842 Exam One

Numeracy

): approximately 50% of the U.S. population has difficulty with simple numeric tasks (e.g. cost/ounce of a grocery item). Decreased numeric skills results in decreased comprehension and can place individuals at risk in certain critical life situations, such as health, environment and financial - many patients don't have the numeracy necessary to function in the current healthcare environment: appointment scheduling, risk magnitude in %s, understanding risk in real health situations (i.e. when considering treatment options), how to weigh risks and benefits in decision making. · cant do long discussions - low patient numeracy among those receiving anticoagulants is associated with higher INR variability and low numeracy patients spent more time above the INR therapeutic range. Estrada, 2004. - individuals asked to rate a disease that kills 1286 out of 10,000 was rated as more dangerous than one that kills 24.14% of the population (Yamagishi, 1997). - representation of risk in percentages (i.e. 10%, 20%) result in benign interpretations of risk to a patient, whereas frequency presentations (i.e. 10 or 20 per 100) led to significant concerns - present risk in raw numbers not % - highly numerate individuals understand numbers better and are more likely to use them in decision making; less numerate individuals are informed more by other non-numeric sources (e.g. emotions, trust, etc). Numerical skill is the best predictor of comprehension (Hibbard, 2007) - decimals are not well understood and should not be used (use real numbers) - simply providing information may not be adequate to ensure good decisions

Transdermal fentanyl

*use of transdermal fentanyl to treat acute pain and to manage pain in opioid naïve patients, despite the fact that this product is contraindicated in these situations* · numerous cases in ISMP newsletters from September 2001 - May 2007 · despite August 2005 Dear Health Professional letter from OrthoMcNeil to bring attention to new black box warnings in product labeling · the problem - sustained concentrations of fentanyl from the transdermal system may not be achieved for 12-24 hours, a time at which acute pain may have begun to subside. In addition, transdermal fentanyl is highly potent (making comparison calculations with other opioids difficult) and not easily titratable. · some practitioners continue to be unaware · May 2007 ISMP newsletter - report of a post-op patient with a morphine infusion following surgery, who was discharged the next day. A nurse applied a 75 mcg/hr patch just prior to discharge, and gave the patient 3 patches to take home as well as a prescription for oxycodone tablets PRN. The patient died within 12 hours of discharge, and coroner attributed the death to the fentanyl. The patient was opiate naïve, did not have chronic pain, and was being managed for sleep apnea and pneumonia at the time of his surgery. · More recent fatal incidents being reported (see ISMP, August 8, 2013) have been attributed to "bystander apathy". The fatal events describe ingestion or absorption of patches by small children. Do patients understand the danger of fentanyl patches if ingested or worn by an unintended party after already being worn by a patient for 3 days and then disposed of?

5-FU overdose

- August, 2006 - 43 y.o. Canadian woman with nasopharyngeal carcinoma (potentially curable malignancy) died from an accidental overdose of 5-FU o ISMP Canada conducted a root-cause analysis and made the report available via the internet to promote learning o Patient was treated in an ambulatory clinic on a protocol of 5-FU and cisplatin - patient received the 5-FU dose of 4000 mg/m2 over 4 hours instead of 4 days § Order was as follows: 5-FU 5250 mg (4000 mg/m2) iv once continuous over 4 days... Continuous infusion via ambulatory infusion pump (Baseline regimen dose = 1000 mg/m2/day = 4000 mg/m2/4 days). · One IV bag, change IV bag once a day § 5-FU bag contained 130 ml of solution (45.6 mg 5-FU/ml) § nurse programmed the infusion pump to deliver 5-FU @ 28.8 ml/hr - but this was the total amount of solution to be administered over 24 hours, not 1 hour; correct infusion rate was 1.2 ml/hr · a 2nd nurse who served as the double-check failed to identify the error · 4 hours later the patient noted that the pump was beeping and that the infusion bag was empty; she returned to the clinic and the error was immediately recognized; on-call physician noted that there was no suggested treatment and that the patient should call the next day; patient was advised to stay well hydrated. o Patient called the next day and advised to come in for monitoring; patient was feeling well and preferred not to come in; patient attending became aware of the error and conducted a literature search; patient called 2 days later and asked to come in the following day for a re-assessment; patient then complaining of nausea, vomiting and throat discomfort; she was treated and discharged and admission was arranged for the next day as no beds were available; during the following weeks she developed profound mucositis and pancytopenia, circulatory collapse and multi-organ failure; she died 22 days after the overdose. § Outpatient management because they didn't have beds § Analysis · Protocol design with 4-days of 5-FU in 1 infusion bag increased the likelihood of the error · Complex calculations were conducted at the bedside, and both forgot to divide the daily dose by 24 hours · Pharmacy label was difficult to read and listed the ml/24 h first and then the ml/hour in parenthesis o Nurses had confirmation bias, seeing the 28.8/ ml/24 h as the hourly infusion rate · Nurse involved in the double-check was distracted and on the way to performing another task at the time; she couldn't find a calculator so performed the calculation in her head and on scrap paper; the checking process was informal and unstructured. · Workload complexity - work on the unit required multi-tasking (checking labs, weighing patients, assessing patients, reviewing orders, label and calculations, pump programming and patient education), and these were not sequenced in a step-wise fashion such that high-risk tasks were performed simultaneously with other tasks · Pump design - programming choices listed as mg/ml, u/ml or ml (meaning ml/hour); prompt for container size required entry of the volume to be infused; review screen did not provide data on duration of the infusion that had been programmed; pump didn't have error-reduction software that could detect excessive dosing · Lack of protocol familiarity - nurse was new to the unit and had never administered a 4-day 5-FU infusion · Lack of preparation - staff were uncertain how to best manage the patient once the overdose was detected o 12/15 - FDA approves emergency antidote for 5-FU toxicity - uridine triacetate (Vistogard); administer within 4 days of 5-FU dose

ER visits in older adults

- Budnitz et al - studied ADEs among patients 65 years and older presenting to the ER Sources - For ADE data - National Electronic Injury Surveillance System (NEISS) (2004-05) For data on outpatient prescriptions - National Ambulatory Medical Care Survey (2004), National Hospital Ambulatory Medical Care Survey (2004) - provide info on outpatient visits and prescription rates Compared Beers criteria medications with other medications Beers criteria - consensus base list of medications considered always potentially inappropriate or potentially inappropriate in the elderly Identified 4492 ADE cases Estimated ~ 177,000 ER visits in the U.S. for ADEs occurred annually in 2004-2005 Estimated 3.6% were for Beers criteria medications considered to be always potentially inappropriate · More than 50% were for anticholinergics, antihistamines, nitrofurantoin or propoxyphene Estimated 33.3% were for 3 other medications - warfarin (17.3%), insulin (13.0%) and digoxin (3.2%) · Of 14 medications with > 1% of ADEs, only digoxin was included in the Beers criteria (as potentially inappropriate) Cases d/t warfarin - 73% with bleeding and 44% requiring hospitalization Cases d/t insulin - 95% with hypoglycemia and 24% involved seizure/loss of consciousness Cases d/t digoxin - 80% required hospitalization 9 of the top10 medications most commonly resulting in ER visits for an ADE in the elderly involved 3 classes/categories - oral anticoagulants/anti-platelet agents, antidiabetic agents and narrow therapeutic index drugs · caused ~ 50% of ER visits but prescribed in only 9.4% of outpatient visits · suggest that monitoring, communication and follow-up may not be adequate - improved utilization may have a greater impact on reducing ADEs than would targeted reductions of lower risk medications (e.g. Beers criteria)

