Medication Errors An Opportunity to Improve

FSHP Medication Errors An Opportunity to Improve Laura Monroe-Duprey, BS Pharm, PharmD Joanie Spiro Stevens, PharmD, BCPS Disclosure Laura Monroe-Duprey - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. Joanie Spiro Stevens - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. Pharmacist Objectives Compare and contrast medication errors and adverse drug events (ADE) Describe methods and responsibilities for reporting errors Summarize Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA) Analyze pediatric and adult medication error examples Apply strategies for reducing medication risks Technician Objectives Identify medication errors and adverse drug events (ADE) Recognize methods and responsibilities for reporting errors Define Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA) Summarize pediatric and adult medication error examples Describe strategies for reducing medication risks Have you ever made an error To err is human; to forgive, divine. -Alexander Pope, An Essay on Criticism 1688-1744 http://cartoonsmix.com/cartoons/cartoon-question-mark.html Accessed 5/10/17. http://poetry.eserver.org/essay-on-criticism.html Accessed 5/10/17. 1

Medication Error Definition: 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. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use." Causes of Medication Errors Cause: Rarely the failure of a single element or person Combined effects Types of failures: Latent failures in the system Active failures by people Solutions: Recognize and correct latent failures Increase redundancy Establish systems to minimize risk of medication errors http://www.nccmerp.org/about-medication-errors Accessed 4/30/17 http://www.ismp.org/newsletters/acutecare/articles/20020601.asp Accessed 4/30/17. http://patientsafetyed.duhs.duke.edu/module_e/swiss_cheese.html Accessed 5/10/17. Where Medication Errors Occur Prescribing 39-49% Physician Physician extender Pharmacist Transcribing 11-12% Physician Physician extender Pharmacist Nurse Nonhealthcare professional Dispensing 11-14% Pharmacist Pharmacy technician Pharmacy student Administering 26-38% Nurse Respiratory therapist Monitoring Physician Physician extender Pharmacist Nurse Respiratory therapist Medication Errors vs. Adverse Drug Events Anywhere along the medication use process Vogenberg FR, Benjamin D. The Medication-Use Process and the Importance of Mastering Fundamentals. Pharmacy and Therapeutics. 2011;36(10):651-652. Leape L, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events: ADE Prevention Study Group. JAMA. 1995;274(1):35 43. Bates D, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274(1):29 34. Adverse Drug Event (ADE) Definition: An injury, large or small, caused by the use (including nonuse) of a drug. 2 types of ADEs 1) Preventable ADEs - Caused as a result of an error 2) Non-preventable ADEs - Occur despite proper usage a) Also known as an Adverse Drug Reaction (ADR) Adverse Drug Reaction (ADR) any unexpected, unintended, undesired, or excessive response to a drug that requires discontinuing the drug (therapeutic or diagnostic) requires changing the drug therapy requires modifying the dose (except for minor dosage adjustments) necessitates admission to a hospital prolongs stay in a healthcare facility necessitates supportive treatment significantly complicates diagnosis negatively affects prognosis or results in temporary or permanent harm, disability, or death. Includes allergic reactions and idiosyncratic reactions Leape LL, Kabcenell A, Berwick DM, et al. Reducing adverse drug events. Breakthrough series Guide Institute for Healthcare Improvement, Boston, 1998, p.84-91. American Society of Health-System Pharmacists. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health-Syst Pharm. 1995;52(4):417-419. 2

