med safety nj ph a 10 10 11 final 3 (97-2003)

Medication Safety & Error Medication Safety & Error PreventionPrevention

Shaukat Patel MS R.Ph.

Clinical Pharmacist.

Shore Medical Center

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Learning ObjectivesLearning Objectives• Pharmacist and Pharmacy Technician

– Identify the most common types of medication errors & factors leading up to them

– List systems/programs currently in practice to prevent/minimize medication errors

– Define medication error versus adverse drug event (ADE)

– Explain resources/educational tools available to pharmacists on ADE & medication errors

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Seriousness of Medication ErrorsSeriousness of Medication Errors

– To Err Is Human: Building a Safer Health System

• Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals

– That's more deaths than from:» motor vehicle accidents» breast cancer» AIDS

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Seriousness of Medication ErrorsSeriousness of Medication Errors

• 2005 FDA study

– 1 death per day

– 1.3 million injuries per year

– Length of stay increased 12 days

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Medication ErrorMedication Error

• Definition– Any preventable event that MAY cause or lead to inappropriate

medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer

– May be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use

Definitions

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Medication Error:

Any error in the process of ordering, transcribing, dispensing, administering and monitoring a medication. A medication error may or may not result in an actual or potential adverse drug event.

DefinitionsAdverse Drug Event:

Any injury caused by the use (or nonuse) of a drug.

Potential Adverse Drug Event:

An error that had the potential to cause an adverse drug event, but did not, either by interception or ‘luck.’

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What Classifies as a Med Error?What Classifies as a Med Error?

• At any step in the medication process

• Omissions

• Commissions

• Documentation

• Even if there is no consequence

• Near Misses

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Guess the Med ErrorGuess the Med Error

1. Patient receives IV piggyback (same drug and dose) belonging to another patient

2. Patient receives 20 units of insulin instead of 10 units

3. Nurse notices patient allergic to medication ordered and notifies doctor to change order

4. Technician charts heart rate in blood sugar column- nurse corrects the entry

Definitions of Medication errors• Mistaken diagnoses and errors in

treatment are examples of errors of commission;

• Missed diagnoses, and needed treatments not given are errors of omission.

• A mistake that has not caused harm is a near miss.

Definitions of Medication errors• When harm is caused by a mistake, it is

termed a Preventable Adverse Event.

• Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example, a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are Adverse Drug Reactions.

Types of medication Error• Prescribing Error; Incorrect drug.

Illegible prescriptions or medication orders that lead to errors that reach the patient.

• Omission Error; The failure to administer an ordered dose to a patient before the next scheduled dose, if any. Also missed diagnoses, and needed treatments not given are errors of omission.

Types of medication Error

• Wrong time error; Administration of medication outside a predefined time interval from its scheduled administration time.

• Unauthorized drug error; Administration to the patient of medication not authorized by a legitimate prescriber for the patient.

Types of medication Error

• Improper dose error;

• Administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber.

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Types of medication Error

• Wrong route of administration:

• Vinca alkaloids must only be administered intravenously . Some times given intrathecaly and can be fatal.

Types of medication Error

• Wrong dosage-form error; Administration to the patient of a drug product in a different dosage form than ordered by the prescriber

• Wrong drug-preparation error; Drug product incorrectly formulated or manipulated before administration.

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Types of medication Error

Wrong administration-technique error; Inappropriate procedure or improper technique in the administration of a drug

Deteriorated drug error; Expired drugs Administration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised

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Types of medication Error• Monitoring error; Failure to review a

prescribed regimen for appropriateness and detection of problems, or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy

• Compliance error; Inappropriate patient behavior regarding adherence to a prescribed medication regimen

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Philips J et al. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm. 2001 Oct 1;58(19):1835-41

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Philips J et al. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm. 2001 Oct 1;58(19):1835-41

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What Causes Med Errors?What Causes Med Errors?

