Adverse Drug Event Trigger Tool

Intended use of this tool:

This tool is intended to assist surveyors to identify:
1. The extent to which facilities have identified resident-specific risk factors for adverse drug events,
2. The extent to which facilities developed and implemented systems and processes to minimize risks associated with medications that are known to
be high-risk and problem-prone, and
3. When a preventable adverse event has occurred, and evaluate if the nursing home identified the issue and responded appropriately to mitigate
harm to the individual and prevent recurrence.

Definitions:
• Adverse Event: An untoward, undesirable, and usually unanticipated event that causes death, serious injury, harm, or the risk thereof.
• Adverse Drug Event: An injury resulting from drug-related medical interventions.
• Adverse Drug Reaction: Harm directly caused by a drug at normal doses.
• Anticholinergic Effects: Physical symptoms resulting from drugs that counter the action of acetylcholine including increased blood pressure,
respiratory distress, clumsiness/unsteadiness, bloating/constipation/ileus, nausea/vomiting, dry mouth, delirium, drowsiness/lethargy/fatigue,
urinary retention, hallucinations, memory problems, and blurred vision.
• Prescribing Cascade: Adverse reaction to one drug that goes unrecognized or is misinterpreted resulting in the prescriber inappropriately
prescribing a subsequent drug to treat the signs/symptoms of the adverse reaction.
• Polypharmacy: Multiple definitions exist, but most include reference to drugs without indication and the number of medications used (e.g., more
than 10).
• Risk Factor: Issue or condition that increases the potential for an adverse event to occur. Risk factors include resident level issues such as
medications prescribed, age, and concurrent conditions as well as system level issues such as lack of staff knowledge related to high risk
medications and unclear protocols to address lab results.

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
Change in • PRN or routine use of • Falls • Administration of • Is there an assessment and determination of pain
mental opioid medication • Hallucinations Narcan etiology?
status/delirium • Opioid naiveté • Delusions • Transfer to hospital • Does the resident’s pain management regime
related to opioid (someone who has • Disorientation or • Call to physician address the underlying etiology?
use not been taking confusion regarding new onset of • For a change in mental status, is there evidence
opioids) • Light-headedness, relevant signs or that the physician conducted an evaluation of the
• Opioids used in dizziness, or vertigo symptoms underlying cause, including medications?
combination with • Lethargy or • Abrupt stop order for • Is there evidence of a system for ensuring that
sedatives or other somnolence medication residents are routinely assessed for pain,
opioids • Agitation including monitoring for effectiveness of pain
• History of opioid • Anxiety relief and side effects of medication (e.g., over-
abuse • Unresponsiveness sedation)?
• Opioid tolerance • Decreased • If receiving PRN and routinely, is there
• Severe pain • BP consideration for the timing of administration of
• Low fluid • Pulse the PRN?
intake/dehydration • Pulse oximetry • Can staff describe signs/symptoms of over-
• Low body weight sedation?
• Respirations
• History of head • Is there evidence of a system for ensuring “hand
injury, traumatic off” communication includes the resident’s pain
brain injury, or status and time of last dose?
seizures • Do the resident, family, and direct caregivers
know signs and symptoms of over-sedation and
steps to take if noted (e.g., alert the nurse)?
• Is there evidence the facility implements non-
pharmacological pain management approaches?
• Is there a system to ensure extended-release
formulations are delivered correctly (e.g.,
medications not crushed)?
Change in • PRN or routine use of • Falls • Transfer to hospital • Does the medical record include consistent
mental psychotropic • Confusion • Call to physician documentation of clinical indication, e.g., do
status/delirium medication • Sedation regarding new onset of physician notes, care plan, and tracking sheets
related to • Use of more than one • Cardiac arrhythmias relevant signs or all address the same indication?

