Article Figures & Data
Tables
Estimated Value 95% CI Sensitivity 29% 27%-31% Specificity 93% 92%-94% PPV 57% 54%-60% NPV 81% 80%-81% LR+ 4.22 3.78-4.72 LR– 0.76 0.74-0.78 ADE = adverse drug effect; LR+ = positive likelihood ratio; LR− = negative likelihood ratio; NPV = negative predictive value; PPV = positive predictive value.
Note: Based on the number of patients with an ADE (reported symptom established as an ADE, true and false positive and true and false negative).
ADEa Patients Self-Reporting ADE, No. (%) Main Therapeutic Drug Group Associated With ADE No. (%) of Therapeutic Drug Group With ADEb Severity Bothered, No. (%) Reported to Physician, No. (%) Sensitivity, % Specificity, % Bruise easily 266 (31) Antithrombotic agents (eg, aspirin, warfarin) 249 (49) Mild 55 (21) 74 (28) 53 90 Difficulty stopping a small cut from bleeding 101 (12) Antithrombotic agents (eg, aspirin, warfarin) 97 (19) Mild 26 (26) 22 (22) 73 72 Up at night to urinate 153 (18) Diuretics (eg, furosemide, bendroflumethiazide) 147 (44) Mild 43 (28) 33 (22) 18 95 Dizziness or lightheadedness 117 (14) Diuretics (eg, furosemide, bendroflumethiazide) 19 (6) Mild 71 (61) 73 (62) 28 84 Beta-blocking agents (eg, bisoprolol, atenolol, metoprolol) 32 (13) Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) 32 (31) Psychoanaleptics (eg, amitriptyline, doxepin) 10 (15) Psycholeptics (eg, benzodiazepine derivatives, trifluoperazine) 15 (31) Unsteadiness while standing 75 (9) Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) 28 (27) Mild 39 (52) 33 (44) 4 100 Psychoanaleptics (eg, amitriptyline, doxepin) 10 (15) Psycholeptics (eg, benzodiazepine derivatives, trifluoperazine) 20 (42) Constipation 137 (16) Calcium channel blockers (eg, amlodipine, lercanidipine, diltiazem) 28 (21) Mild 69 (50) 73 (53) 22 89 Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) 40 (39) Psychoanaleptics (eg, amitriptyline, doxepin) 11 (17) Indigestion or heartburn 115 (13) Antithrombotic agents (eg, aspirin, warfarin) 92 (18) Mild 38 (33) 57 (50) 12 89 Anti-inflammatory and antirheumatic products (eg, diclofenac, ibuprofen, etoricoxib) 23 (32) Fatigue or unusual tiredness 87 (10) Beta-blocking agents (eg, bisoprolol, atenolol, metoprolol) 38 (15) Mild 43 (49) 24 (28) 17 92 Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) 30 (29) Dry mouth 84 (10) Diuretics (eg, furosemide, bendroflumethiazide) 50 (15) Mild 28 (33) 17 (20) 33 77 Psychoanaleptics (eg, amitriptyline, doxepin) 12 (18) Ankle swelling 68 (8) Calcium channel blockers (eg, amlodipine, lercanidipine, diltiazem) 68 (52) Mild 25 (37) 44 (65) 27 90 Cough 66 (8) Agents acting on the renin-angiotensin system (eg, ramipril, perindopril, lisinopril) 62 (52) Mild 35 (53) 37 (56) 18 90 Muscle pain or weakness 57 (7) Serum lipid–reducing agents (eg, atorvastatin, pravastatin, rosuvastatin, simvastatin) 48 (43) Mild 43 (75) 27 (47) 18 96 ADE = adverse drug effect.
↵a ADE is a patient-reported symptom that was established as an ADE per independent clinician review.
b The proportion of patients with an ADE to this therapeutic drug group as a percentage of the overall number of patients prescribed medication from this therapeutic group during the study period.
Physiologic System ADEa Main Therapeutic Drug Group Associated With ADE Severity Rating Hospital A&E (n = 32), No. (%) Hospital Outpatient (n = 26), No. (%) Central nervous system Dizziness/unsteadiness on feet/falls Beta-blocking agents, diuretics, psychoanaleptics, psycholeptics, analgesics Moderate 13 (41) 3 (12) Gastrointestinal Pain in abdomen, diarrhea Anti-inflammatory and antirheumatic products, proton-pump inhibitors Mild 11 (34) 8 (31) Cardiovascular Fainting Beta-blocking agents, diuretics Moderate 3 (9) 1 (4) Genitourinary Up at night to urinate, urinating more or less often Diuretics Mild 2 (6) 5 (19) Musculoskeletal Muscle pain or weakness Serum lipid–reducing agents Mild 0 3 (12) A&E = accident & emergency department; ADE = adverse drug effect.
↵a ADE is a patient-reported symptom that was established as an ADE per independent clinician review.
Additional Files
The Article in Brief
Identifying Adverse Drug Events in Older Community-Dwelling Patients
Caitriona Cahir , and colleagues
Background Patient reporting of suspected adverse drug events could increase knowledge about the safety of medication and provide important information to healthcare professionals. This study evaluates a patient-reported instrument for identifying adverse drug events in older adults with multiple medical conditions in the community setting
What This Study Found Older adults often do not recognize a medical symptom as an adverse effect of their medication. In the study, patients 70 years of age or older were asked if they had experienced a list of 74 symptoms in the previous six months and if, (1) they believed the symptom was related to their medication; (2) the symptom had bothered them; (3) they had discussed it with their family physician, and (4) they required hospital care due to the symptom. Self-reported symptoms were independently reviewed by two clinicians who determined the likelihood that the symptom was an adverse drug event. Family physician medical records were also reviewed for any report of an adverse drug event. Among 859 participating patients, 674 (78 percent) were classified as having at least one adverse drug event during the study period. Antithrombotic drugs (intended to reduce the formation of blood clots) were most frequently associated with adverse drug events, with 86 percent of patients prescribed aspirin and warfarin reporting bruising, bleeding, and indigestion. Patients were most bothered by muscle pain and weakness (75 percent), dizziness or lightheadedness (61 percent), and unsteadiness on their feet (52 percent) but did not associate these symptoms with their medication. Patients were less bothered by more prevalent adverse drug events; only 21 percent were bothered by minor hemorrhages from antithrombotic therapy. On average, patients reported 39 percent of adverse drug events to their family physician. Patients who did not do so felt the symptoms were the result of old age and did not want to bother their doctors.
Implications
- The authors call for health information technology and patient outreach programs to manage and track medication symptoms and help patients monitor their medications.