Adverse Drug Events (ADEs)

Adverse drug event (ADE) "injury resulting from medical intervention related to a drug" (Kohn, Corrigan, Donaldson 2000).
Adverse drug reaction (ADR) "harms directly caused by a drug at normal doses"
Medication error The "inappropriate use of a drug that may or may not result in harm;" such errors may occur during prescribing, transcribing, dispensing, administration, adherence, or monitoring of a drug (Nebeker, Barach, Samore 2004)

Incidence and prevalence

ADEs Present on Admission

"ADEs account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year.(PSNET 2015).

Inpatient ADE's

ADEs affect nearly 5% of hospitalized patients, making them one of the most common types of inpatient errors; ambulatory patients may experience ADEs at even higher rates."(PSNET 2015). The U.S. Dept. of Health & Human Services, Agency for Healthcare Research and Quality published yearly accounts of reported hospital acquired ADEs associated with five drug treatments for the years 2010 through 2014 as follows:

ADE Source Medication 20101 20112 20123 20134 20145
Digoxin 11,650 9,400 11,000 8,800 10,000
Hypoglycemic Agents 930,863 920,000 760,000 760,000 780,000
IV Heparin 170,973 150,000 140,000 170,00 200,000
Low Molecular Weight Heparin and Factor Xa Inhibitor 335,826 330,000 310,000 240,000 250,000
Warfarin 171,609 180,000 150,000 140,000 120,000
Total ADE (sum) 1,620,921 1,594,000 1,372,000 1,320,000 1,360,000

The current National Action Plan for Adverse Drug Event Prevention is focused on measuring and monitoring the burden of ADEs, identifying key determinants of ADEs, reviewing incentives and strategies to prevent ADEs. High priority prevention targets include anticoagulants, diabetes agents and opioids. Many departments and organizations within the U.S. Government are participating in the National Action Plan for Adverse Drug Event Prevention. The Military Health System's Partnership For Patients Campaign is working to reduce ADEs from high-risk medications by instituting the following Sustainment Guide for Adverse Drug Events January 24, 2014:

