LUNCH AND LEARN Medication Safety Issues and Recommended Strategies Related to Sterile Compounding January 12, 2018 Featured Speaker: Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. 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. 2 www.proce.com 1
Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to www.proce.com/pharmediumrx Print your CE Statement online Live CE Deadline: February 9, 2018 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 www.proce.com 2
Resources Visit www.proce.com/pharmediumrx to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Medication Safety Issues and Recommended Strategies Related to Sterile Compounding Christina Michalek, BS, RPh, FASHP Medication Safety Specialist Institute for Safe Medication Practices 6 www.proce.com 3
Objectives Describe the evolution of quality and safety in infusion therapy Identify the most common unsafe practices and at risk behaviors related to the production of compounded sterile preparations List at least three effective strategies to reduce medication errors related to sterile compounding Prioritize selected strategies to prevent harm and improve safety during sterile preparation and compounding activities 7 Outline Brief overview of safety throughout the medication use process as it relates to infusion therapy Review of selected sterile compounding errors with system analysis of the events Discussion of error reduction strategies that can be employed during sterile compounding activities Focus on system changes and the expected leverage of selected strategies 8 www.proce.com 4
Intravenous (IV) Medication Use Essential component of care Clinically advantageous Immediate therapeutic effect High plasma levels Reach target effect quickly Image courtesy of twobee at FreeDigitalPhotos.net 9 IV Medication Errors Occur in all phases of the medication use process Potential for significant harm 10 www.proce.com 5
IV Medication Errors Prescribing Verifying Transcription Administration Dispensing Preparation Monitoring 11 Advances Supporting Infusion Management Computerized Prescriber Order Entry Pharmacy Verification Barcode Medication Administration (BCMA) Smart Infusion Pumps Active Surveillance 12 www.proce.com 6
Preparation Fluid transfer and syringe pumps Multiple vendors Automated pumping/software systems Multi ingredient solutions (parenteral nutrition) Automated robotic systems Multiple vendors Automated workflow software Multiple products (standalone and health record supplied) 13 The Issues Sterility Sterility Preventing microbial contamination 1975: Nationwide epidemic of septicemia caused by contaminated intravenous products reported 1984: 11 patients received contaminated hospital pharmacyprepared cardioplegia solutions resulting in five deaths 2005: 10 patients died after being exposed to cardioplegia solution contaminated with gram negative rods 2012: over 700 patients received contaminated injections; resulting in more than 60 deaths 14 www.proce.com 7
The Issues Preparation 2006: infant dies from a 1,000 fold zinc overdose (mcg and mg zinc sulfate were confused) added to parenteral nutrition solution 2005 and 2006: a neonate and a child each died after compounding errors undetected during final verification led to administration of medications in 23.4% sodium chloride 15 The Issues Preparation 2007: several patients died after receiving an IV colchicine product (gout) compounded at a concentration higher than standard 2012: 1300 ml of dextrose 10% and 0.45% sodium chloride compounded incorrectly 16 www.proce.com 8
The Issues Preparation 2010: pharmacy staff mistakenly prepared 1000 mg dose of valproate sodium (seizures) with vecuronium (muscle blocking agent) 17 The Issues Preparation 2014: patient ordered to receive intravenous fosphenytoin for seizure control, but instead received rocuronium 18 www.proce.com 9
The Issues Preparation 2015: Calcium gluconate used instead of sterile water for injection Near miss gentamicin for newborn Near miss cefazolin reconstituted with calcium gluconate Near miss ampicillin for a newborn 19 Sterile Compounding Errors and Patient Harm Significant patient safety incidents related to sterile compounding have occurred for years and continue to occur Observational studies showed a mean error rate of 9% Error rates with complex solutions were as high as 37% 12.5% of manually prepared compounded sterile preparations (CSPs) failed accuracy measurements One third of hospitals (consistently) report having a compounding event over past 5 years Data submitted to the ISMP s National Medication Errors Reporting Program (MERP) has repeatedly shown manual inspection of IV admixture ingredients is not a totally effective deterrent in preventing preparation and dispensing errors Observational studies: Flynn EA, Pearson RE, Barker K. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm. 1997;54(8):904 912. 12.5% of manually compounded CSPs: Seger AC, Churchill WW, Keohane CA, et al. Impact of robotic antineoplastic preparation on safety, workflow and costs. J Oncol Pract. 2012;8(6):344 349. One third report having an adverse event: 2016 State of Pharmacy Compounding Survey Pharmacy Purchasing and Products, April 2016 20 www.proce.com 10
Unsafe Practices, At Risk Behaviors and Strategies to Avoid Error 21 Risks and Failure Modes Through analysis of error reports, on site risk assessments and root cause analyses, additional risks for compounding sterile preparation have been identified: Lack of standardization Lack of use of technology Poor environment Variability in practices Lack of an appreciation for the risk How can that have happened? Don t you double check? Image courtesy of Morguefile.com 22 www.proce.com 11
Risks and Failure Modes Poor environment Insufficient or inadequate workspace Counter preparation, staging, verification space Number and size of hoods Failing to provide adequate segregation of items contributing to mixups Temperature and lighting 23 Risks and Failure Modes Poor Environment Distractions During work order review During preparation of products During validation/verification Variable workflow Variable production speed (individual based) 24 www.proce.com 12
