If Someone You Know is Experiencing a Reaction to Medicine, Read This

Pharmacovigilance – a term so commonly recognized among healthcare providers that most understand ‘pharmacovigilance’ at a surface level, without exploring its full scope beyond just knowing it as pharmacovigilance.

Many are familiar with pharmacovigilance as it pertains to reporting adverse drug reactions (ADRs) and ensuring medication safety.

However, the depth of pharmacovigilance, its regulatory aspects, and its role in post-marketing drug safety can sometimes be overlooked.

According to the pharmacy and poisons board (PPB), many reportable cases, particularly in community pharmacies, remain unreported. This gap highlights a critical need for increased vigilance and reporting practices to enhance patient safety and monitor potential adverse effects effectively.

In these notes, we will highlight some of the most important aspects of pharmacovigilance. To help you get started, we’ll cover the following key topics:

1. What is pharmacovigilance?
2. Why is pharmacovigilance important?
3. Who can report and how (in Kenya)
4. What can you report as a pharmacovigilance helper?
5. What are the pharmacovigilance reporting tools?
6. What does the PPB do with pharmacovigilance data?

What is pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO 2024).

Why is pharmacovigilance important?

Pharmacovigilance is essential for patient safety, yet several barriers can hinder effective reporting.

These include fear of consequences, time constraints, lack of training, a blame culture among healthcare workers, and the need for organizational support and leadership.

However, these challenges should not discourage reporting, as the benefits of pharmacovigilance far outweigh the obstacles.

Here is why pharmcovigilance is important;

• Greater understanding of medicine induced disorders
• Early signals and warning for potentially severe adverse drug reactions
• Greater awareness of agents that commonly cause medicine induced disorders
• Better patient care
• Prevention of medical product related morbidity and mortality
• Minimize immunization errors
• Huge saving in healthcare cost
• Better patient confidence and trust
• Rational drug use

Who can report and how in Kenya

Anyone can report adverse drug reactions (ADRs) and other safety concerns related to medications, including:

1. Healthcare Providers – consultants, physicians, pharmacists, pharmaceutical technologists, clinicians, nurses, dentists and lab personnel.
2. Patients and Caregivers.
3. Pharmaceutical Companies.

Reporting can be done through this ways;

Using this link: PvERS: the Pharmacovigilance Electronic Reporting System

Dial:  *271# on your mobile phone

What can you report as a pharmacovigilance helper?

1. Adverse events
2. Side effects
3. Adverse drug reactions
4. Medication errors
5. Adverse events following immunization
6. Blood transfusion reaction
7. Incidences following use of medical devices

Pharmacovigilance reporting tools

When you log into the PBB’s PvERS portal, you’ll find color-coded forms designed for different types of reporting, each serving a specific purpose:

There are more in-depth guidelines on what to fill in the forms on the PvERS portal.

Below are the reporting tools found in the pharmacy and poisons board portal;

1. Adverse Events Following Immunization (AEFI) form – White
2. Adverse Drug Reaction (ADR) form – Yellow
3. Quality defects/poor quality form – Pink
4. Medical devices incidence form – Green
5. Blood transfusion reaction form – Cream/Off white
6. Medical error form – Blue
7. Patient alert card

What does the PPB do with pharmacovigilance data?

The PPB has a comprehensive pharmacovigilance system that includes various organizations, institutions, and resources dedicated to ensuring medication safety.

This system supports the timely collection, assessment, and communication of risks and benefits associated with medicines, providing essential information to aid decision-making across all levels of healthcare.

Let’s dig into the latest pharmacovigilance summary report of April 1st to June 30st 2024 (Q4) to better explain why the data is so important.

From the report we can easily get the following statistics;

1. Number of Suspected Adverse Drug Reactions (SADRs)
2. Suspected medicines
3. Commonly Reported Suspected Adverse Reactions
4. Adverse Events Following Immunization (AEFI) (vaccines mentioned)
5. Medication Error Outcome
6. Drugs with Medication Errors

The above information is very essential for any healthcare provider in enhancing public health and patient safety.

Here are screenshots if you prefer not to open the PDF file above.

1. Screenshot showing Number of Suspected Adverse Drug Reactions (SADRs)

2. Screenshot showing Commonly Reported Suspected Adverse Reactions

3. Screenshot showing Drugs with Medication Errors

Final Thoughts

Pharmcovigilance reporting can be best achieved if most healthcare providers participate in reporting.

Why are you not reporting?