Medication SafetyPart 1

Medication safety terminology

Relationship between medication errors, adverse drug events & adverse drug reactions

Medication error classification

Factors contributing to medication errors

Outline

An iatrogenic hazard or incident associated with medications

May be attributable to error (human, or system, or both), immunologic response or idiosyncratic response

Is always unexpected or undesirable to the patient and the health professional

A medication misadventure may or may not cause an injury to a patient

Medication Misadventure

An injury form a medicine (or lack of intended medicine)

Adverse Drug Event (ADE)

Any unexpected, unintended, undesired, or excessive response to a drug that:

1. Requires discontinuing the drug (therapeutic or diagnostic),2. Requires changing the drug therapy,3. Requires modifying the dose (except minor dose adjustments),4. Necessitates admission to a hospital,5. Prolongs stay in a health care facility,6. Necessitates supportive treatment,7. Significantly complicates diagnosis,8. Negatively affects prognosis, or9. Results in temporary or permanent harm, disability, or death

Adverse Drug Reaction (ADR)

An allergic reaction (an immunologic hypersensitivity, occurring as the result of unusual sensitivity to a drug)

and

An idiosyncratic reaction (an abnormal susceptibility to a drug that is peculiar to the individual)

are considered ADRs

ADRs

An expected, well-known reaction resulting in little or no change in patient management

The frequency of this effect is predictable and the intensity is dose-related

e.g. drowsiness or dry mouth due to administration of certain antihistamines

Side Effect

Any preventable event that has the potential to lead to inappropriate medication use or patient harm while the drug is in the control of the healthcare professional, patient, or consumer

Medication Error

Relationship between Medication errors, ADEs, ADRs

ADR

ADEMedication

Error

Medication MisadventureA

B ED

C

Medication misadventures (A) include all things that can go wrong in drug use

ADRs (C) are a subset of ADE and are not related to an error (e.g. allergies)

Section (D) is ADEs resulting from a medication error (e.g. reactions resulting from unintentional overdose)

Relationship between Medication errors, ADEs, ADRs

ADEs within section (B) but are not part of sections (C) or (D) are side effects (expected and unavoidable)

Section (E) includes medication errors that don’t result in patient harm (e.g. dose administered late but did not result harm in the patient)

Relationship between Medication errors, ADEs, ADRs

Medication Use Process

•Assessing the need for/selecting the correct drug

•Individualizing the therapeutic regimen

Prescribing•Reviewing the order for correctness of

dosing and indication•Compounding/preparing the drug

Dispensing

•Administering the right drug to the right patient

•Administering the drug when indicated

Administering

Medication Use Process - Cont’d

•Monitoring and documenting patient response

•Reevaluation drug selection, frequency, & duration

Monitoring

•Communicating and collaborating among caregiversSystems/Management

Control

Medication Errors

Any preventable event that has the potential to lead to inappropriate medication use or patient harm while the drug is in the control of the healthcare professional, patient, or consumer

Medication Error Definition

Medication errors cause at least one death every day

and

injure approximately 1.3 million people annually in the United States

Medication Errors

Prescribing Error

• Incorrect drug selection (based on indications, contraindications, known allergies, existing drug therapy, and other factors), dose, dosage form, quantity, route, concentration, rate of administration, or instructions for use of a drug product ordered or authorized by physician

Omission Error

• The failure to administer an ordered dose to a patient before the next scheduled dose

Classification A) Type of Event

Wrong Time Error

• Administration of medication outside a predefined time interval from its scheduled administration time

Improper Dose Error

• Administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber or administration of duplicate doses to the patient, i.e.one or more dosage units in addition to those that were ordered

Classification A) Type of Event

Unauthorized Drug Error

• Administration to the patient of medication not authorized by a legitimate prescriber for the patient

Wrong Dosage Form Error

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

Classification A) Type of Event

Wrong Drug Preparation Error

• Drug product incorrectly formulated or manipulated before administration

Wrong Administration-Technique Error

• Inappropriate procedure or improper technique in the administration of a drug

Classification A) Type of Event

Deteriorated Drug Error

• Administration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised

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

Classification A) Type of Event

Compliance Error

• Inappropriate patient behavior regarding adherence to a prescribed medication regimen

Other Medication Error

• Any medication error that does not fall into one of above predefined categories

Classification A) Type of Event

Classification B) Step of Medication Use Process

Prescribing

Monitoring

AdministeringDispensing

Systems

Miscommunication (verbal & telephone orders) Poor handwriting/ Use of abbreviations Product confusion (e.g. sound/look-alike) Inaccurate dosage calculation Availability of multiple concentrations Preparation of drug product outside pharmacy Stress (workload & environment) Environment (e.g. lighting, noise levels, frequent

interruptions)

Factors That Contribute to Medication Errors

Inadequate staffing Student providing care Shift change Lack of experienced personnel on duty New employee (< 6 months) Equipment failure or malfunction Inappropriate abbreviations used in prescribing Labeling errors Lack of patient education Reference material (inaccurate, out of date)

Factors That Contribute to Medication Errors - Cont’d

Drugs that are involved in the majority of medication errors that resulted in serious injury or death

High-Alert Drugs Definition

Insulin Opiates/Narcotics Concentrated injectable potassium Intravenous anticoagulants Concentrated sodium chloride solutions Antiarrhythmics Chemotherapy Parentral CCBs and BBs Oral hypoglycemics Warfarin

High-Alert Drugs Examples

Drug or Drug Class Risk Factors Risk Reduction Strategies

Insulin Use of ‘’U’’ abbreviation for ‘’units’’

Require the word ‘’units’’ be spelled out on all orders

Potassium injection & NaCl solutions

-Availability as floor stock-Extemporaneous mixing

Remove concentrated product from patient care units and centralize admixture to pharmacy

Intravenous anticoagulants

Multidose containers and availability of multiple concentrations

Use single dose containers, limit available concentrations

High-Alert Drugs Risk Reduction Strategies

These refer to names of medications, which due to their spelling, may look similar to other medications’ names

Distribution/administration of these medications may be prone to errors

Also refer to product labeling/packagingExample Prozac ® and Proscar ®

Look-Alike Medications

These refer to names of medications, which due to their pronunciation, may sound similar to other medications’ names

Distribution/administration of these medications may be prone to errors

Example◦ Dianben ® and Diovan®◦ Furosemide and Famotidine

Sound-Alike Medication