Background
Methods
Study design
Selection of the expert panel
Identification of candidate indicators
Definitions
High-risk prescribing
Overprescribing
Design of the rating form and supporting materials
Candidate indicators | Median “necessity” rating after rating round 2 | Accepted for the 3rd round |
---|---|---|
ADR: falls and fall-related injuries | ||
A. History of fall and prescribed one single antidepressant with sedating, anticholinergic, or orthostatic properties (TCA, mirtazapine, or trazodone) | 7 | Accepted |
B. History of fall and prescribed one single antidepressant with sedating, anticholinergic, or orthostatic properties (TCA, mirtazapine, or trazodone) with one further fall risk-increasing drug | 8 | Redundant |
C. History of fall and prescribed one single antidepressant with sedating, anticholinergic, or orthostatic properties (TCA, mirtazapine, or trazodone) with two or more further fall risk-increasing drugs | 9 | Redundant |
Rating constructs and scales
Necessity of review
Rating construct | Definition and rating scales |
---|---|
Necessity of review | For an average patient treated with antidepressants in primary care: Assuming no overprescribing/high-risk prescribing, how necessarya is it to conduct a critical review* of antidepressant use within the next 3 months in order to prevent adverse effects/reduce medication burden? 1–3 = not necessary; 4–6 = might be necessary; 7–9 = clearly necessary |
Likelihood of harm | How likely is it that the patient will experience an adverse drug reaction if the clinical situation was to be continued for another year? 1–3 = unlikely; 4–6 = possible; 7–9 = probable |
Severity of harm | If the patient experienced an adverse drug event as a result of antidepressant use, how severe would it be? 1–3 = minor; 4–6 = moderate; 7–9 = major |
Likelihood and severity of harm
Rating scales
RAM process
Results
Expert panel composition
Candidate indicators
High-risk prescribing
Overprescribing
RAM process
High-risk prescribing
High-risk prescribing indicators | Median | Agreement | Range |
---|---|---|---|
A. Cardiovascular adverse effects | |||
1. Prescribed SNRI, TCA (in doses ≥ 50 mg/day)A, or tranylcypromineB - and the patient has a history of chronic heart failure | 8 | 90% | 6–9 |
2. Prescribed TCA (in doses ≥ 50 mg/day) - and the patient has a history of ischemic heart disease | 8 | 100% | 7–9 |
3. Prescribed > 20 mg citalopram or > 10 mg escitalopram daily - and the patient is aged ≥ 65 years (risk of QTc prolongation) | 7 | 70% | 2–9 |
4. Prescribed citalopram and escitalopram - and the patient has long QT syndrome or is at risk of long QT syndrome (e.g., (advanced) chronic heart failure, ischemic heart disease, myocardial hypertrophy, bradyarrhythmias, or an ongoing risk of hypokalaemiac) | 9 | 100% | 7–9 |
5. Prescribed citalopram, escitalopram, or TCA (in doses ≥ 50 mg/day) - and the patient is co-prescribed ≥ 1 further drug with any risk of TdPc | 7 | 78% | 6–9 |
6. Prescribed TCA (in doses ≥ 50 mg/day), SNRI, bupropion, or tranylcypromineB - and the patient has developed tachycardia | 8 | 90% | 6–9 |
7. Prescribed fluoxetine, paroxetine, or bupropion - and the patient is co-prescribed metoprolol or propranolol (risk of bradycardia) | 7 | 60% | 2–9 |
8. Prescribed SNRI, TCA (in doses ≥ 50 mg/day), bupropion, or tranylcypromine - and the patient has uncontrolled hypertensionc | 8 | 100% | 7–9 |
9. Prescribed SNRI, TCA (in doses ≥ 50 mg/day), bupropion, or tranylcypromine - and achieving hypertension control requires ≥ 3 antihypertensive drugs | 8 | 80% | 4–9 |
B. Orthostatic hypotension (OH)/dizziness | |||
1. Prescribed TCA (in doses ≥ 50 mg/day), trazodone, or tranylcypromine - and the patient has developed persistent OH/dizziness under treatment | 8 | 100% | 7–9 |
2. Prescribed SSRI, SNRI, or mirtazapine - and the patient is aged ≥ 65 years and has developed persistent OH/dizziness under treatment | 8 | 100% | 7–9 |
3. Prescribed TCA (in doses ≥ 50 mg/day), trazodone, or tranylcypromine - and the patient is aged ≥ 65 years and co-prescribed ≥ 1 further drug with known blood pressure lowering effect (e.g., α-blockers, β-blockers, nitrates, SGLT inhibitors, levodopa, antipsychotics)c | 7 | 60% | 5–9 |
