Ghalib Abbasi, RPh, MS, PharmD Pharmacy Technology Consultant Florida, USA

Transcription

1 Ghalib Abbasi, RPh, MS, PharmD Pharmacy Technology Consultant Florida, USA

2 Disclosure Information Let s Fly! IV Medication Errors in the Hospital Pharmacy Ghalib Abbasi I have no financial relationship to disclose I will not discuss off label use and/or investigational use in my presentation.

3 Learning Objectives At the completion of this activity, you will be able to: Recognize the prevalence, source, and preventability of medication and pharmacy errors. Describe the impact of hospital pharmacy errors on hospital operations and patient outcomes. Explain the sterile medication preparation workflow and identify steps most prone to errors. List the internal and external factors impacting task performance and contributing to pharmacy medication errors. Identify IV medication preparation practices that can increase the potential for medication errors. Employ the recommended measures to prevent IV medication errors in the pharmacy.

4 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

5 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

6 Medication errors: an ongoing challenge The frequency of medication errors and preventable medication-related injuries represents a very serious cause for concern. - [IOM Preventing Medication Errors 2006]

7 Medication errors can impact patient safety A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer [NCC MERP] Can occur during all stages of the medication use process An adverse drug event (ADE) is defined as any injury due to medication ADEs that are associated with a medication error are considered preventable ADEs Medication errors Potential ADEs ADEs Nonpreventable ADEs (ADRs) Preventable ADEs Adapted from IOM Preventing medication errors 2006

8 Medication errors occur frequently in US hospitals and preventable ADEs can carry significant costs 2006 Institute of Medicine (IOM) report estimated that 1.5 million preventable ADEs occur in the US per year When errors at all stages of the medication use process are taken into account, it is estimated that ~1 medication error occurs per patient per day in hospital care Total estimated cost associated with preventable ADEs in US hospitals was $3.5 billion (2006 USD) based on previously derived length of stay and treatment costs Costs associated with preventable ADEs Average added length of stay Average added cost to hospital 4.6 days $5,857 per event Table adapted from Bates 1997 JAMA

9 Pharmacy errors contribute to overall medication error and preventable adverse drug event rates Dispensing medication is inherently risky and [ ] dispensing errors are inevitable occurrences in community and hospital pharmacies around the world. - [James 2009 IJPP] Errors by stage (errors associated with preventable or potential ADEs) Source of primary error associated with preventable or potential ADEs 38% 11% 12% 39% Physician Ordering Transcription and Verification Pharmacy Dispensing Nurse Administration 26% 14% 11% 49% Physician Ordering Transcription and Verification Pharmacy Dispensing Nurse Administration Adapted from Bates 1995 JAMA and Leape 1995 JAMA Medication errors in the hospital pharmacy are, by definition, preventable

10 Recent data estimate that 4% to 21% of hospital medication errors are attributable to the pharmacy Data from the USP MEDMARX reporting system [Santell 2003 J Clin Pharmacol] indicate that 21% of medication errors originate in the dispensing stage (i.e. in the pharmacy) Oncology ward study found that 8.9% of chemotherapy medication errors* were pharmacy dispensing errors (2.8% due to wrong med / wrong dose) [Ford 2006 J Oncol Pract] Pediatric cancer center study indicated that 4% of chemotherapy medication errors originated in the pharmacy [Watts 2013 Pediatr Blood Cancer] Administering 37% Monitoring 1% Dispensing 21% Prescribing 15% Documenting 26% Like medication ordering and administration, the pharmacy process continues to be prone to errors Adapted from data from USP MEDMARX reporting system [Santell 2003 J Clin Pharmacol] * excluding untimely arrival

11 Medication errors are an ongoing concern in US hospitals and are, by definition, preventable The hospital pharmacy is the source of many medication errors