Risks and Failure Modes Variability in practice Tremendous variation in: Information available Compounding processes Documentation processes Labeling procedures Verification steps Image courtesy of yodiyim at Freedigitalimages.net 25 Risks and Failure Modes Workflow Using manual processes when automation is available Lacking or outdated clinical decision support during drug selection and production Low volume (rarely prepared) solutions 26 www.proce.com 13
Risks and Failure Modes Lack of viable technology Lack of use of technology Growing, but still in it s infancy In 2011: 2.5% reported using robotic device for syringes 20.4% used parenteral nutrition compounder 3.6% had remote video supervision of compounding 11.9% used barcoding during verification Use of specific gravity measurements, rarely reported In 2016: 19% using IV workflow management Pedersen CA, Schneider PJ and Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration 2011. Am J Health Syst Pharm. 2012;69:768 85. Pharmacy Purchasing and Products State of Pharmacy Automation 2016 27 Risks and Failure Modes Education Initial competency assessment Ongoing competency evaluation Pharmacist versus Technician Trust/Careful Behavior to emulate One of the strongest predictors of high level safety behaviors is observing that behavior in one s peers Culture (reporting; near miss/close call) Event investigation 28 www.proce.com 14
Risks and Failure Modes Staffing Weekend/evenings/nights/holidays Unexpected staffing issues Call outs Computer or technology down time Areas/functions that require specialty training Shift length (planned/unplanned) Breaks Avoiding the hero syndrome 29 Focused Areas for Attention Events that can cause attention failures Distractions (external and internal) Pressure for turn around Workload Processes that would lend themselves to a checklist Database maintenance Processes that would lend themselves to an independent double check 30 www.proce.com 15
Failure to Appreciate Risk Lack of awareness Senior leadership Risk managers Pharmacists Images courtesy of digitalart, hywards, Stuart Miles at FreeDigitalPhotos.net People more acutely aware of what they read or hear on the news 31 Guidelines in Place and Filling the Gaps United States Pharmacopoeia (focuses primarily on sterility) Chapter <797> Chapter <800> and associated chapters The missing piece needing to be addressed. ISMP s guidelines to address the gaps 2016 revision to more strongly address use of emerging technologies Coupled with 2018 2019 ISMP Targeted Medication Safety Best Practices for Hospitals 32 www.proce.com 16
ISMP Guidelines www.ismp.org 33 Technology/Automation Create a strategic plan for implementation of automation and technology for sterile compounding Technology solutions (e.g., systems that include barcode scanning verification of ingredients, gravimetric verification of drug and diluent volumes, and/or robotic image recognition) are utilized to augment manual processes for preparing and verifying CSPs At a minimum both barcoding and gravimetrics are used when preparing chemotherapy and ideally, for pediatric CSPs (several SEMIAUTOMATED MANUAL systems and highly automated robotic systems utilize barcoding and gravimetrics). 34 www.proce.com 17
ISMP Targeted Medication Safety Best Practices 35 ISMP Best Practice #11 When compounding sterile preparations, perform an independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container 36 www.proce.com 18
At risk Behaviors and Human Factors Confirmation bias at drug selection Look alike drug names and packaging Complacency with processes or procedures Overriding alerts and alarms Altered perception of risk Memory lapse Over reliance on technology Grab and go mentality Skipping steps due to time; workload issues 37 System Changes and Leveraging Strategies 38 www.proce.com 19
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 an error to occur Emphasis on redesign of system to make it impossible or more difficult to err 39 Active Failures Occur between human and system Readily apparent (most of the time) e.g., pushing the wrong button, ignoring a warning Almost always involve a person on the front line Sharp end 40 www.proce.com 20
Latent Conditions Less apparent; hidden until contribute to an error or patient harm Accidents waiting to happen e.g., multiple infusion devices in use Alignment of multiple latent failures = adverse event Swiss cheese 41 Latent failure model of complex system failure modified from James Reason, 1991 No pharmacy review; No protocols Ambiguous order Drug availability Inadequate practitioner orientation No Independent or automated double check Communication System Drug Info System Drug Storage System Staff Education Other and systems Competency 42 www.proce.com 21
Blame Paradox Practitioners are human They will never be error free even when they are very careful Errors can always be tied to a system based cause or latent failure in the system which set up the practitioner for error 43 Strategy Rank Order of Error Reduction Strategies Power (Leverage) 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 High ( Blunt end ) (e.g., removing KCl) Medium (e.g., independent double checks) Low ( Sharp end ) (e.g., limit verbal orders) 44 www.proce.com 22
Error Reduction Strategies Forcing functions Barriers and fail safes Automation and computerization Redundancies Recovery Standardization and protocols Performance shaping factors (e.g., checklists, reminders) Rules and policies Education Information Don t make mistakes! / be careful Improve system reliability Improve human reliability 45 We ve Come a Long Way. BUT Image courtesy of anankkml at FreeDigitalPhotos.net 46 www.proce.com 23
Perhaps the most important distinguishing feature of high reliability organizations is their collective preoccupation with the possibility of failure James Reason West J Med. 2000 June; 172(6): 393 396. 47 48 www.proce.com 24