Medication Error vs. ADE Medication Errors Potential ADEs ADEs Preventable ADEs Non-preventable ADEs (also known as ADRs) Incidence of Medication Errors and Adverse Drug Events ~1 medication error per patient per day > 1.5 million preventable ADEs each year in the US ~400,000 of these occur in the hospital setting Estimated annual cost of preventable ADEs = $3.5 billion Underestimated due to variability of definitions used & methods used to identify Chart review Voluntary reporting Observation Trigger method Miller MR, Robinson KA, Lubomski LH, et al. Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Saf Health Care. 2007;16:116-126. Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi:https://doi.org/10.17226/11623. Takata GS, Mason W, Taketomo C. Development, Testing, and Findings of a Pediatric- Focused Trigger Tool to Identify Medication-Related Harm in US Children s Hospitals. Pediatrics. 2008;121(4):e927-e935. Incidence of Medication Errors and Adverse Drug Events Factors Placing Pediatric Patients at Increased Risk for Medication Errors Changing pharmacokinetic parameters at various ages and stages of development Need for calculation of individualized doses based on patient s age, weight (mg/kg), body surface area (mg/m2), and clinical condition Lack of available dosage forms and concentrations appropriate for administration to neonates, infants, and children. Frequently, dosage formulations are extemporaneously compounded and lack stability, compatibility, or bioavailability data Need for precise dose measurement and appropriate drug delivery systems Lack of published information or Food and Drug Administration-approved labeling regarding dosing, pharmacokinetics, safety, efficacy, and clinical use of drugs in the pediatric population Kaushal R, Bates DW, Landrigan C, et al. Medication Errors and Adverse Drug Events in Pediatric Inpatients. JAMA. 2001;285(16):2114-2120. doi:10.1001/jama.285.16.2114. Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi:https://doi.org/10.17226/11623. Levine SR, Cohen MR, Blanchard NR, et al. Guidelines for preventing medication errors in pediatrics. J Pediatr Pharmacol Ther 2001;6:426-442. Reporting 3

To Err is Human The Quality of Health Care in America 1998 Project Medical errors are major risk to public health Medication errors alone, either while in a hospital or elsewhere, was estimated to account for over 7,000 deaths annually Public insulation Liability insurance and culture contributions To Err is Human Recommendations contained in this report suggest a four-tiered approach: 1. establish a national focus to create leadership, research, tools and protocols to enhance the knowledge base about safety; 3. raise standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups; 1. Identify and learn from errors through immediate and strong mandatory reporting efforts, as well as the encouragement of voluntary efforts, both with the aim of making sure the system continues to be made safer for patients; 3. create safety systems inside health care organizations through the implementation of safe practices at the delivery level. This level is the ultimate target of all the recommendations. Kohn L, Corrigan J, Donaldson M, eds. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 1999. ISBN: 9780309068376. To Err is Human Medication Error Reporting IOM Recommendation Recommendation 5.1 Nationwide mandatory reporting system for providers which allows for collection of standard information Recommendation 5.2 Center of Patient Safety to describe and disseminate information on voluntary reporting systems Recommendation 6.1 Legislation to protect peer review patient safety data Recommendation 8.2 Health Care organizations should implement proven medication safety practices To Err is Human What is the benefit of MANDATORY reporting? Ten Year Journey Medicare Modernization Act of 2003 Mandated the Centers for Medicare and Medicaid Services to sponsor study by IOM To formulate a national agenda by developing estimates of the incidence of such errors and determining the efficacy of prevention strategies Ten Year Journey Health Care Organizations so that progress toward improved medication safety can be accurately demonstrated (2007) Preventing Medication Errors: Quality Chasm Series http://books.nap.edu/catalog11623.html accessed 5.09.17 http://www.nap.edu accessed 5.09.17 4