12 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

13 US hospital pharmacy studies reveal errors in up to 12.5% of prepared doses, including up to 9% of compounded IV doses Study Design Definition of error Error rate (% of doses) IV compounding-specific error rates Flynn 1997 Direct observational study in 5 hospital pharmacies Deviations from specifications in patient-specific or hospital compounding procedures Overall mean error rate of 9% (mean daily error rate of 6-10%) Speth 2013 Case study in one hospital pharmacy following adoption of an IV workflow manager Self-reported error rates for IV medications Error rate decreased from 1.4% to 0.8% of prepared doses Non-IV compounding-specific error rates Flynn 1999 Direct observational study in one hospital pharmacy Deviations in dispensing from physician orders (excluded compounded meds) Error rate of 3.23%; ( % for medication order sets) Cina 2006 Poon 2006 Direct observational study in one hospital pharmacy Direct observational study in one hospital pharmacy Discrepancies between dispensed medications and physician orders or replenishment reports, or deviations from standard pharmacy policies Overall error rate of 3.6%; 2.9% for first doses (patient-specific meds) Pre-bar coding error rate of 0.88%; post-bar coding error rate of 0.57% James 2009 Review of reported error rates during the dispensing process Error rates during the dispensing process (includes outpatient pharmacies) In 14 observational studies in US hospitals, unprevented incident rate of %

14 Medication errors, including errors with compounded IV medications, can put patients at risk By definition, high-alert medications (including several compounded IV medications) have the potential to cause patient harm Among compounded IV medications, pharmacy errors are most common for nutritional solutions, syringes, antineoplastics, and small-volume injectables IV medication errors are more frequently associated with patient harm than non-iv medication errors [Hicks 2006 J Infus Nurs] Nutritional solutions, manual process Error rate Nutritional solutions, Nutritional 37% Nutritional solutions, partly Nutritional Error automated manual solutions, process No error Nutritional Error Nutritional partly automated solutions, 22% Syringes process No error Syringes 12% Small-volume injectables Small-volume Small-volume injectables 8% Antineoplastic admixtures Antineoplastic Antineoplastic Antineoplastic admixtures 7% Large-volume Large-volume injectables Large-volume injectables 4% Large-volume Baxter Mini-Bag Baxter Mini- Plus Baxter Mini-Bag Plus 2% Baxter Mini-Bag Number Number of of prepared doses doses Number of prepared doses Error rates for compounded IV admixtures, adapted from Flynn 1997 Am J Health Syst Pharm Depending on the medication involved, patients can be put at risk by errors in the pharmacy

15 Many medication errors in the pharmacy have the potential to lead to patient harm NCC MERP classifies medication errors in terms of their potential for patient harm Categories A-D events with the capacity to cause error or errors not causing harm Categories E and F: errors causing temporary harm Category G: errors causing permanent harm Categories H and I: errors that can lead to death In a study in a tertiary medical center, 22.8% of pharmacy errors had the potential to cause patient harm (included IV and non-iv medications)* Given pharmacy s annual volume of ~6 million orders, this translated to >10,000 errors with the potential to cause patient harm per year No potential for harm 74.5% Potential for harm 22.8% Unable to determine 2.7% Significant 14.6% Serious 7.7% Lifethreatening 0.5% Adapted from Cina 2006 Jt Comm J Qual Patient Saf * did not specifically use NCC MERP classification

16 The clinical impacts of a medication error in the pharmacy can lead to fatalities Alissa Shin case Description: newborn received fatal Zn overdose in a TPN preparation Cause: erroneous entry of Zn concentration by pharmacist (330 mg instead of 330 μg); error was not detected prior to compounding or during verification Emily Jerry case Description: fatal overdose of NaCl in a two year-old patient s IV chemotherapy preparation Cause: chemotherapy medication was compounded using 23.4% NaCl solution instead of the standard 0.9% solution Texas heparin overdose cases Description: 14 infants (2 of whom died) received a 100X overdose of heparin while in the hospital NICU Cause: mixing error

17 Emily Jerry.. YouTube Video (5 min)

18 Financial Impacts of Medication Errors in the Pharmacy Medication preparation errors are one component of additional costs Adverse Drug Events 1997 Bates et al. estimated $2.8M in added annual costs associated with managing preventable ADEs for a single 726 bed hospital (same study estimated that dispensing errors accounted for 14% of preventable ADEs) Waste 2008 pharmacy audit in a 650+ bed hospital estimated that >30,000 IV bags were wasted annually, at a cost of >$390,000 Causes of waste include incorrect dose preparation, absence of dose tracking and dose expiration Reduced Efficiency Labor associated with remediating order entry, calculation, or dose preparation errors Re-verification requiring pharmacist presence Pharmacy errors can reduce efficiency and increase costs

