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Ibogaine safety and risk management

Operational Tools

Ibogaine Safety and Risk Management

Educational material; not a treatment relationship.

Print a blank template and complete it offline. This website does not collect participant information.

These tools are for information quality, handoff, and accountability. Their job is to organize the case for clinical review. Numeric risk scores, dosing recommendations, and automated green light decisions would require future validation and separate regulatory review.

Participant Rights and Grievance Checklist

Participant Rights and Grievance Checklist

Responsibility: Program / system · Facilitator
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Provider identity and role

rights

refusal

alternatives

interpreter needs

records

complaint route

independent escalation contact.

Provider Disclosure Sheet

Provider Disclosure Sheet

Responsibility: Program / system · Facilitator
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Credentials

licensure/scope

ibogaine experience

medical responsibility

ownership/referral relationships

conflicts

emergency partners.

Deferral and Referral Summary

Deferral and Referral Summary

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Reason for deferral

urgent concerns

what can be corrected

specialty referral

alternative treatment

reassessment conditions.

Arrival / Secondary Verification Checklist

Arrival / Secondary Verification Checklist

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Current ECG or labs when indicated

medication changes

last substance exposure

withdrawal

illness

emergency contact

travel and discharge plan.

Early Departure / Informed Refusal Record

Early Departure / Informed Refusal Record

Responsibility: Program / system · Facilitator
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Capacity

unresolved risks

alternatives offered

participant decision

transport

emergency instructions

follow-up.

Destination / Home Environment Readiness

Destination / Home Environment Readiness

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Housing

support person

mobility barriers

substance access

transportation

medications

emergency access

caregiving responsibilities.

Self-Harm and Crisis Safety Plan

Self-Harm and Crisis Safety Plan

Responsibility: Facilitator · Clinical team
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Known triggers

warning signs

participant-selected supports

access to means

emergency contacts

escalation plan.

Relapse Prevention Plan

Relapse Prevention Plan

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

High-risk situations

early warning signs

first response

naloxone/MOUD where relevant

support contacts

response after a lapse.

Onsite Observation Sheet

Onsite Observation Sheet

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Core fieldObservation / timeObservation / timeObservation / time
Time-linked vitals and rhythm summary
intake/output
mobility
emesis
mental status
medications
unresolved concerns.
Shift Handoff Tool

Shift Handoff Tool

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Clinical continuity

Rhythm and ECG trajectory

Vital signs and observation times

Current symptoms and changes

Medication changes

Vomiting and nausea triggers

Hydration, intake, and output where relevant

Mobility and assistance needed

Sleep

Unresolved medical concerns

Relational continuity

Preferred communication

Sensory preferences

Touch boundaries

Changes in trust, fear, or mistrust

What currently helps

What currently agitates

Participant understanding

Unresolved experiential concerns

Decisions and transfer of responsibility

Pending decisions and next actions

Responsible person and next review

Outgoing staff, incoming staff, and handoff time

Incident / Grievance Report

Incident / Grievance Report

Responsibility: Program / system · Facilitator
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Participant complaint or safety event

people involved

immediate response

escalation

retaliation protection

resolution and quality review.

Family / Trusted Support Handout

Family / Trusted Support Handout

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Expected recovery

warning signs

reduced opioid tolerance

medication plan

how to help without controlling the participant

emergency contacts.

Discharge Packet Checklist

Discharge Packet Checklist

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Medical summary

medication plan

warning signs

follow-up

records

addiction care

crisis contacts

support plan

next appointments.

Ibogaine Pre Treatment Review

Ibogaine Pre Treatment Review

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Identity

indication

treatment goals

medical and psychiatric history

substance timeline

withdrawal risk

prior ibogaine exposure

consultations

unresolved concerns

authorization decision and rationale.

Medication and Interaction Review

Medication and Interaction Review

Responsibility: Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Agent

dose

indication

last dose

QT liability

rate or conduction effect

CYP2D6 relevance

other metabolic pathway

sedative or serotonergic concern

withdrawal risk if held

responsible prescriber

plan

source.

Cardiovascular Risk Review

Cardiovascular Risk Review

Responsibility: Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

History

family history

syncope

structural disease

baseline rate and rhythm

PR

QRS

QT

QTc

correction method

morphology

ectopy

prior ECG comparison

electrolytes

QT active medications

cardiology interpretation.

Baseline Treatment Record

Baseline Treatment Record

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Time

vital signs

ECG review

relevant labs

withdrawal state

hydration

mental status

mobility

weight

recent medications

last substance use

symptoms

product verification

clinician proceed decision.

Acute Monitoring Record

Acute Monitoring Record

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Time stamped rhythm

rate

blood pressure

symptoms

consciousness

orientation

ataxia

vomiting

oxygenation when indicated

withdrawal

interventions

clinician notifications

repeat ECG and labs.

ECG Change Tracking Sheet

ECG Change Tracking Sheet

Responsibility: Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Time

heart rate

rhythm

QT

QTc

formula

PR

QRS

morphology

ectopy

pauses

symptoms

electrolytes

medications

action

reviewer.

Emergency Transfer Summary

Emergency Transfer Summary

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Product

source

amount

administration times

coadministered drugs

last substances

ECG findings and trend

labs

vitals

event chronology

interventions

response

allergies

medical history

medication list

contact

receiving facility.

Discharge Readiness Review

Discharge Readiness Review

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Cardiac reassessment

physiological stability

mental status

mobility

oral intake

medication plan

withdrawal and MOUD plan

warning symptoms

transport

supervision

referrals

follow up

understanding.

Adverse Event Report

Adverse Event Report

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Event description

onset

severity

objective findings

treatment

outcome

causality assessment

expectedness

product and dose

coexposures

reporting requirements

follow up.

Near Miss Review

Near Miss Review

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Hazard

how detected

potential consequence

failed barrier

successful barrier

contributing system factors

corrective action

owner

completion date

audit date.

Post Treatment Follow Up

Post Treatment Follow Up

Responsibility: Facilitator · Clinical team
Applies in: Medically supervised administration · Research setting
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

Substance use

craving

withdrawal

overdose

MOUD

mood

sleep

psychosis or mania symptoms

suicidality

function

pain

medical follow up

referrals

integration needs.

Facility Readiness Audit

Facility Readiness Audit

Responsibility: Facilitator · Program / system
Applies in: Multiple settings
Guidance, scope, and evidence

Complete offline · Date: ____________________ · Completed by: ____________________

ECG and monitoring capability

defibrillation

airway and oxygen

suction

emergency medications per medical protocol

IV capability where used

backup power

staffing roles

escalation authority

EMS access

receiving facility

records

rehearsal date.