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Adverse 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 that are known to be high-risk and problem-prone, and 3. When a preventable 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 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. • : 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 • 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 the PRN? • Low fluid • Pulse • Can staff describe signs/symptoms of over- intake/dehydration • Pulse oximetry • sedation? Low body weight • Respirations • Is there evidence of a system for ensuring “hand • History of head 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 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. status record contain documentation of risk vs. • Emotional changes benefits? Clinical rationale? (including new anger, • If an EHR is used, are finger stick glucose sadness, stubbornness) testing results incorporated into it? • Lightheadedness, • Is there evidence that finger stick glucose results dizziness are routinely reviewed for effectiveness as part • Hunger of the care plan? • Nausea • Is there evidence that the facility routinely • Complaints of blurred educates caregivers on risk factors and or impaired vision symptoms/signs of hypoglycemia? • Tingling or numbness • Is the resident and family educated regarding the in lips and/or tongue signs and symptoms of hypoglycemia and • Weakness, fatigue, or regarding the resident’s diabetes management somnolence plan • Incoordination • Does the facility have low blood sugar protocols • Seizures in place? • Unconsciousness • Is there a system to ensure lab results, including • Rapid heartbeat 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. Ketoacidosis • Diabetic residents • Lab results indicating: • Stat order for lab • Is there evidence of a system for routine related to insulin with concurrent • Profound testing including to monitoring of blood sugar? therapy illnesses dehydration evaluate blood sugar • If the resident refuses antidiabetic medication or • Infection • Elevated blood and fluid and consumes foods not included in usual/planned • Diabetic residents glucose electrolyte status diet, is there evidence of an interdisciplinary with consistently high • Ketones in urine • Stat order for insulin plan to address refusals that includes the blood glucose levels • Excessive thirst • New order for and prescriber and the family, as appropriate? • Episodes of high • Frequent urination administration of IV • For residents with risk factors for ketoacidosis,

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. 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 • , • 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? ) 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 • 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 )? 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.

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. Electrolyte • Use of diuretics • Abnormal electrolytes • Abrupt stop order for • For residents with risk factors for dehydration, imbalance • Advanced age • Dry skin and mucous diuretic medication does the care plan reflect interdisciplinary (including • Dependence in ADLs membranes including • New order for labs approaches for prevention including: dehydration and – especially eating cracked lips • New order for and • Monitoring for signs and symptoms of acute kidney • Diagnosis of • Poor skin turgor administration of IV dehydration, and injury) related to dementia • Thirst fluids • Observation/documentation of consumption diuretic use • Fluid restrictions • Confusion • Transfer to hospital of liquids? • Recent diarrhea or • Concentrated urine • Is there evidence of a system for timely vomiting and/or decreased identification of residents with risk factors for • Hot weather or other output dehydration? trigger for increased • Lethargy • Does the facility have protocols for: fluid needs • Elevated temperature • Hydration? • Use of medical • Low BP with increase • Monitoring intake and output? devices that increase in pulse • Dehydration risk assessment? fluid needs (e.g., air- • Weight loss • Fluid intake assessment? fluidized mattresses) • 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? Drug • Concurrent routine • Elevated function • Abrupt stop of all • Is there evidence of a system for ensuring related to and PRN orders for tests acetaminophen residents with orders for routine or PRN acetaminophen acetaminophen and • Fatigue or weakness products acetaminophen do not receive more than 4 grams medications • Abdominal pain • Transfer to hospital in a 24 hour period? containing • Loss of appetite • New order for liver • Is there evidence of a system to ensure that acetaminophen • Jaundice, including function tests medications that contain acetaminophen are • Failure to have a yellowing of sclera • New order for N- flagged to alert medication nurses that the maximum daily dose • Itching resident has more than one medication of acetaminophen • Bruising containing acetaminophen ordered?

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. 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 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 medications? • Visual disturbances antibody (e.g., • (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 appropriately communicated to the physician • Nausea/vomiting 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 reflect interdisciplinary monitoring for • Rapid or pounding 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 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 S/S • Anticoagulants • Swelling of soft • Cyclosporine tissues • Potassium • Shortness of breath supplements • Wheezing • Persistent non- productive cough

Acute 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 interdisciplinary monitoring for signs/symptoms • Antiepileptics • Uncontrollable eye of adverse drug reactions to lithium? • Calcium movements • Is there a system to ensure extended-release antagonists • Seizures formulations are delivered correctly (e.g., • Coma 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 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. administration: • Lethargy • Order for ECG including when panic values are obtained? • Antidepressants • Numbness, tingling, • Administration of • Is there evidence of a system to ensure changes • Benzodiazepines weakness, or Narcan, L-carnitine, or in condition are identified and assessed • Antibiotics involuntary muscle activated charcoal promptly, including an assessment of twitching, medications? • Increased heart rate • For residents with risk factors for drug toxicity • Decreased respirations 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)? Drug toxicity • History of renal • Elevated kidney • Orders for abrupt • Is there evidence in the medical record for related to disease/insufficiency function tests discontinuation of clinical indication? antibiotics • Concurrent • Elevated liver function medication • Is the order time limited? administration with: tests • ECG order • Does the care plan and/or medication • Medications that • Elevated serum • Order for Stat lab administration record (MAR) reflect special raise PT/INR or potassium work instructions related to administration PTT • Decrease in platelets such as taking with food or water, infusing IV • Phenytoin • Nausea/vomiting antibiotic over certain time period, monitoring of • Other antibiotics • Diarrhea drug levels and other labs (as appropriate)? • Loss of appetite • Is there evidence of a system to ensure changes • Flushing of skin in condition are identified and assessed • Lethargy promptly, including an assessment of • Dizziness medications? • • Hearing loss Is there a system to ensure lab results are appropriately communicated to the physician • Rash including when panic values are obtained? • Seizures • For residents with liver or kidney disease, is • Ventricular there evidence of additional monitoring to arrhythmias ensure antibiotics do not adversely affect kidney • 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.

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 cardiac status for residents receiving blood • Visual disturbances 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.