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Adverse Drug Events (ADEs)

Definitions:

Adverse drug event	Harm caused by the use of a drug; the harm may have been preventable or non-preventable.
Adverse drug reaction	Unintended and noxious response to a drug, properly administered, at a normal dose.
Medication error	The inappropriate use of a drug that did or could have caused patient harm.
Mistake	An act or omission by any caregiver which would have been judged wrong by knowledgeable peers at the time it occurred.
Near miss	A mistake that does not reach the patient or if it reaches the patient does not result in injury or harm.
Side-effect	A desirable or undesirable response to a drug which is not the primary effect for which the drug was chosen.

Medication error is a term that assigns blame and presumes wrongdoing. In a culture of safety, shame and blame are no longer the preferred institutional response to patient harm. The preferred response is systemic change that reduces the possibility of similar events.

The term "adverse drug event" (ADE) is preferred over "medication error" because it is patient centered. Rather than blaming one healthcare provider, it focuses attention upon actual harm experienced by a patient within a healthcare setting.

Adverse drug events are presumed to be the leading source of patient harm. The Agency for Healthcare Research and Quality believes that ADEs are responsible for more than 770,000 patient injuries and death each year. ADEs result in both avoidable and unavoidable patient harm.

To be fair, nursing deserves tremendous credit for its success in limiting ADEs. In spite of chronic understaffing and minimal technological support, nursing has protected the patient. A study by Bates et al. determined that nurses intercepted at least half of all preventable ADEs (pADE) prior to drug administration.

A literature review by Kanjanarat et al. focused on the harm resulting from pADEs. In ten (10) studies from 1994-2001, they found:

A pADE can occur at any point from prescription to administration:
- prescription of wrong drug, dose or route account for about 48% of pADEs
- transcription errors for 11% of pADEs
- dispensing errors for about 14% of pADEs
- administration errors for about 28% of pADEs
In-hospital pADEs ranged from 18.7 - 73.2% of recorded ADEs
Cardiovascular drugs were associated with 4.3 - 28.1% of pADEs
The most common harmful outcomes were:
- allergic reactions
- hepatic or renal problems
- cardiovascular problems
- hematologic & coagulation problems
- CNS problems
Medication classes most associated with pADEs:
- antihypertensives: bradycardia or hypotension
- antibiotics: allergy
- anticoagulant (warfarin): hemorrhage
- opioids: overdose (respiratory depression), low dose (pain, stress etc.)

An outpatient study by Ma (2007) found:

56% ADEs occur at the time of ordering, 34% at administration, 6% at transcription, 4% at dispensing.
2 - 7% of ADEs result in hospitalization; 28% of those hospitalizations were preventable.
Serious ADEs reported to the FDA increased 2.6 times from 1998-2005.
Drug classes associated with death, in descending order: 1) Analgesic 2) Antipsychotic 3) Anti-rheumatics 4) Immunomodulators 5) Antineoplastics
Non-fatal ADEs by drug class: Hormones (estrogen, insulin, etc.), Anti-rheumatics, Immunomodulators, Antidepressants, NSAIDs, Anticoagulants
Top 3 E-code Florida 2006 FFS hospital claims were: 1) Anticoagulants, 2) Corticosteroids, 3) Antineoplastics

Institute of Medicine Recommendations for the prevention of medication errors:

Implementation of computerized provider order entry (CPOE) with a Decision-Support System can reduce pADEs by 17 - 62%
Including a pharmacist during rounds of patient care units can reduce pADEs by 66%.
Have a pharmacist available on call for consultation after normal pharmacy hours
Employ special procedures and written protocols for the use of high-risk IV and oral medications.

Joint Commission National Patient Safety Goals

Adapted 2009 Joint Commission National Patient Safety Goals (Medication Safety)
Identifier	Goal	Prevention
NPSG.01.01.01	Improve Patient Identification	Use at least two patient identifiers when administering medication, e.g. patient name & medical record #
NPSG.02.01.01	Verify Verbal Orders	Authorized Receiver documents verbal order or test and reads back the complete verbal order or test result to the Sender, who then affirms.
NPSG.03.03.01	Look-alike Sound-alike Drugs	Each organization will annually select at least 10 Look-alike/sound-alike (LASA) drug combinations from the Joint Commission LASA List. Staff will be notified of the risk for confusion and when possible substitutions will be made.
NPSG.03.04.01	Label Medications	In all procedure settings, label and verify (2 team members) all medication or solutions (for example, syringes, medicine cups, basins) with the medication: name, concentration and amount, whether on and off the sterile field.
NPSG.03.05.01	Improve Anticoagulant Safety	Use only: oral unit dose, pre-filled syringes or pre-mixed infusion bags when administering long-term anticoagulant prophylaxis. For pediatric patients, use only products specifically designed for administration to children.

Reduce your risk of pADE involvement:

Knowledge:

Take all the time necessary to thoroughly understand your patient's diagnoses and the side-effects common to the drug treatments for those ailments.
Use your resources; the pharmacy is your ally; consult them.
Identify an "on-site consultant" to lead intervention when an ADE occurs.
Demand real-time access to current nursing, medical and pharmaceutical references and use them to improve care.
Consider carrying a handheld medication reference with drug indications, doses, routes, interactions, and other considerations.
Demand the time and support necessary to master drug administration devices common to your work setting.
Share what you learn.
"Incident report" every near-miss as well as ADEs that cause harm. Organizations can't improve without information.
Promote practice drills to identify and reinforce appropriate staff response to ADEs.

Communications:

Document and clarify any confusing orders with the prescriber.
Confirm any order, or dispensing circumstance, that is unusual with pharmacy.
Encourage adoption of Point of Care electronic charting and computerized physician order entry with decision support.
Transcribe orders in printed block letters.
Avoid abbreviations when transcribing.
Verify every order which contains an abbreviation on the the Joint Commission "Do Not Use" list.
Reduce decimal point confusion: 'Always lead; never follow'
- DO precede a decimal point with a numeral; e.g., 0.5 mg
- Do Not place a decimal point & zero after a numeral; e.g., 20.0 mg
- Document, clarify and "incident report" any order which does not conform to policy.
Employ the Joint Commission 'identifier' NPSG.02.01.01 for all verbal patient treatment related communications (see chart above).
Notify pharmacy and "Incident report" any circumstance that could lead to "Look-alike, Sound-alike" confusion.
Don't rely on memory; document each drug administration as soon as possible.
Verify the completeness and accuracy of patient information as the patient enters and transitions through the medical system. Incomplete information is responsible for about 50% of errors and 20% of pADEs.

High Risk Populations:

Neonate/Infant body mass, smaller plasma volume, and inefficient liver and kidney clearance, compared to older children and adults, tend to make drug and dose errors significantly more serious. Reiter (2002) succinctly expresses the issue with: "The neonate is in a rapid and continuous state of maturation, which can influence significantly the therapeutic and toxic effects of drug therapy."
Geriatric patients often require daily medications, both OTC and prescribed, to manage multiple diagnoses. Ensuring continuation of necessary medications after an intervention is an important aspect of safe care. The more complex the medication regimen, the greater the chance of interactions and side-effects. Alterations in drug absorption and clearance must be anticipated in even the healthy elderly.
Critical Care (High-Risk OB, ER, OR, ICU) environments are known to have the greatest risk of serious adverse drug events and outcomes. These practice areas require the highest level of vigilance and the lowest tolerance for deviations from policy.

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