CPOE system association with mortality

- Han et al implemented a commercial *adult-based* CPOE system with decision support at a *children's hospital* Tested hypothesis that this system would reduce mortality for children who undergo inter-facility transport for specialized critical care - since this population represented a "first encounter cohort of patients to the hospital system" - CPOE system was rapidly implemented over a 6-day period - Analyzed mortality rates among this population for 13 mo. before CPOE implementation and for 5 months post-implementation - Mortality rate increased significantly from 2.8% pre-CPOE to 6.6% post-CPOE CPOE remained a significant variable associated with mortality after adjustment for other variables - i.e. no differences in patient demographics pre- vs. post-CPOE - Didn't collect/report any ADE data - Concluded that there may be subpopulations such as this who don't benefit or may actually experience negative consequences from a new intervention

impact of unit-based clinical pharmacists in an inpatient pediatric setting

- Kaushal et al determined rates of serious medication errors across 3 types of inpatient pediatric units (PICU, general medical and surgical) in a pediatric hospital before and after an intervention period with a unit-based clinical pharmacist (all with a Pharm.D. degree), NYC 3 pediatric units, ICU- involved all day, other units- involved only in the morning o Authors point out that unit-based clinical pharmacists (i.e. making rounds and other traditional functions) may be one of the most promising non-information technology interventions to reducing medication errors § Authors also note that only ~ 30% of hospitals nationwide have pharmacists participating on rounds § Also point out that such an intervention may increase rates of intercepted near misses (potential ADEs) o Studied a 6-8 week baseline period (including other control units) and a 3-month study period § The unit-based clinical pharmacist was present full-time in the ICU and for mornings only in the other units · Functions included providing information, facilitating communication, assisting nurses with drug preparation and monitoring order transcription · Noted that the pharmacist on surgical unit had difficulty attending rounds, which were very early in the morning o Nurses evaluated patient records for errors and ADEs (to prevent bias) § Defined serious medication errors as all preventable ADEs and non-intercepted near misses o Unit-based clinical pharmacists were associated with a decrease in serious medication errors in the ICU § In the ICU, the rate of intercepted near misses rose from 32 >> 57/1000 patients during the intervention period § Most detected errors occurred during drug ordering § Speculate that lower error rates or part-time nature on the other units may have prevented detection of any differences o Length of stay was not different pre- vs. post-intervention for any patient group o Rate of interception erros increased

Pharmacist impact in internal medicine -

- Kucukarslan evaluated the impact of pharmacist participation on rounds upon the incidence of preventable ADEs on general medicine units over ~ 3 mo. o Patients receiving care involving a pharmacist on the rounding team on 1 unit were compared to those on a separate unit without such pharmacist involvement § Pharmacist patient ratio reported to be appx. 1:15 on the rounding unit and 1:30 on the control unit · Pharmacists for both groups were reported to have B.S. degrees with 2-25 years of experience § A list of medications targeted for evaluation d/t cost or safety concerns were reviewed in addition to a daily review of MARs o Random patient records were selected for subsequent evaluation o Rate of ADEs was reduced by 78% - 26.5/1000 days >>> 5.7/1000 days o Pharmacists documented 150 recommendations, with 147 being accepted § Most common: dosing changes and addition of a drug (21%) o Authors point out the value of having the pharmacist placed proximate to both the medication selection step and to patient information o Much lower rate of ADRs when pharmacist is on rounds, proximate to ordering set is beneficial

CPOE

- Lack of process design may have led to failure Rapid implementation Multiple concomitant changes along with CPOE: removed all floorstock medications (now centrally located in the pharmacy dept.), orders could not be written until patient actually arrived on the unit, complexity of CPOE required 1 clinician just to enter orders (~ 10 mouse clicks/order), during busy times, computer bandwith was sometimes exceeded and screens were frozen Following CPOE, < half of patients received critical care antibiotics and vasoactive agents within recommended timelines

Indication based prescribing

- Note ~ 1/1000 prescriptions are associated w incorrect drug selection in prescribing, transcribing, dispensing or administration. Many are noted to occur during order entry when selecting a drug from a drop-down menu or pick list. o Occurs in order entry - A primary cause is drug name similarity o Recent examples: § Risperidone and ropinirole § Hydroxyzine and hydralazine § Hydroxychloroquine and hydroxyurea § Rapaflo (silodosin) and rapamune (sirolimus) § Acetaminophen and acetazolamide § Valacylovir and valganciclovir § Penicillamine and penicillin - Benefits of indications-based prescribing: can't fix everything but can tighten things up, off-label indication can be confusing o Prevention of errors o Patient education o Improved communication - HC team & patient families o Improved medication reconciliation o Improved prescribing - i.e. entering an indication and receiving optimal medication recommendations based upon HER o Measuring drug effectiveness - i.e. learning re: off-label use

overriding computer safety alerts

- Van der Sijs conducted a literature review regarding prescriber response to medication safety alerts 17 publications were reviewed safety alerts were overridden by prescribers 49-96% of the time 3 papers described the impact of overridden alerts · adverse events observed in 2.3%, 2.5% and 6% of the override situations the authors point out that some alerts may have low specificity/sensitivity, be unclear, or potentially produce work flow disruptions (i.e. a high override rate can impair safe conditions via decreasing credibility); these could then result in prescribers ignoring or incorrectly responding to alerts alert fatigue is a likely factor in override situations

dispensing errors rates

- data suggests an approximate error rate in ~ 1.7% of prescriptions, but w a broad range of (1.7-24%) - Teagarden et al, 2005; Flynn et al, 2003. - Data from a study of mail order pharmacy practice has demonstrated an error rate of 0.075% (16 errors/21,252 prescriptions), all of which involved prescription processing/order entry and none of which involved the mechanical stages of dispensing All errors appeared to be quite minor - i.e. no errors of drug selection, strength or dosage form - What do dispensing errors reveal re: the likelihood of ADEs/potential ADEs among outpatients? Would dispensing errors be the main source of ADEs/potential ADEs in the outpatient arena? One factor but not only factor, tip of the iceberg Transparency of the retail/community pharmacy industry: (Hong K, et al. Res Soc Admin Pharm 15:823; 2019) Point out that hospital settings have been sharing their error data and error management strategies via multiple publications/presentations; the authors also note the lack of such evidence from the community/retail pharmacy practice arena Community pharmacy corporations selected based upon largest market share Corporations contacted re: strategies to manage medication errors AND transparency 7/9 replied, 4 refused to answer d/t corporate policy; 3 replied w answers unrelated to the questions NY Times article - Jan 31, 2020 - Pharmacists across the U.S. warn that to do more w less has made medication errors more likely - understaffed & chaotic workplaces described o Authors also note that the majority of state boards of pharmacy do not require error reporting

LASA auto-detection

- developed algorithm for detecting potential LA/SA errors (ASHP system) - algorithm flags order as possible error based upon medication order, diagnosis and drug indications - i.e. examination for mismatches between diagnosis and known drug indications - identified errors where cycloserine (69% of cycloserine orders) was ordered instead of cyclosporine - noted that this type of automated detection can be employed to prevent errors in real time via indication alerts if accurate diagnostic information is available - also noted that indication alerts alone won't prevent dispensing errors until accurate and complete indication information is available to pharmacists *Errors occur in dispensing process over 50% of the time*

