Institute for Safe Medication Practices High-alert Medications: Understanding System Base Causes and Practical Error Reduction Strategies Hedy Cohen, RN, BSN, MS Institute for Safe Medication Practices www.ismp.org hcohen@ismp.org © 2006 Institute for Safe Medication Practices

Are medication errors really that bad…? © 2006 Institute for Safe Medication Practices

The Institute of Medicine (IOM) 44,000 to 98,000 deaths per year from medical errors - more than from breast cancer or AIDS 7,000 to 16,000 deaths per year from medication errors - 1 out of 131 outpatient and - 1 out of 854 inpatient deaths To Err is Human: Building a Safer Health System, 1999 IOM report released late in December of that year, before senate and hose recess began, slow day on the hill and in the news….. $2 billion/yr in hospital costs from preventable adverse drug events (ADE’s) © 2006 Institute for Safe Medication Practices

Agency for Healthcare Research and Quality (AHRQ) 5 per 10,000 doses administered cause serious harm translates into 50 serious ADEs per month 5.3% of orders written contain a medication error Only 1.5% of ADEs in hospitals are ever reported AHRQ: www.ahrq.gov/qual/aderial/aderia.htm “Research in Action: Reducing and Preventing Adverse Drug Events to Decrease Hospital Costs”

TJC National Patient Safety Goal Improve the safety of using high-alert medications a. Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, sodium chloride >0.9%) from patient care units b. Standardize and limit the number of drug concentrations available in the organization

Verbal Order for 18 Month Old “Get this kid morphine .8”

© 2006 Institute for Safe Medication Practices

Why do Medication Errors Occur?

Human Factors The study of the interrelationships between humans, the tools they use and the environment in which they live and work Success comes with improving the human-system interface How have we gained knowldege about human error? Through the study of human factors…the study of human factors The study of human factors generally deals with the interactions between people and systems, machines, and other people….. Human factors is definded as the study of the interrelationships between human, the tools they use, and the environment in which they live and work. Much of the work in human factors is on improving the humns-system interface by designeing better systems and processes…this is where the bulk of our course will take us. People with machines: human error often cited as the cause of medical mishaps, what is less frequently acknowledged is the notion that poorly designed human-machine interface can facilitate human error has design of machines taken into account human capabilities, limitations, and characteristics? Humna receiving input from a cahine, processin that input, and crating an outpautt that goest ot he machine….sensation and perception play a role Inefficient, frustrating, error prone, takes too long to use or train, does not fit into the work flow or work area, use of the wrong tool, avoid using the tool, not using all the tools capabilities, Human factors engineering…. To understand human factors and these interrelationships between people and…we need to undertand human congintion. © 2006 Institute for Safe Medication Practices

PARIS IN THE THE SPRING

Individuals Limitation of human performance limited short-term memory time constraints normalization of deviance limited ability to multi-task interruptions stress heuristics fatigue and psychological factors environmental factors

Medication System Key Elements Drug Device Acquisition, Use, and Monitoring Environmental Factors, Staffing Patterns and Work Flow Staff Competency and Education Patient Education Quality Processes and Risk Management Patient Information Drug Information Communication of Information Drug Labeling, Packaging, and Nomenclature Drug Storage, Stock, Standardization, and Distribution

No maximum dose warnings Diagnosis or allergy not communicated Ambiguous drug order Inadequate patient education Patient Information System Communication System Drug Info System Other systems The latent failure model of complex system failure modified from James Reason, 1991 © 2006 Institute for Safe Medication Practices

High-alert Medications Small number of medications that have a high risk of causing injury if misused Errors may or may not be more common with these than with other medications, but the consequences of errors may be devastating

High-alert Medications Adrenergic agonists Adrenergic antagonists IV Anesthetics agents Antiarhythmics IV Antithrombotic agents Carioplegic solutions Chemotherapeutic agents Dextrose, hypertonic Dialysis solutions Epidural or intrathecal drugs Hypoglycemics, oral Inotropic drugs Liposomals Moderate sedation agents IV, oral for children Narcotics/opiates Neuromuscular blocking agents IV heparin and oral warfarin, thrombolytics Radiocontrast agents, IV Total parenteral solutions. © 2006 Institute for Safe Medication Practices

Specific High-alert Medications Nitropruside injection Potassium chloride concentrate IV Potassium phosphates injection concentrate Promethazine, IV Sodium chloride for injection concentrate Sterile water for injection, inhalation and irrigation Colchicine injection Epoprostenol (Flolan) IV Insulin Magnesium sulfate injection Methotrexate tablets Oxytocin IV © 2006 Institute for Safe Medication Practices

High-alert Medications Collective thinking from: Reports submitted to USP-ISMP MERP Reports in the literature Input from practitioners Input from safety expertsISMP advisory board

High Risk Patient Populations Patients with renal/liver impairment Pregnant/breast feeding patients Neonates Elderly/chronically ill Patients on multiple medications Oncology patients

Primary Principles in Error Reduction Reduce or eliminate possibility of errors Make errors visible Minimize the consequence of errors © 2006 Institute for Safe Medication Practices

Rank Order of Error Reduction Strategies Forcing functions and constraints  Automation and computerization Standardization and protocols Checklists and double check systems Rules and policies Education / Information © 2006 Institute for Safe Medication Practices