19 Medication errors in the hospital pharmacy, including IV compounding errors, are a common occurrence Errors in the hospital pharmacy can have serious clinical and financial impacts

20 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

21 Medication preparation and dispensing involves multiple steps that rely on human diligence Pharmacy technician Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Pharmacist verification checkpoints Medication preparation involves multiple manual steps (e.g. component assembly, dose preparation, verification) that rely on the diligence of pharmacy personnel This process represents a human system that is susceptible to human error

22 Pharmacy errors frequently involve the wrong dose, wrong drug, or wrong quantity Studies reveal several common pharmacy errors: Wrong quantity Wrong strength / dose Wrong drug For IV compounding, wrong dose shown to account for 69% of errors, with 22% of errors deviating by 15% from labeled dose [Flynn 1997 Am J Health Syst Pharm] Error type Number errors (%) 7-month study period Incorrect quantity 2,970 (59%) Incorrect strength 571 (11%) Incorrect medication 554 (11%) Incorrect dosage form 443 (9%) Label error 204 (4%) Order entry 180 (4%) Expired 141 (3%) Other 6 (<1%) Missing medication 3 (<1%) Reconstitution 3 (<1%) Total 5,075 (100%) Table adapted from Cina 2006 Jt Comm J Qual Patient Saf As with other processes relying on human vigilance, human factors are a major contributor to errors in the pharmacy

23 Even simple, familiar tasks are susceptible to human error An error is the failure of a planned action to be completed as intended (i.e. error of execution) or the use of a wrong plan to achieve an aim (i.e. error of planning) Errors of execution are also called slips or lapses Errors of planning are also called mistakes Even on simple tasks, humans are prone to error Task Error probability Read a checklist or digital display incorrectly Carry out visual inspection incorrectly Read 10-digit number incorrectly Record information or read graph incorrectly 0.01 Type character incorrectly 0.01 Do simple arithmetic incorrectly Fail to notice adverse indicator 0.1 Table adapted from Smith, Reliability, Maintainability and Risk, 6 th ed.,2005

24 Information processing and task performance are influenced by numerous internal and external factors Intrinsic factors Individual characteristics Training Experience Sensory register Environmental factors Physical Personal Organizational Long-term memory Working memory Task demands Stress factors Personal Circumstantial Adapted from Grasha 2012 US Pharm and Smith, Reliability, Maintainability and Risk, 6 th ed Human reliability depends on intrinsic, environmental, and stress factors that can impact task performance

25 Question Read the following statement. What does it say? BUAPMAGY FBRQP BATFS APF LQW

26 Human biases can lead to errors (1 of 4) Answer: BUAPMAGY FBRQP BATFS APF LQW The human brain uses previous experience to fill in gaps, thus the incorrect conclusion that the statement was Pharmacy error rates are low Human cognitive processes, while adaptive in most contexts, can also promote or fail to detect errors

27 Human biases can lead to errors (2 of 4) Confirmation bias The human brain fills in perceptual gaps based on previous experience Information is interpreted in a way that confirms previous experience and avoids information or interpretations that contradict preconceptions Examples: Reading a new unfamiliar drug name (e.g. acetazolamide) as that of an older, familiar drug (acetahexamide) Failure to detect rare events Assuming that the 101 st dose checked is correct, given that the first 100 were correct

28 Another example x Are you able to read the following statement? Y0UR M1ND 15 R34D1NG 7H15 4U70M471C4LLY W17H0U7 3V3N 7H1NK1NG 4B0U7 17 How about these drug names? D0BUTAM1N3 CLON4Z3P4M 3P1N3PHR1N3

29 Human biases can lead to errors (3 of 4) Selective attention The brain works best when doing one task at a time Attention is therefore dedicated to what is perceived to be most important, allowing potentially critical information to be ignored Examples: Participating in a conversation at a party where several conversations are taking place simultaneously Focusing on drug names while ignoring dose or formulation information (e.g. 10,000 units/ml versus 10 units/ml heparin) Did you notice anything out of place on the preceding slide?