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
psychotropic psychotropic • Orthostatic symptoms • If receiving PRN and routinely, is there
medication use medication including hypotension • New order for restraint consideration for the timing of administration of
(including more than one drug • Destabilized blood • Abrupt stop order for the PRN?
antipsychotics, from the same class sugar medication • Is there evidence of a system for ensuring the
antidepressants, or different classes • Akathisia resident is routinely assessed for effectiveness of
anxiolytics, and • Advanced age • Parkinsonism the medication and signs/symptoms of adverse
hypnotics) • Polypharmacy • Anticholinergic effects drug reactions/events?
• Is there a system for monitoring for involuntary
movements?
• Is there evidence that the facility has attempted
gradual dose reduction or rationale documented
if not attempted?
• Is there evidence the facility implements non-
pharmacological approaches and
interdisciplinary management of the condition
that the medication targets?
• Is there evidence in the medical record that the
resident or representative were involved in
decisions related to medication use?
• Is there a system to ensure extended-release
formulations are delivered correctly (e.g.,
medications not crushed)?
Hypoglycemia • Insulin use • Hypoglycemia (e.g., • Stat administration of • Does the care plan reflect interdisciplinary
related to use of • Sliding scale insulin <50 mg/dl) Glucagon or IV monitoring for:
antidiabetic use • Falls dextrose • Signs/symptoms of hypoglycemic episodes?
medication • Oral hypoglycemic • Headache • Administration of • Changes in oral intake?
medication use • Shakiness, orange juice or other • Is there evidence blood glucose testing and
• Decrease in oral nervousness, anxiety high sugar food or insulin administration are coordinated with
intake while taking • Sweating, chills, fluids in response to meals?
antidiabetic clamminess blood sugar reading or • Is there evidence the facility has addressed any
medication • Irritability, impatience symptoms pharmacy recommendations?
• Change in mental • Transfer to hospital • If sliding scale insulin is used, does the medical

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and
Adverse Drug increase the potential for Symptoms (S/S) - Any of
Event (ADE) ADEs. Multiple factors these may indicate an
increase risk. ADE may have occurred.
status
• Emotional changes
(including new anger,
sadness, stubbornness)
• Lightheadedness,
dizziness
• Hunger
• Nausea
• Complaints of blurred
or impaired vision
• Tingling or numbness
in lips and/or tongue
• Weakness, fatigue, or
somnolence
• Incoordination
• Seizures
• Unconsciousness
• Rapid heartbeat
Ketoacidosis • Diabetic residents • Lab results indicating:
related to insulin with concurrent • Profound
therapy illnesses dehydration
• Infection • Elevated blood
• Diabetic residents glucose
with consistently high • Ketones in urine
blood glucose levels • Excessive thirst
• Episodes of high • Frequent urination
Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
Triggers: Clinical
Surveyor Probes - These questions are designed to
Interventions - These
assist in the investigation. A negative answer does
actions may indicate an
not necessarily indicate noncompliance.
ADE occurred.
record contain documentation of risk vs.
benefits? Clinical rationale?
• If an EHR is used, are finger stick glucose
testing results incorporated into it?
• Is there evidence that finger stick glucose results
are routinely reviewed for effectiveness as part
of the care plan?
• Is there evidence that the facility routinely
educates caregivers on risk factors and
symptoms/signs of hypoglycemia?
• Is the resident and family educated regarding the
signs and symptoms of hypoglycemia and
regarding the resident’s diabetes management
plan
• Does the facility have low blood sugar protocols
in place?
• Is there a system to ensure lab results, including
finger stick blood glucose results, are
appropriately communicated to the physician
and the dietician including when panic values
are obtained?
• Is there evidence that glucose monitoring
equipment is maintained and that staff technique
meets standards of practice.
• Stat order for lab • Is there evidence of a system for routine
testing including to monitoring of blood sugar?
evaluate blood sugar • If the resident refuses antidiabetic medication or
and fluid and consumes foods not included in usual/planned
electrolyte status diet, is there evidence of an interdisciplinary
• Stat order for insulin plan to address refusals that includes the
• New order for and prescriber and the family, as appropriate?
administration of IV • For residents with risk factors for ketoacidosis,
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
physical and/or • Nausea/vomiting fluids does the care plan reflect multi-disciplinary
emotional stress or • Abdominal pain • Transfer to hospital monitoring for signs/symptoms of ketoacidosis?
trauma • Weakness/fatigue • Is there evidence that the facility routinely
• A diabetic resident • Shortness of breath educates caregivers on risk factors and
that frequently • Fruity-scented breath symptoms/signs of ketoacidosis?
declines antidiabetic • Confusion • Does the facility have elevated blood sugar
medications or • Rapid respirations protocols in place?
consumes foods not • Elevated temperature • If sliding scale insulin is used, does the medical
included in diet record contain documentation of risk vs.
benefits? Clinical rationale?
• Is there a system to ensure lab results, including
finger stick results, are appropriately
communicated to the physician and the dietician
including when panic values are obtained?
Bleeding related • Anticoagulant, • Elevated PT/INR, PTT • Stat order for PT/INR, • Does the medical record include documentation
to antiplatelet, or • Low platelet count PTT, platelet count, or of clinical indication?
antithrombotic thrombolytic • Bruising CBC • Is there evidence the facility routinely monitors
medication use medication use • Nosebleeds • Abrupt stop order for lab results of all residents on
• Concurrent use of • Bleeding gums medication anticoagulant/antiplatelet therapy?
more than one • Prolonged bleeding • Administration of • Is there a system to ensure lab results, including
antithrombotic from wound, IV, or Vitamin K PT/INRs, are appropriately communicated to the
medication (e.g., use surgical sites • Transfer to hospital physician including when panic values are
of aspirin while on • Blood in urine, feces, obtained?
anticoagulants) or vomit • Is there evidence that the facility educates
• History of stroke or • Coughing up blood caregivers on risk factors and symptoms and
GI bleed • Abrupt onset signs that may be indicative of excessive
• NSAID medication hypotension bleeding due to antithrombotic medications?
use while on • Are residents/families educated regarding the
anticoagulants risks associated with antithrombotic medication
• Antibiotics use while use and the signs and symptoms of excessive
on anticoagulants bleeding?
• Amiodarone use • Is there evidence of system to alert prescribers