• Human vs. System factors• Lack of or poor communication• Making assumptions• Complicated or high-risk processes• Not following policies/procedures• Not updating policies/procedures• Environment

Common causes of medication errors

A. Human factors

B. Systems

C.Abbreviations

D.Oral orders

E. Look-alike and sound-alike drugs

F. Dosage calculation

G.At-risk population

H.At-risk drugs22

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Handwriting MisinterpretationHandwriting Misinterpretation

• Illegibility

• Drug name look-alike

• Blurring of drug name with other info

• Omissions of information

• Reports• Coumadin 5 mg dispensed for Cogentin 0.5 mg

Handwriting

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Communication ErrorsCommunication Errors

• Handwriting

• Transcription

• Decimals

• Look-alike/sound-alike

• Sig abbreviations

• Verbal orders

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Unclear HandwritingUnclear Handwriting

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Unclear HandwritingUnclear Handwriting

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Written Rx Best Practices - Written Rx Best Practices - AbbreviationsAbbreviations

• “Do Not Use” abbreviations list– QD/QOD/QID write out direction– Drug name write out drug name– UD write “as directed”– Eye/ear directions

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Written Rx Best Practices – Weights, Written Rx Best Practices – Weights, Volumes, MeasuresVolumes, Measures

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Written Rx Best Practices – Weights, Written Rx Best Practices – Weights, Volumes, MeasuresVolumes, Measures

• U write “unit”• IU write “international unit”• CC write mL or milliliter• µg write “mcg”• Apothecary units

– Grains/drams– ʒ, , etc℥

• Space between drug name and strength

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Written Rx Best Practices - DecimalsWritten Rx Best Practices - Decimals

• Avoid whenever possible– Use 500 mg for 0.5 g– Use 125 mcg for 0.125 mg

• Avoid “naked” decimals– Risperdal 0.5 mg instead of Risperdal .5 mg

• Avoid trailing zeros– Colchicine 1 mg instead of 1.0 mg

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Written Rx Best Practices - DecimalsWritten Rx Best Practices - Decimals

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What’s the Error?What’s the Error?

• Patient is on oral vancomycin. Doctor orders vancomycin IV. Patient is given IV vancomycin, but not oral vancomycin for 2 days– Need for communication– No room for assumption (you know what happens when you

assume)

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““Look-Alike” DrugsLook-Alike” Drugs

Amiodarone Amrinone

Amlodipine Amiloride

Hydroxyzine Hydralazine

Prednisone Prednisolone

Celexa Celebrex

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““Sound-alike” DrugsSound-alike” Drugs

Mellaril Elavil

Paxil Taxol

Prilosec Prozac

Cerebyx Celebrex

OxyContin Oxycodone

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Problems With Verbal OrdersProblems With Verbal Orders

• Verbal orders leave extra room for errors to occur• Communication issues

– Accents, dialects– Background noise/interruptions– Unfamiliar drug names/terms

• More steps = more risk of error

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Types of Verbal Order ErrorsTypes of Verbal Order Errors

• Wrong Drug• Clonidine misheard as Klonopin• Amiodarone misheard as amrinone

• Wrong Dose• Toradol 15 mg misheard as 50 mg

• Wrong Labs• Blood glucose misheard as 257 instead of 157 patient

received 6 units of insulin instead of 2

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Preventing Verbal Order ErrorsPreventing Verbal Order Errors

• Read back procedure

• Cincinnati Children’s Hospital reduced verbal order errors from 9% to ZERO by simply using read-back

Source: Vossmeyer MT. Improving patient safety using a verbal order read back process. Pediatric Academic Societies Annual Meeting; 2006 Apr 29; San Fransisco, CA.

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The Response to a Med ErrorThe Response to a Med Error

• Always notify the physician and take immediate corrective action for the patient

• Management must be involved

• Document, document, document

• Never try to hide an error

• Report the error

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The “Other” VictimThe “Other” Victim

• No one feels worse than the person who made the mistake

• Involve that person in the post-error process

• Make sure the person knows the process that failed and that the process needs attention, not the person

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The “Other” VictimThe “Other” Victim• ISMP Safety Alert July 14th, 2011

– Too many abandon the “second victims” of medical errors

• Just 7 months after making a mathematical error that led to an overdose of calcium chloride and the subsequent death of a critically ill infant, a veteran nurse took her own life

• The healthcare industry as a whole has not widely communicated or implemented effective support mechanisms to address the deeply personal, social, spiritual, and professional crisis often experienced by the “second victims” of fatal errors

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The “Other” VictimThe “Other” Victim

• ISMP Safety Alert July 14th, 2011

– The second victims of errors have the right to:

• Be treated with respect• Participate in the process of learning from the error • Be held accountable in a fair and just culture• Not to be abandoned by the healthcare organization, and to

be supported by their peers and organizational leaders.

