2017 Pharmacy Education Series

Transcription

1 2017 Pharmacy Education Series Featured Speaker: Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices October 18, 2017 Improving Patient Safety: Preventing Medication Errors Through Event Analysis Online Evaluation, Self-Assessment and CE Credit Submission of an online post test and evaluation is the only way to obtain CE credit for this webinar Go to Webinar attendees will also receive an with a direct link to the web page Print your CE statement of completion online Credit for live or enduring (not both) Deadline: November 17, 2017 CPE Monitor (applicable to pharmacists and pharmacy technicians) CE credit automatically uploaded to NABP/CPE Monitor upon completion of posttest and evaluation (user must complete the claim credit step) CE Broker this CE activity is approved for State of Florida Medication Safety CE credit. Pharmacists and pharmacy technicians licensed in the State of Florida must provide their license number to info@proce.com for completed CE credit to be posted to CE Broker. Attendance Code Code will be provided at the end of today s activity 2 1

2 How to Ask a Question Locate menu bar on your computer desktop Click orange arrow button to open menu box Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No! Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Click hyperlink 4 2

3 October 18, Pharmacy Education Series Featured Speaker: Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices Improving Patient Safety: Preventing Medication Errors Through Event Analysis It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Ms. Michalek does not have any relevant commercial and/or financial relationships to disclose. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature. 5 CE Activity Information & Accreditation (Pharmacist and Pharmacy Technician CE) 2.0 contact hours This CE activity is approved for State of Florida Medication Safety CE credit. Funding: This activity is self funded through CHSPSC

4 Improving Patient Safety: Preventing Medication Errors Through Event Analysis CHS Medication Safety Webinar October 18, 2017 Presented by: Christina Michalek BS, FASHP 7 Disclosure Christina Michalek declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria

5 Objectives Explain system based causes of error and how to use this information to ensure patient safety through the prevention of medication errors Recognize the difference between prospective and retrospective risk identification and the difference between active and latent failures Outline strategies to identify multiple root causes of a medication error Discuss how human behavior, practice environment, and performance shaping strategies may be used in error reduction and prevention 9 My Goals for You Use what you already know added to what is discussed today to help you to be more proactive in identifying risk and preventing medication events Empower you to use system thinking in your daily work Facilitate analysis and identification of the root causes of errors Leave you with ideas and strategies to help prevent medication errors

6 Outline Risk identification: How do we identify risk? System thinking: How do we analyze events? Error prevention and reduction Root cause analysis: Identifying causal factors in an event 11 Finding errors: Risk Identification

7 Risk Identification The detection of an actual or potential problem associated with patient care Recognizing variations in process or expected outcomes which may or may not involve patient harm Raise a concern before it contributes to an adverse effect/error Error reporting Risk identification 13 Risk is Everywhere Risk is not inherently bad Healthcare can be safe but not risk free Which risks are worth taking? Image courtesy of moggara12 at FreeDigitalPhotos.net

8 Identification Methodology Prospective/Proactive Risk Condition or state of being Hazardous condition or behavior Retrospective Error May or may not have reached the patient May or may not have resulted in harm 15 The Tip of the Iceberg Lot use: Voluntary event reports BUT. beware of what s hiding below

9 Analyzing risk using error reporting alone may cause us to believe we don t have any medication safety issues; we re safe 17 Question Based on studies, what percentage of adverse drug events are reported? a. 80% b. 50% c. 20% d. 5%

10 Voluntary Reporting Studies of medical services suggest that only 1.5% of all adverse events result in an incident report. O.Neil A., Ann Intern Med 1993; 119: Less than 4% of all adverse drug events involving use of rescue drugs were reported Schade, Am J Med Qual 2006 Sep Oct;21(5): Voluntary Reporting Engages frontline staff this is good May be difficult for busy frontline staff to initiate reports Can be an indicator of organizational culture Low volume may indicate fear of punishment Consistency in information collected can be a challenge Retrospective (error has occurred)

11 Cultural Factors and Reporting Concern about medication error rates Analysis of errors by discipline (silos) That s pharmacy s problem Nothing changes That can t happen here 21 Enhancing Reporting Make it a goal Emphasize reporting of close calls/near misses Easier to talk about events that did not reach a patient Give feedback Good Catch Award Program

12 Other Sources of Information Technology data (retrospective) Rapid response team reports (retrospective) Focused medication reviews (prospective) Chart review coding, triggers (retrospective) FMEAs (prospective) RCAs (retrospective) Self Assessments (prospective) Safety or executive walk rounds (prospective) Safety briefings/staff meetings (prospective) FMEA: failure mode and effects analysis RCA: root cause analysis 23 Concurrent Risk Assessment Pharmacy interventions Nursing interventions Triggers and markers (also could be retrospective) Active surveillance change over time Clinical decision support Observation

