Safety Assessment and Plan When Initiating Antidepressant Therapy
Your assessment and plan must prioritize suicide risk monitoring, particularly during the first 1-2 months of treatment, as SSRIs are associated with increased nonfatal suicide attempts (odds ratio 2.25) and the risk is greatest early in treatment. 1, 2
Baseline Safety Assessment
Suicide Risk Evaluation
- Document current suicidal ideation, intent, plan, and access to means at every visit, with heightened vigilance during initial treatment and dose adjustments 2, 3
- Screen for risk factors including prior suicide attempts, family history of suicide, bipolar disorder, substance use, and recent psychosocial stressors 2
- Establish a safety plan with emergency contacts and crisis resources before prescribing 2
Medical Contraindications and Drug Interactions
- Review all current medications for serotonergic agents (triptans, tramadol, MAOIs) to prevent serotonin syndrome, which requires immediate hospitalization if advanced symptoms develop 2
- Screen for bleeding risk factors if patient takes NSAIDs, aspirin, or warfarin, as SSRIs increase bleeding risk when combined with these agents 2
- Assess cardiovascular history, particularly for venlafaxine (increased cardiovascular events) and escitalopram doses >20mg (QT prolongation) 1
- Document seizure history if considering bupropion (increased seizure risk) and hepatic function if considering nefazodone (hepatotoxicity risk) 1
Comorbidity Screening
- Screen for bipolar disorder history, as antidepressants can precipitate mania without mood stabilizer coverage 2
- Assess for substance use disorders that may interfere with treatment adherence 4
- In diabetic patients, monitor for depression recurrence as this population has elevated rates requiring ongoing surveillance 1
Safety Plan Documentation
Monitoring Schedule
- Schedule follow-up within 1-2 weeks of initiation, then every 2-4 weeks during dose titration, then monthly once stable 4, 2
- Use standardized depression scales (PHQ-9) at each visit to objectively track response 4
Patient and Family Education (FDA-Mandated)
- Provide the FDA Medication Guide and review it with patient and family members present 2
- Instruct patient and caregivers to monitor daily for: new or worsening anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, worsening depression, and suicidal ideation 2
- Emphasize these symptoms may be abrupt in onset and require immediate contact with prescriber 2
- Warn against abrupt discontinuation without medical supervision due to discontinuation syndrome risk 2
Specific Adverse Effect Monitoring
- Common side effects to anticipate and document: nausea (most common reason for discontinuation), vomiting, constipation, diarrhea, dizziness, headache, insomnia, sexual dysfunction, and somnolence 1
- Paroxetine specifically carries higher sexual dysfunction risk and should be avoided in older adults 1
- Monitor for behavioral activation/agitation, particularly in younger patients, supporting gradual dose titration 5
Treatment Response Timeline
- Document that full response requires 6-8 weeks at therapeutic dose before declaring treatment failure 4, 3
- Plan to reassess and modify treatment if inadequate response after 6-8 weeks 4
Critical Safety Documentation
Assessment Section
- Current suicidal ideation: present/absent, with severity rating
- Prior suicide attempts and psychiatric hospitalizations
- Complete medication list with attention to serotonergic agents, anticoagulants, and CYP2D6 substrates
- Cardiovascular risk factors, seizure history, hepatic function
- Bipolar screening results
- Baseline depression severity score (PHQ-9)
- Patient and family understanding of warning signs
Plan Section
- Specific antidepressant chosen with rationale based on adverse effect profile, drug interactions, and patient preference 1
- Starting dose (typically subtherapeutic "test dose" to minimize initial activation) with titration schedule 5
- Follow-up interval (1-2 weeks initially) 4, 2
- Emergency contact plan and crisis resources provided
- FDA Medication Guide provided and reviewed
- Family/caregiver education completed
- Plan for reassessment at 6-8 weeks 4
- Duration of continuation therapy after remission: minimum 6-12 months for first episode, longer for recurrent depression 4, 3
Common Pitfalls to Avoid
- Never prescribe antidepressants without establishing suicide risk monitoring protocol, as the increased risk of nonfatal suicide attempts with SSRIs is well-documented 1
- Do not combine multiple serotonergic agents without careful risk-benefit analysis due to serotonin syndrome risk 2
- Avoid declaring treatment failure before 6-8 weeks at therapeutic dose 4, 3
- Do not omit family/caregiver education, as they are essential for monitoring day-to-day behavioral changes 2