Sustainment Guide for Adverse Drug Events January 24, 2014
Improve Management of Heparin
Improve Management of Warfarin
  • Consistently use standardized weight-based heparin protocol throughout facility
  • Limit to no more than two protocols
    • Use preprinted order forms or ordering protocols
    • Establish guidelines to hold heparin and provide reversal therapy for heparin over-anticoagulation
    • Ensure protocol address how to evaluate and treat patients with heparin-induced thrombocytopenia (HIT)
    • Ensure heparin dosing protocols account for the use of thrombolytics and GIIb/IIIa inhibitors
    • Ensure heparin is not administered within 6-12 hours of a dose of LMWH
    • Ensure appropriate monitoring parameters are implemented and used reliably
  • Implement standardized concentrations of heparin
  • Use pre-mixed infusions and ready-to-administer products when available
  • Remove high-concentration products from floor stock
  • Separate look-alike/sound-alike (LASA) products (names and packaging) when using or storing
  • Implement effective independent double checks
  • Use smart pumps (if available) with accurate drug libraries to infuse heparin
  • Administer boluses from pharmacy prepared syringes or set up smart pump libraries
  • Make heparin-flush available only in syringes
  • Do not accept heparin orders with unapproved abbreviations (i.e. U for units, etc.)
  • Use LMWH when appropriate, instead of heparin
  • Use auxiliary labels for high-alert medications consistently throughout the facility
  • Consistently use standardized protocols and dosing
    • Use preprinted order forms or ordering protocols that are prominently labeled by indication (i.e. A. Fib, DVT, etc.)
    • Standardized protocols for the initiation and maintenance of warfarin therapy including, Vitamin K dosing guidelines
    • Develop an evidence-based protocol, to discontinue and restart warfarin preoperatively
    • Develop a evidence-based protocol, to bridge warfarin therapy with more rapidly-acting anticoagulants such as heparin or LMWH
  • Use ONLY oral unit-dose products, when these products are available
  • Ensure effective implementation of independent double checks
  • Minimize available strengths of oral formulations to the essential few
  • Ensure efficient access to laboratory results (i.e. available within 2 hrs) and/or use of point-of-care testing at the bedside
  • Include a nutrition consult to avoid drug/food interactions and educate the patient about them
  • Create daily CHCS report of patients on warfarin for nutrition education
  • Use medication reconciliation to improve handoffs of medication information
  • Engage patients by developing educational programs and training at an appropriate literacy level
  • Implement system to properly verify inventory stocking in the Automated Dispensing Cabinets
  • Utilize auxiliary labels for high-alert medications consistently within the organization
Improve Management of Narcotics
Improve Management of Insulin
  • Consistently use standardized protocols for initiation and maintenance of pain management
    • Use protocols and pre-printed orders (CPOE order sets) where possible for PCA, postoperative, epidural, and intrathecal pain management
    • Include dose calculations, maximum bolus doses, prescribed dose, monitoring guidelines, and options for non-opioid analgesics
    • Establish standard naloxone regime which can be given prior to contacting physician, based on a protocol signed by a physician
  • Standardize monitoring protocols including documentation of vital signs and pain score following each dose
  • Use appropriate monitoring for adverse effects of narcotics and opiates
  • Minimize multiple drug strengths
  • Implement standard concentrations of narcotics/opiates
  • Establish formulas for narcotic dose-equivalences
  • Widely circulate formulas for narcotic dose-equivalences to all staff
  • Prepare narcotic/opiate infusions in the pharmacy ONLY
  • Use smart pumps with accurate drug libraries
  • Label distal end of all access lines to distinguish IV from EPIDURAL
  • Use tubing without injection ports for EPIDURAL
  • Standardize to single drug as opiate of choice for PCA or use dose equivalencies for multiple drug choices
  • Consult a pain specialist if physician are not knowledgeable about pain control
  • Increase use of non-pharmacologic intervention for pain and anxiety
  • Educate patient/family about PCA use before surgical procedure
  • Dose narcotics to a pain score mutually agreed upon by patient & provider prior to procedure
  • Use medication reconciliation to improve handoffs of medication information
  • Educate patients regarding hypotension and dizziness upon rising
  • Anticipate and schedule toileting for high-risk patients
  • Consistently use standardized pre-printed diabetic and insulin infusion orders
  • When prescribing insulin, include or refer to defined standards for laboratory testing and clinical monitoring of patients
  • Ensure appropriate monitoring through more rapid testing of blood glucose
  • Use a diabetic management flow sheet to track blood glucose values, carbohydrate intake and insulin administration
  • Eliminate or limit the use of sliding insulin dosage scales; if used standardize it through use of a protocol/preprinted order form or computer order set that clearly designates the specific increments of insulin coverage
  • Standardize to a single concentration of IV-infusion insulin
  • Prepare all infusions in the pharmacy
  • Do not accept insulin orders with unapproved abbreviations (i.e. U for units, trailing zero, etc.)
  • Implement different means to separate LASA insulins (i.e. individual bins) and to make them look different or call attention to important information (i.e. auxiliary/colored labels, highlighter, etc.)
  • Utilize Tallman lettering to distinguish LASA insulins
  • Do not dispense insulin in original container only; label the vial with patient’s name and expiration date. Use vial for single patient use ONLY
  • Use smart pumps with accurate drug libraries
  • Implement effective independent double checks
  • Consider patient’s usual time for meals and timeframe for insulin administration
  • Consider unique delivery devices such as insulin pen with proper safeguards (i.e. dispensed by pharmacy ONLY, label each pen with patient’s name, auxiliary label for single patient use, identified authorized staff to administer it, etc.)
  • Allow and encourage patient self-management (or parents for young pediatric patients) when patients and parents are capable and willing
  • Encourage patients to question doses and timing of insulin administration
  • Utilize auxiliary labels for high-alert medications consistently within the organization

Culture of safety

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.

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, Boyle, Vander (1995) determined that nurses intercepted about half of all preventable ADEs prior to drug administration.

Prevention of ADEs by the healthcare facility

Reduce your risk of pADE involvement:



Preparation and Administration of Medications

High Risk Populations:

Instant Feedback:
Harm caused by use of a drug is known as:
Adverse Drug Event
Medication Error