13 Specific Risk Identification Methods 25 Self Assessments

14 Self Assessments 27 Failure Mode and Effects Analysis (FMEA) A proactive process to identify potential errors and determine possible effects Team based, systematic, proactive approach Identify the ways that a process or design Can fail Why it might fail What will happen if it fails How it can be made safer Veterans Affairs National Center for Patient Safety

15 Failure modes Detectability Probability Severity Risk priority number FMEA 29 Healthcare (HFMEA)

16 Consider the Process Flow Who purchases? Where stored? Who prescribes? How is it ordered? Where is it used? How does it arrive? Who administers it? How/who monitors? Who adjusts therapy? How is administration documented? How is it reordered? What COULD happen?

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18 External Data Joint Commission Sentinel Event Alerts FDA MedWatch notifications ISMP publications National Alert Network (NAN) Alerts The Joint Commission Journal on Quality and Patient Safety Media what your administrator and board are following 35 External Data

19 Triggers An easily identifiable, focused item representing an opportunity (or clue) that may lead to an adverse event Medications, laboratory tests, patient conditions Something went wrong Effective method for measuring harm 37 Pharmacist Interventions During order entry or verification Dose adjustments, drug selection recommendations Customized screening alerts Patient information, lab information, drug database warnings Active surveillance triggers

20 Observation Requires a direct observer Compared observation of what was administered to original order 2002 study Found almost 1 in 5 (19%) of the doses were in error 7% were rated potentially harmful 39 Observation Take this further than medication administration Processes (verbal orders, compounding, programming infusion pumps, workflow) Storage conditions Communication dynamics

21 Technology Data Information systems Alerts Overrides Missing patient information Barcode medication administration Wrong medications, wrong patient, wrong time Automated Dispensing Cabinets Overrides Infusion pumps Hard maximum limit triggers Soft low and maximum limit triggers 41 Question Test your knowledge. Which of the following methods can be used to identify risk? a. Technology decision support alerts that trigger during use b. Shift to shift briefings c. Reviewing ADC reports d. All of the above

22 System thinking: How to analyze events 43 Systems Thinking A system is a group of interacting, interrelated, and interdependent components that form a complex and unified whole A way of understanding the relationship among a system s parts, rather than the parts themselves

23 To Err is Human No one is immune Human error is not a behavioral choice Least manageable link in error Manage causes and consequences of errors through system design 45 Blame Paradox Practitioners are human They will never be error free even when they are very careful Errors can always be tied to system base caused or latent failures in the system which set up the practitioner for error

24 We All Drift Drifting = at risk behaviors Primary reasons Desire to accomplish more Fading perceptions of risk Unknowingly create unjustifiable risk Convince one s self they are in a safe place Everyone s doing it that way 47 Drift Behavioral choice that increases risk where risk is not recognized, or is mistakenly believed to be justified Driven by perception of consequences Immediate and certain consequences are strong Delayed and uncertain consequences are weak System based causes; culture tolerant of risk It s never happened here syndrome

25 Everyday Risk Choices Drift Wearing seat belts in cars Using a mobile phone while driving Texting while driving Driving over the speed limit Right turn on red without stopping 49 Everyday Risk at Work Choices Drift Perform time outs Correct double check when needed or required Labeling of all syringes and bowls Read back or repeat back of verbal/telephone orders Reuse of single dose vials Using bar code scanning systems Responding to computer alerts Have the medication administration record (MAR) at the bedside

26 Assume That Errors Will Occur Assume that errors are inevitable Many factors, latent (blunt end) and active (sharp end), must be present and in proper alignment for error to occur Emphasis on redesign of system to make it more difficult to err 51 Latent (System) Failures Incomplete information about a patient Unclear communication of a drug order Lack of computer warnings (interactions, allergies, dosages, etc.) Ambiguous drug references Drug storage (look alike/sound alike medications, hazardous chemicals) Unclear policies/procedures Failed checking processes

27 Limitations on Human Performance Limited ability to multi task Interruptions and distractions Fatigue and psychological factors Environnemental factors (light, noise, temperature) Human Factors Confirmation bias Dependence on heuristics during times of stress Normalization of deviance 53 Different Things That are Too Similar