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
while on and nursing staff when anticoagulants are
anticoagulants combined with other drugs which increase the
• Dietary changes risk of bleeding?
affecting vitamin K • Does the resident’s dietary plan include
intake (e.g., dark recognition of foods that interact with
leafy greens) antithrombotic medications (e.g., is there a plan
to ensure consistent intake of foods and
beverages rich in Vitamin K for residents on
warfarin)?
Thrombo- • Anticoagulant • Pain or tenderness and • Stat order for PT/INR • Is there evidence the facility routinely monitors
embolism medication used; swelling of upper or • Stat chest x-ray, lab results of all residents on
related to • Prolonged immobility lower extremity • Transfer to hospital anticoagulant/antiplatelet therapy?
anticoagulant • Recent major surgery • Increased warmth, • Is there a system to ensure lab results, including
medication use • Prior history of edema and/or PT/INRs, are appropriately communicated to the
venous erythema of affected physician including when sub-therapeutic values
thromboembolic extremity are obtained?
events • Unexplained shortness • Is there evidence that the facility educates
• Consistently sub- of breath caregivers on risk factors and symptoms and
therapeutic PT/INR • Chest pain signs that may be indicative of
• Coughing thromboembolism?
• Hemoptysis
• Feelings of anxiety or
dread

Prolonged • Opioid medication • Constipation (lack of • New orders for • Is there evidence of a bowel regimen in place
constipation, use (routine or PRN) bowel movement for laxative, stool such as routine orders for stool
ileus, or • Uncontrolled pain three or more days or softeners, softener/laxative?
impaction • Recent abdominal straining to move suppositories and/or • For residents with risk factors for constipation,
related to opioid surgery bowels regardless of enemas does the care plan reflect interdisciplinary
medication use • Advanced age frequency) • New order for monitoring for signs/symptoms of constipation
• Diagnosis of • Bloating or abdominal abdominal x-rays and an interdisciplinary plan to prevent it
dementia, distension • Transfer to hospital including dietary management?