30 Another example x Are you able to read the following statement? Y0UR M1ND 15 R34D1NG 7H15 4U70M471C4LLY W17H0U7 3V3N 7H1NK1NG 4B0U7 17 How about these drug names? D0BUTAM1N3 CLON4Z3P4M 3P1N3PHR1N3

31 Human biases can lead to errors (4 of 4) Normalization of deviance Practices that deviate from an established standard can become normal in the absence of negative feedback Examples: Driving: speeding, rolling stops, failure to signal Using shortcuts during dose preparation Reliance on habits Humans tend to equate habit with competence, and tension, stress, or unfamiliarity can cause us to revert to past habits, rather than recently learned adaptive ways of managing a task Example: Preparing multiple medication doses simultaneously

32 Even when performing simple or familiar tasks, humans are prone to error Several known human biases can lead to errors and cannot be completely avoided in any process relying on human diligence

33 Pharmacy-centered studies have identified several internal and external causes of error Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Common causes of human error in the pharmacy: Workload Distractibility Interruptions Work environment Similar drug names or drug packaging Other factors

34 Increased external demands are associated with pharmacy errors Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Common causes of human error in the pharmacy: Workload Distractibility Interruptions Work environment Similar drug names or drug packaging Other factors Flynn 1999 study: dispensing error rate correlated with interruption frequency and individual distractibility Greater distractibility Adapted from Flynn 1999 Am J Health Syst Pharm

35 Look-alike drug names or labels can lead to errors Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Common causes of human error in the pharmacy: Workload Distractibility Interruptions Work environment Similar drug names or drug packaging Other factors Example of look-alike drug packages (solutions containing different NaCl concentrations) [Pennsylvania Patient Safety Authority 2007]

36 Several additional internal and external factors are known to contribute to pharmacy errors Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Common causes of human error in the pharmacy: Workload Distractibility Interruptions Work environment Similar drug names or drug packaging Other factors Internal factors: Fatigue, illness, hunger Stressors Training Unfamiliarity with task External factors: Shift patterns Staffing levels Order complexity e.g. Beso 2005 study identified illness and inadequate training or knowledge as common causes of pharmacy errors (11.6% and 9.4%, respectively)

37 Verification processes are in place to mitigate human error Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Pharmacist verification checkpoints Common causes of human error in the pharmacy: Workload Distractibility Interruptions Work environment Similar drug names or drug packaging Other factors These factors may be mitigated through checking processes, but these measures alone are not sufficient to prevent all errors

38 Relying on human vigilance alone to detect all errors is not sufficient Receipt of medication order Pharmacist check Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Human beings are not proficient at catching rare events (e.g. medication order or dose preparation errors) Pharmacists in a tertiary academic medical center failed to detect 20.9% of errors (0.75% of all doses) [Cina 2006 J Qual Patient Saf] Based on annual volume of 6 million orders, equals ~45,000 undetected errors/year for a single hospital pharmacy with about 10,600 that have the potential for harm Error type Total (% of filled doses) Total errors 5,075 (3.6%) Detected errors (detected by pharmacist during routine verification) Undetected errors (errors intercepted by research observer) 4,016 (2.9%) 1,059 (0.75%) Table adapted from Cina 2006 Jt Comm J Qual Patient Saf

39 The convergence of several human and systems failures can lead to patient death Recall the Emily Jerry case, wherein a pediatric patient s medication was compounded with 23.4% NaCl instead of 0.9% NaCl Several factors came together to cause this fatal error The pharmacist was busy and had taken no breaks and had not eaten during his shift Routine maintenance on the pharmacy system overnight caused a delay in IV admixture preparation Pharmacist was directed to dispense the order right away and then felt rushed to check the solution prepared by the technician Pharmacist saw an empty bag of 0.9% NaCl and assumed that the correct solution had been used [It is] unsettling and cautionary to realize that any other healthcare practitioner who has made a serious medical error could easily be in [his] position because we are all susceptible to human error, and we all occasionally drift into rushed practice habits when forced upon us by systems and conditions that seem to demand it. - [ISMP 2009]

40 Existing pharmacy workflow practices can also increase susceptibility to human error Existing dose preparation practices can increase the potential for medication errors Simultaneous preparation of more than one compounded product can lead to: Selection of the wrong drug for compounding Verification of the wrong drug by the pharmacist Label application errors Use of the syringe pull-back method for verification Inability to detect wrong drug errors Relies on individual s memory to recall volume pulled

41 Like other human systems, medication preparation, verification, and dispensing are subject to human factors that inevitably lead to errors Relying on human capabilities alone to avoid or detect errors is not sufficient