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PreventionPrevention

• Simplicity• Standardization• Education and training• Automation• Multidisciplinary communication• Layers of security / double checks• Reporting

Reducing medication errors through technology

• Computerized Physician Order Entry (CPOE)

• Digital Assistants (PDAs)

• Internet

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Medical Administration Record

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CPOE can

• Reduce errors / adverse drug events 55-80%;

• Produce legible and complete orders;

• Flag laboratory results that affect prescribing;

• Inform ordering MDs of drug interactions, allergies, and duplication;

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Allergy Screen

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CPOE can

• Transmit orders to pharmacy when written;

• Minimize dosing errors; and

• Automatically calculate total doses

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Bar Code Point of Care

Health Care Technology

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BPOC Bedside Device

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Wireless Laptop computer with a touch screen and bar code scanner

Barcode Technology

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Nurse barcode scans name tag

Nurse barcode scans patient identification bracelet

Patient MAR appears on bedside laptop

Scheduled and prn meds are scanned

Warnings/alerts are issued when indicated

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Bar Coding/eMARBar Coding/eMAR• Report from Brigham and Women’s

Hospital– Reduced patient mix-up by 57%– Reduced wrong dose by 42%– Reduced risk of getting a drug

without an order by 61%– Cut transcription errors from 6% to

zero

Patient Scanning

• Durability

• Reliability

• Is the wrist band on the wrist?

• Addressing patient concerns

Medication Scanning

• Manufacturer bar codes

• Repackaging

• Adding barcodes to existing package

• Quality control

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ADE, ADR, & Medication ErrorsADE, ADR, & Medication Errors

Adverse Drug

Events

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Adverse Drug EventsAdverse Drug Events

• Impact

– 7000 deaths/year due to medication errors

– 2 out of every 100 admissions experience preventable ADE

– Average increased hospital cost of preventable ADE: $4,700 per admission or $2 billion nationwide

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Consequences of ADEsConsequences of ADEs

Anaphylaxis – penicillin

Deafness – gentimycin

Pseudo. colitis –clindamycin

Thrombocytopenia –heparin

GI upset –erythromycin

Urticaria – phenytoin

Death $$$$

Permanent disability $$$$

Threat to Life $$$

Hospitalization $$$

ER visit $$$

Inconvenience $

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ADR Trigger ReportADR Trigger Report

• Steroids

• Vitamin K

• Romazicon

• Naloxone

• Protamine

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Reporting ErrorsReporting Errors

• Institution should encourage non-punitive reporting in a database that’s easy to access and use

• Report ASAP– Details fresh– No editorializing– Option to remain anonymous

• Pharmacists are in an ideal situation to report

Pharmacist: “The backbone” ofPharmacist: “The backbone” ofReporting Errors Reporting Errors

..

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Reporting SystemReporting System

What makes for an effective reporting system?

• Easy to access and use– Web– Phone– Paper

• Ability to stay anonymous– Comfort

• Follow up• Ability to trend

– Find patterns– Reduce reoccurrence– Reduce risk

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Effective Approach (“New Look”)Effective Approach (“New Look”)

• Non-punitive environment

• Emphasis on multifactorial nature of error

• Assumption that errors will occur

• Emphasis on caregiver interaction

• Sharp end, blunt end• Emphasis on systems, not people

Reference: Cook et al. A tale of two stories. Contrasting views of patient safety

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Non-Punitive Approaches to Error Non-Punitive Approaches to Error ReductionReduction

• Reward practitioners for reporting

• Provide feedback about medication errors and system-based improvements

• Maintain confidentiality of individuals involved in an error

• Educate the community about error prevention efforts

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Human Error Human Error Human Limits• Human brain can store 7+/- 2 items at a time

• Miller GA. The magical number seven, plus or minus two: some limits on our capacity for processing information. 1956.

• Cowan N. The magical number 4 in short-term memory: a reconsideration of mental storage capacity. Behav Brain Sci 2001.

• Limited memory

• Limited ability to observe events

• Bad at estimating probabilities

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Computer Error Computer Error

Computer Limits

• Can only do things correctly with the correct input from a user

• Lack common sense

• Can only mimic an expert’s way of working

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Check the Profile!Check the Profile!