Reporting Errors Ten Year Journey Patient Rights to Their Medication Management Be the source of control for all medication management decisions that affect them (that is, the right to selfdetermination). Accept or reject medication therapy on the basis of their personal values. Be adequately informed about their medication therapy and alternative treatments. Ask questions to better understand their medication regimen. Receive consultation about their medication regimen in all health settings and at all points along the medication-use process. Designate a surrogate to assist them with all aspects of their medication management. Expect providers to tell them when a clinically significant error has occurred, what the effects of the event on their health (short- and long-term) will be, and what care they will receive to restore their health. Ask their provider to report an adverse event and give them information about how they can report the event themselves. Ten Year Journey Issues for Nurses, Physicians and Pharmacists Patient Discussions Review the patient s medication list routinely and during care transitions.*jc Review different treatment options. Review the name and purpose of the selected medication. *HCAPHS Discuss when and how to take the medication. *BOP Discuss important and likely side effects and what to do about them. *HCAPHS Discuss drug drug, drug food, and drug disease interactions. Review the patient s or surrogate s role in achieving appropriate medication use. Review the role of medications in the overall context of the patient s health Where to report Reporting Errors Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps)) Contact your health-care provider right away so that they can advise you on the necessary actions to take. Also, urge the provider to report the problem to FDA's MedWatch hotline, at 800-FDA-1088. Your health care provider, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit MedWatch. Medical devices (including in vitro diagnostic products) Combination products Special nutritional products (infant formulas, and medical foods) Cosmetics Foods/beverages (including reports of serious allergic reactions) https://www.fda.gov/safety/medwatch/default.htm accessed 4.23.17 5

Reporting What Not to Report to FDA MedWatch: Tobacco Safety Reporting Portal https://www.safetyreporting.hhs.gov/fpsr/workflowloginio.aspx?metinstance=d432215bcd68831461e102e11540ad46662 CAE5D Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/esub/index Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm227351.pdf Reporting on Dietary Supplementshttp://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm Reporting on Veterinary Medicine Productshttp://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) http://www.fda.gov/safety/reportaproblem/questionsandanswersproblemreporting/default.htm FDA reports process Medwatch FDA CDER DDI DSOB https://www.fda.gov/safety/medwatch/default.htm accessed 4.23.17 Reporting Errors The National Alert Network (NAN) publishes the alerts from the National Medication Errors Reporting Program. NAN encourages the sharing and reporting of medication errors, so that lessons learned can be used to increase the safety of the medication use system. Reporting Errors The mission NCCMERP is to maximize the safe use of medications and to increase awareness of medication errors through open communication, increased reporting and promotion of medication error prevention strategies. www.nccmerp.org/report-medication-errors accessed 5.14.17 Reporting Errors Recognize methods and responsibilities for reporting errors MedMarx https://www.fda.gov/safety/medwatch/default.htm https://vaers.hhs.gov/index co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States. Reporting Errors Why do we report errors? What do the number of errors reported at our facility mean? What are the challenges with voluntary reporting? 6

Reporting Errors Best Designs Simple, intuitive Requirement for front line staff- only information easily known Non-punitive Ability to be anonymous Medication Error Examples Categorizing Medication Errors NCC MERP Medication Error Assessment http://www.nccmerp.org/sites/default/files/indexcolor2001-06-12.pdf accessed 4/30/17 http://www.nccmerp.org/sites/default/files/indexcolor2001-06-12.pdf accessed 4/30/17 Algorithm RCA http://www.nccmerp.org/sites/default/files/algorcolor2001-06-12.pdf accessed 4/30/17 7

RCA Root Cause Analysis The When s The Why s RCA What is a Root Cause? A root cause is a factor that caused the original variance Ideal state - permanently eliminate through process improvement Root cause analysis uses tools, techniques and other approaches with goal of cause finding Can there be multiple root causes? RCA Computer OSA PA ordering Bipap Medication dose Failure Mode Effects Analysis (FMEA) Location of pt What is a FMEA? Process used to prospectively identify and prioritize failures in the system Failure When a system or part of a system performs in a way that is not intended or desirable. Mode The way or manner in which something, such as a failure, can happen. Failure mode is the manner in which something can fail. Effects The results or consequences of a failure mode. Analysis The detailed examination of the elements or structure of a process. How to Conduct an FMEA 1 2 3 4 Select a high risk process Create flow chart of the process Determine each step that can fail (failure modes) Evaluate possible and potential consequence that each failure mode can have 5 6 7 8 Identify causes of the failure mode Assess the severity, probability, likelihood of detection for each failure mode Implement actions to reduce the occurrence of the highest ranked failure modes Maintain the redesigned process http://www.jcrinc.com/assets/1/14/fmea10_sample_pages.pdf Accessed 5/14/17. http://www.mentorhealth.com/control/joint-commission-requirements-on-fmea Accessed 4/29/17. 8