42 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

43 Preventing pharmacy errors is critical The pharmacy is the source of large numbers of administered medications The closer that a medication error is to the patient, the less likely it is to be intercepted In a busy hospital pharmacy, low error rates can translate into a significant number of errors with the potential to reach patients and cause harm

44 Healthcare delivery is still unnecessarily risky During the five-year period in which passenger deaths aboard major US airlines hit a total of zero (2001 to 2006), American hospitals killed an estimated 250,000 to 500,000 patients with medical mistakes. That s the equivalent of crashing approximately 1,400 fully loaded Boeing 747s with no survivors! - [Nance Why Hospitals Should Fly 2008] Safety in commercial aviation was drastically improved by systematic changes to catch and absorb inevitable human errors Buffers against normal human error are critical in any human system, including healthcare delivery

45 Several measures are recommended to prevent medication errors in the pharmacy Medical mistakes are merely human mistakes committed within a human system inadequately designed to catch and neutralize those mistakes in time. - [Nance Why Hospitals Should Fly 2008] Staff training Adequate training; ensuring that tasks are carried out by qualified trained individuals Reduction of errorpromoting conditions Minimization of distractions Tallman lettering to distinguish between look-alike drug names Streamlined workflow Workflow supporting the preparation of a single dose at once and detailed record keeping Pharmacist review of orders, labels, and prepared doses Technological solutions Solutions that can automate or support manual activities to reduce the potential for error

46 Positive safety impacts of technological solutions on medication ordering and administration Errors and injuries can, in fact, be prevented by redesigning systems to make it difficult, and sometimes impossible, for caregivers to make mistakes. - [Leape 2009 Clin Chim Acta] Smart infusion pumps Reduced administration error rates due to dosing alerts BCMA Reductions in administration errors and hospital / ICU LOS costs Medication administration Medication preparation Patient assessment Medication ordering Pharmacist evaluation EHR Complete patient record supports safe medication ordering CPOE Reduced prescribing error rates and medical error risk Technologies that remove opportunities for human error have reduced medication ordering and administration errors

47 Technologies aimed at preventing pharmacy errors and increasing efficiency The lack of a standardized, automated process in an IV compounding cleanroom renders that controlled environment vulnerable to human error, thereby jeopardizing control over patient safety. - [Speth 2011 PP&P] There are a number of technologies that can support improved preparation / dispensing of medications, including compounded IV drugs: Medication administration Medication preparation Patient assessment Medication ordering Pharmacist evaluation Automated compounding / dispensing Electronic pharmacy order entry Telepharmacy Barcoding Workflow management systems

48 IV workflow managers support multiple critical steps to promote correct IV medication preparation and verification An IV workflow manager can be used to supplement key IV medication preparation and verification tasks susceptible to human error Workflow queues Dose tracking and record keeping Receipt of medication order Automated Pharmacist calculation check s Label generation Stock selection Dose preparation Product labeling Pharmacist inspection Dose dispensed Barcode assisted medication preparation, automated calculations Image capture and remote verification IV workflow management systems provide an opportunity to prevent IV compounding errors and improve efficiency

49 The key to preventing medication errors in the hospital pharmacy is implementing approaches to buffer against inevitable human errors For IV compounding, implementation of a pharmacy workflow manager can help reduce error rates and promote greater efficiency

50 Overview Prevalence of medication and pharmacy errors Impacts of hospital pharmacy errors Why errors occur Preventing medication errors in the hospital pharmacy Summary

51 Pharmacies can improve the safety and efficiency of the medication preparation process Medication error rates are unacceptably high and the hospital pharmacy is a key source of errors Medication preparation and dispensing is subject to inevitable human factors that lead to errors Reliance on human diligence alone is not enough to prevent all pharmacy errors, nor is it enough to eliminate all inefficiency The implementation of measures to buffer against normal human errors in the hospital pharmacy is critical Technologies that support manual medication preparation and dispensing steps can help to prevent errors

52 Call to action: improving medication safety At all levels of healthcare delivery, including the hospital pharmacy, error reduction is critical Pharmacy stakeholders should: ASSESS their pharmacy s capabilities, challenges, and potential sources of error or inefficiency EVALUATE all available options to help improve medication safety, including: Optimizing staff training and workflow practices Limiting external factors that can lead to error Implementation of a pharmacy workflow manager or other automated process to automate or support human activities in the pharmacy