Key Safeguarding Strategies Simplify - reduce steps and number of options Standardize options Externalize or centralize error prone processes Differentiate items (appearance, location) © 2006 Institute for Safe Medication Practices

Key Safeguarding Strategies Reminders Improved access to information Use of constraints that limit access or use Forcing functions Failsafe Use of defaults Failure analysis for new products and procedures © 2006 Institute for Safe Medication Practices

Simplify Decrease number of available sizes and concentrations a single heparin size/concentration is available reduce the number of vials available

Standardize Order Communication Create, disseminate and enforce ordering guidelines create a negative list for dangerous abbreviations eliminate trailing zeros; use leading zeros standard procedure for verbal orders standardized concentrations of critical care drug infusions, weight-based heparin protocol, etc

Standardize Order Communication Eliminate acronyms, coined names, apothecary system, use of non-standard symbols, etc. TPN (IV nutrition or Taxol, Platinol, Navelbine) Irrigate wound with TAB

Externalize or Centralize Centralize preparation of intravenous solutions prepare pediatric IV medications in pharmacy outsource Use commercially prepared premixed products premixed magnesium sulfate, heparin, etc.

finished files are the result of years of scientific study combined with the experience of many years © 2006 Institute for Safe Medication Practices

Finished Files are the result oF years oF scientiFic study combined with the experience oF many years © 2006 Institute for Safe Medication Practices

Differentiate Use tall man lettering DOBUTamine DOPamine

Differentiate Items by Senses Tactile cues tape on regular insulin vial for blind diabetics; octagonal shape of neuromuscular blocker container Use of color red color to “draw out” warnings; appearance of solutions, tablets, etc.; “color coding” Sense of smell useful in conjunction with check systems

Differentiate Similar Drugs Purchase one of the products from another source hydroxyzine from company B when company A’s hydroxyzine 50 mg/mL injection looks similar to their hydralazine 50 mg/mL injection Apply upper case lettering to dissimilar portions of the name Use other means to “make things look different” or call attention to important information stickers, labels, enhancement with pen or marker Dopamine vs. Dobutamine

© 2006 Institute for Safe Medication Practices

© 2006 Institute for Safe Medication Practices

Separate Problem Products Look-alike packaging store hydroxyzine 50 mg tablets and hydralazine 50 mg tablets far apart Look-alike drug names computer mnemonics designed so similar names do not appear on same screen i.e., carboplatin/cisplatin; vinblastine/vincristine not listed in order on preprinted chemotherapy form

Reminders Place auxiliary labels on containers for clinical warnings and error prevention messages check for pregnancy, lactation note about cross allergy between aspirin and ketorolac reminder on Norvasc container about Navane confusion maximum dose warning

Reminders Incorporate warnings into computer order processing and selection of medications from dispensing equipment Place labels on IV lines to prevent mix-ups between IV lines and enteral feeding lines Protocols, checklists, visual and audible alarms

Sum the digits below reading left to right: 1000+20+1000+30+1000+40+1000+10=?

Checklists and Double-checks Independent double-checks Develop checklists around the use of high alert drugs © 2006 Institute for Safe Medication Practices

Access to Information Use computerized drug information resources Information at point of care Computer order entry systems that merge patient and drug information, provide warnings, screen orders for safety, etc. Readily available texts in current publication Pharmacists presence in patient care areas Use of medical records librarian at CME and on rounds

Limit Drug Use Peer reviewed drug approval process Restricted therapy attending physician cosigns chemotherapy orders; consult to specialty required Staff credentialing Automatic reassessment of orders or rewrites Prescribe autostop to limit dose or duration Use medications with reduced dosing frequency Parameters to change IV to PO as appropriate

Establish Area Specific Guidelines for Unit Stock Medications Assess unit-specific needs and agree on requirements, accounting for known safety issues Standardize and purchase pharmaceuticals in unit dose or pre-mixed containers as much as possible Acquire or enhance safety in use of automated drug distribution systems Standardize emergency equipment and medication storage on each unit © 2006 Institute for Safe Medication Practices

Devices

Forcing Functions Makes errors immediately visible. Ensures that parts from different systems are not interchangeable; forces proper methods of use (lock and key design) oral syringe should not be able to fit onto an intravenous line example: preprinted order forms or computer options that “force” selection from limited number of medications, available dosages, etc.

Failsafe Use products that design error out of the system automatic fail-safe clamping mechanism on intravenous infusion pumps dangerous order can’t be processed in computer system (hard stops) smart pumps (hard stops)

Redundancies Independent checks probability that two individuals will make the same error is small; therefore, having one person check the work of another is essential calculations for pediatric patients, high alert medications, etc., performed independently by at least two individuals, with identical conclusions

Use of Defaults Pre-established parameters take effect unless action is taken to modify clinical pathways device defaults morphine concentration default for PCA pump Pharmacy IV compounder defaults to drug concentrations available in pharmacy

FMEA for New Products Formal safety review (e.g., formulary committee, risk management committee) of new medications and drug delivery devices examine for ambiguous or difficult to read labeling, error-prone packaging, sound-alike product names, etc. use failure analysis to determining safety of medications and devices and to guide error prevention methods in a proactive manner

Insanity is doing the same things the same way and expecting different results Albert Einstein © 2006 Institute for Safe Medication Practices