 Medication safety terminology  Relationship between medication errors, adverse drug events & adverse drug reactions  Medication error classification  Factors contributing to medication errors

 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

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

 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, or 9. Results in temporary or permanent harm, disability, or death

 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

 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

 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

ADR ADE Medication Error Medication Misadventure A B E D 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)

 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)

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

Monitoring and documenting patient response Reevaluation drug selection, frequency, & duration Monitoring Communicating and collaborating among caregivers Systems/ Management Control

 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 errors cause at least one death every day and  injure approximately 1.3 million people annually in the United States

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

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

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

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

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

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

PrescribingMonitoringAdministeringDispensingSystems

 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)

 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)

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

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

Drug or Drug Class Risk FactorsRisk Reduction Strategies InsulinUse 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

 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/packaging Example Prozac ® and Proscar ®

 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