleep. If Benadryl (or IV Benadryl) administered, review chart to determine if it was ordered for symptoms of an allergic reaction to a drug or blood transfusion administered either during the hospitalization or prior to admission (used to count only those ADEs that occurred in the hospital, but more info gathered about patient use of meds if reactions that started as an outpatient are also considered)M8: Romazicon – reverses benzodiazepines. Determine why Romazicon used. Often used after post-procedure to reverse effects of Versed (midazolam). If Romazicon given after benzodiazepine administration (e.g. Xanax -- alprazolam, Ativan – lorazepam, Restoril – temazepam), an ADE may have occurred. With excess benzo admistration, severe hypotension or prolonged sedation may occur .M9: narcan given to reverse effects of narcotics. Unless given specifically post-procedure, use of narcan on floor probably indicates an ADEM10: : anti-emetics: N/V commonly the result of drug administration in surgical and non-surgical settings. Anti-emetics are commonly given. N/V that interferes with feeding/eating, post-op recovery, or delayed discharge suggests an ADE. One or two episodes of N/V treated successfully with anti-emetics suggest no ADE. Use clinical judgment to determine whether or not harm occurred.M11: oversedation/hypotension: review MD progress notes, nursing notes or multi-disciplinary notes for evidence of over-sedation and lethargy. Review VS records or graphics for episodes of hypotension related to the administration of a sedative, analgesic, or muscle relaxant. Intentional OD is not considered and ADE.M12: abrupt stop: although d/c of meds is a common finding during chart review, abruptly stopping meds is a trigger requiring further investigation for cause. A sudden change in patient condition requiring adjustment of med is often related to an ADE. “Abrupt” is best described as a unexpected stop of deviation from typical ordering practice, e.g. D/C IV abx to change to an oral form is not unexpectedM13: for ADEs detected but not related to one of the medication triggers above
9 ADE Triggers Trigger yield (from Rozich study): M11: over-sedation/hypotensionM12: abrupt medication stopM13: OtherTrigger yield (from Rozich study):anti-emetic use most numerous -- ~ 7% of ADEsabrupt medication stop accounted for ~ 35% of ADEsmost common: anticoagulants, sedatives, pain medications, antibiotics, insulinM11: oversedation/hypotension: review MD progress notes, nursing notes or multi-disciplinary notes for evidence of over-sedation and lethargy. Review VS records or graphics for episodes of hypotension related to the administration of a sedative, analgesic, or muscle relaxant. Intentional OD is not considered and ADE.M12: abrupt stop: although d/c of meds is a common finding during chart review, abruptly stopping meds is a trigger requiring further investigation for cause. A sudden change in patient condition requiring adjustment of med is often related to an ADE. “Abrupt” is best described as a unexpected stop of deviation from typical ordering practice, e.g. D/C IV abx to change to an oral form is not unexpectedM13: for ADEs detected but not related to one of the medication triggers aboveTrigger Yield: From 1704 charts, 2187 triggers found and 413 were true ADEs. Anti-emetic trigger found 916 times with 64 ADEs determined = ~ 7% of total ADEs. Abrupt med stop found 248 times with 86 ADEs attributed (35% of ADEs).
10 Identifying and Measuring ADEs Form multi-disciplinary team – at least 3 peopleDecide on list of triggers for your facilityReview trigger tool; each chart review requires its own form whether or not an ADE is identifiedTwo primary record reviewers who have clinical backgrounds and knowledge about the contents and layout of the hospital’s record as well as about how care is provided in the hospital. IHI trigger tool has traditionally used nurses, pharmacists, and RTs on their team. Experienced nurses have been the best reviewers!A physician who does not review the records but authenticates the consensus of the two primary record reviewers – findings of adverse events. ratings of severity, and provides answers to questions the reviewers may have
11 Identifying and Measuring ADEs Random sample of 10 patient charts every 2 weeksObtain a few extra in case those selected do not match criteria for evaluationRecords need to be:Closed and completeInpatients with LOS at least 24 hoursPatient age 18 years or olderExclude inpatient psych and rehab patientsSample 10 records from 1-15 of each month and 10 records from 16 – end of month => two time points generates two data pointsAvoid outpatient recordsInstead of reviewing ALL patient records to detect triggers and investigating them to determine if an ADE has occurred, use samplingRandom – each record has an equal change of being selected, e.g. every 10th patient ; small hospitals with fewer than 10 inpatients per 2 weeks, review all charts
12 Identifying and Measuring ADEs Where to look? Discharge summary – may include adverse eventsMedication Administration Record (MAR)Laboratory resultsPrescriber ordersNursing notesPhysician 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 ADETrigger tool not meant to identify ALL adverse events in a single record
14 Identifying and Measuring ADEs Systematically/selectively review portions of the chart where the triggers are most likely foundIf trigger found, review portion of chart that will reveal whether or not an ADE occurredIf harmful event found, determine level of harm (E – I) and briefly describe ADEUse professional judgment to make determinationDo not read through entire chart. INR values found in the lab section of the chartTrigger present? 2) section of chart => trigger 3) if ADE, determine level of harmProfessional judgment: anti-emetic given an hour after a narcotic. If patient continued to receive the narcotic without the anti-emetic, no ADE. If each time the narcotic given, anti-emetic given = ADE.Reviewers will find many positive triggers, but will identify a few ADEs. Physician input will be critical.
15 Identifying and Measuring ADEs Complete ADE Patient Record Review Sheet for the sampled chartsSummarize findings in the ADE Monthly Summary SheetFor each chart reviewed, documentWhether or not an ADE occurredNumber of ADEsTotal number of medication doses received (optional)
16 Outcome Measures/Calculations Percent of Admissions with an ADETotal N# with ADE from sample/total N# of records in sampleIf 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 MeasuresWe will track your measures (Percent of Admissions with an ADE and ADEs per 1000 doses) over time in a run chartAre 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 –Improvement Tracker available for use --
19 Tools available on IHI.org Other trigger tools availableICU Adverse Event Trigger ToolPediatric Trigger Toolkit: Measuring ADEs in the Children’s HospitalTrigger Tools for Measuring ADEs in the Nursing Home