FMEA Review of Each Step of the Process Step in Process Failure Proximate Effects Severity Probability Likelihood Risk Actions Modes Causes of Priority to Detection Number Reduce Failure Mode Rate the following on a scale of 1-10 Severity 10 = most severe effect Probability 10 = very likely to occur Detection 10 = very unlikely to detect Risk Priority Number = Severity x Probability x Detection https://www.patientsafety.va.gov/professionals/onthejob/hfmea.asp Accessed 4/20/17. http://www.ihi.org/resources/pages/tools/failuremodesandeffectsanalysistool.aspx Accessed 5/22/17. FMEA Scoring System Severity Probability No effect (1) Remote (1): no known occurrence; or happens < 10 % of the time Slight annoyance (2): may affect the system Low (3): possible, but no known data; or Moderate system problem (3): may affect the happens 10-30 % of the time patient Moderate (5): documented but less frequent; or Major system problem (5): may affect the patient happens 40-60% of the time Minor injury (7): temporary patient harm High (7): documented and frequent; or happens 70-80% of the time Major injury (9): permanent lessening of body function, surgical intervention required, Very high (10): documented, almost certain; or disfigurement happens 90-100% of the time Terminal injury or death (10) http://www.ihi.org/resources/pages/tools/failuremodesandeffectsanalysistool.aspx Accessed 5/22/17. FMEA Scoring System Likelihood of Detection Very high (1): error almost always detected; or we ll catch it 9 of 10 times High (3): error likely to be detected; or we ll catch it 7 of 10 times Moderate (5): moderate likelihood of detection; or we ll catch it 5 of 10 times Low (8): low likelihood of detection; or we ll catch it 2 of 10 times FMEA Pediatric Hospital Example Hundreds of patient specific oral medication doses are dispensed from the pharmacy each day. Potential for numerous errors: Wrong medication, concentration, dose Inappropriate storage conditions Expired medication or medication not available Contamination Dispensing delay Evaluate our oral fill list process. Remote (10): detection not possible at any point; or we ll never catch it! (0 of 10) http://www.ihi.org/resources/pages/tools/failuremodesandeffectsanalysistool.aspx Accessed 5/22/17. FMEA Ex. The Process Oral List Prints Strip of individual doses separated for 1 medication Pharmacist verifies final product Labels are separated by drug and storage condition Individual doses drawn into syringe Pharmacist signs label Bulk bottle selected and set on counter with labels Label syringe Individual syringes are bagged Expiration and personnel number written on labels Bulk bottle and individual syringes lined up for checking Bagged doses sorted into bins based on storage location FMEA Ex. Review of Each Process Step in Process Bulk bottle and individual syringes lined up for checking. Failure Modes a) Wrong bottle placed next to syringes. b) Confusion of bottle placement before or after syringes drawn up from that bottle. c) Syringe mixed in with those from another medication. Proximate Causes 1) Human error 2) Workflow interruptions (phone calls, STAT orders, etc) 3) Environment al factors 4) Limited space on counter Effects a) Patient could receive wrong med. Severity Probability Likelihood of Detection Risk Actions to Reduce Failure Priority Mode Number 5 5 3 75 1) Implement bag system to group doses with bulk bottle for each medication 2) Reduce environmental factors & workflow interruptions, when possible 3) Provide appropriate staff for effective process: -Added technician position to help with the 10 pm list 4) Address space constraints: -Created an additional list at 10 pm to reduce the volume of the 5 pm list Bagged doses separated into unit bins Bulk bottles returned to storage location 9