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
Parkinson’s, multiple • Abdominal pain • Is fluid intake monitored?
sclerosis, or • Headaches associated • Are residents/families taught signs/symptoms of
quadriplegia with symptoms above constipation and the importance of reporting
• Low fluid intake or • Diarrhea or leaking them?
dehydration stool • Are bowel movements (frequency and size)
• Decreased mobility • Decreased bowel monitored routinely by nursing staff?
sounds • Is bowel status routinely addressed by the
• Nausea/vomiting physician?
• Decreased or absent • Upon the initiation of opioids, did the prescriber
ability to urinate acknowledge the increased of risk of
• Rapid heartbeat constipation and adjust the plan of care as
• Sweating indicated?
• Fever • Is there a protocol in place to address
• Low or elevated BP constipation (e.g., a process to provide routine or
standing order bowel medications when a
resident hasn’t had a bowel movement)? If so, is
the staff aware of and compliant with the
protocol?
• Does the clinical record reflect that the dietician
was made aware of an opioid being ordered so
that nutritional approaches to prevent
constipation could be considered?
• Is there evidence of a system for ensuring that
residents are routinely assessed for pain,
including monitoring for effectiveness of pain
relief and side effects of medication (e.g.,
constipation)?
• Is there evidence that the facility implements
non-pharmacological pain management
approaches?

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.

Risk Factors - These
Adverse Drug increase the potential for
Event (ADE) ADEs. Multiple factors
increase risk.
Electrolyte • Use of diuretics
imbalance • Advanced age
(including • Dependence in ADLs
dehydration and – especially eating
acute kidney • Diagnosis of
injury) related to dementia
diuretic use • Fluid restrictions
• Recent diarrhea or
vomiting
• Hot weather or other
trigger for increased
fluid needs
• Use of medical
devices that increase
fluid needs (e.g., air-
fluidized mattresses)
Drug toxicity • Concurrent routine
related to and PRN orders for
acetaminophen acetaminophen and
medications
containing
acetaminophen
• Failure to have a
maximum daily dose
of acetaminophen
Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
Adverse Drug Event Trigger Tool
Triggers: Signs and
Symptoms (S/S) - Any of
these may indicate an
ADE may have occurred.
• Abnormal electrolytes
• Dry skin and mucous
membranes including
cracked lips
• Poor skin turgor
• Thirst
• Confusion
• Concentrated urine
and/or decreased
output
• Lethargy
• Elevated temperature
• Low BP with increase
in pulse
• Weight loss
• Elevated liver function
tests
• Fatigue or weakness
• Abdominal pain
• Loss of appetite
• Jaundice, including
yellowing of sclera
• Itching
• Bruising
Triggers: Clinical
Surveyor Probes - These questions are designed to
Interventions - These
assist in the investigation. A negative answer does
actions may indicate an
not necessarily indicate noncompliance.
ADE occurred.
• Abrupt stop order for • For residents with risk factors for dehydration,
diuretic medication does the care plan reflect interdisciplinary
• New order for labs approaches for prevention including:
• New order for and • Monitoring for signs and symptoms of
administration of IV dehydration, and
fluids • Observation/documentation of consumption
• Transfer to hospital of liquids?
• Is there evidence of a system for timely
identification of residents with risk factors for
dehydration?
• Does the facility have protocols for:
• Hydration?
• Monitoring intake and output?
• Dehydration risk assessment?
• Fluid intake assessment?
• Does every resident have access to fluids?
• Are protocols in place to ensure hydration during
extreme heat?
• Are care plan approaches to ensure adequate
hydration resident-specific and known to staff
caring for the resident?
• Are residents provided with the assistance they
need to drink, including between meals?
• Abrupt stop of all • Is there evidence of a system for ensuring
acetaminophen residents with orders for routine or PRN
products acetaminophen do not receive more than 4 grams
• Transfer to hospital in a 24 hour period?
• New order for liver • Is there evidence of a system to ensure that
function tests medications that contain acetaminophen are
• New order for N- flagged to alert medication nurses that the
acetylcysteine resident has more than one medication
containing acetaminophen ordered?
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
order or protocol in • Confusion • Is there evidence of a system to ensure changes
place • Edema/ascites in condition are identified, assessed, including
• Maximum daily dose an assessment of medications, and
of acetaminophen communicated to the physician promptly?
routinely nears or • Is there evidence that the facility implements
exceeds 4 gm non-pharmacological pain management
• Uncontrolled pain approaches?
• Residents with liver • Is there evidence of a system for ensuring that
damage residents are routinely assessed for pain,
• Residents that including monitoring for effectiveness of pain
consume three or relief and side effects of medication?
more alcoholic drinks • Is there a system to ensure extended-release
per day formulations are delivered correctly (e.g.,
medications not crushed)?
Drug toxicity • Advanced age • Elevated digoxin level • New order for and • Does the care plan reflect interdisciplinary
related to • Hypokalemia • Abnormal electrolytes administration of IV monitoring for signs/symptoms of digoxin
digoxin • Hypomagnesaemia • Lethargy, drowsiness, fluids toxicity?
• Hypothyroidism fatigue • Transfer to hospital • Is apical pulse prior to administration of digoxin
• Decreased renal • Neuralgia • New order for and with the drug held when pulse rate <60 bpm
function • Headache administration of (unless other parameters are set by the
• Drugs that impair • Dizziness activated charcoal physician)?
renal function • Confusion • New order for and • Is there evidence of a system to ensure changes
• Drugs that cause • Hallucinations administration of in condition are identified and assessed
hypokalemia • Seizures digoxin-specific promptly, including an assessment of
• Visual disturbances antibody (e.g., medications?
(e.g., yellow-green Digibind) • Is there evidence of a system for routine
distortion, snowy • Abrupt stop order for monitoring of renal function and serum
vision, photophobia) medication medication concentration level?
• Anorexia, weight loss • Is there a system to ensure lab results are
• Nausea/vomiting appropriately communicated to the physician
including when panic values are obtained?
• Abdominal pain
• Diarrhea