28 The Power of the Human Mind Aoccdrnig to rscheearch at Cmabrigde Uinervtisy, it deosn t mttaer in haht oredr the ltteers in a wrod are, the olny iprmoent tihng is that the frist and lsat ltteer be at the rghit pclae. The rset can be a tatol mses and you can sitll raed it wouthit a porbelm. This is bcuseae the huamn mnid deos not raed ervey lteter by istlef, but the wrod as a wlohe. Amzanig huh? 55 Key Elements of the Medication Use System 1. Patient information 2. Drug information 3. Communication of drug information 4. Labeling, packaging, and nomenclature 5. Drug storage, stock, standardization, and distribution 6. Device acquisition, use, and monitoring 7. Environmental factors 8. Staff competency and education 9. Patient education 10. Quality, culture, and risk management issues

29 Investigation and Analysis of Errors ISMP Assess ERR Medication System Worksheet 57 Error Reduction Strategies

30 Primary Principles for Error Reduction Reduce or eliminate the possibility of error Make errors visible Minimize the consequence of errors Report and analyze internal errors Report errors externally and use external information 59 Error Reduction Strategies Strategy Fail safes and constraints Forcing functions Automation and computerization Standardization Redundancies Reminders and checklists Rules and policies Education and information Suggestions to be more vigilant Car won t start if alcohol is detected on breath Reminder signs and checkpoints Rule/Law: It s illegal to drive over the allowable alcohol limit Power (Leverage) High ( Blunt end ) Medium Low ( Sharp end )

31 Maximize Access to Information Necessary information at the appropriate time 61 Use Constraints to Limit Access Reduce access to dangerous items Prohibit pharmacy access by non pharmacists Limit number of choices/concentrations Move problem products out of reach Concentrated electrolytes Neuromuscular blocking agents

32 Forcing Functions Ensures that parts from different systems are not interchangeable Forces proper methods of use Makes errors immediately visible Preprinted order forms or computer options that force selection (limited list of medications or available dosages) Oral syringe should not be able to fit onto an intravenous line 63 Forcing Functions: Prevent from happening

33 Hazardous chemicals Neuromuscular blocking agents Limit Access Restrict use 65 Simplify Reduce the number of options

34 Available Heparin Concentrations 10 units/ml 100 units/ml 1 ml vial 10 ml vial 1,000 units/ml 1 ml vial 2 ml vial 10 ml vial 30 ml vial 5,000 units/ml 1 ml vial 10 ml vial 10,000 units/ml 1 ml vial 4 ml vial 5 ml vial 10 ml vial 20,000 units/ml 1 ml vial 5 ml vial 67 Simplify Reduce the number of options

35 Use commerciallyavailable products Outsource low volume solutions Prepare chemotherapy in a centralized location with specialized staff Externalize Transfer error prone tasks 69 No single failure can cause an event Second pathway prevents failure Redundancy Multiple pathways

36 Question According to studies, what percentage of errors can be identified by an independent doublecheck? a. 20% b. 60% c. 75% d. 95% 71 Redundancy Double checks Can be an important safety strategy Takes extra time Some believe may lead to more mistakes as staff may rely upon the checker to catch the mistake Work best when independent No cues from the person who carried out the work

37 Redundancy Double checks Identify a high rate of errors Study of prescriptions awaiting pick up 5,700 prescriptions 240 filled in error (2.1% considered potentially harmful) Studies where artificial errors were introduced 93 97% were identified by an independent double check Hard to find your own mistakes (confirmation bias) 73 Situational Awareness Enhance understanding to reduce drifting into unsafe behaviors Simulation Clinical scenarios Real life conditions Initial and ongoing training Used in pharmacy school education (and other medical disciplines) Available in many hospitals

38 Positive Performance Shaping Improve human performance Environment Temperature Lighting Noise Distractions Workload Shift length Importance of breaks Multi tasking Mixed messages Rewarding risky behavior 75 Checklists/Reminders Assist with remembering Reminders Order sets (e.g., management of hypoglycemia) Auxiliary labeling (e.g., For Intravenous Use ONLY FATAL IF GIVEN BY OTHER ROUTES ) Checklists IV Compounder set up Adding a new drug to a database Complex validation processes (e.g., chemotherapy preparation)

39 Summing Up Error Reduction Strategies Error prevention strategies are not mutually exclusive The fastest and easiest solution may not always be the best and may introduce new sources of error People cannot be expected to compensate for work systems 77 Root Cause Analysis (RCA)