FMEA Ex. Top Risk Priority Numbers (RPN) Bulk bottle and individual syringes lined up for checking RPN: 75 Pharmacist verifies final product RPN: 75 Labels are separated by drug and storage condition RPN: 63 Bulk bottle selected and set out on counter with corresponding labels RPN: 63 FMEA Ex. Summary of Actions Implement bag system to group doses with bulk bottle for each medication Provide appropriate staffing for effective process Add technician position to help with the 10 pm list Address space constraints Create an additional list at 10 pm to reduce the volume of the 5 pm list Add a blank label with black division line in between each medication and strength that prints on list Provide training with computerized inventory system & expectation to remove bulk bottle when new bottle opened Place label from inventory system on bottle when removed from system FMEA Ex. Summary of Actions Cont. Separate bins containing look alike/sound alike medications and utilize tall man lettering on bin labels Pull 1 bulk bottle at a time to fill 1 strip of labels Place refrigerate sticker on bottles requiring refrigeration Provide training to ensure storage requirements are known Create separate area for pharmacists to check syringes Reduce environmental factors & workflow interruptions Strategies to Reduce Error Risk Fail-safes and Constraints Use Most powerful and effective strategy Involve system changes in product design or how individuals interact Example Preventing scanning on administration unless the pharmacist verification sticker has been placed on the label https://www.ismp.org/newsletters/ambulatory/archives/200602_4.asp Accessed 5-12-17. 10

Forcing Functions Use Creation of a hard stop to ensure important information is provided before proceeding Example Hospital Formulary Forcing Functions - Examples Requiring an acknowledgement of high dose Requiring an indication & duration Forcing Functions - Example Medication warning messages require an acknowledgement reason Automation and Computerization Pros Limit reliance on memory Lessen potential for human error Example Computerized physician order entry software that includes clinical decision support Automation and Computerization - Examples IV room processing and tracking software Inventory tracking software Databases that provide warning related to allergies, drug interactions, or doses outside the recommended range Standardization Pro Reduces complexity and variation of a process Use Uniform model to adhere to when performing tasks Cons Less effective than previous strategies when used alone Relies on human vigilance to ensure the process is followed 11

Standardization - Examples Order sets Medication administration Redundancies Pro Reduces the likelihood both individuals will make the same error Use Incorporate duplicate steps or an additional individual in the process Con Potential failure if the redundancy is omitted or ignored http://www.snjourney.com/clinicalinfo/meds/calc.htm Redundancies - Examples Chemotherapy verification Redundancies - Examples Double check of high alert medications Filling of patient specific doses Redundancies - Examples Patient counseling Reminders and Checklists Use Highlight important information Example Look-alike, sound-alike lists & alerts built into order entry system Example Auxiliary stickers to distinguish dose, route, storage 12

Rules and Policies Pro Guide staff toward an intended positive outcome Use Combine with other strategies that target the system Cons Potential to add unnecessary complexity May be met with resistance especially when implemented in response to an error Use relies on memory Education Pro Increases awareness to topic Example: Use In combination with other strategies Con Effect relies on the individual s ability to remember the information presented Automated Response AUTOMATED RESPONSE A response done over and over again as part of a routine A repetitive learned behavior during the course of a person s experience A reaction to a specific input Limitations on Human Performance Multi-tasking Dependence on heuristics when under time limits or stress conditions Environmental Fatigue- high or low volume Normalization of deviance Distractions 13

Best Practice#11 When compounding sterile preparations, perform an independent verification to ensure 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 Other Resources Errors Human Tendency ISMP quarterly reports ASHP online CDC :https://www.cdc.gov/medicationsafety/library.html FDA : https://www.fda.gov/drugs/drugsafety/default.htm 14

FSHP Medication Errors An Opportunity to Improve Laura Monroe-Duprey, BS Pharm, PharmD Joanie Spiro Stevens, PharmD, BCPS 15