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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 [email protected] Order stated: “Cytoxan 4 g/m2 days 1-4” Administered as: 4 g/m2 EACH DAY for four days 2 Are medication errors really that bad…? 3 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 4 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” 5 TJC National Patient Safety Goal 3. 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 6 7 Verbal Order for 18 Month Old “Get this kid morphine .8” 8 9 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 11 PARIS IN THE THE SPRING 12 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 13 Medication System Key Elements • Patient Information • Drug Information • Communication of Information • Drug Labeling, Packaging, and Nomenclature • Drug Storage, Stock, Standardization, and Distribution 14 • Drug Device Acquisition, Use, and Monitoring • Environmental Factors, Staffing Patterns and Work Flow • Staff Competency and Education • Patient Education • Quality Processes and Risk Management Diagnosis or allergy not communicated Patient Information System Ambiguous drug order Communication System No maximum dose warnings Drug Info System Inadequate patient education Other systems The latent failure model of complex system failure modified from James Reason, 1991 15 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 16 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. Specific High-alert Medications • • • • • • • Colchicine injection • Epoprostenol (Flolan) IV Insulin Magnesium sulfate injection• Methotrexate tablets • Oxytocin IV • Nitropruside injection Potassium chloride concentrate IV Potassium phosphates injection concentrate Promethazine, IV Sodium chloride for injection concentrate • Sterile water for injection, inhalation and irrigation 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 19 High Risk Patient Populations • • • • • • 20 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 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 Key Safeguarding Strategies • Simplify - reduce steps and number of options • Standardize options • Externalize or centralize error prone processes • Differentiate items (appearance, location) 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 Simplify • Decrease number of available sizes and concentrations – a single heparin size/concentration is available – reduce the number of vials available 25 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 26 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 27 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. 28 finished files are the result of years of scientific study combined with the experience of many years 29 Finished Files are the result oF years oF scientiFic study combined with the experience oF many years 30 31 Differentiate • Use tall man lettering DOBUTamine DOPamine 32 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 33 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 34 35 36 37 38 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 39 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 40 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 41 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 43 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 44 Limit Drug Use • Peer reviewed drug approval process • Restricted therapy – attending physician cosigns chemotherapy orders; consult to specialty required • • • • • 45 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 46 47 Devices 48 49 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. 50 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) 51 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 52 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 53 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 54 Insanity is doing the same things the same way and expecting different results Albert Einstein