adverse-event-reporting-guidelines

name	adverse-event-reporting-guidelines
description	Regulatory guidelines for adverse event and technical complaint reporting in pharmaceutical patient support calls, used to verify proper AE/TC handling procedures

Adverse Event & Technical Complaint Reporting Guidelines

Overview

These guidelines define the regulatory requirements for identifying, documenting, and reporting adverse events (AEs) and technical complaints (TCs) during patient support calls. Use them to verify that the call agent followed proper reporting procedures.

When to Use

Use these guidelines when evaluating whether an agent correctly handled adverse events or technical complaints reported during a call.

Adverse Event Identification

What Qualifies as an Adverse Event

Any undesirable medical occurrence in a patient administered a pharmaceutical product, whether or not considered related to the product:

• New symptoms or worsening of existing symptoms
• Hospitalizations or ER visits
• Disability or incapacity
• Life-threatening events
• Medication errors with clinical consequences

Required Information to Collect

For every identified AE, the agent must gather:

1. Reporter information: Patient name, contact details
2. Patient information: Age/DOB, gender, relevant medical history
3. Product information: Drug name, dose, route, indication
4. Event description: Symptoms, onset date, severity, duration, outcome
5. Concomitant medications: All other medications the patient is taking
6. Causality assessment: Temporal relationship to the product
7. Action taken: Changes to therapy, medical intervention sought

Severity Classification

Level	Definition	Example
Mild	Awareness of symptom, easily tolerated	Mild nausea, transient headache
Moderate	Discomfort causing interference with daily activity	Persistent headaches, dizziness affecting mobility
Severe	Incapacitating, inability to perform daily activities	Hospitalization, significant disability
Serious	Life-threatening, requires intervention to prevent permanent damage	Anaphylaxis, organ failure

Technical Complaint Identification

What Qualifies as a Technical Complaint

Any report concerning the quality, performance, or safety of a pharmaceutical product's physical attributes:

• Packaging defects (broken seal, damaged container)
• Labeling errors (wrong info, missing info, illegible text)
• Product appearance changes (color, odor, consistency)
• Device malfunction (injector failure, dosing mechanism issues)
• Delivery or storage concerns (temperature excursion, delayed shipment)
• Billing or system errors affecting product access

Agent Compliance Requirements

During the Call

1. Recognize AE/TC triggers — listen for symptom language, product quality concerns
2. Do NOT dismiss — every patient-reported concern must be documented
3. Do NOT diagnose — agents must never provide medical opinions or diagnoses
4. Do NOT advise stopping medication — only a physician can modify treatment
5. Document verbatim — record the patient's exact words when describing events
6. Recommend physician contact — always advise the patient to follow up with their doctor
7. Explain the process — inform the patient that a report will be filed and why

After the Call

1. Complete the AE/TC report form within 24 hours
2. Escalate serious AEs to the pharmacovigilance team immediately
3. Flag any events requiring expedited regulatory reporting (serious, unexpected)
4. Document all follow-up actions and timelines

Evaluation Criteria

When reviewing a call for AE/TC compliance:

• Did the agent identify all reportable events? (no missed AEs/TCs)
• Was required information collected? (minimum: reporter, patient, product, event)
• Was the patient informed appropriately? (no medical advice, physician referral given)
• Was verbatim documentation captured? (patient's own words recorded)
• Were proper escalation steps followed? (severity-appropriate handling)