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
• Palpitations
• Shortness of breath
• Syncope
• Lower extremity
edema
• Irregular or slow heart
rate
• Irregular respirations
Drug toxicity • History of • Abnormal thyroid • Abrupt stop order for • Is there evidence of a system to ensure changes
related to thyrotoxicosis studies, including TSH medication in condition are identified and assessed
levothyroxine • Advanced age • Headache • Transfer to hospital promptly, including an assessment of
• Cardiac arrhythmias • Leg cramps medications?
• Tremors • Is there evidence of a system for ensuring lab
• Heat intolerance tests to monitor thyroid functions are ordered
• Increased sweating and drawn?
• Diarrhea • Is there a system to ensure lab results are
• Nervousness or appropriately communicated to the physician
irritability including when panic values are obtained?
• Chest pain • For residents with risk factors for drug toxicity
• Shortness of breath related to levothyroxine use, does the care plan
• Rapid or pounding reflect interdisciplinary monitoring for
heartbeat signs/symptoms of adverse drug reactions to
levothyroxine?
• Insomnia
Drug toxicity • Renal artery stenosis Hyperkalemia S/S • Transfer to hospital • Is there evidence of a system to ensure changes
related to • Impaired renal • Elevated potassium • Stat order for lab work in condition are identified and assessed
angiotensin- function levels • Abrupt stop order for promptly, including an assessment of
converting • Aortic valve • Fatigue medication medications?
enzyme (ACE) stenosis/cardiac • Weakness • Is there evidence of a system for ensuring serum
inhibitors outflow obstruction • Dizziness, syncope For hyperkalemia may also potassium, BUN, and creatinine levels are drawn
• Congestive Heart • Headaches see: routinely?
Failure • Slow, weak, or • Stat order for IV • Is there a system to ensure lab results are
calcium appropriately communicated to the physician