ISMP vaccine errors

- estimate (based upon spontaneous reports) that errors occur in 27-35% of vaccinations - July newsletter provides summary of 4yr of vaccination errors based on > 1700 reports/mostly in outpatient settings - Most frequent error types: o Wrong vaccine - 23% o Wrong age for vaccination - 20% o Wrong vaccine dose - 12% o Extra vaccine dose - 9% o Wrong vaccine interval - 7% - Emerging error, error prone environment, not a lot of data yet

Budnitz

- estimated that ADEs resulted in 0.6% of ER visits (all causes) - most common types of ADEs: dematologic (26%), GI (14%), neurologic (14%), metabolic/endocrine (10.5%) and bleeding/coagulation (9.8%) 33% d/t allergic reactions and 32% d/t unintentional overdose (responsible for ~ 53% of hospitalizations) - most common drug classes resulting in ADEs (accounting for ~27% of ADEs): insulin, opioids, anticoagulants, amoxicillin-containing, and antihistamine/cough-cold agents - most common drug classes resulting in hospitalizations (accounting for ~ 38% of hospitalizations): anticoagulants, insulins, opioids, oral hypoglycemics, and antineoplastics insulin or warfarin involved in > 25% of hospitalizations

Perception vs. reality

- few published reports have described the above contrast - policy makers may not be aware of the fact that fewer resources are being devoted to a much larger problem - crashes make the news, while ADEs often go unnoticed or are attributed to other factors this helps to produce a distortion among the public and policymakers

Limitations of outpatient studies

- no information re: causality - no information re: impact of other pharmacotherapy, co-morbid conditions, etc. (no patient factors) - error studies don't include outcome data (i.e. ADE or not?) - death certificate studies don't provide a precise determination d/t lack of inclusion of a "medication error" or "medical error" categorization (drug is listed by not what happened) - spontaneous (voluntary) reports represent a very small sample that can be biased based upon multiple factors - i.e. new vs. old drugs, trending concerns based upon recent data, etc.

Evans

- studied a computer-assisted program for antibiotic therapy 545 patients were managed with the assistance of an anti-infectives-management program - consisted of multiple functions, including drug/susceptibility recommendations, automated monitoring of renal function to suggest altered dosing and dosing/route/interval recommendations for specific uses compared results to that of 1136 patients admitted to the same unit in the 2 years prior to implementing the program physicians followed suggestions re: the anti-infective agent in 46% of orders, but followed dosing/interval recommendations in (93%) of orders program associated with reductions in orders for drugs that patients were allergic to (35 vs. 146), excessive drug doses (87 vs. 405), and mismatches in antibiotic susceptibility (12 vs. 206), all of which were statistically significant adverse events related to anti-infective agents were also significantly reduced (4 vs. 28)

Inpatient ADEs in adults (Classen)

- study of 6 high alert meds in the Medicare Patient Safety Monitoring System (MPSMS) - study employed a chart review algorithmic approach to identify med exposure and ADEs - based on ~ 25,000 hospital visits in 2004, ADEs occurred at the following rates for these agents: warfarin - 8.2% insulin/hypoglycemics - 10.7% heparin - 13.6% digoxin - 0.5% antibiotic-associated C Diff - 0.6% (thought to be preventable) - most were associated w increased LOS and both in-hospital and 30-day mortality - no information on what factors contributed to or were associated with these ADEs

serious Adverse events reported to FDA

- study of serious ADEs reported to FDA (i.e. voluntary reports) from 1998-2005 serious ADEs = resulted in health outcome of death, teratogenicity, disability, hospitalization, life threatening or required intervention to prevent harm found a 2.6-fold increase in ADEs and a 2.7-fold increase in fatal ADEs during the time period ADE increases outpaced by 4x the rate of outpatient prescriptions Increases were related to relatively few drugs (298 of the 1489 drugs with reports were related to 87% of events) Disproportionate share of ADEs by patients > 65 y - 12.6% of population vs. 33.6% of events (vs. children - 25.8% of population but 7.4% of events) Spontaneous reports represent ~5% of what is actually happening - authors concluded that "existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy, and institutional changes."

Phillips et al

- the above comparison of 20-year trends in accidental deaths from medications in comparison to deaths from various types of transportation demonstrates the emerging problem with medication-related deaths o in 1998, accidental deaths from prescription *medications was 5-fold greater than from all of these types of transportation* combined (10,133/1,887 = 5.37)

Ten most common lethal medication errors in hosptials

1. concentrated potassium chloride injections 2. insulin errors 3. intravenous calcium and magnesium (respiratory failure) a. calcium chloride contains 13.6 mEq of Ca/gm; calcium gluconate contains 4.65 mEq/gm- not interchangeable 4. inadvertent administration of 50% dextrose (without dilution) 5. known allergy- hopefully tightened up 6. miscalculated digoxin dose in pediatrics (product manipulation, dose under 0.1) 7. confusing vincristine and vinblastine a. max dose of vincristine is 2 mg (neurotoxicity), while 6 mg/m2 for vinblastine (myelosuppression) 8. concentrated sodium chloride injections a. cases where 23.4% sodium chloride was employed to dilute antibiotics i. famous case where pharmacist went to jail 9. intravenous opioids a. availability of a variety of concentrations 10. aminophylline errors a. e.g. 7.4 mg ordered for an infant, but 7.4 ml (185 mg) administered >> death

Heparin

3 neonates died at an Indiana hospital in 2006 after receiving an overdose of heparin; 2-3 other infants were also affected by the error 1 ml heparin vials that contained 10,000 u/ml were placed incorrectly into a unit-based automated dispensing cabinet by pharmacy technicians where 1 ml, 10 u/ml vials were stored - the vials looked very similar Baxter, the manufacturer, issued a nationwide safety alert and redesigned the packaging and label of the higher strength heparin vials · November 2007 - a California Hospital had the same error occur in newborn twins, children of Dennis Quaid and Kimberly Buffington; both had bleeding but recovered. o 60 Minutes focused on similarity of the vials and the nurses failure to correctly read the labels § did not focus on confirmation bias - whereby practitioners only see what they think they should see when retrieving vials from a specific known location where correct product normally is stored § didn't focus beyond human vigilance - i.e. that the system itself contributed to the error by not having failsafe systems such as point-of-care barcode technology · i.e. multiple nurses and technicians at different hospitals all made the same error § despite warnings from ISMP after the first incidents, no regulatory or accrediting bodies required any implementation of risk-reduction activities

Errors and ADEs in ambulatory care

: lack of data Most ADE studies have been conducted in the inpatient environment and little is known about the occurrence of ADEs in the ambulatory/outpatient environment, as well as the risk factors and approaches that may mitigate ADEs in this setting. Errors associated with computerized prescribing systems in the outpatient arena: Nanji et al, 2011 - retrospective study of 3050 prescriptions generated by computers and sent to a retail pharmacy outlet across 3 states; could have been sent by hand, fax or e-transmission - 452 (11.7%) of prescriptions contained one or more errors, and 163 (35%) of these were considered as potential ADEs - most common error was missing information (61%), especially for duration, dose and frequency - error rates varied from 5-38% across the different computer prescribing systems, as did error types and their association with rates of potential ADEs - the error rates are similar to what is observed with handwritten prescriptions - the authors caution re: implementation w/o adequate processes in place - note: it has also by demonstrated (Moniz et al, 2011) that electronic transmission of prescriptions to retail pharmacies (from CPOE systems in physicians offices) reduces dispensing errors by ~ 50% compared with printing the prescription from the CPOE system and providing it to the patient. Taking transcription out of the process can improve erros

