High-alert Medications:Understanding System Base Causes and Practical Error

Reduction Strategies

Hedy Cohen, RN, BSN, MSInstitute for Safe Medication Practices

www.ismp.orghcohen@ismp.org

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Order stated: “Cytoxan 4 g/m2 days 1-4”

Administered as: 4 g/m2 EACH DAY for four days

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Are medication errors really that bad…?

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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

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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”

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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

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Verbal Order for 18 Month Old

“Get this kid morphine .8”

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Why do Medication Errors Occur?

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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

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PARIS IN THE

THE SPRING

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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

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Medication System Key Elements

• Patient Information• Drug Information• Communication of

Information• Drug Labeling,

Packaging, and Nomenclature

• Drug Storage, Stock, Standardization, and Distribution

• Drug Device Acquisition, Use, and Monitoring

• Environmental Factors, Staffing Patterns and Work Flow

• Staff Competency and Education

• Patient Education• Quality Processes and

Risk Management

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The latent failure model of complex system failuremodified from James Reason, 1991

Diagnosis or allergy not communicated

Ambiguous drug order

No maximum dose warnings

Patient InformationSystem

CommunicationSystem

Drug InfoSystem

Other systems

Inadequatepatient

education

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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.

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

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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

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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

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

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Simplify

• Decrease number of available sizes and concentrations– a single heparin size/concentration is

available– reduce the number of vials available

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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

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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

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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.

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finished files are the result of years of scientific study combined with the experience of many years

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Finished Files are the result oF years oF

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many years

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Differentiate

• Use tall man letteringDOBUTamineDOPamine

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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

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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

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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

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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

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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=?

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Checklists and Double-checks

• Independent double-checks

• Develop checklists around the use of high alert drugs

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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

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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

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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

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Devices

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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.

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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)

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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

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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

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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