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
• Dehydration irregular pulse • Stat order for including when panic values are obtained?
• History of • Nausea Kayexalate • For residents with risk factors for drug toxicity
hypersensitivity to • Abnormal heart • New order for related to ACE inhibitor use, does the care plan
ACE inhibitors rhythm/ECG diuretics reflect interdisciplinary monitoring for
• Concurrent use with: abnormalities signs/symptoms of adverse drug reactions to
• Diuretics ACE Inhibitors?
• NSAIDs Angioedema S/S
• Anticoagulants • Swelling of soft
• Cyclosporine tissues
• Potassium • Shortness of breath
supplements • Wheezing
• Persistent non-
productive cough

Acute Kidney Failure S/S

• Elevated
BUN/creatinine
Reduced/absent urine
output
• Swelling of feet/legs
• Nausea/vomiting
• Anorexia
• Flank pain
Drug toxicity • Advanced age • Severe mental status • Stat drug levels and • Is there evidence in the medical record for
related to • Liver impairment or mood changes CBC ordered clinical indication?
phenytoin • Kidney impairment • Changes in gait, • Abnormal therapeutic • Is there evidence of a system for ensuring
balance or drug levels therapeutic drug levels are drawn routinely?
coordination • Abrupt stop order for • Is there a system to ensure lab results are
• Drowsiness medication appropriately communicated to the physician
• Loss of consciousness • Transfer to hospital including when panic values are obtained?
• Uncontrollable eye • Is there evidence of a system to ensure changes
movements in condition are identified and assessed

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
• Uncontrollable promptly, including an assessment of
shaking/jerking medications?
motions • For residents with risk factors for drug toxicity
• Slow/slurred speech related to phenytoin use, does the care plan
• Nausea/vomiting; reflect interdisciplinary monitoring for
• Decreased respirations signs/symptoms of adverse drug reactions to
phenytoin?
• Is there a system to ensure extended-release
formulations are delivered correctly (e.g.,
medications not crushed)?
Drug toxicity • Advanced age • Elevated serum • Stat order for ECG • Is there evidence in the medical record for
related to • History of lithium lithium level • Stat order for drug clinical indication?
lithium toxicity • Elevated serum level • Is there evidence of a system for ensuring
• Kidney impairment sodium level • Stat order for IV therapeutic drug levels are drawn routinely?
• Hypothyroidism • Diarrhea hydration • Is there a system to ensure lab results are
• Decreased PO intake • Nausea/vomiting • Transfer to hospital appropriately communicated to the physician
• Dehydration • Weakness/dizziness including when panic values are obtained?
• Concurrent • Stomach pain\ • Is there evidence of a system to ensure changes
administration of: • Hand tremors or in condition are identified and assessed
• Diuretics muscle twitches promptly, including an assessment of
• ACE inhibitors • Slurred speech medications?
• NSAIDS • Abnormal ECG • For residents with risk factors for drug toxicity
• Neuroleptics • Incoordination related to lithium use, does the care plan reflect
• Antiepileptics • Uncontrollable eye interdisciplinary monitoring for signs/symptoms
movements of adverse drug reactions to lithium?
• Calcium
• Seizures • Is there a system to ensure extended-release
antagonists
• Coma formulations are delivered correctly (e.g.,
medications not crushed)?
Drug toxicity • Existing liver disease • Loss of appetite, • Stat order for drug • Is there evidence of a system for ensuring
related to • Impaired renal • Nausea/vomiting level (VPA) therapeutic drug levels are drawn routinely?
valproic acid function • Confusion • Order for brain CT • Is there a system to ensure lab results are
• Concurrent • Dizziness (looking for edema) appropriately communicated to the physician