ER visits for ADEs

: such data may provide a signal re: how common ADEs occur in the outpatient arena. - Budnitz et al - studied ADEs that lead to ER visits Source - National Electronic Injury Surveillance System (2004-05) Probability sample (n=63) of all U.S. hospitals trained coders reviewed clinical records of each ER visit for injuries, poisonings and ADEs ADE = an ER visit for a condition that the physician attributed to a drug (allergic reaction, poisoning) studied 21,298 ADEs over the 2-year period annual U.S. estimates of ~ 701,000 ADEs or 2.4/1000 in ERs 3487 (16%) required hospitalization patients > 65y. were more likely to suffer an ADE (RR = 2.4) and more likely to require hospitalization (RR=6.8) (elderly patients are more at risk) · 5.9% rate in patients > 65y similar to ER visits for MVA · ADE rate also higher among children < 5y. drugs requiring regular monitoring (antidiabetic agents, warfarin, anticonvulsants, digoxin, lithium) - accounted for 41.5% of hospitalizations and were involved in most unintentional ODs

Beers criteria

Beers criteria is not a good predictor of ADEs in outpatient, drugs with low therapeutic index and increase need for monitoring casue more ADEs

CDS

CDS- computer decision support systems, may have too much alerts, useful alerts are a minority

Leadership Issues

Change from patient safety as responsibility of a select few to all employees (safety comes form strong leaders) Traps: -Reacting defensively to safety issues -If incidents arise, blame the providers/front-end operators -Withholding the truth re: patient safety issues -Focusing on the wrong metrics - i.e. # of patients seen or scripts filled per hour

Appropriate leadership behaviors

Changing culture - embedding patient safety into employee culture Ownership for patient safety *Emphasizing learning* rather than discipline/retaliation Investigation of causality and system re-design Develop a reporting system Establish regular communications/briefings -Regular training -Checklists, hard stops, etc. that make it easier to do the right thing and difficult to do the wrong thing -Full transparency and disclosure Encouraging imagination - don't always be reactive to the last big mistake Prioritize employees >>> prioritize patient safety key points for management: -emphasize contribution vs. fault finding · understand the multitude of factors that led to the problem > emphasis is on learning and improvement emphasize positive inquiry · identify what works and replicate it - requires close contact with frontline operators (e.g. focus groups, workshops) · don't just focus on areas with multiple incident reports are other areas better (& why?) or are they under-reporting? Some are more transparent · Trust will follow establishment of a positive inquiry approach o · Sample question: · What do you need to make things safer for our patients (and what can I do)?

JCAHO

Designing processes and standards to assess quality improvement and patient safety Has established a series of patient safety goals e.g. drug reconciliation, eliminating dangerous abbreviations

Pharmacy industry and fear

Disease mongering or medicalization- condition branding to foster the creation of new disorders under the guise of promoting health e.g. Purell slogan - "imagine a touchable world" e.g. marketing cholesterol as a disease - pharmaceuticals to treat risk factors may use fear of death for sales promotion advertisements begin within 1 year of market entry, and before there is any post-marketing surveillance of actual risks spending on DTC advertising doesn't match major causes of death in U.S. - e.g. 1/3 of spending in 2005 was for sleep medications the 5 most advertised drugs in 2014 were: Cialis, Humira, Lyrica, Viagra and Eliquis every $1 of DTC advertising leads to a $4.20 rise in sales · ads rarely mention lifestyle changes but rather emotion, with medications as a means of regaining control and obtaining social approval · now moving beyond focus groups by exploring consumers to product images while undergoing brain MRI scans - neuromarketing

Non-intentional/involuntary actions

Failure of actions to go as intended/planned - i.e. slips and lapses (failing to remember to do something), AKA execution and/or storage failures · 2 conditions are necessary - the performance of a largely automatic task in familiar surroundings and a marked degree of attentional 'capture' by something other than the job in hand.

intentional but mistaken actions

Failure of intended actions to achieve the desired consequences - i.e. AKA mistakes or planning failures d/t failure of expertise - (applying a plan inappropriately) OR d/t lack of expertise (applying a plan w/o adequate knowledge/skills) Problem resides in the adequacy of the plan rather than in the conformity of the actions for some prior intention. Rather than action not being what was intended, the intention was not appropriate. These likely arise from higher-level processes than slips or lapses. These tend to be more subtle (i.e. harder to detect), more complex and less well understood than slips, and as such tend to be far more dangerous. e.g.- applying a plan inappropriately: providing 1 or more low therapeutic index agents to a patient with limited - no education/experience, no counseling, no immediate follow-up, and no plan to see the patient for 3 months, resulting in a serious error. e.g. - lack of expertise: remembering (incorrectly) the only requirement when a patient has a toxic concentration following high dose methotrexate is to continue the leucovorin, rather than significantly increasing the dose of leucovorin and continuing hydration & alkalization as well.

Promotion of fear by politicians

H.L. Mencken, 1920: "the whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, all of them imaginary."

national initiatives

Health policy changes are difficult to establish d/t a myriad of stakeholders Larger problem may be viewed as expanding access to the millions of uninsured in the U.S. How to finance patient safety, when most events go unacknowledged and healthcare costs are already excessive? -Money for technology for safe safety may not be there -Note that cost objections by automobile manufacturers also led to a delay of uniform seat belt applications in automobiles -Protecting patients from harm has yet to become engrained in health provider culture; denial?

New medication-use system

IOM defines a system as - "a set of interdependent elements interacting to achieve a common aim"; hard to apply this definition to healthcare delivery within the U.S. - more a silo approach with few systems that facilitate adequate communication, teamwork or safety WHO in 2000 ranked U.S. 37th (last among G-7 nations) in overall healthcare system performance among 190 countries 2014 - France #1, U.S. again #37 U.S. spends more per capita on healthcare than any other nation Reimbursement based upon volume of visits, scripts and procedures is not working well and has perverse incentives - would need to move to a system that reimburses based upon prevention or reversal of illness, evidence based medicine and harm reduction instead Current system may be irreparable

Etoposide overdose

ISMP April, 2017 - 11 mo. old received daily etoposide infusions over 5 days despite precipitate visibility in the solution. The infant w a rare form of cancer led the oncologists to develop a custom chemo plan. The intended dose of 3.3 mg/kg/d x 5 days was mis-transcribed as 33 mg/kg/d x 5 days. The high concentration diluted in only 100 ml caused the precipitation. Despite numerous occlusions requiring flushing and re-access of the IV port, none of the nurses reported this to the pharmacists or oncologists. Patient outcome remained unclear at the time of reporting. - Custom chemo is common in pediatrics, wont have standard plan most of the time, no stop system, no clinical decision support

drug supply

Impact pharmacy operations Shortages impact every step of the medication-use process · Electronic health record (EHR), automation, smart pumps - all designed for using the same product all the time Reprogramming of computer applications for basic preparations such as lack of NaCl, lack of certain product strength, formulations, etc. · Leads to confusion and excess pharmacy workload, all of which goes unmeasured; increased error risk w IV meds as the number of complex manipulations increases

computerized automated surveillence of ADEs

Kilbridge et al conducted a study to compare the incidence and types of ADEs in a university medical center vs. a community hospital by employing a computerized surveillance system as well as voluntary reporting Events identified by the computer were subsequently reviewed by pharmacists and judged for causality/severity over an 8 month period A single centralized laboratory served both hospitals, and some of the information systems components were common to both institutions, including the laboratory system and the common clinical data repository that would receive real time data; the 2 institutions were also connected by a computerized network

