Proactively Identifying Risk and Medication Errors in Home Infusion: How to Ensure Consistent Learnings When Events Occur Matthew Grissinger, RPh, FISMP, FASCP Director, Error Reporting Programs, Institute for Safe Medication Practices Horsham, PA Laura J. Haynes, PharmD, BCPS, CPHQ, ASQ CSSGB Manager of Quality and Patient Safety at Penn Medicine at Home – Penn Home Infusion Therapy King of Prussia, PA
Financial Disclosure 1. Disclosure of Relevant Financial Relationships I have the following financial relationships to disclose : Matt Grissinger - Wife is an employee of Johnson & Johnson Laura Haynes – Husband is an employee of Anthem 2. Disclosure of Off-Label and/or Investigative Uses Matt Grissinger and Laura Haynes - We will not discuss off label use and/or investigational use in my presentation 2
Learning Objectives • Explain the concept of system-based causes of medication errors • Identify examples of latent failures in each phase of the medication use process in the home care setting. • Describe system enhancements to prevent and detect errors before they reach the patient. • Review methods to both identify and reports areas of risk associated with home infusion pharmacy. • Describe the human potential for error and historical prospective of quality/safety within healthcare • Understand 2 major tools (5 whys and fishbone diagram) needed to identify a root cause for event occurrence • Identify the root causes from event review examples by using the 2 above tools. 3
Multifactorial nature of errors • Many factors, latent and active, must be present and in proper alignment for error to occur • Error investigations always concentrate on sharp (active) end ( front line staff ) where patient/caregiver interaction occurs • Contributing factors and blunt end (latent) errors often originate where organizational policies, procedures and resource allocation decisions are made
History-Taking Medication Use System Referral: Document Medication- Medication related History History and Orders Medication Inventory Management Ordering Formulary, Inventory purchasing management decisions Diagnostic/ Medication Order verified Therapeutic Ordered and submitted Decisions Made Pharmacy Management Surveillance Receive Prepare Deliver Referral; Order Entry Medication & medications & Incident/adverse Evaluate order Supplies Supplies event surveillance and reporting Administration Management Monitor/Evaluate Response Document Administer Medication Education Administer Document Intervene as Assess and according to administration Select the Educate patient Educate staff indicated for document order and and associated correct drug & regarding regarding adverse patient response standards for information supply medication medications reaction/error to medication drug 38%
Key Elements of Medication Use Device Acquisition, Use & Patient Information Monitoring Drug Information Environmental Factors Communication Staff Competency & Education Labeling, Packaging & Drug Storage, Stock, & Nomenclature Distribution Patient Education Quality & Risk Management
Patient Information • Lack of critical patient information • Laboratory values, • Height, • Weight, • Diagnoses, • Allergies, • Other drug therapy, etc. • Patient misidentification
Processes Associated with Patient Information • Essential patient information is obtained • Is it communicated? • Readily available in useful form • Where is it documented? • Considered when prescribing, dispensing, and administering medications • Lack of drug information systems that merge with patient information
Patient Information • New Referral Intake • What are you asking for? • Who does intake? • Can a patient be admitted without critical information? • Paper vs Electronic Health Record 9
Communication of Drug Information • Orders • Handwritten prescriptions • Verbal/telephone orders • Ambiguous orders • Hold orders • Transmission of Orders • Fax-related problems • Electronic prescribing • Intimidation/Disruptive Behavior
Home Infusion Order Entry Systems • No clinical decision support (CDS) • Co-morbidities? • Allergies and Reactions • Communication of new reaction/anaphylaxis • You dispense epi-pens, are they used? 11
Home Infusion Order Entry Systems • Weights, but is it lbs. or kgs? • Free texting of drug names • Pharmacy AND nursing documentation, • Pharmacy looks at nursing notes? • Nursing looks at pharmacy notes? • Supply lists 12
Order Entry • Pharmacist #1 enters order. Who checks that? • Patient • Order • Allergies • Comorbidities • Weight-based dosing? • Supplies (and who fixes them?) 13
Chemotherapy • New orders for each cycle or do you just refill based on the original order? • How do you know if there is a change in the order? • What course is the patient on? • Preparing drugs ahead of time without confirming labs (and drug gets delivered) 14
Compounding Environment • Overall workflow • Does delivery take precedence over safety • Environment for compounding • Are you 797 or 800 compliant? • Space to prepare • Counter space to check • Doors going in/out of clean room • Where is final product stored? 15
Pharmacy Preparation • Labels of bottles on compounder facing forward? • Double check of restocking vials on compounder • Barcode verification on compounder vs patient • Open vials cluttering the hood • “just in case” • When are labels applied? • What is included in the final check? • Focus on looking for particulate matter, but is it the right patient? 16
Checking of Final Product • Pullback method = proxy method • ISMP TMSBP • How many vials? All or just one? With a pulled back syringe • Vials, syringes, order, label, final product segregated from others • Eric Cropp • IDC when on-call or not on-call 18
ISMP Targeted Best Practices • ……perform an independent verification to ensure that the proper ingredients are added, including confirmation of the proper volume of each ingredient prior to its addition to the final container. • Specifically, eliminate the use of proxy methods of verification for compounded sterile preparations of medications • e.g., the “syringe pull - back method,” https://www.ismp.org/sites/default/files/attachments/2019-01/TMSBP-for-Hospitalsv2.pdf 19
Staff Competency and Education • Knowledge and skills related to safe medication practices • Inadequate orientation • Workload for trainers • Individualized time for orientation • Inadequate baseline competency evaluation • Specialties • Oncology
Staff Education and Competency • What does training include? • Are pharmacists only doing order entry but expected to check OR prepare when on-call? • What is competency? • Ongoing education • News/ISMP updates/changes to your practice • Internal newsletter 21
Quality Process and Risk Management • How are you identifying risk/unsafe processes? • Hazardous condition/error reporting • Ask your employees • Measures • Waste • Interruptions • Returned pumps • # of calls • Changes in workflow, did it work? 22
Pharmacy Huddles • Who is going out today? • Any hold-ups? • New admits • Discharged patients • What should be picked up? • Drug shortages 23
Human Potential for Error
Institute of Medicine / National Academy of Medicine • Part I - To Err is Human • Part 2 – Crossing the Quality Chasm • Preventing Medication Errors with the Quality Chasm
• “ Whatever humans have learned had to be learned as a consequence only of trial and error experience. Humans have learned only through mistakes.” - R. Buckminster Fuller 26
Science of Improvement • Based on 2 main types of knowledge • Subject Matter Knowledge • Profound Knowledge http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx 27
Profound Knowledge Appreciation of a System Theory of Psychology Knowledge Understanding Variation http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx 28
Pioneers in Quality and Safety Methodologies • W. Edwards Deming • Daniel Kahneman • George Box • Joseph M. Juran http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx W.E. Deming, The New Economics , 1994, Chapter 4 29
“We are making progress against medical errors but much more effort is needed… No one should ever expect perfection, zero errors, or ‘six sigma’. What we should expect, and what I believe is attainable, are zero patient injuries.” - Michael Cohen 30
A Tool for Event Review – 5 Whys 31
5 Whys • What is it? • When do you do it? • Who does it? • Why do you do it? • How is it done? http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx 32
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