Technician Education Day May 24, 2014 Ft. Lauderdale, FL The Pharmacy Technician s Role in Keeping Our Patients Safe Antonia Zapantis, MS, PharmD, BCPS Associate Professor, Nova Southeastern University College of Pharmacy 7,000 are medication -related deaths 1. IOM. To Err is Human. 1998. 2. IOM. Preventing Medication Errors: Quality Chasm S Disclosure The presenter has no other financial or personal relationships with commercial entities that may have direct or indirect interest in the subject matter of this presentation Institute of Medicine (IOM) 1,2 44,000-98,000 medical errors in US hospitals result in death ~1.5 million preventable adverse events per year Preventable errors Est cost between $17 to $29 billion per year Avg increased hospital cost of $4700- $8,750 per admission 1. IOM. To Err is Human. 1998. 2. IOM. Preventing Medication Errors: Quality Chasm Series 2006 Objectives 1 2 3 4 5 Define a medication error Define cultures associated with safety Discuss root cause analysis and its role in medication error reduction Discuss the process of Failure Mode and Effects Analysis (FMEA) Describe the role of technology in reducing the occurrence of medication errors Preventing Medication Errors: Quality Chasm Series A paradigm shift in the patient-provider relationship Communicate more with patients at each point of healthcare delivery Pts or their surrogates should take more active role Healthcare system needs to do a better job of educating pts & of providing ways self-education Using information technologies to reduce medication errors In prescribing and dispensing medications Improved labeling and packaging IOM. Preventing Medication Errors: Quality Chasm Series. 2006. 1
Classification WHAT IS A MEDICATION ERROR? Medication vs. Medical Prescribing Omission Compliance Drug deterioration Unauthorized drug usage Dosage form Administration technique Monitoring Drug preparation Timing Pharmacists Mutual Insurance Company Claims (1989-2001) 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 Wrong drug dispensed 50% Wrong strength dispensed 25% Wrong directions 9% Failure to detect a prescribing error 8% Counseling 2% National Coordinating Council for Medication Error Reporting and Prevention Medication Safety: The Swiss Cheese Effect Potential error: A mistake in prescribing, dispensing, or planned medication administration that is detected and corrected through intervention (by a health care provider or patient) near miss 2
A look through time at our culture Punitive Lessons from Denver Nurses gave slow IV push instead based on drug reference book Benzathine is insoluble & obstructs blood flow to lungs After 1.8mL had been administered the infant became unresponsive 3 nurses were indicted by a grand jury for negligent homicide 2 agreed to legal sanctions before trial 1 plead not guilty & went to trial Aspden P, et al. (ed). Preventing Medication Errors. 2007. National Academies Press. Punitive Culture Name, shame and blame Individuals are fully and sometimes solely accountable for the outcomes of patients under their care Necessary for disciplinary action in order to maintain power and safety Disciplinary action safety related to severity of the undesirable outcome Bad practitioners = Frequent or harmful errors Need to weed out these individuals for safer healthcare environments ISMP (Institute of Safe Medication Practices) Non-profit organization Publishes ISMP Medication Safety Alert Distribute information to alert health care providers of potential med errors or med errors which have occurred in other institutions Available to come to an institution for review of specific error or system Lessons from Denver Treatment of congential syphilis in a one-day old infant Order written for Benzathine penicillin G 150,000U IM Pharmacist misread order as 1,500,000 units Label indicated that 2.5 ml = 1,500,000 units Nurse expressed concern about number of injections = 5 (max 0.5 ml per IM injection in neonate) Aspden P, et al. (ed). Preventing Medication Errors. 2007. National Academies Press. ISMP s Evaluation Identified >50 system failures Focus on the multiple underlying system failures which shape individual behavior and create the conditions under which med errors occur Providing optimal med safety requires that latent system failure are recognized and corrected We must look beyond blaming individuals! Aspden P, et al. (ed). Preventing Medication Errors. 2007. National Academies Press. 3
A look through time at our culture Just Culture Neither supports punitive nor blame-free cultures wholly when errors occur Safety is valued in the organization Organization continually looks for risks that pose a threat Careful thinking about risky behavioral choices Always thinking about the most reliable ways to get the job done correctly http://mcbrideandgroom.clarksrule.com/wp-content/uploads/2009/03/swing.jpg Blame-free Culture Even the most experienced, knowledgeable, vigilant, and caring workers could make mistakes that could lead to patient harm Recognition that workers who made honest errors were not truly blameworthy, nor was there much benefit for punishment for unintentional acts Not fully supportive of an industry wide desire to become wholly blame-free Purpose of a Non-Punitive Policy To encourage reporting of medication errors as a means to assess and improve the medication use process and provide a safe environment for patient care without worries of sanctions. A look through time at our culture Punitive Blame-Free Just Cause: Different types of Error Unintentional & unpredictable behavior Undesirable outcome, either because a planned action is not completed as intended or the wrong plan is used to achieve an aim Drift into unsafe habits, to lose perception of the risk attached to everyday behaviors, or mistakenly believe the risk to be justified Risk is understood & intentional Human error At-risk behavior Reckless behavior http://www.phmic.com/sitecollectiondocuments/pharmacy%20liability 4