Slip

Look alike sound alike medication error during a busy shift in a pharmacy w multiple distractions

presenting information

More recent recommendations summarize critical information to include in patient decision aids (Trevena, 2013). The authors note that presenting risk information with numeric estimates significantly improves risk comprehension vs. presenting such risk estimates with word descriptors. The authors also note that communicating uncertainly (i.e. confidence intervals) doesn't improve risk perceptions, but can increase patient worry and avoidance of decision-making.

error defintion

NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) error definition ~ "preventable event that can lead to inappropriate medication use or harm while the medication is in the control of the health care professional, patient, or consumer." The problem with focusing on errors - very few (~1%) result in actual adverse drug events (ADEs); most errors do not result in patient injury Available technology is better at capturing and cataloging errors vs. actual events (ADEs) o Systems are set up for ordering, distribution and billing, but not for monitoring outcomes

Dana-Farber chemotherapy

November 1994 - 39 y.o. Boston Globe health reporter Betsy Lehman died of complications from an overdose of cyclophosphamide; subsequently it was discovered that a second patient, 52 y.o. Maureen Bateman, also had received the same overdose and suffered serious heart damage Intended order - cyclophosphamide 4 gm/m2 over 4 days Received order - cyclophosphamide 4 gm/m2 daily over 4 days · Orders were written by a fellow, countersigned by other physicians, filled by pharmacy and administered by nursing A data manager reviewing the patients records for the study they were enrolled on noticed the error 3 months after the incidents Staff were informed 3 days later and internal reviews were conducted; not reported to the Mass. Dept of Public Health until 1 month later, the day after a special report on the incident in the Globe · David Livingston, the physician-in-chief, resigned his position following the accidents · In May, Steven Steckel, the pharmacy director, resigned · At a research institution such as this, high-dose chemotherapy is common and cognitive lock may prevent detection · Eventually led to a cultural change at Dana-Farber Rather than creating a patient safety office, safety became the responsibility of senior clinical leaders throughout the organization Developed and refined error reporting through pharmacy interventions, incident reports, etc. and began to conduct root-cause analysis of critical incidents Focused upon system design and information technology to prevent errors through forcing functions Developed partnerships with other organizations - Mass. Coalition for the Prevention of Medication Errors o In 2012, the Betsy Lehman Center for Patient Safety was established Aftermath: Mass. Board of Registration in Nursing began disciplinary proceedings in 1999 against 18 nurses involved in the incident; 2 other nurses agreed to have their licenses placed on probation for 1 year Dana Farber's president David Nathan strongly defended the nurses, noting they had already been exonerated by 3 other groups - Mass. Dept. of Public Health, JCAHO and DanaFarber and that the error was d/t misreading an ambiguous protocol and that the institution has taken responsibility Board of Nursing executive director, Theresa Bonanno - stated that the professional standard of care extended beyond the hospital's guidelines · System problem

Use of barcode eMAR

Poon et al, 2010 - demonstrated reduction in error rates in order transcription and medication administration, and also reduction in potential ADEs (3.1% >>> 1.6%); authors attributed this to elimination of hand-written misinterpretations and to decision support *Closed loop administration technique*

Examination of RPh working conditions in retail

Prescription drug time guarantees are common (ISMP newsletter v17, #8, 9/6/12) per a community pharmacy survey (673/10,248 responded) - 62% indicated that their pharmacies have policies/procedures re: fill times - 27% advertise a time guarantee; 49% of these don't allow pharmacists to exceed the time guarantee (most often cited was 15min to fill 1-3 scripts) - 49% indicated they were penalized for not meeting the time guarantee - reasons for not meeting the guarantee: adjudication, inadequate resources, clarification and patient services/education. - 23% indicated that bonuses were offered for meeting guarantees - 39% indicated they were challenged by the workload d/t time guarantees and did not have management support if times were not met - 83% indicated that time guarantees contributed to dispensing errors - of pharmacists involved in dispensing errors related to time guarantees, 37% did not report the error - ISMP noted that pharmacists "are sometimes given incentives for meeting time goals, but more often they are punished for not meeting them." However, reasons for not achieving time goals are for accuracy confirmation, patient education, promoting adherence, etc., which are all crucial patient safety elements.

national quality forum

Public-private partnership of all portions of the healthcare system Formed to develop a common approach to measuring healthcare quality and to develop system-wide quality improvements Has established 34 safe healthcare practices that should be universally applied to reduce harm Most successful safety practices to date have been clinical (AHRQ, 2001) · e.g. thomboprophylaxis to prevent VTE, infection prevention, glycemic control, etc.

Fear/emotions

Studies show that fear-driven advertising is more likely to influence those who are more informed, suggesting greater awareness makes emotional messages more meaningful (Gardner, 2008) By many industries to expand market share - there are not good opportunities to make money by reminding people that they are safer and have more longevity than ever before, but huge profits are possible through fear promotion

preventable event etiology

Systems vs. people (healthcare professionals) *mostly a systems problem* Competent people working in unsafe situations or some incompetence or both some incompetence and unsafe systems? Strategies now being developed to correct systems problems Glacial progress · Healthcare and informatics systems are very heterogenous · Resistance to change by personnel · Data for given strategies is slow to accumulate · Progress to date Research - much unfunded, some supported by AHRQ Most all is hospital specific

Computer looks for ADEs

The surveillance system queried patient data daily from each institution using a set of 69 rules to identify possible ADEs e.g. orders for naloxone, toxic drug concentrations, heparin and thrombocytopenia The voluntary reporting system allows health care personnel at both institutions to report incidents such as medication errors and ADEs anonymously (if they wished); these reports that were medication related were also reviewed by the pharmacists - The overall rates of ADEs were 4.4/100 admissions at the university hospital and 6.2/100 admissions at the community hospital Types of events that were more common in the community hospital setting were antibiotic-associated colitis, hypoglycemia that was drug induced and ADEs related to anticoagulation The computerized surveillance method detected ADEs at a 3.6 X greater rate than that of voluntary reporting for the university hospital and at a 12.3 X greater rate for the community hospital

Budnitz 2006

These are older drugs - noted that 16 of the above 18 drugs had been in use 20 years large proportion of ADEs d/t older agents being used suboptimally - note that this data may be an underestimate and does not capture mortality data; also not categorized in terms of preventability, causality or # of medications - authors point out that other unintentional injuries considered unavoidable have been significantly mitigated in rate and severity using preventative strategies - e.g. airbags, child-resistant containers since the above outpatient ADE problem may be d/t a variety of factors (e.g. dispensing and prescribing problems, as well as patient education and follow-up), it will require a more comprehensive mitigation strategy resulting in substantial changes to the outpatient care model

VA healthcare system

Transformed under Ken Kizer Implemented bar coding, electronic medical records and computerized physician order entry (CPOE) · Now an example of cultural change

Herding and culture

What others think often matters to us deeply given our need to be social There is human tendency to conform with group norms · We have more comfort with those who share the same thoughts/values is typically confined to social networks - e.g. silicone implant panic occurred in U.S. and Canada, but not in Europe

