Imagine a situation where you were invited for an interview, you are in the waiting area and you have about 15mins to compose yourself. Only then do you notice you now have time to attend to your pounding headache. You grab some painkillers from your bag and wait for the headache to subside. Just then the pretty office admin comes your way with a gracious smile ushering you into your interview. Suddenly you hear your stomach rumbling and it appears your intestines are trying to avert some explosions. And in a split second you only manage a weak hi and you walk out. Run. To save yourself.
How about this; do you know someone who has had a never-ending cough? Not productive. Just an irritating dry cough. Day in, day out. This cough is not contagious. The person does not have a cold, a chest infection and neither are they smokers. But the cough is persistent, year in year out. And it comes in the most notorious of ways. Imagine this person walking to the podium to give a key note speech and shortly after the opening remarks, they serenade the audience with a bout of dry irritating cough that appears to suck the living daylights out of them.
What an embarrassment!
When you observe closely, this person has actually been on some long-term anti-hypertensive medication. Is there a connection between this medication and the cough?
And lastly, your soon to be spouse informs you that they have planned a surprise destination for your honeymoon!
All you know is you will be flying to your destination! A first time for you to travel outside the country!
That in itself is a dream come true! Right there you know it’s going to be an amazing trip. One of your travel preparations is you have to get some vaccinations.
But a week after you get your jabs, you are so lethargic, you haven’t left your bed. You seem to have a fever and you are drenching in sweat. The injection site is still swollen and painful to touch! Ooh my!
These three are examples of what we call, Adverse events or adverse drug reaction (ADR).
- An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- An adverse drug reaction (ADR) is an injury caused by taking a medication.
Everyone of us has a right to healthcare. Quality, affordable and safe treatment options have become the goal for your healthcare provider, your in-country Health Authority and world health leaders.
And therefore, to achieve safe treatment options, everyone must play their part.
You see, when you experience any of the three mentioned events, your goal as a patient is to inform your doctor, nurse or Pharmacist immediately. We encourage you to disclose all the medication one is undertaking. Whether long term or short term. Your healthcare provider will immediately work on alleviating the injurious event.
The Healthcare professional attending to your case must also submit this report to both the Pharmaceutical company that manufactures/distributes that medication in the country and the Health Authority. In Kenya the body governing medicines is the Pharmacy & Poisons Board.
While the Pharmaceutical companies play an integral role in providing healthcare solutions, they do have a regulatory mandate to be responsible and accountable for the risks and the benefits associated with the medicines they manufacture.
The Health Authority on the other hand has a mandate to its citizenry in ensuring health technologies provided in any given country are of quality, safe and are efficacious.
“But why do I need to report this adverse event and yet it’s a known ‘side effect’?” “As a matter of fact, the issue ‘died off’ after a while and I didn’t even need to go see a doctor?” You might ask.
Let me give an in-depth illustration into why it’s vital for you to share any Adverse Events encountered; you see before any medicinal product is approved and registered for either human or animal consumption, the drug substance must have gone through a clinical trial where between 1,000 to 3,000 subjects were exposed to this product to understand its benefit and risks. When you consider these figures in relation to the human race (composed of about 7 billion people); <3,000 is too small a number to vividly represent every patient’s needs and outcomes.
When growing up; our parents or loved ones cherished us by constantly reminding us how special and unique we are. Medically speaking, I can confirm that you are indeed special and unique. No one has the exact copy of your DNA and this explains why we get varying reactions to any given drug.
Here is a simplified chronology of steps taken after your AE is collected;
You, the patient
Engage your doctor, nurse or Pharmacist by reporting any Adverse Event you come across from the treatment given.
The Pharma company
The Pharma company will receive your AE report and will give an account to the Health Authorities why that risk occurred to you and provide procedures of how the risk should be minimized.
The Health Authority
This report is then reviewed thoroughly by the Health Authority and the necessary regulations and treatment guidelines are established.
World Health leaders
Your Health Authority shares the insights from the report containing your adverse event data with world health leaders.
From this engagement a pool of similar incidents is noted and ways to minimize risks to a certain class of patients is shared amongst the Health Authorities across the world.
The Healthcare professional
This new information is then relayed to your doctor, nurse or Pharmacist and they gain new knowledge on how to give you the best care the next time you visit them.
Please engage your doctor, nurse or Pharmacist whenever you encounter any untoward event after treatment.
Article authored by Dr Wangui Mathenge, a Pharmacovigilance consultant at