Pharmacovigilance signal
Urgent active signal
Medication-associated vulnerability: probable
24-hour falls probability
31%
Personalised baseline: 12% | +19 pp
48-hour falls probability
43%
Trend: rising over previous 18 hours
Required clinical action
Same-day review
Prescriber or pharmacist review advised
Patient and medication context
EHPSEUDONYMISED
- Patient
- EH-0427 — female, 83
- Setting
- Assisted living; night-time transfers independently attempted
- Frailty status
- Moderate/severe frailty; prior fall within 6 months
- Mobility
- Walker indoors; recent reported unsteadiness
- Renal/hepatic flag
- eGFR mildly reduced; no acute hepatic flag
- Device
- Infinity Watch connected; 91% data completeness; last sync 07:45
N-of-1 baseline active
Recent dose change
FRID cluster present
Near-term risk trajectory
Current 24h risk31%
050100
Current 48h risk43%
050100
Medication-attributable vulnerability74/100
lowreviewurgent
Risk is a near-term probability estimate for clinician review, not a definitive prediction of an individual event.
Signal classification
| Axis | Classification |
|---|---|
| Severity | Increased vulnerability; no fall yet |
| Urgency | Same-day clinical review |
| Plausibility | Probable medication contribution |
| Expectedness | Known class effects: sedation, orthostasis, anticholinergic burden |
| Preventability | Probably preventable with earlier medication review and transfer precautions |
| Reportability | Internal safety case now; formal ADR assessment if fall, injury, collapse or serious near miss occurs |
Medication exposure and clinician review options
| Medicine | Current concern | Mechanism | Review option for clinician consideration | Signal |
|---|---|---|---|---|
| Zopiclone 7.5 mg nocte Dose increased 3 nights ago |
Nocturnal sedation and transfer instability | Sedation, ataxia, psychomotor slowing | Review dose, duration and indication; consider non-pharmacological sleep pathway or lower-risk plan | High |
| Oxybutynin 5 mg bd | Anticholinergic burden with confusion/nocturnal urgency risk | Confusion, blurred vision, urinary effects | Review anticholinergic load; consider bladder-symptom alternatives or deprescribing review | High |
| Ramipril 10 mg od | MAP below personalised baseline after morning dose | Hypotension/orthostasis | Review BP profile, timing, hydration, renal function and postural measurements | Mod |
| Tramadol 50 mg prn Taken twice yesterday |
Additional sedation and dizziness burden | Sedation, dizziness, respiratory suppression risk | Review analgesia need, timing, constipation/nocturnal toileting, and safer pain plan | Mod |
Clinician actionSame-day medication review; pharmacist/prescriber triage.
Care actionIncrease night-time transfer observation and hydration review.
Safety actionCapture near-fall/fall outcomes and update case status.
Active mechanisms and wearable contributors
Sedative loadZopiclone dose increase + tramadol use; reduced nocturnal movement stability.
Orthostatic patternMAP 9 mmHg below N-of-1 baseline; morning dip detected.
Anticholinergic burdenOxybutynin contribution; confusion/urgency pathway plausible.
Nocturnal transfer exposure3 bed-exit events after midnight; gait proxy volatility raised.
Infinity Watch stream
| Measure | Current | N-of-1 deviation |
|---|---|---|
| MAP | 72 mmHg | -9 mmHg |
| Heart rate | 88 bpm | +6 bpm |
| Oxygen saturation | 94% | -2.5% |
| Respiratory rate | 19/min | +2/min |
| Activity volatility | Raised | night-time instability |
Pharmacovigilance workflow
07:45 — Signal generated
PV score crossed urgent threshold: medicine exposure + N-of-1 deviation + 48h risk rise.
PV score crossed urgent threshold: medicine exposure + N-of-1 deviation + 48h risk rise.
07:46 — Case opened
Structured safety case EH-PV-2026-0619-0427 created.
Structured safety case EH-PV-2026-0619-0427 created.
07:47 — Escalation routed
Assigned to nurse lead, clinical pharmacist and prescriber queue.
Assigned to nurse lead, clinical pharmacist and prescriber queue.
Pending — Clinical review
Medication review, postural BP, hydration/infection screen and observation plan to be documented.
Medication review, postural BP, hydration/infection screen and observation plan to be documented.
| Field | Simulated content |
|---|---|
| Case ID | EH-PV-2026-0619-0427 |
| Status | Pre-event pharmacovigilance signal; no fall documented |
| Suspected medicines | Zopiclone, oxybutynin, ramipril, tramadol cluster |
| Alternative explanations | Possible dehydration and poor sleep; infection not yet excluded |
| Required outcome capture | Medication action, observations, postural BP, symptoms, falls/near-falls over 48h |
| Reporting route | Internal safety review now; suspected ADR assessment if harm event occurs |
| Item | Version / status |
|---|---|
| MAV engine | v6.0 simulation |
| Falls probability layer | Personalised Adaptive Learning Layer active |
| Pharmacovigilance rules | PV ruleset 0.3; urgent threshold crossed |
| Data quality | 91% wearable completeness; medication list requires pharmacist confirmation |
| Clinician override | Not yet entered |
| Export | Case summary, CSV/JSON and governance log simulated |
Structured pharmacovigilance note
URGENT MEDICATION-ASSOCIATED FALLS VULNERABILITY SIGNAL
Patient EH-0427 has a probable medication-associated falls vulnerability signal. Current 24h falls probability is 31% and 48h probability is 43%, increased from a personalised baseline of 12%.
Primary active mechanisms: sedative load after recent zopiclone dose increase, anticholinergic burden from oxybutynin, possible hypotension/orthostasis linked to ramipril timing, and additional dizziness/sedation burden from tramadol use.
Recommended clinician workflow: same-day medication review, postural BP assessment, hydration/infection screen, night-time transfer precautions, and outcome capture over the next 48 hours.
Patient-facing message released: caution and contact guidance only. No medication change instruction issued.
Patient-facing information companion preview
This is the controlled patient view. It informs and escalates; it does not diagnose, assign causality or advise medication change.
Falls safety companion
Extra caution today
Your care team has detected a change that may increase your chance of feeling unsteady.
What to do now
Stand slowly, use your walking aid, keep your call bell or phone nearby, and ask for help if you feel dizzy, weak, drowsy or confused.
Medicines
Do not stop, start, skip or change any medicine unless your doctor, nurse or pharmacist tells you to.
Care team status
Your care team has been notified and may review your observations and medicines.
Symptom check
Report dizziness, faintness, unusual sleepiness, confusion, new weakness, or a near fall.
Aggregate pharmacovigilance intelligence
For quality improvement, real-world evidence and safety review. Values below are simulated cohort summaries.
| Signal cluster | Cases this month | Conversion to fall/near-fall | Priority |
|---|---|---|---|
| Sedative + opioid overlap | 18 | 22% | High |
| Anticholinergic burden + nocturnal urgency | 13 | 15% | Review |
| Antihypertensive timing + MAP dip | 21 | 11% | Review |
| Hypoglycaemia-risk therapy + frailty | 6 | 17% | Review |
Recursive development gates
| G1 Detects pre-event vulnerability signal | Pass in simulation |
| G2 Separates clinician and patient permissions | Pass |
| G3 Creates auditable case record | Pass |
| G4 Preserves pharmacovigilance/reporting boundary | Pass |
| G5 Requires validation against clinical outcomes | Pending real-world study |