Pharmacovigilance 101: Reporting Adverse Drug Reactions in Kenya

Ensuring medicine safety matters for every patient and provider in Kenya. This article walks you through the fundamentals of pharmacovigilance and shows how you can report adverse drug reactions (ADRs) effectively under the Kenyan system.

What Is Pharmacovigilance?

Pharmacovigilance refers to monitoring, detecting, assessing, and preventing adverse effects of medicines after they reach the market. It helps safeguard patients and improves medicine-use outcomes.

In Kenya, the Pharmacy and Poisons Board (PPB) maintains the national pharmacovigilance system.

The purpose is clear. Medicines that get regulatory approval still carry unknown risks when used in real-world settings. Pharmacovigilance fills that gap. It allows health professionals, manufacturers, and the public to report suspected ADRs and trigger safety actions.

Why Reporting Adverse Drug Reactions Matters

When ADRs go unreported, unsafe medicines might remain in use longer than they should. Conversely, reporting leads to:

• safer patient care;

• updated product information;

• withdrawal of harmful products when needed;

• improved public trust in health systems.

In Kenya, low reporting rates remain a barrier to full pharmacovigilance-effectiveness. A study noted that the number of ADR reports in Kenya was far lower than expected compared to population size.

The Kenyan Framework for ADR Reporting

The PPB issued Guidelines for the National Pharmacovigilance System in Kenya.

These guidelines define:

• What to report (suspected ADRs, poor-quality medicines)

• Who can report (healthcare providers, patients, manufacturers)

• Where and how to report (forms, online / paper systems)

• What happens to reports (analysis, signal-detection, regulatory action)

For example, the ADR reporting form (also known as the “Yellow Form”) is part of the toolkit.

Step-by-Step Guide: How to Report an ADR in Kenya

1. Recognise a Suspected ADR

Stay alert for any noxious and unintended response to a medicine, used at normal doses for prophylaxis, diagnosis, or therapy.

2. Gather Key Information

Collect essential data such as:

• patient details (age, gender, health status)

• medicine details (name, dose, batch, start date)

• description of reaction (onset, outcome)

• reporter’s details and contact

3. Complete the ADR Reporting Form

Use the PPB-approved form (paper or online). Ensure all mandatory fields are filled.

4. Submit the Report to the National Pharmacovigilance Centre

Send your completed form to the centre, which operates under PPB. Use email, online portal, or postal address as directed.

5. Follow Up & Retain Copies

Keep a copy of the report. Monitor the patient and if the reaction evolves, you may submit a follow-up.

6. Understand What Happens Next

The centre will process your report, evaluate the signal, and may recommend regulatory action such as label change, withdrawal, or communications.

Common Barriers in ADR Reporting and How to Overcome Them

1. Low Awareness and Training

Many healthcare providers feel uncertain or unaware about reporting procedures.

Solution: Provide continuous training, integrate ADR-reporting in routine practice, and promote a culture of medication safety.

2. Infrastructure Limitations

A study in Kenya found key issues: unreliable internet access, hybrid paper-electronic systems, usability challenges.

Solution: Use offline reporting when connectivity is poor; strengthen paper systems as backup; ensure mobile-friendly tools.

3. Minimal Feedback to Reporters

When reporters do not get feedback, motivation declines.

Solution: Establish feedback loops and show how reports lead to action to encourage ongoing participation.

Practical Tips for Healthcare Providers and Patients

• Report as soon as you suspect an ADR.

• Don’t wait for certainty: suspected ADRs still matter.

• Capture complete information; missing data delays action.

• If you are a patient experiencing a reaction, ask the provider to submit a report or do so yourself using PPB channels.

• Retain medication packaging, batch numbers, and reaction details – they help signal-detection.

• Encourage your institution to include ADR-reporting in routine workflows.

 

How Clarity Pharma Consultancy Can Help

If you’re a healthcare provider, institution, or pharmaceutical stakeholder seeking guidance on pharmacovigilance compliance, Clarity Pharma Consultancy offers expert support.

We help you build robust ADR-reporting systems, train staff, implement quality-management protocols, and navigate regulatory requirements under the PPB’s national pharmacovigilance framework. Let’s ensure your medicine-safety practices are up to standard.

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