4. Prescribed SSRI, SNRI, or mirtazapine - and the patient is aged ≥ 65 years and co-prescribed ≥ 2 further drugs with blood pressure lowering effect (e.g., α-blockers, β-blockers, nitrates, SGLT inhibitors, levodopa, antipsychotics) | 7 | 67% | 5–9 |
C. Falls and fall-related injuries | |||
1. Prescribed any antidepressant - and the patient is aged ≥ 65 years and co-prescribed ≥ 1 further fall risk-increasing drugc | 7 | 60% | 2–9 |
2. Prescribed any antidepressant - and the patient has a history of falls | 8 | 60% | 2–9 |
3. Prescribed any antidepressant - and the patient has cognitive impairment or dementia | 7 | 60% | 2–9 |
4. Prescribed any antidepressant - and the patient has a history of stroke and co-prescribed ≥ 1 further fall-risk-increasing drug | 8 | 70% | 2–9 |
D. Cognitive decline and delirium | |||
1. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient has cognitive impairment or dementia | 8 | 90% | 6–9 |
2. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient has a history of delirium and co-prescribed ≥ 1 further drug known to induce delirium (e.g., benzodiazepines, opioids, antihistamines, diuretics)c | 8 | 100% | 7–9 |
3. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient is aged ≥ 65 years and co-prescribed ≥ 2 further drugs known to induce delirium (e.g., benzodiazepines, opioids, antihistamines, diuretics) | 9 | 100% | 7–9 |
E. Serotonin syndrome | |||
1. Prescribed tranylcypromine - and the patient is co-prescribed ≥ 1 further serotonergic drug (e.g., tramadol, fentanyl, triptans, metoclopramide, SSRI, SNRI, TCA)c | 7 | 70% | 5–9 |
2. Prescribed SSRI, SNRI, or TCA (in doses ≥ 50 mg/day) - and the patient is co-prescribed ≥ 2 further serotonergic drugs other than tranylcypromine (e.g., tramadol, fentanyl, triptans, metoclopramide, another serotonergic antidepressant) | 8 | 80% | 5–9 |
F. Gastrointestinal bleeding | |||
1. Prescribed SSRI or SNRI - and the patient is aged ≥ 65 years and co-prescribed a single of the following without GI protection: antiplatelet, anticoagulant, and NSAID | 7 | 60% | 6–9 |
2. Prescribed SSRI or SNRI - and the patient is aged ≥ 65 years and co-prescribed ≥ 2 of the following: antiplatelet, anticoagulant, and NSAID (regardless of GI protection) | 8 | 100% | 7–9 |
3. Prescribed SSRI or SNRI - and the patient has at least one risk factor for GI bleeding (history of peptic ulcer disease, GI bleeding, or hemophilia) and co-prescribed ≥ 1 of the following: antiplatelet, anticoagulant, and NSAID (regardless of GI protection) | 9 | 70% | 2–9 |
G. Bleeding | |||
1. Prescribed SSRI - and the patient has a history of a bleeding event and co-prescribed ≥ 1 of the following: anticoagulant or antiplatelet | 8 | 70% | 6–9 |
2. Prescribed SSRI - and the patient has at least one risk factor for intracranial bleeding (aged ≥ 65 years, history of stroke, history of dementia) and co-prescribed ≥ 1 of the following: anticoagulant or antiplatelet | 7 | 90% | 5–9 |
H. Constipation | |||
1. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient has persistent constipation | 7 | 70% | 5–9 |
2. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient is aged ≥ 65 years and co-prescribed ≥ 2 further drugs known to have constipating effects (e.g., calcium antagonists, opioid, antihistamines, antipsychotics) | 8 | 90% | 5–9 |
I. Hyponatremia | |||
1. Prescribed any antidepressant - and the patient has developed hyponatremia (< 130 mmol/l) under treatment without being treated with a diuretic | 7 | 90% | 6–9 |
2. Prescribed SSRI or SNRI - and the patient is aged ≥ 65 years and co-prescribed ≥ 2 further drugs known to cause hyponatremia (e.g., (thiazide) diuretics, antipsychotics, anticonvulsants, proton pump inhibitors)c | 8 | 80% | 2–9 |
J. Hepatic injury | |||
1. Prescribed agomelatine - and the patient has developed elevated serum transaminase levels (> 3 times the upper normal range) under treatment | 9 | 90% | 6–9 |
2. Prescribed agomelatine - and the patient has a hepatic impairment (i.e., cirrhosis or active liver disease) | 8 | 80% | |
K. Voiding disorders | |||
1. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient has a history of voiding disorders (e.g., urinary retention or benign prostatic hyperplasia) or has developed urinary retention under treatment | 7 | 60% | 3–9 |
L. Glaucoma | |||
1. Prescribed anticholinergic antidepressant opipramol, other TCAs (in doses ≥ 50 mg/day), or paroxetine - and the patient has a history of angle closure glaucoma or has developed angle closure glaucoma under treatment | 8 | 60% | 6–9 |