Just Culture Type of Behavior Description Suggested Response Human Error Unintentional acts Console At Risk Short cuts Coach Reckless Intentional Substantial risk Outside the norm Discipline Purpose of Error Reporting To increase awareness of medication errors To examine and evaluate the causes of medication errors To recommend strategies relative to system modifications, practice standards and guidelines, and changes in packaging, labeling, and product identity Maintain systems to support and provide feedback to reporters so that appropriate prevention strategies can be developed in facilities Reports Should Include Incident Report Forms A description of the error or preventable adverse drug reaction. What went wrong? If this was this an actual medication error (reached the patient) or are you expressing concern about a potential error or writing about an error that was discovered before it reached the patient? The patient outcome Where it occurred? The generic & brand names of all products involved The dosage form, concentration or strength, etc. How was the error discovered/intercepted? If the error was resolved? Please state your recommendations for error prevention ERROR FOLLOW-UP A Rose by Another Name Incident report forms Variance forms Medication Errors Reporting Program (MERP) Error Follow Up Biggest complaint patients have regarding pharmacy errors: They are usually more upset about the response, or lack of response they receive than with the actual error Report Errors Near-misses Hazardous conditions 5
Sentinel Event Dennis Quaid Twins 1 ml vial (10,000 units/ml) vs. 1 ml vial (10 units/ml) 2006 Indiana An unexpected occurrence that results in unanticipated death or major, permanent loss of function 6 neonates administered dose 3 died 2007 California 3 neonates administered dose No fatalities 2008 Texas 17 neonates administered doses *** Sentinel Event & Medical Error are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events*** 2 died http://www.seamedical.com/images/quaidtwins Error with EPInephrine Aug 2004 Triple Check, Plus Two Check each prescription 3 times 16 yoa male w/ priapism Inject 1:1,000,000 solution of epinephrine into penis = Add 1:1,000 (1mg/mL) Epi to 1 L NS When entering the prescription/ order information When selecting the bottle/vial from the shelf While filling the medication/ order Dr. thought 1:1,000 dilution was 1mg/L Process 1 Process 2 Process 3 Pt received 4mg of undiluted drug into penis Cardiac Arrest & DIED http://www.phmic.com/sitecollectiondocuments/pharmacy%20liability Root Cause Analysis Identifies the factors that underlie variation in performance Focuses primarily on the systems & processes, not individual performance End Result Action Plan Identifies the strategies to reduce risk of similar events occurring in the future Addresses responsibility for implementation, oversight, pilot testing, time lines, measurement strategies Triple Check, Plus Two Plus two additional checks Check the NDC/scan Process 1 Show and Tell before dispensing Process 2 To the patient, nurse, pharmacist http://www.phmic.com/sitecollectiondocuments/pharmacy%20liabilit 6
Questions that should only be answered by the pharmacist Why does my medication look different? Why are the directions different than what my doctor told me? I m allergic to Can I take this Medication? Avoiding drug mix-ups (ISMP) Verify the NDC code Open the bottle in front of the patient to confirm appearance and indication Unit dose medication In-patient Out-Patient? (Done in Europe) Limit use of abbreviations http://www.phmic.com/sitecollectiondocuments/pharmacy%20liability% Avoiding drug mix-ups (ISMP) Repeat back all telephone orders, spell the drug name, and ask for indication Use magnifying lenses and place orders/prescriptions at eye level under good light during transcription Why do errors occur? Change the appearance of look-alike product names on the computer, pharmacy shelf, product labels, and medication records ex. tall man lettering Avoiding drug mix-ups (ISMP) Affix name alert stickers in areas where look or sound-a-likes are stored Store look or sound a-likes in different locations Use at least 2 independent checks in the dispensing process One person interprets and enters the rx The other person checks the label against the original and product. Put the most detail oriented person here http://www.jointcommission.org/nr/rdonlyres/969f94e2-6908-4a30-a1b4-efe9bdb23d24/0/se_rc_medication_errors.jpg 7
Approximately 45-50% of medication errors reported to the USP-ISMP Medication Error Reporting Program (MERP) and FDA MEDWatch Program are related to problems with product labeling, packaging or nomenclature. Technology Initiatives in Patient Safety Proulx SM. Managing Pharmaceuticals to Reduce Medication Errors. ISMP. 2003. Available at: Technology Initiatives in the Healthcare System Prescribing Monitoring Transcribing/ Repackaging Administration http://www.jointcommission.org/nr/rdonlyres/969f94e2-6908-4a30-a1b4-efe9bdb23d24/0/se_rc_medication_errors.jpg FMEA: Process Steps (What would be the consequences of each failure?) Effects Modes (What could go wrong?) In-Patient Prescribing/Transcribing Computerized Physician Order Entry (CPOE) Can reduce medical errors by up to 70% 1998 - only 1/3 of U.S. hospitals have CPOE Causes (Why would the failures happen?) http://www.lifespan.org/imagesi/servi-tech-image-58718-cpoe1 o.jpg 8
CPOE Some hospitals with CPOE: Brigham and Women s Hospital Ohio State University Medical Center University of Virginia Health System University Hospital of Arkansas Medical College of Virginia Health System University of Illinois at Chicago Medical Center Vanderbilt University Medical Center VA System Cleveland Clinic Florida Broward Health System Memorial Health System Jackson Memorial Hospital Assessment Question A sentinel event results in an unanticipated death or major, permanent loss of function True False Feb 2004 FDA Bar Coding Rule FDA estimates: 50% increase in the interception of medication errors at the "dispensing and administration" stages 413,000 fewer adverse events over the next 20 years $7.2 billion cost to the 6,000 hospitals Assessment Question According to the Joint Commission, what continues to be the leading root cause of medical errors? A. Communication issues B. Lack of training C. Lack of leadership D. Workload Considerations Planning is key! Takes a long time to plan Will not prevent all errors Has potential to create new types of errors CPOE is time-consuming for ordering practitioners Expensive! Upfront costs: $500K to $15 million Assessment Question When can medication errors occur? A. Only when filling the prescription B. Cannot occur during monitoring C. At any point in the medication use process D. Only during administration 9