An Important “Dot” Understanding and Improving Medication Safety in Pediatrics Paul Sharek, MD, MPH Assistant Professor of Pediatrics, Stanford University Medical Director of Quality Management Chief Clinical Patient Safety Officer Vice President of Quality, Safety, and Outcomes Management Lucile Packard Children’s Hospital 0
The Basics Learning objectives Unique challenges to ensuring medication safety in children Burden of medication harm in children Review Best Practices in pediatric medication safety Introduce “next generation” strategies (high reliability constructs) for pediatric medication safety Take home messages Harm (including medication related harm) occurs at high frequency in children’s hospitals Numerous best practices to improve medication safety. Taking it the next level: Translating high reliability concepts into health care is the next generation of medication safety 1
How we will spend the next 30 minutes… • Introduction • Epidemiology of harm (medication related) in children • Best practices in medication safety • Institute for Healthcare Improvement • NICHQ • Others • The next generation of patient safety interventions (high reliability science) • Summary 2
I. Uniqueness of Children Special issues for children- relevant to medication safety 1. Weight based dosing (and weights change frequently) 2. Organ system development is variable, affecting metabolizing and excretion 3. Meds mixed by pharmacists or nurses at time of use 4. Pediatric meds often need to be diluted from adult formulations 5. Many pediatric medications come in multiple formulations 6. Children less likely to recognize/communicate an error or harm 3
II. The Burden of Harm in Children Adverse Drug Event (ADE) Adverse Drug Event (ADE) - An injury, large or small, caused by the use (including non-use) of a drug. This may be as harmless as a drug rash or as serious as death. 4
II. The Burden of Harm in Children Medication Error (ME) Definition: Any error in the process of : Ordering Transcribing Dispensing Administering Monitoring a medication Caveats Medication errors are not defined by outcome May not result in an actual adverse drug event 5
II. The Burden of Harm in Children Harm vs. Error (IHI) “Error”: concept of preventability, process -focused “Adverse event”: harm, outcome focused Relationship between errors and adverse events Adverse Errors Events 6
II. The Burden of Harm in Children Medication errors and ADEs in Children Kaushal et al, JAMA , 2001;285:2114-2120 * Total ADE rate 2.3 per 100 admissions *p value <0.005 7
II. The Burden of Harm in Children Age Specific Error Rates (per 100 admissions) Kaushal et al, JAMA , 2001;285:2114-2120 8
II. The Burden of Harm in Children Unit Specific Error Rates (per 100 orders) Kaushal et al, JAMA , 2001;285:2114-2120 9
II. The Burden of Harm in Children ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 960 Pediatric Inpatients; 11.1 ADEs per 100 admissions; 22x more ADEs than incident reports 10
II. The Burden of Harm in Children ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 11
II. The Burden of Harm in Children Pediatrics: ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 ADE Severity Level 100 90 80 70 60 Percent 50 40 30 20 10 0 E F G H I NCC MERP severity level 12
Severity Rating of Adverse Events* Category E: contributed to or resulted in temporary harm to the patient and required intervention Category F: contributed to or resulted in temporary harm to the patients and required initial or prolonged hospitalization Category G: contributed to or resulted in permanent patient harm Category H: required intervention to sustain life Category I: contributed to or resulted in the patient’s death *Source: National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) 13
II. The Burden of Harm in Children ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 14
II. The Burden of Harm in Children ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 15
II. The Burden of Harm in Children PICU Trigger Tool Trial: In Press Total Patient Count: 734 Average AEs over all Patients: 2.03/patient Total Triggers: 2,816 Total # AEs identified: 1,488 Average AEs in patients with adverse events: 3.27 / patient Total Number of Patients with Adverse Events: 455 (62%) Overall # AEs per 100 pt. Days= 28.6 91% of patients with an AE Average AEs per Trigger (Positive Identified with a Trigger (=416/455) Predictive Value of any given trigger): Number of patients with multiple (> 0.444 1) Unique AEs: 245 (33%) Average Triggers per Patient: 3.84 Average LOS: 7.1 Days Mean Time for Chart Reviews: 24.7 minutes (per reviewer) 16
II. The Burden of Harm in Children PICU Trigger Tool Trial: In Press Interv. Prolon to sustain g hosp. Perm. life harm • 256 (17.20%) AEs were classified as ADEs • No ADEs contributed to patient death 17
II. The Burden of Medication Harm in Children PICU Trigger Tool Trial: In Press Statically significant risk factors: • Surgical patients (preventable ADEs) • Intubated patients (preventable ADEs) • >18 yo patients (preventable ADEs) • 13-18 yo and >18 yo patients (total ADEs ) 18
II. The Burden of Harm in Children Where the Adverse Drug Events Occur vs. Errors (David Classen) * History-Taking Obtain Document Medication-related Medication History History ADEs = 49% Medication Inventory Management Prescribing errors 39% Ordering ADEs = 11% Formulary, Inventory purchasing decisions management Transcription Diagnostic/ Errors = 12% Medication Order verified Therapeutic Ordered and submitted Decisions Made Surveillance ADEs =14% Pharmacy Management Dispensing Incident/adverse Dispense/ Errors = 11% Select Prepare event surveillance Evaluate order distribute medication medication and reporting medication ADEs = 26% Admin errors = 38% Administration Management Monitor/Evaluate Response Document Administer Medication Education Assess and Administer Document Select the document Intervene as according to patient response administration correct drug for Educate patient Educate staff indicated for order and to medication and associated the correct regarding regarding adverse standards for according to information patient medication medications reaction/error drug defined 19 parameters
II. The Burden of Harm in Children Summary findings 1. Overall: 11.1 ADEs per 100 admissions 2. Opiates 51% of all ADEs in children 3. Vast majority of medication related harm is temporary 1. Hospital wide 2. PICU setting 4. Most harm occurs at ordering and administration stages 5. 17% of all harm in PICU setting is drug related 6. Preventable ADEs in PICU: Risk factors 1. Surgical patient 2. Intubated patient 3. Increasing age 20
III. Best practices for Medication Safety-overview • Institute for Healthcare Improvement (IHI) • National Initiative for Child Health Quality (NICHQ) • Harvard group (Bates/Kaushal/etc) recommendations • American Academy of Pediatrics (AAP) recommendations 21
III. Best Practices IHI 100,000 Lives Campaign (12.2004) 1. Deploy Rapid Response Teams…at the first sign of patient decline 2. Deliver Reliable, Evidence-Based Care for Acute Myocardial Infarction…to prevent deaths from heart attack 3. Prevent Adverse Drug Events (ADEs) …by implementing medication reconciliation 4. Prevent Central Line Infections…by implementing a series of interdependent, scientifically grounded steps 5. Prevent Surgical Site Infections…by reliably delivering the correct perioperative antibiotics at the proper time 6. Prevent Ventilator- Associated Pneumonia…by implementing a series of interdependent, scientifically grounded steps 22
III. Best Practices IHI Generation 2: The 5 Million Lives Campaign 100,000 lives campaign interventions PLUS New interventions targeted at harm: Prevent Pressure Ulcers ... • Reduce Methicillin-Resistant Staphylococcus aureus (MRSA) • Infection … • Reduce Surgical Complications ... • Deliver Reliable, Evidence-Based Care for Congestive Heart Failure … • Get Boards on Board …. • Prevent Harm from High-Alert Medications ... starting with a focus on anticoagulants, sedatives, narcotics, and insulin 23
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