M. Sleep disturbances/agitation | |||
1. Prescribed SSRI, SNRI, MAOI, or bupropion - and the patient has persistent sleeping disturbances (e.g., insomnia, restless leg syndrome) or is experiencing agitation | 7 | 90% | 6–9 |
N. Sexual dysfunction | |||
1. Prescribed SSRI or SNRI - and the patient has developed sexual dysfunction | 8 | 90% | 6–9 |
Overprescribing
Overprescribing indicators | Median | Agreement | Range |
---|---|---|---|
Depression | |||
1. Prescribed an antidepressant - and the patient has a first episode of mild depression | 8 | 70% | 3–9 |
2. Co-prescribed two antidepressants - and the patient has a first episode of moderate depression | 8 | 67% | 3–9 |
3. Prescribed an antidepressant in monotherapy for ≥ 4 weeks - and the patient is aged < 65 years with no signs of clinically relevant symptom improvement1 | 7 | 80% | 4–9 |
4. Prescribed an antidepressant in monotherapy for ≥ 6 weeks - and the patient is aged ≥ 65 years with no signs of clinically relevant symptom improvement1 | 9 | 90% | 6–9 |
5. Prescribed an antidepressant in monotherapy - and the patient has previously used two or more different antidepressants (inadequate response) | 7 | 70% | 3–9 |
6. Prescribed an antidepressant in monotherapy, combination, or augmentation > 12 months for a first episode of moderate or severe depression - and the patient has achieved full remission | 7 | 80% | 3–9 |
7. Prescribed an antidepressant in monotherapy, combination, or augmentation > 2 years with a history of 2 or more depressive episodes with functional impairment in the last 5 years - and the patient has achieved full remission | 7 | 70% | 4–9 |
8. Prescribed SSRI at a dose of > 1 DDD - and the patient has no clinically relevant symptom improvement under an SSRI dose ≤ 1 DDD (no further dose increase if symptoms remain/worsen) | 8 | 70% | 3–9 |
9. Prescribed two antidepressants - and none of those is mirtazapine, mianserin, or trazodone | 8 | 90% | 6–9 |
Anxiety | |||
1. Prescribed an antidepressant for ≥ 8 weeks - and the patient is aged < 65 years with no signs of clinically relevant symptom improvement1 | 8 | 90% | 6–9 |
2. Prescribed an antidepressant for ≥ 12 weeks - and the patient is aged ≥ 65 years with no signs of clinically relevant symptom improvement | 8 | 100% | 7–9 |
3. Prescribed an antidepressant > 12 months for anxiety - and the patient has achieved full remission | 7 | 70% | 2–9 |
4. Prescribed an antidepressant for anxiety - and the patient is co-prescribed benzodiazepine > 4 weeks | 9 | 100% | 7–9 |
Insomnia | |||
1. Prescribed TCA ≥ 50 mg/day for insomnia2 - and the patient has no other indications for an antidepressant | 7 | 70% | 5–9 |
2. Prescribed trazodone ≥ 50 mg/day for insomnia - and the patient has no other indications for an antidepressant | 8 | 80% | 5–9 |
3. Prescribed mirtazapine ≥ 30 mg/day for insomnia - and the patient has no other indications for an antidepressant | 7 | 80% | 3–9 |
4. Prescribed a sedating antidepressant > 8 weeks for insomnia - and the patient has no other indications for an antidepressant | 8 | 80% | 5–9 |
Pain | |||
1. Prescribed a TCA ≥ 75 mg/day for neuropathic pain - and the patient has no other indications for an antidepressant | 7 | 60% | 3–9 |
2. Prescribed venlafaxine ≥ 150 mg/day for neuropathic pain - and the patient has no other indications for an antidepressant | 8 | 80% | 6–9 |
3. Prescribed SSRI or mirtazapine for neuropathic pain - and the patient has no other indications for an antidepressant | 8 | 90% | 6–9 |
4. Prescribed any antidepressant for non-specific low back pain - and the patient has no other indications for an antidepressant | 8 | 90% | 6–9 |
5. Prescribed TCA or SNRI as analgesic for pain (e.g., pain other than neuropathic pain, tension headache, migraine, or fibromyalgia syndrome) - and the patient has no other indications for an antidepressant | 8 | 70% | 5–9 |
Miscellaneous | |||
1. Prescribed any antidepressant - and the patient has chronic heart failure and a first episode of mild or moderate depression | 7 | 70% | 2–9 |
2. Prescribed any antidepressant - and the patient has dementia and a first episode of mild or moderate depression | 7 | 70% | 2–9 |
3. Prescribed agomelatine - and the patient is aged ≥ 75 years | 7 | 70% | 5–9 |