The Journey of an Adverse Drug Reaction (ADR) Report: From Clinic to Global Database

Introduction

Effective pharmacovigilance is a cornerstone of public health, ensuring the ongoing safety of medicinal products after they enter the market. The fundamental unit of this system is the Adverse Drug Reaction (ADR) report. This briefing outlines the structured journey of an ADR report, from initial clinical observation to its role in global safety monitoring, and highlights the critical importance of each step in the process.

1. What is an Adverse Drug Reaction (ADR) Report?

An Adverse Drug Reaction (ADR) report is the formal documentation of a noxious, unintended response to a medicinal product. It serves as the primary data source for pharmacovigilance, capturing essential details about the patient, the suspected product, the nature of the reaction, and its outcome. Each report is a crucial component of the early-warning system for identifying potential risks associated with medicines.

2. The Standard Pathway of an ADR Report

The journey of an ADR from initial observation to regulatory action follows a systematic process:

1. Detection: A healthcare professional (HCP) or patient observes a suspected ADR.
2. Reporting (ICSR Generation): An Individual Case Safety Report (ICSR) is created and submitted to the national pharmacovigilance centre (e.g., NAFDAC in Nigeria) via designated channels.
3. Triage and Data Verification: The national centre assesses the report for completeness and seriousness, and may conduct follow-ups to obtain additional information.
4. Coding and Standardization: The report's clinical information is coded using standardized terminologies (e.g., MedDRA) and formatted according to international standards (ICH E2B).
5. National Signal Detection: The national centre aggregates ICSRs in its database to identify statistically significant patterns or new potential risks.
6. MAH Assessment: The Marketing Authorization Holder (MAH) of the suspected product also receives and assesses the report, incorporating it into periodic aggregate safety reports (e.g., PSURs).
7. Global Data Sharing: Significant reports are shared with international databases, such as the WHO's VigiBase, to contribute to global signal detection.
8. Regulatory Action: If a risk is confirmed, authorities and MAHs may take action, including label updates, risk minimization measures, or product recalls.
9. Post-Action Monitoring: The effectiveness of any intervention is monitored through ongoing surveillance.

3. The Critical Role of Data Quality and Regulatory Standards

The utility of the entire pharmacovigilance process depends on high-quality data and standardized systems.

• Data Quality: Incomplete or inaccurate reports, particularly those missing product batch numbers or clear timelines, can impede timely signal detection and risk assessment.
• Technical Framework: The integrity of the process relies on:
  • MedDRA: A globally standardized terminology that ensures consistency in the classification of adverse events.
  • ICH E2B: The international standard for the electronic transmission of ICSRs, ensuring interoperability.
  • VigiBase: The WHO's global ICSR database, facilitating the analysis of safety data from over 170 countries.

4. Case Study: The 2022 Gambian AKI Outbreak

In mid-2022, clinicians in The Gambia observed a sharp increase in acute kidney injury (AKI) among young children. The consistent reporting of a potential association with specific cough and cold syrups triggered a national investigation. These initial Adverse Drug Reaction (ADR) reports from frontline healthcare professionals were the first critical step.

Subsequent collaboration between Gambian health authorities, the World Health Organization (WHO), and international laboratories confirmed that the syrups were contaminated with diethylene glycol (DEG) and ethylene glycol (EG). The finding led to a WHO global medical product alert, an international product recall, and a reinforced focus on medicine quality surveillance.

This event illustrates the fundamental principle of pharmacovigilance: a single, well-documented clinical suspicion, when reported correctly, can initiate a cascade of events that protects public health on a global scale.

5. Common Challenges in the Reporting Chain

Despite the established process, several challenges can compromise its effectiveness:

• Under-reporting: A persistent issue driven by time constraints, lack of awareness, or uncertainty about causality.
• Poor Data Quality: Incomplete fields or vague narratives diminish a report's analytical value.
• System Fragmentation: Lack of interoperability between clinical and regulatory databases can create data silos and delays.
• Resource Limitations: Connectivity and infrastructure limits can hinder reporting in some settings.

6. Frequently Asked Questions (FAQ)

Q1: What constitutes a high-quality ADR report?

A: A report that is complete, accurate, and clear. Key elements are listed in the checklist below.

Q2: Who is responsible for reporting ADRs?

A: All stakeholders. HCPs provide clinical context; patients offer firsthand experience; MAHs are mandated to report ADRs they receive; and clinical trial investigators report SUSARs.

Q3: How are timelines and urgency handled?

A: Not all reports follow the same timeline. Serious and unexpected reactions require expedited reporting to regulators, typically within 7-15 calendar days, to ensure rapid signal detection. Non-serious events are often reported in periodic summaries.

Q4: Can a single ADR report lead to regulatory action?

A: While action is typically based on aggregated data, a single, well-documented report of a serious and unexpected event can trigger an immediate investigation.

7. Checklist for Submitting an Actionable ADR Report

To improve the quality of submissions, clinicians should ensure the following are included:

• Patient Details: Demographics and relevant medical history.
• Product Information: Exact product name, manufacturer, and batch/lot number.
• Chronology: Precise dates of drug initiation and reaction onset.
• Reaction Description: Clear details of signs, symptoms, tests, and interventions.
• Concomitant Medications: A list of all other medications being taken.
• Reporter Contact Information: To allow for necessary follow-up.

8. How IntraHub Africa Strengthens Pharmacovigilance Systems

IntraHub Africa provides expertise and solutions at every stage of the pharmacovigilance process. We assist MAHs, CROs, healthcare organizations with:

Implementing E2B-compatible reporting systems and MedDRA coding.

Training clinical staff and Qualified Persons for Pharmacovigilance (QPPVs).

Signal detection, case triage, and regulatory documents.

Integrating mobile and web reporting solutions for patients and clinicians.

To strengthen your organization's pharmacovigilance capabilities and ensure regulatory compliance, contact IntraHub Africa for tailored solutions in system setup, and training.

References

Centers for Disease Control and Prevention (CDC). (2023). Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications—The Gambia, June–September 2022. MMWR Morbidity and Mortality Weekly Report, 72(9), 231–234. https://www.cdc.gov/mmwr/volumes/72/wr/mm7209a1.htm

World Health Organization (WHO). (2022). Medical Product Alert N°6/2022: Contaminated cough syrups (The Gambia). https://www.who.int/news/item/05-10-2022-medical-product-alert-n°6-2022

Jallow, M., et al. (2023). Cough syrups: silent killer of Gambian children. International Journal of Surgery, 109(4), 1–2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10389612

WHO investigates cough syrups after deaths of 66 children in Gambia. (2022). The BMJ, 379, o2423. https://www.bmj.com/content/379/bmj.o2423

Kidney International Editorial. (2023). Endemic rise in cases of acute kidney injury in children in Indonesia and Gambia: what is the likely culprit and why? Kidney International, 104(2), 217–220.

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