40 Definitions Root Cause: Most fundamental reason an event has occurred Contributing Factor: Additional reasons, not necessarily the most basic reason that an event has occurred 79 Characteristics of RCA Retrospective process for identifying the most basic, causal factors that underlie variation/event Identifies behavioral risk points and their potential contribution to the event Human error At-risk or reckless behavior Identifies system risk points as analysis digs deeper by repeatedly asking Why? and How? System failures Identification of risk-reduction strategies, action plan, measures

41 Why is RCA Important? Preventable adverse events will happen and are destined to repeat Provides understanding of conditions that lead or can lead to patient harm Jumping prematurely to solutions may miss the target and not fix the problem Opportunity for shared accountability and learning All members of RCA team crucial to success 81 Root Cause(s) Analysis A retrospective process for identifying the most basic or causal factors that underlie variation in performance, including the occurrence, or possible occurrence of a sentinel event TJC Glossary of Terms

42 Root Cause(s) Analysis Effective and lasting change can occur only when the root causes of variation in performance are discovered and remedied TJC Glossary of Terms 83 The Goals of RCA/Event Investigation What happened? What normally happens? What does procedure require? Why did it happen? How were we managing it? Increasing value

43 Goals of an RCA Create a detailed chronological sequence of the event Next move from an event-oriented explanation to a system-oriented explanation of the event Identify all the human errors and behavioral choices that led to the event Human error is not a behavioral choice Identify the underlying causes of each human error and incorrect behavioral choice Breech of policy, not following procedure, cutting a corner Determine how we were managing the risk before the event 85 Why, why, why, why

44 Why Did It Happen? What are the individual s performance shaping factors? o Information? o Equipment/Tools? o Job/Task? o Qualifications/Skills? o Individual Factors? o Environment/Facilities? o Organizational Environment? o Supervision? o Communication? 87 Why Did It Happen? What are the system-based causes? o Lack of patient information? o Lack of drug Information? o Failure to communicate? o Labeling, packaging, nomenclature problems? o Drug storage and standardization issue? o Medical device problem? o Lack of patient education? o Lack of staff education/orientation/supervision? o Environmental or staffing issues? o Culture of safety?

45 Why Did It Happen Explain at-risk behaviors o Why was the decision made? Incentives to cut the corner? Perceptions of risk? o How prevalent is the behavior? Individual? Group? 89 The Basics of Event Investigation How was the organization (manager) managing the risk? o Employee to manage? o High skill/competency? o Performance shaping factors (system, individual)? o Maintain high perception of risk? o Strategies? o Barriers, forcing functions, fail safes? o Redundancy? o Recovery?

46 When is RCA Necessary? Not every adverse event Organizations should specify/define require RCA? or investigate through cases reviews or investigative techniques? 91 8 Deadly Sins 1) Focus on individuals 2) Hindsight bias 3) Reacting to emotional component of patient harm 4) Failure to move beyond proximate causes 5) Believing there is a single root cause 6) Response confused with proactive risk management 7) Tunnel vision (both causes and actions) 8) Weak error reduction strategies

47 Kellogg KM, et al. BMJ Qual Saf 2017;26: Summary of RCA Process Appoint a team Train the team on the RCA process Create an initial sequence/timeline of the event Gather information Interviews/observations/simulations/literature Synthesize information Identify root causes and contributing factors Develop an action plan Communicate the action plan Implement the action plan Measure effectiveness

48 Nurse administered 51 g of magnesium sulfate, which resulted in a patient death

49 Ambiguous order Failure model of complex system failure modified from James Reason, 1991 No pharmacy review; No protocols Floor Stock; 5 vials of Mag Sulfate Inadequate practitioner orientation No Independent Double Check Communication System Drug Info System Drug Storage System Staff Education and Competency Risk management 97 Question Test your knowledge Which of the following is considered a highleverage safety strategy? a. Providing a lecture on a new drug b. Performing a FMEA for a new infusion pump c. Applying high alert labels to medications

50 Question Test your knowledge. All of the following are examples of safety strategies except: a. Maximizing use of premixed solutions b. Educating staff about high alert medications c. Simultaneously performing double checks d. Utilizing allergy bracelets for patients 99 Conclusion Risk identification must go beyond just voluntary error reporting It is best to utilize prospective, retrospective, and concurrent methods of risk identification Error prevention requires emphasis on performance shaping strategies During a RCA, avoid focus on a specific individual; instead, focus on the system based causes of the error

51 ISMP National Medication Errors Reporting Program and Vaccine Errors Reporting Program ISMP is a federally certified patient safety organization (PSO)

52 Update on Current Pharmacy Initiatives and Strategies Jerry H. Reed, MS, RPh, FASCP, FASHP Senior Director, Pharmacy Services Community Health Systems