Imagine you have been invited for an interview. You have about 15 minutes before you meet the panel so you decide to attend to your pounding headache. You grab some painkillers and wait for the headache to subside. Just as the pretty office admin comes to usher you into your interview suddenly your stomach rumbles and your intestines feel like they would explode.
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. 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. This will be your first time to travel outside the country. 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 drenched in sweat. The injection site is still swollen and painful to the touch.
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 the 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. Therefore, to achieve safe treatment options, everyone must play their part.
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 taking, 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 or distributes that medication in the country and the health authority. In Kenya, the agency governing medicines is the Pharmacy and Poisons Board.
While 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 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.
Well, it’s vital for you to share any adverse events encountered. 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 seven 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.
Please engage your doctor, nurse or pharmacist whenever you encounter any untoward event after treatment.
Founder and MD, PVCC Consulting