Jacobs

al implemented a CPOE system with decision support over an 8-month period within a children's hospital Physicians, nurses, and respiratory therapists were involved in the CPOE system design prior to implementation Developed pediatric-specific information (e.g. critical care order sets, medication dose-range checking) Analyzed for work-flow incompatibility in order to correct problems prior to implementation Optimized the # of workstations prior to implementation System was implemented in a step-wise fashion - critical care unit was not attempted until successful implementation on a medical unit Noted that in this study, CPOE was associated with a decrease in mortality - Pediatric dosing system decreased ADEs, if done appropriately it will work well A subsequent study of CPOE upon ADEs among 1197 pediatric inpatients also demonstrated a significant decrease in preventable ADEs (46>>26) and potential ADEs (94 >> 35) post-CPOE. Holdsworth, et al. 2007

Unit dose studies

all conducted by the pharmacy profession, one day supply to patient in hospital was a huge finding · employ single unit packaged medications in individual patient drawers delivered to nursing units 1 or more times per day University of Arkansas Medical Center -Conducted studies of an experimental unit dose system, whereby a card system was used to dispense regularly scheduled pre-packaged unit doses for delivery approximately every 2 hours -Observers recorded nursing errors during a 6-month control period and a 2-month study period. · in the end, the hospital accepted the new system but *failed to fund it* - "Thus the operation was a success, but the patient died". University of Kentucky: Began operating a hospital-wide unit dose system in the 1960s Delivered individual patient drawers 4 X per day Compared to tradition medication systems (i.e. individual prescription order or floor-stock systems) of 4 local university or community hospitals to determine differences re: errors reaching the patients Error types: Commission - any dose incorrectly administered to a patient (e.g. unordered drug, wrong strength or form) Omission - any dose incorrectly not administered to a patient Error auditing performed by direct observation (mainly with pharmacy students) of nursing medication distribution · Took ~12 years to implement unit doses

ADE definition

an adverse drug event is an injury resulting from medication intervention related to a drug (preventable or ADRs) Focus should be towards preventable ADEs and not ADRs

Potential ADE

an error that has the potential to result in at least significant injury; note, all Potential ADEs are preventable Near misses, caught before patient is injured

sentinel event

an unexpected occurrence involving death or serious injury

ADR

an unexpected, unintended or excessive response to a medication that occurs at doses used in therapy or prophylaxis Excludes therapeutic failures, poisoning, drug abuse and events that are preventable Not due to errors can occur by chance ADRs don't encompass medication errors, ADRs are a subset of ADEs

Presenting data as RR

can be misleading RR is often used to argue for the effectiveness of drugs (Skolbekken 1998) RR risk of 2.0 for blood clots reported for Ortho Evra patch by FDA in 2006; women who were on the patch had twice the risk of blood clots than those who used OCs twice the risk sounds like a lot, but what is the baseline risk? Adverse treatment effects provided in relative terms are viewed more negatively than when presented in absolute terms (McGettigan, 1999) Presentation as absolute risk (probability) gives much more info · 6/10,000 was the absolute blood clot risk for the Evra patch Vs. 3/10,000 King's Fund 2003 study of deaths per news story 8571 deaths per story on smoking 0.33 deaths per story on vCJD (mad cow disease - note name change from BSE)

factors that increase risk of ADEs

consider when doing a root cause analysis workload interruptions, time pressures and fatigue >>> burnout communication deficits - with patients, with other providers lack of process development and inadequate technology not following standard processes on a bad day d/t lack of personnel lack of understanding of risks lack of learning from past risks by healthcare systems, d/t healthcare cultural deficits lack of patient education about risks patient factors - # of medications, age, organ function, multiple diseases drug supply

factors related to prescribing errors

decline in renal or hepatic function - 13.9% history of allergy to the same medication class - 12.1% · e.g. oxacillin for a patient with a penicillin allergy wrong name, form or abbreviation - 11.4% · e.g. dicloxacillin 100 mg instead of doxycycline 100 mg dose calculation errors - 11.1% · e.g. ampicillin 300 mg/kg Q6h instead of 300 mg/kg/d in 4 doses atypical and critical dosage frequency considerations - 10.8% · e.g. methotrexate daily instead of weekly

DTC

direct to consumer advertising - implores a "pill for every ill"; according to the CDC, ~46% in the U.S. take at least 1 prescription medication and ~37% of those over 60 y. use > 5 medications Growth in Rx use especially in older patients ~ 60% increase in the number of prescriptions in the 10 years between 1992- 2003 especially for chronic diseases, where drugs are replacing other interventions elderly projected at ~20% by 2030 drug therapy now the 3rd most costly healthcare expenditure more healthcare access results in more prescription drug use - 53% vs. 20% without access in 2007-8; CDC

Lapse

dispensing a pediatric powder for suspension w/o actually mixing it w H2O

typical error cycle

exploration usually ends (erroneously) at proximal cause = human error, most events are due to complex system failure, but it is easier to blame a person and not the system

Narrative effect

if the story can become part of a larger ongoing narrative, it will be strengthened by the larger story line and is likely to be covered e.g. 1995 Ebola outbreak in Congo killed 255 and received extensive media coverage; the Hot Zone by Richard Preston was published in 1994 (fictious novel) e.g. 1998 Congo coup/civil war that resulted in ~ 3 million deaths over several years received almost no media coverage; the war fit no existing narrative and was irrelevant to wealthy nations terrorism by Islamic radicals is a current strong narrative while terrorism by Caucasian, paranoid, anti-government radicals (e.g. Timothy McVeigh) is not; domestic terrorism doesn't appear to have a narrative at present

Medication safety

inadequate standardization many terms - ADE, medication misadventure, etc. makes comparisons among studies sometimes difficult focus of studies -some highlight fairly minor, inconsequential or inconceivable errors as drivers of decisions (e.g. a system being able to deliver PO and PR acetaminophen at the same time, a 1000 fold overdose of ceftriaxone; almost impossible to do, large IV bag would be noticed would take all day to infuse) *but fail to consider errors that are the result of omission (e.g. venous thromboembolism)*

Misadventure

includes events that are always unexpected but may be too broad (i.e. includes idiosyncratic reactions and ADRs)

advanced therapeutics

inevitably leads to increased risk; not only due to new agents but increased regimen complexity chances for use of multiple agents and mix-ups increases chances for multiple prescribers and pharmacies (lack of communication)

ISMP

institute for safe medical practices Monthly newsletter has some good information on contemporary medication errors and events

Risk

magnitude x probability (Barnbaum D., 2002). - note that this simple equation doesn't consider Benefit, which can often make purposeful Risk worthwhile

Phillips 2001

medication error cases from hospitals and ambulatory care settings and private homes that were received by the FDA Adverse Event Reporting System (ADERS) between 1993-98. Each report classified using predefined criteria/taxonomy Data included 5366 error reports 68.2% led to serious patient outcomes 9.8% (469) were fatal · 37% in patients > 60 years · estimated years of life lost (Raisch, et al 2004): 70-79y > 71 deaths x 5 yr = 355 life yr lost 60-69 > 47 deaths x 15 yr = 705 life yr lost 0-9 > 49 deaths x 75 yr = 3675 life yr lost (more lifes to live) most common errors resulting in mortality · wrong dose (40.9%) · wrong drug (16%) · wrong route (9.5%) most common causes- study tried to understand causality · performance/knowledge deficits (44%) · communication errors (15.8%) Riskier drugs are associated with more cases