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and
Adverse Drug increase the potential for Symptoms (S/S) - Any of
Event (ADE) ADEs. Multiple factors these may indicate an
increase risk. ADE may have occurred.
administration: • Lethargy
• Antidepressants • Numbness, tingling,
• Benzodiazepines weakness, or
• Antibiotics involuntary muscle
twitching,
• Increased heart rate
• Decreased respirations
Drug toxicity • History of renal • Elevated kidney
related to disease/insufficiency function tests
antibiotics • Concurrent • Elevated liver function
administration with: tests
• Medications that • Elevated serum
raise PT/INR or potassium
PTT • Decrease in platelets
• Phenytoin • Nausea/vomiting
• Other antibiotics • Diarrhea
• Loss of appetite
• Flushing of skin
• Lethargy
• Dizziness
• Hearing loss
• Rash
• Seizures
• Ventricular
arrhythmias
• Peripheral neuropathy
Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.
Triggers: Clinical
Interventions - These
actions may indicate an
ADE occurred.
• Order for ECG
• Administration of
Narcan, L-carnitine, or
activated charcoal
• Orders for abrupt
discontinuation of
medication
• ECG order
• Order for Stat lab
work
Surveyor Probes - These questions are designed to
assist in the investigation. A negative answer does
not necessarily indicate noncompliance.
including when panic values are obtained?
• Is there evidence of a system to ensure changes
in condition are identified and assessed
promptly, including an assessment of
medications?
• For residents with risk factors for drug toxicity
related to valproic acid use, does the care plan
reflect interdisciplinary monitoring for
signs/symptoms of adverse drug reactions to
valproic acid?
• Is there a system to ensure extended-release
formulations are delivered correctly (e.g.,
medications not crushed)?
• Is there evidence in the medical record for
clinical indication?
• Is the order time limited?
• Does the care plan and/or medication
administration record (MAR) reflect special
instructions related to antibiotic administration
such as taking with food or water, infusing IV
antibiotic over certain time period, monitoring of
drug levels and other labs (as appropriate)?
• Is there evidence of a system to ensure changes
in condition are identified and assessed
promptly, including an assessment of
medications?
• Is there a system to ensure lab results are
appropriately communicated to the physician
including when panic values are obtained?
• For residents with liver or kidney disease, is
there evidence of additional monitoring to
ensure antibiotics do not adversely affect kidney
 Adverse Drug Event Trigger Tool
Risk Factors - These Triggers: Signs and Triggers: Clinical
Surveyor Probes - These questions are designed to
Adverse Drug increase the potential for Symptoms (S/S) - Any of Interventions - These
assist in the investigation. A negative answer does
Event (ADE) ADEs. Multiple factors these may indicate an actions may indicate an
not necessarily indicate noncompliance.
increase risk. ADE may have occurred. ADE occurred.
• Esophagitis or liver function, i.e., additional lab work,
• Symptoms of monitoring intake/output?
hypoglycemia • Is there evidence of a system to evaluate
• Phlebitis appropriate use of antibiotics, i.e. an antibiotic
stewardship program?
• For residents with risk factors for drug toxicity
related to antibiotic use, does the care plan
reflect interdisciplinary monitoring for
signs/symptoms of adverse drug reactions to
antibiotics?
• Is there a system to ensure that dietary
adjustments are made if needed when antibiotics
are ordered?
• Is there a system to ensure antibiotics are not
given in conjunction with medications that
impact their absorption (e.g., Milk of
Magnesia)?
Altered cardiac • Advanced age • Fainting • Abrupt stop of • Is there evidence of a system to ensure changes
output related to • History of heart • Falls medication in condition are identified and assessed
cardiac attack, arrhythmia, • Elevation/drop in BP • IV fluids promptly, including an assessment of
medications cardiomyopathies, or • Bradycardia • Transfer to hospital medications?
(blood pressure CHF • Dizziness • For residents with risk factors for altered cardiac
medications, • Light-headedness input related to cardiac medications, does the
beta blockers) • Nausea care plan reflect interdisciplinary monitoring for
• Sweating signs/symptoms of altered cardiac output?
• Weakness/fatigue • Is there a system to ensure routine monitoring of
• Visual disturbances cardiac status for residents receiving blood
pressure medications (e.g., blood pressure
• Clamminess
monitoring)?
• Loss of consciousness

Disclaimer: Use of this tool is not mandated by the Centers for Medicare & Medicaid Services (CMS) for regulatory compliance nor does
its use ensure regulatory compliance.