Table 2.
Descriptive statistics of included ADE reports, by severity
| Overall (N = 3174) | Serious ADEsa (N = 1800) | |
|---|---|---|
| ADE types, n (%) | ||
| Adverse drug reactionb | 2340 (73.7) | 1362 (75.7) |
| Non-adherence | 357 (11.3) | 257 (14.3) |
| Allergyb | 249 (7.8) | 58 (3.2) |
| Supratherapeutic dose | 90 (2.8) | 52 (2.9) |
| Drug–drug interaction | 44 (1.4) | 22 (1.2) |
| Drug misuse | 28 (0.9) | 14 (0.8) |
| Subtherapeutic dose | 24 (0.8) | 11 (0.6) |
| Other (e.g., drug-disease interaction) | 14 (0.4) | 9 (0.5) |
| Treatment failure | 14 (0.4) | 9 (0.5) |
| Drug withdrawal | 10 (0.3) | Suppressed |
| Incorrect drug | Suppressed | Suppressed |
| Most common ADE drugs, n (%) | ||
| Hydrochlorothiazide | 120 (3.8) | 77 (4.3) |
| Ramipril | 113 (3.6) | 53 (2.9) |
| Apixaban | 99 (3.1) | 65 (3.6) |
| Furosemide | 99 (3.1) | 67 (3.7) |
| Acetylsalicylic acid | 95 (3.0) | 67 (3.7) |
| Warfarin | 88 (2.8) | 56 (3.1) |
| Rivaroxaban | 83 (2.6) | 47 (2.6) |
| Empagliflozin | 68 (2.1) | 58 (3.2) |
| Spironolactone | 66 (2.1) | 37 (2.1) |
| Sulfamethoxazole/trimethoprim | 58 (1.8) | 26 (1.4) |
| Most common ADE symptoms/diagnoses, n (%) | ||
| Hyponatremia | 223 (7.0) | 157 (8.7) |
| Acute kidney injury | 174 (5.5) | 126 (7.0) |
| Rash | 169 (5.3) | 36 (2.0) |
| Gastrointestinal hemorrhage | 127 (4.0) | 103 (5.7) |
| Hyperkalemia | 88 (2.8) | 45 (2.5) |
| Hypotension | 86 (2.7) | 51 (2.8) |
| Hypoglycemia | 83 (2.6) | 49 (2.7) |
| Bradycardia | 72 (2.3) | 43 (2.4) |
| Confusion | 71 (2.2) | 53 (2.9) |
| Nausea | 70 (2.2) | 26 (1.4) |
| ADE certainty, n (%) | ||
| Certain | 502 (15.8) | 291 (16.2) |
| Probable | 1791 (56.4) | 1081 (60.1) |
| Possible | 862 (27.2) | 419 (23.3) |
| Unlikely | 19 (0.6) | 9 (0.5) |
| Most serious ADE outcome reported, n (%) | ||
| Unknown | 249 (7.8) | 0 |
| Other (e.g., change in medication therapy) | 347 (10.9) | 0 |
| Worsened pre-existing condition | 84 (2.7) | 0 |
| Emergency visit | 694 (21.9) | 0 |
| Hospitalisation extended | 177 (5.6) | 177 (9.8) |
| Hospitalisation | 1393 (43.9) | 1393 (77.4) |
| Permanent disability | 10 (0.3) | 10 (0.6) |
| Life threatening | 211 (6.7) | 211 (11.7) |
| Fetal defect | 0 | 0 |
| Death | 9 (0.3) | 9 (0.5) |
ADE adverse drug event, ED emergency department, GP general practitioner
aSerious ADEs are those with an outcome of fetal defect, permanent disability, hospitalisation, extended hospitalisation, life threatening, or death
bOf the 2589 adverse drug reactions (ADRs) and allergies in the final cohort, 570 were not sent to PharmaNet because they were reported before the start of the randomised control trial and 606 reports were for drugs not eligible to be listed in PharmaNet (e.g., non-prescription drugs). Patients under 19 years old or with ADE outcomes of life threatening, fetal defect, or death were also excluded from the trial. 1129 patients with 1286 ADRs/allergies were included in the trial, of whom 538 patients with 648 ADRs/allergies were randomised to the control group where the ADR/allergy record was not sent to PharmaNet leaving 591 patients with 638 ADRs/allergy reports in PharmaNet as a part of the trial