Med Safety as a public policy problem

much written on medication safety in recent years; limited work has been publicized in the lay press despite the increased risk of more powerful and complex pharmacotherapy within a compromised delivery system; there are few well conducted studies that document the extent of the problem public isn't as aware especially across multiple domains. Most studies to date in the inpatient domain - most drug use occurs elsewhere; as the last line of defense and the most likely health professional to regularly interact with patients regarding their medication use, pharmacists may be in the best position to mitigate drug misadventures yet are infrequently involved or recognized d/t lack of rewards, employer focus or acknowledgement. Occurs outpatient, but no studies

error types

non-intentional or involuntary actions intentional but mistaken actions

limitations of technology

o Pharmacist-physician communications via a CPOE system supporting interprofessional communication (Pontefract et al, 2016) o Pharmacist messages received sign-off < 50% of the time within 48h, which was lower than the investigators expected § Suggested that uni-directional communication via a CPOE system may not be optimal § Suggested that an established pharmacist-physician collaborative working relationship was important to impact prioritization and response to messages Need collaborative relationships

Magnesium overdose

o pharmacist supervisor called to assist the IV room pharmacist with the preparation of 2 high-dose chemotherapy infusions o protocol included high dose cisplatin and etoposide § cisplatin infusion included both magnesium 5 gm/L and mannitol 50 gm/l · patients mistakenly received 55 gm/l of magnesium instead (magnesium vials were located alongside mannitol on the shelve, and were retrieved in haste) · both patients coded within an hour of receiving the infusions; 1 died immediately, the other sometime later · error discovered after patient labs during the code came back with extremely high magnesium levels

Confirmation bias

once we form an opinion, we embrace info that supports this view and reject info that does not; brains seek to confirm beliefs that are established · algorithms employed in internet searches and social media can significantly contribute to this type of bias · no increased risked by stories lead to panic, once we form an opinion we use information that supports that view

Medication error and ADE contributors

overdoses - 61%, underdoses - 39% 90 (45%) rated as potentially serious or severe 19.5% among pediatric patients contributing factors: -dosing calculation use -multiple zeros -dose < 1 -documentation decimal -wide dosage range · levothyroxine involved in 19% -injectables and oral liquids *for low therapeutic drugs, severe events occur more often*

Pharmacist in ICU settings

pharmacists on care team in ICU and controlled rounds Leape et al also examined pharmacist impact in an ICU setting - focus was on # of ADEs o point out that the typical pharmacist role in the healthcare system is reactive rather than preemptive and that the specialized knowledge of a pharmacist is not utilized at the time of ordering when it may be most useful - study carried out in 2 ICUs at a large tertiary care hospital over 6-month control period followed by a 12-month study period o study unit - 17-bed medical ICU o control unit - 15-bed coronary care unit § average daily census and nurse and physician staff ratios were similar in the 2 units o compared outcomes in the study unit pre- and post-intervention, as well as between the study unit and the control unit post-intervention § randomly selected 75 patients from each of the 3 groups as well as 50 patients from the control unit during the pre-intervention phase o intervention: providing an experienced senior pharmacist to attend rounds in the ICU with the care team; pharmacist was also present for consultation/assistance during the remainder of the morning § control ICU: a pharmacist was available on the unit for some of the day but did not make rounds measured the # and type of pharmacist interventions and the % acceptance rate via a pharmacist report form *Pharmacist are correcting orders or providing drug information*

Impact of pharmacist counseling after hospitalization

prospective study, usual care vs. experimental model - Schnipper performed a study of drug related problems during and following hospitalization and to determine the impact of patient counseling and pharmacist follow-up upon ADEs o Authors point out that ~ 12-17% of internal medicine patients experience an ADE following hospital discharge, with ~ 50% of these being preventable o Study of 178 patients discharged from the general medicine service § Patients consenting to participation were randomized to usual care (review of medications by a ward-based pharmacist and discharge counseling by a nurse) or discharge counseling (with review of preadmission regimen and resolution of discrepancies) and follow-up by a pharmacist o Patients in the study group received an intervention consisting of pharmacist counseling at discharge and a follow-up phone call 3-5 days post-discharge § The follow-up consisted of a review of medications, further regimen clarification, side effects, monitoring for adherence and physician feedback o Intervention group - medication non-adherence was found to be 23% as well as difficulty obtaining refills (18%) or difficulty obtaining meds d/t costs (11%) § Pharmacists recommended 80 changes in 55 patients at discharge § Issues identified and reviewed o 30 days post-discharge, preventable ADEs were found in 11% of the control group and 1% of the intervention group § identified via contact and questioning of all patients by a research assistant 30 days after discharge § blinded collection o surveys of patient satisfaction re: instructions for discharge medications, showed high rates of satisfaction in both groups - Intervention group - 97% vs. Usual care - 92% § patient is usually happy if treated well, even if not receiving a lot of care, no great for outcome studies o preventable ADEs were d/t several factors, including discrepancies, inappropriate prescribing, lack of access/non-adherence or inadequate monitoring o the high rate of discrepancies 30 days after discharge suggested to the authors that other providers had introduced new discrepancies (outpatient- lack of team based care) o the Joint Commission now mandates medication reconciliation at admission and discharge, but institutions are struggling with implementation (med reconcillation) § Relying upon patient history to construct an admission medication list is likely problematic § Medications often change at discharge d/t formulary restrictions § Should it be the routine job of pharmacy to not only reconcile medications and counsel, but to conduct follow-up? (where he wants to see us go)

Mitigation deficiencies

public policy to date has been effective in assuring appropriate labeling and bottling, safety of chemical entities and requiring prescription for most dangerous agents public policy not yet effective in addressing complexity of use - i.e. management, patient education, application and distribution not addressed or acknowledged by the for profit, fee for service, corporate-controlled healthcare system - payment based upon # of patients seen, prescriptions filled, etc. rather than quality & safety recent quote by a noted author and healthcare practitioner: · "I am more appalled now than in 1973 by our national politics, by the way house staff are forced to spend much of their time at computers, by the fact that patients have no idea that electronic health records are designed to optimize billing and insurance payments rather than their care, and by the way non-physician executives at the top of hospital systems, having never been trained in patient care, dictate the terms of the profession. Bergman, S. JAMA, July 10, 2019.

bounded rationality

rationality is limited when humans make decisions; by the tractability of the decision problem, cognitive limitations and time. A set of boundaries or constraints that tend to complicate the rational decision-making process

2 systems of thought

reason (head) - works slow and makes decisions that are easy to explain feeling (gut) - fast and the source of quick judgments based upon intuition and emotions; often difficult to explain works by recalling examples - if these can be recalled easily, then it must be common (availability heuristic) often reaches irrational conclusions · will judge risk as higher if it is described as 1 in 100 rather than 1% works well in a nomadic hunter/gatherer society, but is less useful today, especially with fear mongering produces judgments that are adjusted by head (when we think hard) often gut takes over because it is a quick way to make judgement (often irrational)

Communicating risk

recommendation is for health professionals to communicate information on risk that is clear and evidence-based and to acknowledge areas of uncertainty (Hackett, 2008)

emotion

risk may be understood by humans based more upon emotions rather than evidence much of the information that people are presented with may not even be the key factor in the decision making process re: risk interpretation. (Grimes, 1999) risk is "socially constructed", such that it becomes a risk when judged to be a risk; communities help to reinforce (or not) beliefs, understanding and concerns (Hackett, 2008) · e.g. parents refusing MMR vaccination for their children d/t view that risk of autism is > risk of measles; also linked to mistrust of the government