• Review of key patient information during script entering helps prevent mistakes– Name– Gender– Contact info– Date of Birth– Allergies/Previous idiosyncratic rxns– Conditions

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Multi-Point ChecksMulti-Point Checks

• Multipoint checks on a prescription help to ensure accuracy in Rx entering

• Read the label 3 times– When obtaining package– When using the package– When discarding or returning to stock

Don’t rely on shelf tags! Rely on what’s in your hands!

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Check the Route!Check the Route!

• Significant contribution to fatal errors

• Requires vigilance and clarity of communication to prevent

• Labeling

• Examples• Eye/ear preparations irritation

• Vinca alkaloids given intrathecally

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Preventing Drug Mix-UpsPreventing Drug Mix-Ups

• Find a way to differentiate items that look similar but may be confused– Purchase one product from a different source– “Tall Boy” lettering style

• hydOXYzine vs. hydALAzine• vinBLASTine vs. vinCRISTine

– Use other means to make drug products look different• Stickers, labels, etc

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Preventing Drug Mix-UpsPreventing Drug Mix-Ups

• Separate problem products

– Store look-alike drugs separately whenever possible

– Use red shelf separators to distance the products

– Cisplatin/carboplatin and vincristine/vinblastine not listed in order on preprinted chemo forms

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Training/EducationTraining/Education

• All pharmacists and support staff should complete some type Quality Assurance training/CE at least annually

• Utilize multiple CE opportunities to learn about medication errors & patient safety

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Workflow Workflow

• Validate patient using DOB, MAR#, FIN# • Verify patient allergies on every visit • Contact the prescriber if further clarification is necessary

– drug name, strength, quantity– directions or any aspect of the prescription

• Document discussion• Review High Risk Medication Alerts in the computer system and

verify correct selection of medication– Reduce “alert fatigue”

• Work area free of clutter and distractions

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Key PointsKey Points

• It is human to err, but it is also human to react and create solutions

• Errors happen every day, but don’t always cause harm

• Prevention is multi-factorial

• Response to an error is paramount

• Reporting is the foundation for improvement

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Case ExerciseCase Exercise• A 91-year-old female

• transferred to a hospital-based skilled nursing unit from the acute care hospital for continued wound care

• intravenous (IV) antibiotics for methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis of the heel

• She was on IV vancomycin and began to have frequent, large stools

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Case ExerciseCase Exercise• The attending physician ordered a test for Clostridium difficile on

Friday, and was then off for the weekend. • That night the test result came back positive• The lab called infection control, who in turn notified the float nurse

caring for the patient• RN did not notify physician on call or the regular nursing staff.

Isolation signs were posted on the patient's door and chart and the result was noted in the patient's nursing record.

• Each RN who subsequently cared for this patient assumed that the physician had been notified, in large part because the patient was receiving vancomycin. However, the patient required oral vancomycin to treat C.difficile, not IV vancomycin

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Case ExerciseCase Exercise

• What are the systems/processes involved in this incident?

• What were the failure points?

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AnalysisAnalysis

• MD failed to check the result of an ordered test

• Float RN wrongly assumed that MD had been notified of the result

• RN incorrectly assumed that IV vancomycin was adequate therapy

• Pharmacist responsibility?

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Failure PointsFailure Points• Laboratory system for reporting critical results

• Is a positive C. difficile culture considered a panic result?• To whom are panic values reported?

• RN/MD communication• Does the institution foster an environment where RNs can

comfortably question MD orders?

• Pharmacist– Antibiotic stewardship

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ResourcesResources

• Institute of Safe Medicine Practice (ISMP)– www.ismp.org– Newsletter

• American Society of Hospital Pharmacists– Report to ISMP– Report to Medwatch– Safety Alerts, Warnings and Recalls

• National Patient Safety Foundation– Healthcare Providers– Patients and Families

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ReferencesReferences• To Err Is Human: Building a Safer Health System. Kohn, et al.• Poon, E et al. Effect of Bar-Code Technology on the Safety of

Medication Administration. N Engl J Med 2010; 362:1698-1707.May 6, 2010

• Philips J et al. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm. 2001 Oct 1;58(19):1835-41

• CDC. National Vital Statistics Reports. Deaths: Final Data for 2007.• ISMP. ISMP Homepage (and other links from this page).

http://www.ismp.org/.

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Thank YouThank You