M6 — Adverse Reaction Loop

1. 📌 Overview & Purpose

Goal: Adverse drug reactions (ADR) selalu missed sebab pesakit lupa nak email doktor atau jumpa balik. M6 buka channel "ngadu balik kat AI yang sama" → cross-ref RX 14 hari recent → broadcast alert ke seluruh eco → mencegah ulangan + register permanent allergy.

Lifecycle continuity feature: Demonstrates eco-system value beyond single encounter. Shows that ALESA isn't just transactional but stewards patient safety across time.

Compliance: NPRA pharmacovigilance reporting (mandatory) · MOH adverse event registry contribution.

2. 👤 User Stories

3. ✅ Functional Requirements

4. ⚙️ Non-Functional Requirements

5. 🗄️ Data Model

6. 🔌 API + MCP

POST   /api/v1/adr/report                      # patient via M1
       Body: { session_id, symptoms, suspected_drug?, severity_self }
       Returns: { adr_id, severity_classified, broadcast_pending, escalation }

GET    /api/v1/adr/{adr_id}                    # detail
POST   /api/v1/adr/{adr_id}/safety-check       # 4-question gate
       Body: { lip_swelling, breathing, dizziness, rash }

POST   /api/v1/adr/{adr_id}/escalate-999       # anaphylaxis path
POST   /api/v1/adr/{adr_id}/broadcast          # internal · trigger 4-channel notify

GET    /api/v1/adr/{adr_id}/npra-form          # structured form fill
POST   /api/v1/adr/{adr_id}/npra-submit        # doctor verify + submit

GET    /api/v1/adr/blocks/{patient_id}         # current blocks
POST   /api/v1/adr/blocks/override             # doctor override (with reason)

GET    /api/v1/adr/dashboard                   # aggregate analytics

# MCP Tools
adr_severity_classify     WHO scale + naranjo
allergy_class_lookup      Cross-react matrix
broadcast_orchestrator    Parallel 4-channel send
npra_form_compose         Structured ADR form
prescribe_block_check     Pre-RX check (M5 calls this)

7. 🔁 State Machine

┌──────────────────┐
│ PATIENT_REPORT   │ from M1 intake
└────────┬─────────┘
         ▼
┌──────────────────┐
│ SAFETY_CHECK     │ 4 questions
└────────┬─────────┘
         ▼
   ┌─────┴─────┬─────────┬───────────┐
   ▼           ▼         ▼           ▼
ANAPHYLAXIS  SEVERE    MODERATE    MILD
   │           │         │           │
   ▼           ▼         ▼           ▼
ESCALATE     ESCALATE  STOP_DRUG   MONITOR
999/ED       OPD       +ANTIHIST   24-48h
   │           │         │           │
   └─────┬─────┴─────────┴───────────┘
         ▼
┌──────────────────┐
│ CROSS_REF_RX     │ last 14-30 days
└────────┬─────────┘
         ▼
┌──────────────────┐
│ BROADCAST_4CH    │ doctor · pharmacy · admin · registry
└────────┬─────────┘
         ▼
┌──────────────────┐
│ AUTO_BLOCK       │ same drug class
└────────┬─────────┘
         ▼
┌──────────────────┐
│ NPRA_PREP        │ if severity ≥ moderate
└────────┬─────────┘
         ▼ (doctor verify)
┌──────────────────┐
│ NPRA_SUBMIT      │ regulator notify
└────────┬─────────┘
         ▼
┌──────────────────┐
│ FOLLOW_UP_BOOK   │ M7 trigger
└────────┬─────────┘
         ▼ (resolved / refractory)
┌──────────────────┐
│ CLOSED           │ permanent registry update
└──────────────────┘

8. 🤖 Agent Specification

M6 mostly orchestration + decision tree. LLM untuk: (a) severity classification natural language, (b) NPRA form auto-fill, (c) patient-friendly explanation BM/EN.

• Model: Llama 8B (decision tree heavy) untuk classify · Llama 70B untuk NPRA form (clinical quality)
• Memory: patient RX history (M5 source) · cross-class matrix · Naranjo questionnaire
• Guardrails: Anaphylaxis = NEVER auto-resolve · always 999 path · Naranjo doctor verify · NPRA submit doctor sign-off mandatory

9. 🎨 UI/UX

• Patient PWA: ADR intake flow continued from M1 · 4-question safety modal · severity result card · 999 emergency banner if anaphylaxis
• Doctor Filament: ADR alerts inbox · pesakit yg pernah preskripsi · severity badge · Naranjo verify form · NPRA submit button
• Pharmacy Filament: Active blocks list per patient · override request inbox
• Admin Filament: Aggregate dashboard (per-drug ADR rate · trend)
• Registry visibility: Allergy alert visible di every M4 encounter detail · M5 dispense check · M2 briefing

10. ✔️ Acceptance Criteria

• AC-6.1: Anaphylaxis detection + 999 escalation <5s pada 10 simulated cases · 100% catch
• AC-6.2: 4-channel broadcast arrives all recipients <30s
• AC-6.3: Auto-block effective on M5 within 5 min of ADR report
• AC-6.4: Cross-class matrix coverage 95% (penicillins · sulfa · NSAIDs · opioids · etc)
• AC-6.5: NPRA form auto-fill accuracy ≥90% on 20 sample · doctor edit ≤3 fields
• AC-6.6: Permanent allergy registry visible in all 3 PA contexts (M2/M4/M5)
• AC-6.7: Override workflow audited · clinical justification mandatory
• AC-6.8: Doc Zam clinical review 20 ADR scenarios → ≥18 acceptable
• AC-6.9: No double-counting (same ADR reported via different channels merge)

11. 🧪 Test Plan

12. 🔗 Dependencies

• Hard: M1 PSPA (intake channel) · M5 PHPA (RX history · auto-block consumer) · M9 (audit + cross-tenant consent)
• Soft: M4 DRPA (doctor inbox alert) · M7 ADPA (follow-up booking) · M8 XCCN (cross-clinic propagation)
• External: NPRA pharmacovigilance reporting interface (form spec · submission API)

13. 🏃 Sprint Allocation

14. ⚠️ Module-Specific Risks