2 theories of complex systems

some types of technology are inherently open to fail, and adding more safety features only raises the layers of complexity - subject to chains of failure and resists understanding by operators; suggested only to run marginal technologies alternative is that people can handle highly complex technologies if the organization is adequately developed with high reliability; employees all are adequately trained and empowered. Key elements: safety is a priority from top to bottom, redundancy so the inevitable errors are caught in time, a structure allowing key decision making at all levels, workers who maintain skills by practicing for these events, and a focus on learning lessons from trial and error. Contemporary Examples - air traffic controllers, nuclear power plants and submarines, DuPont.

rule of typical things

something "typical" triggers intuition, and these tend to be followed even when not logical § e.g. students asked to estimate probability of (1) massive flood somewhere in U.S. where > 1000 people die; or (2) an earthquake in CA causing a flood where > 1000 people die · Scenario 2 was rated as 1/3 more likely than scenario 1, despite the fact that it is by logic less likely then the 1st scenario

inpatient pediatric (Holdsworth)

studied ADEs among pediatric inpatients at one hospital over a 9-month period (NY hospital; kids recovering from cardiac surgery given less than needed and left in pain - Studied 1197 consecutive admissions to the PICU and the General Pediatric unit (The neonatal care unit was not studied) - Only medication orders that reached the medication administration record (MAR) were analyzed - Identified 76 ADEs and 94 potential ADEs - A common ADE was underdosing of opioid analgesics following major surgery - Determined that medication exposure was the only factor predictive of adverse events in multivariate analysis - Determined that patients with both ADEs and potential ADEs were less likely to be routinely discharged, such that patient disposition was not related to the adverse event itself. Are ADEs a consequence rather than a cause of more severe illness? CMI is disease severity, >8 medications patient is at greater risk for ADE

Example rule

the easier it is to recall examples of something, the more likely that "something" is. "Experience keeps a dear school, but fools will learn in no other", Benjamin Franklin, mid 18th century(can attribute to particular issue) e.g. current fear of opioids is leading to restrictions and underuse for patients with significant pain, but other agents with major mortality risks (insulin, anticoagulants) are not even being acknowledged in the media · no public discussion about these other drugs being dangerous e.g. despite expert warnings about pandemics, preparation, etc., many people didn't understand how a pandemic can have a marked impact across societies and impact multiple domains · lack of preparation For the Example rule, negative (dreadful) images are remembered more than positive (ordinary) images · Negative things are remembered more If one can imagine the situation happening to them, they typically rate the risk higher Risk perception research - shows that we overestimate being killed by catastrophic events featured on the evening news AND underestimate dying from events that are much more likely but kill only 1 person at a time - chronic diseases such as diabetes and heart disease, ADEs, etc. · e.g. most lay people think that accidents and disease kill equal #s, yet disease kills 17x more people · Risk is also a common feature in many fictional dramas that likely influence our risk perception

Transportation vs healthcare

transportation accidents are studied and regulated in much more detail -NTSB has investigated transportation accidents for over 33 years and has issued thousands of recommendations (National entity that investigates incidents( -Although NTSB is an independent agency w/o regulatory authority, 82% of the recommendations have been followed. -NTSB also publishes an annual review of accident data, an annual report to Congress and press releases -NTSB also maintains an aviation accident database -The NTSB also conducts safety studies to determine the impact of government regulations -The NTSB *devotes enormous resources* to the above, although the number of deaths is small and decreasing · Overall risk is decreased For medication errors or ADEs, there is no federal or independent entity with a functionality similar to the NTSB *We don't have a national entity*

Inpatient population

underreporting is a main theme - most literature to date stems from studies of inpatients, mainly adults - few studies include hard outcome data (e.g. patient outcome or disposition) or detailed information on causality - underreporting is common for a variety of reasons; the Betsy Lehman center recently reported that Massachusetts mandates that hospitals and surgery centers report medication errors resulting in serious injury and death. In 2017, facilities in the state reported 52 such errors; yet a recent study by this group found a greater number of such errors among a group of patients following 277 surgeries at just 1 hospital. - how rates of ADEs and potential ADEs change over time, and what are the most common drugs and process deficits involved in causality are not routinely reported or analyzed

cost estimates

weak data - business case has not yet been met Reimbursement models don't yet reward for safety improvements Without continuous monitoring for preventable events, most such events are not acknowledged or investigated Studies that have attempted to measure costs demonstrate that such events are quite costly (e.g. Mass. 2019 Betsy Lehman Center report - in 2017, 62,000 medical errors resulting in $617 million in excess insurance claims). However, in the current system, providers/institutions are often paid not only for healthcare services that result in preventable events but also for the additional services to address the complications/sequela of such events. Healthcare markets are using choice restriction to mitigate costs, such that leveraging safety performance to acquire greater market share is unlikely NCC MERP cautions against using error rates to compare healthcare organizations

Societal recognition

what does society deem most dangerous? - chainsaws, motorcycles, guns, global warming, tsunamis, terrorists, ebola, zika, Covid or... prescription drugs & the healthcare system?

Perception of risk

what we perceive in terms of risk perception is not necessarily reality e.g. if terrorists were hijacking and crashing a passenger jet per week in the U.S., a person flying once per month would have a 1 in 135,000 chance of dying in a hijacking; compare this to the annual risk of dying in a car crash - 1 in 6000. Gardner, 2008 single car crashes are not typically covered on major news outlets perception of risk may be based upon fear more than statistics - Inman "..the only thing we have to fear is fear itself...unreasoning, unjustified terror which paralyzes needed efforts to convert retreat into advance"; president Roosevelt first presidential address. Fear is on the rise in modern countries and is becoming a cultural norm, mainly d/t technology (*fear sells*) o Misjudging risk can have significant consequences - e.g. resource misallocation - terrorism instead of chronic disease or preventable ADEs. - factors that effect risk perception: Aronson, 2006. Acute events are labeled as risky but the opposite is true

Medmarx usp data report

wrong drug errors represent ~ 8% of medication errors in outpatient pharmacy, and occur in ~ 0.13% of all dispensed prescriptions. A wrong drug error rate of 0.13% for 3.7 billion prescriptions (2006 U.S. number of outpatient prescriptions) would translate to 4.8 million wrong drug errors. 2008 MEDMARX data report, USP.`

Systems to report ADEs

· beginning to emerge across the U.S. FDA MedWatch USP MEDMARX NCC MERP Patient Safety Reporting System-VA Individual systems with different definitions and databases may not allow for a broad interpretation and across the board solutions *we need a central system* May not represent an adequate sample of major events (or the most important) A central system that collects and analyzes reports across all healthcare domains is needed · Spontaneous reporting systems typically collect a minority of actual events (MedWatch, minority of reports) · No U.S. government entity is responsible for collecting and analyzing ADE or error data re: patient safety Other dangerous industries have such government support - NTSB, NRC, CPSA *no government entities for ADEs* Patient Safety and Quality Improvement Act of 2005 - empowered DHHS (via AHRQ) to develop a national reporting system; information reported would be protected from legal discovery. · Process required organizations to "voluntarily" submit their data to a Patient Safety Organization (PSO). PSOs may provide general information on trends rather than specific events, and are generally not transparent outside of the organization. · Only voluntarily reporting

Group polarization

· groups of like-minded individuals usually come to conclusions that are more extreme than the average individual view within the group · If the group distrusts authority, then anti-government movements can result (ideal for radicalizing opinion) from information sharing alone via blogs, chat rooms, etc. o e.g. anti-vaccination movements in U.S. and England